市場調査レポート

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生物製剤開発業務受託機関市場：業界動向と世界の予測 - 生物学的製剤タイプ別、事業規模別、治療領域別、地域別

Biologics Contract Research Organization Market: Industry Trends and Global Forecasts - Distribution by Type of Biologic, Scale of Operation, Therapeutic Area, and Geography

出版日: 2025年07月04日
発行: Roots Analysis
ページ情報: 英文 235 Pages
納期: 即日から翌営業日

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概要
図表
目次

概要

サンプル依頼リストに入れる

生物製剤開発業務受託機関市場：概要

世界の生物製剤開発業務受託機関の市場規模は、今年215億米ドルとなりました。同市場は、予測期間中に13％の有利なCAGRで成長すると予測されています。

市場セグメンテーションでは、市場規模と機会分析を以下のパラメータで区分しています。

生物製剤タイプ

ワクチン
細胞療法
遺伝子療法
抗体
組み換えタンパク質/ペプチド
その他

事業規模

臨床事業
前臨床事業

治療領域

がん領域
心血管疾患
炎症性疾患
神経疾患
その他

地域

北米
欧州
アジア太平洋
ラテンアメリカ
中東・北アフリカ
その他の地域

生物製剤の医薬品開発業務受託機関市場：成長と動向

生物製剤は製薬業界で最も急速に成長している分野の一つです。これは、効果的で個別化された薬理学的介入の必要性により、この分野の技術革新が急速に進んでいることに起因しています。しかし、生物製剤の開発と臨床試験は非常に複雑でコストのかかるプロセスであり、専門的な知識と高度なバイオプロセス技術が要求されます。その結果、多くの生物製剤企業が創薬や臨床研究業務のアウトソーシングを選択しています。

Biologics Contract Research Organization Market-IMG1

現在、生物製剤企業は、開発プロセスを外部のサービス・プロバイダーに委託し、自社は医薬品の研究開発に責任を持つというビジネスモデルを採用しています。これらの外部研究サービス・プロバイダーは、様々な生物製剤開発業務受託機関（CRO）であり、通常開発企業が担う1つ以上の責任を担っています。そのような責任の例としては、プロトコールの設計、治験の選択またはモニタリング、報告書の評価、米国FDAに提出する書類の作成などがあります。生物製剤CROが提供する主な利点には、時間効率、費用対効果、技術革新の鍵、品質革新などがあります。その結果、生物製剤開発業務受託機関市場は、生物製剤スポンサーの高まる研究開発需要を満たすため、徐々に拡大すると予想されます。

生物製剤開発業務受託機関市場：主要インサイト

当レポートでは、生物製剤開発業務受託市場の現状を調査し、潜在的な成長機会を特定しています。主な調査結果は以下の通りです。

現在、160の企業が様々な種類の生物製剤に関する開発業務受託サービスや臨床試験サポートを提供するために必要な能力を有していると主張しています。
全体の約50%が臨床サービスのみを提供しており、そのうち12%のCROが生物製剤の臨床研究に関連するすべてのサービスを提供しています。
現在の市場情勢は断片化されており、前臨床および臨床研究をサポートする広範なポートフォリオを持つ老舗企業と専門サービスプロバイダーが混在しています。
大手製薬会社は現在、社内の研究開発業務の45％近くをCROに委託していると推定されます。
開発業務受託企業の3分の2以上は北米と欧州を拠点としており、その多くは中小企業です。
競合優位性を獲得するため、各社は既存の能力を積極的に拡大し、それぞれのサービスをさらに充実させるとともに、進化する業界のベンチマークに対応しています。

Biologics Contract Research Organization Market-IMG2

現在、8,000を超える製品候補が生物製剤開発企業により評価中／開発中であり、生物製剤開発業務受託市場に機会をもたらしています。
この分野への利害関係者の関心の高まりは、最近の提携活動の増加にも反映されています。2016年以降、業界参入企業はスポンサーおよび/または他のCROと複数の契約を締結しています。
CROの20％近くが臨床および前臨床スケールで生物製剤の調査サービスを提供しています。
ワンストップショップの需要が高まる中、業界利害関係者は、主にM&Aや内部拡張を通じて、生物製剤研究に関連する能力を積極的に統合しています。

Biologics Contract Research Organization Market-IMG3

同市場は今後10年間、CAGR～13％で成長すると予想され、その機会は治療領域別、事業規模別、生物製剤タイプ別、エンドユーザー別、地域別にうまく分散されると思われます。

生物製剤開発業務受託機関市場の参入企業例

Biocon
Covance
ICON
Medpace
Pharmaron
PPD
PRA Health Sciences
Syneos Health
Vimta Labs
WuXi AppTec

章の概要
予測調査手法と主要な前提条件
世界の生物製剤CRO市場
北米の生物製剤CRO市場
欧州の生物製剤CROサービス市場
アジア太平洋の生物製剤CROサービス市場
ラテンアメリカにおける生物製剤CROサービス市場
ラテンアメリカにおける生物製剤CROサービス市場

第12章 SWOT分析

第13章結論

第14章調査記録

第15章付録I：表形式データ

第16章付録II：企業および組織の一覧

図表

List of Tables

Table 4.1 Attributes of Transactional Outsourcing Based Business Model
Table 4.2 Comparison of Key Factors Considered by Biologic Developers for Selecting a CRO Partner: Harvey Ball Analysis
Table 5.1 Biopharmaceutical CROs: Information on Year of Establishment, Location of Headquarters, Company Size and Types of Biologics
Table 5.2 Biopharmaceutical Preclinical CROs: Information on Types of Services Offered
Table 5.3 Biopharmaceutical Clinical CROs: Information on Types of Services Offered
Table 6.1 Biocon: Company Overview
Table 6.2 Biocon: Future Outlook
Table 6.3 Covance: Company Overview
Table 6.4 Covance: Future Outlook
Table 6.5 ICON: Company Overview
Table 6.6 ICON: Future Outlook
Table 6.7 Medpace: Company Overview
Table 6.8 Medpace: Future Outlook
Table 6.9 Pharmaron: Company Overview
Table 6.10 Pharmaron: Future Outlook
Table 6.11 PPD: Company Overview
Table 6.12 PPD: Future Outlook
Table 6.13 PRA Health Sciences: Company Overview
Table 6.14 PRA Health Sciences: Future Outlook
Table 6.15 Syneos Health: Company Overview
Table 6.16 Syneos Health: Future Outlook
Table 6.17 VIMTA Labs: Company Overview
Table 6.18 WuXi App-Tec: Company Overview
Table 6.19 WuXi App Tec: Future Outlook
Table 7.1 Benchmark Analysis: Peer Groups
Table 8.1 Partnerships and Collaborations: List of Agreements, Since 2016
Table 9.1 Mergers and Acquisitions: List of Mergers / Acquisitions, Since 2016
Table 9.2 Mergers and Acquisitions: Information on Key Value Drivers, Since 2016
Table 9.3 Mergers and Acquisitions: Deal Multiples, Since 2016
Table 15.1 Biopharmaceutical CROs: Distribution by Year of Establishment, Company Size and Location of Headquarters
Table 15.2 Biopharmaceutical CROs: Distribution by Scale of Operation
Table 15.3 Biopharmaceutical Preclinical CROs: Distribution by Year of Establishment
Table 15.4 Biopharmaceutical Preclinical CROs: Distribution by Company Size
Table 15.5 Biopharmaceutical Preclinical CROs Distribution by Location of Headquarters
Table 15.6 Biopharmaceutical Preclinical CROs: Distribution by Types of Biologics
Table 15.8 Biopharmaceutical Preclinical CROs: Distribution by Types of Services Offered
Table 15.9 Biopharmaceutical Preclinical CROs: Distribution by Number of Services Offered
Table 15.10 Biopharmaceutical Preclinical CROs: Distribution by Types of Biologics and Types Services Offered
Table 15.11 Biopharmaceutical Clinical CROs: Distribution by Year of Establishment
Table 15.12 Biopharmaceutical Clinical CROs: Distribution by Company Size
Table 15.13 Biopharmaceutical Clinical CROs: Distribution by Location of Headquarters
Table 15.14 Biopharmaceutical Clinical CROs: Distribution by Types of Biologics
Table 15.15 Biopharmaceutical Clinical CROs: Distribution by Types of Services Offered
Table 15.16 Biopharmaceutical Clinical CROs: Distribution by Number of Services Offered
Table 15.17 Biopharmaceutical Clinical CROs: Distribution by Types of Biologics and Types of Services Offered
Table 15.18 Biocon: Annual Service Revenues, Since 2016 (INR Billion)
Table 15.19 Covance: Annual Service Revenues, Since 2016 (USD Billion)
Table 15.20 ICON: Annual Revenues, Since 2016 (USD Billion)
Table 15.21 Medpace: Annual Service Revenues, Since 2016 (USD Billion)
Table 15.22 PPD: Annual Service Revenues, Since 2016 (USD Billion)
Table 15.23 PRA Health Sciences: Annual Revenues, Since 2016 (USD Billion)
Table 15.24 Syneos: Annual Service Revenues, Since 2016 (USD Billion)
Table 15.25 Vimta Labs: Annual Service Revenues, Since 2016 (INR Billion)
Table 15.26 WuXi AppTec: Annual Service Revenues, Since 2016 (USD Billion)
Table 15.27 Partnerships and Collaborations: Distribution by Year of Partnership
Table 15.28 Partnerships and Collaborations: Distribution by Type of Partnership Model
Table 15.29 Partnerships and Collaborations: Distribution by Year of Partnership and Type of Partnership Model
Table 15.30 Most Active Players: Distribution by Number of Partnerships
Table 15.31 Partnerships and Collaborations: Distribution by Scale of Operation
Table 15.32 Partnerships and Collaborations: Distribution by Geography
Table 15.33 Partnerships and Collaborations: Country-Wise Distribution
Table 15.34 Partnerships and Collaborations: Intercontinental and Intracontinental Agreements
Table 15.35 Mergers and Acquisitions: Distribution by Year of Merger / Acquisition (Since 2016)
Table 15.36 Mergers and Acquisitions: Distribution by Type of Merger / Acquisition
Table 15.37 Mergers and Acquisitions: Distribution by Year and Type of Agreement
Table 15.38 Mergers and Acquisitions: Continent-wise Distribution
Table 15.39 Mergers and Acquisitions: Continent-wise Distribution
Table 15.40 Mergers and Acquisitions: Country-wise Distribution
Table 15.41 Mergers and Acquisitions: Ownership Change Matrix
Table 15.42 Mergers and Acquisitions: Key Value Drivers
Table 15.43 Mergers and Acquisitions: Distribution by Year of Acquisition and Key Value Drivers
Table 15.44 Mergers and Acquisitions: Deal Multiples Based on Revenue
Table 15.45 Mergers and Acquisitions: Deal Multiples Based on Year of Experience
Table 15.46 Global Biopharmaceutical CROs Market: Distribution by Types of Biologics
Table 15.47 Global Biopharmaceutical CROs Market: Distribution by Therapeutic Area
Table 15.48 Global Biopharmaceutical CROs Market: Distribution by Scale of Operation
Table 15.49 Global Biopharmaceutical CROs Market: Distribution by Geography
Table 15.50 Biopharmaceutical CROs Market in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.51 Biopharmaceutical CROs Market for Oncological Disorders in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.52 Biopharmaceutical CROs Market for Cardiovascular Disorders in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.53 Biopharmaceutical CROs Market for Inflammatory Disorders in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.54 Biopharmaceutical CROs Market for Neurological Disorders in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.55 Biopharmaceutical CROs Market for Other Therapeutic Areas in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.56 Biopharmaceutical CROs Market for Preclinical Operations in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.57 Biopharmaceutical CROs Market for Clinical Operations in North America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.58 Biopharmaceutical CROs Market in Europe, Till 2035 (USD Million)
Table 15.59 Biopharmaceutical CROs Market for Oncological Disorders in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.60 Biopharmaceutical CROs Market for Cardiovascular Disorders in Europe, Till 2035 (USD Million)
Table 15.61 Biopharmaceutical CROs Market for Inflammatory Disorders in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.62 Biopharmaceutical CROs Market for Neurological Disorders in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.63 Biopharmaceutical CROs Market for Other Therapeutic Areas in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.64 Biopharmaceutical CROs Market for Preclinical Operations in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.65 Biopharmaceutical CROs Market for Clinical Operations in Europe, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.66 Biopharmaceutical CROs Market in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.67 Biopharmaceutical CROs Market for Oncological Disorders in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.68 Biopharmaceutical CROs Market for Cardiovascular Disorders in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.69 Biopharmaceutical CROs Market for Inflammatory Disorders in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.70 Biopharmaceutical CROs Market for Neurological Disorders in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.71 Biopharmaceutical CROs Market for Other Therapeutic Areas in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.72 Biopharmaceutical CROs Market for Preclinical Operations in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.73 Biopharmaceutical CROs Market for Clinical Operations in Asia-Pacific, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.74 Biopharmaceutical CROs Market for Preclinical Operations in Latin America, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.75 Biopharmaceutical CROs Market for Preclinical Operations in Middle East North Africa, Conservative, Base and Optimistic Scenarios, Till 2035 (USD Million)
Table 15.76 Biopharmaceutical CROs Market: Conservative, Base and Optimistic Scenarios (USD Million)

List of Figures

Figure 3.1 Types of Biologics
Figure 3.2 Stages of the Drug Development Process
Figure 3.3 Commonly Offered Services by CROs
Figure 3.4 Advantages of Outsourcing Operations to CROs
Figure 3.5 Risks Associated with Outsourcing Operations to CROs
Figure 4.1 Guiding Models for Outsourcing
Figure 4.2 Key Characteristics of Transactional Outsourcing Model
Figure 4.3 Key Characteristics of Performance / Outcome based Business Model
Figure 4.4 Steps to Consider before Outsourcing
Figure 4.5 Key Considerations while Selecting a CRO Partner
Figure 4.6 Role of CROs in the Drug Development Process
Figure 5.1 Biopharmaceutical CROs: Distribution by Year of Establishment, Company Size and Location of Headquarters
Figure 5.2 Biopharmaceutical CROs: Distribution by Scale of Operation
Figure 5.3 Biopharmaceutical Preclinical CROs: Distribution by Year of Establishment
Figure 5.4 Biopharmaceutical Preclinical CROs: Distribution by Company Size
Figure 5.5 Biopharmaceutical Preclinical CROs Distribution by Location of Headquarters
Figure 5.6 Biopharmaceutical Preclinical CROs: Distribution by Types of Biologics
Figure 5.7 Biopharmaceutical Preclinical CROs: Distribution by Types of Services Offered
Figure 5.8 Biopharmaceutical Preclinical CROs: Distribution by Number of Services Offered
Figure 5.9 Biopharmaceutical Preclinical CROs: Distribution by Types of Biologics and Types of Services Offered
Figure 5.10 Biopharmaceutical Clinical CROs: Distribution by Year of Establishment
Figure 5.11 Biopharmaceutical Clinical CROs: Distribution by Company Size
Figure 5.12 Biopharmaceutical Clinical CROs: Distribution by Location of Headquarters
Figure 5.13 Biopharmaceutical Clinical CROs: Distribution by Types of Biologics
Figure 5.14 Biopharmaceutical Clinical CROs: Distribution by Types of Services Offered
Figure 5.15 Biopharmaceutical Clinical CROs: Distribution by Number of Services Offered
Figure 5.16 Biopharmaceutical Clinical CROs: Distribution by Types of Biologics and Types of Services Offered
Figure 6.1 Biocon: Annual Services Revenues, Since 2016 (INR Billion)
Figure 6.2 Biocon: Service Portfolio
Figure 6.3 Covance: Annual Services Revenues, Since 2016 (USD Billion)
Figure 6.4 Covance: Service Portfolio
Figure 6.5 ICON: Annual Revenues, Since 2016 (USD Billion)
Figure 6.6 ICON: Service Portfolio
Figure 6.7 Medpace: Annual Services Revenues, Since 2016 (USD Billion)
Figure 6.8 Medpace: Service Portfolio
Figure 6.9 Medpace: Regulatory Affair Capabilities
Figure 6.10 Pharmaron: Service Portfolio
Figure 6.11 PPD: Annual Services Revenues, Since 2016 (USD Billion)
Figure 6.12 PPD: Service Portfolio
Figure 6.13 PRA Health Sciences: Annual Revenues, Since 2016 (USD Billion)
Figure 6.14 PRA Health Sciences: Service Portfolio
Figure 6.15 Syneos Health: Annual Services Revenues, Since 2016 (USD Billion)
Figure 6.16 Syneos Health: Service Portfolio
Figure 6.17 Vimta Labs: Annual Service Revenues, Since 2016 (INR Billion)
Figure 6.18 Vimta Labs: Service Portfolio
Figure 6.19 WuXi App Tec: Annual Services Revenues, Since 2016 (USD Billion)
Figure 6.20 WuXi App Tec: Service Portfolio
Figure 7.1 Benchmark Analysis: Distribution by Company Size and Location of Headquarters
Figure 7.2 Benchmark Analysis: Peer Group I
Figure 7.3 Benchmark Analysis: Peer Group II
Figure 7.4 Benchmark Analysis: Peer Group III
Figure 7.5 Benchmark Analysis: Peer Group IV
Figure 7.6 Benchmark Analysis: Peer Group V
Figure 7.7 Benchmark Analysis: Peer Group VI
Figure 7.8 Benchmark Analysis: Peer Group VII
Figure 7.9 Benchmark Analysis: Peer Group VIII
Figure 8.1 Partnerships and Collaborations: Distribution by Year of Partnership
Figure 8.2 Partnerships and Collaborations: Distribution by Type of Partnership Model
Figure 8.3 Partnerships and Collaborations: Distribution by Year of Partnership and Type of Partnership Model
Figure 8.4 Most Active Players: Distribution by Number of Partnerships
Figure 8.5 Partnerships and Collaborations: Distribution by Scale of Operation
Figure 8.6 Partnerships and Collaborations: Distribution by Geography
Figure 8.7 Partnerships and Collaborations: Country-Wise Distribution
Figure 8.8 Partnerships and Collaborations: Intercontinental and Intracontinental Agreements
Figure 9.1 Mergers and Acquisitions: Distribution by Year of Merger / Acquisition (Since 2016)
Figure 9.2 Mergers and Acquisitions: Distribution by Type of Merger / Acquisition
Figure 9.3 Mergers and Acquisitions: Distribution by Year and Type of Merger / Acquisition
Figure 9.4 Mergers and Acquisitions: Continent-wise Distribution
Figure 9.5 Mergers and Acquisitions: Region-wise Distribution
Figure 9.6 Mergers and Acquisitions: Country-wise Distribution
Figure 9.7 Mergers and Acquisitions: Ownership Change Matrix
Figure 9.8 Mergers and Acquisitions: Key Value Drivers
Figure 9.9 Mergers and Acquisitions: Distribution by Year of Acquisition and Key Value Drivers
Figure 9.10 Mergers and Acquisitions: Deal Multiples Based on Revenue
Figure 9.11 Mergers and Acquisitions: Deal Multiples Based on Year of Experience
Figure 10.1. AC Matrix: Pictorial Representation
Figure 10.2. AC Matrix: Positioning of Different Biologics in North America
Figure 10.3. AC Matrix: Positioning of Different Biologics in Europe
Figure 10.4. AC Matrix: Positioning of Different Biologics in Asia Pacific
Figure 11.1 Biopharmaceutical CROs: Market Forecast Methodology
Figure 11.2 Global Biopharmaceutical CROs Market, Till 2035
Figure 11.3 Global Biopharmaceutical CROs Market: Distribution by Types of Biologics
Figure 11.4 Global Biopharmaceutical CROs Market: Distribution by Therapeutic Area
Figure 11.5 Global Biopharmaceutical CROs Market: Distribution by Scale of Operation
Figure 11.6 Global Biopharmaceutical CROs Market: Distribution by Geography
Figure 11.7 Biopharmaceutical CROs Market in North America, Till 2035 (USD Million)
Figure 11.8 Biopharmaceutical CROs Market for Oncological Disorders in North America, Till 2035 (USD Million)
Figure 11.9 Biopharmaceutical CROs Market for Cardiovascular Disorders in North America, Till 2035 (USD Million)
Figure 11.10 Biopharmaceutical CROs Market for Inflammatory Disorders in North America, Till 2035 (USD Million)
Figure 11.11 Biopharmaceutical CROs Market for Neurological Disorders in North America, Till 2035 (USD Million)
Figure 11.12 Biopharmaceutical CROs Market for Other Therapeutic Areas in North America, Till 2035 (USD Million)
Figure 11.13 Biopharmaceutical CROs Market for Preclinical Operations in North America, Till 2035 (USD Million)
Figure 11.14 Biopharmaceutical CROs Market for Clinical Operations in North America, Till 2035 (USD Million
Figure 11.15 Biopharmaceutical CROs Market in Europe, Till 2035 (USD Million)
Figure 11.16 Biopharmaceutical CROs Market for Oncological Disorders in Europe, Till 2035 (USD Million)
Figure 11.17 Biopharmaceutical CROs Market for Cardiovascular Disorders in Europe, Till 2035 (USD Million)
Figure 11.18 Biopharmaceutical CROs Market for Inflammatory Disorders in Europe, Till 2035 (USD Million)
Figure 11.19 Biopharmaceutical CROs Market for Neurological Disorders in Europe, Till 2035 (USD Million)
Figure 11.20 Biopharmaceutical CROs Market for Other Therapeutic Areas in Europe, Till 2035 (USD Million)
Figure 11.21 Biopharmaceutical CROs Market for Preclinical Operations in Europe, Till 2035 (USD Million)
Figure 11.22 Biopharmaceutical CROs Market for Clinical Operations in Europe, Till 2035 (USD Million)
Figure 11.23 Biopharmaceutical CROs Market in Asia-Pacific, Till 2035 (USD Million)
Figure 11.24 Biopharmaceutical CROs Market for Oncological Disorders in Asia-Pacific, Till 2035 (USD Million)
Figure 11.25 Biopharmaceutical CROs Market for Cardiovascular Disorders in Asia-Pacific, Till 2035 (USD Million)
Figure 11.26 Biopharmaceutical CROs Market for Inflammatory Disorders in Asia-Pacific, Till 2035 (USD Million)
Figure 11.27 Biopharmaceutical CROs Market for Neurological Disorders in Asia-Pacific, Till 2035 (USD Million)
Figure 11.28 Biopharmaceutical CROs Market for Other Therapeutic Areas in Asia-Pacific, Till 2035 (USD Million)
Figure 11.29 Biopharmaceutical CROs Market for Preclinical Operations in Asia-Pacific, Till 2035 (USD Million)
Figure 11.30 Biopharmaceutical CROs Market for Clinical Operations in Asia-Pacific, Till 2035 (USD Million)
Figure 11.31 Biopharmaceutical CROs Market in Latin America, Till 2035 (USD Million)
Figure 11.32 Biopharmaceutical CROs Market in Middle East North Africa, Till 2035 (USD Million)
Figure 11.33 Biopharmaceutical CROs Market: Conservative, Base and Optimistic Scenarios (USD Million)
Figure 12.1 Biopharmaceutical CROs SWOT Analysis: Overview
Figure 12.2 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 13.1 Concluding Remarks: Current Market Landscape for Preclinical Biopharmaceutical CROs
Figure 13.2 Concluding Remarks: Current Market Landscape for Clinical Biopharmaceutical CROs
Figure 13.3 Concluding Remarks: Recent Partnerships
Figure 13.4 Concluding Remarks: Mergers and Acquisitions
Figure 13.5 Concluding Remarks: Clinical Trial Analysis
Figure 13.6 Concluding Remarks: Market Sizing and Opportunity Analysis

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: OVERVIEW

As per Roots Analysis, the global biologics contract research organization market valued at USD 21.5 billion in the current year is anticipated to grow at a lucrative CAGR of 13% during the forecast period.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Biologic

Vaccines
Cell Therapy
Gene Therapy
Antibodies
Recombinant Proteins / Peptides
Others

Scale of Operation

Clinical Operations
Preclinical Operations

Therapeutic Area

Oncological Disorders
Cardiovascular Disorders
Inflammatory Disorders
Neurological Disorders
Other Therapeutic Areas

Geography

North America
Europe
Asia-Pacific
Latin America
Middle East and North Africa
Rest of the World

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: GROWTH AND TRENDS

Biologics represent one of the fastest growing segments of the pharmaceutical industry. This can

be attributed to the rapid pace of innovation in this field, driven by the need for effective and personalized pharmacological interventions. However, the development and clinical testing of biologics is a highly complex and costly process that demands specialized expertise and advanced bioprocessing technologies. As a result, many biopharmaceutical companies are choosing to outsource their drug discovery and clinical research operations.

Currently, biopharmaceutical companies are embracing a business model, wherein the development processes are outsourced to external service providers, whereas the company itself is responsible for the R&D of drugs. These external research service providers are various biopharma contract research organizations (CRO) that take on one or more responsibilities typically held by a developer. Examples of such responsibilities include protocol design, selection or monitoring of investigations, evaluation of reports, and preparation of documentation for submission to the US FDA. Key advantages offered by biopharma CRO include time efficiency, cost effectiveness, key to innovation, and quality innovation. Consequently, the biologics contract research organization market is anticipated to expand gradually to fulfil the growing R&D demands of biopharmaceutical sponsors.

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: KEY INSIGHTS

The report delves into the current state of the biologics contract research organization market and identifies potential growth opportunities within industry. Some key findings from the report include:

Presently, 160 players claim to have the necessary capabilities to offer contract research services and clinical trial support for different types of biopharmaceutical products.
About 50% of all the players offer only clinical services; of these, 12% CROs provide all the services associated with clinical research of biologics.
The current market landscape is fragmented, featuring a mix of well-established players and specialty service providers, having extensive portfolios to support preclinical and clinical research.
It is estimated that big pharma players presently outsource close to 45% of their internal R&D operations to CROs.
More than two-thirds of the contract research service providers are based in North America and Europe; most of these players are small and mid-sized companies.
In order to gain a competitive edge, companies are actively expanding their existing capabilities in order to further augment their respective offerings and also comply with evolving industry benchmarks.

Over 8,000 product candidates are currently being evaluated / under development biologic drug developers, presenting opportunities in the biologics contract research organization market.
The growing interest of stakeholders in this field is also reflected in the increase in partnership activity in the recent past; since 2016, industry players have signed multiple deals with sponsor and / or other CROs.
Close to 20% of the CROs provide research services for biologics at the clinical and preclinical scales.
With the rising demand for one-stop shops, industry stakeholders are actively consolidating their capabilities related to biopharmaceutical research, mostly through mergers and acquisitions, and internal expansions.

The market is expected to grow at a CAGR of ~13% in the coming decade; the opportunity is likely to be well distributed across therapeutic areas, scales of operation, types of biologics, end users and geographical regions.

Example Players in the Biologics Contract Research Organization Market

Biocon
Covance
ICON
Medpace
Pharmaron
PPD
PRA Health Sciences
Syneos Health
Vimta Labs
WuXi AppTec

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global biologics contract research organization market, focusing on key market segments, including [A] type of biologic, [B] scale of operation, [C] therapeutic area and [D] geography.
Market Landscape: A comprehensive evaluation of the biopharmaceutical services market, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] types of biologics manufactured, [E] scale of operation and [F] types of services offered (including clinical services and preclinical services).
Company Profiles: In-depth profiles of CROs engaged in offering biopharmaceutical related services, focusing on [A] overview of the company, [B] financial information (if available), [C] service portfolio and [D] recent developments and an informed future outlook.
Benchmarking Analysis: A comprehensive benchmark analysis of players engaged in biologics contract research organization market based on the [A] capabilities of companies with a peer groups with an aim to gain a competitive edge.
Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the biologics contract research organization market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] most active players (in terms of number of partnerships signed), [D] scale of operation and [E] geography.
Mergers and Acquisitions: An in-depth analysis of the mergers and acquisitions undertaken in this domain, based on relevant parameters, such as [A] year of acquisition, [B] type of collaboration, [C] geography, [D] most active acquirers, [E] ownership change matrix, [F] key value drivers and [G] acquisition deal multiples.
Attractiveness Competitiveness Matrix: A comprehensive acquisition target analysis, considering the historical trend of the activity of companies that have acquired other firms since 2016, and providing a means for other industry players to identify potential acquisition targets.
SWOT Analysis: An analysis of industry affiliated trends, opportunities and challenges, which are likely to impact the evolution of biologics contract research organization market; it includes a Harvey ball analysis, assessing the relative impact of each SWOT parameter on industry dynamics.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?
Which are the leading companies in this market?
What factors are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

ADDITIONAL BENEFITS

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Detailed Report Walkthrough Session with Research Team
Free Updated report if the report is 6-12 months old or older

1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
- 1.2.1. Research Assumptions
- 1.2.2. Project Methodology
- 1.2.3. Forecast Methodology
- 1.2.4. Robust Quality Control
- 1.2.5. Key Considerations
  - 1.2.5.1. Demographics
  - 1.2.5.2. Economic Factors
  - 1.2.5.3. Government Regulations
  - 1.2.5.4. Supply Chain
  - 1.2.5.5. COVID Impact / Related Factors
  - 1.2.5.6. Market Access
  - 1.2.5.7. Healthcare Policies
  - 1.2.5.8. Industry Consolidation
1.3 Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3 Introduction

3.1. Chapter Overview
3.2. Overview of Biologics
- 3.2.1. Types of Biologics
3.3. Overview of Contract Research Organizations (CROs)
3.4. Evolution of CROs
3.5. Classification of CROs
3.6. Services Offered by CROs
3.7. Advantages of Outsourcing Operations to CROs
3.8. Risks Associated with Outsourcing Operations to CROs

4. GUIDE TO OUTSOURCING

4.1. Chapter Overview
4.2. Outsourcing Biologics Research
4.3. Models of Outsourcing
- 4.3.1. Transactional Outsourcing Model
- 4.3.2. Performance / Outcome-based Business Model
- 4.3.3. Staff Augmentation Model
- 4.3.4. Phase-Dependent Outsourcing Model
4.4. Selecting an Appropriate Outsourcing Model
- 4.4.1. Hybrid Approach
4.5. Selecting a CRO Partner
- 4.5.1. Key Considerations for Outsourcing Biologics-related Operations
4.6. Role of CROs in the Drug Development Process
- 4.6.1. Discovery and Preclinical Research
- 4.6.2. Early Clinical Research
- 4.6.3. Clinical Research and Laboratory Services
4.7. Conclusion

5. MARKET LANDSCAPE

5.1. Chapter Overview
5.2. Biopharmaceutical CROs: Overall Market Landscape
- 5.2.1. Analysis by Year of Establishment, Company Size and Location of Headquarters
- 5.2.2. Analysis by Scale of Operation
5.3. Preclinical Biopharmaceutical CROs
- 5.3.1. Analysis by Year of Establishment
- 5.3.2. Analysis by Company Size
- 5.3.3. Analysis by Location of Headquarters
- 5.3.4. Analysis by Type of Biologic
- 5.3.5. Analysis by Type of Services Offered
5.4. Clinical Biopharmaceutical CROs
- 5.4.1. Analysis by Year of Establishment
- 5.4.2. Analysis by Company Size
- 5.4.3. Analysis by Location of Headquarters
- 5.4.4. Analysis by Type of Biologics
- 5.4.5. Analysis by Type of Services Offered

6. COMPANY PROFILES

6.1. Chapter Overview
6.2. Biocon
- 6.2.1. Company Overview
- 6.2.2. Financial Information
- 6.2.3. Services Portfolio
- 6.2.4. Future Outlook
6.3. Covance
- 6.3.1. Company Overview
- 6.3.2. Service Portfolio
- 6.3.3. Financial Information
- 6.3.4. Future Outlook
6.4. ICON
- 6.4.1. Company Overview
- 6.4.2. Financial Information
- 6.4.3. Service Portfolio
- 6.4.4. Future Outlook
6.5. Medpace
- 6.5.1. Company Overview
- 6.5.2. Financial Information
- 6.5.3. Service Portfolio
- 6.5.4. Future Outlook
6.6. Pharmaron
- 6.6.1. Company Overview
- 6.6.2. Services Portfolio
- 6.6.3. Future Outlook
6.7. PPD
- 6.7.1. Company Overview
- 6.7.2. Service Portfolio
- 6.7.3. Financial Information
- 6.7.4. Future Outlook
6.8. PRA Health Sciences
- 6.8.1. Company Overview
- 6.8.2. Financial Information
- 6.8.3. Service Portfolio
- 6.8.4. Future Outlook
6.9. Syneos Health
- 6.9.1. Company Overview
- 6.9.2. Financial Information
- 6.9.3. Services Portfolio
- 6.9.4. Future Outlook
6.10. Vimta Labs
- 6.10.1. Company Overview
- 6.10.2. Services Portfolio
- 6.10.3. Financial Information
- 6.10.4. Future Outlook
6.11. WuXi AppTec
- 6.11.1. Company Overview
- 6.11.2. Financial Information
- 6.11.3. Service Portfolio
- 6.11.4. Future Outlook

7. BENCHMARK ANALYSIS

7.1. Chapter Overview
7.2. Methodology
7.3. Benchmark Analysis: Peer Groups
- 7.3.1. Peer Group I
- 7.3.2. Peer Group II
- 7.3.3. Peer Group III
- 7.3.4. Peer Group IV
- 7.3.5. Peer Group V
- 7.3.6. Peer Group VI
- 7.3.7. Peer Group VII
- 7.3.8. Peer Group VIII

8. PARTNERSHIPS AND COLLABORATIONS

8.1. Chapter Overview
8.2. Partnership Models
8.3. Biopharmaceutical CROs: Recent Partnerships and Collaborations
- 8.3.1. Analysis by Year of Partnership
- 8.3.2. Analysis by Type of Partnership Model
  - 8.3.2.1. Analysis by Year of Partnership and Type of Partnership Model
- 8.3.3. Most Active Players: Analysis by Number of Partnerships
- 8.3.4. Analysis by Scale of Operation
- 8.3.5. Analysis by Geography
  - 8.3.5.1. Country-wise Analysis
  - 8.3.5.2. Intercontinental and Intracontinental Agreements

9. MERGERS AND ACQUISITIONS

9.1. Chapter Overview
9.2. Merger and Acquisition Models
9.3. Biopharmaceutical CROs: Mergers and Acquisitions
- 9.3.1. Analysis by Year of Acquisition
- 9.3.2. Analysis by Type of Collaboration
- 9.3.3. Analysis by Geography
  - 9.3.3.1. Continent-wise Distribution
  - 9.3.3.2. Country-wise Distribution
- 9.3.4. Ownership Change Matrix
- 9.3.5. Most Active Acquirers: Analysis by Number of Acquisitions
9.4. Distribution by Key Value Drivers
- 9.4.1. Analysis by Key Value Drivers
- 9.4.2. Analysis by Key Value Drivers and Year of Acquisitions
9.5. Valuation Analysis: Acquisition Deal Multiples

10. ATTRACTIVENESS COMPETATIVENESS MATRIX

10.1. Chapter Overview
10.2. AC Matrix: Overview
- 10.2.1. Strong Business Segment
- 10.2.2. Average Business Segment
- 10.2.3. Weak Business Segment
10.3. Analytical Methodology
10.4. AC Matrix: Contract Manufacturing Scenario in North America
10.5. AC Matrix: Contract Manufacturing Scenario in Europe
10.6. AC Matrix: Contract Manufacturing Scenario in Asia Pacific and Middle East

11. MARKET FORECAST

11.1. Chapter Overview
11.2. Forecast Methodology and Key Assumptions
11.3. Global Biopharmaceutical CROs Market
- 11.3.1. Global Biopharmaceutical CROs Market: Distribution by Types of Biologics
- 11.3.2. Global Biopharmaceutical CROs Market: Distribution by Therapeutic Area
- 11.3.3. Global Biopharmaceutical CROs Market: Distribution by Scale of Operation
- 11.3.4. Global Biopharmaceutical CROs Market: Distribution by Geography
11.4. Biopharmaceutical CROs Market in North America
- 11.4.1. Biopharmaceutical CROs Market in North America: Distribution by Therapeutic Area
  - 11.4.1.1. Biopharmaceutical CROs Market for Oncological Disorders in North America, Till 2035
  - 11.4.1.2. Biopharmaceutical CROs Market for Cardiovascular Disorders in North America, Till 2035
  - 11.4.1.3. Biopharmaceutical CROs Market for Inflammatory Disorders in North America, Till 2035
  - 11.4.1.4. Biopharmaceutical CROs Market for Neurological Disorders in North America, Till 2035
  - 11.4.1.5. Biopharmaceutical CROs Market for Other Therapeutic Areas in North America, Till 2035
- 11.4.2. Biopharmaceutical CROs Market in North America: Distribution by Scale of Operation
  - 11.4.2.1. Biopharmaceutical CROs Market for Preclinical Operations in North America, Till 2035
  - 11.4.2.2. Biopharmaceutical CROs Market for Clinical Operations in North America, Till 2035
11.5. Biopharmaceutical CRO Services Market in Europe
- 11.5.1. Biopharmaceutical CRO Services Market: Distribution by Therapeutic Area in Europe
  - 11.5.1.1. Biopharmaceutical CRO Services Market for Oncological Disorders in Europe, Till 2035
  - 11.5.1.2. Biopharmaceutical CRO Services Market for Cardiovascular Disorders in Europe, Till 2035
  - 11.5.1.3. Biopharmaceutical CRO Services Market for Inflammatory Disorders in Europe, Till 2035
  - 11.5.1.4. Biopharmaceutical CRO Services Market for Neurological Disorders in Europe, Till 2035
  - 11.5.1.5. Biopharmaceutical CRO Services Market for Other Therapeutic Areas in Europe, Till 2035
- 11.5.2. Biopharmaceutical CRO Services Market: Distribution by Scale of Operation in Europe
  - 11.5.2.1. Biopharmaceutical CRO Services Market for Preclinical Operations in Europe, Till 2035
  - 11.5.2.2. Biopharmaceutical CRO Services Market for Clinical Operations in Europe, Till 2035
11.6. Biopharmaceutical CRO Services Market in Asia-Pacific
- 11.6.1. Biopharmaceutical CRO Services Market: Distribution by Therapeutic Area in Asia-Pacific
  - 11.6.1.1. Biopharmaceutical CRO Services Market for Oncological Disorders in Asia-Pacific, Till 2035
  - 11.6.1.2. Biopharmaceutical CRO Services Market for Cardiovascular Disorders in Asia-Pacific, Till 2035
  - 11.6.1.3. Biopharmaceutical CRO Services Market for Inflammatory Disorders in Asia-Pacific, Till 2035
  - 11.6.1.4. Biopharmaceutical CRO Services Market for Neurological Disorders in Asia-Pacific, Till 2035
  - 11.6.1.5. Biopharmaceutical CRO Services Market for Other Therapeutic Areas in Asia-Pacific, Till 2035
- 11.6.2. Biopharmaceutical CRO Services Market: Distribution by Scale of Operation in Asia-Pacific
  - 11.6.2.1. Biopharmaceutical CRO Services Market for Preclinical Operations in Asia-Pacific, Till 2035
  - 11.6.2.2. Biopharmaceutical CRO Services Market for Clinical Operations in Asia-Pacific, Till 2035
11.7. Biopharmaceutical CRO Services Market in Latin America
11.8. Biopharmaceutical CRO Services Market in Middle East North America

12. SWOT ANALYSIS

12.1. Chapter Overview
12.2. Strengths
12.3. Weaknesses
12.4. Opportunities
12.5. Threats
12.6. Comparison of SWOT Factors

生物製剤開発業務受託機関市場：業界動向と世界の予測 - 生物学的製剤タイプ別、事業規模別、治療領域別、地域別

Biologics Contract Research Organization Market: Industry Trends and Global Forecasts - Distribution by Type of Biologic, Scale of Operation, Therapeutic Area, and Geography

生物製剤開発業務受託機関市場：概要

生物製剤の医薬品開発業務受託機関市場：成長と動向

生物製剤開発業務受託機関市場：主要インサイト

生物製剤開発業務受託機関市場の参入企業例

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3章 イントロダクション

第4章 アウトソーシングガイド

第5章 市場情勢

第6章 企業プロファイル

第7章 ベンチマーク分析

第8章 パートナーシップとコラボレーション

第9章 合併と買収

第10章 魅力と競争力のマトリックス

第11章 市場予測

第12章 SWOT分析

第13章 結論

第14章 調査記録

第15章 付録I：表形式データ

第16章 付録II：企業および組織の一覧

List of Tables

List of Figures

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: OVERVIEW

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: GROWTH AND TRENDS

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: KEY INSIGHTS

Example Players in the Biologics Contract Research Organization Market

BIOLOGICS CONTRACT RESEARCH ORGANIZATION MARKET: RESEARCH COVERAGE

KEY QUESTIONS ANSWERED IN THIS REPORT

REASONS TO BUY THIS REPORT

ADDITIONAL BENEFITS

TABLE OF CONTENTS

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3 Introduction

4. GUIDE TO OUTSOURCING

5. MARKET LANDSCAPE

6. COMPANY PROFILES

7. BENCHMARK ANALYSIS

8. PARTNERSHIPS AND COLLABORATIONS

9. MERGERS AND ACQUISITIONS

10. ATTRACTIVENESS COMPETATIVENESS MATRIX

11. MARKET FORECAST

12. SWOT ANALYSIS

13. CONCLUDING REMARKS

14. SURVEY TRANSCRIPTS

15. APPENDIX I: TABULATED DATA

16. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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3章イントロダクション

第4章アウトソーシングガイド

第5章市場情勢

第6章企業プロファイル

第7章ベンチマーク分析

第8章パートナーシップとコラボレーション

第9章合併と買収

第10章魅力と競争力のマトリックス

第11章市場予測

第13章結論

第14章調査記録

第15章付録I：表形式データ

第16章付録II：企業および組織の一覧