市場調査レポート

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医療機器開発業務受託機関（CRO）の世界市場：対象治療領域・運営規模・デバイスクラス・提供される臨床サービスのタイプ・提供される前臨床サービスのタイプ、主要地域別、業界動向と予測（2022年～2035年

Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, Key Geographies: Industry Trends & Global Forecasts, 2022-2035

出版日: 2023年07月01日 | 発行: Roots Analysis

| ページ情報: 英文 552 Pages | 納期: 即日から翌営業日

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全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

当レポートでは、世界の医療機器開発業務受託機関（CRO）市場について調査分析し、市場情勢、セグメント分析、地域分析、企業プロファイルなどを提供しています。

章の概要
範囲と調査手法
ブランドポジショニングマトリックス：Labcorp
ブランドポジショニングマトリックス：IQVIA
ブランドポジショニングマトリックス：Syneos Health
ブランドポジショニングマトリックス：PPD
ブランドポジショニングマトリックス：ICON
ブランドポジショニングマトリックス：Charles River Laboratories
ブランドポジショニングマトリックス：WuXi AppTec
ブランドポジショニングマトリックス：Medpace

第10章臨床試験分析

章の概要
範囲と調査手法
医療機器：臨床試験分析
医療機器：登録患者人口別の分析

第11章合併と買収

章の概要
合併と買収のモデル
医療機器CRO：合併と買収

第12章医療機器開発業務受託機関（CRO）における総保有コスト

章の概要
前提条件と調査手法
医療機器開発業務受託機関（CRO）の経費
医療機器開発業務受託機関（CRO）の総保有コスト（2022年～2042年）
医療機器開発業務受託機関（CRO）の総保有コスト：CAPEX・OPEXコスト別の分析（2022年・2042年）
おわりに

第13章調査の考察

章の概要
回答者の指定
提供されるサービスのタイプ
対象治療領域
平均年間プロジェクト数
市場機会

第14章市場規模と機会分析

章の概要
前提条件と予測手法
全体的な医療機器CRO市場（2022年～2035年）
北米の医療機器CRO市場（2022年～2035年）
欧州の医療機器CRO市場（2022年～2035年）
アジア太平洋の医療機器CRO市場（2022年～2035年）
その他の地域の医療機器CRO市場（2022年～2035年）

第15章 SWOT分析

第16章動向と機会

章の概要
接続デバイス数の予想される増加
データ分析とリアルタイムモニタリングソリューションの採用
クラウドベースコンピューティング・ストレージソリューションに対するニーズ
規制当局の承認を得るためのリアルワールドエビデンスに対する需要の高まり
おわりに

第17章インタビューの書き起こし

章の概要
HungaroTrial
ClinChoice
NAMSA
CTC North
CW Research & Management
CROMSOURCE
Metrics Research
Vyomus Consulting
A+ Science
AtoZ-CRO

第18章付録1：データの表

第19章付録2：企業・組織のリスト

図表

LIST OF TABLES

Table 3.1 Comparison of Key Factors Considered by Medical Device Developers While Selecting a CRO Partner: Harvey Ball Analysis
Table 4.1 Medical Device CROs: List of Clinical Service Providers
Table 4.2 Medical Device Clinical CROs: Information on Device Class
Table 4.3 Medical Device Clinical CROs: Information on Type of Clinical Operation Service Offered
Table 4.4 Medical Device Clinical CROs: Information on Type of Regulatory Affairs- Related Service Offered
Table 4.5 Medical Device Clinical CROs: Information on Additional Service Offered
Table 4.6 Medical Device Clinical CROs: Information on Medical Device Regulatory Compliance Authorities
Table 4.7 Medical Device CROs: List of Preclinical Service Providers
Table 4.8 Medical Device Preclinical CROs: Information on Type of Preclinical Services Offered
Table 4.9 Medical Device CROs: List of Standalone Service Providers
Table 5.1 General Guidelines for Market Authorization and Reimbursement for Medical Devices
Table 5.2 Device Classification: US
Table 5.3 Device Classification: Canada
Table 5.4 Data Requirements and Characteristics of Province-wide HTA Processes in Canada
Table 5.5 Device Classification: Mexico
Table 5.6 Device Classification: Europe
Table 5.7 List of CE Directives in Europe
Table 5.8 Conformity Assessment Modules in Europe
Table 5.9 Device Classification: Australia
Table 5.10 Reimbursement and Pricing Approval Process of Medical devices in Australia
Table 5.11 Device Classification: Brazil
Table 5.12 Device Classification: China
Table 5.13 Device Classification: India
Table 5.14 Device Classification: Japan
Table 5.15 Medical Devices Reimbursement Categories
Table 5.16 Device Classification: New Zealand
Table 5.17 Device Classification: Singapore
Table 5.18 Device Classification: South Korea
Table 5.19 Device Classification: South Africa
Table 5.20 Device Classification: Thailand
Table 5.21 Medical Devices Regulatory Landscape Summary
Table 5.22 Medical Devices Reimbursement Landscape Summary
Table 6.1 Avania: Company Overview
Table 6.2 Avania: Recent Developments and Future Outlook
Table 6.3 Charles River Laboratories: Company Overview
Table 6.4 Charles River Laboratories: Recent Developments and Future Outlook
Table 6.5 CROMSOURCE: Company Overview
Table 6.6 CROMSOURCE: Recent Development and Future Outlook
Table 6.7 CSSi LifeSciences: Company Overview
Table 6.8 Eurofins Medical Device Testing: Company Overview
Table 6.9 Eurofins Medical Device Testing: Recent Development and Future Outlook
Table 6.10 IQVIA: Company Overview
Table 6.11 IQVIA: Recent Development and Future Outlook
Table 6.12 Medpace: Company Overview
Table 6.13 Medpace: Recent Development and Future Outlook
Table 6.14 NAMSA: Company Overview
Table 6.15 NAMSA: Recent Development and Future Outlook
Table 6.16 Qserve Group: Company Overview
Table 6.17 Qserve Group: Recent Development and Future Outlook
Table 6.18 WuXi AppTec: Company Overview
Table 6.19 WuXi AppTec: Recent Development and Future Outlook
Table 8.1 Competitive Benchmarking Analysis: Peer Groups Definitions and Inclusions
Table 11.1 Medical Device CRO Market: List of Mergers and Acquisitions, 2015-2022
Table 11.2 Acquisitions: Key Value Drivers
Table 13.1 Survey Insights: Overview of Respondents
Table 13.2 Survey Insights: Designation and Seniority Level of Respondents
Table 13.3 Survey Insights: Information on Type of Service Offered
Table 13.4 Survey Insights: Information on Target Therapeutic Area
Table 13.5 Survey Insights: Information on Average Number of Projects
Table 13.6 Survey Insights: Information on Market Opportunity
Table 14.1 Key Assumptions
Table 18.1 Medical Device Clinical CROs: Distribution by Year of Establishment
Table 18.2 Medical Device Clinical CROs: Distribution by Company Size
Table 18.3 Medical Device Clinical CROs: Distribution by Location of Headquarters
Table 18.4 Medical Device Clinical CROs: Distribution by Company Size and Location of Headquarters
Table 18.5 Medical Device Clinical CROs: Distribution by Area of Specialization
Table 18.6 Medical Device Clinical CROs: Distribution by Device Class
Table 18.7 Medical Device Clinical CROs: Distribution by Type of Clinical Operation Services Offered
Table 18.8 Medical Device Clinical CROs: Distribution by Distribution by Year of Establishment, Type of Clinical Services Offered, and Geography
Table 18.9 Medical Device Clinical CROs: Distribution by Type of Regulatory Affairs Related Services Offered
Table 18.10 Medical Device Clinical CROs: Distribution by Type of Additional Services Offered
Table 18.11 Medical Device Clinical CROs: Distribution by Type of Medical Device Regulatory Compliance Authorities
Table 18.12 Medical Device Preclinical CROs: Distribution by Year of Establishment
Table 18.13 Medical Device Preclinical CROs: Distribution by Company Size
Table 18.14 Medical Device Preclinical CROs: Distribution by Location of Headquarters
Table 18.15 Medical Device Preclinical CROs: Distribution by Company Size and Location of Headquarters
Table 18.16 Medical Device Preclinical CROs: Distribution by Type of Preclinical Services Offered
Table 18.17 Medical Device Preclinical CROs: Distribution by Year of Establishment, Type of Preclinical Services Offered, and Geography
Table 18.18 Medical Device Standalone CROs: Distribution by Year of Establishment
Table 18.19 Medical Device Standalone CROs: Distribution by Company Size
Table 18.20 Medical Device Standalone CROs: Distribution by Location of Headquarters
Table 18.21 Medical Device Standalone CROs: Distribution by Company Size and Location of Headquarters
Table 18.22 Competitive Benchmarking: Distribution by Region and Company Size
Table 18.23 Competitive Benchmarking: Small Players based in North America (Peer Group I)
Table 18.24 Competitive Benchmarking: Mid-sized Players based in North America (Peer Group II)
Table 18.25 Competitive Benchmarking: Large Players based in North America (Peer Group III)
Table 18.26 Competitive Benchmarking: Small Players based in Europe (Peer Group IV)
Table 18.27 Competitive Benchmarking: Mid-sized Players based in Europe (Peer Group V)
Table 18.28 Competitive Benchmarking: Large Players based in Europe (Peer Group VI)
Table 18.29 Competitive Benchmarking: Small Players based in Asia-Pacific (Peer Group VII)
Table 18.30 Competitive Benchmarking: Mid-sized Players based in Asia-Pacific (Peer Group VIII)
Table 18.31 Competitive Benchmarking: Large Players based in Asia-Pacific (Peer Group IX)
Table 18.32 Competitive Benchmarking: Small Players based in Rest of the World (Peer Group X)
Table 18.33 Competitive Benchmarking: Mid-sized Players based in Rest of the World (Peer Group XI)
Table 18.34 Brand Positioning of Key Industry Players: Unfair Advantage
Table 18.35 Brand Positioning of Key Industry Players: Reasons to Believe
Table 18.36 Brand Positioning Matrix: Labcorp
Table 18.37 Brand Positioning Matrix: IQVIA
Table 18.38 Brand Positioning Matrix: Syneos Health
Table 18.39 Brand Positioning Matrix: PPD
Table 18.40 Brand Positioning Matrix: ICON
Table 18.41 Brand Positioning Matrix: Charles River Laboratories
Table 18.42 Brand Positioning Matrix: WuXi AppTec
Table 18.43 Brand Positioning Matrix: Medpace
Table 18.44 Clinical Trial Analysis: Distribution by Trial Registration Year, 2015-2022
Table 18.45 Clinical Trial Analysis: Distribution by Trial Status
Table 18.46 Clinical Trial Analysis: Distribution by Phase of Development
Table 18.47 Clinical Trial Analysis: Distribution by Study Design
Table 18.48 Clinical Trial Analysis: Distribution by Therapeutic Area
Table 18.49 Clinical Trial Analysis: Distribution by Geography
Table 18.50 Clinical Trial Analysis: Distribution by Trial Registration Year and Geography
Table 18.51 Clinical Trial Analysis: Distribution by Trial Status and Geography
Table 18.52 Clinical Trial Analysis: Distribution by Type of Sponsor
Table 18.53 Most Active Players: Distribution by Number of clinical Trials
Table 18.54 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Registration Year
Table 18.55 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Phase of Development
Table 18.56 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
Table 18.57 Clinical Trial Analysis: Distribution of Enrolled Patient Population Trial Status and Geography
Table 18.58 Mergers and Acquisitions: Cumulative Year-Wise Trend (2015-2022)
Table 18.59 Mergers and Acquisitions: Distribution by Type of Agreement
Table 18.60 Mergers and Acquisitions: Distribution by Year and Type of Agreement
Table 18.61 Mergers and Acquisitions: Continent-wise Distribution
Table 18.62 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Table 18.63 Mergers and Acquisitions: Country-wise Distribution
Table 18.64 Mergers and Acquisitions: Ownership Change Matrix
Table 18.65 Mergers and Acquisitions: Distribution by Type of Company
Table 18.66 Mergers and Acquisitions: Distribution by Key Value Drivers
Table 18.67 Mergers and Acquisitions: Distribution by Key Value Drivers and Year of Acquisition
Table 18.68 Total Cost of Ownership: Capital Expenditures (CAPEX)
Table 18.69 Total Cost of Ownership: Operational Expenditures (OPEX)
Table 18.70 Total Cost of ownership in Medical Devices Contract Research Organization, 2022-2042 (USD Million)
Table 18.71 Total Cost of Ownership of Medical Devices Contract Research Organization: Distribution by CAPEX and OPEX, 2022 and 2042 (USD Million)
Table 18.72 Total Cost of Ownership in Medical Devices Contract Research Organization, 2022: Distribution by CAPEX (USD Million)
Table 18.73 Total Cost of Ownership in Medical Devices Contract Research Organization, 2022-2042: Distribution by OPEX (USD Million)
Table 18.74 Survey Insights: Distribution of Respondents by Designation and Seniority Level
Table 18.75 Survey Insights: Distribution of Respondents by Type of Service Offered
Table 18.76 Survey Insights: Distribution of Respondents by Therapeutic Area
Table 18.77 Survey Insights: Distribution of Respondents by Average Number of Projects
Table 18.78 Survey Insights: Distribution of Respondents by Market Opportunity
Table 18.79 Overall Medical Device CROs Market, 2022-2035 (USD Billion)
Table 18.80 Medical Device CROs Market, 2022, 2028 and 2035: Distribution by Therapeutic Area (USD Billion)
Table 18.81 Medical Device CROs Market, 2022-2035: Distribution by Scale of Operation (USD Billion)
Table 18.82 Medical Device CROs Market, 2022-2035: Distribution by Device Class (USD Billion)
Table 18.83 Medical Device CROs Market, 2022-2035: Distribution by Type of Clinical Service Offered (USD Billion)
Table 18.84 Medical Device CROs Market, 2022-2035: Distribution by Type of Preclinical Service Offered (USD Billion)
Table 18.85 Medical Device CROs Market, 2022, 2028 and 2035: Distribution by Geography (USD Billion)
Table 18.86 Medical Device CROs Market in North America, 2022-2035 (USD Billion)
Table 18.87 Medical Device CROs Market for CNS Disorders in North America, 2022-2035 (USD Billion)
Table 18.88 Medical Device CROs Market for Cardiovascular Disorders in North America, 2022-2035 (USD Billion)
Table 18.89 Medical Device CROs Market for Oncological Disorders in North America, 2022-2035 (USD Billion)
Table 18.90 Medical Device CROs Market for Bone Disorders in North America, 2022-2035 (USD Billion)
Table 18.91 Medical Device CROs Market for Respiratory Disorders in North America, 2022- 2035 (USD Billion)
Table 18.92 Medical Device CROs Market for Pain Disorders in North America, 2022-2035 (USD Billion)
Table 18.93 Medical Device CROs Market for Ophthalmic Disorders in North America, 2022- 2035 (USD Billion)
Table 18.94 Medical Device CROs Market for Psychological Disorders in North America, 2022-2035 (USD Billion)
Table 18.95 Medical Device CROs Market for Metabolic Disorders in North America, 2022- 2035 (USD Billion)
Table 18.96 Medical Device CROs Market for Other Therapeutic Areas in North America, 2022-2035 (USD Billion)
Table 18.97 Medical Device CROs Market for Class I Devices in North America, 2022-2035 (USD Billion)
Table 18.98 Medical Device CROs Market for Class II Devices in North America, 2022-2035 (USD Billion)
Table 18.99 Medical Device CROs Market for Class III Devices in North America, 2022-2035 (USD Billion)
Table 18.100 Medical Device CROs Market for Clinical Trial Management Services in North America, 2022-2035 (USD Billion)
Table 18.101 Medical Device CROs Market for Consulting Services in North America, 2022- 2035 (USD Billion)
Table 18.102 Medical Device CROs Market for Data Management Services in North America, 2022-2035 (USD Billion)
Table 18.103 Medical Device CROs Market for Regulatory Affairs Management Services in North America, 2022-2035 (USD Billion)
Table 18.104 Medical Device CROs Market for Other Clinical Services in North America, 2022-2035 (USD Billion)
Table 18.105 Medical Device CROs Market for Material Characterization and Analytical Services in North America, 2022-2035 (USD Billion)
Table 18.106 Medical Device CROs Market for Biocompatibility Testing Services in North America, 2022-2035 (USD Billion)
Table 18.107 Medical Device CROs Market for Sterility and Microbiology Testing Services in North America, 2022-2035 (USD Billion)
Table 18.108 Medical Device CROs Market for Other Preclinical Services in North America, 2022-2035 (USD Billion)
Table 18.109 Medical Device CROs Market in Europe, 2022-2035 (USD Billion)
Table 18.110 Medical Device CROs Market for CNS Disorders in Europe, 2022-2035 (USD Billion)
Table 18.111 Medical Device CROs Market for Cardiovascular Disorders in Europe, 2022- 2035 (USD Billion)
Table 18.112 Medical Device CROs Market for Oncological Disorders in Europe, 2022-2035 (USD Billion)
Table 18.113 Medical Device CROs Market for Bone Disorders in Europe, 2022-2035 (USD Billion)
Table 18.114 Medical Device CROs Market for Respiratory Disorders in Europe, 2022-2035 (USD Billion)
Table 18.115 Medical Device CROs Market for Pain Disorders in Europe, 2022-2035 (USD Billion)
Table 18.116 Medical Device CROs Market for Ophthalmic Disorders in Europe, 2022-2035 (USD Billion)
Table 18.117 Medical Device CROs Market for Psychological Disorders in Europe, 2022-2035 (USD Billion)
Table 18.118 Medical Device CROs Market for Metabolic Disorders in Europe, 2022-2035 (USD Billion)
Table 18.119 Medical Device CROs Market for Other Therapeutic Areas in Europe, 2022-2035 (USD Billion)
Table 18.120 Medical Device CROs Market for Class I Devices in Europe, 2022-2035 (USD Billion)
Table 18.121 Medical Device CROs Market for Class II Devices in Europe, 2022-2035 (USD Billion)
Table 18.122 Medical Device CROs Market for Class III Devices in Europe, 2022-2035 (USD Billion)
Table 18.123 Medical Device CROs Market for Clinical Trial Management Services in Europe, 2022-2035 (USD Billion)
Table 18.124 Medical Device CROs Market for Consulting Services in Europe, 2022-2035 (USD Billion)
Table 18.125 Medical Device CROs Market for Data Management Services in Europe, 2022- 2035 (USD Billion)
Table 18.126 Medical Device CROs Market for Regulatory Affairs Management Services in Europe, 2022-2035 (USD Billion)
Table 18.127 Medical Device CROs Market for Other Clinical Services in Europe, 2022-2035 (USD Billion)
Table 18.128 Medical Device CROs Market for Material Characterization and Analytical Services in Europe, 2022-2035 (USD Billion)
Table 18.129 Medical Device CROs Market for Biocompatibility Testing Services in Europe, 2022-2035 (USD Billion)
Table 18.130 Medical Device CROs Market for Sterility and Microbiology Testing Services in Europe, 2022-2035 (USD Billion)
Table 18.131 Medical Device CROs Market for Other Preclinical Services in Europe, 2022- 2035 (USD Billion)
Table 18.132 Medical Device CROs Market in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.133 Medical Device CROs Market for CNS Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.134 Medical Device CROs Market for Cardiovascular Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.135 Medical Device CROs Market for Oncological Disorders in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.136 Medical Device CROs Market for Bone Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.137 Medical Device CROs Market for Respiratory Disorders in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.138 Medical Device CROs Market for Pain Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.139 Medical Device CROs Market for Ophthalmic Disorders in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.140 Medical Device CROs Market for Psychological Disorders in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.141 Medical Device CROs Market for Metabolic Disorders in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.142 Medical Device CROs Market for Other Therapeutic Areas in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.143 Medical Device CROs Market for Class I Devices in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.144 Medical Device CROs Market for Class II Devices in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.145 Medical Device CROs Market for Class III Devices in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.146 Medical Device CROs Market for Clinical Trial Management Services in Asia- Pacific, 2022-2035 (USD Billion)
Table 18.147 Medical Device CROs Market for Consulting Services in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.148 Medical Device CROs Market for Data Management Services in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.149 Medical Device CROs Market for Regulatory Affairs Management Services in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.150 Medical Device CROs Market for Other Clinical Services in Asia-Pacific, 2022- 2035 (USD Billion)
Table 18.151 Medical Device CROs Market for Material Characterization and Analytical Services in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.152 Medical Device CROs Market for Biocompatibility Testing Services in Asia- Pacific, 2022-2035 (USD Billion)
Table 18.153 Medical Device CROs Market for Sterility and Microbiology Testing Services in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.154 Medical Device CROs Market for Other Preclinical Services in Asia-Pacific, 2022-2035 (USD Billion)
Table 18.155 Medical Device CROs Market in Rest of the World, 2022-2035 (USD Billion)
Table 18.156 Medical Device CRO Market for CNS Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.157 Medical Device CROs Market for Cardiovascular Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.158 Medical Device CROs Market for Oncological Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.159 Medical Device CROs Market for Bone Disorders in Rest of the World, 2022- 2035 (USD Billion)
Table 18.160 Medical Device CROs Market for Respiratory Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.161 Medical Device CROs Market for Pain Disorders in Rest of the World, 2022- 2035 (USD Billion)
Table 18.162 Medical Device CROs Market for Ophthalmic Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.163 Medical Device CROs Market for Psychological Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.164 Medical Device CROs Market for Metabolic Disorders in Rest of the World, 2022-2035 (USD Billion)
Table 18.165 Medical Device CROs Market for Other Therapeutic Areas in Rest of the World, 2022-2035 (USD Billion)
Table 18.166 Medical Device CROs Market for Class I Devices in Rest of the World, 2022- 2035 (USD Billion)
Table 18.167 Medical Device CROs Market for Class II Devices in Rest of the World, 2022- 2035 (USD Billion)
Table 18.168 Medical Device CROs Market for Class III Devices in Rest of the World, 2022- 2035 (USD Billion)
Table 18.169 Medical Device CROs Market for Clinical Trial Management Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.170 Medical Device CROs Market for Consulting Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.171 Medical Device CROs Market for Data Management Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.172 Medical Device CROs Market for Regulatory Affairs Management Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.173 Medical Device CROs Market for Other Clinical Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.174 Medical Device CROs Market for Material Characterization and Analytical Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.175 Medical Device CROs Market for Biocompatibility Testing Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.176 Medical Device CROs Market for Sterility and Microbiology Testing Services in Rest of the World, 2022-2035 (USD Billion)
Table 18.177 Medical Device CROs Market for Other Preclinical Services in Rest of the World, 2022-2035 (USD Billion)

LIST OF FIGURES

Figure 2.1 Executive Summary: Overall Market Landscape
Figure 2.2 Executive Summary: Clinical Trial Analysis
Figure 2.3 Executive Summary: Mergers and Acquisitions
Figure 2.4 Executive Summary: Total Cost of Ownership
Figure 2.5 Executive Summary: Market Sizing and Opportunity Analysis
Figure 3.1 Historical Timeline of Medical Device Inventions
Figure 3.2 Medical Device: Development Process and Timeline
Figure 3.3 Types of CROs Engaged in the Medical Device Market
Figure 3.4 Services Offered by CROs
Figure 3.5 Risks / Challenges Associated with Outsourcing Operations to CROs
Figure 4.1 Medical Device Clinical CROs: Distribution by Year of Establishment
Figure 4.2 Medical Device Clinical CROs: Distribution by Company Size
Figure 4.3 Medical Device Clinical CROs: Distribution by Location of Headquarters
Figure 4.4 Medical Device Clinical CROs: Distribution by Company Size and Location of Headquarters
Figure 4.5 Medical Device Clinical CROs: Distribution by Area of Specialization
Figure 4.6 Medical Device Clinical CROs: Distribution by Device Class
Figure 4.7 Medical Device Clinical CROs: Distribution by Type of Clinical Operation Service Offered
Figure 4.8 Medical Device Clinical CROs: Distribution by Year of Establishment, Type of Clinical Service Offered and Geography
Figure 4.9 Medical Device Clinical CROs: Distribution by Type of Regulatory Affairs-related Service Offered
Figure 4.10 Medical Device Clinical CROs: Distribution by Type of Additional Service Offered
Figure 4.11 Medical Device Clinical CROs: Distribution by Type of Medical Device Regulatory Compliance Authority
Figure 4.12 Medical Device Preclinical CROs: Distribution by Year of Establishment
Figure 4.13 Medical Device Preclinical CROs: Distribution by Company Size
Figure 4.14 Medical Device Preclinical CROs: Distribution by Location of Headquarters
Figure 4.15 Medical Device Preclinical CROs: Distribution by Company Size and Location of Headquarters
Figure 4.16 Medical Device Preclinical CROs: Distribution by Type of Preclinical Service Offered
Figure 4.17 Medical Device Preclinical CROs: Distribution by Year of Establishment, Type of Preclinical Service Offered and Geography
Figure 4.18 Medical Device Standalone CROs: Distribution by Year of Establishment
Figure 4.19 Medical Device Standalone CROs: Distribution by Company Size
Figure 4.20 Medical Device Standalone CROs: Distribution by Location of Headquarters
Figure 4.21 Medical Device Standalone CROs: Distribution by Company Size and Location of Headquarters
Figure 5.1 Key Regulatory Authorities for Medical Devices
Figure 5.2 Medical Devices Review / Approval Process in the US
Figure 5.3 Healthcare Insurance Coverage in the US: Distribution by Type of Coverage
Figure 5.4 Medical Devices National Coverage Determination Process in the US
Figure 5.5 Medical Devices Review / Approval Process in Canada
Figure 5.6 Healthcare Insurance Coverage in Canada: Distribution by Type of Coverage
Figure 5.7 Medical Devices Review / Approval Process in Mexico
Figure 5.8 Regulatory Bodies in EU5 Countries
Figure 5.9 Steps involved in CE Marking Process
Figure 5.10 Medical Devices Review / Approval Process in Europe
Figure 5.11 Medical Devices Review / Approval Process in the UK
Figure 5.12 Healthcare Insurance Coverage in the UK: Distribution by Type of Coverage
Figure 5.13 Reimbursement Process for Medical Devices in the UK
Figure 5.14 Healthcare Insurance Coverage in France: Distribution by Type of Coverage
Figure 5.15 Reimbursement Process for Medical Devices through List of Products and Services Qualifying for Reimbursement
Figure 5.16 Healthcare Insurance Coverage in Germany: Distribution by Type of Coverage
Figure 5.17 Reimbursement Process for In-Patient Setting in Germany
Figure 5.18 Reimbursement Process for Out-Patient Care in Germany
Figure 5.19 Healthcare Insurance Coverage in Italy: Distribution by Type of Coverage
Figure 5.20 Reimbursement Process for Medical Devices in Italy
Figure 5.21 Healthcare Insurance Coverage in Spain: Distribution by Type of Coverage
Figure 5.22 Reimbursement Process for Medical Devices in Spain
Figure 5.23 Medical Devices Review / Approval Process in Australia
Figure 5.24 Healthcare Insurance Coverage in Australia: Distribution by Type of Coverage
Figure 5.25 Medical Devices Review / Approval Process in Brazil
Figure 5.26 Reimbursement Process for Medical Devices in Brazil
Figure 5.27 Medical Devices Review / Approval Process in China
Figure 5.28 Healthcare Insurance Coverage in China: Distribution by Type of Coverage
Figure 5.29 Reimbursement Approval Process for Medical Devices in Shanghai
Figure 5.30 Medical Devices Review / Approval Process in India
Figure 5.31 Healthcare Insurance Coverage in Israel: Distribution by Type of Coverage
Figure 5.32 Medical Devices Review / Approval Process in Japan
Figure 5.33 Snapshot of the Regulatory and Reimbursement Process in Japan
Figure 5.34 Healthcare Insurance Coverage in Japan: Distribution by Type of Coverage
Figure 5.35 Reimbursement Process for New Medical Devices in Japan
Figure 5.36 Medical Devices Review / Approval Process in New Zealand
Figure 5.37 Healthcare Insurance Coverage in New Zealand: Distribution by Type of Coverage
Figure 5.38 Medical Devices Review / Approval Process in Singapore
Figure 5.39 Medical Devices Review / Approval Process in South Korea
Figure 5.40 Healthcare Insurance Coverage in South Korea: Distribution by Type of Coverage
Figure 5.41 Medical Devices Review / Approval Process in South Africa
Figure 5.42 Medical Devices Review / Approval Process in Taiwan
Figure 5.43 Healthcare Insurance Coverage in Taiwan: Distribution by Type of Coverage
Figure 5.44 Medical Devices Review / Approval Process in Thailand
Figure 5.45 Heat Map Analysis: Comparison of Regional Regulatory Control for Medical Devices
Figure 5.46 Regulatory Control for Medical Devices: Regional Distribution by Device Risk Category
Figure 6.1 Avania: Service Portfolio
Figure 6.2 Charles River Laboratories: Service Portfolio
Figure 6.3 CROMSOURCE: Service Portfolio
Figure 6.4 CSSi LifeSciences: Service Portfolio
Figure 6.5 Eurofins Medical Device Testing: Preclinical Service Portfolio
Figure 6.6 Eurofins Medical Device Testing: Clinical Service Portfolio
Figure 6.7 IQVIA: Service Portfolio
Figure 6.8 Medpace: Service Portfolio
Figure 6.9 NAMSA: Service Portfolio
Figure 6.10 Qserve Group: Service Portfolio
Figure 6.11 WuXi AppTec: Preclinical Service Portfolio
Figure 6.12 WuXi AppTec: Clinical Service Portfolio
Figure 7.1 Key Attributes for Selection of Key Performance Indicators (KPIs)
Figure 7.2 Types of KPIs
Figure 7.3 Financial Indicators: Comparative Analysis of KPIs considered by Big Pharma Companies
Figure 7.4 Financial Indicators: Sponsors' (Big Pharma) Perspective
Figure 7.5 Financial Indicators: Contract Service Providers' Perspective
Figure 7.6 Process / Capability Indicators: Comparative Analysis of KPIs considered by Big Pharma Companies
Figure 7.7 Process / Capability Indicators: Sponsors' (Big Pharma) Perspective
Figure 7.8 Process / Capability Indicators: Contract Service Providers' Perspective
Figure 7.9 Market Reputation Indicators: Comparative Analysis of KPIs considered by Big Pharma Companies
Figure 7.10 Market Reputation Indicators: Sponsors' (Big Pharma) Perspective
Figure 7.11 Market Reputation Indicators: Contract Service Providers' Perspective
Figure 7.12 Comparison of Key Factors to be considered while selecting KPIs for Medical Devices
Figure 8.1 Competitive Benchmarking: Distribution by Region and Company Size
Figure 8.2 Competitive Benchmarking: Small Players based in North America (Peer Group I)
Figure 8.3 Competitive Benchmarking: Mid-sized Players based in North America (Peer Group II)
Figure 8.4 Competitive Benchmarking: Large Players based in North America (Peer Group III)
Figure 8.5 Competitive Benchmarking: Small Players based in Europe (Peer Group IV)
Figure 8.6 Competitive Benchmarking: Mid-sized Players based in Europe (Peer Group V)
Figure 8.7 Competitive Benchmarking: Large Players based in Europe (Peer Group VI)
Figure 8.8 Competitive Benchmarking: Small Players based in Asia-Pacific (Peer Group VII)
Figure 8.9 Competitive Benchmarking: Mid-sized Players based in Asia-Pacific (Peer Group VIII)
Figure 8.10 Competitive Benchmarking: Large Players based in Asia-Pacific (Peer Group IX)
Figure 8.11 Competitive Benchmarking: Small Players based in Rest of the World (Peer Group X)
Figure 8.12 Competitive Benchmarking: Mid-sized Players based in Rest of the World (Peer Group XI)
Figure 8.13 Competitive Benchmarking Summary
Figure 9.1 Brand Positioning of Key Industry Players: Unfair Advantage
Figure 9.2 Brand Positioning of Key Industry Players: Reasons to Believe
Figure 9.3 Brand Positioning Matrix: Labcorp
Figure 9.4 Brand Positioning Matrix: IQVIA
Figure 9.5 Brand Positioning Matrix: Syneos Health
Figure 9.6 Brand Positioning Matrix: PPD
Figure 9.7 Brand Positioning Matrix: ICON
Figure 9.8 Brand Positioning Matrix: Charles River Laboratories
Figure 9.9 Brand Positioning Matrix: WuXi AppTec
Figure 9.10 Brand Positioning Matrix: Medpace
Figure 10.1 Clinical Trial Analysis: Distribution by Trial Registration Year, 2015-2022
Figure 10.2 Clinical Trial Analysis: Distribution by Trial Status
Figure 10.3 Clinical Trial Analysis: Distribution by Phase of Development
Figure 10.4 Clinical Trial Analysis: Distribution by Study Design
Figure 10.5 Clinical Trial Analysis: Distribution by Therapeutic Area
Figure 10.6 Clinical Trial Analysis: Distribution by Geography
Figure 10.7 Clinical Trial Analysis: Distribution by Trial Registration Year and Geography
Figure 10.8 Clinical Trial Analysis: Distribution by Trial Status and Geography
Figure 10.9 Clinical Trial Analysis: Distribution by Type of Sponsor
Figure 10.10 Most Active Players: Distribution by Number of Clinical Trials
Figure 10.11 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Registration Year
Figure 10.12 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Phase of Development
Figure 10.13 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
Figure 10.14 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Status and Geography
Figure 11.1 Mergers and Acquisitions: Cumulative Year-Wise Trend (2015-2022)
Figure 11.2 Mergers and Acquisitions: Distribution by Type of Agreement
Figure 11.3 Mergers and Acquisitions: Distribution by Year and Type of Agreement
Figure 11.4 Mergers and Acquisitions: Continent-wise Distribution
Figure 11.5 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Figure 11.6 Mergers and Acquisitions: Country-wise Distribution
Figure 11.7 Mergers and Acquisitions: Ownership Change Matrix
Figure 11.8 Mergers and Acquisitions: Distribution by Type of Company
Figure 11.9 Mergers and Acquisitions: Distribution by Key Value Drivers
Figure 11.10 Mergers and Acquisitions: Distribution by Year of Acquisition and Key Value Drivers
Figure 12.1 Total Cost of Ownership: Capital Expenditures (CAPEX)
Figure 12.2 Total Cost of Ownership: Operational Expenditures (OPEX)
Figure 12.3 Total Cost of Ownership of Medical Devices Contract Research Organizations, 2022-2042 (USD Million)
Figure 12.4 Total Cost of Ownership of Medical Devices Contract Research Organizations: Distribution by CAPEX and OPEX Costs, 2022 and 2042 (USD Million)
Figure 12.5 Total Cost of Ownership of Medical Devices Contract Research Organizations: Distribution by CAPEX Costs, 2022-2042 (USD Million)
Figure 12.6 Total Cost of Ownership of Medical Devices Contract Research Organizations: Distribution by OPEX Costs, 2022-2042 (USD Million)
Figure 13.1 Survey Insights: Distribution of Respondents by Designation and Seniority Level
Figure 13.2 Survey Insights: Distribution of Respondents by Type of Service Offered
Figure 13.3 Survey Insights: Distribution of Respondents by Therapeutic Area
Figure 13.4 Survey Insights: Distribution of Respondents by Average Number of Annual Projects
Figure 13.5 Survey Insights: Distribution of Respondents by Market Opportunity
Figure 14.1 Overall Medical Device CROs Market, 2022-2035 (USD Billion)
Figure 14.2 Medical Device CROs Market, 2022, 2028 and 2035: Distribution by Therapeutic Area (USD Billion)
Figure 14.3 Medical Device CROs Market, 2022-2035: Distribution by Scale of Operation (USD Billion)
Figure 14.4 Medical Device CROs Market, 2022-2035: Distribution by Device Class (USD Billion)
Figure 14.5 Medical Device CROs Market, 2022-2035: Distribution by Type of Clinical Service Offered (USD Billion)
Figure 14.6 Medical Device CROs Market, 2022-2035: Distribution by Type of Preclinical Service Offered (USD Billion)
Figure 14.7 Medical Device CROs Market, 2022, 2028 and 2035: Distribution by Geography (USD Billion)
Figure 14.8 Medical Device CROs Market in North America, 2022-2035 (USD Billion)
Figure 14.9 Medical Device CROs Market for CNS Disorders in North America, 2022-2035 (USD Billion)
Figure 14.10 Medical Device CROs Market for Cardiovascular Disorders in North America, 2022-2035 (USD Billion)
Figure 14.11 Medical Device CROs Market for Oncological Disorders in North America, 2022-2035 (USD Billion)
Figure 14.12 Medical Device CROs Market for Bone Disorders in North America, 2022-2035 (USD Billion)
Figure 14.13 Medical Device CROs Market for Respiratory Disorders in North America, 2022-2035 (USD Billion)
Figure 14.14 Medical Device CROs Market for Pain Disorders in North America, 2022-2035 (USD Billion)
Figure 14.15 Medical Device CROs Market for Ophthalmic Disorders in North America, 2022-2035 (USD Billion)
Figure 14.16 Medical Device CROs Market for Psychological Disorders in North America, 2022-2035 (USD Billion)
Figure 14.17 Medical Device CROs Market for Metabolic Disorders in North America, 2022-2035 (USD Billion)
Figure 14.18 Medical Device CROs Market for Other Disorders in North America, 2022-2035 (USD Billion)
Figure 14.19 Medical Device CROs Market for Class I Devices in North America, 2022-2035 (USD Billion)
Figure 14.20 Medical Device CROs Market for Class II Devices in North America, 2022-2035 (USD Billion)
Figure 14.21 Medical Device CROs Market for Class III Devices in North America, 2022-2035 (USD Billion)
Figure 14.22 Medical Device CROs Market for Clinical Trial Management Services in North America, 2022-2035 (USD Billion)
Figure 14.23 Medical Device CROs Market for Consulting Services in North America, 2022-2035 (USD Billion)
Figure 14.24 Medical Device CROs Market for Data Management Services in North America, 2022-2035 (USD Billion)
Figure 14.25 Medical Device CROs Market for Regulatory Affairs Management Services in North America, 2022-2035 (USD Billion)
Figure 14.26 Medical Device CROs Market for Other Clinical Services in North America, 2022-2035 (USD Billion)
Figure 14.27 Medical Device CROs Market for Material Characterization and Analytical Services in North America, 2022-2035 (USD Billion)
Figure 14.28 Medical Device CROs Market for Biocompatibility Testing Services in North America, 2022-2035 (USD Billion)
Figure 14.29 Medical Device CROs Market for Sterility and Microbiology Testing Services in North America, 2022-2035 (USD Billion)
Figure 14.30 Medical Device CROs Market for Other Preclinical Services in North America, 2022-2035 (USD Billion)
Figure 14.31 Medical Device CROs Market in Europe, 2022-2035 (USD Billion)
Figure 14.32 Medical Device CROs Market for CNS Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.33 Medical Device CROs Market for Cardiovascular Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.34 Medical Device CROs Market for Oncological Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.35 Medical Device CROs Market for Bone Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.36 Medical Device CROs Market for Respiratory Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.37 Medical Device CROs Market for Pain Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.38 Medical Device CROs Market for Ophthalmic Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.39 Medical Device CROs Market for Psychological Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.40 Medical Device CROs Market for Metabolic Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.41 Medical Device CROs Market for Other Disorders in Europe, 2022-2035 (USD Billion)
Figure 14.42 Medical Device CROs Market for Class I Devices in Europe, 2022-2035 (USD Billion)
Figure 14.43 Medical Device CROs Market for Class II Devices in Europe, 2022-2035 (USD Billion)
Figure 14.44 Medical Device CROs Market for Class III Devices in Europe, 2022-2035 (USD Billion)
Figure 14.45 Medical Device CROs Market for Clinical Trial Management Services in Europe, 2022-2035 (USD Billion)
Figure 14.46 Medical Device CROs Market for Consulting Services in Europe, 2022-2035 (USD Billion)
Figure 14.47 Medical Device CROs Market for Data Management Services in Europe, 2022-2035 (USD Billion)
Figure 14.48 Medical Device CROs Market for Regulatory Affairs Management Services in Europe, 2022-2035 (USD Billion)
Figure 14.49 Medical Device CROs Market for Other Clinical Services in Europe, 2022-2035 (USD Billion)
Figure 14.50 Medical Device CROs Market for Material Characterization and Analytical Services in Europe, 2022-2035 (USD Billion)
Figure 14.51 Medical Device CROs Market for Biocompatibility Testing Services in Europe, 2022-2035 (USD Billion)
Figure 14.52 Medical Device CROs Market for Sterility and Microbiology Testing Services in Europe, 2022-2035 (USD Billion)
Figure 14.53 Medical Device CROs Market for Other Preclinical Services in Europe, 2022-2035 (USD Billion)
Figure 14.54 Medical Device CROs Market in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.55 Medical Device CROs Market for CNS Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.56 Medical Device CROs Market for Cardiovascular Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.57 Medical Device CROs Market for Oncological Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.58 Medical Device CROs Market for Bone Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.59 Medical Device CROs Market for Respiratory Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.60 Medical Device CROs Market for Pain Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.61 Medical Device CROs Market for Ophthalmic Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.62 Medical Device CROs Market for Psychological Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.63 Medical Device CROs Market for Metabolic Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.64 Medical Device CROs Market for Other Disorders in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.65 Medical Device CROs Market for Class I Devices in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.66 Medical Device CROs Market for Class II Devices in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.67 Medical Device CROs Market for Class III Devices in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.68 Medical Device CROs Market for Clinical Trial Management Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.69 Medical Device CROs Market for Consulting Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.70 Medical Device CROs Market for Data Management Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.71 Medical Device CROs Market for Regulatory Affairs Management Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.72 Medical Device CROs Market for Other Clinical Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.73 Medical Device CROs Market for Material Characterization and Analytical Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.74 Medical Device CROs Market for Biocompatibility Testing Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.75 Medical Device CROs Market for Sterility and Microbiology Testing Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.76 Medical Device CROs Market for Other Preclinical Services in Asia-Pacific, 2022-2035 (USD Billion)
Figure 14.77 Medical Device CROs Market in Rest of the World, 2022-2035 (USD Billion)
Figure 14.78 Medical Device CRO Market for CNS Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.79 Medical Device CROs Market for Cardiovascular Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.80 Medical Device CROs Market for Oncological Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.81 Medical Device CROs Market for Bone Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.82 Medical Device CROs Market for Respiratory Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.83 Medical Device CROs Market for Pain Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.84 Medical Device CROs Market for Ophthalmic Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.85 Medical Device CROs Market for Psychological Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.86 Medical Device CROs Market for Metabolic Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.87 Medical Device CROs Market for Other Disorders in Rest of the World, 2022-2035 (USD Billion)
Figure 14.88 Medical Device CROs Market for Class I Devices in Rest of the World, 2022-2035 (USD Billion)
Figure 14.89 Medical Device CROs Market for Class II Devices in Rest of the World, 2022-2035 (USD Billion)
Figure 14.90 Medical Device CROs Market for Class III Devices in Rest of the World, 2022-2035 (USD Billion)
Figure 14.91 Medical Device CROs Market for Clinical Trial Management Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.92 Medical Device CROs Market for Consulting Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.93 Medical Device CROs Market for Data Management Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.94 Medical Device CROs Market for Regulatory Affairs Management Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.95 Medical Device CROs Market for Other Clinical Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.96 Medical Device CROs Market for Material Characterization and Analytical Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.97 Medical Device CROs Market for Biocompatibility Testing Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.98 Medical Device CROs Market for Sterility and Microbiology Testing Services in Rest of the World, 2022-2035 (USD Billion)
Figure 14.99 Medical Device CROs Market for Other Preclinical Services in Rest of the World, 2022-2035 (USD Billion)
Figure 15.1 Medical Device CROs Market: SWOT Analysis
Figure 15.2 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 16.1 Future Trends and Opportunities for Medical Device CROs

Product Code: RA100370

INTRODUCTION

According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, just over 35 medical devices received approval by the USFDA, every year. It is worth highlighting that, since 2020, the USFDA has approved around 105 medical devices. Moreover, the medical devices are expected to capture more than 40% of the global medtech industry and this value is projected to grow at a steady pace over the coming years. In this context, the number of medical device focused clinical trials have increased at a considerable rate, over the past few years. However, only a few players engaged in this domain claim to have the technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the required infrastructure and capabilities to carry out research in this domain. In addition, various regulatory guidelines render medical devices subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives. Specifically, post the onset of the COVID-19 pandemic, there has been a substantial increase in the demand for medical devices as they have the ability to enable early diagnosis, as well as provide non-invasive and effective treatments.

Given the surge in demand for medical devices in the recent past, coupled to the aforementioned constraints faced by developers, a large number of small, as well as well-established, players prefer to outsource a significant share of their respective clinical operations and regulatory affairs management to contract research organizations (CROs). Since 2010, over 75 CROs have been established in this domain. Further, in order to support the growing demand, medical device CROs have been re-evaluating and bolstering their existing capabilities to offer a wide range of services to their clients. Integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics, is another key initiative being undertaken by several CROs to distinguish themselves from their competitors. To enable expansion of their existing capabilities, more than 55 acquisitions and / or strategic alliances have been established by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall medical devices market, we believe that the medical devices CROs market is likely to witness consistent grow, till 2035.

SCOPE OF THE REPORT

The 'Medical Devices Contract Research Organizations Market (3rd Edition) by Target Therapeutic Area (Cardiovascular Disorders, CNS Disorders, Metabolic Disorders, Oncological Disorders, Ophthalmological Disorders, Orthopedic Disorders, Pain Disorders, Psychological Disorders, Respiratory Disorders, and Others), Scale of Operation (Clinical / Preclinical), Device Class (Class I, Class II, Class III), Type of Clinical Service Offered (Clinical Trial Management, Data Management, Regulatory Affairs Management, Consulting), Type of Preclinical Service Offered (Biocompatibility Testing, Sterility, Microbiology Testing, Material Characterization, Analytical Services), and Key Geographies (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035' report features an extensive study of the current market landscape and future opportunities associated with the medical device contract research organizations market. The study also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report features:

A detailed overview of the overall landscape of medical devices CROs, along with information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World), area of specialization (medical device and in vitro diagnostics), device class (class I, class II, and class III), types of services offered by [A] clinical service providers (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers.

An elaborate discussion on the various guidelines established and issued by major regulatory bodies for medical device approval, across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), and Asia-Pacific and Rest of the World (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). It also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.

Elaborate profiles of key players (shortlisted on the basis of the company competitiveness analysis) that specialize in offering services for both clinical and preclinical stage development of medical devices.. Each profile features a brief overview of the company, along with information on their year of establishment, number of employees, location of headquarters, key executives, medical device focused service portfolio, recent developments, and an informed future outlook.

An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers engaged in this domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.

A competitive benchmarking, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups (small, mid-sized and large players based in North America, Europe, Asia-Pacific, and Rest of the World), and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.

A detailed brand positioning analysis of leading industry players (shortlisted on the basis of revenues generated in 2021), highlighting the current perceptions regarding their proprietary brands by taking into consideration several relevant aspects, such as number of service(s) offered and device class.

An in-depth analysis of completed, ongoing, and planned clinical studies focused on medical devices, based on several relevant parameters, such as trial registration year, trial phase, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), target therapeutic area(s) and key geographical regions.

A detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2022, based on several relevant parameters, such as year, type of agreements and geographical location of the companies.

A detailed analysis of the total cost of ownership for a medical device contract research service provider. It features an informed estimate of direct and indirect expenses taking into consideration 19 relevant parameters, over a span of 20 years.

A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.

A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the medical devices contract research market over the coming years. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] target therapeutic area (Cardiovascular disorders, CNS disorders, Metabolic disorders, Oncological disorders, Ophthalmological disorders, Orthopedic disorders, Pain disorders, Psychological disorders, Respiratory disorders, and Others), [B] scale of operation (clinical and preclinical), [C] device class (class I, class II and class III), [D] types of clinical services offered (clinical trial management, consulting, data management, regulatory affairs management and others) [E] types of preclinical services offered (material characterization and analytical services, biocompatibility testing, sterility and microbiology testing and others), and [F] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic tracks of the industry's evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following stakeholders:

Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)

Lee King (Senior Vice President, Business Development and Marketing)

Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA)

Claus Hemiker (Head, Business Development)

Christian Wolflehner (General Manager, CW Research & Management)

Troy W. Mccall (Chief Commercial Officer, CROMSOURCE)

Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research)

C. Omprakash (Technical Director and Partner, Vyomus Consulting)

Tania Persson (Director of Business Development, A+ Science)

Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts' views

While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED

Who are the key players engaged in offering contract research services for medical devices?

Which regions represent the key contract research hubs for medical devices?

What are the key regulatory guidelines, related to medical devices that have been established across various geographies?

What are the key value drivers of the merger and acquisition activity observed within this domain?

What percentage of the medical devices research operations are presently outsourced?

What are the likely future trends in contract research services market for medical devices?

How is the current and future opportunity likely to be distributed across key market segments?

What is the total cost of ownership required to set up a medical device contract research organization?

CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured during our research. It offers a high-level view on the current state of the medical devices contract research market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides a brief introduction to medical devices, highlighting the key historical and development milestones, and classification of such devices. It also provides a general overview of the concept of CROs, featuring a discussion on the historical evolution of contract research services market in the medical device domain. Further, it presents details related to the various types of CROs that operate within the medical device market and the different types of services offered. It further lists the advantages as well as challenges associated with outsourcing medical device research and clinical operations to contract service providers, along with the key parameters that need to be considered while selecting a CRO partner.

Chapter 4 features a detailed overview of the current market landscape of medical devices CROs, along with information on several relevant parameters, such as their year of establishment, company size (in terms of company size), location of headquarters (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World), area of specialization (medical device and in vitro diagnostics), device class (class I, class II, and class III), types of services offered by [A] clinical service providers (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers.

Chapter 5 features a discussion on the various guidelines established by major regulatory bodies for medical device approvals across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), and Asia-Pacific and Rest of the World (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.

Chapter 6 features detailed profiles of key players (shortlisted on the basis of the company competitiveness analysis) engaged in this domain. Each profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key executives, details related to contract research services offered, recent developments, and an informed future outlook.

Chapter 7 features an analysis on the key value drivers and performance indicators used by sponsor companies to evaluate service providers engaged in this domain, based on information gathered via secondary research (for top-ten medical device players), as well as credible inputs from primary research.

Chapter 8 presents a competitive benchmarking of the various players engaged in this domain. It highlights the capabilities of small-sized, mid-sized and large companies in terms of their expertise in medical device services. The analysis allows companies to compare their existing capabilities within and beyond their respective peer groups (small, mid-sized and large players based in North America, Europe, Asia-Pacific, and Rest of the World) and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.

Chapter 9 provides an elaborative brand positioning analysis of leading industry players (shortlisted on the basis of revenues generated in 2021), highlighting the current perceptions regarding their proprietary brands by taking into consideration several relevant aspects, such as number of services offered and device class.

Chapter 10 presents a detailed analysis of completed, ongoing, and planned clinical studies focused on medical devices, based on several relevant parameters, such as trial registration year, trial phase, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), target therapeutic area(s) and key geographical regions.

Chapter 11 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2022 (till March). It is worth mentioning that the data captured during our research was analysed based on multiple parameters, such as year, type of agreements and geographical location of the companies.

Chapter 12 detailed analysis of the total cost of ownership for a medical device contract research service provider. It features an informed estimate of direct and indirect expenses taking into consideration 19 relevant parameters, over a span of 20 years.

Chapter 13 presents insights from the survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.

Chapter 14 presents an insightful market forecast analysis, highlighting the likely growth of the medical devices contract research market till the year 2035. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] target therapeutic area (Cardiovascular disorders, CNS disorders, Metabolic disorders, Oncological disorders, Ophthalmological disorders, Orthopedic disorders, Pain disorders, Psychological disorders, Respiratory disorders, and Others), [B] scale of operation (clinical and preclinical), [C] device class (class I, class II and class III), [D] types of clinical services offered (clinical trial management, consulting, data management, regulatory affairs management and others) [E] types of preclinical services offered (material characterization and analytical services, biocompatibility testing, sterility and microbiology testing and others), and [F] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

Chapter 15 provides a discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics.

Chapter 16 presents a discussion on the upcoming opportunities / trends of medical device contract services market that are likely to impact the future evolution of this domain over the coming years. These include (but not limited to) growth in number of connected devices, adoption of data analytics and real-time monitoring solutions, growing need for cloud-based computing and storage solutions and growing demands for real-world evidence to obtain regulatory approval.

Chapter 17 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interview held with Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial), Lee King (Senior Vice President, Business Development and Marketing), Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA), Claus Hemiker (Head, Business Development), Christian Wolflehner (General Manager, CW Research & Management), Troy Mccall (Chief Operating Officer, CROMSOURCE), Nazish Urooj (Senior Manager, Medical & Clinical Operations, Metrics Research), C. Omprakash (Technical Director and Partner, Vyomus Consulting), Tania Persson (Director of Business Development, A+ Science) and Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO).

Chapter 18 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix that provides the list of companies and organizations mentioned in the report.

1. PREFACE

1.1. Scope of the Report
1.2. Market Segmentation
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines

2. EXECUTIVE SUMMARY

2.1. Chapter Overview

3. INTRODUCTION

3.1. Chapter Overview
3.2. Overview of Medical Devices
- 3.2.1. Historical Evolution of Medical Devices
- 3.2.2. Classification of Medical Devices
3.3. Overview of Contract Research Organizations (CROs)
- 3.3.1. Evolution of CROs
3.4. Role of CROs in the Medical Device Industry
3.5. Types of Medical Device CROs
3.6. Types of Services Offered by CROs
3.7. Advantages of Outsourcing Operations to CROs
3.8. Risks and Challenges Associated with Outsourcing
3.9. Key Considerations WhileSelecting a Suitable CRO Partner

4. MARKET LANDSCAPE

4.1. Chapter Overview
4.2. Medical Device CROs: Clinical Service Providers
- 4.2.1. Analysis by Year of Establishment
- 4.2.2. Analysis by Company Size
- 4.2.3. Analysis by Location of Headquarters
- 4.2.4. Analysis by Company Size and Location of Headquarters
- 4.2.5. Analysis by Area of Specialization
- 4.2.6. Analysis by Device Class
- 4.2.7. Analysis by Type of Clinical Operation Service Offered
- 4.2.8. Analysis by Type of Regulatory Affairs-related Service Offered
- 4.2.9. Analysis by Type of Additional Service Offered
- 4.2.10. Analysis by Medical Device Regulatory Compliance Authority
4.3. Medical Device CROs: Preclinical Service Providers
- 4.3.1. Analysis by Year of Establishment
- 4.3.2. Analysis by Company Size
- 4.3.3. Analysis by Location of Headquarters
- 4.3.4. Analysis by Company Size and Location of Headquarters
- 4.3.5. Analysis by Type of Preclinical Service Offered
4.4. Medical Device CROs: Standalone Service Providers
- 4.4.1. Analysis by Year of Establishment
- 4.4.2. Analysis by Company Size
- 4.4.3. Analysis by Location of Headquarters
- 4.4.4. Analysis by Company Size and Location of Headquarters

5. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES

5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
- 5.3.1. The US Scenario
  - 5.3.1.1. Regulatory Authority
  - 5.3.1.2. Review / Approval Process
  - 5.3.1.3. Reimbursement Landscape
    - 5.3.1.3.1. Payer Mix
    - 5.3.1.3.2. Reimbursement Process
- 5.3.2. The Canadian Scenario
  - 5.3.2.1. Regulatory Authority
  - 5.3.2.2. Review / Approval Process
  - 5.3.2.3. Reimbursement Landscape
    - 5.3.2.3.1. Payer Mix
    - 5.3.2.3.2. Reimbursement Process
- 5.3.3. The Mexican Scenario
  - 5.3.3.1. Regulatory Authority
  - 5.3.3.2. Review / Approval Process
  - 5.3.3.3. Reimbursement Landscape
    - 5.3.3.3.1. Payer Mix
5.4. Regulatory and Reimbursement Landscape in Europe
- 5.4.1. Overall Scenario
  - 5.4.1.1. Overview of Regulatory Authorities
  - 5.4.1.2. Overall Review / Approval Process
- 5.4.2. The UK Scenario
  - 5.4.2.1. Regulatory Authority
  - 5.4.2.2. Review / Approval Process
  - 5.4.2.3. Reimbursement Landscape
    - 5.4.2.3.1. Payer Mix
    - 5.4.2.3.2. Reimbursement Process
- 5.4.3. The French Scenario
  - 5.4.3.1. Regulatory Authority
  - 5.4.3.2. Review / Approval Process
  - 5.4.3.3. Reimbursement Landscape
    - 5.4.3.3.1. Payer Mix
    - 5.4.3.3.2. Reimbursement Process
- 5.4.4. The German Scenario
  - 5.4.4.1. Regulatory Authority
  - 5.4.4.2. Review / Approval Process
  - 5.4.4.3. Reimbursement Landscape
    - 5.4.4.3.1. Payer Mix
    - 5.4.4.3.2. Reimbursement Process
- 5.4.5. The Italian Scenario
  - 5.4.5.1. Regulatory Authority
  - 5.4.5.2. Review / Approval Process
  - 5.4.5.3. Reimbursement Landscape
    - 5.4.5.3.1. Payer Mix
    - 5.4.5.3.2. Reimbursement Process
- 5.4.6. The Spanish Scenario
  - 5.4.6.1. Regulatory Authority
  - 5.4.6.2. Review / Approval Process
  - 5.4.6.3. Reimbursement Landscape
    - 5.4.6.3.1. Payer Mix
    - 5.4.6.3.2. Reimbursement Process
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
- 5.5.1. The Australian Scenario
  - 5.5.1.1. Regulatory Authority
  - 5.5.1.2. Review / Approval Process
  - 5.5.1.3. Reimbursement Landscape
    - 5.5.1.3.1. Payer Mix
    - 5.5.1.3.2. Reimbursement Process
- 5.5.2. The Brazilian Scenario
  - 5.5.2.1. Regulatory Authority
  - 5.5.2.2. Review / Approval Process
  - 5.5.2.3. Reimbursement Landscape
    - 5.5.2.3.1. Payer Mix
    - 5.5.2.3.2. Reimbursement Process
- 5.5.3. The Chinese Scenario
  - 5.5.3.1. Regulatory Authority
  - 5.5.3.2. Review / Approval Process
  - 5.5.3.3. Reimbursement Landscape
    - 5.5.3.3.1. Payer Mix
    - 5.5.3.3.2. Reimbursement Process
- 5.5.4. The Indian Scenario
  - 5.5.4.1. Regulatory Authority
  - 5.5.4.2. Review / Approval Process
  - 5.5.4.3. Reimbursement Landscape
    - 5.5.4.3.1. Payer Mix
- 5.5.5. The Israeli Scenario
  - 5.5.5.1. Regulatory Authority
  - 5.5.5.2. Review / Approval Process
  - 5.5.5.3. Reimbursement Landscape
    - 5.5.5.3.1. Payer Mix
- 5.5.6. The Japanese Scenario
  - 5.5.6.1. Regulatory Authority
  - 5.5.6.2. Review / Approval Process
  - 5.5.6.3. Reimbursement Landscape
    - 5.5.6.3.1. Payer Mix
    - 5.5.6.3.2. Reimbursement Process
- 5.5.7. The New Zealand Scenario
  - 5.5.7.1. Regulatory Authority
  - 5.5.7.2. Review / Approval Process
  - 5.5.7.3. Reimbursement Landscape
    - 5.5.7.3.1. Payer Mix
    - 5.5.7.3.2. Reimbursement Process
- 5.5.8. The Singapore Scenario
  - 5.5.8.1. Regulatory Authority
  - 5.5.8.2. Review / Approval Process
  - 5.5.8.3. Reimbursement Landscape
    - 5.5.8.3.1. Payer Mix
    - 5.5.8.3.2. Reimbursement Process
- 5.5.9. The South Korean Scenario
  - 5.5.9.1. Regulatory Authority
  - 5.5.9.2. Review / Approval Process
  - 5.5.9.3. Reimbursement Landscape
    - 5.5.9.3.1. Payer Mix
    - 5.5.9.3.2. Reimbursement Process
- 5.5.10. The South African Scenario
  - 5.5.10.1. Regulatory Authority
  - 5.5.10.2. Review / Approval Process
  - 5.5.10.3. Reimbursement Landscape
- 5.5.11. The Taiwan Scenario
  - 5.5.11.1. Regulatory Authority
  - 5.5.11.2. Review / Approval Process
  - 5.5.11.3. Reimbursement Landscape
    - 5.5.11.3.1. Payer Mix
    - 5.5.11.3.2. Reimbursement Process
- 5.5.12. The Thailand Scenario
  - 5.5.12.1. Regulatory Authority
  - 5.5.12.2. Review / Approval Process
  - 5.5.12.3. Reimbursement Landscape
5.6. Comparison of Regional Regulatory Control
5.7. Concluding Remarks

6. COMPANY PROFILES

6.1. Chapter Overview
6.2. Avania (Formerly known as Factory CRO)
- 6.2.1. Company Overview
- 6.2.2. Service Portfolio
- 6.2.3. Recent Developments and Future Outlook
6.3. Charles River Laboratories
- 6.3.1. Company Overview
- 6.3.2. Service Portfolio
- 6.3.3. Recent Developments and Future Outlook
6.4. CROMSOURCE
- 6.4.1. Company Overview
- 6.4.2. Service Portfolio
- 6.4.3. Recent Developments and Future Outlook
6.5. CSSi LifeSciences
- 6.5.1. Company Overview
- 6.5.2. Service Portfolio
- 6.5.3. Recent Developments and Future Outlook
6.6. Eurofins Medical Device Testing
- 6.6.1. Company Overview
- 6.6.2. Service Portfolio
- 6.6.3. Recent Developments and Future Outlook
6.7. IQVIA
- 6.7.1. Company Overview
- 6.7.2. Service Portfolio
- 6.7.3. Recent Developments and Future Outlook
6.8. Medpace
- 6.8.1. Company Overview
- 6.8.2. Service Portfolio
- 6.8.3. Recent Developments and Future Outlook
6.9. NAMSA
- 6.9.1. Company Overview
- 6.9.2. Service Portfolio
- 6.9.3. Recent Developments and Future Outlook
6.10. Qserve Group
- 6.10.1. Company Overview
- 6.10.2. Service Portfolio
- 6.10.3. Recent Developments and Future Outlook
6.11. WuXi AppTec
- 6.11.1. Company Overview
- 6.11.2. Service Portfolio
- 6.11.3. Recent Developments and Future Outlook

7. MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS

7.1. Chapter Overview
7.2. Definition and Importance of Key Performance Indicators (KPIs)
7.3. Key Considerations for Selection of KPIs
7.4. Types of KPIs
- 7.4.1. Financial Indicators
  - 7.4.1.1. Most Important KPIs
    - 7.4.1.1.1. Financial Stability
    - 7.4.1.1.2. Cost of Services Offered
    - 7.4.1.1.3. Comparative Analysis of Financial Indicators
  - 7.4.1.2. Industry Perspective
    - 7.4.1.2.1. Sponsors' (Big Pharma) Perspective
    - 7.4.1.2.2. Contract Service Providers' Perspective
- 7.4.2. Process and Capability Indicators
  - 7.4.2.1. Most Important KPIs
    - 7.4.2.1.1. Proximity to Sponsor
    - 7.4.2.1.2. Capability to Innovate / Mitigate Risk
    - 7.4.2.1.3. Strength of Service Portfolio
    - 7.4.2.1.4. Comparative Analysis of Process / Capability Indicators
  - 7.4.2.2. Industry Perspective
    - 7.4.2.2.1. Sponsors' (Big Pharma) Perspective
    - 7.4.2.2.2. Contract Service Providers' Perspective
- 7.4.3. Market Reputation Indicators
  - 7.4.3.1. Most Important KPIs
    - 7.4.3.1.1. Flexibility / Adaptability
    - 7.4.3.1.2. Time Management
    - 7.4.3.1.3. Quality / Reliability
    - 7.4.3.1.4. Regulatory Compliance / Track Record
    - 7.4.3.1.5. Comparative Analysis of Market Reputation Indicators
  - 7.4.3.2. Industry Perspective
    - 7.4.3.2.1. Sponsors' (Big Pharma) Perspective
    - 7.4.3.2.2. Contract Service Providers' Perspective
7.5. Comparison of Key Performance Indicators
7.6. Concluding Remarks

8. COMPETITIVE BENCHMARKING

8.1. Chapter Overview
8.2. Assumptions and Methodology
8.3. Competitive Benchmarking by Region
- 8.3.1. Competitive Benchmarking: Small Players based in North America (Peer Group I)
- 8.3.2. Competitive Benchmarking: Mid-sized Players based in North America (Peer Group II)
- 8.3.3. Competitive Benchmarking: Large Players based in North America (Peer Group III)
- 8.3.4. Competitive Benchmarking: Small Players based in Europe (Peer Group IV)
- 8.3.5. Competitive Benchmarking: Mid-sized Players based in Europe (Peer Group V)
- 8.3.6. Competitive Benchmarking: Large Players based in Europe (Peer Group VI)
- 8.3.7. Competitive Benchmarking: Small Players based in Asia-Pacific (Peer Group VII)
- 8.3.8. Competitive Benchmarking: Mid-sized Players based in Asia-Pacific (Peer Group VIII)
- 8.3.9. Competitive Benchmarking: Large Players based in Asia-Pacific (Peer Group IX)
- 8.3.10. Competitive Benchmarking: Small Players based in RoW (Peer Group X)
- 8.3.11. Competitive Benchmarking: Mid-sized Players based in RoW (Peer Group XI)
8.4. Concluding Remarks

9. BRAND POSITIONING OF KEY INDUSTRY PLAYERS

9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Brand Positioning Matrix: Labcorp
9.4. Brand Positioning Matrix: IQVIA
9.5. Brand Positioning Matrix: Syneos Health
9.6. Brand Positioning Matrix: PPD
9.7. Brand Positioning Matrix: ICON
9.8. Brand Positioning Matrix: Charles River Laboratories
9.9. Brand Positioning Matrix: WuXi AppTec
9.10. Brand Positioning Matrix: Medpace

10. CLINICAL TRIAL ANALYSIS

10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Medical Devices: Clinical Trial Analysis
- 10.3.1. Analysis by Trial Registration Year
- 10.3.2. Analysis by Trial Status
- 10.3.3. Analysis by Phase of Development
- 10.3.4. Analysis by Study Design
- 10.3.5. Analysis by Therapeutic Area
- 10.3.6. Analysis by Geography
- 10.3.7. Analysis by Trial Registration Year and Geography
- 10.3.8. Analysis by Trial Status and Geography
- 10.3.9. Analysis by Type of Sponsor
- 10.3.10. Most Active Players: Analysis by Number of Clinical Trials
10.4. Medical Devices: Analysis by Enrolled Patient Population
- 10.4.1. Analysis by Trial Registration Year
- 10.4.2. Analysis by Phase of Development
- 10.4.3. Analysis by Geography
- 10.4.4. Analysis by Trial Status and Geography

11. MERGERS AND ACQUISITIONS

11.1. Chapter Overview
11.2. Merger and Acquisition Models
11.3. Medical Device CROs: Mergers and Acquisitions
- 11.3.1. Analysis by Year of Merger / Acquisition
- 11.3.2. Analysis by Type of Agreement
- 11.3.3. Regional Analysis
  - 11.3.3.1. Analysis by Continent
  - 11.3.3.2. Intercontinental and Intracontinental Deals
  - 11.3.3.3. Analysis by Country
- 11.3.4. Ownership Change Matrix
- 11.3.5. Analysis by Type of Company
- 11.3.6. Analysis by Key Value Drivers
  - 11.3.6.1. Analysis by Year of Acquisition and Key Value Drivers

12. TOTAL COST OF OWNERSHIP IN MEDICAL DEVICES CONTRACT RESEARCH ORGANIZATION

12.1. Chapter Overview
12.2. Assumptions and Methodology
12.3. Expenditures Incurred by a Medical Device Contract Research Organization
- 12.3.1. Capital Expenditures (CAPEX)
- 12.3.2. Operational Expenditures (OPEX)
12.4. Total Cost of Ownership of Medical Devices Contract Research Organizations, 2022-2042
12.5. Total Cost of Ownership of Medical Devices Contract Research Organizations: Analysis by CAPEX and OPEX Costs, 2022 and 2042
- 12.5.1. Total Cost of Ownership of Medical Devices Contract Research Organizations: Analysis by CAPEX Costs, 2022-2042
- 12.5.2. Total Cost of Ownership of Medical Devices Contract Research Organizations: Analysis by OPEX Costs, 2022-2042
12.6. Concluding Remarks

13. SURVEY INSIGHTS

13.1. Chapter Overview
13.2. Designation of Respondents
13.3. Types of Services Offered
13.4. Target Therapeutic Area
13.5. Average Number of Annual Projects
13.6. Market Opportunity

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

14.1. Chapter Overview
14.2. Assumptions and Forecast Methodology
14.3. Overall Medical Device CROs Market, 2022-2035
- 14.3.1. Medical Device CROs Market: Analysis by Therapeutic Area, 2022, 2028 and 2035
- 14.3.2. Medical Device CROs Market: Analysis by Scale of Operation, 2022-2035
- 14.3.3. Medical Device CROs Market: Analysis by Device Class, 2022-2035
- 14.3.4. Medical Device CROs Market, 2022-2035: Analysis by Type of Clinical Service Offered, 2022-2035
- 14.3.5. Medical Device CROs Market, 2022-2035: Analysis by Type of Preclinical Service Offered, 2022-2035
- 14.3.6. Medical Device CROs Market: Analysis by Geography, 2022, 2028 and 2035
14.4. Medical Device CROs Market in North America, 2022-2035
- 14.4.1. Medical Device CROs Market in North America: Analysis by Therapeutic Area, 2022-2035
  - 14.4.1.1. Medical Device CROs Market for CNS Disorders in North America, 2022-2035
  - 14.4.1.2. Medical Device CROs Market for Cardiovascular Disorders in North America, 2022-2035
  - 14.4.1.3. Medical Device CROs Market for Oncological Disorders in North America, 2022-2035
  - 14.4.1.4. Medical Device CROs Market for Bone Disorders in North America, 2022-2035
  - 14.4.1.5. Medical Device CROs Market for Respiratory Disorders in North America, 2022-2035
  - 14.4.1.6. Medical Device CROs Market for Pain Management Disorders in North America, 2022-2035
  - 14.4.1.7. Medical Device CROs Market for Ophthalmic Disorders in North America, 2022-2035
  - 14.4.1.8. Medical Device CROs Market for Psychological Disorders in North America, 2022-2035
  - 14.4.1.9. Medical Device CROs Market for Metabolic Disorders in North America, 2022-2035
  - 14.4.1.10. Medical Device CROs Market for Other Disorders in North America, 2022-2035
- 14.4.2. Medical Device CROs Market in North America: Analysis by Device Class, 2022-2035
  - 14.4.2.1. Medical Device CROs Market for Class I Devices in North America, 2022-2035
  - 14.4.2.2. Medical Device CROs Market for Class II Devices in North America, 2022-2035
  - 14.4.2.3. Medical Device CROs Market for Class III Devices in North America, 2022-2035
- 14.4.3. Medical Device CROs Market in North America: Analysis by Type of Clinical Service Offered, 2022-2035
  - 14.4.3.1. Medical Device CROs Market for Clinical Trial Management Services in North America, 2022-2035
  - 14.4.3.2. Medical Device CROs Market for Consulting Services in North America, 2022-2035
  - 14.4.3.3. Medical Device CROs Market for Data Management Services in North America, 2022-2035
  - 14.4.3.4. Medical Device CROs Market for Regulatory Affairs Management Services in North America, 2022-2035
  - 14.4.3.5. Medical Device CROs Market for Other Clinical Services in North America, 2022-2035
- 14.4.4. Medical Device CROs Market in North America: Analysis by Type of Preclinical Service Offered, 2022-2035
  - 14.4.4.1. Medical Device CROs Market for Material Characterization and Analytical Services in North America, 2022-2035
  - 14.4.4.2. Medical Device CROs Market for Biocompatibility Testing Services in North America, 2022-2035
  - 14.4.4.3. Medical Device CROs Market for Sterility and Microbiology Testing Services in North America, 2022-2035
  - 14.4.4.4. Medical Device CROs Market for Other Preclinical Services in North America, 2022-2035
14.5. Medical Device CROs Market in Europe, 2022-2035
- 14.5.1. Medical Device CROs Market in Europe: Analysis by Therapeutic Area, 2022-2035
  - 14.5.1.1. Medical Device CROs Market for CNS Disorders in Europe, 2022-2035
  - 14.5.1.2. Medical Device CROs Market for Cardiovascular Disorders in Europe, 2022-2035
  - 14.5.1.3. Medical Device CROs Market for Oncological Disorders in Europe, 2022-2035
  - 14.5.1.4. Medical Device CROs Market for Bone Disorders in Europe, 2022-2035
  - 14.5.1.5. Medical Device CROs Market for Respiratory Disorders in Europe, 2022-2035
  - 14.5.1.6. Medical Device CROs Market for Pain Management Disorders in Europe, 2022-2035
  - 14.5.1.7. Medical Device CROs Market for Ophthalmic Disorders in Europe, 2022-2035
  - 14.5.1.8. Medical Device CROs Market for Psychological Disorders in Europe, 2022-2035
  - 14.5.1.9. Medical Device CROs Market for Metabolic Disorders in Europe, 2022-2035
  - 14.5.1.10. Medical Device CROs Market for Other Disorders in Europe, 2022-2035
- 14.5.2. Medical Device CROs Market in Europe: Analysis by Device Class, 2022-2035
  - 14.5.2.1. Medical Device CROs Market for Class I Devices in Europe, 2022-2035
  - 14.5.2.2. Medical Device CROs Market for Class II Devices in Europe, 2022-2035
  - 14.5.2.3. Medical Device CROs Market for Class III Devices in Europe, 2022-2035
- 14.5.3. Medical Device CROs Market in Europe: Analysis by Type of Clinical Service Offered, 2022-2035
  - 14.5.3.1. Medical Device CROs Market for Clinical Trial Management Services in Europe, 2022-2035
  - 14.5.3.2. Medical Device CROs Market for Consulting Services in Europe, 2022-2035
  - 14.5.3.3. Medical Device CROs Market for Data Management Services in Europe, 2022-2035
  - 14.5.3.4. Medical Device CROs Market for Regulatory Affairs Management Services in Europe, 2022-2035
  - 14.5.3.5. Medical Device CROs Market for Other Clinical Services in Europe, 2022-2035
- 14.5.4. Medical Device CROs Market in Europe: Analysis by Type of Preclinical Service Offered, 2022-2035
  - 14.5.4.1. Medical Device CROs Market for Material Characterization and Analytical Services in Europe, 2022-2035
  - 14.5.4.2. Medical Device CROs Market for Biocompatibility Testing Services in Europe, 2022-2035
  - 14.5.4.3. Medical Device CROs Market for Sterility and Microbiology Testing Services in Europe, 2022-2035
  - 14.5.4.4. Medical Device CROs Market for Other Preclinical Services in Europe, 2022-2035
14.6. Medical Device CROs Market in Asia-Pacific, 2022-2035
- 14.6.1. Medical Device CROs Market in Asia-Pacific: Analysis by Therapeutic Area, 2022-2035
  - 14.6.1.1. Medical Device CROs Market for CNS Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.2. Medical Device CROs Market for Cardiovascular Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.3. Medical Device CROs Market for Oncological Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.4. Medical Device CROs Market for Bone Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.5. Medical Device CROs Market for Respiratory Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.6. Medical Device CROs Market for Pain Management Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.7. Medical Device CROs Market for Ophthalmic Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.8. Medical Device CROs Market for Psychological Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.9. Medical Device CROs Market for Metabolic Disorders in Asia-Pacific, 2022-2035
  - 14.6.1.10. Medical Device CROs Market for Other Disorders in Asia-Pacific, 2022-2035
- 14.6.2. Medical Device CROs Market in Asia-Pacific: Analysis by Device Class, 2022-2035
  - 14.6.2.1. Medical Device CROs Market for Class I Devices in Asia-Pacific, 2022-2035
  - 14.6.2.2. Medical Device CROs Market for Class II Devices in Asia-Pacific, 2022-2035
  - 14.6.2.3. Medical Device CROs Market for Class III Devices in Asia-Pacific, 2022-2035
- 14.6.3. Medical Device CROs Market in Asia-Pacific: Analysis by Type of Clinical Service Offered, 2022-2035
  - 14.6.3.1. Medical Device CROs Market for Clinical Trial Management Services in Asia-Pacific, 2022-2035
  - 14.6.3.2. Medical Device CROs Market for Consulting Services in Asia-Pacific, 2022-2035
  - 14.6.3.3. Medical Device CROs Market for Data Management Services in Asia-Pacific, 2022-2035
  - 14.6.3.4. Medical Device CROs Market for Regulatory Affairs Management Services in Asia-Pacific, 2022-2035
  - 14.6.3.5. Medical Device CROs Market for Other Clinical Services in Asia-Pacific, 2022-2035
- 14.6.4. Medical Device CROs Market in Asia-Pacific: Analysis by Type of Preclinical Service Offered, 2022-2035
  - 14.6.4.1. Medical Device CROs Market for Material Characterization and Analytical Services in Asia-Pacific, 2022-2035
  - 14.6.4.2. Medical Device CROs Market for Biocompatibility Testing Services in Asia-Pacific, 2022-2035
  - 14.6.4.3. Medical Device CROs Market for Sterility and Microbiology Testing Services in Asia-Pacific, 2022-2035
  - 14.6.4.4. Medical Device CROs Market for Other Preclinical Services in Asia-Pacific, 2022-2035
14.7. Medical Device CROs Market in Rest of the World, 2022-2035
- 14.7.1. Medical Device CROs Market in Rest of the World: Analysis by Therapeutic Area, 2022-2035
  - 14.7.1.1. Medical Device CROs Market for CNS Disorders in Rest of the World, 2022-2035
  - 14.7.1.2. Medical Device CROs Market for Cardiovascular Disorders in Rest of the World, 2022-2035
  - 14.7.1.3. Medical Device CROs Market for Oncological Disorders in Rest of the World, 2022-2035
  - 14.7.1.4. Medical Device CROs Market for Bone Disorders in Rest of the World, 2022-2035
  - 14.7.1.5. Medical Device CROs Market for Respiratory Disorders in Rest of the World, 2022-2035
  - 14.7.1.6. Medical Device CROs Market for Pain Management Disorders in Rest of the World, 2022-2035
  - 14.7.1.7. Medical Device CROs Market for Ophthalmic Disorders in Rest of the World, 2022-2035
  - 14.7.1.8. Medical Device CROs Market for Psychological Disorders in Rest of the World, 2022-2035
  - 14.7.1.9. Medical Device CROs Market for Metabolic Disorders in Rest of the World, 2022-2035
  - 14.7.1.10. Medical Device CROs Market for Other Disorders in Rest of the World, 2022-2035
- 14.7.2. Medical Device CROs Market in Rest of the World: Analysis by Device Class, 2022-2035
  - 14.7.2.1. Medical Device CROs Market for Class I Devices in Rest of the World, 2022-2035
  - 14.7.2.2. Medical Device CROs Market for Class II Devices in Rest of the World, 2022-2035
  - 14.7.2.3. Medical Device CROs Market for Class III Devices in Rest of the World, 2022-2035
- 14.7.3. Medical Device CROs Market in Rest of the World: Analysis by Type of Clinical Service Offered, 2022-2035
  - 14.7.3.1. Medical Device CROs Market for Clinical Trial Management Services in Rest of the World, 2022-2035
  - 14.7.3.2. Medical Device CROs Market for Consulting Services in Rest of the World, 2022-2035
  - 14.7.3.3. Medical Device CROs Market for Data Management Services in Rest of the World, 2022-2035
  - 14.7.3.4. Medical Device CROs Market for Regulatory Affairs Management Services in Rest of the World, 2022-2035
  - 14.7.3.5. Medical Device CROs Market for Other Clinical Services in Rest of the World, 2022-2035
- 14.7.4. Medical Device CROs Market in Rest of the World: Analysis by Type of Preclinical Service Offered, 2022-2035
  - 14.7.4.1. Medical Device CROs Market for Material Characterization and Analytical Services in Rest of the World, 2022-2035
  - 14.7.4.2. Medical Device CROs Market for Biocompatibility Testing Services in Rest of the World, 2022-2035
  - 14.7.4.3. Medical Device CROs Market for Sterility and Microbiology Testing Services in Rest of the World, 2022-2035
  - 14.7.4.4. Medical Device CROs Market for Other Preclinical Services in Rest of the World, 2022-2035

15. SWOT ANALYSIS

15.1. Chapter Overview
15.2. Strengths
15.3. Weaknesses
15.4. Opportunities
15.5. Threats
15.6. Concluding Remarks

16. FUTURE TRENDS AND OPPORTUNITIES

16.1. Chapter Overview
16.2. Anticipated Growth in Number of Connected Devices
16.3. Adoption of Data Analytics and Real-Time Monitoring Solutions
16.4. Need for Cloud-based Computing and Storage Solutions
16.5. Growing Demand for Real World Evidence to Obtain Regulatory Approval
16.6. Concluding Remarks

17. INTERVIEW TRANSCRIPTS

17.1. Chapter Overview
17.2. HungaroTrial
- 17.2.1. Company Snapshot
- 17.2.2. Interview Transcript: Lajos Sarosi, Chief Executive Officer and Co-founder
17.3. ClinChoice
- 17.3.1. Company Snapshot
- 17.3.2. Lee King, Senior Vice President of Business Development and Marketing
17.4. NAMSA
- 17.4.1. Company Snapshot
- 17.4.2. Christopher Rupp, Vice President of Global Marketing and Commercial Operations
17.5. CTC North
- 17.5.1. Company Snapshot
- 17.5.2. Claus Hemiker, Head of Business Development
17.6. CW Research & Management
- 17.6.1. Company Snapshot
- 17.6.2. Christian Wolflehner, General Manager
17.7. CROMSOURCE
- 17.7.1. Company Snapshot
- 17.7.2. Troy McCall, Chief Operating Officer
17.8. Metrics Research
- 17.8.1. Company Snapshot
- 17.8.2. Nazish Urooj, Senior manager, Medical & Clinical Operations
17.9. Vyomus Consulting
- 17.9.1. Company Snapshot
- 17.9.2. C. Omprakash, Technical Director and Partner
17.10. A+ Science
- 17.10.1. Company Snapshot
- 17.10.2. Tania Persson, Director of Business Development
17.11. AtoZ-CRO
- 17.11.1 Company Snapshot
- 17.11.2. Alexa Foltin-Mertgen, Business Development Manager

医療機器開発業務受託機関（CRO）の世界市場：対象治療領域・運営規模・デバイスクラス・提供される臨床サービスのタイプ・提供される前臨床サービスのタイプ、主要地域別、業界動向と予測（2022年～2035年

Medical Devices Contract Research Organizations Market by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered, Key Geographies: Industry Trends & Global Forecasts, 2022-2035

目次

第1章 序文

第2章 エグゼクティブサマリー

第3章 イントロダクション

第4章 市場情勢

第5章 医療機器の規制と償還の情勢

第6章 企業プロファイル

第7章 医療機器開発者とCROの関係：重要な価値促進要因と実績の指標

第8章 競合ベンチマーキング

第9章 主な業界企業のブランドポジショニング

第10章 臨床試験分析

第11章 合併と買収

第12章 医療機器開発業務受託機関（CRO）における総保有コスト

第13章 調査の考察

第14章 市場規模と機会分析

第15章 SWOT分析

第16章 動向と機会

第17章 インタビューの書き起こし

第18章 付録1：データの表

第19章 付録2：企業・組織のリスト