Cell and Gene Therapy CROs Market, 2018-2030

  • ID: 4702518
  • Report
  • 238 Pages
  • Roots Analysis
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The Cell and Gene Therapy Service Market is Expected to Grow at About 9% Annually Between 2018 and 2030

FEATURED COMPANIES

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  • Bioville
  • Epeius Biotechnologies
  • IQVIA
  • Novella Clinical
  • SMS-oncology
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In the recent past, cell and gene therapies have emerged as promising treatment options for a myriad of complex clinical conditions, including cancers and inherited disorders. Currently, more than 25 such advanced therapy medicinal products are available in the market; examples of recently approved therapies include Alofisel® (2018), LUXTURNA™ (2017), YESCARTA™ (2017), Kymriah™ (2017) and INVOSSA™ (2017). In addition, over 500 cell and gene therapy candidates are being investigated in different stages of clinical development, across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials that are currently active were initiated to evaluate the potential of these therapies across multiple therapeutic indications. Due to several development challenges, such as fragile nature of cells being used, safety and efficacy issues, laborious procedures for conducting clinical studies, complex regulatory framework and exorbitant costs, it is difficult for the companies with limited expertise and finances to successfully develop these therapies in-house. The aforementioned challenges have led several players to outsource a significant part of their clinical stage research to capable contract research organizations (CROs), which claim to offer cost-efficient solutions as well as intellectual and operational expertise.

In fact, various therapy developers have partnered with CROs to seek their support in advancing product candidates towards approval. Moreover, contract service providers have formed alliances to enhance their capabilities and provide an integrated suite of services. It is also worth highlighting that the industry has witnessed some consolidation in the last five years as smaller players have been acquired in an effort to widen the parent company’s geographical reach. Furthermore, service providers have invested in developing / adopting advanced tools, technologies and platforms in order to provide robust and evidence-based clinical data for approval. Given these technological advancements, the cost and time-related advantages of outsourcing research and the expanding pipeline of cell and gene therapy candidates, the demand for CROs is projected to grow in the foreseen future.

The ‘Cell and Gene Therapy CROs Market, 2018-2030’ report features a comprehensive study on the current landscape of contract research service providers in the cell and gene therapy sector. The study presents an in-depth analysis, highlighting the capabilities of stakeholders engaged in this domain, across different regions of the globe. Amongst various elements, the report includes:

  • An assessment of the current market landscape, featuring a comprehensive list of more than 70 active CROs and a detailed analysis based on a number of parameters, such as the company size, location of their headquarters, year of establishment, type of therapy (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operations (scale and preclinical) and types of services offered including [A] clinical services (clinical trial management, clinical trial monitoring, data management and project management, clinical safety and quality studies, regulatory services, consultancy services and IT / informatics services) and [B] preclinical services (bioanalytical services, toxicology studies, in vivo studies, preclinical safety and quality studies and support services).
  • A comprehensive discussion on the various outsourcing business models adopted in this field, along with a list of key considerations that need to be taken into account by therapy developers while selecting a CRO partner.
  • Elaborate profiles of prominent players that offer contract research services for cell and gene therapies; each profile provides an overview of the company, its financial status (if available), information on its service(s) portfolio and a detailed future outlook.
  • A comprehensive benchmark analysis, highlighting the key focus areas of small, mid- and large companies, comparing their existing capabilities within and beyond their respective peer groups, and providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
  • A comprehensive clinical trial analysis of ongoing studies related to the cell and gene therapy candidates in order to estimate the total number of product candidates under clinical evaluation. It provides detailed information related to clinical trials based on various parameters, such as geography, current status of trials, type of cell therapies (stem cells, T cells, dendritic cells, NK cells and tumor cells), key therapeutic area(s), disease indication(s) and number of patients enrolled.
  • A detailed analysis of the recent collaborations (since 2013) focused on the contract services signed for cell and gene therapies based on various parameters, such as the year of establishment, type of agreement, type of services for which the companies partnered, type of cell and gene therapy and geographical location.
  • A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall cell and gene therapy CRO market.

One of the key objectives of this report is to evaluate the current opportunity and the future potential of the cell and gene therapy CROs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long-term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on [A] type of therapy (cell therapy and gene therapy) [B] scale of operation (clinical and preclinical), [C] type of therapeutic areas (oncology and non-oncology) and [D] geographical region regions (covering North America, Europe, Asia Pacific and rest of the world). To account for the uncertainties associated with the growth of cell and gene therapy CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

Example Highlights

  • With more than 70 CROs offering services for the development and clinical stage operations of cell and gene therapies, the outsourcing market landscape is fragmented, featuring a mix of small-sized (less than 50 employees, 34%), mid-sized (51-500 employees, 41%), large (501-5,000 employees, 12%) and very large sized (more than 5,000 employees, 13%) companies. Examples of very large companies include (in alphabetical order, no selection criteria) CMIC Group, Covance, ICON, Medpace, PPD, and Syneos Health.
  • More than half of the CROs claim to provide clinical stage support only.  Examples of companies offering clinical services include (in alphabetical order, no selection criteria) BioniX, CTI Clinical Trial & Consulting, FGK Clinical Research, JSB Solutions, Linical Accelovance, PRC Clinical and Symbion Research International.Around one-third of the total number of CROs provide both clinical and preclinical stage services; examples of such companies include (in alphabetical order, no selection criteria) Boston Biomedical Associates, Creative BioLabs, FARMACORE BIOTECHNOLOGY, GenoSafe®, IQVIA and Quality Assistance.
  • Popular clinical development services offered by contract service providers include clinical trial management (46%), safety and quality studies (36%), clinical trial monitoring (24%) and clinical project management (20%). In terms of preclinical stage services, 51% currently provide safety and quality studies, 41% presently offer ADME studies and in vivo studies, respectively and 30% currently provide toxicology studies.
  • More than 1,000 ongoing clinical studies of cell therapies (including stem cell therapies, T-cell therapies, dendritic cell therapies, NK cell therapies and tumor cell therapies)were registered across different geographies in the last five years. Amongst many others, oncological disorders (57%) emerged as the most researched therapeutic area by therapy developers in this domain.
  • Several collaborations have been inked amongst various stakeholders in this domain during the period 2013-2018. Most of these partnerships were outsourcing agreements (41%), signed between CROs and sponsor companies to advance the development of various therapies. Service alliances (8%) were another important type of partnerships, representing deals signed between different CROs to expand their service portfolio. It is important to highlight that over 15 mergers and acquisitions have taken in the last five years. Examples of companies that were recently acquired are SNBL USA’s preclinical business by Altasciences (September 2018), Ascendance Biotechnology by BioIVT (March 2018) and MPI Research by Charles River Laboratories (February 2018).
  • Driven by the rapidly evolving pipeline and increasing adoption of novel tools and technologies, we expect the cell and gene therapy services market to grow at an annualized rate of ~9% between 2018 and 2030. It is important to highlight that North America (primarily US) and Europe currently capture the largest share (in terms of revenues) in cell and gene therapy CRO market. This is followed by Asia Pacific and the rest of the world, which currently capture about 25-30% of the overall market share. This trend is unlikely to change significantly in the future.
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FEATURED COMPANIES

  • 4Clinics
  • Bioville
  • Epeius Biotechnologies
  • IQVIA
  • Novella Clinical
  • SMS-oncology
  • MORE

1. Preface
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. Executive Summary

3. Introduction
3.1. Chapter Overview
3.2. An Overview of Contract Research Organizations (CROs)
3.2.1. Evolution of CROs
3.2.2. Modern CROs and Prevalent Outsourcing Trends
3.3. Services Offered by CROs
3.4. Classification of CROs
3.5. Advantages of Outsourcing to CROs
3.6. Risks Associated with Outsourcing to CROs
3.7. Role of CROs in the Development of Advanced Therapy Medicinal Products (ATMPs)
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-based Business Model
4.3.3. Outcome-based Business Model
4.3.4. Phase-dependent Outsourcing Models
4.4. Selecting a CRO Partner
4.4.1. Key Considerations
4.5. Role of CROs in Drug Development
4.6. Conclusion

5. Current Market Landscape
5.1. Chapter Overview
5.2. Cell and Gene Therapy CROs: Overall Market Landscape
5.2.1. Analysis by Location of Headquarters
5.2.2. Analysis by Employee Size
5.2.3. Analysis by Scale of Operations
5.3. Cell and Gene Therapy: Clinical CROs
5.3.1. Analysis by Region
5.3.2. Analysis by Employee Size
5.3.3. Analysis by Type of Therapy
5.3.4. Analysis by Type of Services
5.4. Cell and Gene Therapy: Preclinical CROs
5.4.1. Analysis by Region
5.4.2. Analysis by Employee Size
5.4.3. Analysis by Type of Therapy
5.4.4. Analysis by Type of Services

6. Company Profiles
6.1. Chapter Overview
6.2. Players based in North America
6.2.1. Cato Research
6.2.1.1. Company Overview
6.2.1.2. Service Portfolio
6.2.1.3. Future Outlook
6.2.2. Charles River Laboratories
6.2.2.1. Company Overview
6.2.2.2. Financial Information
6.2.2.3. Services Portfolio
6.2.2.4. Future Outlook
6.2.3. Covance
6.2.3.1. Company Overview
6.2.3.2. Financial Information
6.2.3.3. Service Portfolio
6.2.3.4. Future Outlook
6.2.4. Creative Biolabs
6.2.4.1. Company Overview
6.2.4.2. Service Portfolio
6.2.4.3. 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. 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. 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. Future Outlook
6.3.2. BioniX
6.3.2.1. Company Overview
6.3.2.2. Service Portfolio
6.3.2.3. Future Outlook
6.3.3. JSB Solutions
6.3.3.1. Company Overview
6.3.3.2. Service Portfolio
6.3.3.3. Future Outlook
6.3.4. Quality Assistance
6.3.4.1. Company Overview
6.3.4.2. Financial Information
6.3.4.3. Service Portfolio
6.3.4.4. Future Outlook
6.4. Players based in Asia
6.4.1. CMIC Group
6.4.1.1. Company Overview
6.4.1.2. Financial Information
6.4.1.3. Service Portfolio
6.4.1.4. Future Outlook
6.4.2. Pharmaseed
6.4.2.1. Company Overview
6.4.2.2. Serviced Portfolio
6.4.2.3. Future Outlook

7. Benchmark Analysis
7.1. Chapter Overview
7.2. Benchmark Analysis: Methodology
7.3. Benchmark Analysis: Peer Groups
7.3.1. Peer Group I
7.3.2. Peer Group II
7.3.3. Peer Group III
7.3.4. Peer Group IV
7.3.5. Peer Group V

8. Clinical Trial Analysis
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Cell and Gene Therapy Clinical Trials
8.3.1. Analysis by Trial Registration Year
8.3.2. Analysis by Type of Cell Therapy
8.3.3. Analysis by Phase of Development
8.3.4. Analysis by Type of Cell Therapy and Phase of Development
8.3.5. Analysis by Geography
8.3.6. Analysis by Type of Cell Therapy, Phase of Development and Geography
8.3.7. Analysis by Therapeutic Indications
8.3.8. Analysis by Therapeutic Indications and Phase of Development
8.3.9. Analysis by Therapeutic Indications, Phase of Development and Geography
8.4. Cell and Gene Therapy Clinical Trials: Analysis by Patients Enrolled
8.4.1. Analysis by Type of Cell Therapy
8.4.2. Analysis by Type of Cell Therapy and Geography
8.4.3. Analysis by Type of Cell Therapy, Phase of Development and Geography

9. Collaborations
9.1. Chapter Overview
9.2. Partnership Models
9.3. Cell and Gene Therapy CROs: List of Partnerships
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership Model
9.3.3. Analysis by Year and Type of Partnership
9.3.4. Analysis by Type of Therapy
9.3.5. Analysis by Type of Therapy and Type of Partnership
9.3.6. Most Active Players: Analysis by Number of Partnerships
9.3.7. Regional Distribution
9.4. Cell and Gene Therapy CROs: List of Mergers and Acquisitions
9.4.1. Analysis by Year
9.4.2. Geographical Activity
9.4.3. Ownership Change Matrix
9.5. Key Acquisitions: Deal Multiples

10. Market Sizing And Opportunity Analysis
10.1. Chapter Overview
10.2. Scope of the Forecast
10.3. Forecast Methodology
10.4. Overall Cell and Gene Therapy CROs Market, 2018-2030
10.4.1. Cell and Gene Therapy CROs Market, 2018-2030: Distribution by Therapeutic Area
10.4.2. Cell and Gene Therapy CROs Market, 2018-2030: Distribution by Scale of Operation
10.4.3. Cell and Gene Therapy CROs Market, 2018-2030: Distribution by Type of Therapy
10.4.4. Cell and Gene Therapy CROs Market, 2018-2030: Distribution by Geography
10.5. Cell and Gene Therapy CROs Market in North America, 2018-2030
10.5.1. Cell and Gene Therapy CROs Market in North America, 2018-2030: Distribution by Therapeutic Area
10.5.1.1. Cell and Gene Therapy CROs Market for Oncological Indications in North America, 2018-2030
10.5.1.2. Cell and Gene Therapy CROs Market for Non-Oncological Indications in North America, 2018-2030
10.5.2. Cell and Gene Therapy CROs Market in North America, 2018-2030: Distribution by Type of Therapy
10.5.1.1. Cell and Gene Therapy CROs Market for Cell Therapy in North America, 2018-2030
10.5.1.2. Cell and Gene Therapy CROs Market for Gene Therapy in North America, 2018-2030
10.6. Cell and Gene Therapy CROs Market in Europe, 2018-2030
10.6.1. Cell and Gene Therapy CROs Market in Europe, 2018-2030: Distribution by Therapeutic Area
10.6.1.1. Cell and Gene Therapy CROs Market for Oncological Indications in Europe, 2018-2030
10.6.1.2. Cell and Gene Therapy CROs Market for Non-Oncological Indications in Europe, 2018-2030
10.6.2. Cell and Gene Therapy CROs Market in Europe, 2018-2030: Distribution by Type of Therapy
10.6.1.1. Cell and Gene Therapy CROs Market for Cell Therapy in Europe, 2018-2030
10.6.1.2. Cell and Gene Therapy CROs Market for Gene Therapy in Europe, 2018-2030
10.7. Cell and Gene Therapy CROs Market in Asia Pacific, 2018-2030
10.7.1. Cell and Gene Therapy CROs Market in Asia Pacific, 2018-2030: Distribution by Therapeutic Area
10.7.1.1. Cell and Gene Therapy CROs Market for Oncological Indications in Asia Pacific, 2018-2030
10.7.1.2. Cell and Gene Therapy CROs Market for Non-Oncological Indications in Asia Pacific, 2018-2030
10.7.2. Cell and Gene Therapy CROs Market in Asia Pacific, 2018-2030: Distribution by Type of Therapy
10.7.1.1. Cell and Gene Therapy CROs Market for Cell Therapy in Asia Pacific, 2018-2030
10.7.1.2. Cell and Gene Therapy CROs Market for Gene Therapy in Asia Pacific, 2018-2030
10.8. Cell and Gene Therapy CROs Market in Rest of the World, 2018-2030
10.8.1. Cell and Gene Therapy CROs Market in Rest of the World, 2018-2030: Distribution by Therapeutic Area
10.8.1.1. Cell and Gene Therapy CROs Market for Oncological Indications in Rest of the World, 2018-2030
10.8.1.2. Cell and Gene Therapy CROs Market for Non-Oncological Indications in Rest of the World, 2018-2030
10.8.2. Cell and Gene Therapy CROs Market in Rest of the World, 2018-2030: Distribution by Type of Therapy
10.8.1.1. Cell and Gene Therapy CROs Market for Cell Therapy in Rest of the World, 2018-2030
10.8.1.2. Cell and Gene Therapy CROs Market for Gene Therapy in Rest of the World, 2018-2030

11. SWOT Analysis
11.1. Chapter Overview
11.2. Strengths
11.3. Weaknesses
11.4. Opportunities
11.5. Threats
11.6. Concluding Remarks

12. Conclusion
12.1. Given the Growing Pipeline of Cell and Gene Therapies, the Demand for Contract Services is Anticipated to Increase
12.2. Presently, CROs Claim to Possess Superior Technical Expertise and Capabilities to Handle Challenging Aspects of Early Stage Research
12.3. The Market for Cell and Gene Therapy Services is Concentrated in North America and Europe, the Key Innovation Hubs
12.4. Players have Entered into Strategic Collaborations to Support the Development of Pipelines or Expand their Capabilities
12.5. Owing to the Advantages Offered by Outsourcing, the Market for Cell and Gene Therapy R&D Services is Anticipated to be Worth Multi-Billion Dollars over the Next Decade

13. Interview And Survey Transcripts
13.1 Chapter Overview
13.2. Changhai Hospital
13.2.1. Company Snapshot
13.2.2. Interview Transcript: Xian-Bao Zhan, Professor of Medicine and Director, Department of Oncology
13.3. University of Colorado
13.3.1. Company Snapshot
13.3.2. Interview Transcript: Enkhtsetseg Purev, Assistant Professor of Medicine

14. Appendix 1: Tabulated Data

15. Appendix 2: List Of Companies And Organizations

List of Tables

Table 3.1 List of Approved ATMP Products
Table 5.1 Cell and Gene Therapy Clinical CROs: List of Companies
Table 5.2 Cell and Gene Therapy Clinical CROs: Details of Service Portfolio
Table 5.3 Cell and Gene Therapy Preclinical CROs: List of Companies
Table 5.4 Cell and Gene Therapy Preclinical CROs: Details of Service Portfolio
Table 6.1 Cato Research: Company Overview
Table 6.2 Cato Research: Future Outlook
Table 6.3 Charles River Laboratories: Company Overview
Table 6.4 Charles River Laboratories: Future Outlook
Table 6.5 Covance: Company Overview
Table 6.6 Covance: Future Outlook
Table 6.7 Creative Biolabs: Company Overview
Table 6.8 Creative Biolabs: Future Outlook
Table 6.9 IQVIA: Company Overview
Table 6.10 IQVIA: Future Outlook
Table 6.11 Medpace: Company Overview
Table 6.12 Medpace: Future Outlook
Table 6.13 Accelera: Company Overview
Table 6.14 Accelera: Future Outlook
Table 6.15 BioniX: Company Overview
Table 6.16 BioniX: Future Outlook
Table 6.17 JSB Solutions: Company Overview
Table 6.18 JSB Solutions: Future Outlook
Table 6.19 Quality Assistance: Company Overview
Table 6.20 Quality Assistance: Future Outlook
Table 6.21 CMIC Group: Company Overview
Table 6.22 CMIC Group: Future Outlook
Table 6.23 Pharmaseed: Company Overview
Table 6.24 Pharmaseed: Future Outlook
Table 7.1 Benchmark Analysis: Peer Groups
Table 9.1 Cell and Gene Therapy CROs: List of Partnerships
Table 9.2 Cell and Gene Therapy CROs: List of Mergers and Acquisitions
Table 9.3 Key Acquisitions: Deal Multiples
Table 14.1 Cell and Gene Therapy CROs: Global Distribution by Location
Table 14.2 Cell and Gene Therapy CROs: Global Distribution by Employee Size
Table 14.3 Cell and Gene Therapy CROs: Distribution by Scale of Operations
Table 14.4 Cell and Gene Therapy Clinical CROs: Distribution by Region
Table 14.5 Cell and Gene Therapy Clinical CROs: Distribution by Location (Country-wise)
Table 14.6 Cell and Gene Therapy Clinical CROs: Distribution by Employee Size
Table 14.7 Cell and Gene Therapy Clinical CROs: Distribution by Type of Therapy
Table 14.8 Cell and Gene Therapy Clinical CROs: Distribution by Type of Services
Table 14.9 Cell and Gene Therapy Preclinical CROs: Distribution by Region
Table 14.10 Cell and Gene Therapy Preclinical CROs: Distribution by Location (Country-wise)
Table 14.11 Cell and Gene Therapy Preclinical CROs: Distribution by Employee Size
Table 14.12 Cell and Gene Therapy Preclinical CROs: Distribution by Type of Therapy
Table 14.13 Cell and Gene Therapy Preclinical CROs: Distribution by Type of Services
Table 14.14 Charles River Laboratories: Annual Revenues, 2013-H1 2018 (USD Billion)
Table 14.15 Covance: Annual Revenues, 2016-2017 (USD Billion)
Table 14.16 IQVIA: Annual Revenues, 2013-H1 2018 (USD Million)
Table 14.17 IQVIA: Distribution of Annual Revenue by Operating Business Segments
Table 14.18 Medpace: Annual Net Revenues, 2013-H1 2018 (USD Million)
Table 14.19 Medpace: Distribution of Net Service Revenue by Size of Company
Table 14.20 Quality Assistance: Annual Net Revenues, 2013-2017 (USD Million)
Table 14.21 CMIC Group: Annual Net Revenues, 2013-2017 (USD Million)
Table 14.22 Benchmark Analysis: Peer Group I
Table 14.23 Benchmark Analysis: Peer Group II
Table 14.24 Benchmark Analysis: Peer Group III
Table 14.25 Benchmark Analysis: Peer Group IV
Table 14.26 Benchmark Analysis: Peer Group V
Table 14.27 Clinical Trial Analysis: Distribution by Start Year (2012-2017) and Geography
Table 14.28 Clinical Trial Analysis: Distribution by Type of Cell Therapy
Table 14.29 Clinical Trial Analysis: Distribution by Phase of Development
Table 14.30 Clinical Trial Analysis: Distribution by Type of Cell Therapy and Phase of Development
Table 14.31 Clinical Trial Analysis: Distribution by Therapeutic Indications
Table 14.32 Clinical Trial Analysis: Distribution by Therapeutic Indications and Phase of Development
Table 14.33 Clinical Trial Analysis: Distribution of Patients Enrolled by Type of Cell Therapy
Table 14.34 Partnerships: Cumulative Trend by Year (2013-2018)
Table 14.35 Partnerships: Distribution by Type of Partnership Model
Table 14.36 Partnerships: Distribution by Year and Type of Partnership Model (2013-2018)
Table 14.37 Partnerships: Distribution by Type of Therapy
Table 14.38 Partnerships: Distribution by Type of Therapy and Type of Partnership Model
Table 14.39 Partnerships: Distribution by Most Active Players
Table 14.40 Partnerships: Regional Distribution
Table 14.41 Partnerships: Distribution by International and Local Acquisitions
Table 14.42 Mergers and Acquisitions: Year-Wise Trend
Table 14.43 Mergers and Acquisitions: Regional Distribution by Intercontinental and Intracontinental Agreements
Table 14.44 Mergers and Acquisitions: Ownership Change Matrix
Table 14.45 Overall Cell and Gene Therapy CROs Market, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.46 Cell and Gene Therapy CROs Market: Distribution by Therapeutic Area, 2018-2030 (USD Billion)
Table 14.47 Cell and Gene Therapy CROs Market: Distribution by Scale of Operation, 2018-2030 (USD Billion)
Table 14.48 Cell and Gene Therapy CROs Market: Distribution by Type of Therapy, 2018-2030 (USD Billion)
Table 14.49 Cell and Gene Therapy CROs Market: Distribution by Geography, 2018-2030 (USD Billion)
Table 14.50 Cell and Gene Therapy CROs Market in North America, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.51 Cell and Gene Therapy CROs Market for Oncological Indications in North America, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.52 Cell and Gene Therapy CROs Market for Non-Oncological Indications in North America, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.53 Cell and Gene Therapy CROs Market for Cell Therapy in North America, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.54 Cell and Gene Therapy CROs Market for Gene Therapy in North America, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.55 Cell and Gene Therapy CROs Market in Europe, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.56 Cell and Gene Therapy CROs Market for Oncological Indications in Europe, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.57 Cell and Gene Therapy CROs Market for Non-Oncological Indications in Europe, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.58 Cell and Gene Therapy CROs Market for Cell Therapy in Europe, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.59 Cell and Gene Therapy CROs Market for Gene Therapy in Europe, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.60 Cell and Gene Therapy CROs Market in Asia Pacific, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.61 Cell and Gene Therapy CROs Market for Oncological Indications in Asia Pacific, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.62 Cell and Gene Therapy CROs Market for Non-Oncological Indications in Asia Pacific, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.63 Cell and Gene Therapy CROs Market for Cell Therapy in Asia Pacific, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.64 Cell and Gene Therapy CROs Market for Gene Therapy in Asia Pacific, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.65 Cell and Gene Therapy CROs Market in Rest of the World, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.66 Cell and Gene Therapy CROs Market for Oncological Indications in Rest of the World, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.67 Cell and Gene Therapy CROs Market for Non-Oncological Indications in Rest of the World, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.68 Cell and Gene Therapy CROs Market for Cell Therapy in Rest of the World, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)
Table 14.69 Cell and Gene Therapy CROs Market for Gene Therapy in Rest of the World, Conservative, Base and Optimistic Scenario, 2018-2030 (USD Billion)

List of Figures

Figure 3.1 Stages of Drug Development Process
Figure 3.2 Services Provided by CROs
Figure 3.3 Advantages of Outsourcing to CROs
Figure 3.4 Risk Associated with Outsourcing to CROs
Figure 3.5 Classification of ATMPs
Figure 3.6 Types of Cells Incorporated in CTMPs
Figure 4.1 Factors Influencing Outsourcing Decisions
Figure 4.2 Guiding Models for Outsourcing
Figure 4.3 Key Characteristics of Transactional Outsourcing Model
Figure 4.4 Key Characteristics of Performance-based Business Model
Figure 4.5 Key Steps Leading to Outcome-based Business Model
Figure 4.6 Key Considerations for Selecting CROs
Figure 4.7 Role of a CRO in Different Phases of Drug Development
Figure 5.1 Cell and Gene Therapy CROs: Distribution by Geographical Location
Figure 5.2 Cell and Gene Therapy CROs: Distribution by Employee Size
Figure 5.3 Cell and Gene Therapy CROs: Distribution by Scale of Operations
Figure 5.4 Cell and Gene Therapy Clinical CROs: Distribution by Region
Figure 5.5 Cell and Gene Therapy Clinical CROs: Distribution by Location (Country-wise)
Figure 5.6 Cell and Gene Therapy Clinical CROs: Distribution by Employee Size
Figure 5.7 Cell and Gene Therapy Clinical CROs: Distribution by Type of Therapy
Figure 5.8 Cell and Gene Therapy Clinical CROs: Distribution by Type of Services
Figure 5.9 Cell and Gene Therapy Preclinical CROs: Distribution by Region
Figure 5.10 Cell and Gene Therapy Preclinical CROs: Distribution by Location (Country-wise)
Figure 5.11 Cell and Gene Therapy Preclinical CROs: Distribution by Employee Size
Figure 5.12 Cell and Gene Therapy Preclinical CROs: Distribution by Type of Therapy
Figure 5.13 Cell and Gene Therapy Preclinical CROs: Distribution by Type of Services
Figure 6.1 Cato Research: Service Portfolio
Figure 6.2 Charles River Laboratories: Annual Revenues, 2013-H1 2018 (USD Billion)
Figure 6.3 Charles River Laboratories: Service Portfolio
Figure 6.4 Covance: Annual Revenues, 2016-2017 (USD Billion)
Figure 6.5 Covance: Service Portfolio
Figure 6.6 Creative Biolabs: Service Portfolio for CAR-T Therapy Development
Figure 6.7 Creative Biolabs: Service Portfolio for TCR Therapy Development
Figure 6.8 IQVIA: Annual Revenues, 2013-H1 2018 (USD Million)
Figure 6.9 IQVIA: Distribution of Annual Revenue by Operating Business Segments
Figure 6.10 IQVIA: Service Portfolio
Figure 6.11 Medpace: Annual Revenues, 2013-H1 2018 (USD Million)
Figure 6.12 Medpace: Distribution of Service Revenue by Size of Client Company
Figure 6.13 Medpace: Service Portfolio
Figure 6.14 Medpace: Regulatory Services
Figure 6.15 Accelera: Service Portfolio
Figure 6.16 BioniX: Service Portfolio
Figure 6.17 JSB Solutions: Service Portfolio
Figure 6.18 Quality Assistance: Annual Net Revenues, 2013-2017 (USD Million)
Figure 6.19 Quality Assistance: Service Portfolio
Figure 6.20 CMIC Group: Annual Net Revenues, 2013-2017 (USD Million)
Figure 6.21 CMIC Group: Service Portfolio
Figure 6.22 Pharmaseed: Service Portfolio
Figure 7.1 Benchmark Analysis: Distribution of Companies by Establishment Year and Region
Figure 7.2 Benchmark Analysis: Peer Group I
Figure 7.3 Benchmark Analysis: Peer Group II
Figure 7.4 Benchmark Analysis: Peer Group III
Figure 7.5 Benchmark Analysis: Peer Group IV
Figure 7.6 Benchmark Analysis: Peer Group V
Figure 8.1 Clinical Trial Analysis: Distribution by Start Year (2012-2017) and Geography
Figure 8.2 Clinical Trial Analysis: Distribution by Type of Cell Therapy
Figure 8.3 Clinical Trial Analysis: Distribution by Phase of Development
Figure 8.4 Clinical Trial Analysis: Distribution by Type of Cell Therapy and Phase of Development
Figure 8.5 Clinical Trial Analysis: Distribution by Type of Cell Therapy and Geography
Figure 8.6 Clinical Trial Analysis: Distribution by Type of Cell Therapy, Phase of Development and Geography
Figure 8.7 Clinical Trial Analysis: Distribution by Therapeutic Indications
Figure 8.8 Clinical Trial Analysis: Distribution by Therapeutic Indications and Phase of Development
Figure 8.9 Clinical Trial Analysis: Distribution by Therapeutic Indication, Phase of Development and Geography
Figure 8.10 Clinical Trial Analysis: Distribution of Patients Enrolled by Type of Cell Therapy
Figure 8.11 Clinical Trial Analysis: Distribution of Patient Enrolled by Type of Cell Therapy and Geography
Figure 8.12 Clinical Trial Analysis: Distribution of Patient Enrolled by Type of Cell Therapy, Phase of Development and Geography
Figure 9.1 Partnerships: Cumulative Trend by Year (2013-2018)
Figure 9.2 Partnerships: Distribution by Type of Partnership Model
Figure 9.3 Partnerships: Distribution by Year and Type of Partnership Model (2013-2018)
Figure 9.4 Partnerships: Distribution by Type of Therapy
Figure 9.5 Partnerships: Distribution by Type of Therapy and Type of Partnership Model
Figure 9.6 Partnerships: Most Active Players
Figure 9.7 Partnerships: Regional Distribution
Figure 9.8 Partnerships: Distribution by International and Local Agreements
Figure 9.9 Mergers and Acquisitions: Year-Wise Trend (2013-2018)
Figure 9.10 Mergers and Acquisitions: Intercontinental and Intracontinental Acquisitions
Figure 9.11 Mergers and Acquisitions: Ownership Change Matrix
Figure 10.1 Overall Cell and Gene Therapy CROs Market, Base Scenario, 2018-2030 (USD Billion)
Figure 10.2 Cell and Gene Therapy CROs Market: Distribution by Therapeutic Area, 2018-2030 (USD Billion)
Figure 10.3 Cell and Gene Therapy CROs Market: Distribution by Scale of Operation, 2018-2030 (USD Billion)
Figure 10.4 Cell and Gene Therapy CROs Market: Distribution by Type of Therapy, 2018-2030 (USD Billion)
Figure 10.5 Cell and Gene Therapy CROs Market: Distribution by Geography, 2018-2030 (USD Billion)
Figure 10.7 Cell and Gene Therapy CROs Market in North America, Base Scenario, 2018-2030 (USD Billion)
Figure 10.8 Cell and Gene Therapy CROs Market for Oncological Indications in North America, Base Scenario, 2018-2030 (USD Billion)
Figure 10.9 Cell and Gene Therapy CROs Market for Non-Oncological Indications in North America, Base Scenario, 2018-2030 (USD Billion)
Figure 10.10 Cell and Gene Therapy CROs Market for Cell Therapy in North America, Base Scenario, 2018-2030 (USD Billion)
Figure 10.11 Cell and Gene Therapy CROs Market for Gene Therapy in North America, Base Scenario, 2018-2030 (USD Billion)
Figure 10.12 Cell and Gene Therapy CROs Market in Europe, Base Scenario, 2018-2030 (USD Billion)
Figure 10.13 Cell and Gene Therapy CROs Market for Oncological Indications in Europe, Base Scenario, 2018-2030 (USD Billion)
Figure 10.14 Cell and Gene Therapy CROs Market for Non-Oncological Indications in Europe, Base Scenario, 2018-2030 (USD Billion)
Figure 10.15 Cell and Gene Therapy CROs Market for Cell Therapy in Europe, Base Scenario, 2018-2030 (USD Billion)
Figure 10.16 Cell and Gene Therapy CROs Market for Gene Therapy in Europe, Base Scenario, 2018-2030 (USD Billion)
Figure 10.17 Cell and Gene Therapy CROs Market in Asia Pacific, Base Scenario, 2018-2030 (USD Billion)
Figure 10.18 Cell and Gene Therapy CROs Market for Oncological Indications in Asia Pacific, Base Scenario, 2018-2030 (USD Billion)
Figure 10.19 Cell and Gene Therapy CROs Market for Non-Oncological Indications in Asia Pacific, Base Scenario, 2018-2030 (USD Billion)
Figure 10.20 Cell and Gene Therapy CROs Market for Cell Therapy in Asia Pacific, Base Scenario, 2018-2030 (USD Billion)
Figure 10.21 Cell and Gene Therapy CROs Market for Gene Therapy in Asia Pacific, Base Scenario, 2018-2030 (USD Billion)
Figure 10.22 Cell and Gene Therapy CROs Market in Rest of the World, Base Scenario, 2018-2030 (USD Billion)
Figure 10.23 Cell and Gene Therapy CROs Market for Oncological Indications in Rest of the World, Base Scenario, 2018-2030 (USD Billion)
Figure 10.24 Cell and Gene Therapy CROs Market for Non-Oncological Indications in Rest of the World, Base Scenario, 2018-2030 (USD Billion)
Figure 10.25 Cell and Gene Therapy CROs Market for Cell Therapy in Rest of the World, Base Scenario, 2018-2030 (USD Billion)
Figure 10.26 Cell and Gene Therapy CROs Market for Gene Therapy in Rest of the World, Base Scenario, 2018-2030 (USD Billion)
Figure 11.1 Cell and Gene Therapy CROs Market: SWOT Analysis
Figure 11.2 Comparison of SWOT Factors: Harvey Ball Analysis
Figure 12.1 Overall Cell and Gene Therapy CROs Market, Conservative, Base and Optimistic Scenarios, 2018

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FEATURED COMPANIES

  • 4Clinics
  • Bioville
  • Epeius Biotechnologies
  • IQVIA
  • Novella Clinical
  • SMS-oncology
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Research Methodology
The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary sources. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

  • Annual reports
  • Investor presentations
  • SEC filings
  • Industry databases
  • News releases from company websites
  • Government policy documents
  • Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

Chapter Outlines

  • Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view of current scenario of cell and gene therapy CRO services market and its likely evolution in the mid-long term.
  • Chapter 3 provides a general introduction to CROs, featuring insights on the historical evolution of such organizations, and legacy and contemporary trends in outsourcing activity. It also includes details on the various types of services offered by different CROs. Further, the chapter highlights the several advantages and risks associated in partnering with contract service providers, and also describes the role of CROs in the development of ATMPs.
  • Chapter 4 provides a detailed discussion on the business models that are commonly adopted by the biopharmaceutical industry for outsourcing. In addition, the chapter includes information on various factors that drive sponsors towards outsourcing and key parameters that sponsors must consider while choosing CROs at each phase of drug development process.
  • Chapter 5 provides a comprehensive view on the global landscape of cell and gene therapy CROs. It includes information related to over 70 CROs that claim to offer services for cell and gene therapies. It features an in-depth analysis of the players based on geographical location, company size, year of establishment, scale of operation, and range of services offered by clinical and preclinical CROs.
  • Chapter 6 features detailed profiles of key CROs offering cell and gene therapy related services, across different geographies. Each company profile includes a brief overview of the company, financial details / information (if available), information on service portfolios and a comprehensive future outlook.
  • Chapter 7 presents a benchmark analysis of the various players engaged in this domain. It highlights the capabilities of the companies in terms of their expertise across various services related to the development of cell and gene therapies. The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to become more competitive in the industry.
  • Chapter 8 features a comprehensive clinical trial analysis of ongoing clinical studies for the evaluation of various cell and gene therapy product candidates. The analysis provides details related to cell and gene therapy clinical studies investigated across various geographies, based on the number of trials registered, start year of the clinical trial, current trial status, current phase of development, key therapeutic area (including indication-wise distribution), type of cell therapeutic (stem cells, T cells, dendritic cells, NK cells and tumor cells) and number of enrolled patients.
  • Chapter 9 provides an elaborate discussion and analysis of the various partnerships / collaborations that have been inked among the different players in the market. It includes a brief description on various types of partnerships models (such as outsourcing agreements, licensing agreements, service alliances, mergers and acquisitions) that have been employed by stakeholders in this domain since 2013. In addition, this chapter features details insights on mergers and acquisition in this domain.
  • Chapter 10 features a comprehensive market forecast analysis, highlighting the likely growth of cell and gene therapy contract research service market till the year 2030. We have provided inputs on the likely distribution of the opportunity by type of therapy (cell therapy and gene therapy), scale of operations (clinical and preclinical), type of therapeutic area (oncology and non-oncology) and across different regions (North America, Europe, Asia Pacific and rest of the world).
  • Chapter 11 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of cell and gene therapies research services, under a SWOT framework.
  • Chapter 12 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the industry.
  • Chapter 13 is a collection of interview transcripts of the discussions that were held key stakeholders in the industry. We have presented details of interviews held with Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital) and Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado).
  • Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
  • Chapter 15 is an appendix, which provides the list of companies and organizations mentioned in the report.
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  • 4Clinics
  • Accelera
  • AccelLAB
  • Accord Research
  • ACF Bioservices
  • Adaptimmune
  • Advanced BioScience Laboratories
  • Advanced Cell Diagnostics
  • AGINKO Research
  • Altasciences
  • Amulet Capital Partners
  • Anterogen
  • Argint International
  • Ascendance Biotechnology
  • Asterand Bioscience
  • Aurigon
  • Avance Biosciences
  • Bio-Techne
  • BioAgilytix
  • BioIVT
  • BioniX
  • Bioville
  • Boston Biomedical Associates
  • BrainStorm Cell Therapeutics
  • Cambridge Biomedical
  • Cato Research
  • Ce3
  • Cell and Gene Therapy Catapult
  • Cellectis
  • CERB
  • CHA Health Systems
  • Charles River Laboratories
  • Chiesi Farmaceutici
  • Cinven
  • Citoxlab
  • City of Hope
  • Clean Cells
  • CMIC Group
  • CombiGene
  • Comparative Biosciences
  • Covance
  • Creative Biolabs
  • CTI Clinical Trial and Consulting Services
  • Dendreon
  • DiscGenics
  • Duke University
  • Epeius Biotechnologies
  • Evotec
  • Farmacore Biotecnologia
  • FGK Clinical Research
  • Fibrocell
  • GeneWerk
  • GenoSafe
  • Genprex
  • GlaxoSmithKline
  • Global Centre for Medical Innovation
  • Green Cross LabCell
  • Gsap
  • HILDEBRAND PHARMA CONSULTING
  • Holostem Terapie Avanzate
  • Human Stem Cells Institute
  • HuMurine Technologies
  • Huntingdon Life Sciences
  • i.e. Advising
  • ICON
  • ICRC-Weyer
  • Imanis Life Sciences
  • Immunicum
  • IPM Biotech
  • IQVIA
  • Japan Tissue Engineering
  • JSB Solutions
  • JW CreaGene
  • Kite Pharma, a Gilead Sciences Company
  • Kolon TissueGene
  • LabCorp
  • Linical Accelovance
  • Lovelace Biomedical
  • Medelis
  • MEDIPOST
  • Medpace
  • Mesoblast
  • MI Bioresearch
  • Midlands Independent Review Board
  • Mitsubishi Tanabe Pharma
  • MolMed
  • MPI Research
  • NexImmune
  • Noble Life Sciences
  • North American Science Associates (NAMSA)
  • Novartis
  • NovaTrials
  • Novella Clinical
  • Oncobiomed
  • PAREXEL
  • PathoQuest
  • Pharmaceutical Product Development (PPD)
  • Pharmaceutical Research Management
  • Pharmahungary Group
  • Pharmaseed
  • Pharmicell
  • Pilgrim Quality Solutions
  • PRC Clinical
  • PSI CRO
  • PSNResearch
  • Quality Assistance
  • Reliance Life Sciences
  • Renova Therapeutics
  • Research Dynamics Consulting Group
  • Sanofi
  • SCiAN Services
  • Sermes CRO
  • Sernova
  • Shanghai Sunway Biotech
  • Shenzhen Sibiono GeneTech
  • SMS-oncology
  • SNBL USA
  • SOTIO
  • Spark Therapeutics
  • Spring Valley Laboratories
  • Symbion Research International
  • Syneos Health
  • Synteract
  • Taconic Biosciences
  • Terumo
  • TFS
  • The Cell Factory
  • The CLINICAL TRIAL Company Group
  • Theradex Oncology
  • TiGenix
  • TransCell Science
  • Translational Drug Development
  • Vericel
  • Veristat
  • Vivotecnia
  • Wake Forest Innovations
  • WCCT Global
  • WCG Clinical
  • Worldwide Clinical Trials
  • WuXi AppTec
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