The "Cell and Gene Therapy CRO Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Cell Therapy, Type of Genetic Modification, Stage of Development, Therapeutic Area, End-users and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy CRO market is estimated to grow from $1.65 billion in 2024 to $3.51 billion by 2035, representing a CAGR of 7.1% during the forecast period 2024-2035.

The new research study consists of industry trends, detailed cell and gene therapy CRO market analysis, key market insights, market impact analysis, market forecast and opportunity analysis. The rise in the opportunity for contract research organizations over the next decade is likely to be the result of the anticipated rise in the demand for cell and gene therapies.

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential for the contract research organizations serving the cell and gene therapy industry, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035.

Presently, over 90 cell and gene therapies have been approved globally. Notable examples of recently approved therapies include (in reverse chronological order of year of approval) Fucaso (2023; developed by IASO Bio) for the treatment of multiple myeloma, Elvediys, (2023; developed by Sarepta Therapeutics) for the treatment of duchenne muscular dystrophy and Vyjuvek (2023; developed by Krystal Biotech) for the treatment of dystrophic epidermolysis bullosa. Additionally, more than to 3,500 clinical studies are currently evaluating cell and gene therapies across 16 therapeutic areas.

In addition to the biotechnology companies developing cell and gene therapies, there are several stakeholders in the market that are defining the success of these immunotherapies. In addition to the CROs, there are companies that are providing suitable clinical trial software solutions for clinical trial management. These platform providers are also working on exploring novel platforms that can allow decentralized / virtual clinical trials for cell and gene therapies. One such company is the US based Jeeva Clinical Trials, which is developing a SaaS platform aimed at reducing the travel burden for participants. In addition, there are companies developing cell and gene therapy supply chain software to allow the drug developers and CROs to manage the supply chains.

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

Competitive Landscape of Cell and Gene Therapy Contract Research Organizations

The cell and gene therapy CRO market features over 105 large, mid-sized and small contract research organizations that are engaged in offering services for cell and gene therapy across preclinical, clinical, and commercial scales of operation. Currently, 80% of the contract research organizations offer their expertise for the advancement of cell and gene therapies to drug developers in order to ensure efficiency, from initial research and development to clinical trials and regulatory approvals; notable examples (in alphabetical order) include Absorption Systems, Accelera, Advanced BioScience Laboratories, and Advanced Cell Diagnostics. In addition, majority of these companies are actively involved in offering clinical trial management services, followed by clinical research monitoring services.

It is worth highlighting that, in recent years, ATMPs have emerged as one of the potential therapeutic modalities that are likely to change the standardized management in order to control the onset of chronic diseases. Thus, the growing demand for novel cell and gene therapies, approvals from various regulatory bodies and technological advancements in order to streamline the drug discovery and clinical research processes, are expected to drive the cell and gene therapy CRO market growth during the forecast period.

Clinical Trials Analysis: Over 3,500 Trials are Evaluating Cell and Gene Therapies to Treat Myriad of Disease Indications

Over the years, cell and gene therapy contract research organizations have made significant efforts to conduct clinical trials for evaluating the efficacy of these therapies for targeting various disorders, including oncological disorders, neurological disorders, and cardiovascular disorders. Majority (49%) of these trials were registered in North America.

Further, the maximum number of patients (110,585) have been enrolled in clinical trials conducted in North America, which account for 32% of the overall patient enrollment. It is worth mentioning that Chongqing Precision Biotech is conducting the maximum number of trials in this industry for various therapeutic areas, including oncological disorders, autoimmune / inflammatory disorders and liver disorders. This is followed by Chia Tai Tianqing Pharmaceutical with majority of its therapy candidates in the phase II clinical trials.

Market Trends Analysis: Partnerships and Collaborations have Fueled Cell and Gene Therapy CRO Market Growth

Several stakeholders have been forging alliances with other industry / non-industry players in the cell and gene therapy CRO industry. It is worth highlighting that, since 2015, over 65 strategic partnerships have been established in this domain. Interestingly, most of the agreements signed between the stakeholders were instances of acquisitions.

Cell and Gene Therapy CRO Market Drivers: Complexity of the Drug Modality and Expertise Offered by CROs

It is a well-known fact that the development and clinical evaluation of cell and gene therapies is both challenging and cost intensive, and only a few therapeutic developers have the required technical expertise to carry out in-house clinical research. This can be attributed to the peculiar requirements associated with acquiring the necessary infrastructure and capabilities to carry out research, along with advanced product development expertise. The aforementioned challenges are believed to be the key factors for driving the outsourcing of research operations to a cell and gene therapy CRO.

Cell and Gene Therapy CRO Market Share Insights

The market research report presents an in-depth analysis of the various firms / organizations in the cell and gene therapy CRO market, across different segments, as defined below:

• Historical Trend: 2018-2023
• Base Year: 2023
• Forecast Period: 2024-2035
• Market Size Value in 2024: $1.65 Billion
• Growth Rate: CAGR of 7.1% from 2024 to 2035

Key Attributes:

Key Topics Covered:

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

3.1. Chapter Overview

3.2. Market Dynamics

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

6.4. Selecting an Appropriate Outsourcing Model

6.5. Selecting a CRO Partner

6.6. Role of CROs in Drug Development

6.7. Concluding Remarks

7. MARKET LANDSCAPE

7.1. Chapter Overview

7.2. Cell and Gene Therapy CROs: Overall Market Landscape

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

8.4. CMIC

8.5. ICON

8.6. Labcorp

8.7. Linical

8.8. Medpace

8.9. Novotech

8.10. PPD

8.11. Precision for Medicine

8.12. QPS

8.13. Syneos Health

9. BENCHMARKING ANALYSIS

9.1. Chapter Overview

9.2. Key Assumptions and Methodology

9.3. Cell and Gene Therapy CROs: Benchmark Analysis

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

11. MERGERS AND ACQUISITIONS

11.1. Chapter Overview

11.2. Merger and Acquisition Models

11.3. Cell and Gene Therapy CROs: Mergers and Acquisitions

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

13.4. Gene Therapy: Clinical Trial Analysis

14. TOTAL COST OF OWNERSHIP

14.1 Chapter Overview

14.2. Assumptions and Methodology

14.3. Key Parameters

14.4 Total Cost of Ownership

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)

16.4. Key Market Segmentations

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

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

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

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

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

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

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

25. APPENDIX I: TABULATED DATA

26. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

For more information about this report visit https://www.researchandmarkets.com/r/1q9mqp

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