Cell & Gene Therapy Bioanalytical Testing Services Market Size, Share & Trends Analysis Report By Test Type, By Stage Of Development, By Product Type, By Indication, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global cell & gene therapy bioanalytical testing services market size was valued at USD 473.4 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.3% from 2023 to 2030. Capitalizing on the 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. Moreover, rising research activities in cell & gene therapy coupled with the rising funding for clinical research in cell & gene therapy are some other factors supporting the demand for these services in the market. Cell & gene therapies remain popular in the treatment of cancer, autoimmune diseases, rare diseases, and others. CAR-T therapies are one of the most advanced therapies, which can detect and kill 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.

The outbreak of the COVID-19 pandemic had a damaging effect on the overall biopharmaceutical industry. Supply chain disruption and delays in conducting clinical research slowed market growth. However, clinical trials resumed owing to growth in-organic strategic initiatives adopted by major players while mitigating the impact of the pandemic. Moreover, public organizations also provided funding for conducting clinical cell & gene therapy trials.

For instance, in April 2023, California Institute for Regenerative Medicine invested USD 89.0 million in various stem cell & gene therapy research. Such initiatives helped in mitigating the negative impact of the COVID-19 pandemic and, thereby, supporting the growth of the cell & gene therapy bioanalytical testing services industry.

The development of cell & gene therapy is expensive. Therapy costs can range from around USD 4,00,000 to over 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 pipeline is 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.

Test Type Insights

The bioavailability & bioequivalence studies segment dominated the cell & gene therapy bioanalytical testing services market and accounted for the largest revenue share of 35.3% in 2022. 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. Using such drugs for clinical research could lead to the failure of clinical research as the drug can be toxic to humans. 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 with a CAGR of 7.7% during 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. Moreover, it also gives a better idea related to bioavailability, exposure, half-life, clearance, and metabolism, which are essential for success and failure in clinical settings. Hence, the ever-increasing pipeline of cell & gene products supports the demand for pharmacokinetics services and thereby supports segmental growth.

Stage of Development Insights

The non-clinical segment dominated the market and accounted for the largest revenue share of 66.1% in 2022. 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 significant interest of researchers in creating potential cell & gene therapies is improving the number of non-clinical trials for cell & gene therapy and thereby supporting the segment’s market growth.

For instance, as per the American Society of Gene & Cell Therapy, in May 2021, there were around 1,745 therapies in development. Preclinical therapies accounted for the majority, with around 70% of the therapies in preclinical studies. The high demand among researchers for getting the therapy into the clinical stage is further supporting the demand for non-clinical bioanalytical testing services, thus promoting segment growth.

The clinical segment is expected to grow with a CAGR of 6.9% CAGR across the forecast period. Assay-based studies, reagent selection, stability monitoring and 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 clinical analysis with human subjects is an essential part of the drug approval process. Moreover, it also gives the researchers better insights into drug safety as well. These factors support the demand for bioanalytical testing services at the clinical stage. For instance, 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

Cell therapy dominated the market and accounted for the largest revenue share of 42.3% in 2022. 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 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 focused on cell therapy only. The high potential of cell therapy in treatments and a significant number of clinical studies conducted using cell therapy support segment growth.

The gene-modified cell therapy segment is expected to grow with the fastest CAGR of 7.8% across 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 cancers, especially when other treatments show little promise. Additionally, CAR-T therapy has shown remarkable results in treating Leukemia and Lymphoma. CAR-NK cell therapy is considered a promising cancer therapy and is considered safer that CAR T-cell therapies for treating cancer. All the aforementioned factors are boosting the demand for clinical research for Gene-Modified Cell Therapy, thus boosting the demand for bioanalytical testing services for gene-modified cell therapy.

Indication Insight

The oncology segment dominated the market and accounted for the largest revenue share of 48.0% in 2022. The high burden of cancer worldwide and the growing demand for an effective treatment option for cancer treatment is one of the major reasons for the segment growth. Increasing R&D activities related to the development of new cell & gene therapy drugs for cancer and the significant number of funding by the public and private organizations for cancer research based on this therapy are some other factors boosting the segment market. For instance, in March 2023, Gates Grubstake Fund provided USD 1.5 million to translational researchers affiliated with the Gates Institute to conduct research in cell & gene therapy to aid the treatment of leukemia, multiple myeloma, and other diseases.

The rare diseases segment is expected to grow with a CAGR of 7.7% across the forecast period. Small molecules and other drugs only help in reducing the symptoms of several rare diseases and do not always provide a cure for the diseases. The majority of rare diseases are caused by a defect in a single gene. Hence, using gene therapies where certain genes are adjusted to treat someone’s disease - acts as a promising approach for treatment. This is increasing the demand for cell & gene therapy-based clinical studies and thus is supporting the demand for bioanalytical tests and thereby boosting the market growth.

Regional Insights

North America dominated the cell & gene therapy bioanalytical testing services market and accounted for the largest revenue share of 40.3% in 2022. The high dominance of the region is mainly due to the high 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 in the U.S. providing quality services in the region has further boosted the revenue shares of the region in the market.

Asia Pacific is anticipated to register the fastest CAGR of 7.6% during the forecast period in the market. The cost-effectiveness associated with outsourcing bioanalytical testing services in the region is one of the key factors that is supporting the regional market growth. Furthermore, many developed economies are outsourcing clinical trials to Asia Pacific countries, such as China, India, and South Korea. In addition, recruitment for clinical trials is easier in Asia Pacific as compared to North America and Europe due to the large & diverse patient pools available in these countries. All the above-mentioned factors also support the regional market.

The public organizations in the region are actively investing in boosting the research activities of the biotech sector. For instance, in March 2023, the South Korean government stated that it would invest USD 438.4 million to conduct research in the development of regenerative medicine, developing new technologies and equipment for the biotech sector. Such investment Is expected to boost the regional market growth.

Key Companies & Market Share Insights

The major players operating across the cell & gene therapy bioanalytical testing services industry 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. Some prominent players in the global cell & gene therapy bioanalytical testing services market include

• BioAgilytix Labs

• KCAS Bioanalytical Services

• IQVIA, Inc.

• Laboratory Corporation of America Holdings

• Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)

• Prolytix

• Pharmaron

• Charles River Laboratories

• Syneos Health

• SGS SA

• Intertek Group Plc

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 of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global cell & gene therapy bioanalytical testing services market report based on test type, product type, stage of development, 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 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