細胞・遺伝子治療CRO市場（第4版）：業界動向と世界の予測（～2035年）細胞治療タイプ別、遺伝子組み換えタイプ別、開発段階別、治療領域別、エンドユーザー別、および主要な地理的地域

細胞・遺伝子治療CROの市場規模は、2024年に16億5,300万米ドルとなり、2024年～2035年の予測期間中に7.1％のCAGRで拡大すると予測されています。

細胞・遺伝子治療薬の候補は、現在効果的な治療法が開発段階にある疾患を含め、希少疾患や複雑な疾患の治療において有望な結果を示しています。細胞療法では、損傷した細胞や組織を修復したり置き換えたりするためにヒト細胞を移植し、特定の細胞セットを変化させたり回復させたりすることで治療を促進することに注目する必要があります。これらの細胞は、患者（自家細胞）から供給されることもあれば、ドナー（同種細胞）から供給されることもあります。逆に、遺伝子治療は、体内外の細胞に遺伝子を置換、不活性化、導入することによって、根本的な遺伝的問題に対処し、疾患の治療や予防を行うことを目的としています。治療的介入の中には、細胞治療と遺伝子治療の両方に分類されるものがあることは注目に値します。その作用機序は通常、特定の細胞タイプにおける遺伝子の改変と、それに続く患者の体内への挿入を伴います。

現在、90以上の細胞治療と遺伝子治療が世界的に承認されています。最近の承認例としては、多発性骨髄腫治療薬のFucaso（2023年、IASO Bioが開発）、デュシェンヌ型筋ジストロフィー治療薬のElvediys（2023年、Sarepta Therapeutics社が開発）、ジストロフィー性表皮水疱症治療薬のVyjuvek（2023年、Krystal Biotechが開発）などがあります。さらに、3,500以上の臨床研究が進行中で、16の治療分野で細胞療法と遺伝子療法が評価されています。これらの治療法を開発しているバイオテクノロジー企業に加えて、市場の利害関係者がその成功に貢献しています。開発業務受託機関（CRO）とは別に、臨床試験ソフトウェアソリューションを提供する企業は、臨床試験管理において重要な役割を果たしています。これらのプラットフォームプロバイダーは、細胞治療や遺伝子治療の分散型／バーチャル臨床試験を促進するための新しいプラットフォームを模索しています。米国を拠点とするJeeva Clinical Trials社もその一つで、臨床試験参加者の移動負担を軽減することを目的としたSaaSプラットフォームを開発しています。さらに、医薬品開発企業やCROがサプライチェーンを管理できるよう、細胞・遺伝子治療のサプライチェーンソフトウェアを開発している企業もあります。

細胞・遺伝子治療の情勢が急速に進展する中、CROは複雑な規制状況を乗り切り、試験デザインを最適化し、前臨床から臨床へのシームレスな移行を促進する専門知識を有しています。これらの要因により、予測期間中、契約サービスプロバイダーには大きな市場成長機会がもたらされると期待されます。

当レポートでは、世界の細胞・遺伝子治療CRO市場について調査し、市場の概要とともに、細胞治療タイプ別、遺伝子組み換えタイプ別、開発段階別、治療領域別、エンドユーザー別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 序文

第2章 調査手法

第3章 経済およびその他のプロジェクト特有の考慮事項

第4章 エグゼクティブサマリー

第5章 イントロダクション

第6章 アウトソーシングガイド

• 章の概要
• 細胞および遺伝子治療研究：アウトソーシングの必要性
• アウトソーシングモデル
• 適切なアウトソーシングモデルの選択
• CROパートナーの選択
• 医薬品開発におけるCROの役割
• 結論

第7章 市場情勢

• 章の概要
• 細胞・遺伝子治療CRO：市場情勢

第8章 企業プロファイル

• 章の概要
• Aixial
• Altasciences
• CMIC
• ICON
• Labcorp
• Linical
• Medpace
• Novotech
• PPD
• Precision for Medicine
• QPS
• Syneos Health

第9章 ベンチマーク分析

• 章の概要
• 主な前提と調査手法
• 細胞・遺伝子治療CRO：ベンチマーク分析
• 結論

第10章 パートナーシップとコラボレーション

第11章 合併と買収

第12章 主な買収ターゲット

第13章 臨床試験の分析

• 章の概要
• 範囲と調査手法
• 細胞治療：臨床試験分析
• 遺伝子治療：臨床試験分析

第14章 総所有コスト

第15章 SWOT分析

第16章 世界の細胞・遺伝子治療CRO市場

• 章の概要
• 主な前提と調査手法
• 世界の細胞・遺伝子治療CRO市場、過去の動向（2018年～2023年）および予測（2024年～2035年）
• 主要な市場セグメンテーション

第17章 細胞・遺伝子治療CRO市場、細胞治療タイプ別

第18章 細胞・遺伝子治療CRO市場、遺伝子組み換えタイプ別

第19章 細胞・遺伝子治療CRO市場、開発段階別

第20章 細胞・遺伝子治療CRO市場、治療領域別

第21章 細胞・遺伝子治療CRO市場、エンドユーザー別

第22章 細胞・遺伝子治療CRO市場、主要地域別

第23章 エグゼクティブ洞察

第24章 結論

第25章 付録I：表形式データ

第26章 付録II：企業および団体一覧

List of Tables

• Table 5.1 List of Approved ATMP Products
• Table 6.1 Attributes of Transactional Outsourcing Model
• Table 7.1 List of Cell and Gene Therapy CROs
• Table 7.2 Cell and Gene Therapy CROs: Information on Scale of Operation
• Table 7.3 Cell and Gene Therapy CROs: Information on Type of Preclinical Services Offered
• Table 7.4 Cell and Gene Therapy CROs: Information on Type of Clinical Services Offered
• Table 7.5 Cell and Gene Therapy CROs: Information on Type of Regulatory Services Offered
• Table 7.6 Cell and Gene Therapy CROs: Information on Type of General Services Offered
• Table 8.1 Cell and Gene Therapy CROs: List of Companies Profiled
• Table 8.2 Aixial: Company Overview
• Table 8.3 Aixial: Service Portfolio
• Table 8.4 Altasciences: Company Overview
• Table 8.5 Altasciences: Service Portfolio
• Table 8.6 Altasciences: Recent Developments and Future Outlook
• Table 8.7 CMIC: Company Overview
• Table 8.8 CMIC: Service Portfolio
• Table 8.9 CMIC: Recent Developments and Future Outlook
• Table 8.10 ICON: Company Overview
• Table 8.11 ICON: Service Portfolio
• Table 8.12 ICON: Recent Developments and Future Outlook
• Table 8.13 Labcorp: Company Overview
• Table 8.14 Labcorp: Service Portfolio
• Table 8.15 Labcorp: Recent Developments and Future Outlook
• Table 8.16 Linical: Company Overview
• Table 8.17 Linical: Service Portfolio
• Table 8.18 Linical: Recent Developments and Future Outlook
• Table 8.19 Medpace: Company Overview
• Table 8.20 Medpace: Service Portfolio
• Table 8.21 Novotech: Company Overview
• Table 8.22 Novotech: Service Portfolio
• Table 8.23 Novotech: Recent Developments and Future Outlook
• Table 8.24 PPD: Company Overview
• Table 8.25 PPD: Service Portfolio
• Table 8.26 PPD: Recent Developments and Future Outlook
• Table 8.27 Precision for Medicine: Company Overview
• Table 8.28 Precision for Medicine: Service Portfolio
• Table 8.29 Precision for Medicine: Recent Developments and Future Outlook
• Table 8.30 QPS: Company Overview
• Table 8.31 QPS: Service Portfolio
• Table 8.32 QPS: Recent Developments and Future Outlook
• Table 8.34 Syneos Health: Company Overview
• Table 8.35 Syneos Health: Service Portfolio
• Table 8.36 Syneos Health: Recent Developments and Future Outlook
• Table 9.1 Benchmark Analysis: Information on Peer Groups
• Table 10.1 Cell and Gene Therapy CRO: List of Partnerships and Collaborations, 2015-2023
• Table 10.2 Partnerships and Collaborations: Information on Type of Agreement
• Table 11.1 Cell and Gene Therapy CROs: List of Mergers and Acquisitions, 2015-2023
• Table 11.2 Cell and Gene Therapy CRO Mergers and Acquisitions: Information on Key Value Drivers and Area of Expertise, 2015-2023
• Table 11.3 Mergers and Acquisitions: Information on Deal Multiples, 2015-2023
• Table 12.1 Potential Strategic Acquisition Targets Amongst Small Players
• Table 12.2 Potential Strategic Acquisition Targets Amongst Mid-sized Players
• Table 14.1 Total Cost of Ownership: Sample Dataset for Large / Very Large Companies
• Table 23.1 Aixial: Company Snapshot
• Table 23.2 Gsap: Company Snapshot
• Table 23.3 CATO SMS: Company Snapshot
• Table 23.4 Anonymous Company: Company Snapshot
• Table 25.1 Cell and Gene Therapy CROs: Distribution by Year of Establishment
• Table 25.2 Cell and Gene Therapy CROs: Distribution by Company Size
• Table 25.3 Cell and Gene Therapy CROs: Distribution by Location of Headquarters (Region)
• Table 25.4 Cell and Gene Therapy CROs: Distribution by Location of Headquarters (Country)
• Table 25.5 Cell and Gene Therapy CROs: Distribution by Scale of Operation
• Table 25.6 Cell and Gene Therapy CROs: Distribution by Area of Expertise
• Table 25.7 Cell and Gene Therapy CROs: Distribution by Type of Cell Therapy
• Table 25.8 Cell and Gene Therapy CROs: Distribution by Type of Preclinical Services Offered
• Table 25.9 Cell and Gene Therapy CROs: Distribution by Type of Clinical Services Offered
• Table 25.10 Cell and Gene Therapy CROs: Distribution by Type of Regulatory Services Offered
• Table 25.11 Cell and Gene Therapy CROs: Distribution by Type of General Services Offered
• Table 25.12 CMIC: Annual Revenues, FY 2018-Q1 FY 2024 (JPY Billion)
• Table 25.13 Labcorp: Annual Revenues, FY 2018- FY 2023 (USD Billion)
• Table 25.14 Linical: Annual Revenues, FY 2021-H1 FY 2024 (JPY Million)
• Table 25.15 Medpace: Annual Revenues, FY 2018-FY 2023 (USD Million)
• Table 25.16 Syneos Health: Annual Revenues, FY 2018-3M FY 2023 (USD Billion)
• Table 25.17 Benchmark Analysis: Distribution by Location of Headquarters and Company Size
• Table 25.18 Partnerships and Collaborations: Cumulative Year-wise Trend, 2015-2023
• Table 25.19 Partnerships and Collaborations: Distribution by Type of Partnership
• Table 25.20 Partnerships and Collaborations: Distribution by Year and Type of Partnership
• Table 25.21 Partnerships and Collaborations: Distribution by Area of Expertise
• Table 25.22 Partnerships and Collaborations: Intracontinental and Intercontinental Agreements
• Table 25.23 Partnerships and Collaborations: Local and International Agreements
• Table 25.24 Most Active Players: Distribution by Number of Partnerships
• Table 25.25 Mergers and Acquisitions: Cumulative Year-wise Trend, 2015-2023
• Table 25.26 Mergers and Acquisitions: Distribution by Type of Agreement
• Table 25.27 Mergers and Acquisitions: Distribution by Key Value Drivers
• Table 25.28 Mergers and Acquisitions: Distribution by Year of Acquisition and Key Value Drivers
• Table 25.29 Most Active Acquirers: Distribution by Number of Acquisitions
• Table 25.30 Mergers and Acquisitions: Intercontinental and Intracontinental
• Table 25.31 Mergers and Acquisitions: Local and International
• Table 25.32 Mergers and Acquisitions: Deal Multiples Based on Revenues
• Table 25.33 Clinical Trial Analysis for Cell Therapies: Cumulative Year-wise Trend, 2018-2023
• Table 25.34 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Status
• Table 25.35 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Registration Year and Trial Status
• Table 25.36 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Phase
• Table 25.37 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Registration Year and Trial Phase
• Table 25.38 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Registration
• Table 25.39 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Status
• Table 25.40 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Phase
• Table 25.41 Clinical Trial Analysis for Cell Therapies: Distribution by Therapeutic Area
• Table 25.42 Clinical Trial Analysis for Cell Therapies: Distribution by Study Design
• Table 25.43 Clinical Trial Analysis for Cell Therapies: Distribution by Type of Sponsor / Collaborator
• Table 25.44 Most Active Industry Players: Distribution by Number of Registered Trials
• Table 25.45 Clinical Trial Analysis for Cell Therapies: Distribution of Number of Registered Trials by Geography
• Table 25.46 Clinical Trial Analysis for Cell Therapies: Distribution of Number of Registered Trials by Trial Status and Geography
• Table 25.47 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Geography
• Table 25.48 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Status and Geography
• Table 25.49 Clinical Trial Analysis for Gene Therapies: Cumulative Year-wise Trend, 2018-2024
• Table 25.50 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Status
• Table 25.51 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Registration Year and Trial Status, 2018-2024
• Table 25.52 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Phase
• Table 25.53 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Registration Year and Trial Phase, 2018-2024
• Table 25.54 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Registration Year, 2018-2024
• Table 25.55 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Status
• Table 25.56 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Phase
• Table 25.57 Clinical Trial Analysis for Gene Therapies: Distribution by Therapeutic Area
• Table 25.58 Clinical Trial Analysis for Gene Therapies: Distribution by Study Design
• Table 25.59 Clinical Trial Analysis for Gene Therapies: Distribution by Type of Sponsor / Collaborator
• Table 25.60 Most Active Industry Players: Distribution by Number of Registered Trials
• Table 25.61 Clinical Trial Analysis for Gene Therapies: Distribution of Number of Registered Trials by Geography
• Table 25.62 Clinical Trial Analysis for Gene Therapies: Distribution of Number of Registered Trials by Trial Status and Geography
• Table 25.63 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Geography
• Table 25.64 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Status and Geography
• Table 25.65 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y0-Y20 (USD Million)
• Table 25.66 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y0: Distribution of CAPEX
• Table 25.67 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y1-Y20: Distribution by OPEX (USD Million)
• Table 25.68 Global Cell and Gene Therapy CRO Market, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.69 Global Cell and Gene Therapy CRO Market, Forecasted Estimates (2024-2035): Conservative Scenario (USD Million)
• Table 25.70 Global Cell and Gene Therapy CRO Market, Forecasted Estimates (2024-2035): Optimistic Scenario (USD Million)
• Table 25.71 Cell and Gene Therapy CRO Market: Distribution by Type of Cell Therapy, 2018, 2024 and 2035
• Table 25.72 Cell and Gene Therapy CRO Market for CAR-T, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.73 Cell and Gene Therapy CRO Market for TCR-T, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.74 Cell and Gene Therapy CRO Market for CAR-NK, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.75 Cell and Gene Therapy CRO Market for Others, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.76 Cell and Gene Therapy CRO Market: Distribution by Type of Genetic Modification, 2018, 2024 and 2035
• Table 25.77 Cell and Gene Therapy CRO Market for Ex vivo, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.78 Cell and Gene Therapy CRO Market for In vivo, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.79 Cell and Gene Therapy CRO Market: Distribution by Stage of Development, 2018, 2024 and 2035
• Table 25.80 Cell and Gene Therapy CRO Market for Clinical, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.81 Cell and Gene Therapy CRO Market for Preclinical, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.82 Cell and Gene Therapy CRO Market for Discovery, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.83 Cell and Gene Therapy CRO Market: Distribution by Therapeutic Area, 2018, 2024 and 2035
• Table 25.84 Cell and Gene Therapy CRO Market for Oncological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.85 Cell and Gene Therapy CRO Market for Rare Diseases, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.86 Cell and Gene Therapy CRO Market for Neurological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.87 Cell and Gene Therapy CRO Market for Metabolic Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.88 Cell and Gene Therapy CRO Market for Musculoskeletal Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.89 Cell and Gene Therapy CRO Market for Cardiovascular Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.90 Cell and Gene Therapy CRO Market for Immunological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.91 Cell and Gene Therapy CRO Market for Dermatological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.92 Cell and Gene Therapy CRO Market for Infectious Diseases, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.93 Cell and Gene Therapy CRO Market for Blood Disorders Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.94 Cell and Gene Therapy CRO Market for Other Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.95 Cell and Gene Therapy CRO Market: Distribution by End-users, 2018, 2024 and 2035
• Table 25.96 Cell and Gene Therapy CRO Market for Industry Players, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.97 Cell and Gene Therapy CRO Market for Non-Industry Players, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.98 Cell and Gene Therapy CRO Market: Distribution by Key Geographical Regions, 2018, 2024 and 2035
• Table 25.99 Cell and Gene Therapy CRO Market in North America, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.100 Cell and Gene Therapy CRO Market in the US, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.101 Cell and Gene Therapy CRO Market in Canada, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.102 Cell and Gene Therapy CRO Market in Rest of North America, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.103 Cell and Gene Therapy CRO Market in Europe, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.104 Cell and Gene Therapy CRO Market in Spain, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.105 Cell and Gene Therapy CRO Market in France, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.106 Cell and Gene Therapy CRO Market in the UK, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.107 Cell and Gene Therapy CRO Market in Italy, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.108 Cell and Gene Therapy CRO Market in Germany, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.109 Cell and Gene Therapy CRO Market in Russia, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.110 Cell and Gene Therapy CRO Market in Rest of Europe, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.111 Cell and Gene Therapy CRO Market in Asia-Pacific, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.112 Cell and Gene Therapy CRO Market in China, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.113 Cell and Gene Therapy CRO Market in Japan, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.114 Cell and Gene Therapy CRO Market in South Korea, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.115 Cell and Gene Therapy CRO Market in India, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.116 Cell and Gene Therapy CRO Market in Australia, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.117 Cell and Gene Therapy CRO Market in Rest of Asia-Pacific, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Table 25.118 Cell and Gene Therapy CRO Market in Rest of the World, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)

List of Figures

• Figure 2.1 Research Methodology: Project Methodology
• Figure 2.2 Research Methodology: Forecast Methodology
• Figure 2.3 Research Methodology: Robust Quality Control
• Figure 2.4 Research Methodology: Key Market Segmentations
• Figure 3.1 Lessons Learnt from Past Recessions
• Figure 4.1 Executive Summary: CROs Market Landscape (I /II)
• Figure 4.2 Executive Summary: CROs Market Landscape (II /II)
• Figure 4.3 Executive Summary: Partnerships and Collaborations
• Figure 4.4 Executive Summary: Mergers and Acquisitions
• Figure 4.5 Executive Summary: Cell Therapy Clinical Trial Analysis
• Figure 4.6 Executive Summary: Gene Therapy Clinical Trial Analysis
• Figure 4.7 Executive Summary: Market Sizing and Opportunity Analysis
• Figure 5.1 Stages of the Drug Development Process
• Figure 5.2 Type of Services Offered by CROs
• Figure 5.3 Classification of ATMPs
• Figure 5.4 Types of Cells Incorporated in Cell Therapy Medicinal Products
• Figure 5.5 Advantages of Outsourcing Operations to CROs
• Figure 5.6 Risks Associated with Outsourcing to CROs
• Figure 6.1 Outsourcing Models
• Figure 6.2 Key Characteristics of Transactional Outsourcing Model
• Figure 6.3 Key Characteristics of Performance -based Business Model
• Figure 6.4 Role of a CRO in Different Phases of Drug Development
• Figure 6.5 Key Considerations for Outsourcing Cell and Gene Therapy Operations
• Figure 7.1 Cell and Gene Therapy CROs: Distribution by Year of Establishment
• Figure 7.2 Cell and Gene Therapy CROs: Distribution by Company Size
• Figure 7.3 Cell and Gene Therapy CROs: Distribution by Location of Headquarters (Region)
• Figure 7.4 Cell and Gene Therapy CROs: Distribution by Location of Headquarters (Country)
• Figure 7.5 Cell and Gene Therapy CROs: Distribution by Area of Expertise
• Figure 7.6 Cell and Gene Therapy CROs: Distribution by Type of Cell Therapy
• Figure 7.7 Cell and Gene Therapy CROs: Distribution by Scale of Operation
• Figure 7.8 Cell and Gene Therapy CROs: Distribution by Type of Preclinical Services Offered
• Figure 7.9 Cell and Gene Therapy CROs: Distribution by Type of Clinical Services Offered
• Figure 7.10 Cell and Gene Therapy CROs: Distribution by Type of Regulatory Services Offered
• Figure 7.11 Cell and Gene Therapy CROs: Distribution by Type of General Services Offered
• Figure 8.1 CMIC: Annual Revenues, FY 2018-Q1 FY 2024 (JPY Billion)
• Figure 8.2 Labcorp: Annual Revenues, FY 2018- FY 2023 (USD Billion)
• Figure 8.3 Linical: Annual Revenues, FY 2021- H1 FY 2024 (JPY Million)
• Figure 8.4 Medpace: Annual Revenues, FY 2018-FY 2023 (USD Million)
• Figure 8.5 Syneos Health: Annual Revenues, FY 2018-3M FY 2023 (USD Billion)
• Figure 9.1 Benchmark Analysis: Distribution of Players by Location of Headquarters and Company Size
• Figure 9.2 Benchmarking Analysis: Small Players Based in North America (Peer Group I)
• Figure 9.3 Benchmarking Analysis: Mid-Sized Players Based in North America (Peer Group II)
• Figure 9.4 Benchmarking Analysis: Large and Very Large Players Based in North America (Peer Group III)
• Figure 9.5 Benchmarking Analysis: Small Players Based in Europe (Peer Group IV)
• Figure 9.6 Benchmarking Analysis: Mid-sized Players Based in Europe (Peer Group V)
• Figure 9.7 Benchmarking Analysis: Large and Very Large Players Based in Europe (Peer Group VI)
• Figure 9.8 Benchmarking Analysis: Small, Mid-sized, Large and Very Large Players Based in Asia-Pacific (Peer Group VII)
• Figure 9.9 Benchmarking Analysis: Small and Mid-sized Players Based in Rest of the World (Peer Group VIII)
• Figure 10.1 Partnerships and Collaborations: Cumulative Year-wise Trend, 2015-2023
• Figure 10.2 Partnerships and Collaborations: Distribution by Type of Partnership
• Figure 10.3 Partnerships and Collaborations: Distribution by Year and Type of Partnership
• Figure 10.4 Partnerships and Collaborations: Distribution by Area of Expertise
• Figure 10.5 Most Active Players: Distribution by Number of Partnerships
• Figure 10.6 Partnerships and Collaborations: Intracontinental and Intercontinental Agreements
• Figure 10.7 Partnerships and Collaborations: Local and International Agreements
• Figure 11.1 Mergers and Acquisitions: Cumulative Year-wise Trend, 2015-2023
• Figure 11.2 Mergers and Acquisitions: Distribution by Type of Agreement
• Figure 11.3 Mergers and Acquisitions: Distribution by Key Value Drivers
• Figure 11.4 Mergers and Acquisitions: Distribution by Year of Agreement and Key Value Drivers
• Figure 11.5 Most Active Acquirers: Distribution by Number of Acquisitions
• Figure 11.6 Local and International Mergers and Acquisitions
• Figure 11.7 Intercontinental and Intracontinental Mergers and Acquisitions
• Figure 11.8 Mergers and Acquisitions: Deal Multiples Based on Revenues
• Figure 13.1 Clinical Trial Analysis for Cell Therapies: Scope and Methodology
• Figure 13.2 Clinical Trial Analysis for Gene Therapies: Scope and Methodology
• Figure 13.3 Clinical Trial Analysis for Cell Therapies: Cumulative Year-wise Trend, 2018-2023
• Figure 13.4 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Status
• Figure 13.5 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Registration Year and Trial Status, 2018-2023
• Figure 13.6 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Phase
• Figure 13.7 Clinical Trial Analysis for Cell Therapies: Distribution by Trial Registration Year and Trial Phase, 2018-2023
• Figure 13.8 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Registration Year, 2018-2023
• Figure 13.9 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Status
• Figure 13.10 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Phase
• Figure 13.11 Clinical Trial Analysis for Cell Therapies: Distribution by Therapeutic Area
• Figure 13.12 Clinical Trial Analysis for Cell Therapies: Distribution by Study Design
• Figure 13.13 Clinical Trial Analysis for Cell Therapies: Distribution by Type of Sponsor / Collaborator
• Figure 13.14 Most Active Industry Players: Distribution by Number of Registered Trials
• Figure 13.15 Clinical Trial Analysis for Cell Therapies: Distribution of Number of Registered Trials by Geography
• Figure 13.16 Clinical Trial Analysis for Cell Therapies: Distribution of Number of Registered Trials by Trial Status and Geography
• Figure 13.17 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Geography
• Figure 13.18 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient Population by Trial Status and Geography
• Figure 13.19 Clinical Trial Analysis for Gene Therapies: Cumulative Year-wise Trend, 2018-2024
• Figure 13.20 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Status
• Figure 13.21 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Registration Year and Trial Status, 2018-2024
• Figure 13.22 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Phase
• Figure 13.23 Clinical Trial Analysis for Gene Therapies: Distribution by Trial Registration Year and Trial Phase, 2018-2024
• Figure 13.24 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Registration Year, 2018-2024
• Figure 13.25 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Status
• Figure 13.26 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Phase
• Figure 13.27 Clinical Trial Analysis for Gene Therapies: Distribution by Therapeutic Area
• Figure 13.28 Clinical Trial Analysis for Gene Therapies: Distribution by Study Design
• Figure 13.29 Clinical Trial Analysis for Gene Therapies: Distribution by Type of Sponsor / Collaborator
• Figure 13.30 Most Active Industry Players: Distribution by Number of Registered Trials
• Figure 13.31 Clinical Trial Analysis for Gene Therapies: Distribution of Number of Registered Trials by Geography
• Figure 13.32 Clinical Trial Analysis for Gene Therapies: Distribution of Number of Registered Trials by Trial Status and Geography
• Figure 13.33 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Geography
• Figure 13.34 Clinical Trial Analysis for Gene Therapies: Distribution of Enrolled Patient Population by Trial Status and Geography
• Figure 14.1 Total Cost of Ownership: Capital Expenditures (CAPEX)
• Figure 14.2 Total Cost of Ownership: Operational Expenditures (OPEX)
• Figure 14.3 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y0-Y20 (USD Million)
• Figure 14.4 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y0: Distribution of CAPEX
• Figure 14.5 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y1-Y20: Distribution by OPEX (USD Million)
• Figure 15.1 Cell and Gene Therapy Service Providers: SWOT Analysis
• Figure 15.2 Comparison of SWOT Factors: Harvey Ball Analysis
• Figure 16.1 Global Cell and Gene Therapy CRO Market, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 16.2 Global Cell and Gene Therapy CRO Market, Forecasted Estimates (2024-2035): Conservative Scenario (USD Million)
• Figure 16.3 Global Cell and Gene Therapy CRO Market, Forecasted Estimates (2024-2035): Optimistic Scenario (USD Million)
• Figure 17.1 Cell and Gene Therapy CRO Market: Distribution by Type of Cell Therapy, 2018, 2024 and 2035
• Figure 17.2 Cell and Gene Therapy CRO Market for CAR-T, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 17.3 Cell and Gene Therapy CRO Market for TCR-T, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 17.4 Cell and Gene Therapy CRO Market for CAR-NK, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 17.5 Cell and Gene Therapy CRO Market for Others, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 18.1 Cell and Gene Therapy CRO Market: Distribution by Type of Genetic Modification, 2018, 2024 and 2035
• Figure 18.2 Cell and Gene Therapy CRO Market for Ex vivo, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 18.3 Cell and Gene Therapy CRO Market for In vivo, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 19.1 Cell and Gene Therapy CRO Market: Distribution by Stage of Development, 2018, 2024 and 2035
• Figure 19.2 Cell and Gene Therapy CRO Market for Clinical, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 19.3 Cell and Gene Therapy CRO Market for Preclinical, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 19.4 Cell and Gene Therapy CRO Market for Discovery, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.1 Cell and Gene Therapy CRO Market: Distribution by Therapeutic Area, 2018, 2024 and 2035
• Figure 20.2 Cell and Gene Therapy CRO Market for Oncological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.3 Cell and Gene Therapy CRO Market for Rare Diseases, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.4 Cell and Gene Therapy CRO Market for Neurological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.5 Cell and Gene Therapy CRO Market for Metabolic Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.6 Cell and Gene Therapy CRO Market for Musculoskeletal Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.7 Cell and Gene Therapy CRO Market for Cardiovascular Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.8 Cell and Gene Therapy CRO Market for Immunological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.9 Cell and Gene Therapy CRO Market for Dermatological Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.10 Cell and Gene Therapy CRO Market for Infectious Diseases, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.11 Cell and Gene Therapy CRO Market for Blood Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 20.12 Cell and Gene Therapy CRO Market for Other Disorders, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 21.1 Cell and Gene Therapy CRO Market: Distribution by End-users, 2018, 2024 and 2035
• Figure 21.2 Cell and Gene Therapy CRO Market for Industry Players, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 21.3 Cell and Gene Therapy CRO Market for Non-Industry Players, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.1 Cell and Gene Therapy CRO Market: Distribution by Key Geographical Regions, 2018, 2024 and 2035
• Figure 22.2 Cell and Gene Therapy CRO Market in North America, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.3 Cell and Gene Therapy CRO Market in the US, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.4 Cell and Gene Therapy CRO Market in Canada, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.5 Cell and Gene Therapy CRO Market in Rest of North America, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.6 Cell and Gene Therapy CRO Market in Europe, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.7 Cell and Gene Therapy CRO Market in Spain, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.8 Cell and Gene Therapy CRO Market in France, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.9 Cell and Gene Therapy CRO Market in the UK, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.10 Cell and Gene Therapy CRO Market in Italy, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.11 Cell and Gene Therapy CRO Market in Germany, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.12 Cell and Gene Therapy CRO Market in Russia, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.13 Cell and Gene Therapy CRO Market in Rest of Europe, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.14 Cell and Gene Therapy CRO Market in Asia-Pacific, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.15 Cell and Gene Therapy CRO Market in China, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.16 Cell and Gene Therapy CRO Market in Japan, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.17 Cell and Gene Therapy CRO Market in South Korea, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.18 Cell and Gene Therapy CRO Market in India, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.19 Cell and Gene Therapy CRO Market in Australia, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.20 Cell and Gene Therapy CRO Market in Rest of Asia-Pacific, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 22.21 Cell and Gene Therapy CRO Market in Rest of the World, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 24.1 Concluding Remarks: Overall Market Landscape
• Figure 24.2 Concluding Remarks: Partnerships and Collaborations
• Figure 24.3 Concluding Remarks: Mergers and Acquisitions
• Figure 24.4 Concluding Remarks: Clinical Trial Analysis for Cell Therapies
• Figure 24.5 Concluding Remarks: Clinical Trial Analysis for Gene Therapies
• Figure 24.6 Concluding Remarks: Market Sizing and Opportunity Analysis (I / II)
• Figure 24.7 Concluding Remarks: Market Sizing and Opportunity Analysis (II / II)

Cell and Gene Therapy CRO Market (4th Edition): Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Cell Therapy (CAR-NK, CAR-T, TCR-T, and Others), Type of Genetic Modification (Ex vivo and In vivo), Stage of Development (Discovery, Preclinical, and Clinical), Therapeutic Area (Blood Disorders, Cardiovascular Disorders, Dermatological Disorders, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Musculoskeletal Disorders, Neurological Disorders, Oncological Disorders, Rare Diseases, and Other disorders), End-Users (Industry Players and Non-Industry Players) and Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World)

The Cell and Gene Therapy CRO Market is valued at USD 1,653 million in 2024 growing at a CAGR of 7.1% during the forecast period 2024-2035.

Cell and gene therapy candidates have shown promising outcomes in treating rare and complex diseases, including conditions for which effective treatments are currently in development phase. It's essential to note that in cell therapy, human cells are transplanted to repair or replace damaged cells or tissues, facilitating treatment through the alteration or restoration of specific cell sets. These cells may be sourced from the patient (autologous cells) or a donor (allogeneic cells). Conversely, gene therapy aims to address underlying genetic issues to treat and prevent diseases by replacing, inactivating, or introducing genes into cells, either inside or outside the body. It's noteworthy that some therapeutic interventions can be categorized as both cell and gene therapies. The mechanism of action typically involves gene alteration in specific cell types and subsequent insertion into the patient's body.

Currently, over 90 cell and gene therapies have received global approval. Recent examples of approved therapies include Fucaso (2023; developed by IASO Bio) for treating multiple myeloma, Elvediys (2023; developed by Sarepta Therapeutics) for treating Duchenne muscular dystrophy, and Vyjuvek (2023; developed by Krystal Biotech) for treating dystrophic epidermolysis bullosa. Moreover, more than 3,500 clinical studies are underway, evaluating cell and gene therapies across 16 therapeutic areas. Besides biotechnology companies developing these therapies, other stakeholders in the market contribute to their success. Apart from Contract Research Organizations (CROs), companies providing clinical trial software solutions play a crucial role in clinical trial management. These platform providers are exploring novel platforms to facilitate decentralized/virtual clinical trials for cell and gene therapies. One such company is Jeeva Clinical Trials, based in the US, which is developing a SaaS platform aimed at reducing the travel burden for trial participants. Additionally, there are companies developing cell and gene therapy supply chain software to help drug developers and CROs manage supply chains.

With the rapidly evolving landscape of cell and gene therapy, CROs bring expertise in navigating complex regulatory frameworks, optimizing study designs, and facilitating the seamless transition from preclinical to clinical success. These factors are expected to present significant market growth opportunities for contract service providers during the forecast period.

Key Market Segments

Type of Cell Therapy

CAR-NK

CAR-T

TCR-T

• Others

Type of Genetic Modification

• Ex vivo
• In vivo

Stage of Development

• Discovery
• Preclinical
• Clinical

Therapeutic Area

• Blood Disorders
• Cardiovascular Disorders
• Dermatological Disorders
• Immunological Disorders
• Infectious Diseases
• Metabolic Disorders
• Musculoskeletal Disorders
• Neurological Disorders
• Oncological Disorders
• Rare Diseases
• Other Disorders

End-users

• Industry Players
• Non- Industry Players

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

Research Coverage:

• This introductory chapter presents insights into historical development of Contract Research Organizations (CROs), ongoing trends in outsourcing, and the array of services they offer. Beginning with a brief overview of CROs, it traces the evolution of the contract research services market. Various types of CROs and their service offerings are discussed, followed by an examination of the benefits and potential pitfalls of collaborating with these service providers. Additionally, the chapter underscores the pivotal role CROs play in advancing Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies, within the pharmaceutical landscape.
• A comprehensive examination of the contract research service provider market within the cell and gene therapy sector is conducted, based on the factors such as establishment year, company size measured by employee count, headquarters location, specialized expertise in cell therapy and gene therapy, operational scale encompassing discovery, preclinical, clinical, and commercial phases, and the range of preclinical services provided (such as toxicology studies, in-vivo testing, safety studies, PK/ADME studies, bioanalytical studies, and other preclinical services). Additionally, the assessment covers the spectrum of clinical services offered, such as clinical trial management / clinical project management, clinical research monitoring, data management, safety, and pharmacovigilance, along with other clinical services. Regulatory services provided, including legal representation, GAP analysis, Technical Dossier Submission, and IND Preparation, are also scrutinized. Moreover, the evaluation extends to general support services offered, such as consulting, training, biostatistics, post-market assessment, and reimbursement assistance.
• Comprehensive profiles are provided for cell and gene therapy CROs, major contract research organizations offering services across preclinical, clinical, and commercial scales, situated in North America, Europe, and Asia-Pacific. Each profile encompasses a concise company overview, particulars concerning their cell and gene therapy service offerings, recent advancements, and an insightful perspective on future prospects.
• An in-depth benchmark analysis is conducted to assess the strengths and capabilities of different entities operating within this sector. This evaluation focuses on the expertise of companies across a spectrum of services pertinent to cell and gene therapy development. By facilitating comparisons among peer groups, the analysis enables companies to gauge their current capabilities, identify areas for improvement, and strategize for enhanced competitiveness within the industry.
• An exhaustive examination is conducted on the partnerships forged among stakeholders within the cell and gene therapy contract research sector, considering various pertinent parameters. These include the year of partnership, type of partnership, areas of expertise involved, identification of the most prolific players based on the number of partnerships established, and the geographical distribution of partnership activity within this domain spanning the period from 2015 to 2023.
• A comprehensive analysis is conducted on the mergers and acquisitions within this sector spanning the period from 2015 to 2023, considering various pertinent parameters. These include the year of agreement, type of agreement, key value drivers underlying the deal, identification of the most prolific players based on the number of agreements signed, and the geographical locations of the involved companies. Additionally, the chapter offers insights into the financial terms of the deals, if available, to delineate the deal multiples in terms of the acquired firm's annual revenues at the time of acquisition and its years of experience in this domain.
• An in-depth examination of acquisitions within the cell and gene therapy domain is conducted, focusing on the historical trend of acquiring activity by key players since 2015. The analysis aims to provide industry stakeholders with insights to identify potential acquisition.
• An extensive examination of concluded, in-progress, and forthcoming clinical investigations into diverse cell and gene therapies. This analysis considers multiple pertinent factors, including the year of trial registration, trial status, phase of the trial, patient demographics, sponsoring entity, leading industry participants (by trial registration volume), research design, targeted therapeutic fields, and primary geographical locations.
• A thorough examination of the overall expenses incurred by large and very large contract research organizations (CROs) specializing in cell and gene therapy. This analysis focuses on the costs related to setting up and sustaining a CRO facility over both short and long durations. The chapter presents findings derived from an in-depth investigation into the total cost of ownership for cell and gene therapy CROs spanning the timeframe from Y0 to Y20.
• A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry's evolution highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry.
• A comprehensive market forecast analysis has been conducted to gauge the present market size and future prospects for cell and gene therapy Contract Research Organizations (CROs) over the next decade. Drawing from various factors including anticipated adoption patterns and validated through primary research, we have developed an informed projection of market development from 2024 to 2035. The report outlines the expected distribution of current and projected opportunities within the cell and gene therapy CRO market. Additionally, to accommodate potential uncertainties and strengthen our model, we have presented three forecast scenarios - conservative, base, and optimistic - reflecting distinct trajectories for industry growth.
• Comprehensive projections of current and future cell & gene therapy CRO market across different types of cell therapy, such as CAR-NK, CAR-T, TCR-T, and others.
• Detailed projections of current and future cell and gene therapy CRO market across different types of genetic modification, such as ex vivo and in vivo.
• Comprehensive predictions of the current and future cell and gene therapy CRO industry across different stages of development, such as clinical, preclinical and discovery.
• Detailed projections of the current and future cell and gene therapy CRO market across different therapeutic area, such as blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders.
• Comprehensive projections of the current and future cell & gene therapy CRO market across different end users, namely industry players and non-industry players.
• Detailed projections of the current and future cell and gene therapy CRO industry across various geographies, namely North America, Europe, Asia-Pacific and Rest of the World.

Key Benefits of Buying this Report

• The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with a pulse on the Cell and Gene Therapy CRO Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Leading Market Companies

• Altasciences
• Allucent

CMIC

• Labcorp
• Linical
• Medpace

PPD

• Precision for Medicine

QPS

• Syneos Health

CMED

ICON

• Pharmalex
• Novotech

TABLE OF CONTENTS

Table Of Contents

1. PREFACE

• 1.1. Introduction
• 1.2. Market Share Insights
• 1.3. Key Market Insights
• 1.4. Report Coverage
• 1.5. Key Questions Answered
• 1.6. Chapter Outlines

2. RESEARCH METHODOLOGY

• 2.1. Chapter Overview
• 2.2. Research Assumptions
• 2.3. Project Methodology
• 2.4. Forecast Methodology
• 2.5. Robust Quality Control
• 2.6. Key Market Segmentations
• 2.7. Key Considerations
  • 2.7.1. Demographics
  • 2.7.2. Economic Factors
  • 2.7.3. Government Regulations
  • 2.7.4. Supply Chain
  • 2.7.5. COVID Impact
  • 2.7.6. Market Access
  • 2.7.7. Healthcare Policies
  • 2.7.8. Industry Consolidation

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

• 3.1. Chapter Overview
• 3.2. Market Dynamics
  • 3.2.1. Time Period
    • 3.2.1.1. Historical Trends
    • 3.2.1.2. Current and Future Estimates
  • 3.2.2. Currency Coverage and Foreign Exchange Rates
    • 3.2.2.1. Major Currencies Affecting the Market
    • 3.2.2.2. Factors Affecting Currency Fluctuations and Foreign Exchange Rates
    • 3.2.2.3. Impact of Foreign Exchange Rate Volatility on the Market
    • 3.2.2.4. Strategies for Mitigating Foreign Exchange Risk
  • 3.2.3. Trade Policies
    • 3.2.3.1. Impact of Trade Barriers on the Market
    • 3.2.3.2. Strategies for Mitigating the Risks Associated with Trade Barriers
  • 3.2.4. Recession
    • 3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
    • 3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
  • 3.2.5. Inflation
    • 3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
    • 3.2.5.2. Potential Impact of Inflation on the Market Evolution

4. EXECUTIVE SUMMARY

• 4.1 Chapter Overview

5. INTRODUCTION

• 5.1. Chapter Overview
• 5.2. Overview of Contract Research Organizations (CROs)
• 5.3. Classification of CROs
• 5.4. Evolution of CROs
• 5.5. Modern CROs and Prevalent Outsourcing Trends
• 5.6. Type of Services Offered by CROs
• 5.7. Role of CROs in Development of Advanced Therapy Medicinal Products (ATMPs)
• 5.8. Advantages of Outsourcing Operations to CROs
• 5.9. Risks Associated with Outsourcing to CROs
• 5.10. Future Perspectives

6. GUIDE TO OUTSOURCING

• 6.1. Chapter Overview
• 6.2. Cell and Gene Therapy Research: Need for Outsourcing
• 6.3. Outsourcing Models
  • 6.3.1. Transactional Outsourcing Model
  • 6.3.2. Performance-based Business Model
  • 6.3.3. Outcome-based Business Model
  • 6.3.4. Staff Augmentation Model
  • 6.3.5. Phase-Dependent Outsourcing Model
• 6.4. Selecting an Appropriate Outsourcing Model
• 6.5. Selecting a CRO Partner
• 6.6. Role of CROs in Drug Development
  • 6.6.1. Discovery and Preclinical Research
  • 6.6.2. Early Clinical Research
  • 6.6.3. Clinical Research and Laboratory Services
  • 6.6.4. Key Considerations for Outsourcing Cell and Gene Therapy Operations
• 6.7. Concluding Remarks

7. MARKET LANDSCAPE

• 7.1. Chapter Overview
• 7.2. Cell and Gene Therapy CROs: Overall Market Landscape
  • 7.2.1. Analysis by Year of Establishment
  • 7.2.2. Analysis by Company Size
  • 7.2.3. Analysis by Location of Headquarters
  • 7.2.4. Analysis by Area of Expertise
  • 7.2.5. Analysis by Type of Cell Therapy
  • 7.2.6. Analysis by Scale of Operation
  • 7.2.7. Analysis by Type of Preclinical Services Offered
  • 7.2.8. Analysis by Type of Clinical Services Offered
  • 7.2.9. Analysis by Type of Regulatory Services Offered
  • 7.2.10. Analysis by Type of General Support Services Offered

8. COMPANY PROFILES

• 8.1. Chapter Overview
• 8.2. Aixial
  • 8.2.1. Company Overview
  • 8.2.2. Service Portfolio
  • 8.2.3. Recent Developments and Future Outlook
• 8.3. Altasciences
  • 8.3.1. Company Overview
  • 8.3.2. Service Portfolio
  • 8.3.3. Recent Developments and Future Outlook
• 8.4. CMIC
  • 8.4.1. Company Overview
  • 8.4.2. Financial Information
  • 8.4.3. Service Portfolio
  • 8.4.4. Recent Developments and Future Outlook
• 8.5. ICON
  • 8.5.1. Company Overview
  • 8.5.2. Service Portfolio
  • 8.5.3. Recent Developments and Future Outlook
• 8.6. Labcorp
  • 8.6.1. Company Overview
  • 8.6.2. Financial Information
  • 8.6.3. Service Portfolio
  • 8.6.4. Recent Developments and Future Outlook
• 8.7. Linical
  • 8.7.1. Company Overview
  • 8.7.2. Financial Information
  • 8.7.3. Service Portfolio
  • 8.7.4. Recent Developments and Future Outlook
• 8.8. Medpace
  • 8.8.1. Company Overview
  • 8.8.2. Financial Information
  • 8.8.3. Service Portfolio
  • 8.8.4. Recent Developments and Future Outlook
• 8.9. Novotech
  • 8.9.1. Company Overview
  • 8.9.2. Service Portfolio
  • 8.9.3. Recent Developments and Future Outlook
• 8.10. PPD
  • 8.10.1. Company Overview
  • 8.10.2. Service Portfolio
    • 8.2.9.3. Recent Developments and Future Outlook
• 8.11. Precision for Medicine
  • 8.11.1. Company Overview
  • 8.11.2. Service Portfolio
  • 8.11.3. Recent Developments and Future Outlook
• 8.12. QPS
  • 8.12.1. Company Overview
  • 8.12.2. Service Portfolio
  • 8.12.3. Recent Developments and Future Outlook
• 8.13. Syneos Health
  • 8.13.1. Company Overview
  • 8.13.2. Financial Information
  • 8.13.3. Service Portfolio
  • 8.13.4. Recent Developments and Future Outlook

9. BENCHMARKING ANALYSIS

• 9.1. Chapter Overview
• 9.2. Key Assumptions and Methodology
• 9.3. Cell and Gene Therapy CROs: Benchmark Analysis
  • 9.3.1. Benchmarking Analysis of Small Players based in North America (Peer Group I)
  • 9.3.2. Benchmarking Analysis of Mid-sized Players based in North America (Peer Group II)
  • 9.3.3. Benchmarking Analysis of Large and Very Large Players based in North America (Peer Group III)
  • 9.3.4. Benchmarking Analysis of Small Players based in Europe (Peer Group IV)
  • 9.3.5. Benchmarking Analysis of Mid-sized Players based in Europe (Peer Group V)
  • 9.3.6. Benchmarking Analysis of Large and Very Large Players based in Europe (Peer Group VI)
  • 9.3.7. Benchmarking Analysis of Small, Mid-sized, Large and Very Large Players based in Asia-Pacific (Peer Group VII)
  • 9.3.8. Benchmarking Analysis of Small and Mid-sized Players based in Rest of the World (Peer Group VIII)
• 9.4. Concluding Remarks

10. PARTNERSHIPS AND COLLABORATIONS

• 10.1. Chapter Overview
• 10.2. Partnership Models
• 10.3. Cell and Gene Therapy Contract Research Organizations: Partnerships and Collaborations
  • 10.3.1. Analysis by Year of Partnership
  • 10.3.2. Analysis by Type of Partnership
  • 10.3.3. Analysis by Year and Type of Partnership
  • 10.3.4. Analysis by Area of Expertise
  • 10.3.5. Most Active Players: Analysis by Number of Partnerships
  • 10.3.6. Analysis by Geography
    • 10.3.6.1. Intracontinental and Intercontinental Agreements
    • 10.3.6.2. Local and International Agreements

11. MERGERS AND ACQUISITIONS

• 11.1. Chapter Overview
• 11.2. Merger and Acquisition Models
• 11.3. Cell and Gene Therapy CROs: Mergers and Acquisitions
  • 11.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
  • 11.3.2. Analysis by Type of Agreement
  • 11.3.3. Analysis by Key Value Drivers
  • 11.3.4. Analysis by Year of Agreement and Key Value Drivers
  • 11.3.5. Most Active Acquirers: Analysis by Number of Acquisitions
  • 11.3.6. Analysis by Geography
    • 11.3.6.1. Local and International Mergers and Acquisitions
    • 11.3.6.2. Intracontinental and Intercontinental Mergers and Acquisitions
  • 11.3.7. Key Acquisitions: Deal Multiples

12. KEY ACQUISITION TARGETS

• 12.1. Chapter Overview
• 12.2. Key Assumptions and Parameters
• 12.3. Scope and Methodology
• 12.4. Potential Strategic Acquisition Targets Amongst Small Players
• 12.5. Potential Strategic Acquisition Targets Amongst Mid-sized Players

13. CLINICAL TRIAL ANALYSIS

• 13.1. Chapter Overview
• 13.2. Scope and Methodology
• 13.3. Cell Therapy: Clinical Trial Analysis
  • 13.3.1. Analysis by Trial Registration Year
  • 13.3.2. Analysis by Trial Status
  • 13.3.3. Analysis by Trial Registration Year and Trial Status
  • 13.3.4. Analysis by Trial Phase
  • 13.3.5. Analysis by Trial Registration Year and Trial Phase
  • 13.3.6. Analysis of Enrolled Patient Population by Trial Registration Year
  • 13.3.7. Analysis of Enrolled Patient Population by Trial Status
  • 13.3.8. Analysis of Enrolled Patient Population by Trial Phase
  • 13.3.9. Analysis by Therapeutic Area
  • 13.3.10. Analysis by Study Design
  • 13.3.11. Analysis by Type of Sponsor / Collaborator
  • 13.3.12. Most Active Industry Players: Analysis by Number of Registered Trials
  • 13.3.13. Analysis of Number of Registered Trials by Geography
  • 13.3.14. Analysis of Number of Registered Trials by Trial Status and Geography
  • 13.3.15. Analysis of Enrolled Patient Population by Geography
  • 13.3.16. Analysis of Enrolled Patient Population by Trial Status and Geography
• 13.4. Gene Therapy: Clinical Trial Analysis
  • 13.4.1. Analysis by Trial Registration Year
  • 13.4.2. Analysis by Trial Status
  • 13.4.3. Analysis by Trial Registration Year and Trial Status
  • 13.4.4. Analysis by Trial Phase
  • 13.4.5. Analysis by Trial Registration Year and Trial Phase
  • 13.4.6. Analysis of Enrolled Patient Population by Trial Registration Year
  • 13.4.7. Analysis of Enrolled Patient Population by Trial Status
  • 13.4.8. Analysis of Enrolled Patient Population by Trial Phase
  • 13.4.9. Analysis by Therapeutic Area
  • 13.4.10. Analysis by Study Design
  • 13.4.11. Analysis by Type of Sponsor / Collaborator
  • 13.4.12. Most Active Industry Players: Analysis by Number of Registered Trials
  • 13.4.13. Analysis of Number of Registered Trials by Geography
  • 13.4.14. Analysis of Number of Registered Trials by Trial Status and Geography
  • 13.4.15. Analysis of Enrolled Patient Population by Geography
  • 13.4.16. Analysis of Enrolled Patient Population by Trial Status and Geography

14. TOTAL COST OF OWNERSHIP

• 14.1 Chapter Overview
• 14.2. Assumptions and Methodology
• 14.3. Key Parameters
• 14.4 Total Cost of Ownership (Sample Dataset)
  • 14.4.1 Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, Y0-Y20
  • 14.4.2. Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations: Analysis by CAPEX, Y0
  • 14.4.3. Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations: Analysis by OPEX, Y1-Y20

15. SWOT ANALYSIS

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

16. GLOBAL CELL AND GENE THERAPY CRO MARKET

• 16.1. Chapter Overview
• 16.2. Key Assumptions and Methodology
• 16.3. Global Cell and Gene Therapy CRO Market, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 16.3.1. Scenario Analysis
    • 16.3.1.1. Conservative Scenario
    • 16.3.2.2 Optimistic Scenario
• 16.4. Key Market Segmentations

17. CELL AND GENE THERAPY CRO MARKET, BY TYPE OF CELL THERAPY

• 17.1. Chapter Overview
• 17.2. Key Assumptions and Methodology
• 17.3. Cell and Gene Therapy CRO Market: Distribution by Type of Cell Therapy, 2018, 2024 and 2035
  • 17.3.1. CAR-T: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 17.3.2. TCR-T: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 17.3.2. CAR-NK: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 17.3.3. Others: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
• 17.4. Data Triangulation and Validation

18. CELL AND GENE THERAPY CRO MARKET, BY TYPE OF GENETIC MODIFICATION

• 18.1. Chapter Overview
• 18.2. Key Assumptions and Methodology
• 18.3. Cell and Gene Therapy CRO Market: Distribution by Type of Genetic Modification, 2018, 2024 and 2035
  • 18.3.1. Ex vivo: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 18.3.2. In vivo: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
• 18.4. Data Triangulation and Validation

19. CELL AND GENE THERAPY CRO MARKET, BY STAGE OF DEVELOPMENT

• 19.1. Chapter Overview
• 19.2. Key Assumptions and Methodology
• 19.3. Cell and Gene Therapy CRO Market: Distribution by Stage of Development, 2018, 2024 and 2035
  • 19.3.1. Clinical: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 19.3.2. Preclinical: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 19.3.3. Discovery: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
• 19.4. Data Triangulation and Validation

20. CELL AND GENE THERAPY CRO MARKET, BY THERAPEUTIC AREA

• 20.1. Chapter Overview
• 20.2. Key Assumptions and Methodology
• 20.3. Cell and Gene Therapy CRO Market: Distribution by Therapeutic Area, 2018, 2024 and 2035
  • 20.3.1. Oncological Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.2. Rare Diseases: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.3. Neurological Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.4. Metabolic Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.5. Musculoskeletal Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.6. Cardiovascular Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.7. Immunological Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.8. Dermatological Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.9. Infectious Diseases: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.10. Blood Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 20.3.11. Other Disorders: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
• 20.4. Data Triangulation and Validation

21. CELL AND GENE THERAPY CRO MARKET, BY END-USERS

• 21.1. Chapter Overview
• 21.2. Key Assumptions and Methodology
• 21.3. Cell and Gene Therapy CRO Market: Distribution by End-users, 2018, 2024 and 2035
  • 21.3.1. Industry Players: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 21.3.2. Non-Industry Players: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
• 21.4. Data Triangulation and Validation

22. CELL AND GENE THERAPY CRO MARKET, BY KEY GEOGRAPHICAL REGIONS

• 22.1. Chapter Overview
• 22.2. Key Assumptions and Methodology
• 22.3. Cell and Gene Therapy CRO Market: Distribution by Key Geographical Regions, 2018, 2024 and 2035
  • 22.3.1. North America: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.1.1. US: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.1.2. Canada: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.1.3. Rest of North America: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 22.3.2. Europe: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.1. Spain: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.2. France: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.3. UK: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.4. Italy: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.5. Germany: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.6. Russia: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.2.7. Rest of Europe: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 22.3.3. Asia-Pacific: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.3.1. China: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.3.2. Japan: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.3.3. South Korea: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.3.4. India: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.3.5. Australia: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
    • 22.3.3.6. Rest of Asia-Pacific: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
  • 22.3.4. Rest of the World: Historical Trends (2018-2023) and Forecasted Estimates (2024-2035)
• 22.4. Data Triangulation and Validation and Validation

23. EXECUTIVE INSIGHTS

• 23.1. Chapter Overview
• 23.2. Aixial
  • 23.2.1. Company Snapshot
  • 23.2.2. Interview Transcript: Victor Iorgulescu, Business Development Executive
• 23.3. Gsap
  • 23.3.1. Company Snapshot
  • 23.3.2. Interview Transcript: Mor Moshe, Clinical Trial Manager
• 23.4. CATO SMS
  • 23.4.1. Company Snapshot
  • 23.4.2. Interview Transcript: Jessica Bliven (Former Director, Marketing and Sales)
• 23.5. Anonymous Company
  • 23.5.1. Company Snapshot
  • 23.5.2. Interview Transcript: Rhonda Henry, Former President

24. CONCLUDING REMARKS

• 24.1 Chapter Overview

25. APPENDIX I: TABULATED DATA

26. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS