Bioassay Services Market

Bioassay Services Market for Cell and Gene Therapy by Type of Therapy, Therapeutic Area, Scale of Operation and Geography (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World): Industry Trends and Global Forecasts, 2021-2035

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Bioassay Services Market Overview

The bioassay services market for cell and gene therapy is estimated to be worth $155 million in 2021 and is expected to grow at compounded annual growth rate (CAGR) of 30.1% during the forecast period. 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 market 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 witness a steady market growth during the forecast period.

This image highlights the context of  Cell and Gene Therapy Bioassay Service market report. This image provides list of Cell and Gene Therapy Bioassay Service Providers. This image presents current market landscape of Cell and Gene Therapy Bioassay Service Providers.

Key Companies Providing Bioassay Services for Cell and Gene Therapy

Examples of key companies providing bioassay services for cell and gene therapy market (which have also been profiled in this market report; the complete list of companies is available in the full report) include CCRM, Nexelis, Pacific BioLabs, PPD Laboratories, WuXi Advanced Therapies, AnaBioTec, Intertek Pharmaceutical Services, Lonza and Porton Bio. This market report includes an easily searchable excel database of all the companies providing bioassay services for cell and gene therapies, worldwide.

Recent Developments in Bioassay Services Market:

Several recent developments have taken place in cell and gene therapy bioassay. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In September 2023, GTP Bioways entered into a partnership with Texcell with an aim to extend process development and GMP manufacturing of biopharmaceuticals and viral testing, viral clearance, and bioassays. 
  • In September 2022, KCAS acquired Active Biomarkers in order to add world-class bioanalytical expertise and an additional European footprint for large molecule and cell/gene therapy bioassay services.

Scope of the Report

The “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, 2021-2035” market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the cell and gene therapy bioassay service providers during the forecast period. The market research report also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in cell & gene therapy bioanalytical testing services market.

This image highlights the geographical distribution of Cell and Gene Therapy Bioassay Service Providers. This image highlights competitive analysis of players engaged in the domain of Cell and Gene Therapy Bioassay Services. This image provides information on global events attended by the Cell and Gene Therapy Bioassay service providers.

In addition to other elements, the market research report includes:

  • A detailed assessment of the overall market landscape of the cell & gene therapy bioanalytical testing 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 this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity of bioassay services market. We have provided an informed estimate of the evolution of the market for the forecast period 2021-2035. 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 market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

This image highlights information on T-Cell and Gene Therapy Pipeline. This image presents analysis of more than 260 cell therapy developers that are anticipated to partner with cell and gene therapy bioassay service providers. This image provides information on the current and future market trends and potential growth of Cell and Gene Therapy Bioassay Services domain.

The opinions and insights presented in the market report are backed by a deep understanding of key insights generated from both secondary and primary research. The information presented in this market research report 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 market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is gene therapy?

Answer: Gene therapy refers to the treatment of congenital and hereditary disorders using foreign genes delivered to patients’ cells.

Question 2: How big is the cell and gene therapy services market?

Answer: The bioassay services market size for cell and gene therapy is estimated to be worth $155 million in 2021.

Question 3: What is the projected market growth of the bioassay services market for cell and gene therapy?

Answer: The bioassay services market for cell and gene therapy is expected to grow at compounded annual growth rate (CAGR) of over 30.1% during the forecast period 2021 - 2035.

Question 4: Who are the leading CROs providing bioassay services for cell and gene therapy?

Answer: Examples of key CROs providing bioassay services for cell and gene therapy (which have also been profiled in this market report; the complete list of companies is available in the full report) include CCRM, Nexelis, Pacific BioLabs, PPD Laboratories, WuXi Advanced Therapies, AnaBioTec, Intertek Pharmaceutical Services, Lonza and Porton Bio.

Question 5: How many companies are currently engaged in bioassay services market for cell and gene therapy?

Answer: Over 40 companies are currently engaged in bioassay services market for cell and gene therapy.

Question 6: How much money is invested each year in the bioassay services market for cell and gene therapy?

Answer: Annually, close to USD 20 billion is invested each year in bioassay services market for cell and gene therapy, by both public and private institutions for advancing the ongoing development in the industry.

Question 7: Which region is the hub for players engaged in the bioassay services market for cell and gene therapy?

Answer: North America emerged as the hub for players engaged in bioassay services market for cell and gene therapy, with over 60% of the players established in the region.

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