DUBLIN, Dec. 19, 2022 /PRNewswire/ -- The "Cell and Gene Therapy CRO Market: Distribution by Area of Expertise, Scale of Operation, Therapeutic Area, and Geography: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.
The "Cell and Gene Therapy CROs Market (3rd Edition), 2022-2035" report features an extensive study of the current market landscape and future potential of the cell and gene therapy CROs market, over the next decade.
One of the key objectives of this report was to evaluate the current opportunity and the future growth potential of the cell and gene therapy CROs market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035.
How is the research and development (R&D) activity evolving in the cell and gene therapy industry?
At present, cell and gene therapy industry is one of the fastest growing therapeutic segments, already having contributed to some of the most significant disruptions in the biopharmaceutical domain.
Till date, 23 cell and gene therapies have been approved by the Food and Drug Administration (FDA) in the US, while more than 1,000 IND applications have been filed for candidates being evaluated in ongoing clinical studies. This further indicates a remarkable scientific progress and therapeutic promise of these breakthrough drug candidates.
What is the need for contract research organizations (CROs) in the cell and gene therapy domain?
At present, only a few therapeutic developers have the required technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the necessary infrastructure and capabilities to carry out research.
Other key concerns shared by contemporary innovators include limited availability of expertise, high rate of attrition of pipeline drugs / therapies and prolonged development timelines.
The aforementioned challenges are believed to be the key factors for driving the outsourcing of research operations to a cell and gene therapy CRO, which claim to be well-aware of the nuances of advanced therapy medicinal products (ATMPs) design and development, as well as cell and gene therapy manufacturing process.
What are the current opportunities in the cell and gene therapy CRO market?
Due to the upsurge in the research and development related to genetic engineering, there has been a considerable increase in the development of cell and gene therapies.
Consequently, there has been a parallel rise in outsourcing of services as more clinical studies are anticipated to start. Specifically, cell and gene therapy companies have made significant investments to support the development / adoption of advanced tools, technologies and platforms, to generate more robust and evidence based clinical data, which is required for gaining the marketing authorizations across different geographies.
For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain. Further, CROs are believed to play a significant role in the successful approval of these drugs in a highly evolving regulatory environment. Since 2005, over 40 CROs have been established in this domain. It is worth mentioning that cell and gene therapy CROs are bolstering their existing capabilities to offer a wide range of services to their clients.
What are the recent developments and expected trends in the cell and gene therapy industry?
Presently, more than 3,570 cell and gene therapies are being evaluated across various stages of clinical development for a myriad of disease indications.
Given that the demand for cell and gene therapies is indubitably rising, more than 53% mergers and acquisitions have been undertaken by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall cell and gene therapies market, we believe that the cell and gene therapy CRO market is likely to witness a consistent growth, till 2035.
What are the key challenges faced by cell and gene therapy CROs?
One of the key challenges faced by cell and gene therapy CROs is the lack of understanding of the standard operating procedures (SOPs). In addition, various regulatory guidelines render therapies subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake research initiatives.
What are the key value drivers in the cell and gene therapy market?
A significant rise in healthcare expenditure, R&D spending and booming research have emerged as key value drivers in the cell and gene therapy domain.
How is the revenue generation potential associated with cell and gene therapy CROs likely to evolve in the coming years?
The cell and gene therapy CROs market is likely to witness a substantial growth in the coming years. It is worth mentioning that, presently in terms of area of expertise, the market is likely to be driven by cell therapies, and this trend is unlikely to change in the foreseen future as well.
Further, based on scale of operation, majority of the revenue share is likely to be associated with clinical operations. Specifically, in terms of global regions, the cell and gene therapy market in Asia-Pacific is likely to grow at a relatively faster pace (21%), in the long term.
Who are the key players engaged in the cell and gene therapy CROs market?
The key players engaged in this domain (which have also been capture in this report) include Altasciences, Allucent, Accelera Charles River Laboratories, Creative Biolabs, CMIC, Evotec, ICON, IQVIA, Labcorp, Medpace, PPD, Precision For Medicine, QPS and Syneos Health.
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Contract Research Organizations (CROs)
3.2.1. Evolution of CROs
3.2.2. Modern CROs and Prevalent Outsourcing Trends
3.3. Type of Services Offered by CROs
3.4. Classification of CROs
3.5. Role of CROs in Development of Advanced Therapy Medicinal Products (ATMPs)
3.6. Advantages of Outsourcing Operations to CROs
3.7. Risks Associated with Outsourcing to CROs
3.8. Future Perspectives
4. GUIDE TO OUTSOURCING
4.1. Chapter Overview
4.2. Outsourcing Cell and Gene Therapy Research
4.3. Guiding Models of Outsourcing
4.4. Selecting an Appropriate Outsourcing Model
4.5. Selecting a CRO Partner
4.6. Role of CROs in Drug Development
4.7. Concluding Remarks
5. MARKET LANDSCAPE
5.1. Chapter Overview
5.2. Cell and Gene Therapy CROs: Overall Market Landscape
6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Players based in North America
6.2.1. Altasciences
6.2.2. Allucent (Formerly Known as CATO SMS)
6.2.3. Charles River Laboratories
6.2.4. Creative Biolabs
6.2.5. IQVIA
6.2.6. Medpace
6.2.7. PPD
6.2.8. Precision for Medicine
6.2.9. QPS
6.3. Players based in Europe
6.3.1. Accelera
6.3.2. Evotec
6.3.3. ICON
6.3.4. Syneos Health
6.4. Players based in Asia-Pacific
6.4.1.1. CMIC Group
6.4.2. Labcorp
7. COMPETITIVE BENCHMARKING
7.1. Chapter Overview
7.2. Assumptions and Key Methodology
7.3. Competitive Benchmarking by Region
7.4. Concluding Remarks
8. PARTNERSHIPS AND COLLABORATIONS
8.1. Chapter Overview
8.2. Partnership Models
8.3. Cell and Gene Therapy CROs: Partnerships and Collaborations
9. MERGERS AND ACQUISITIONS
9.1. Chapter Overview
9.2. Merger and Acquisition Models
9.3. Cell and Gene Therapy CROs: Mergers and Acquisitions
10. KEY ACQUISITION TARGETS
10.1. Chapter Overview
10.2. Scoring Criteria and Key Assumptions
10.3. Scope and Methodology
10.4. Potential Strategic Acquisition Targets Amongst Small Players
10.5. Potential Strategic Acquisition Targets Amongst Mid-sized Players
11. LIKELY PARTNER ANALYSIS FOR CELL THERAPY CROs
11.1. Chapter Overview
11.2. Scoring Criteria and Key Assumptions
11.3. Scope and Methodology
11.4. Key Potential Strategic Partners for Cell Therapy CROs
12. LIKELY PARTNER ANALYSIS FOR GENE THERAPY CROs
12.1. Chapter Overview
12.2. Scoring Criteria and Key Assumptions
12.3. Scope and Methodology
12.4. Key Potential Strategic Partners for Gene Therapy CROs
13. CLINICAL TRIAL ANALYSIS
13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Cell Therapies: Analysis by Number of Clinical Trials
13.4. Cell Therapies: Analysis by Enrolled Patient Population
13.5. Gene Therapies: Analysis by Number of Clinical Trials
13.6. Gene Therapies: Analysis by Enrolled Patient Population
14. TOTAL COST OF OWNERSHIP FOR CELL AND GENE THERAPY CONTRACT RESEARCH ORGANIZATIONS
14.1 Chapter Overview
14.2. Key Parameters
14.3. Assumptions and Methodology
14.4. Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations, 2022-2042
15. MARKET FORECAST AND OPPORTUNITY ANALYSIS
15.1. Chapter Overview
15.2. Key Assumptions and Methodology
15.3. Global Cell and Gene Therapy CROs Market, 2022-2035
16. SWOT ANALYSIS
16.1. Chapter Overview
16.2. Strengths
16.3. Weaknesses
16.4. Opportunities
16.5. Threats
16.6. Comparison of SWOT Factors
17. CONCLUSION
17.1. Chapter Overview
18. INTERVIEW AND SURVEY TRANSCRIPTS
18.1. Chapter Overview
18.2. CATO SMS
18.2.1. Company Snapshot
18.2.2. Survey Transcript: Jessica Bliven, Director, Marketing and Sales
18.3. Changhai Hospital, Second Military Medical University
18.4. University of Colorado
19. APPENDIX I: TABULATED DATA
20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
For more information about this report visit https://www.researchandmarkets.com/r/6ot1q1
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