Cell and Gene Therapy Bioanalytical Testing Services Market Size, Trends, Analysis, and Outlook By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Others), By Product (Gene Therapy, Gene-Modified Cell Therapy, Cell

Cell and Gene Therapy Bioanalytical Testing Services Market Size, Trends, Analysis, and Outlook By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Others), By Product (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, Country, Segment, and Companies, 2024-2030


The global Cell and Gene Therapy Bioanalytical Testing Services market size is poised to register 8.37% growth from 2024 to 2030, presenting significant growth prospects for companies operating in the industry. The industry study analyzes the global Cell and Gene Therapy Bioanalytical Testing Services market across By Test Type (Bioavailability & Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, Others), By Product (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).

The Cell and Gene Therapy Bioanalytical Testing Services Market is witnessing significant growth and therapeutic innovation in 2024 and beyond, driven by advancements in cell therapy manufacturing, gene editing technologies, and regulatory frameworks aimed at accelerating the development, characterization, and commercialization of cell-based therapies, gene therapies, and regenerative medicine products for treating genetic disorders, rare diseases, and cancer indications that pose significant healthcare challenges, unmet medical needs, and patient morbidity in cell therapy research, gene therapy trials, and personalized medicine applications worldwide. Cell and gene therapy bioanalytical testing services encompass a wide range of analytical assays, bioassays, and quality control tests performed by contract research organizations (CROs), analytical laboratories, and testing facilities to assess the safety, potency, and purity of cell therapy products, gene therapy vectors, or genetically modified cells intended for clinical use, regulatory submission, or commercial distribution, providing critical data, analytical support, and regulatory compliance expertise to cell therapy developers, gene therapy manufacturers, and biopharmaceutical companies navigating the complex landscape of cell and gene therapy development, production, and regulatory approval processes in the biopharmaceutical industry. Key trends include the development of validated assays, reference standards, and analytical methodologies that address specific requirements, regulatory guidelines, and manufacturing challenges associated with cell and gene therapy products, as well as the adoption of advanced technologies, high-throughput screening platforms, and next-generation sequencing (NGS) techniques for comprehensive characterization, molecular profiling, and functional assessment of therapeutic cells, viral vectors, or gene editing tools used in cell-based therapies, gene-based treatments, or genome editing applications. Additionally, there is a growing emphasis on data integrity, assay validation, and regulatory compliance measures that ensure analytical accuracy, method robustness, and product safety in cell and gene therapy testing services, as well as a growing focus on collaborative partnerships, regulatory harmonization efforts, and industry standards development that promote best practices, quality standards, and technology transfer initiatives in bioanalytical testing, fostering innovation, quality assurance, and patient safety in the emerging field of cell and gene therapy development.

Cell and Gene Therapy Bioanalytical Testing Services Market Drivers, Trends, Opportunities, and Growth Opportunities

This comprehensive study discusses the latest trends and the most pressing challenges for industry players and investors. The Cell and Gene Therapy Bioanalytical Testing Services market research analyses the global market trends, key drivers, challenges, and opportunities in the industry. In addition, the latest Future of Cell and Gene Therapy Bioanalytical Testing Services survey report provides the market size outlook across types, applications, and other segments across the world and regions. It provides data-driven insights and actionable recommendations for companies in the Cell and Gene Therapy Bioanalytical Testing Services industry.

Key market trends defining the global Cell and Gene Therapy Bioanalytical Testing Services demand in 2024 and Beyond

The industry continues to remain an attractive hub for opportunities for both domestic and global vendors. As the market evolves, factors such as emerging market dynamics, demand from end-user sectors, a growing patient base, changes in consumption patterns, and widening distribution channels continue to play a major role.

Cell and Gene Therapy Bioanalytical Testing Services Market Segmentation- Industry Share, Market Size, and Outlook to 2030

The Cell and Gene Therapy Bioanalytical Testing Services industry comprises a wide range of segments and sub-segments. The rising demand for these product types and applications is supporting companies to increase their investment levels across niche segments. Accordingly, leading companies plan to generate a large share of their future revenue growth from expansion into these niche segments. The report presents the market size outlook across segments to support Cell and Gene Therapy Bioanalytical Testing Services companies scaling up production in these sub-segments with a focus on expanding into emerging countries.

Key strategies adopted by companies within the Cell and Gene Therapy Bioanalytical Testing Services industry

Leading Cell and Gene Therapy Bioanalytical Testing Services companies are boosting investments to capitalize on untapped potential and future possibilities across niche market segments and surging demand conditions in key regions. Further, companies are leveraging advanced technologies to unlock opportunities and achieve operational excellence. The report provides key strategies opted for by the top 10 Cell and Gene Therapy Bioanalytical Testing Services companies.

Cell and Gene Therapy Bioanalytical Testing Services Market Study- Strategic Analysis Review

The Cell and Gene Therapy Bioanalytical Testing Services market research report dives deep into the qualitative factors shaping the market, empowering you to make informed decisions-
  • Industry Dynamics: Porter's Five Forces analysis to understand bargaining power, competitive rivalry, and threats that impact long-term strategy formulation.
  • Strategic Insights: Provides valuable perspectives on key players and their approaches based on comprehensive strategy analysis.
  • Internal Strengths and Weaknesses: Develop targeted strategies to leverage strengths, address weaknesses, and capitalize on market opportunities.
  • Future Possibilities: Prepare for diverse outcomes with in-depth scenario analysis. Explore potential market disruptions, technology advancements, and economic changes.
Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook- Historic and Forecast Revenue in Three Cases

The Cell and Gene Therapy Bioanalytical Testing Services industry report provides a detailed analysis and outlook of revenue generated by companies from 2018 to 2023. Further, with actual data for 2023, the report forecasts the market size outlook from 2024 to 2030 in three case scenarios- low case, reference case, and high case scenarios.

Cell and Gene Therapy Bioanalytical Testing Services Country Analysis and Revenue Outlook to 2030

The report analyses 22 countries worldwide including the key driving forces and market size outlook from 2021 to 2030. In addition, region analysis across Asia Pacific, Europe, the Middle East, Africa, North America, and South America is included in the study. For each of the six regions, the market size outlook by segments is forecast for 2030.

North America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook- Companies plan for focused investments in a changing environment

The US continues to remain the market leader in North America, driven by a large consumer base, the presence of well-established providers, and a strong end-user industry demand. Leading companies focus on new product launches in the changing environment. The US economy is expected to grow in 2024 (around 2.2% growth in 2024), potentially driving demand for various Cell and Gene Therapy Bioanalytical Testing Services market segments. Similarly, Strong end-user demand is encouraging Canadian Cell and Gene Therapy Bioanalytical Testing Services companies to invest in niche segments. Further, as Mexico continues to strengthen its trade relations and invest in technological advancements, the Mexico Cell and Gene Therapy Bioanalytical Testing Services market is expected to experience significant expansion, offering lucrative opportunities for both domestic and international stakeholders.

Europe Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook-Companies investing in assessing consumers, categories, competitors, and capabilities

The German industry remains the major market for companies in the European Cell and Gene Therapy Bioanalytical Testing Services industry with consumers in Germany, France, the UK, Spain, Italy, and others anticipated to register a steady demand throughout the forecast period, driving the overall market prospects. In addition, the proactive approach of businesses in identifying and leveraging new growth prospects positions the European Cell and Gene Therapy Bioanalytical Testing Services market for an upward trajectory, fostering both domestic and international interest. Leading brands operating in the industry are emphasizing effective marketing strategies, innovative product offerings, and a keen understanding of consumer preferences.

Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook- an attractive hub for opportunities for both local and global companies

The increasing prevalence of indications, robust healthcare expenditure, and increasing investments in healthcare infrastructure drive the demand for Cell and Gene Therapy Bioanalytical Testing Services in Asia Pacific. In particular, China, India, and South East Asian Cell and Gene Therapy Bioanalytical Testing Services markets present a compelling outlook for 2030, acting as a magnet for both domestic and multinational manufacturers seeking growth opportunities. Similarly, with a burgeoning population and a rising middle class, India offers a vast consumer market. Japanese and Korean companies are quickly aligning their strategies to navigate changes, explore new markets, and enhance their competitive edge. Our report utilizes in-depth interviews with industry experts and comprehensive data analysis to provide a comprehensive outlook of 6 major markets in the region.

Latin America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook- Continued urbanization and rising income levels

Rising income levels contribute to greater purchasing power among consumers, spurring consumption and creating opportunities for market expansion. Continued urbanization and rising income levels are expected to sustainably drive consumption growth in the medium to long term.

Middle East and Africa Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook- continues its upward trajectory across segments

Robust demand from Middle Eastern countries including Saudi Arabia, the UAE, Qatar, Kuwait, and other GCC countries supports the overall Middle East Cell and Gene Therapy Bioanalytical Testing Services market potential. Fueled by increasing healthcare expenditure of individuals, growing population, and high prevalence across a few markets drives the demand for Cell and Gene Therapy Bioanalytical Testing Services.

Cell and Gene Therapy Bioanalytical Testing Services Market Company Profiles

The global Cell and Gene Therapy Bioanalytical Testing Services market is characterized by intense competitive conditions with leading companies opting for aggressive marketing to gain market shares. The report presents business descriptions, SWOT analysis, growth strategies, and financial profiles. Leading companies included in the study are BioAgilytix Labs, Charles River Laboratories, Intertek Group Plc, IQVIA Inc, KCAS Bioanalytical Services, Laboratory Corp of America Holdings, Pharmaceutical Product Development Inc (Thermo Fisher Scientific Inc), Pharmaron, Prolytix, SGS SA, Syneos Health

Recent Cell and Gene Therapy Bioanalytical Testing Services Market Developments

The global Cell and Gene Therapy Bioanalytical Testing Services market study presents recent market news and developments including new product launches, mergers, acquisitions, expansions, product approvals, and other updates in the industry.

Cell and Gene Therapy Bioanalytical Testing Services Market Report Scope

Parameters: Revenue, Volume Price

Study Period: 2023 (Base Year); 2018- 2023 (Historic Period); 2024- 2030 (Forecast Period)

Currency: USD; (Upon request, can be provided in Euro, JPY, GBP, and other Local Currency)

Qualitative Analysis
  • Pricing Analysis
  • Value Chain Analysis
  • SWOT Profile
  • Market Dynamics- Trends, Drivers, Challenges
  • Porter’s Five Forces Analysis
  • Macroeconomic Impact Analysis
  • Case Scenarios- Low, Base, High
Market Segmentation:

By Test Type

Bioavailability & Bioequivalence Studies

Pharmacokinetics

Pharmacodynamics

Others

By Product

Gene Therapy

-Ex-vivo

-In-vivo

Gene-Modified Cell Therapy

-CAR T-cell therapies

-CAR-NK cell therapy

-TCR-T cell therapy

-Others

Cell Therapy

By Stage Of Development

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

Geographical Segmentation:
  • North America (3 markets)
  • Europe (6 markets)
  • Asia Pacific (6 markets)
  • Latin America (3 markets)
  • Middle East Africa (5 markets)
Companies

BioAgilytix Labs

Charles River Laboratories

Intertek Group Plc

IQVIA Inc

KCAS Bioanalytical Services

Laboratory Corp of America Holdings

Pharmaceutical Product Development Inc (Thermo Fisher Scientific Inc)

Pharmaron

Prolytix

SGS SA

Syneos Health

Formats Available: Excel, PDF, and PPT


1. Executive Summary
1.1 Cell and Gene Therapy Bioanalytical Testing Services Market Overview and Key Findings, 2024
1.2 Cell and Gene Therapy Bioanalytical Testing Services Market Size and Growth Outlook, 2021- 2030
1.3 Cell and Gene Therapy Bioanalytical Testing Services Market Growth Opportunities to 2030
1.4 Key Cell and Gene Therapy Bioanalytical Testing Services Market Trends and Challenges
1.4.1 Cell and Gene Therapy Bioanalytical Testing Services Market Drivers and Trends
1.4.2 Cell and Gene Therapy Bioanalytical Testing Services Market Challenges
1.5 Competitive Landscape and Key Players
1.6 Competitive Analysis- Growth Strategies Adopted by Leading Cell and Gene Therapy Bioanalytical Testing Services Companies
2. Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook to 2030
2.1 Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook, USD Million, 2021- 2030
2.2 Cell and Gene Therapy Bioanalytical Testing Services Incremental Market Growth Outlook, %, 2021- 2030
2.3 Segment Snapshot, 2024
3. Cell and Gene Therapy Bioanalytical Testing Services Market- Strategic Analysis Review
3.1 Porter's Five Forces Analysis
Threat of New Entrants
Threat of Substitutes
Intensity of Competitive Rivalry
Bargaining Power of Buyers
Bargaining Power of Suppliers
3.2 Value Chain Analysis
3.3 SWOT Analysis
4. Cell and Gene Therapy Bioanalytical Testing Services Market Segmentation Analysis and Outlook
4.1 Market Segmentation and Scope
4.2 Market Breakdown by Type, Application, and Other Segments, 2021-2030
By Test Type
Bioavailability & Bioequivalence Studies
Pharmacokinetics
Pharmacodynamics
Others
By Product
Gene Therapy
-Ex-vivo
-In-vivo
Gene-Modified Cell Therapy
-CAR T-cell therapies
-CAR-NK cell therapy
-TCR-T cell therapy
-Others
Cell Therapy
By Stage Of Development
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
4.3 Growth Prospects and Niche Opportunities, 2023- 2030
4.4 Regional comparison of Market Growth, CAGR, 2023-2030
5. Region-wise Market Outlook to 2030
5.1 Key Findings for Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market, 2025
5.2 Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Type, 2021- 2030
5.3 Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Application, 2021- 2030
5.4 Key Findings for Europe Cell and Gene Therapy Bioanalytical Testing Services Market, 2025
5.5 Europe Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Type, 2021- 2030
5.6 Europe Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Application, 2021- 2030
5.7 Key Findings for North America Cell and Gene Therapy Bioanalytical Testing Services Market, 2025
5.8 North America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Type, 2021- 2030
5.9 North America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Application, 2021- 2030
5.10 Key Findings for South America Cell and Gene Therapy Bioanalytical Testing Services Market, 2025
5.11 South America Pacific Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Type, 2021- 2030
5.12 South America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Application, 2021- 2030
5.13 Key Findings for Middle East and Africa Cell and Gene Therapy Bioanalytical Testing Services Market, 2025
5.14 Middle East Africa Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Type, 2021- 2030
5.15 Middle East Africa Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Application, 2021- 2030
6. Country-wise Market Size Outlook to 2030
6.1 US Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook and Revenue Growth Forecasts
6.2 US Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.3 Canada Market Size Outlook and Revenue Growth Forecasts
6.4 Canada Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.6 Mexico Market Size Outlook and Revenue Growth Forecasts
6.6 Mexico Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.7 Germany Market Size Outlook and Revenue Growth Forecasts
6.8 Germany Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.9 France Market Size Outlook and Revenue Growth Forecasts
6.10 France Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.11 UK Market Size Outlook and Revenue Growth Forecasts
6.12 UK Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.13 Spain Market Size Outlook and Revenue Growth Forecasts
6.14 Spain Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.16 Italy Market Size Outlook and Revenue Growth Forecasts
6.16 Italy Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.17 Rest of Europe Market Size Outlook and Revenue Growth Forecasts
6.18 Rest of Europe Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.19 China Market Size Outlook and Revenue Growth Forecasts
6.20 China Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.21 India Market Size Outlook and Revenue Growth Forecasts
6.22 India Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.23 Japan Market Size Outlook and Revenue Growth Forecasts
6.24 Japan Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.26 South Korea Market Size Outlook and Revenue Growth Forecasts
6.26 South Korea Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.27 Australia Market Size Outlook and Revenue Growth Forecasts
6.28 Australia Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.29 South East Asia Market Size Outlook and Revenue Growth Forecasts
6.30 South East Asia Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.31 Rest of Asia Pacific Market Size Outlook and Revenue Growth Forecasts
6.32 Rest of Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.33 Brazil Market Size Outlook and Revenue Growth Forecasts
6.34 Brazil Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.36 Argentina Market Size Outlook and Revenue Growth Forecasts
6.36 Argentina Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.37 Rest of South America Market Size Outlook and Revenue Growth Forecasts
6.38 Rest of South America Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.39 Middle East Market Size Outlook and Revenue Growth Forecasts
6.40 Middle East Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
6.41 Africa Market Size Outlook and Revenue Growth Forecasts
6.42 Africa Cell and Gene Therapy Bioanalytical Testing Services Industry Drivers and Opportunities
7. Cell and Gene Therapy Bioanalytical Testing Services Market Outlook across Scenarios
7.1 Low Growth Case
7.2 Reference Growth Case
7.3 High Growth Case
8. Cell and Gene Therapy Bioanalytical Testing Services Company Profiles
8.1 Profiles of Leading Cell and Gene Therapy Bioanalytical Testing Services Companies in the Market
8.2 Business Descriptions, SWOT Analysis, and Growth Strategies
8.3 Financial Performance and Key Metrics
BioAgilytix Labs
Charles River Laboratories
Intertek Group Plc
IQVIA Inc
KCAS Bioanalytical Services
Laboratory Corp of America Holdings
Pharmaceutical Product Development Inc (Thermo Fisher Scientific Inc)
Pharmaron
Prolytix
SGS SA
Syneos Health
9. Appendix
9.1 Scope of the Report
9.2 Research Methodology and Data Sources
9.3 Glossary of Terms
9.4 Market Definitions
9.5 Contact Information

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook
Cookie Settings