Cell & Gene Therapy Bioanalytical Testing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Other test Stage of Development), By Product Type ( Gene Therapy, Gene-Modified Cell Therapy, Cell Therapy), By Stage of Development (Non-Clinical, Clinical), By Indication ( Oncology, Infectious Diseases, Neurological disorders, Rare Diseases, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 567.27 Million
CAGR (2026-2031)	9.19%
Fastest Growing Segment	Oncology
Largest Market	North America
Market Size (2031)	USD 961.36 Million

Market Overview

The Global Cell & Gene Therapy Bioanalytical Testing Services Market is projected to grow from USD 567.27 Million in 2025 to USD 961.36 Million by 2031 at a 9.19% CAGR. Cell and gene therapy bioanalytical testing services encompass the specialized scientific assessments required to validate the potency, safety, and viral vector characterization of therapeutic products throughout their development lifecycle. The primary drivers supporting market growth include the rapid accumulation of therapeutic candidates entering clinical phases and the increasing stringency of safety data requirements mandated by health authorities. This surge in development necessitates rigorous third party validation to mitigate risk. According to the Alliance for Regenerative Medicine and the American Society of Gene & Cell Therapy, in the first half of 2025, the global landscape included 1,905 ongoing clinical trials.

One significant challenge that could impede market expansion is the acute shortage of highly specialized personnel capable of developing and validating the complex assays required for these novel modalities. This talent gap often results in operational bottlenecks and increased timelines for therapy developers seeking market approval, thereby constraining the overall capacity of testing service providers to meet rising demand.

Key Market Drivers

The rapid expansion of the cell and gene therapy R&D pipeline is a foundational driver propelling the bioanalytical testing services market, creating immense demand for validation capacity. The proliferation of novel modalities forces developers to rely on specialized partners for safety and potency assays that can keep pace with clinical timelines. According to the American Society of Gene & Cell Therapy, March 2025, in the 'Gene, Cell, & RNA Therapy Landscape: Q4 2024 Quarterly Data Report', the global development pipeline has grown to encompass over 4,000 therapies across all stages. This deep pipeline creates sustained demand for bioanalytical testing, as every new candidate requires rigorous immunogenicity and viral vector characterization.

Substantial growth in capital investments for advanced therapy development further accelerates market demand by providing the financial resources required for premium outsourced bioanalysis. As pharmaceutical entities inject capital into the sector, there is a correlative rise in spending on testing services to ensure regulatory compliance. According to CGTLive, March 2025, in the article 'ASGCT's Q4 2024 Landscape Report Indicates Steady Rate of Growth', the sector's financial vitality was highlighted by Roche’s acquisition of Poseida Therapeutics for approximately $1.5 billion. This momentum is further evidenced by Novartis, which, according to the same source, acquired Kate Therapeutics for $1.1 billion. These high-value transactions underscore the industry’s commitment to advancing complex therapies, directly funding the testing workflows essential for commercialization.

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Key Market Challenges

The acute shortage of highly specialized personnel constitutes a substantial barrier directly hampering the growth of the Global Cell & Gene Therapy Bioanalytical Testing Services Market. Because these advanced therapies rely on intricate biological assays for validation, the workforce must possess specific scientific expertise that is currently in limited supply. This scarcity creates severe operational bottlenecks, as testing service providers struggle to recruit and retain the qualified staff necessary to execute complex validation studies within rigorous regulatory timelines. Consequently, the inability to scale workforce capacity restricts the volume of projects service providers can accept, leading to extended lead times and delays in client product development lifecycles.

The magnitude of this labor supply-demand imbalance is intensified by the rapid expansion of the commercial landscape, which places immense pressure on the available talent pool. According to the Alliance for Regenerative Medicine, in 2025, the global sector expanded to include almost 3,000 therapeutic developers. This high density of developers competes aggressively for the same finite group of bioanalytical experts, driving up attrition rates and hindering testing firms from maintaining the stable, expert teams required to meet the surging demand for safety and potency testing.

Key Market Trends

The Expansion of Specialized Viral Vector Characterization Capabilities is reshaping the bioanalytical market as developers prioritize safety and efficacy in delivery mechanisms. As adeno-associated virus (AAV) vectors solidify their position as the gold standard for gene delivery, testing services are increasingly focused on advanced assays to determine critical quality attributes such as capsid titer and full-to-empty ratios. This technical specialization is directly driven by the surging clinical adoption of these specific vectors, which necessitates rigorous validation distinct from broader therapeutic testing. According to PackGene, September 2025, in the article 'Advances in Cell and Gene Therapy and the Evolving AAV Landscape in 2025 H1', an analysis of clinical data identified 343 active AAV trials, representing a significant 34% increase in development activity for this vector class compared to 2022 benchmarks.

Concurrently, there is a definitive Shift Towards End-to-End Integrated Bioanalytical Service Models, driven by the sector's maturation from experimental research to commercial-scale manufacturing. Service providers are consolidating workflows to offer comprehensive lifecycle management—from early biomarker discovery to post-market surveillance—to support high-value commercial assets. This integration is essential as the market becomes increasingly concentrated around a select group of approved, high-revenue therapies that require consistent, large-scale testing capacity rather than fragmented, project-based analysis. According to the Alliance for Regenerative Medicine, January 2025, in the '2025 State of the Industry Briefing', 75 percent of the global sector's revenue is currently generated by fewer than 10 commercial products, underscoring the critical need for robust, integrated testing platforms capable of supporting these blockbuster therapies.

Segmental Insights

The oncology segment serves as the fastest-growing category in the Global Cell & Gene Therapy Bioanalytical Testing Services Market due to the high concentration of product candidates targeting cancer indications. This surge is largely attributed to the robust clinical pipeline of Chimeric Antigen Receptor T-cell therapies requiring extensive pharmacokinetic and immunogenicity assessments. Furthermore, continuous product authorizations by the US Food and Drug Administration enforce stringent safety monitoring, compelling drug developers to utilize professional testing services. This intense focus on developing curative cancer treatments sustains the rapid expansion of bioanalytical support within this therapeutic area.

Regional Insights

North America commands the leading position in the cell and gene therapy bioanalytical testing services market, driven by a high concentration of biopharmaceutical developers. This dominance is supported by substantial investment in research and development, which creates consistent demand for rigorous safety and efficacy testing. Additionally, the U.S. Food and Drug Administration (FDA) provides a structured regulatory framework that facilitates clinical studies and accelerates product approvals. The region also hosts numerous established contract research organizations, ensuring broad access to essential testing infrastructure. These factors collectively foster a favorable environment for the expansion of therapeutic development services.

Recent Developments

• In May 2025, BioAgilytix announced the expansion of its global Chemistry, Manufacturing, and Controls (CMC) analytical services to better support the growing demand for cell and gene therapy development. This strategic move involved strengthening its operational capabilities and appointing dedicated leadership to oversee the delivery of innovative testing solutions. The expansion was aimed at providing comprehensive bioanalytical support, ensuring that clients could navigate the complex regulatory landscape associated with advanced therapeutics. By enhancing its service offerings, the company reinforced its position as a key partner for ensuring the safety and quality of large-molecule drugs.
• In September 2024, Labcorp expanded its ongoing collaboration with Xcell Biosciences by installing a new automated manufacturing system at its facility in Ann Arbor, Michigan. This initiative was part of a beta access program intended to validate the equipment's ability to scale up cell therapy workflows while maintaining the potency benefits observed in smaller-scale studies. The project focused on using advanced incubation technology to metabolically reprogram therapeutic cells, thereby improving their survival and efficacy in the tumor microenvironment. This effort underscored the company's commitment to advancing downstream analytics and potency testing for cell and gene therapies.
• In August 2024, Eurofins BioPharma Product Testing Italy entered into a strategic partnership with Cellply to enhance the development of advanced therapies through single-cell characterization. This collaboration enabled the laboratory to offer services using a specialized platform that evaluates both the potency and immunophenotype of cell-based products at a single-cell resolution. By leveraging this technology, the company aimed to provide cell and gene therapy developers with in-depth data regarding product consistency and function, thereby accelerating the identification of optimal gene edits and suitable donors for immunotherapy applications.
• In May 2024, KCAS Bio announced a strategic partnership with an Australia-based laboratory, Crux Biolabs, to offer harmonized spectral flow cytometry services across multiple continents. This collaboration was designed to support the global development of cell and gene therapies by providing consistent and high-quality bioanalytical data in Europe, the United States, and Australia. The alliance aimed to streamline the regulatory pathway for drug developers by ensuring that critical flow cytometry assays, which are essential for characterizing cellular therapeutics, could be deployed with identical protocols and performance standards in different regions, thus facilitating global clinical trials.

Key Market Players

• BioAgilytix Labs Inc.
• KCAS Bio
• IQVIA, Inc.
• Laboratory Corporation of America Holdings
• Thermo Fisher Scientific Inc.
• Prolytix pvt ltd
• Pharmaron Biologics (UK) Ltd
• Charles River Laboratories International, Inc.
• Syneos Health Ltd
• Intertek Group Plc

By Test Type	By Product Type	By Stage of Development	By Indication	By Region
Bioavailability & Bioequivalence Studies Pharmacokinetics Pharmacodynamics Other test Stage of Development	Gene Therapy Gene-Modified Cell Therapy Cell Therapy	Non-Clinical Clinical	Oncology Infectious Diseases Neurological disorders Rare Diseases Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cell & Gene Therapy Bioanalytical Testing Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cell & Gene Therapy Bioanalytical Testing Services Market, By Test Type:

• Bioavailability & Bioequivalence Studies
• Pharmacokinetics
• Pharmacodynamics
• Other test Stage of Development

• Cell & Gene Therapy Bioanalytical Testing Services Market, By Product Type:

• Gene Therapy
• Gene-Modified Cell Therapy
• Cell Therapy

• Cell & Gene Therapy Bioanalytical Testing Services Market, By Stage of Development:

• Non-Clinical
• Clinical

• Cell & Gene Therapy Bioanalytical Testing Services Market, By Indication:

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

• Cell & Gene Therapy Bioanalytical Testing Services Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE