[email protected] +44 20 8123 2220 (UK) +1 732 587 5005 (US) Contact Us | FAQ |

Cell and Gene Therapy CRO Market (3rd Edition): Distribution by Area of Expertise (Cell Therapy and Gene Therapy), Scale of Operation (Clinical, Preclinical and Discovery), Therapeutic Area (Oncological Disorders, Neurological Disorders, Cardiovascular Disorders, Infectious Diseases, Metabolic Disorders, Autoimmune Disorders, Blood Disorders, Rare / Genetic Disorders, Ophthalmological Disorders, and Other disorders), and Geography (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, 2022-2035

January 2022 | 330 pages | ID: CDDBE376C092EN
Roots Analysis

US$ 4,799.00

E-mail Delivery (PDF)

Download PDF Leaflet

Accepted cards
Wire Transfer
Checkout Later
Need Help? Ask a Question
The cell and gene therapy CRO market is currently valued at $713 million in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 18% during the forecast period. Cell and gene therapy has demonstrated its potential in treating complex and rare diseases, including those for which effective treatments are currently lacking.

In the case of cell therapy, human cells are transplanted to repair or replace damaged cells or tissues, enabling the alteration or restoration of specific sets of cells. These cells may originate from the patient (autologous cells) or a donor (allogeneic cells). On the other hand, gene therapy aims to address underlying genetic issues to treat and prevent diseases by introducing, inactivating, or replacing genes within cells, either inside or outside the body. It's important to note that some therapeutic interventions can be classified as both cell and gene therapies. These therapies typically involve gene modification in specific cell types before their insertion into the patient's body.

Currently, the cell and gene therapy industry stands as one of the fastest-growing therapeutic segments and has already brought about significant disruptions in the biopharmaceutical domain. To date, the Food and Drug Administration (FDA) in the US has approved 23 cell and gene therapies, with more than 1,000 Investigational New Drug (IND) applications filed for candidates undergoing evaluation in ongoing clinical studies. This remarkable progress highlights the promising potential and scientific advancements of these groundbreaking drug candidates.

Key Market Segments

Area of Expertise
  • Cell Therapies
  • Gene Therapies
Scale of Operation
  • Clinical
  • Preclinical and Discovery
Therapeutic Areas
  • Oncological Disorders
  • Neurological Disorders
  • Cardiovascular Disorders
  • Infectious Diseases
  • Metabolic Disorders
  • Autoimmune Disorders
  • Blood Disorders
  • Rare / Genetic Disorders
  • Ophthalmological Disorders
  • Other Disorders
Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • MENA
  • Latin America
  • Rest of the World
Research Coverage:
  • The report studies the cell and gene therapy CRO market by area of expertise, scale of operation, therapeutic area and key geographical regions
  • The report analyzes factors (such as drivers, restraints, opportunities, and challenges) affecting the market growth.
  • The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
  • The report forecasts the revenue of market segments with respect to major regions.
  • A comprehensive overview of the cell and gene therapy CRO market, including details on year of establishment, company size (number of employees), location of headquarters, areas of expertise (cell therapy and gene therapy), scale of operation (discovery, preclinical, clinical, and commercial), and types of services offered, encompassing preclinical services, clinical services, regulatory services, and general support services.
  • An in-depth analysis of common business models adopted by the biopharmaceutical industry for outsourcing cell and gene therapies, including factors that drive developers toward outsourcing and key considerations for sponsors when choosing CROs at different phases of the drug development process.
  • Detailed profiles of companies based in North America, Europe, and Asia-Pacific offering contract research services for cell and gene therapies at both preclinical and clinical scales of operation. Each profile includes an overview of the company, information about their service portfolio, recent developments, and future outlook.
  • A benchmark analysis of various players in the cell and gene therapy CRO market, highlighting their expertise across different services related to cell and gene therapy development, allowing companies to assess their capabilities relative to their peers.
  • Analysis of recent collaborations within the cell and gene therapy contract research industry, covering parameters like the year of partnership, partnership type, area of expertise, the most active players (based on the number of deals), and regional distribution of partnership activity in the cell and gene therapy CRO market from 2015 to 2022.
  • A detailed examination of mergers and acquisitions that occurred in the cell and gene therapy CRO market from 2015 to 2022, considering factors such as year, agreement type, area of expertise, geographical location of the companies, and key value drivers.
  • An acquisition target analysis based on the historical activity of companies acquiring other firms since 2015, offering insights for industry stakeholders to identify potential acquisition targets.
  • A list of over 310 cell therapy companies anticipated to partner with cell therapy CROs. These companies were selected based on developer strength, pipeline strength, and availability of other cell therapy capabilities.
  • An in-depth analysis of nearly 235 gene therapy companies expected to partner with gene therapy CROs, selected based on developer strength, pipeline strength, and availability of other gene therapy capabilities.
  • An analysis of completed, ongoing, and planned clinical studies for various cell and gene therapies based on parameters such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (based on the number of trials conducted), therapeutic area, and key geographical regions.
  • A detailed analysis of the total cost of ownership for large/very large cell and gene therapy contract research organizations, estimating direct and indirect expenses over a 20-year period.
  • A discussion of trends, key drivers, and challenges in the cell and gene therapy CRO industry under a SWOT framework, assessing the relative impact of each SWOT parameter on the overall cell and gene therapies research services sector.
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 container closure integrity testing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.
  • You will get access to complimentary PPT insights and excel data packs / dynamic dashboards to easily navigate through complex analyses / charts.
Key Market Companies
  • Altasciences
  • Allucent (formerly known as CATO SMS)
  • Accelera
  • Charles River Laboratories
  • CMIC Group
  • Creative Biolabs
  • Evotec
  • ICON
  • IQVIA
  • Labcorp
  • Medpace
  • PPD
  • Precision for Medicine
  • QPS
  • Syneos Health
1. PREFACE

1.1. Scope of the Report
1.2. Market Segmentation
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines

2. EXECUTIVE SUMMARY

2.1. Chapter Overview

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
  4.3.1. Transactional Outsourcing Model
  4.3.2. Performance / Outcome-based Business Model
  4.3.3. Staff Augmentation Model
  4.3.4. Phase-Dependent Outsourcing Models
4.4. Selecting an Appropriate Outsourcing Model
  4.4.1. Hybrid Approach
4.5. Selecting a CRO Partner
  4.5.1 Key Considerations while Outsourcing Cell and Gene Therapy-related Operations
4.6. Role of CROs in Drug Development
  4.6.1. Discovery and Preclinical Research
  4.6.2. Early Clinical Research
  4.6.3. Clinical Research and Laboratory Services
4.7. Concluding Remarks

5. MARKET LANDSCAPE

5.1. Chapter Overview
5.2. Cell and Gene Therapy CROs: Overall Market Landscape
  5.2.1. Analysis by Year of Establishment
  5.2.2. Analysis by Company Size
  5.2.3. Analysis by Location of Headquarters
  5.2.4. Analysis by Scale of Operation
  5.2.5. Analysis by Area of Expertise
  5.2.6. Analysis by Preclinical Services
    5.2.6.1 Analysis by Number of Preclinical Services
    5.2.6.2. Analysis by Type of Preclinical Service(s) Offered
  5.2.7. Analysis by Clinical Services
    5.2.7.1. Analysis by Number of Clinical Services
    5.2.7.2. Analysis by Type of Clinical Service(s) Offered
  5.2.8. Analysis by Type of Regulatory Service(s) Offered
  5.2.9. Analysis by Type of General Support Service(s) Offered

6. COMPANY PROFILES

6.1. Chapter Overview
6.2. Players based in North America
  6.2.1. Altasciences
    6.2.1.1. Company Overview
    6.2.1.2. Service Portfolio
    6.2.1.3. Recent Developments and Future Outlook
  6.2.2. Allucent (Formerly Known as CATO SMS)
    6.2.2.1. Company Overview
    6.2.2.2. Service Portfolio
    6.2.2.3. Recent Developments and Future Outlook
  6.2.3. Charles River Laboratories
    6.2.3.1. Company Overview
    6.2.3.2. Financial Information
    6.2.3.3. Service Portfolio
    6.2.3.4. Recent Developments and Future Outlook
  6.2.4. Creative Biolabs
    6.2.4.1. Company Overview
    6.2.4.2. Service Portfolio
    6.2.4.3. Recent Developments and Future Outlook
  6.2.5. IQVIA
    6.2.5.1. Company Overview
    6.2.5.2. Financial Information
    6.2.5.3. Service Portfolio
    6.2.5.4. Recent Developments and Future Outlook
  6.2.6. Medpace
    6.2.6.1. Company Overview
    6.2.6.2. Financial Information
    6.2.6.3. Service Portfolio
    6.2.6.4. Recent Developments and Future Outlook
  6.2.7. PPD
    6.2.7.1. Company Overview
    6.2.7.2. Financial Information
    6.2.7.3. Service Portfolio
    6.2.7.4. Recent Developments and Future Outlook
  6.2.8. Precision for Medicine
    6.2.8.1. Company Overview
    6.2.8.2. Service Portfolio
    6.2.8.3. Recent Developments and Future Outlook
  6.2.9. QPS
    6.2.9.1. Company Overview
    6.2.9.2. Service Portfolio
    6.2.9.3. Recent Developments and Future Outlook
6.3. Players based in Europe
  6.3.1. Accelera
    6.3.1.1. Company Overview
    6.3.1.2. Service Portfolio
    6.3.1.3. Recent Developments and Future Outlook
  6.3.2. Evotec
    6.3.2.1. Company Overview
    6.3.2.2. Financial Information
    6.3.2.3. Service Portfolio
    6.3.2.4. Recent Developments and Future Outlook
  6.3.3. ICON
    6.3.3.1. Company Overview
    6.3.3.2. Service Portfolio
    6.3.3.3. Recent Developments and Future Outlook
  6.3.4. Syneos Health
    6.3.4.1. Company Overview
    6.3.4.2. Financial Information
    6.3.4.3. Service Portfolio
    6.3.4.4. Recent Developments and Future Outlook
6.4. Players based in Asia-Pacific
    6.4.1.1. CMIC Group
    6.4.1.2. Company Overview
    6.4.1.3. Financial Information
    6.4.1.4. Service Portfolio
    6.4.1.5. Recent Developments and Future Outlook
  6.4.2. Labcorp
    6.4.2.1. Company Overview
    6.4.2.2. Financial Information
    6.4.2.3. Service Portfolio
    6.4.2.4. Recent Developments and Future Outlook

7. COMPETITIVE BENCHMARKING

7.1. Chapter Overview
7.2. Assumptions and Key Methodology
7.3. Competitive Benchmarking by Region
  7.3.1. Competitive Benchmarking: Small Players based in North America (Peer Group I)
  7.3.2. Competitive Benchmarking: Mid-sized Players based in North America (Peer Group II)
  7.3.3. Competitive Benchmarking: Large and Very Large Players based in North America (Peer Group III)
  7.3.4. Competitive Benchmarking: Small Players based in Europe (Peer Group IV)
  7.3.5. Competitive Benchmarking: Mid-sized Players based in Europe (Peer Group V)
  7.3.6. Competitive Benchmarking: Large and Very Large Players based in Europe (Peer Group VI)
  7.3.7. Competitive Benchmarking: Small, Mid-sized, Large and Very Large Players based in Asia-Pacific and RoW (Peer Group VII)
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
  8.3.1. Analysis by Year of Partnership
  8.3.2. Analysis by Type of Partnership
  8.3.3. Analysis by Year and Type of Partnership
  8.3.4. Analysis by Type of Partnership and Company Size
  8.3.5. Analysis by Area of Expertise
  8.3.6. Analysis by Year of Partnership and Area of Expertise
  8.3.7. Analysis by Type of Partnership and Area of Expertise
  8.3.8. Most Active Players: Analysis by Number of Partnerships
  8.3.9. Analysis by Region
    8.3.9.1. Intracontinental and Intercontinental Deals
    8.3.9.2. Local and International Deals

9. MERGERS AND ACQUISITIONS

9.1. Chapter Overview
9.2. Merger and Acquisition Models
9.3. Cell and Gene Therapy CROs: Mergers and Acquisitions
  9.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
  9.3.2. Analysis by Type of Agreement
  9.3.3. Analysis by Region
    9.3.3.1. Mergers and Acquisitions: Continent-wise Distribution
    9.3.3.2. Mergers and Acquisitions: Country-wise Distribution
  9.3.4. Most Active Acquirers: Analysis by Number of Acquisitions
  9.3.5. Analysis by Key Value Drivers
  9.3.6. Analysis by Year of Acquisition and Key Value Drivers
  9.3.7. Key Acquisitions: Deal Multiples

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
  11.4.1. Likely Partner Opportunities for Dendritic Cell Therapy CROs
  11.4.2. Likely Partner Opportunities for NK Cell Therapy CROs
  11.4.3. Likely Partner Opportunities for Stem Cell Therapy CROs
  11.4.4. Likely Partner Opportunities for T-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
  12.4.1. Likely Partner Opportunities in North America
  12.4.2. Likely Partner Opportunities in Europe
  12.4.3. Likely Partner Opportunities in Asia-Pacific and RoW

13. CLINICAL TRIAL ANALYSIS

13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Cell Therapies: Analysis by Number of Clinical Trials
  13.3.1. Analysis by Trial Registration Year
  13.3.2. Analysis by Trial Status
  13.3.3. Analysis by Trial Phase
  13.3.4. Analysis by Type of Sponsor
  13.3.5. Analysis by Geography
  13.3.6. Analysis by Trial Status and Geography
13.4. Cell Therapies: Analysis by Enrolled Patient Population
  13.4.1. Analysis by Trial Registration Year
  13.4.2. Analysis by Trial Phase
  13.4.3. Analysis by Trial Status and Geography
13.5. Gene Therapies: Analysis by Number of Clinical Trials
  13.5.1. Analysis by Trial Registration Year
  13.5.2. Analysis by Trial Status
  13.5.3. Analysis by Trial Phase
  13.5.4. Analysis by Therapeutic Area
  13.5.5. Analysis by Type of Sponsor
  13.5.6. Analysis by Geography
  13.5.7. Analysis by Trial Status and Geography
13.6. Gene Therapies: Analysis by Enrolled Patient Population
  13.6.1. Analysis by Trial Registration Year
  13.6.2. Analysis by Trial Phase
  13.6.3. Analysis by Therapeutic Area
  13.6.4. Analysis by Trial Status and Geography

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 Sample dataset for the estimation of total cost of ownership
  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: Distribution of CAPEX (USD Million)
  14.4.3. Total Cost of Ownership for Large / Very Large Cell and Gene Therapy Contract Research Organizations: Analysis By OPEX, Y1-Y20

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
  15.3.1. Cell and Gene Therapy CROs Market: Analysis by Area of Expertise
    15.3.1.1. Cell Therapy CROs Market, 2022-2035
    15.3.1.2. Gene Therapy CROs Market, 2022-2035
  15.3.2. Cell and Gene Therapy CROs Market: Analysis by Scale of Operation
    15.3.2.1. Cell and Gene Therapy CROs Market for Preclinical Operations, 2022-2035
    15.3.2.2. Cell and Gene Therapy CROs Market for Clinical Operations, 2022-2035
    15.3.2.3. Cell and Gene Therapy CROs Market for Drug Discovery Operations, 2022-2035
  15.3.3. Cell and Gene Therapy CROs Market: Analysis by Therapeutic Area, 2022-2035
    15.3.3.1. Cell and Gene Therapy CROs Market for Oncological Disorders, 2022-2035
    15.3.3.2. Cell and Gene Therapy CROs Market for Neurological Disorders, 2022-2035
    15.3.3.3. Cell and Gene Therapy CROs Market for Cardiovascular Disorders, 2022-2035
    15.3.3.4. Cell and Gene Therapy CROs Market for Infectious Diseases, 2022-2035
    15.3.3.5. Cell and Gene Therapy CROs Market for Metabolic Disorders, 2022-2035
    15.3.3.6. Cell and Gene Therapy CROs Market for Autoimmune Disorders, 2022-2035
    15.3.3.7. Cell and Gene Therapy CROs Market for Blood Disorders, 2022-2035
    15.3.3.8. Cell and Gene Therapy CROs Market for Rare / Genetic Disorders, 2022-2035
    15.3.3.9. Cell and Gene Therapy CROs Market for Ophthalmic Disorders, 2022-2035
    15.3.3.10. Cell and Gene Therapy CROs Market for Other Disorders, 2022-2035
  15.3.4. Cell and Gene Therapy CROs Market: Analysis by Geography, 2022-2035
    15.3.4.1. Cell and Gene Therapy CROs Market in North America, 2022-2035
    15.3.4.2. Cell and Gene Therapy CROs Market in Europe, 2022-2035
    15.3.4.3. Cell and Gene Therapy CROs Market in Asia-Pacific, 2022-2035
    15.3.4.4. Cell and Gene Therapy CROs Market in Latin America, 2022-2035
    15.3.4.5. Cell and Gene Therapy CROs Market in MENA, 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
  18.3.1. University Snapshot
  18.3.2. Survey Transcript: Xian-Bao Zhan, Professor of Medicine, Director, Department of Oncology
18.4. University of Colorado
  18.4.1. University Snapshot
  18.4.2. Survey Transcript: Enkhtsetseg Purev, Assistant Professor of Medicine

19. APPENDIX I: TABULATED DATA

20. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS


More Publications