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 Forecas

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 Forecasts, 2024 - 2030


Cell & Gene Therapy Bioanalytical Testing Services Market Growth & Trends

The global cell & gene therapy bioanalytical testing services market size is expected to reach USD 828.7 million by 2030, growing at a CAGR of 7.3% from 2024 to 2030, according to a new report by Grand View Research, Inc. Increasing R&D activities related to cell and gene therapy, growth in investments by public organizations for cell and gene therapy research and high potential of gene and cell therapy in treating rare diseases are the key factors driving the growth of the market.

Cell and gene therapies have popularly been adopted in the treatment of cancer, autoimmune diseases, and rare diseases. These therapies have shown a significant improvement in patients' clinical conditions, owing to which a significant number of cell and gene therapy drug candidates are in the pipeline. For instance, according to the American Society of Cell and Gene Therapy, over 2,053 gene therapies and 827 non-genetically modified cell therapies were in the pipeline as of January 2023. High number of cell and gene therapy drug candidates in pipeline is promoting the demand for bioanalytical testing services.

Public and private organizations are actively investing in cell and gene therapy-based research. For instance, in April 2023, the California Institute for Regenerative Medicine invested USD 89.0 million in stem cell and gene therapy research. This funding was planned for the development of therapy in the treatment of persistent corneal epithelial defects. Similar fundings in the future is expected to boost the demand for bioanalytical testing services in the forecasted period.

The COVID-19 pandemic had a negative impact on the market for cell & gene therapy bioanalytical testing services. The majority of the cell and gene therapy-based trials were postponed in the pandemic. However, in the post COVID-19 era, the scenario is changing, and many trials are resumed. This is expected to support market growth in the post-COVID-19 period.

Cell & Gene Therapy Bioanalytical Testing Services Market Report Highlights
  • Based on test type, the bioavailability & bioequivalence studies segment accounted for the largest revenue share of around 35.4% in 2023. Bioavailability & bioequivalence studies primarily focus on the R&D of pharmaceutical & biotechnological products such as cell and gene therapies. In cell & gene therapies, bioavailability refers to the proportion of the administered dose of a therapeutic agent that reaches the systemic circulation.
  • Based on product type, cell therapy accounted for the largest revenue share of 42.1% in 2023. Cell therapies have great potential in treating autoimmune diseases, cancers, and other conditions. This is improving the clinical research in cell therapy, thus boosting the demand for bioanalytical services for cell therapy.
  • Based on the stage of development by product type, the non-clinical segment held a share of 66.2% in 2023. Bioanalytical testing for non-clinical stage is essential for obtaining IND approval. The high demand among researchers for transitioning the therapy into the clinical stage is supporting the market growth of the segment.
  • Based on indication, the oncology segment held the maximum revenue share of 49.0% in 2023. The high potential of gene and cell therapy to treat cancer cells effectively is the prime reason for the segment market growth.
  • Asia Pacific is anticipated to witness the highest CAGR of 7.7% during the forecast time frame. Funding for cell and gene therapy-based research by public organizations and the low cost associated with outsourcing bioanalytical services in the region is supporting the segment market growth.
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Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Test Type
1.2.2. Product Type
1.2.3. Stage of Development by Product Type
1.2.4. Indication
1.2.5. Regional scope
1.2.6. Estimates and forecasts timeline.
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.4.5. Details of primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Approach 1: Commodity flow approach
1.7.3. Volume price analysis (Model 2)
1.7.4. Approach 2: Volume price analysis
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Test Type
2.2.2. Product Type
2.2.3. Stage of Development by Product Type
2.2.4. Indication
2.2.5. Regional scope
2.3. Competitive Insights
Chapter 3. Cell & Gene Therapy Bioanalytical Testing Services Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Significant Number Of Cell & Gene Therapy Drug Candidates Under Clinical Trials
3.2.1.2. High Public And Private Investments Across Research And Development Of Novel Cell & Gene Products To Augment Market Growth
3.2.1.3. High Focus Of Biopharmaceutical Companies To Reduce Operational Costs Promoting The Demand For Outsourcing
3.2.2. Market Restraint Analysis
3.2.2.1. Availability Of Alternative Treatment Options At Lower Cost
3.2.2.2. Quality Issues Associated With Outsourcing
3.3. Cell & Gene Therapy Bioanalytical Testing Services Market Analysis Tools
3.3.1. Industry Analysis - Porter’s Five Forces
3.3.2. PESTEL Analysis
Chapter 4. Cell & Gene Therapy Bioanalytical Testing Services Market: Test Type Estimates & Trend Analysis
4.1. Test Type Market Share, 2023 & 2030
4.2. Segment Dashboard
4.3. Global Hematology Testing Market by Test Type Outlook
4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
4.4.1. Bioavailability & Bioequivalence Studies
4.4.1.1. Bioavailability & Bioequivalence Market, 2018 to 2030 (USD Million)
4.4.2. Pharmacokinetics
4.4.2.1. Pharmacokinetics Market, 2018 to 2030 (USD Million)
4.4.3. Pharmacodynamics
4.4.3.1. Pharmacodynamics Market, 2018 to 2030 (USD Million)
4.4.4. Other Test Types
4.4.4.1. Other Test Types Market, 2018 to 2030 (USD Million)
Chapter 5. Cell & Gene Therapy Bioanalytical Testing Services Market: Product Type Estimates & Trend Analysis
5.1. Product type Market Share, 2023 & 2030
5.2. Segment Dashboard
5.3. Global Cell & Gene Therapy Bioanalytical Testing Services Market by Product Type Outlook
5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
5.4.1. Gene Therapy
5.4.1.1. Gene Therapy Market, 2018 to 2030 (USD Million)
5.4.1.2. Ex-vivo
5.4.1.3. Ex-vivo Market, 2018 to 2030 (USD Million)
5.4.1.4. In-vivo
5.4.1.5. In-vivo Market, 2018 to 2030 (USD Million)
5.4.2. Gene-Modified Cell Therapy
5.4.2.1. Gene-Modified Cell Therapy Market, 2018 to 2030 (USD Million)
5.4.2.2. CAR T-cell therapies
5.4.2.3. CAR T-Cell Therapies Market, 2018 to 2030 (USD Million)
5.4.2.4. CAR-NK cell therapy
5.4.2.5. CAR-NK Cell Therapy Market, 2018 to 2030 (USD Million)
5.4.2.6. TCR-T cell therapy
5.4.2.7. TCR-T Cell Therapy Market, 2018 to 2030 (USD Million)
5.4.2.8. Others
5.4.2.9. Others Market, 2018 to 2030 (USD Million)
5.4.3. Cell Therapy
5.4.3.1. Cell Therapy Market, 2018 to 2030 (USD Million)
Chapter 6. Cell & Gene Therapy Bioanalytical Testing Services Market: Stage of Development by Product Type Estimates & Trend Analysis
6.1. Stage of Development by Product Type Market Share, 2023 & 2030
6.2. Segment Dashboard
6.3. Global Cell & Gene Therapy Bioanalytical Testing Services Market Stage of Development by Product Type Outlook
6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
6.4.1. Non-Clinical
6.4.1.1. Non-Clinical Market, 2018 to 2030 (USD Million)
6.4.1.2. Gene Therapy
6.4.1.2.1. Gene Therapy Market, 2018 to 2030 (USD Million)
6.4.1.3. Gene-Modified Cell Therapy
6.4.1.3.1. Gene-Modified Cell Therapy Market, 2018 to 2030 (USD Million)
6.4.1.4. Cell Therapy
6.4.1.4.1. Cell Therapy Market, 2018 to 2030 (USD Million)
6.4.2. Clinical
6.4.2.1. Clinical Market, 2018 to 2030 (USD Million)
6.4.2.2. Gene Therapy
6.4.2.2.1. Gene Therapy Market, 2018 to 2030 (USD Million)
6.4.2.3. Gene-Modified Cell Therapy
6.4.2.3.1. Gene-Modified Cell Therapy Market, 2018 to 2030 (USD Million)
6.4.2.4. Cell Therapy
6.4.2.4.1. Cell Therapy Market, 2018 to 2030 (USD Million)
Chapter 7. Cell & Gene Therapy Bioanalytical Testing Services Market: Indication Estimates & Trend Analysis
7.1. Stage of Development by Indication Market Share, 2023 & 2030
7.2. Segment Dashboard
7.3. Global Cell & Gene Therapy Bioanalytical Testing Services Market Stage of Development by Indication Outlook
7.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
7.4.1. Oncology
7.4.1.1. Oncology Market 2018 to 2030 (USD Million)
7.4.2. Infectious Diseases
7.4.2.1. Infectious Market 2018 to 2030 (USD Million)
7.4.3. Neurological Disorders
7.4.3.1. Neurological Disorders Market 2018 to 2030 (USD Million)
7.4.4. Rare Diseases
7.4.4.1. Rare Diseases Market 2018 to 2030 (USD Million)
7.4.5. Others
7.4.5.1. Others Market 2018 to 2030 (USD Million)
Chapter 8. Cell & Gene Therapy Bioanalytical Testing Services Market: Regional Estimates & Trend Analysis
8.1. Regional Market Share Analysis, 2023 & 2030
8.2. Regional Market Dashboard
8.3. Global Regional Market Snapshot
8.4. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
8.5. North America
8.5.1. Market Estimates and Forecast, 2018 - 2030 (Revenue, USD Million)
8.5.2. U.S.
8.5.2.1. Key Country Dynamics
8.5.2.2. Competitive Scenario
8.5.2.3. Regulatory Framework
8.5.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030
8.5.3. Canada
8.5.3.1. Key Country Dynamics
8.5.3.2. Competitive Scenario
8.5.3.3. Regulatory Framework
8.5.3.4. Canada Market Estimates and Forecasts, 2018 - 2030
8.6. Europe
8.6.1. UK
8.6.1.1. Key Country Dynamics
8.6.1.2. Competitive Scenario
8.6.1.3. Regulatory Framework
8.6.1.4. UK Market Estimates and Forecasts, 2018 - 2030
8.6.2. Germany
8.6.2.1. Key Country Dynamics
8.6.2.2. Competitive Scenario
8.6.2.3. Regulatory Framework
8.6.2.4. Germany Market Estimates and Forecasts, 2018 - 2030
8.6.3. France
8.6.3.1. Key Country Dynamics
8.6.3.2. Competitive Scenario
8.6.3.3. Regulatory Framework
8.6.3.4. France Market Estimates and Forecasts, 2018 - 2030
8.6.4. Italy
8.6.4.1. Key Country Dynamics
8.6.4.2. Competitive Scenario
8.6.4.3. Regulatory Framework
8.6.4.4. Italy Market Estimates and Forecasts, 2018 - 2030
8.6.5. Spain
8.6.5.1. Key Country Dynamics
8.6.5.2. Competitive Scenario
8.6.5.3. Regulatory Framework
8.6.5.4. Spain Market Estimates and Forecasts, 2018 - 2030
8.6.6. Denmark
8.6.6.1. Key Country Dynamics
8.6.6.2. Competitive Scenario
8.6.6.3. Regulatory Framework
8.6.6.4. Denmark Market Estimates and Forecasts, 2018 - 2030
8.6.7. Sweden
8.6.7.1. Key Country Dynamics
8.6.7.2. Competitive Scenario
8.6.7.3. Regulatory Framework
8.6.7.4. Sweden Market Estimates and Forecasts, 2018 - 2030
8.6.8. Norway
8.6.8.1. Key Country Dynamics
8.6.8.2. Competitive Scenario
8.6.8.3. Regulatory Framework
8.6.8.4. Norway Market Estimates and Forecasts, 2018 - 2030
8.7. Asia Pacific
8.7.1. Japan
8.7.1.1. Key Country Dynamics
8.7.1.2. Competitive Scenario
8.7.1.3. Regulatory Framework
8.7.1.4. Japan Market Estimates and Forecasts, 2018 - 2030
8.7.2. India
8.7.2.1. Key Country Dynamics
8.7.2.2. Competitive Scenario
8.7.2.3. Regulatory Framework
8.7.2.4. India Market Estimates and Forecasts, 2018 - 2030
8.7.3. China
8.7.3.1. Key Country Dynamics
8.7.3.2. Competitive Scenario
8.7.3.3. Regulatory Framework
8.7.3.4. China Market Estimates and Forecasts, 2018 - 2030
8.7.4. South Korea
8.7.4.1. Key Country Dynamics
8.7.4.2. Competitive Scenario
8.7.4.3. Regulatory Framework
8.7.4.4. South Korea Market Estimates and Forecasts, 2018 - 2030
8.7.5. Australia
8.7.5.1. Key Country Dynamics
8.7.5.2. Competitive Scenario
8.7.5.3. Regulatory Framework
8.7.5.4. Australia Market Estimates and Forecasts, 2018 - 2030
8.7.6. Thailand
8.7.6.1. Key Country Dynamics
8.7.6.2. Competitive Scenario
8.7.6.3. Regulatory Framework
8.7.6.4. Thailand Market Estimates and Forecasts, 2018 - 2030
8.8. Latin America
8.8.1. Brazil
8.8.1.1. Key Country Dynamics
8.8.1.2. Competitive Scenario
8.8.1.3. Regulatory Framework
8.8.1.4. Brazil Market Estimates and Forecasts, 2018 - 2030
8.8.2. Mexico
8.8.2.1. Key Country Dynamics
8.8.2.2. Competitive Scenario
8.8.2.3. Regulatory Framework
8.8.2.4. Mexico Market Estimates and Forecasts, 2018 - 2030
8.8.3. Argentina
8.8.3.1. Key Country Dynamics
8.8.3.2. Competitive Scenario
8.8.3.3. Regulatory Framework
8.8.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030
8.9. MEA
8.9.1. South Africa
8.9.1.1. Key Country Dynamics
8.9.1.2. Competitive Scenario
8.9.1.3. Regulatory Framework
8.9.1.4. South Africa Market Estimates and Forecasts, 2018 - 2030
8.9.2. Saudi Arabia
8.9.2.1. Key Country Dynamics
8.9.2.2. Competitive Scenario
8.9.2.3. Regulatory Framework
8.9.2.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030
8.9.3. UAE
8.9.3.1. Key Country Dynamics
8.9.3.2. Competitive Scenario
8.9.3.3. Regulatory Framework
8.9.3.4. UAE Market Estimates and Forecasts, 2018 - 2030
8.9.4. Kuwait
8.9.4.1. Key Country Dynamics
8.9.4.2. Competitive Scenario
8.9.4.3. Regulatory Framework
8.9.4.4. Kuwait Market Estimates and Forecasts, 2018 - 2030
Chapter 9. Competitive Landscape
9.1. Recent Developments & Impact Analysis, By Key Market Participants
9.2. Company/Competition Categorization
9.3. Vendor Landscape
9.4. Market Participant Categorization
9.4.1. List of key distributors and channel partners
9.4.2. Key customers
9.4.3. Key company market share analysis, 2023
9.4.4. BioAgilytix Labs
9.4.4.1. Company Overview
9.4.4.2. Financial Performance
9.4.4.3. Service Benchmarking
9.4.4.4. Strategic Initiatives
9.4.5. KCAS Bioanalytical Services
9.4.5.1. Company Overview
9.4.5.2. Financial Performance
9.4.5.3. Service Benchmarking
9.4.5.4. Strategic Initiatives
9.4.6. IQVIA, Inc.
9.4.6.1. Company Overview
9.4.6.2. Financial Performance
9.4.6.3. Service Benchmarking
9.4.6.4. Strategic Initiatives
9.4.7. Laboratory Corporation of America Holdings
9.4.7.1. Company Overview
9.4.7.2. Financial Performance
9.4.7.3. Service Benchmarking
9.4.7.4. Strategic Initiatives
9.4.8. Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
9.4.8.1. Company Overview
9.4.8.2. Financial Performance
9.4.8.3. Service Benchmarking
9.4.8.4. Strategic Initiatives
9.4.9. Prolytix
9.4.9.1. Company Overview
9.4.9.2. Financial Performance
9.4.9.3. Service Benchmarking
9.4.9.4. Strategic Initiatives
9.4.10. Pharmaron
9.4.10.1. Company Overview
9.4.10.2. Financial Performance
9.4.10.3. Service Benchmarking
9.4.10.4. Strategic Initiatives
9.4.11. Charles River Laboratories
9.4.11.1. Company Overview
9.4.11.2. Financial Performance
9.4.11.3. Service Benchmarking
9.4.11.4. Strategic Initiatives
9.4.12. Syneos Health
9.4.12.1. Company Overview
9.4.12.2. Financial Performance
9.4.12.3. Service Benchmarking
9.4.12.4. Strategic Initiatives
9.4.13. SGS SA
9.4.13.1. Company Overview
9.4.13.2. Financial Performance
9.4.13.3. Service Benchmarking
9.4.13.4. Strategic Initiatives
9.4.14. Intertek Group Plc
9.4.14.1. Company Overview
9.4.14.2. Financial Performance
9.4.14.3. Service Benchmarking
9.4.14.4. Strategic Initiatives

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