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CELL AND GENE THERAPY CRO MARKET: OVERVIEW

As per Roots Analysis, the global cell and gene therapy CRO market is estimated to grow from USD 1.7 billion in the current year to USD 3.5 billion by 2035, at a CAGR of 7.1% during the forecast period, till 2035.

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

Type of Cell Therapy

Type of Genetic Modification

Stage of Development

Therapeutic Area

End Users

Key Geographical Regions

CELL AND GENE THERAPY CRO MARKET: GROWTH AND TRENDS

The ongoing advancements in cell and gene therapies domain, along with several FDA-approved therapies, demonstrate the potential of these innovative therapies in treating a wide range of diseases (including rare and complex diseases) for which no effective treatment is currently available. As a result, this promising therapeutic modality has garnered the interest of both investors and drug developers alike. It is worth highlighting that, at present, over 90 cell and gene therapies have been approved globally. Notable examples of recently approved therapies include Elvediys (for the treatment of duchenne muscular dystrophy) developed by Sarepta Therapeutics, Fucaso (for the treatment of multiple myeloma) developed by IASO Bio and Vyjuvek (for the treatment of dystrophic epidermolysis bullosa) developed by Krystal Biotech. In addition, more than 3,500 clinical trials are currently underway to investigate cell and gene therapies across 16 therapeutic areas. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. As the cell and gene therapy field rapidly evolves, CROs offer valuable expertise in optimizing study designs, managing complex regulatory frameworks and seamless transition from preclinical to clinical success. At present, over 105 industry players claim to have the necessary capabilities to offer contract research services across different scales of operations.

CELL AND GENE THERAPY CRO MARKET: KEY INSIGHTS

The report delves into the current state of the cell and gene therapy CRO market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Presently, over 105 players (established as well as start ups) claim to have the necessary capabilities to offer contract research services; majority of these firms are based in North America.

2. Stakeholders offer contract research services for cell and gene therapies across different scales of operations; close to 20% of the players offer all types of clinical services.

3. More than 65 deals have been inked between various stakeholders involved in this domain; acquisitions emerged as the most common type of partnership model.

4. The rising interest of players is reflected by the number of mergers and acquisitions reported in the last few years; 58% of such initiatives were signed to incorporate additional capabilities to their existing portfolio offerings.

5. Since 2019, more than 3,000 clinical trials have been registered for cell therapies; over 70% of the trials recently initiated are currently recruiting patients.

6. Close to 500 clinical trials (with over 48,000 enrolled patients) have been registered to investigate gene therapies, across different geographies.

7. In order to meet the rising demand for cell and gene therapies, stakeholders are striving to upgrade / expand their capabilities to enhance their respective service portfolios.

8. Total cost of ownership model offers an informed estimate of capital and operational expenses associated with the establishment and maintenance of a contract research facility, over a span of 20 years.

9. Driven by the increasing number of chronic indications (requiring novel personalized therapies), and ongoing research on cell and gene therapies, this market is anticipated to grow at a CAGR of 7.1%, till 2035.

10. About 25% of the market is expected to be captured by revenues generated from cell and gene therapies for oncological disorders; it is also worth highlighting that the CRO market in China is likely to grow at a faster pace.

CELL AND GENE THERAPY CRO MARKET: KEY SEGMENTS

Currently, the CAR-T Cell Therapy Market Segment Occupies the Largest Share of the Cell and Gene Therapy CRO Market

Based on the type of cell therapy, the market is segmented into CAR-NK, CAR-T, TCR-T, and others. It is worth highlighting that the CAR-T cell therapies segment is likely to dominate the market in the coming decade. This can be attributed to the proven efficacy of CAR-T cell therapies in treating CD19-positive haematological malignancies, acute lymphoblastic leukemia and multiple myeloma.

Ex Vivo Segment Holds the Maximum Share within the Cell and Gene Therapy CRO Market

Based on the type of genetic modification, the market is segmented into ex vivo and in vivo. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the ex vivo segment and this trend is likely to remain the same in the forthcoming years. This can be attributed to the fact that ex vivo techniques utilize viral vectors, which are effective in delivering and integrating modified genetic material into cells.

Currently, the Clinical Segment Occupies the Largest Share of the Cell and Gene Therapy CRO Market

Based on the stage of development, the market is segmented into discovery, preclinical and clinical. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the clinical segment and this trend is likely to remain the same in the forthcoming years. This can be primarily attributed to the rigorous clinical testing that these therapies undergo in order to meet the regulatory standards before commercialization.

Oncological Disorders Segment is Likely to Dominate the Cell and Gene Therapy CRO Market During the Forecast Period

Based on therapeutic areas, the market is segmented into blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the oncological disorders segment and this trend is likely to remain the same in the forthcoming years.

Industry Players are Likely to Dominate the Cell and Gene Therapy CRO Market During the Forecast Period

Based on end user, the market is segmented into industry and non-industry players. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the industry players and this trend is likely to remain the same in the forthcoming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. Majority share is expected to be captured by CROs based in North America. It is worth highlighting that, over the years, the market for Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Cell and Gene Therapy CRO Market

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

CELL AND GENE THERAPY CRO MARKET: RESEARCH COVERAGE

KEY QUESTIONS ANSWERED IN THIS REPORT

REASONS TO BUY THIS REPORT

ADDITIONAL BENEFITS

TABLE OF CONTENTS

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

3.2.3. Trade Policies

4. EXECUTIVE SUMMARY

5. INTRODUCTION

6. GUIDE TO OUTSOURCING

7. MARKET LANDSCAPE

8. COMPANY PROFILES

9. BENCHMARKING ANALYSIS

10. PARTNERSHIPS AND COLLABORATIONS

11. MERGERS AND ACQUISITIONS

12. KEY ACQUISITION TARGETS

13. CLINICAL TRIAL ANALYSIS

13.4.1. Analysis by Trial Registration Year

14. TOTAL COST OF OWNERSHIP

15. SWOT ANALYSIS

16. GLOBAL CELL AND GENE THERAPY CRO MARKET

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

24. CONCLUDING REMARKS

25. APPENDIX I: TABULATED DATA

26. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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