Cell and Gene Therapy Bioassay Services Market, 2021-2030
INTRODUCTION
Given the various advantages of cell and gene therapies and their ability to address the underlying causes of serious clinical conditions, the preference for such therapeutic modalities has increased over the years. As a result, several cell and gene therapies have been developed and approved for the treatment of a wide range of disease indications. In fact, at the time of this report’s publication, more than 30 such therapies had been approved and over 1,200 therapeutic leads are under evaluation in different stages. Owing to their rising popularity, these upcoming advanced therapeutic products are on the verge of becoming one of the highest valued therapeutic segments within the biopharmaceutical industry. Having said that, as is the case for all biological products, the development of cell and gene therapies is a complex, challenging and cost intensive process. Outsourcing is, therefore, a preferred operational model, with cell and gene therapy innovators relying heavily on specialty contract service providers to handle various aspects of their product development and manufacturing operations. In fact, over three quarters of the biopharmaceutical companies prefer to outsource their operations to the contract service providers and a large part of their expenditure goes to outsourcing services. Amongst the various operations, the outsourcing of analytical testing services, including environment testing, bioanalytical testing, analytical testing, chemistry and stability testing, method development and validation, and product characterization, has witnessed significant rise in recent years.
The rising demand for outsourcing bioanalytical services has prompted the emergence of several contract research organizations that claim to offer bioassay services for cell and gene therapies. These companies usually have relatively more experience and are well equipped with the instruments and technological platforms to offer both pre-developed and customized bioassays. In fact, these companies assist in bringing out the maximum efficiency of study design by offering several cost benefits and reducing the associated timelines. Given the benefits of outsourcing the bioassay services and the ongoing efforts of service providers to further improve / expand their respective offerings, we believe that the cell and gene therapy bioassay services market is likely to evolve at a steady pace, till 2030.
SCOPE OF THE REPORT
The “Cell and Gene Therapy Bioassay Services Market by Type of Therapy (Cell Therapy and Gene Therapy), Therapeutic Area (Oncological Disorders, Infectious Diseases, Autoimmune Disorders, Rare / Genetic Disorders, Cardiovascular Disorders, Metabolic Disorders, Blood Disorders, Neurological Disorders, Ophthalmic Disorders and Other Therapeutic Areas), Scale of Operation (Discovery, Preclinical and Clinical) and Geography (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World): Industry Trends and Global Forecasts, 2021-2030” report features an extensive study of the current landscape and the likely future potential of cell and gene therapy bioassay service providers, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. In addition to other elements, the study includes:
A detailed assessment of the overall market landscape of the cell and gene therapy bioassay services market, providing information on their year of establishment, company size, location of headquarters, location of bioanalytical facilities, type of offering (in vitro and in vivo), type of bioassay(s) offered (pre-developed assay and customized assay), type of bioanalytical services (immunoassay, potency assay, qualitative PCR, digital droplet PCR, flow cytometry, ELISA, immunochemistry and others) and application area (cell therapy, gene therapy and others).
A detailed competitiveness analysis of the cell and gene therapy bioassay service providers based in different geographies, by taking into consideration their service strength (in terms of bioassay offering(s) and number of bioanalytical services offered), service applicability (in terms of number of bioassays offered and application area) and supplier strength (in terms of years of experience in this field and company size).
Tabulated profiles of key players offering a wide range of cell and gene therapy bioassay services across North America, Europe and Asia-Pacific. Each profile includes an overview of the company, financial information (if available), details of its cell and gene therapy bioassay services portfolio, types of offerings, type of bioassay(s) offered, types of bioanalytical services offered, application area, location of bioanalytical facilities, recent developments and an informed future outlook.
An insightful contemporary market trend analysis, featuring the distribution of cell and gene therapy service providers by type of bioanalytical services offered and application area and an analysis of cell and gene therapy service providers, based on type of bioassay and types of bioanalytical services offered. Further, the chapter also features a schematic world map representation, highlighting the location of bioanalytical facilities of cell and gene therapy bioassay service providers.
A detailed analysis of the global events attended by the service providers, based on year of event, type of event, type of services involved and application area, and strategic initiatives taken by various cell and gene therapy bioassay service providers.
A case study of the overall landscape of cell and gene therapy therapeutics market, based on a number of parameters. The market landscape of cell therapies, features distribution of cell therapies across phase of development, therapeutic area and type of developer. Further, the market landscape of cell therapies, features distribution of gene therapies across phase of development of pipeline candidates and key therapeutic areas. The chapter also features information on the developers involved in the domain of cell and gene therapies.
An in-depth analysis of more than 260 cell therapy developers that are anticipated to partner with cell and gene therapy bioassay service providers 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 cell and gene therapy bioassay service providers 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.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of cell and gene therapy bioassay services market. We have provided an informed estimate of the evolution of the market for the period 2021-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of therapy (cell therapy and gene therapy), [B] therapeutic area (oncological disorders, infectious diseases, autoimmune disorders, rare / genetic disorders, cardiovascular disorders, metabolic disorders, blood disorders, neurological disorders, ophthalmic disorders and other therapeutic areas), [C] scale of operation (discovery, preclinical and clinical) and [D] geography (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
The opinions and insights presented in the report are backed by a deep understanding of key insights generated from both secondary and primary research. The information presented in this study was also influenced by discussions held with senior stakeholders in this industry.
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.
KEY QUESTIONS ANSWERED
Who are the leading services providers offering bioassay services related to cell and gene therapies?
What is the relative competitiveness of different cell and gene therapy bioassay service providers?
Which is the commonly offered bioanalytical service (immunoassay, potency assay, qualitative PCR, digital droplet PCR, flow cytometry, ELISA, immunochemistry and others) related to cell and gene therapy?
What are the key trends within the cell and gene therapy bioassay service providers market?
What kind of initiatives are being taken by stakeholders engaged in this domain?
Which players are likely to partner with cell and gene therapy bioassay service providers?
How is the current and future opportunity likely to be distributed across key market segments?
What are the anticipated future trends related to teleradiology services market?
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. Wherever 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.
CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the cell and gene therapy bioassay services market and its likely evolution in the short to mid-term and long term.
Chapter 3 provides a general introduction to bioassays and type of cell and gene therapy bioassays. It also highlights the importance of bioassay and challenges related to cell and gene therapy bioassays. Additionally, it provides a brief introduction to the concept of CROs, featuring a discussion on the role of contract service providers and prevalent outsourcing trends.
Chapter 4 provides a detailed assessment of the overall market landscape of cell and gene therapy bioassay service providers, including information on close to 50 stakeholders and a detailed analysis based on a number of relevant parameters, such as year of establishment, company size, location of headquarters, location of bioanalytical facilities, type of bioassay(s) offered (in vitro and in vivo), type of offerings (pre-developed assay and customized assay), type of bioanalytical services (immunoassay, potency assay, qualitative PCR, digital droplet PCR, flow cytometry, ELISA, immunochemistry and others) and application area (cell therapy, gene therapy and others).
Chapter 5 features an insightful competitiveness analysis of the cell and gene therapy bioassay service providers based in different geographies, based on service strength (in terms of number of offering(s) of bioassays and number of bioanalytical services offered), service applicability (in terms of number of bioassays offered and application area) and supplier strength (in terms of years of experience in this field and company size).
Chapter 6 features tabulated profiles of key players offering a wide range of cell and gene therapy bioassay services across North America. Each profile includes an overview of the company, financial (if available), details of its cell and gene therapy bioassay services portfolio, types of bioassay(s) offered, types of offerings, type of bioanalytical services offered, application area, location of bioanalytical facilities, recent developments and an informed future outlook.
Chapter 7 features tabulated profiles of key players offering a wide range of cell and gene therapy bioassay services across Europe and Asia-Pacific. Each profile includes an overview of the company, financial information (if available), details of its cell and gene therapy bioassay services portfolio, types of bioassay(s) offered, types of offerings, types of bioanalytical services offered, application area, location of bioanalytical facilities, recent developments and an informed future outlook.
Chapter 8 includes a contemporary market trend analysis, featuring the distribution of cell and gene therapy service providers by type of bioanalytical services offered and application area and an analysis of cell and gene therapy service providers, based on type of bioassay and type of bioanalytical services offered. Further, the chapter also features a schematic world map representation, highlighting the location of bioanalytical facilities of cell and gene therapy bioassay service providers.
Chapter 9 includes a detailed analysis of the global events and strategic initiatives taken by the several cell and gene therapy bioassay service providers related to bioassays. The chapter features distribution of events on the basis of year of event, type of event, type of services involved and application area.
Chapter 10 is a case study of the overall landscape of cell and gene therapy therapeutics market, based on number of relevant parameters, such as phase of development, therapeutic area and type of developer, while highlighting key developers. The chapter also features information on the companies involved in the development of cell and gene therapies.
Chapter 11 features an in-depth analysis of more than 260 cell therapy developers that are anticipated to partner with cell and gene therapy bioassay service providers 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 cell and gene therapy bioassay service providers 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 an insightful market forecast analysis, highlighting the likely growth of the cell and gene therapy services market for the time period 2021-2030. In order to provide details on the future outlook, our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of therapy (cell therapy and gene therapy), [B] therapeutic area (oncological disorders, infectious diseases, autoimmune disorders, rare / genetic disorders, cardiovascular disorders, metabolic disorders, blood disorders, neurological disorders, ophthalmic disorders and other therapeutic areas), [C] scale of operation (discovery, preclinical and clinical) and [D] geography (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
Chapter 14 is a summary of the overall report, presenting the insights on the contemporary market trends and the likely evolution of the cell and gene therapy bioassay services market.
Chapter 15 is a collection of interview transcripts of discussions held with various key stakeholders in this market.
Chapter 16 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 17 is an appendix, which contains the list of companies and organizations mentioned in the report.