세포 및 유전자 치료 바이오 분석 검사 서비스 시장 규모, 점유율, 동향 분석 보고서 : 검사 유형별, 개발 단계별, 제품 유형별, 적응증별, 지역별, 부문별 예측(2025-2030년)

Cell And Gene Therapy Bioanalytical Testing Services Market Growth & Trends:

The global cell and gene therapy bioanalytical testing services market size is expected to reach USD 828.7 million by 2030, registering a CAGR of 7.40% from 2025 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 And Gene Therapy Bioanalytical Testing Services Market Report Highlights:

• The bioavailability & bioequivalence studies dominated with a market share of 35.44% in 2024 and are also expected to witness the fastest growth over the forecast period.
• The non-clinical segment dominated the market in 2024. The stage of development segment has been further classified based on the product type, which includes gene therapy, gene-modified cell therapy, and cell therapy.
• The cell therapy segment dominated the product segment in 2024. Cell therapy is the transplantation of human cells to repair or replace damaged tissue or cells. The gene-modified cell therapy segment is expected to register the fastest growth during the forecast period.
• The oncology segment dominated the market and accounted for the largest revenue share in 2024. The rare diseases segment is expected to register the fastest CAGR during the forecast period.
• North America dominated the cell and gene therapy bioanalytical testing services market and accounted for the largest revenue share of 41.57% in 2024. Asia Pacific cell and gene therapy bioanalytical testing services are anticipated to witness the fastest CAGR over the forecast period.

Table of Content

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Market Definitions
• 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
• 1.5. 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
  • 1.7.2. Parent Market Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 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 for Novel Cell & Gene Products
    • 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. Clinical Trials Volume Analysis (2024)
  • 3.3.1. Total Number Of Clinical Trials By Region
  • 3.3.2. Total Number Of Clinical Trials, By Phase
  • 3.3.3. Total Number Of Clinical Trials, By Study Design
  • 3.3.4. Total Number Of Clinical Trials, By Key Therapeutic Area
• 3.4. Pricing Model Analysis
• 3.5. Technology Landscape
• 3.6. Market Analysis Tools
  • 3.6.1. Porter's Five Force Analysis
  • 3.6.2. PESTEL by SWOT Analysis
  • 3.6.3. COVID-19 Impact Analysis

Chapter 4. Cell & Gene Therapy Bioanalytical Testing Services Market: Test Type Estimates & Trend Analysis

• 4.1. Cell & Gene Therapy Bioanalytical Testing Services Market, By Test Type: Segment Dashboard
• 4.2. Cell & Gene Therapy Bioanalytical Testing Services Market, By Test Type: Movement Analysis
• 4.3. Cell & Gene Therapy Bioanalytical Testing Services Market Estimates & Forecasts, By Test Type, 2018 - 2030 (USD Million)
• 4.4. Bioavailability & Bioequivalence Studies
  • 4.4.1. Bioavailability & Bioequivalence Studies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.5. Pharmacokinetics
  • 4.5.1. Pharmacokinetics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.6. Pharmacodynamics
  • 4.6.1. Pharmacodynamics Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 4.7. Others
  • 4.7.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. Cell & Gene Therapy Bioanalytical Testing Services Market: Product Type Estimates & Trend Analysis

• 5.1. Cell & Gene Therapy Bioanalytical Testing Services Market, By Product Type: Segment Dashboard
• 5.2. Cell & Gene Therapy Bioanalytical Testing Services Market, By Product Type: Movement Analysis
• 5.3. Cell & Gene Therapy Bioanalytical Testing Services Market Estimates & Forecasts, By Product Type, 2018 - 2030 (USD Million)
• 5.4. Gene Therapy
  • 5.4.1. Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.2. Ex-vivo
    • 5.4.2.1. Ex-vivo Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.4.3. In-vivo
    • 5.4.3.1. In-vivo Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.5. Gene-Modified Cell Therapy
  • 5.5.1. Gene-Modified Cell Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.5.2. CAR T-cell therapies
    • 5.5.2.1. CAR T-cell therapies Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.5.3. CAR-NK cell therapy
    • 5.5.3.1. CAR-NK cell therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.5.4. TCR-T cell therapy
    • 5.5.4.1. TCR-T cell therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.5.5. Other
    • 5.5.5.1. Other Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 5.6. Cell Therapy
  • 5.6.1. Cell Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. Cell & Gene Therapy Bioanalytical Testing Services Market: Stage of Development by Product Type, Estimates & Trend Analysis

• 6.1. Cell & Gene Therapy Bioanalytical Testing Services Market, By Stage of Development by Product Type: Segment Dashboard
• 6.2. Cell & Gene Therapy Bioanalytical Testing Services Market, By Stage of Development by Product Type: Movement Analysis
• 6.3. Cell & Gene Therapy Bioanalytical Testing Services Market Estimates & Forecasts, By Stage of Development by Product Type, 2018 - 2030 (USD Million)
• 6.4. Non-Clinical
  • 6.4.1. Non-Clinical Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.2. Gene Therapy
    • 6.4.2.1. Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.3. Gene-Modified Cell Therapy
    • 6.4.3.1. Gene-Modified Cell Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.4.4. Cell Therapy
    • 6.4.4.1. Cell Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 6.5. Clinical
  • 6.5.1. Clinical Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.2. Gene Therapy
    • 6.5.2.1. Gene Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.3. Gene-Modified Cell Therapy
    • 6.5.3.1. Gene-Modified Cell Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 6.5.4. Cell Therapy
    • 6.5.4.1. Cell Therapy Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 7. Cell & Gene Therapy Bioanalytical Testing Services Market: Indication Estimates & Trend Analysis

• 7.1. Cell & Gene Therapy Bioanalytical Testing Services Market, By Indication: Segment Dashboard
• 7.2. Cell & Gene Therapy Bioanalytical Testing Services Market, By Indication: Movement Analysis
• 7.3. Cell & Gene Therapy Bioanalytical Testing Services Market Estimates & Forecasts, By Indication, 2018 - 2030 (USD Million)
• 7.4. Oncology
  • 7.4.1. Oncology Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.5. Infectious Diseases
  • 7.5.1. Infectious Diseases Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.6. Neurological disorders
  • 7.6.1. Neurological disorders Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.7. Rare Diseases
  • 7.7.1. Rare Diseases Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 7.8. Others
  • 7.8.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 8. Cell & Gene Therapy Bioanalytical Testing Services Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Dashboard
• 8.2. Regional Market Share Analysis, 2024 & 2030
• 8.3. North America
  • 8.3.1. North America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.2. U.S
    • 8.3.2.1. Key Country Dynamics
    • 8.3.2.2. Competitive Scenario
    • 8.3.2.3. Regulatory Framework
    • 8.3.2.4. U.S. Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.3. Canada
    • 8.3.3.1. Key Country Dynamics
    • 8.3.3.2. Competitive Scenario
    • 8.3.3.3. Regulatory Framework
    • 8.3.3.4. Canada Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.3.4. Mexico
    • 8.3.4.1. Key Country Dynamics
    • 8.3.4.2. Competitive Scenario
    • 8.3.4.3. Regulatory Framework
    • 8.3.4.4. Mexico Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.4. Europe
  • 8.4.1. Europe Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.2. UK
    • 8.4.2.1. Key Country Dynamics
    • 8.4.2.2. Competitive Scenario
    • 8.4.2.3. Regulatory Framework
    • 8.4.2.4. UK Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.3. Germany
    • 8.4.3.1. Key Country Dynamics
    • 8.4.3.2. Competitive Scenario
    • 8.4.3.3. Regulatory Framework
    • 8.4.3.4. Germany Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.4. France
    • 8.4.4.1. Key Country Dynamics
    • 8.4.4.2. Competitive Scenario
    • 8.4.4.3. Regulatory Framework
    • 8.4.4.4. France Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.5. Italy
    • 8.4.5.1. Key Country Dynamics
    • 8.4.5.2. Competitive Scenario
    • 8.4.5.3. Regulatory Framework
    • 8.4.5.4. Italy Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.6. Spain
    • 8.4.6.1. Key Country Dynamics
    • 8.4.6.2. Competitive Scenario
    • 8.4.6.3. Regulatory Framework
    • 8.4.6.4. Spain Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.7. Denmark
    • 8.4.7.1. Key Country Dynamics
    • 8.4.7.2. Competitive Scenario
    • 8.4.7.3. Regulatory Framework
    • 8.4.7.4. Denmark Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.8. Sweden
    • 8.4.8.1. Key Country Dynamics
    • 8.4.8.2. Competitive Scenario
    • 8.4.8.3. Regulatory Framework
    • 8.4.8.4. Sweden Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.4.9. Norway
    • 8.4.9.1. Key Country Dynamics
    • 8.4.9.2. Competitive Scenario
    • 8.4.9.3. Regulatory Framework
    • 8.4.9.4. Norway Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.5. Asia Pacific
  • 8.5.1. Asia Pacific Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.2. Japan
    • 8.5.2.1. Key Country Dynamics
    • 8.5.2.2. Competitive Scenario
    • 8.5.2.3. Regulatory Framework
    • 8.5.2.4. Japan Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.3. China
    • 8.5.3.1. Key Country Dynamics
    • 8.5.3.2. Competitive Scenario
    • 8.5.3.3. Regulatory Framework
    • 8.5.3.4. China Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.4. India
    • 8.5.4.1. Key Country Dynamics
    • 8.5.4.2. Competitive Scenario
    • 8.5.4.3. Regulatory Framework
    • 8.5.4.4. India Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.5. Australia
    • 8.5.5.1. Key Country Dynamics
    • 8.5.5.2. Competitive Scenario
    • 8.5.5.3. Regulatory Framework
    • 8.5.5.4. Australia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.6. South Korea
    • 8.5.6.1. Key Country Dynamics
    • 8.5.6.2. Competitive Scenario
    • 8.5.6.3. Regulatory Framework
    • 8.5.6.4. South Korea Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.5.7. Thailand
    • 8.5.7.1. Key Country Dynamics
    • 8.5.7.2. Competitive Scenario
    • 8.5.7.3. Regulatory Framework
    • 8.5.7.4. Thailand Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.6. Latin America
  • 8.6.1. Latin America Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.2. Brazil
    • 8.6.2.1. Key Country Dynamics
    • 8.6.2.2. Competitive Scenario
    • 8.6.2.3. Regulatory Framework
    • 8.6.2.4. Brazil Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.6.3. Argentina
    • 8.6.3.1. Key Country Dynamics
    • 8.6.3.2. Competitive Scenario
    • 8.6.3.3. Regulatory Framework
    • 8.6.3.4. Argentina Market Estimates and Forecasts, 2018 - 2030 (USD Million)
• 8.7. MEA
  • 8.7.1. MEA Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.2. South Africa
    • 8.7.2.1. Key Country Dynamics
    • 8.7.2.2. Competitive Scenario
    • 8.7.2.3. Regulatory Framework
    • 8.7.2.4. South Africa Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.3. Saudi Arabia
    • 8.7.3.1. Key Country Dynamics
    • 8.7.3.2. Competitive Scenario
    • 8.7.3.3. Regulatory Framework
    • 8.7.3.4. Saudi Arabia Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.4. UAE
    • 8.7.4.1. Key Country Dynamics
    • 8.7.4.2. Competitive Scenario
    • 8.7.4.3. Regulatory Framework
    • 8.7.4.4. UAE Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 8.7.5. Kuwait
    • 8.7.5.1. Key Country Dynamics
    • 8.7.5.2. Competitive Scenario
    • 8.7.5.3. Regulatory Framework
    • 8.7.5.4. Kuwait Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Market Participant Categorization
• 9.2. Company Market Share/Assessment Analysis, 2024
• 9.3. Company Profiles
  • 9.3.1. BioAgilytix Labs
    • 9.3.1.1. Company Overview
    • 9.3.1.2. Financial Performance
    • 9.3.1.3. Service Benchmarking
    • 9.3.1.4. Strategic Initiatives
  • 9.3.2. KCAS Bioanalytical Services
    • 9.3.2.1. Company Overview
    • 9.3.2.2. Financial Performance
    • 9.3.2.3. Service Benchmarking
    • 9.3.2.4. Strategic Initiatives
  • 9.3.3. IQVIA, Inc.
    • 9.3.3.1. Company Overview
    • 9.3.3.2. Financial Performance
    • 9.3.3.3. Service Benchmarking
    • 9.3.3.4. Strategic Initiatives
  • 9.3.4. Laboratory Corporation of America Holdings
    • 9.3.4.1. Company Overview
    • 9.3.4.2. Financial Performance
    • 9.3.4.3. Service Benchmarking
    • 9.3.4.4. Strategic Initiatives
  • 9.3.5. Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
    • 9.3.5.1. Company Overview
    • 9.3.5.2. Financial Performance
    • 9.3.5.3. Service Benchmarking
    • 9.3.5.4. Strategic Initiatives
  • 9.3.6. Prolytix
    • 9.3.6.1. Company Overview
    • 9.3.6.2. Financial Performance
    • 9.3.6.3. Service Benchmarking
    • 9.3.6.4. Strategic Initiatives
  • 9.3.7. Pharmaron
    • 9.3.7.1. Company Overview
    • 9.3.7.2. Financial Performance
    • 9.3.7.3. Service Benchmarking
    • 9.3.7.4. Strategic Initiatives
  • 9.3.8. Charles River Laboratories
    • 9.3.8.1. Company Overview
    • 9.3.8.2. Financial Performance
    • 9.3.8.3. Service Benchmarking
    • 9.3.8.4. Strategic Initiatives
  • 9.3.9. Syneos Health
    • 9.3.9.1. Company Overview
    • 9.3.9.2. Financial Performance
    • 9.3.9.3. Service Benchmarking
    • 9.3.9.4. Strategic Initiatives
  • 9.3.10. SGS SA
    • 9.3.10.1. Company Overview
    • 9.3.10.2. Financial Performance
    • 9.3.10.3. Service Benchmarking
    • 9.3.10.4. Strategic Initiatives
  • 9.3.11. Intertek Group Plc
    • 9.3.11.1. Company Overview
    • 9.3.11.2. Financial Performance
    • 9.3.11.3. Service Benchmarking
    • 9.3.11.4. Strategic Initiatives