Cell and Gene Therapy Bioanalytical Testing Services Market Size, Share, Trends, Growth Outlook

Cell and Gene Therapy Bioanalytical Testing Services Market is estimated to increase at a growth rate of 8.9% CAGR over the forecast period from 2024 to 2030.

The Cell and Gene Therapy Bioanalytical Testing Services Market study analyzes and forecasts the market size across 6 regions and 24 countries for diverse segments including 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).

An Introduction to Cell and Gene Therapy Bioanalytical Testing Services Market in 2024

The Cell and Gene Therapy Bioanalytical Testing Services market in 2024 addresses the need for specialized analytical and testing services to support the development and manufacturing of cell and gene therapies. Bioanalytical testing services encompass a wide range of assays and methodologies for characterizing cellular products, assessing product quality, and ensuring safety and efficacy in clinical applications. Market dynamics are driven by factors such as the increasing investment in cell and gene therapy research and development, regulatory requirements for product characterization and validation, and the demand for outsourcing solutions from biopharmaceutical companies. Collaboration between contract research organizations (CROs), academic institutions, regulatory agencies, and biotechnology companies drives innovation and market growth in cell and gene therapy bioanalytical testing services, supporting the translation of advanced therapies from bench to bedside.

Cell and Gene Therapy Bioanalytical Testing Services Market Trend: Increasing Demand for Bioanalytical Testing Services in Cell and Gene Therapy

A prominent trend in the Cell and Gene Therapy Bioanalytical Testing Services market is the increasing demand for specialized testing services to support the development and commercialization of cell and gene therapies. As the field of cell and gene therapy continues to grow rapidly, there is a rising need for comprehensive bioanalytical testing solutions to assess the safety, efficacy, and quality of these innovative therapies. This trend is driven by the complex nature of cell and gene-based products, regulatory requirements mandating thorough characterization and validation, and the desire to ensure patient safety and product efficacy throughout the therapy's lifecycle.

Cell and Gene Therapy Bioanalytical Testing Services Market Driver: Stringent Regulatory Requirements and Quality Standards

The primary driver for the Cell and Gene Therapy Bioanalytical Testing Services market is the stringent regulatory requirements and quality standards governing the development and commercialization of cell and gene therapies. Regulatory agencies, such as the FDA and EMA, impose rigorous standards for the characterization, potency, purity, and safety of cell and gene-based products, necessitating extensive bioanalytical testing throughout the product development process. Compliance with these regulatory guidelines is paramount for obtaining marketing approval and ensuring patient access to safe and effective therapies. Consequently, biopharmaceutical companies and contract testing laboratories rely on specialized bioanalytical testing services to meet regulatory expectations and mitigate the risks associated with product development.

Cell and Gene Therapy Bioanalytical Testing Services Market Opportunity: Expansion of Testing Capabilities for Novel Modalities and Biomarkers

An opportunity in the Cell and Gene Therapy Bioanalytical Testing Services market lies in the expansion of testing capabilities to accommodate novel modalities and emerging biomarkers. With the continuous evolution of cell and gene therapy technologies and the discovery of new biomarkers for assessing therapeutic response and patient outcomes, there is a growing demand for innovative testing methodologies and platforms. Companies offering bioanalytical testing services can capitalize on this opportunity by investing in research and development to develop cutting-edge assays, analytical techniques, and instrumentation tailored to address the unique challenges posed by advanced cell and gene-based therapies. By staying at the forefront of technological innovation and expanding their testing capabilities, service providers can differentiate themselves in the competitive landscape and meet the evolving needs of the biopharmaceutical industry.

Cell and Gene Therapy Bioanalytical Testing Services 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 Analysis
North America (United States, Canada, Mexico)
Europe (Germany, France, United Kingdom, Spain, Italy, Rest of Europe)
Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific)
South America (Brazil, Argentina, Rest of South America)
Middle East and Africa (Saudi Arabia, UAE, Rest of Middle East, South Africa, Egypt, Rest of Africa)

 

Cell and Gene Therapy Bioanalytical Testing Services Market 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

 

 

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TABLE OF CONTENTS

1 Introduction to 2024 Cell and Gene Therapy Bioanalytical Testing Services Market
1.1 Market Overview
1.2 Quick Facts
1.3 Scope/Objective of the Study
1.4 Market Definition
1.5 Countries and Regions Analyzed
1.6 Units, Currency, and Conversions
1.7 Industry Value Chain

2 Research Methodology
2.1 Market Size Estimation
2.2 Sources and Research Methodology
2.3 Data Triangulation
2.4 Assumptions and Limitations

3 Executive Summary
3.1 Global Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook, $ Million, 2021 to 2030
3.2 Cell and Gene Therapy Bioanalytical Testing Services Market Outlook by Type, $ Million, 2021 to 2030
3.3 Cell and Gene Therapy Bioanalytical Testing Services Market Outlook by Product, $ Million, 2021 to 2030
3.4 Cell and Gene Therapy Bioanalytical Testing Services Market Outlook by Application, $ Million, 2021 to 2030
3.5 Cell and Gene Therapy Bioanalytical Testing Services Market Outlook by Key Countries, $ Million, 2021 to 2030

4 Market Dynamics
4.1 Key Driving Forces of Cell and Gene Therapy Bioanalytical Testing Services Market Industry
4.2 Key Market Trends in Cell and Gene Therapy Bioanalytical Testing Services Market Industry
4.3 Potential Opportunities in Cell and Gene Therapy Bioanalytical Testing Services Market Industry
4.4 Key Challenges in Cell and Gene Therapy Bioanalytical Testing Services Market Industry

5 Market Factor Analysis
5.1 Competitive Landscape
5.1.1 Global Cell and Gene Therapy Bioanalytical Testing Services Market Share by Company (%), 2023
5.1.2 Product Offerings by Company
5.2 Porter’s Five Forces Analysis

6 Growth Outlook Across Scenarios
6.1 Growth Analysis-Case Scenario Definitions
6.2 Low Growth Scenario Forecasts
6.3 Reference Growth Scenario Forecasts
6.4 High Growth Scenario Forecasts

7 Global Cell and Gene Therapy Bioanalytical Testing Services Market Outlook By Segments
7.1 Cell and Gene Therapy Bioanalytical Testing Services Market Outlook by Segments
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

8 North America Cell and Gene Therapy Bioanalytical Testing Services Market Analysis And Outlook To 2030
8.1 Introduction to North America Cell and Gene Therapy Bioanalytical Testing Services Markets in 2024
8.2 North America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Country, 2021-2030
8.2.1 United States
8.2.2 Canada
8.2.3 Mexico
8.3 North America Cell and Gene Therapy Bioanalytical Testing Services Market size Outlook by 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

9 Europe Cell and Gene Therapy Bioanalytical Testing Services Market Analysis And Outlook To 2030
9.1 Introduction to Europe Cell and Gene Therapy Bioanalytical Testing Services Markets in 2024
9.2 Europe Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Country, 2021-2030
9.2.1 Germany
9.2.2 France
9.2.3 Spain
9.2.4 United Kingdom
9.2.4 Italy
9.2.5 Russia
9.2.6 Norway
9.2.7 Rest of Europe
9.3 Europe Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook By 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

10 Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market Analysis And Outlook To 2030
10.1 Introduction to Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Markets in 2024
10.2 Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Country, 2021-2030
10.2.1 China
10.2.2 India
10.2.3 Japan
10.2.4 South Korea
10.2.5 Indonesia
10.2.6 Malaysia
10.2.7 Australia
10.2.8 Rest of Asia Pacific
10.3 Asia Pacific Cell and Gene Therapy Bioanalytical Testing Services Market size Outlook by 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

11 South America Cell and Gene Therapy Bioanalytical Testing Services Market Analysis And Outlook To 2030
11.1 Introduction to South America Cell and Gene Therapy Bioanalytical Testing Services Markets in 2024
11.2 South America Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Country, 2021-2030
11.2.1 Brazil
11.2.2 Argentina
11.2.3 Rest of South America
11.3 South America Cell and Gene Therapy Bioanalytical Testing Services Market size Outlook by 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

12 Middle East And Africa Cell and Gene Therapy Bioanalytical Testing Services Market Analysis And Outlook To 2030
12.1 Introduction to Middle East and Africa Cell and Gene Therapy Bioanalytical Testing Services Markets in 2024
12.2 Middle East and Africa Cell and Gene Therapy Bioanalytical Testing Services Market Size Outlook by Country, 2021-2030
12.2.1 Saudi Arabia
12.2.2 UAE
12.2.3 Oman
12.2.4 Rest of Middle East
12.2.5 Egypt
12.2.6 Nigeria
12.2.7 South Africa
12.2.8 Rest of Africa
12.3 Middle East and Africa Cell and Gene Therapy Bioanalytical Testing Services Market size Outlook by 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

13 Company Profiles
13.1 Company Snapshot
13.2 SWOT Profiles
13.3 Products and Services
13.4 Recent Developments
13.5 Financial Profile
List of 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

14 Appendix
14.1 Customization Offerings
14.2 Subscription Services
14.3 Related Reports
14.4 Publisher Expertise

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