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Cell and Gene Therapy CROs Market by Type of Therapy, Scale of Operation, Preclinical Services Offered, Clinical Services Offered, and Geography : Industry Trends and Global Forecasts, 2021-2030

·14-min read

INTRODUCTION Given their ability to treat a wide range of clinical conditions, including oncological disorders, cardiovascular disorders, genetic disorders, ophthalmic diseases and orthopedic disorders, advanced therapy medicinal products (ATMPs) have revolutionized the delivery of healthcare.

New York, May 28, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell and Gene Therapy CROs Market by Type of Therapy, Scale of Operation, Preclinical Services Offered, Clinical Services Offered, and Geography : Industry Trends and Global Forecasts, 2021-2030" - https://www.reportlinker.com/p06076407/?utm_source=GNW
Presently, over 30 cell and gene therapies have received marketing approval, while around 1,000 therapeutic leads are under evaluation. Considering the advantages of ATMPs, and their ability to address the underlying causes of several serious clinical conditions wherein small molecule drugs have been proven to be inadequate, the preference for such therapeutic modalities is on the rise. In fact, experts believe that, by 2030, 40 - 60 such products are likely to be approved in the US alone. However, as is the case for all biological products, the development of cell and gene therapies is both complex and challenging, as well as subject to heavy regulatory scrutiny. Outsourcing is, therefore, a preferred operational model in this field, with innovator companies relying heavily on specialty contract service providers to handle various aspects of their product development and manufacturing operations.

Contract research organizations (CROs) that claim to have the necessary capabilities to facilitate cell / gene therapy-related R&D, usually have extensive experience and are well-aware of the nuances of ATMP design and development. Moreover, innovators that rely on the aforementioned CROs end up saving significant capital, which would otherwise have been spent on developing R&D infrastructure and / or expertise. Overall, engaging the services of an experienced CRO for cell and gene therapy-related R&D offers certain time-related advantages, as well, to sponsors. Over the years, several contract service providers have also formed strategic alliances and consolidated their positions in the market, by upgrading / expanding existing capabilities and collaborating with other stakeholders in order to expand their service portfolios or geographical reach. Further, CROs have made significant investments towards the development / adoption of advanced tools, technologies and platforms, in order to generate more robust and evidence based clinical data, which is required for gaining the marketing authorizations across different geographies. Given the rising trend of outsourcing in the healthcare industry and the ongoing efforts of service providers to further improve / expand their respective offerings, we believe the cell and gene therapy CRO market is likely to evolve at a steady pace, till 2030.

SCOPE OF THE REPORT

The “Cell and Gene Therapy CROs Market (2nd Edition), 2021-2030: Distribution by Type of Therapy (Cell Therapy and Gene Therapy), Scale of Operation (Clinical and Preclinical), Therapeutic Area (Oncological Disorders, Cardiovascular Disorders, Inflammatory Disorders, Neurological Disorders, and Other Therapeutic Areas), and Geography (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World)” report features an extensive study of the current market landscape and the likely future potential of the cell and gene therapy CROs market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field.

Amongst other elements, the report features:
A detailed review of the overall landscape of the cell and gene therapy services market, highlighting the contributions of CROs, along with the information on their year of establishment, company size, location of headquarters, type of therapy (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operation (clinical 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 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.
A detailed analysis of the various partnerships inked between CROs offering cell and gene therapy related services, which have been established during the period 2015-2020. It includes a brief description of various types of partnerships models (such as outsourcing agreements, licensing agreements, and service alliances) that have been adopted by stakeholders engaged in this domain since 2015.
A detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2020. It is worth mentioning that the data captured during our research was analyzed based on several parameters, such as year, type of acquisition, geographical location of the companies, type of therapy and type of cells.
A detailed acquisition target analysis, taking into consideration historical trend of the activity of players that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets.
An in-depth analysis of more than 260 cell therapy developers that are anticipated to partner with contract research organizations and have been shortlisted on the basis of several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other cell therapy capabilities.
An in-depth analysis of nearly 190 gene therapy developers that are anticipated to partner with contract research organizations and have been shortlisted on the basis of several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other gene therapy capabilities.
A detailed 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 focused clinical studies being carried out across various geographies, based on the number of registered trials, year of trial, current trial status, current phase of development, key therapeutic areas (including indication-wise distribution), type of cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and number of patients enrolled.
A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry.
Elaborate profiles of prominent CROs engaged in offering cell and gene therapy related services. Each company profile features a brief overview of the company, along with information on their year of establishment, number of employees, location of headquarters, key executives, financial details / information (if available), service portfolio, recent developments and an informed future outlook.

One of the key objectives of this report was 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 on the likely evolution of the market in the short to mid-term and long term, for the period 2021-2030. The report also features the likely distribution of the current and forecasted opportunity across [A] type of therapy (cell therapy and gene therapy), [B] scale of operation (clinical and preclinical), [C] target therapeutic area (oncological disorders, metabolic disorders, infectious diseases and other disorders) and [D] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA (Middle East and North Africa) and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry and non-industry players:
Xian-Bao Zhan (Professor of Medicine and Director, Department of Oncology, Changhai Hospital)
Enkhtsetseg Purev (Assistant Professor of Medicine, University of Colorado)

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

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. 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 over the coming 10 years, 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.

KEY QUESTIONS ANSWERED
Who are the leading players engaged in offering cell and gene therapy related research services?
Which business models are most commonly adopted by biopharmaceutical developers for outsourcing cell and gene therapies?
Which partnership models are commonly adopted by stakeholders engaged in this industry?
What are the key value drivers of the merger and acquisition activity in the cell and gene therapy market?
Which players are likely to partner with cell and gene therapy CROs?
Which regions emerged as the key hubs for carrying out clinical studies focused on cell and gene therapies?
How is the current and future market opportunity likely to be distributed across key market segments?
What are the anticipated future trends related to cell and gene therapy related research services?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the current state of cell and gene therapy CROs 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, legacy and contemporary trends in outsourcing activity. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in this domain. Additionally, it includes details on the various types of services offered by different CROs. Further, the chapter highlights advantages and risks associated in partnering with contract service providers, and their role 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 cell and gene therapies. In addition, it 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 detailed review of the overall landscape of the cell and gene therapy services market, highlighting the contributions of CROs, along with the information on year of establishment, company size, location of headquarters, A detailed assessment of the overall market landscape of about 100 CROs offering cell and gene therapies based on a number of relevant parameters, such as type of therapy (cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and gene therapy), scale of operation (clinical 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).

Chapter 6 features elaborate profiles of prominent CROs engaged in offering cell and gene therapy related services. Each company profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key executives, financial details / information (if available), service portfolio, recent developments and an informed 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 an analysis of the various partnerships inked between CROs offering cell and gene therapy related services, which have been established during the period 2015-2020. It includes a brief description of various types of partnerships models (such as outsourcing agreements, licensing agreements, and service alliances) that have been adopted by stakeholders engaged in this domain since 2015.

Chapter 9 presents insights from a detailed analysis of the various mergers and acquisitions that have taken place in this domain, during the period 2015-2020. It is worth mentioning that the data captured during our research was analyzed based on several parameters, such as year, type of acquisition, geographical location of the companies, type of therapy and type of cells.

Chapter 10 provides a detailed acquisition target analysis, taking into consideration historical trend of the activity of players that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets.

Chapter 11 features an in-depth analysis of more than 260 cell therapy developers that are anticipated to partner with contract research organizations and have been shortlisted on the basis of several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other cell therapy capabilities.

Chapter 12 features an in-depth analysis of more than 190 gene therapy developers that are anticipated to partner with contract research organizations and have been shortlisted on the basis of several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other gene therapy capabilities.

Chapter 13 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 focused clinical studies being carried out across various geographies, based on the number of registered trials, year of trial, current trial status, current phase of development, key therapeutic areas (including indication-wise distribution), type of cell therapy (stem cells, T cells, dendritic cells, NK cells and tumor cells) and number of patients enrolled.

Chapter 14 features a comprehensive market forecast analysis, highlighting the likely growth of cell and gene therapy CROs market, for the time period 2021-2030. In order to provide details on the future outlook, our projections have been segmented on the basis of [A] type of therapy (cell therapy and gene therapy) [B] scale of operation (clinical and preclinical), [C] target therapeutic area (oncological disorders, metabolic disorders, infectious diseases and other disorders) and [D] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA (Middle East and North Africa) and rest of the world).

Chapter 15 provides a detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry.

Chapter 16 is a summary of the entire report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 17 is a collection of interview transcripts of the discussions that were held key stakeholders in the industry. The chapter provides 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 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 19 is an appendix, which contains a list of companies and organizations mentioned in this report.
Read the full report: https://www.reportlinker.com/p06076407/?utm_source=GNW

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