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)- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

Cell & Gene Therapy Bioanalytical Testing Services Market Size and Research

The global cell & gene therapy bioanalytical testing services market size was valued at USD 585.19 million in 2023 and is projected to surpass around USD 1,194.92 million by 2033, registering a CAGR of 7.4% over the forecast period of 2024 to 2033. 

Cell & Gene Therapy Bioanalytical Testing Services Market Key Takeaways

• North America dominated the cell & gene therapy bioanalytical testing services market and accounted for the largest revenue share of 40.56% in 2023.
• Asia Pacific is anticipated to witness the fastest CAGR of 7.8% in the forecast period.
• The bioavailability & bioequivalence studies dominated the market with a share of 35.22% in 2023. The segment is also expected to witness the fastest CAGR during the forecast period.
• The pharmacokinetic segment is expected to grow at a CAGR of 7.6% over the forecast period.
• The non-clinical segment dominated the market with a market share of 66.12% in 2023 and is also expected to witness the fastest growth at a CAGR of 7.5% during the forecast period.
• The clinical segment is expected to grow with a CAGR of 7.1% CAGR during the forecast period.
• The cell therapy segment dominated the product segment market with a market share of 42.19% in 2023.
• The gene-modified cell therapy segment is expected is expected to register the fastest CAGR of 7.8% during the forecast period.
• The oncology segment dominated the market and accounted for the largest revenue share of 49.85% in 2023.
• The rare diseases segment is expected to register the fastest CAGR during the forecast period.

Cell & Gene Therapy Bioanalytical Testing Services Market Growth 

One of the primary drivers of demand for its bioanalytical testing services is the realization of the untapped potential of cell and gene treatments in treating life-threatening and uncommon diseases. 

Cell and gene treatments are widely employed in the treatment of cancer, autoimmune illnesses, uncommon diseases, and other conditions. CAR-T treatment is among the most advanced therapeutics. It can detect and kill cancer cells more effectively. CAR-T cell therapies make up the majority of gene-modified cell treatments, with over 90% of them currently in preclinical development for oncology-related disorders. As a result, the factors mentioned above are expected to drive market growth.

Rising research activity in cell therapy, together with increased financing for clinical research in cell and gene therapy, presents an opportunity for the industry. Furthermore, the tremendous increase in the number of cell and gene therapy medication candidates undergoing clinical trials serves as a key market driver. Furthermore, increased financing from various public entities for clinical cell and gene therapy trials is creating new opportunities for the business. For example, in April 2023, the California Institute for Regenerative Medicine funded USD 89.0 million on various stem cell and gene therapy studies.

The development of cell and gene therapies is expensive. Therapy prices range from approximately USD 4,000 to $2 million per dose. The treatment is expensive because of the high costs associated with drug development and manufacture. There is a rising need for manufacturers to lower their in-house expenses while creating cell and gene therapies. As a result, outsourcing clinical research activities like bioanalytical testing and medication manufacture to contract developers lowers the overall cost of cell and gene therapy pharmaceuticals. This is projected to help drive market growth.

A large number of cell and gene therapy-related medications are undergoing clinical trials. For example, ClinicalTrial.gov reported that over 2,261 cell and gene therapy experiments were under development as of May 2023. According to a renowned publisher, Pharma Intelligence, the cell and gene therapy research business in Asia Pacific has grown significantly in recent years. Because of the widespread recognition of the promise of cell and gene therapy in the treatment of life-threatening diseases, Asia Pacific has the bulk of cell and gene therapy pipelines. A large number of trials in cell and gene therapy are likely to drive market expansion.

Cell & Gene Therapy Bioanalytical Testing Services Market Report Scope

Cell & Gene Therapy Bioanalytical Testing Services Market Trends

• Increased Demand: With the expansion of cell and gene therapy pipelines, there's a surge in demand for bioanalytical testing services. This demand is driven by both the rising number of therapies in development and the increasing complexity of these therapies.
• Regulatory Compliance: Regulatory agencies such as the FDA and EMA impose strict requirements for the approval of cell and gene therapies. Bioanalytical testing services are essential for demonstrating product safety, efficacy, and consistency, thereby ensuring compliance with regulatory standards.
• Technological Advancements: The development of novel analytical technologies and techniques has enhanced the capabilities of bioanalytical testing services. This includes advances in mass spectrometry, next-generation sequencing, flow cytometry, and other analytical platforms, enabling more comprehensive characterization of cell and gene therapies.
• Focus on Product Characterization: Comprehensive characterization of cell and gene therapy products is crucial for understanding their molecular and cellular properties, which in turn impacts safety and efficacy. Bioanalytical testing services are increasingly focused on providing in-depth characterization of these products, including identity, potency, purity, and stability assessments.
• Quality Control and Assurance: Maintaining product quality throughout manufacturing processes is paramount in cell and gene therapy development. Bioanalytical testing services are integral to quality control and assurance processes, ensuring consistency and reproducibility of therapeutic products.
• Outsourcing and Collaboration: Many companies are outsourcing bioanalytical testing services to specialized contract research organizations (CROs) with expertise in cell and gene therapy. Additionally, collaborations between industry players and academic institutions are driving innovation in bioanalytical testing methodologies.
• Standardization and Harmonization: As the field matures, there's a growing need for standardization and harmonization of bioanalytical testing methods and protocols. Efforts are underway to develop consensus guidelines and best practices to ensure consistency and comparability of data generated across different laboratories and studies.
• Emerging Markets: The adoption of cell and gene therapies is expanding beyond traditional markets, creating opportunities for bioanalytical testing service providers in emerging regions. However, challenges such as infrastructure limitations and regulatory differences need to be addressed in these markets.
• Focus on Patient Safety: Ensuring the safety of patients receiving cell and gene therapies remains a top priority. Bioanalytical testing services play a crucial role in detecting and mitigating potential risks, such as immunogenicity and off-target effects, through preclinical and clinical testing.

Test Type Insights

The bioavailability & bioequivalence studies dominated the market with a share of 35.22% 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 7.6% 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 66.12% 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 7.1% 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 42.19% 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 49.85% 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 40.56% 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 7.8% 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.

Cell & Gene Therapy Bioanalytical Testing Services Market 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 Top Key Companies:

• 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 Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Cell & Gene Therapy Bioanalytical Testing Services market.

By Test Type 

• Bioavailability & Bioequivalence Studies 
• Pharmacokinetics
• Pharmacodynamics
• Other Test Type

By Product Type 

• 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

By Stage of Development by Product Type 

• Non-Clinical
  • Gene Therapy
  • Gene-Modified Cell Therapy
  • Cell Therapy
• Clinical
  • Gene Therapy
  • Gene-Modified Cell Therapy
  • Cell Therapy

By Indication 

• Oncology
• Infectious Diseases
• Neurological disorders
• Rare Diseases
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)