Summary

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)
Report Link: https://www.rootsanalysis.com/reports/cell-and-gene-therapy-cros-market/230.html
The cell and gene therapy CRO market is expected to reach USD 1,653 million by 2024 anticipated to grow at a CAGR of 7.1% during the forecast period 2024-2035.
Cell and gene therapy candidates have exhibited promising efficacy in addressing rare and intricate diseases, including those for which effective treatments are still under development. It's important to highlight that cell therapy involves the transplantation of human cells to repair or replace damaged cells or tissues, thereby aiding treatment through the modification or reinstatement of specific cell populations. These cells may originate from the patient themselves (autologous cells) or from a donor (allogeneic cells). Conversely, gene therapy seeks to tackle underlying genetic issues to both treat and prevent diseases by introducing, deactivating, or substituting genes within cells, either internally or externally to the body. It's noteworthy that certain therapeutic interventions can be classified as both cell and gene therapies. The typical mechanism of action involves genetic modification in specific cell types followed by their 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 multiple myeloma, Elvediys (2023; developed by Sarepta Therapeutics) for Duchenne muscular dystrophy, and Vyjuvek (2023; developed by Krystal Biotech) for dystrophic epidermolysis bullosa. Moreover, there are more than 3,500 ongoing clinical studies assessing cell and gene therapies across 16 therapeutic domains. Beyond biotechnology firms engaged in developing these therapies, other stakeholders in the market contribute to their advancement. Apart from Contract Research Organizations (CROs), companies offering clinical trial software solutions play a vital role in clinical trial management. These platform providers are exploring innovative avenues to facilitate decentralized or virtual clinical trials for cell and gene therapies. One such example is Jeeva Clinical Trials, based in the US, which is creating a Software as a Service (SaaS) platform aimed at alleviating the travel burden for trial participants. Additionally, there are companies developing supply chain software tailored for cell and gene therapies to aid drug developers and CROs in managing supply chains efficiently. Given the swiftly evolving landscape of cell and gene therapy, CROs bring expertise in navigating intricate regulatory frameworks, optimizing study designs, and facilitating the smooth transition from preclinical to clinical success. These factors are anticipated to present significant market growth opportunities for contract service providers in the forecast period.

Research Coverage:
The introductory chapter offers insights into the historical evolution of Contract Research Organizations (CROs), current outsourcing trends, and the extensive range of services they provide. Starting with a brief overview of CROs, it traces the development of the contract research services market over time. Different types of CROs and their service offerings are discussed, followed by an examination of the benefits and potential drawbacks of partnering with these service providers. Additionally, the chapter highlights the essential role played by CROs in advancing Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies, within the pharmaceutical landscape.
A thorough analysis of the contract research service provider market in the cell and gene therapy sector is conducted, considering factors such as establishment year, company size indicated by employee count, headquarters location, specialized expertise in cell therapy and gene therapy, operational scale covering discovery, preclinical, clinical, and commercial phases, and the range of preclinical services offered (including toxicology studies, in-vivo testing, safety studies, PK/ADME studies, bioanalytical studies, and other preclinical services). Furthermore, the assessment encompasses clinical services provided, such as clinical trial management/clinical project management, clinical research monitoring, data management, safety, and pharmacovigilance, among other clinical services. Regulatory services, including legal representation, GAP analysis, Technical Dossier Submission, and IND Preparation, are also examined. Additionally, the evaluation extends to general support services offered, such as consulting, training, biostatistics, post-market assessment, and reimbursement assistance.
Detailed profiles are offered of the 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.
A comprehensive benchmark analysis is undertaken to evaluate the strengths and capabilities of various entities operating within this sector. This assessment delves deeply into the expertise of companies across a range of services essential to cell and gene therapy development. By enabling comparisons among peer groups, the analysis allows companies to assess their existing capabilities, pinpoint areas for enhancement, and strategize for increased competitiveness within the industry.
A thorough investigation is carried out on the partnerships formed among stakeholders in the cell and gene therapy contract research sector, taking into account several relevant parameters. These parameters encompass the year of partnership, type of partnership, areas of expertise engaged, identification of the most active participants based on the quantity of partnerships established, and the geographical spread of partnership activity within this field from 2015 to 2023.
A thorough analysis is undertaken on the mergers and acquisitions within this sector from 2015 to 2023, taking into consideration various relevant parameters. These parameters encompass the year of agreement, type of agreement, key value drivers behind the deal, identification of the most active participants based on the quantity of agreements signed, and the geographical locations of the involved companies. Additionally, the chapter provides insights into the financial terms of the deals, if available, to outline the deal multiples concerning the acquired firm's annual revenues at the time of acquisition and its tenure 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.
A comprehensive analysis is conducted on completed, ongoing, and planned clinical investigations spanning various cell and gene therapies. This analysis takes into account several pertinent factors, including the year of trial registration, trial status, phase of the trial, patient demographics, sponsoring entity, prominent industry participants (based on trial registration volume), research design, targeted therapeutic fields, and primary geographical locations.
A comprehensive analysis is conducted on the total expenses accrued by large and very large contract research organizations (CROs) specializing in cell and gene therapy. This examination centers on the costs associated with establishing and maintaining a CRO facility over both short and long periods. The chapter presents findings derived from an in-depth investigation into the total cost of ownership for cell and gene therapy CROs, covering 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 thorough market forecast analysis has been undertaken to assess the current market size and future potential for cell and gene therapy Contract Research Organizations (CROs) over the upcoming decade. Drawing on diverse factors, including anticipated adoption trends and validated through primary research, we have formulated an informed projection of market evolution from 2024 to 2035. The report delineates the anticipated distribution of existing and projected opportunities within the cell and gene therapy CRO market. Furthermore, to address potential uncertainties and enhance our model's robustness, we have introduced three forecast scenarios - conservative, base, and optimistic - each representing distinct paths for industry growth.
Detailed 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.
Comprehensive projections of current and future cell and gene therapy CRO market across different types of genetic modification, such as ex vivo and in vivo.
Detailed predictions of the current and future cell and gene therapy CRO industry across different stages of development, such as clinical, preclinical and discovery.
Comprehensive predictions 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.
Detailed projections of the current and future cell & gene therapy CRO market across different end users, namely industry players and non-industry players.
Comprehensive 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

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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 ORGANIZATIONSOMPANIES AND ORGANIZATIONS

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List of Tables/Graphs

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 andTrialStatus, 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 andTrialPhase, 2018-2023
Figure 13.8 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient PopulationbyTrialRegistration Year, 2018-2023
Figure 13.9 Clinical Trial Analysis for Cell Therapies: Distribution of Enrolled Patient PopulationbyTrialStatus
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-
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)