Cell & Gene Therapy Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Test Type (Bioavailability & Bioequivalence Studies), By Product Type, By Stage Of Development By Product Type, By Indication, By Region, And Segment Forecasts, 2024 - 2030

Market Size & Trends

The global cell & gene therapy bioanalytical testing services market size was estimated at USD 506.1 million in 2023 and is expected to grow at a CAGR of 7.3% from 2024 to 2030. Capitalizing untapped potential of cell & gene therapies in treating life-threatening diseases and rare diseases is one of the major factors that is promoting the demand for its bioanalytical testing services.

Cell & gene therapies have popularly been used in the area of cancer, autoimmune diseases, rare diseases, and others. CAR-T therapy is one of the most advanced therapies. It is capable of detecting and killing cancer cells more effectively. CAR-T cell therapies hold a majority of the gene-modified cell therapies, and around 90% of them are currently under preclinical testing for oncology-related diseases. Hence, the aforementioned factors are anticipated to boost the market growth.

Rising research activities in cell therapy coupled with the surge in funding for clinical research in cell & gene therapy is opportunistic for the market. Also, significant growth in the number of cell and gene therapy drug candidates undergoing clinical trials presents as a key driver for the market. Moreover, increasing funding by various public organizations for conducting clinical cell & gene therapy trials is opening new growth avenues for the industry. For instance, in April 2023, the California Institute for Regenerative Medicine invested USD 89.0 million in various stem cell & gene therapy research.

The development of cell & gene therapy is expensive. Therapy costs range from over USD 4,00,000 to 2 million per dose. The high cost of the treatment is due to the high cost involved in drug development and manufacturing. There is a growing need to reduce the in-house costs of manufacturers in developing cell & gene therapy. Therefore, outsourcing clinical research services such as bioanalytical testing and drug manufacturing to contract developers reduces the overall cost of cell & gene therapy drugs. This is expected to support market growth.

A significant number of cell & gene therapy-related drugs are under clinical studies. For instance, according to ClinicalTrial.gov, over 2,261 trials related to cell & gene therapy were under development as of May 2023. According to a leading publisher, Pharma Intelligence, Asia Pacific has witnessed a boom in the cell & gene therapy research industry over the past few years. The majority of cell & gene therapy-related pipelines are in Asia Pacific owing to high awareness about the potential of cell & gene therapy in treating life-threatening diseases. A significant number of trials conducted in cell & gene therapy are expected to support the market growth.

Market Concentration & Characteristics

The market is characterized by moderate-to-high level degree of innovation, including the rapid advancements in cell and gene therapy technologies like development of biosimilars, combination products, and other innovative medicines. Industry participants are investing in innovative techniques and technologies to meet the global demand of the market.

The market is also characterized by the leading players with moderate levels of merger and acquisition (M&A) activity and product launches. Market players such as Syneos Health, Thermos Fischer Scientific Inc., Bayer and others are involved in R&D investments, new product launches and merger and acquisition activities. For instance, in October 2023 , Bayer invested in a new USD 250 million cell therapy manufacturing facility in Berkeley, California. This marks a significant commitment to in-house production of complex medicines, including  bemdaneprocel for Parkinson's disease. By developing capabilities for cell therapy manufacturing, Bayer planned to accelerate the production of transformative treatments and enhance its global supply chain. Such strategic activities as M&A, expansions, partnership, and collaboration, help increase companies’ competitiveness and expand their geographic reach to enter new territories.

Regulatory control and increasing awareness regarding bioanalytical testing of cell & gene therapy (CGT) are paramount in ensuring the safety, efficacy, and quality of these advanced treatments. Regulatory agencies such as the FDA and EMA have established stringent guidelines to govern the development and approval of cell and gene therapies, mandating thorough bioanalytical testing throughout the product lifecycle. This heightened regulatory scrutiny underscores the critical importance of comprehensive testing to mitigate risks and ensure patient safety. Global regulatory policies are being standardized to accelerate the approval process for cell and gene therapy bioanalytical testing services.

The market is characterized by a moderate level of service expansion with the help of specialized expertise and advanced equipment used for accurate testing. The expansion of bioanalytical testing facilities for CGT reflects a growing recognition of the importance of rigorous testing in ensuring the safety and efficacy of these advanced therapies. Introduction of novel methods might act as key factor for expansion. However, widespread adoption of these technologies would depend on regulatory approval and acceptance by industry.

Regional expansion is crucial for any manufacturer in the market space. Bioanalytical testing facilities are expanding to accommodate this demand, equipped with state-of-the-art technology and expertise to characterize these complex therapies accurately. For instance, a January 2023 report from the American Society of Gene and Cell Therapy highlighted a significant expansion in the gene, cell, and RNA therapy pipeline, including various therapeutic interventions in different developmental stages.

Test Type Insights

The bioavailability & bioequivalence studies dominated the market with a share of 35.4% in 2023. The segment is also expected to witness the fastest CAGR during the forecast period. Bioavailability & bioequivalence studies are conducted for drug development. It is used to test the safety and efficacy of the drug during all stages of the trials. Drugs with low bioavailability do not provide therapeutic action. Bioequivalence studies are used to compare the pharmacokinetic profile of a generic drug. A significant number of biosimilar versions of cell & gene drugs entering the pipeline supports the demand for bioequivalence studies in the market.

The pharmacokinetic segment is expected to grow at a CAGR of 7.5% over the forecast period. Pharmacokinetics (PK) studies determine the extent of absorption, distribution, metabolism, and excretion of drugs in the body. This type of study is essential during drug development. These studies help identify the drug's safety and efficacy in the body. In February 2024, Optibrium launched one such solution known as Semeta software, which uses AI to predict drug metabolism to increase the clinical success of the drugs under investigation. This tool is helpful for Drug Metabolism and Pharmacokinetics (DMPK) scientists. Hence, the ever-increasing pipeline of cell & gene products supports the demand for pharmacokinetics services.

Stage of Development by Product Type (Criss-Cross) Insights

The non-clinical segment dominated the market with a market share of 66.2% in 2023 and is also expected to witness the fastest growth at a CAGR of 7.5% during the forecast period. The stage of development segment has been further classified based on the product type, which includes gene therapy, gene-modified cell therapy, and cell therapy. The large pipeline of cell and gene therapeutics in the non-clinical developmental stage further demonstrates the segment's growth potential. For instance, in February 2024, as per the data published by Cell & Gene, 10% of all U.S.FDA registered novel drug pipelines were related to cell & gene therapy. Furthermore, a 2023 report from the American Society of Gene and Cell Therapy highlighted a significant expansion in the gene, cell, and RNA therapy pipeline, including various therapeutic interventions in different developmental stages. The high demand among researchers for transitioning the therapy into the clinical stage is further supporting the demand for non-clinical bioanalytical testing services, thus promoting the segment growth.

The clinical segment is expected to grow with a CAGR of 7.0% CAGR during the forecast period. Assay-based studies, reagent selection, stability monitoring & quantification, pharmacokinetics studies, and method validation are some key bioanalytical services offered in the clinical stage. Across all the clinical phases, bioanalytical testing is conducted to analyze the safety and efficacy of the drug. In the clinical phase, human samples of urine, plasma, and serum are used for bioanalytical testing. This type of analysis on humans is essential for drug approval from the regulatory authority. Moreover, it also gives the researchers better insights into drug safety. As per the American society of Cell & Gene Therapy, there was a significant increase in Phase I clinical trials in gene therapy from 180 therapies in 2020 to 254 therapies in 2021. Hence, the aforementioned factors are anticipated to boost the segment’s growth.

Product Type Insights

The cell therapy segment dominated the product segment market with a market share of 42.1% in 2023. Cell therapy is the transplantation of human cells to repair or replace damaged tissue or cells. Cell therapies have great potential in treating autoimmune diseases, cancers, urinary problems, infectious diseases, neurological disorders, and other diseases. A significant number of clinical research studies are conducted in cell therapy, globally. For instance, according to the American Society of Cell & Gene Therapy, as of January 2023, over 827 studies were exclusively focused on cell therapy. Further, the market is expected to be driven by collaborative initiatives among biotechnology enterprises, pharmaceutical companies, and CDMOs to optimize development efforts. For instance, in January 2024, an Israel-based biotech company, Pluri, announced the launch of a new business segment, PluriCDMO, to provide comprehensive cell and gene therapy bioanalytical testing services.

The gene-modified cell therapy segment is expected is expected to register the fastest CAGR of 7.8% during the forecast period. Gene-modified cell therapy includes CAR T-cell therapies, CAR-NK cell therapy, TCR-T cell therapy, and others. CAR T-cell therapies have gained much traction in the last five years. CAR T-cell therapies are considered very effective against some types of cancer. Where most other treatments prove ineffective, CAR T therapy has shown remarkable results in treating Leukemia and Lymphoma. CAR-NK cell therapy is considered a promising therapy for malignant cancer and is considered safer than CAR T-cell therapies for treating cancer. All the aforementioned factors are boosting the demand for bioanalytical testing services for gene-modified cell therapy.

Indication Insights

The oncology segment dominated the market and accounted for the largest revenue share of 49.0% in 2023. This is attributable to high burden of cancer worldwide and the growing demand for an effective treatment option for cancer treatment. The demand for outsourced development services in oncology has increased due to the emergence of innovative cell and gene therapies designed for cancer treatment. For instance, a report published by the American Cancer Society in December 2023 estimated 1,958,310 new cancer cases with 609,820 related deaths in the U.S. As the incidence of cancer continues to rise globally, there is an increasing demand for innovative and effective treatment options.

The rare diseases segment is expected to register the fastest CAGR during the forecast period. This is attributable to the remarkable progress in cell and gene therapy, including targeted and personalized treatment modalities for previously incurable conditions. CDMOs dedicated to this sector have been pivotal in translating scientific discoveries into viable therapeutic solutions. Their services include process development, manufacturing scale-up, quality assurance, and adherence to regulatory compliance. For instance, in February 2024, Andelyn Biosciences, Inc., a CDMO specializing in cell and gene therapy, was chosen as the manufacturing partner for AAV therapies using its suspension platform by the Foundation for the National Institutes of Health (FNIH). This selection was part of collaborative efforts to accelerate the medicinal partnership Bespoke Gene Therapy Consortium (BGTC).

Regional Insights

North America dominated the cell & gene therapy bioanalytical testing services market and accounted for the largest revenue share of 40.4% in 2023. This significant market share is attributable to the increasing number of cell & gene therapy clinical trials conducted across the U.S. For instance, according to ClinicalTrials.gov, over 1,273 cell & gene therapy trials were registered in the U.S. This is one of the major reasons for the increasing demand for bioanalytical testing services in this region. In addition, the presence of major players such as IQVIA, Laboratory Corporation of America Holdings, Charles River Laboratories, and a few others providing quality services in the region has further boosted the revenue shares of the region in the market.

U.S. Cell & Gene Therapy Bioanalytical Testing Services Market Trends

The market in the U.S. is anticipated to witness significant growth over the forecast period. Numerous novel medications have been approved by the U.S. FDA and are currently being used to treat patients, even though there are hundreds of possible cell and gene therapies under development. As of February 2020, the U.S. had approved nine cell & gene therapy products to treat uncommon inherited disorders, cancer, and eye conditions. Key companies providing cell and gene therapy testing services in the U.S. include Labcorp Drug Development and Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific, Inc.).

Europe Cell & Gene Therapy Bioanalytical Testing Services Market Trends

Europe is identified as a lucrative region in this industry. A supportive regulatory framework in the region helps manufacturers to boost productivity and open a wide scope for developments in the region.  Regulatory agencies, such as the European Medicines Agency (EMA), offer possibilities for fast approval and limited marketing authorization for novel therapies. This favorable regulatory environment promotes investment and innovation in the field of cell & gene therapies.

The UK cell & gene therapy bioanalytical testing services market is anticipated to witness significant growth over the forecast period. Owing to the presence of an independent institute that focuses on therapeutics, as well as leading-edge expertise in cell and gene technologies, such as Stevenage Bioscience Catalyst and The Cell and Gene Therapy Catapult (CGT Catapult). For example, CGT Catapult is an independent innovation and technology organization dedicated to striving to make a difference in the UK's cell and gene therapy companies. Furthermore, the UK is home to numerous prosperous businesses, top-notch academic institutions, and CGT Catapult, which is well-positioned to support market growth.

The cell & gene therapy bioanalytical testing services market in France is anticipated to witness significant growth over the forecast period, as there is a growing demand for biologics, such as gene therapies, cell-based therapies, and monoclonal antibodies. Furthermore, in France, market players implement various strategic initiatives to expand their reach and offer services. For instance, in February 2023, Apax Partners acquired Porsolt, a recognized Global CRO. This partnership was aimed at enhancing Porsolt’s service offering while expanding its product portfolio & capabilities for drug screening, safety, and efficacy for worldwide consumers.

The cell & gene therapy bioanalytical testing services market in Germany is expected to grow at a lucrative pace over the forecast period. The ongoing developments in the regions, such as the advancements in technology & quality clinical resources, are expected to propel this market over the forecast period. In addition, government initiatives for clinical research activities have accelerated the growth of the market. Furthermore, in November 2023, Eli Lilly and Company made a substantial investment of up to USD 100 million to expand its presence in Germany's early-stage biotech ecosystem. This strategic move indicates a comprehensive commitment to fostering innovation, supporting biotech startups, and expanding manufacturing capabilities in Germany's pharmaceutical & biotech landscapes.

Asia Pacific Cell & Gene Therapy Bioanalytical Testing Services Market Trends

Asia Pacific is anticipated to witness the fastest CAGR of 7.7% in the forecast period, owing to the growing pharmaceutical & biotechnology activities, rising healthcare costs, growing investments by key global players in improving regional healthcare, and regulatory body amendments aligning clinical trial evaluation standards according to global standards. Furthermore, conducting clinical trials in countries such as India is less expensive than in Western countries. This has encouraged companies to relocate their production facilities to this region.

The China cell & gene therapy bioanalytical testing services market is expected to grow over the forecast period due to the country’s active investments and expansion of its capabilities in cell & gene therapy. The country has a rapidly growing biotechnology & pharmaceutical sector, and it has shown significant interest and progress in this field. Gene therapies, such as Chimeric Antigen Receptor (CAR) T-cell immunotherapy, have been reported to be effective treatments for diseases such as cancer and HIV infection. China is home to the third-highest number of gene therapy clinical trials worldwide. China's rapidly evolving healthcare landscape and patient needs played a significant role in driving the market.

The cell & gene therapy bioanalytical testing services market in Japan is expected to grow substantially over the forecast period due the rising demand for biopharmaceutical drugs to diagnose & treat various chronic diseases. Japan is one of the world’s largest pharmaceutical markets, actively involved in improving access to biopharmaceutical drugs. Several key players have expanded their contract manufacturing offerings in Japan to increase their product capacity and produce highly potent pharmaceutical dosage forms to stay competitive in the market.

Key Cell & Gene Therapy Bioanalytical Testing Services Company Insights

The major players operating in the market are focused on the adoption of in-organic strategic initiatives such as mergers, partnerships, acquisitions, etc. For instance, in September 2022, KCAS Bioanalytical Services acquired CRO Vitruvian Partners to expand its bioanalytical testing capabilities with large molecule and cell/gene therapy bioassay.

Recent Developments

• In March 2024, Allumiqs and Prolytix entered into a strategic partnership aimed at offering integrated solutions to streamline drug development pipelines. By combining expertise in multiomics and LC-MS/MS solutions with large-molecule drug product lifecycle management, the collaboration aims to provide customers with cohesive solutions, reducing complexities and risks in the R&D process.

• In January 2024, Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific, Inc.) launched the Gibco Cell Therapy Systems Cellmation Software to automate cell therapy manufacturing workflows.

• In September 2023, the Charles River Laboratories company launched Lentivation, a lentiviral vector manufacturing platform. The platform can reduce manufacturing time for gene & gene-modified cell therapies by 60%, translating to fewer months than traditional manufacturing procedures.

• In September 2023, Syneos Health was acquired by a consortium of private investment firm affiliates composed of Patient Square Capital, Elliott Investment Management L.P., and Veritas Capital.

• In August 2023, Labcorp acquired Tufts Medicine’s outreach laboratory business & select assets, initiating a strategic partnership to enhance patient access to testing and streamline laboratory services in Massachusetts. The collaboration aimed to integrate LabCorp’s advanced diagnostics with Tufts Medicine’s healthcare expertise, with a focus on improving patient care and expanding services within the region.

Cell & Gene Therapy Bioanalytical Testing Services Market Report Scope

Global Cell & Gene Therapy Bioanalytical Testing Services Market Report Segmentation

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the cell & gene therapy bioanalytical testing services market report based on test type, product type, stage of development by product type, indication, and region:

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Bioavailability & Bioequivalence Studies 

  • Pharmacokinetics

  • Pharmacodynamics

  • Other Test Type

• Product Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Gene Therapy

    • Ex-vivo

    • In-vivo

  • Gene-Modified Cell Therapy

    • CAR T-cell therapies

    • CAR-NK cell therapy

    • TCR-T cell therapy

    • Other

  • Cell Therapy

• Stage of Development by Product Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Non-Clinical

    • Gene Therapy

    • Gene-Modified Cell Therapy

    • Cell Therapy

  • Clinical

    • Gene Therapy

    • Gene-Modified Cell Therapy

    • Cell Therapy

• Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Infectious Diseases

  • Neurological disorders

  • Rare Diseases

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait