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Global Cell and Gene Therapy CROs Market, 2018-2030: Promising Treatment Options for a Myriad of Complex Clinical Conditions

DUBLIN, Dec. 5, 2018 /PRNewswire/ --

The "Cell and Gene Therapy CROs Market, 2018-2030" report has been added to ResearchAndMarkets.com's offering.

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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.

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.

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.

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.

Key Topics Covered:

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
5.3. Cell and Gene Therapy: Clinical CROs
5.4. Cell and Gene Therapy: Preclinical CROs

6. Company Profiles
6.1. Chapter Overview
6.2. Players based in North America
6.2.1. Cato Research
6.2.2. Charles River Laboratories
6.2.3. Covance
6.2.4. Creative Biolabs
6.2.5. IQVIA
6.2.6. Medpace
6.3. Players based in Europe
6.3.1. Accelera
6.3.2. BioniX
6.3.3. JSB Solutions
6.3.4. Quality Assistance
6.4. Players based in Asia
6.4.1. CMIC Group
6.4.2. Pharmaseed

7. Benchmark Analysis
7.1. Chapter Overview
7.2. Benchmark Analysis: Methodology
7.3. Benchmark Analysis: Peer Groups

8. Clinical Trial Analysis
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Cell and Gene Therapy Clinical Trials
8.4. Cell and Gene Therapy Clinical Trials: Analysis by Patients Enrolled

9. Collaborations
9.1. Chapter Overview
9.2. Partnership Models
9.3. Cell and Gene Therapy CROs: List of Partnerships
9.4. Cell and Gene Therapy CROs: List of Mergers and Acquisitions
9.5. Key Acquisitions: Deal Multiples

10. Market Sizing And Opportunity Analysis

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

Companies Mentioned

  • 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
  • Holostem Terapie Avanzate
  • Human Stem Cells Institute
  • HuMurine Technologies
  • Huntingdon Life Sciences
  • i.e. Advising
  • ICON
  • ICRC-Weyer
  • Imanis Life Sciences
  • Immunicum
  • IPM Biotech
  • Japan Tissue Engineering
  • JSB Solutions
  • JW CreaGene
  • Kite Pharma, a Gilead Sciences Company
  • Kolon TissueGene
  • LabCorp
  • Linical Accelovance
  • Lovelace Biomedical
  • Medelis
  • 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
  • PathoQuest
  • Pharmaceutical Product Development (PPD)
  • Pharmaceutical Research Management
  • Pharmahungary Group
  • Pharmaseed
  • Pharmicell
  • Pilgrim Quality Solutions
  • PRC Clinical
  • 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
  • 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

For more information about this report visit https://www.researchandmarkets.com/research/2qdv96/global_cell_and?w=5

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