Cell and Gene Therapy Bioanalytical Testing Services Market Evolving with Precision Analytics

Revenue, 2025

USD 589.08 Million

Forecast, 2035

USD 1200.62 Million

CAGR, 2026-2035

7.38%

Report Coverage

Global

Cell and Gene Therapy Bioanalytical Testing Services Market Size, Key Players with Segment Analysis

The global cell and gene therapy bioanalytical testing services market size was estimated at USD 589.08 million in 2025 and is predicted to increase from USD 632.55 million in 2026 to approximately USD 1200.62 million by 2035, expanding at a CAGR of 7.38% from 2026 to 2035.

The cell and gene therapy bioanalytical testing services market is rapidly expanding as advanced therapies progress through clinical pipelines, driving demand for precise quality, safety, and regulatory testing. North America dominates due to strong R&D infrastructure, supportive regulations, and high outsourcing to specialized CROs. Growth is fueled by emerging technologies, increased clinical trials, and rising investment, despite high infrastructure costs and complex regulatory landscapes.

Key Takeaways

• Cell and gene therapy bioanalytical testing services market to crossed USD 632.55 million by 2026.
• Market projected at USD 1200.62 million by 2035.
• CAGR of 7.38% expected in between 2026 to 2035.
• North America held a major revenue share in the cell and gene therapy bioanalytical testing services market in 2025.
• Asia-Pacific is expected to witness the fastest growth during the predicted timeframe.
• By test type, the bioavailability & bioequivalence studies segment registered its dominance over the global market in 2025.
• By test type, the pharmacokinetics segment is expected to grow with the highest CAGR in the market during the studied years.
• By stage of development by product type, the non-clinical segment held the largest revenue in the market in 2025.
• By stage of development by product type, the clinical segment is expected to show the fastest growth over the forecast period.
• By product type, the cell therapy segment held a dominant presence in the cell and gene therapy bioanalytical testing services market in 2025.
• By product type, the gene-modified cell therapy segment is expected to witness the fastest growth in the market over the forecast period.
• By indication, the oncology segment registered its dominance over the global market in 2025.
• By indication, the rare diseases segment is expected to grow with the highest CAGR in the market during the studied years.

Executive Summary Table

Bioanalytical Testing: A Critical Backbone for Cell and Gene Therapies

The cell and gene therapy bioanalytical testing services market is driven by rising clinical trial activity, growing R&D investments, and the need for robust quality, safety, and regulatory compliance assessments. Demand is further boosted by technological advancements and outsourcing to specialized CROs. North America dominates the market with strong infrastructure and favourable regulations. Increasing adoption of precision analytics, single-cell techniques, and personalized therapies supports sustained growth, overcoming challenges like high costs and evolving standards.

How AI is Redefining Cell and Gene Bioanalytical Testing

AI integration can significantly improve the cell and gene therapy bioanalytical testing services market by enhancing data accuracy, speed, and reproducibility across complex analytical workflows. Machine learning algorithms enable advanced pattern recognition in high-volume biological datasets, supporting faster biomarker identification and potency assessment. AI-driven automation streamlines sample analysis, reduces human error, and optimizes assay development. Additionally, predictive analytics support regulatory compliance, improve quality control, and accelerate clinical development timelines, strengthening overall testing efficiency and reliability.

Trends & Future Outlook of the Cell and Gene Therapy Bioanalytical Testing Services Market

Expansion of Advanced Analytical Technologies

Emerging tools like single-cell sequencing and high-resolution mass spectrometry enhance sensitivity and precision in testing, enabling deeper characterization of complex therapies and better insight into efficacy and safety profiles.

Growing Outsourcing to Specialized CROs

 Biotech firms increasingly partner with contract research organizations to access expertise, scalable infrastructure, and regulatory support, reducing development costs while maintaining high-quality testing standards.

Regulatory Harmonization and Evolving Standards

Global regulatory agencies are aligning guidelines for bioanalytical testing, pushing the adoption of standardized protocols and enhancing quality assurance, which supports market growth and smoother global therapy approvals.

Regional Market Leadership and Expansion

North America continues to dominate due to strong investment and innovation hubs, while Asia-Pacific shows rapid growth as infrastructure improves and more clinical trials are conducted internationally.

Infectious Disease Prevalence Has Driven the Growth of the Cell and Gene Therapy Bioanalytical Testing Services Market

Major Investments in the Cell and Gene Therapy Bioanalytical Testing Services Market

• In 2025, Bharat Biotech announced a US$75 million investment to launch a vertically integrated cell and gene therapy R&D and manufacturing facility in Hyderabad, bolstering local production of viral vectors and analytical testing capabilities.
• In February 2024, Miltenyi Biotec inaugurated a Cell & Gene Therapy Center of Excellence in Hyderabad to support advanced research and bioanalytical testing, reflecting increased global investment into testing infrastructure. Miltenyi Biotec is opening its first office in India and investing in the Miltenyi Innovation and Technology Center, a CGT Centre of Excellence (COE), in Hyderabad.
• In October 2025, the Saudi government’s Vision 2030 initiative is backing over SAR 1.5 billion in biotechnology R&D, including support for bioanalytical testing services and gene therapy regulatory frameworks.

Segmental Insights

Test Type Insights

How Bioavailability & Bioequivalence Studies Segment Dominated the Market?

The bioavailability & bioequivalence studies segment dominates the cell and gene therapy bioanalytical testing services market due to strict regulatory requirements for safety, efficacy, and consistency evaluation. The complex nature of advanced therapies demands specialized assays for biodistribution, potency, and immunogenicity. Growing clinical trial activity and widespread outsourcing to expert CROs further strengthen demand for these essential testing services.

Pharmacokinetics

The pharmacokinetics segment is estimated to be fastest growing segment in the market due to increasing demand for detailed assessment of therapy absorption, distribution, metabolism, and elimination. Advanced therapies’ complex biological behavior necessitates precise PK profiling. Rising clinical trial activity, regulatory emphasis on PK data, and adoption of innovative analytical tools further drive growth in pharmacokinetic testing within cell and gene therapy development.

Stage of Development by Product Type Insights

How Did Non-Clinical Become a Dominant Segment in the Cell and Gene Therapy Bioanalytical Testing Services Market?

The non-clinical segment dominates because early safety, toxicity, and mechanism-of-action studies are critical for cell and gene therapies before human trials. Extensive animal testing, regulatory mandates for preclinical evidence, and complex biological assessments drive sustained demand for bioanalytical services in non-clinical development, supported by advanced analytical platforms and expert CRO partnerships.

Clinical

The clinical segment is anticipated to be the fastest-growing in the market due to expanding late-phase trials and increased approvals of cell and gene therapies. Demand for rigorous safety, efficacy, and pharmacokinetic data drives extensive clinical bioanalytical testing. Enhanced regulatory focus, broader patient enrollment, and outsourcing to specialized service providers further accelerate growth in clinical testing services.

Product Type Insights

Which Product Type Segment Led the Cell and Gene Therapy Bioanalytical Testing Services Market?

The cell therapy segment dominates because of its widespread adoption in treating cancers, autoimmune disorders, and regenerative conditions. High complexity, stringent safety requirements, and the need for comprehensive bioanalytical testing, including potency, identity, and purity assessments, drive demand. Increasing clinical trials and outsourcing to specialized CROs further reinforce its market dominance.

Gene-Modified Cell Therapy

The gene-modified cell therapy segment is estimated to be the fastest-growing segment due to the rising adoption of advanced therapies like CAR-T and CRISPR-based treatments. Its complex genetic modifications require extensive bioanalytical testing for safety, efficacy, and vector characterization. Increasing clinical trials, regulatory focus on precise monitoring, and outsourcing to specialized CROs further accelerate growth in this high-demand segment.

Indication Insight

How is the Oncology Dominant Segment in the Cell and Gene Therapy Bioanalytical Testing Services Market?

The oncology segment dominates because cell and gene therapies are extensively developed for cancer treatment, including CAR-T and gene-modified therapies. High clinical trial activity, complex therapeutic requirements, and stringent regulatory oversight drive demand for comprehensive bioanalytical testing, ensuring safety, efficacy, and quality in oncology-focused advanced therapies.

Rare Diseases

The rare diseases segment is anticipated to be the fastest-growing in the market due to increasing development of personalized cell and gene therapies targeting genetic disorders. Rising patient demand, supportive regulatory incentives, and complex bioanalytical requirements for safety, efficacy, and vector characterization drive the need for specialized testing services, accelerating growth in this niche segment.

Regional Distribution

• North America registered dominance in the cell and gene therapy bioanalytical testing services market in 2025. 
• The U.S. led the market by capturing the largest revenue share of the market in 2025. 
• Asia Pacific is expected to be the fastest-growing region in the studied years.
• China is anticipated to grow at a rapid CAGR during the forecast period. 
• Europe is expected to grow at a significant CAGR in the market during the forecast period.
• The UK is anticipated to grow at a rapid CAGR during the forecast period.

Which Factors Made the North America Region the Dominant Region in the Market?

North America dominated the cell and gene therapy bioanalytical testing services market in 2025. North America dominates the market due to a well-established biotechnology infrastructure, strong R&D investments, and supportive regulatory frameworks. The region hosts numerous advanced CROs, extensive clinical trial activity, and early adoption of innovative technologies, ensuring robust bioanalytical testing capabilities and maintaining leadership in the global cell and gene therapy ecosystem.

U.S. Market Trends

The U.S. leads the North American cell and gene therapy bioanalytical testing services market due to its advanced biotechnology ecosystem, high R&D investment, and presence of numerous specialized CROs. Strong regulatory support, extensive clinical trial activity, and early adoption of innovative testing technologies further reinforce the country’s dominance in bioanalytical services for advanced therapies.

Which Factors Make Asia Pacific the Fastest-Growing Region in the Global Market?

Asia Pacific is estimated to host the fastest-growing cell and gene therapy bioanalytical testing services market during the forecast period. The Asia-Pacific region is the fastest-growing market for cell and gene therapy bioanalytical testing services due to increasing investment in biotechnology infrastructure, rising clinical trial activity, and government initiatives supporting advanced therapies. Growing outsourcing to specialized CROs, expanding healthcare access, and adoption of innovative analytical technologies further drive rapid growth, positioning the region as a key emerging hub for bioanalytical testing.

China Market Trends

China dominates the Asia-Pacific market due to substantial government support, rapid expansion of biotechnology infrastructure, and growing R&D investment. The country hosts numerous clinical trials, advanced CROs, and manufacturing facilities, while regulatory reforms and the adoption of innovative analytical technologies enhance testing capabilities, positioning China as the region’s leader in advanced therapy bioanalytical services.

How Big is the Success of Europe in the Market?

Europe is expected to grow at a significant CAGR in the cell and gene therapy bioanalytical testing services market during the forecast period. Europe is witnessing notable growth in the market due to increasing investment in advanced therapies, supportive regulatory frameworks, and the expansion of specialized CROs. Strong clinical trial activity, collaborations between biotech companies and research institutes, and adoption of innovative analytical technologies enhance testing capabilities, driving the region’s steady growth in bioanalytical services.

UK Market Trends

The UK dominates Europe’s cell and gene therapy bioanalytical testing services market due to its strong biotechnology ecosystem, robust R&D investment, and presence of leading CROs. Supportive regulatory frameworks, extensive clinical trial activity, and early adoption of advanced analytical technologies further strengthen the country’s position as a key hub for bioanalytical testing in advanced therapies.

Top Vendors in the Market & Their Offerings

SWOT Analysis

Strengths:

• High demand for specialized testing due to the complex nature of cell and gene therapies.
• Strong presence of experienced CROs offering advanced bioanalytical capabilities.
• Regulatory emphasis on safety, efficacy, and quality drives consistent service need.

Weaknesses:

• High operational costs and need for sophisticated infrastructure.
• Limited skilled workforce in specialized analytical techniques.
• Complex regulatory compliance can delay service delivery.

Opportunities:

• Growing clinical trials and pipeline of advanced therapies globally.
• Integration of AI and automation to improve efficiency and accuracy.
• Expansion in emerging markets like the Asia-Pacific with supportive government initiatives.

Threats:

• Stringent and evolving global regulatory requirements.
• High competition from established CROs and new entrants.
• Rapid technological changes may require constant investment in equipment and training.

Recent Developments in the Cell and Gene Therapy Bioanalytical Testing Services Market

• In February 2025, Labcorp Drug Development unveiled a comprehensive suite of validated AAV (adeno-associated virus) vector quantification and characterization assays under GMP conditions. These new services enable gene therapy developers to accurately assess vector identity, potency, and purity. The launch addresses rising demand for regulatory-compliant testing in gene therapy trials and supports faster development timelines while ensuring robust quality control.
• In January 2025, ICON plc, a clinical research organization company, announced a partnership with a leading gene therapy company to provide centralized bioanalytical testing and integrated sample logistics across multi-center clinical trials. This collaboration improves standardization of testing protocols, reduces turnaround times, and ensures consistent, high-quality data from diverse trial sites, thereby enhancing the reliability of clinical study results and accelerating global cell and gene therapy development programs.

Segments Covered in the Report

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
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA