U.S. Cell And Gene Therapy Clinical Trial Services Market Size, Share & Trends Analysis Report By Service (Site Identification, Patient Recruitment), By Phase (Phase I, Phase II), By Therapeutic Areas, By Therapy Type, And Segment Forecasts, 2024 - 2030

U.S. Cell And Gene Therapy Clinical Trial Services Market Size, Share & Trends Analysis Report By Service (Site Identification, Patient Recruitment), By Phase (Phase I, Phase II), By Therapeutic Areas, By Therapy Type, And Segment Forecasts, 2024 - 2030


U.S. Cell And Gene Therapy Clinical Trial Services Market Growth & Trends

The U.S. cell and gene therapy clinical trial services market is expected to reach USD 28.58 billion by 2030, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 22.9% from 2024 to 2030. Cell and gene therapies (CGTs) hold great potential in treating a wide range of diseases, including cancer, genetic disorders, and certain infectious diseases. Therefore, a number of pharmaceutical companies are investing in CGT to create a strong position in the market. Increased R&D funding and investments from both private and public sectors for discovering and developing innovative CGTs drive market growth.

Besides, significant progress is being made toward a digitalized scenario as the traditional clinical trial has increased the cost of running trials and the commercial risk of failure. Thereby, clinical studies are driven by the rising adoption of advanced technologies that rapidly accelerate the digital transformation of their processes. In addition, increasing mergers & acquisitions in the cell and gene therapy industry fuels market growth. For instance, in August 2022, Marken acquired Cedra Express’s medical courier business. This acquisition expanded the company as a clinical trial and logistics provider services for cells & gene therapies.

Globally, oncology (cancers) remain the leading cause of death, which has gained the increased attention of biotechnology and pharmaceutical companies to develop new cell and gene therapy. This led to the rise in the innovation of cell and gene therapy, creating immense demand for clinical trial services. Moreover, an increase in favorable government initiatives and innovations in the field of oncology is driving the market for oncology cells and gene therapy clinical trials. Likewise, growing R&D activities for oncology, an increase in favorable government initiatives, and innovations in the field of oncology are driving the market for oncology cell and gene therapy clinical trials. In addition, a growing pipeline of drug candidates for cancer is expected to fuel the segment growth over the forecast period.

The COVID-19 pandemic has impacted the clinical trial supply and logistics market due to a slowdown of overall clinical trial activity in the early stages of the pandemic. The pandemic has led to massive disruption in supply chain management, which became the primary factor restraining the market growth. However, with the adoption of virtual technologies, the CGT clinical trial industry was able to revamp its revenues post-2020.

Furthermore, the key participants are engaged in strategies such as collaboration, partnership, acquisition, agreements, collaborations, and launches, among others, to expand their global footprints and product portfolio. These players offer quality logistics services to strengthen manufacturing, storage, & distribution workflows. For instance, in May 2023, CSafe and Modality Solutions partnered to provide cold chain solutions for cell & gene therapies. The integrated solution will include Modality Solution’s cold chain engineering capabilities and CSafe’s shipping solutions to offer quality, predictability, and regulatory compliance to the CGT supply chain.

U.S. Cell and Gene Therapy Clinical Trial Services Market Report Highlights
  • Based on service, the regulatory services segment held the largest share of 21.8% in 2023, owing to increased support for safety, study design, and cell and gene therapy manufacturing, further contributing to the segment growth. These services add major value to clinical trials during the product clinical trials and production
  • Based on phase, the phase II segment dominated the market with a revenue share of 48.4% in 2023. Segment growth can be attributed to emerging clinical trial projects and increasing investments in R&D by industry & non-industry sponsors
  • Based on therapeutic areas, the oncology segment dominated the market in 2023 with a revenue share of 56.4%. The key factors contributing to the growth include the growing burden of cancer, rising R&D activities for oncology, surging demand for new cell & gene therapy, adoption of personalized medicine, and preclinical studies for cancer immunotherapy
  • Based on therapy type, the gene-modified cell therapy segment is anticipated to register the fastest CAGR of 23.6% over the forecast period. High growth is attributed to the increased pipeline for gene-modified cell therapies and innovations in treating cancer, autoimmune conditions, & neurological diseases.
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Chapter 1. Research Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Segment Definitions
1.1.2. Service
1.1.3. Phase
1.1.4. Therapeutic Areas
1.1.5. Therapy Type
1.2. Regional Scope
1.3. Estimates And Forecast Timeline
1.4. Objectives
1.4.1. Objective - 1
1.4.2. Objective - 2
1.4.3. Objective - 3
1.5. Research Methodology
1.6. Information Procurement
1.6.1. Purchased Database
1.6.2. GVR’s Internal Database
1.6.3. Secondary Sources
1.6.4. Primary Research
1.7. Information Or Data Analysis
1.7.1. Data Analysis Models
1.8. Market Formulation & Validation
1.9. Model Details
1.9.1. Commodity Flow Analysis
1.9.2. Parent Market Analysis
1.10. List Of Secondary Sources
1.11. List Of Abbreviations
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. U.S. Cell and Gene Therapy Clinical Trial 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. Increasing Investments and R&D Funding for the Development of Cell and Gene Therapeutics
3.2.1.2. Growing Adoption of Novel Technologies in Clinical Research and Supply Chain
3.2.1.3. Increasing Mergers & Acquisitions in the Cell and Gene Therapy Industry
3.2.2. Market Restraint Analysis
3.2.2.1. Obstacles in Patient Recruitment and Retention
3.2.2.2. Stringent Regulations Pertaining to Clinical Trial Design and Logistics
3.3. U.S. Cell and Gene Therapy Clinical Trial Services Market Analysis Tools
3.3.1. Service Analysis - Porter’s
3.3.1.1. Supplier Power
3.3.1.2. Buyer Power
3.3.1.3. Substitution Threat
3.3.1.4. Threat Of New Entrant
3.3.1.5. Competitive Rivalry
3.3.2. PESTEL Analysis
3.4. Clinical Trial Supply & Logistics Industry: Impact of COVID -19
3.4.1. Impact Of COVID-19
3.4.2. Supply Chain
3.4.3. Changing Market Trends
3.5. Logistics Challenges
3.5.1. Novel Services Offered in the Clinical Trial Supply & Logistics Field to Overcome the Challenges Associated With Supply Chain Logistics
3.5.1.1. Incorporation of Novel Technology
3.5.1.2. Advancements in Storage Technology
3.5.1.3. Mode of Distribution Analysis
3.5.1.4. Clinical Trial Supply Chain
3.6. Cell & Gene Therapy Clinical Trials Volume Analysis (2020 - 2022)
3.6.1. Global CGT Trial Volume from 2020 to 2022
3.6.1.1. Region-wise CGT Trial Volume, 2022
3.6.1.2. Major Country Share (%) in CGT Trials, 2022
3.6.1.3. By Study Design Share (%) in CGT Trials, 2022
3.6.1.4. By Indication Share (%) in CGT Trials, 2022
3.7. Regulatory Framework
3.7.1. U.S.
3.7.2. Europe
3.7.3. China
3.7.3.1. Regulatory challenges & risk of selling unapproved cell therapies
3.7.4. Japan
Chapter 4. U.S. Cell and Gene Therapy Clinical Trial Services Market: Service Estimates & Trend Analysis
4.1. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Service: Segment Dashboard
4.2. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Service: Movement Analysis
4.3. U.S. Cell and Gene Therapy Clinical Trial Services Market Estimates & Forecasts, By Service, 2018 - 2030
4.3.1. Site Identifications
4.3.1.1. Site Identification U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.2. Patient Recruitments
4.3.2.1. Patient Recruitments U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.3. Laboratory Services
4.3.3.1. Laboratory Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.4. Regulatory Services
4.3.4.1. Regulatory Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5. Supply and Logistic Services
4.3.5.1. Supply and Logistic Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.2. Logistics & Distribution
4.3.5.2.1. Logistics & Distribution U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.3. Storage & Retention
4.3.5.3.1. Storage & Retention U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.4. Packaging, Labeling, And Blinding
4.3.5.4.1. Packaging, Labeling, And Blinding U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.5. Manufacturing
4.3.5.5.1. Manufacturing U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.6. Comparator Sourcing
4.3.5.6.1. Comparator Sourcing U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.7. Regulatory and customs support
4.3.5.7.1. Regulatory and Customs Support U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.5.8. Other Services
4.3.5.8.1. Other Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
4.3.6. Others
4.3.6.1. Others U.S. Cell and Gene Therapy Clinical Trial Services Market, 2018 to 2030 (USD Million)
Chapter 5. U.S. Cell and Gene Therapy Clinical Trial Services Market: Phase Estimates & Trend Analysis
5.1. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Phase: Segment Dashboard
5.2. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Phase: Movement Analysis
5.3. U.S. Cell and Gene Therapy Clinical Trial Services Market Estimates & Forecasts, By Phase, 2018 - 2030
5.3.1. Phase I
5.3.1.1. Phase I U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
5.3.2. Phase II
5.3.2.1. Phase II U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
5.3.3. Phase III
5.3.3.1. Phase III U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
5.3.4. Phase IV
5.3.4.1. Phase IV U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
Chapter 6. U.S. Cell and Gene Therapy Clinical Trial Services Market: Therapeutic Areas Estimates & Trend Analysis
6.1. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Therapeutic Areas: Segment Dashboard
6.2. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Therapeutic Areas: Movement Analysis
6.3. U.S. Cell and Gene Therapy Clinical Trial Services Market Estimates & Forecasts, By Therapeutic Areas, 2018 - 2030
6.3.1. Oncology
6.3.1.1. Oncology U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
6.3.2. Central Nervous System (CNS) Disorders
6.3.2.1. Central Nervous System (CNS) Disorders U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
6.3.3. Cardiovascular Diseases
6.3.3.1. Cardiovascular Diseases U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
6.3.4. Infectious Diseases
6.3.4.1. Infectious Diseases U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
6.3.5. Musculoskeletal
6.3.5.1. Musculoskeletal U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
6.3.6. Others
6.3.6.1. Others U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
Chapter 7. U.S. Cell and Gene Therapy Clinical Trial Services Market: Therapy Type Estimates & Trend Analysis
7.1. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Therapy Type: Segment Dashboard
7.2. U.S. Cell and Gene Therapy Clinical Trial Services Market, By Therapy Type: Movement Analysis
7.3. U.S. Cell and Gene Therapy Clinical Trial Services Market Estimates & Forecasts, By Therapy Type, 2018 - 2030
7.3.1. Gene Therapy
7.3.1.1. Gene Therapy U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
7.3.2. Gene-Modified Cell Therapy
7.3.2.1. Gene-Modified Cell Therapy U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
7.3.2.2. CAR T-cell therapies
7.3.2.2.1. CAR T-cell therapies U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
7.3.2.3. CAR-NK cell therapy
7.3.2.3.1. CAR-NK cell therapy U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
7.3.2.4. TCR-T cell therapy
7.3.2.4.1. TCR-T cell therapy U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
7.3.2.5. Others
7.3.2.5.1. Others U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
7.3.3. Cell Therapy
7.3.3.1. Cell Therapy U.S. Cell and Gene Therapy Clinical Trial Services Market 2018 to 2030 (USD Million)
Chapter 8. Competitive Landscape
8.1. Company Categorization
8.1.1. By CROs
8.1.2. By CGT Supply/Logistics Providers
8.1.3. Service Heat Map Analysis
8.1.3.1. By CGT Sponsor Companies
8.1.3.2. By CGT Supply/Logistics Providers
8.1.4. Global Company Market Share Analysis, 2023
8.2. Company Profiles (By CGT Clinical Trial Sponsors)
8.2.1. Novartis AG
8.2.1.1. Company Overview
8.2.1.2. Financial Performance
8.2.1.3. Service Benchmarking
8.2.1.4. Strategic Initiatives
8.2.2. Takeda Pharmaceutical Company Limited.
8.2.2.1. Company Overview
8.2.2.2. Financial Performance
8.2.2.3. Service Benchmarking
8.2.2.4. Strategic Initiatives
8.2.3. Gilead Sciences, Inc.
8.2.3.1. Company Overview
8.2.3.2. Financial Performance
8.2.3.3. Service Benchmarking
8.2.3.4. Strategic Initiatives
8.2.4. Amgen Inc.
8.2.4.1. Company Overview
8.2.4.2. Financial Performance
8.2.4.3. Service Benchmarking
8.2.4.4. Strategic Initiatives
8.2.5. bluebird bio, Inc.
8.2.5.1. Company Overview
8.2.5.2. Financial Performance
8.2.5.3. Service Benchmarking
8.2.5.4. Strategic Initiatives
8.2.6. Regeneron Pharmaceuticals Inc.
8.2.6.1. Company Overview
8.2.6.2. Financial Performance
8.2.6.3. Service Benchmarking
8.2.6.4. Strategic Initiatives
8.2.7. CRISPR Therapeutics
8.2.7.1. Company Overview
8.2.7.2. Financial Performance
8.2.7.3. Service Benchmarking
8.2.7.4. Strategic Initiatives
8.2.8. Pfizer
8.2.8.1. Company Overview
8.2.8.2. Financial Performance
8.2.8.3. Service Benchmarking
8.2.8.4. Strategic Initiatives
8.3. Company Profiles (By CGT Supply/Logistics Providers)
8.3.1. Biocair
8.3.1.1. Company Overview
8.3.1.2. Financial Performance
8.3.1.3. Service Benchmarking
8.3.1.4. Strategic Initiatives
8.3.2. Modality Solutions LLC
8.3.2.1. Company Overview
8.3.2.2. Financial Performance
8.3.2.3. Service Benchmarking
8.3.2.4. Strategic Initiatives
8.3.3. BioLife Solutions, Inc.
8.3.3.1. Company Overview
8.3.3.2. Financial Performance
8.3.3.3. Service Benchmarking
8.3.3.4. Strategic Initiatives
8.3.4. Marken
8.3.4.1. Company Overview
8.3.4.2. Financial Performance
8.3.4.3. Service Benchmarking
8.3.4.4. Strategic Initiatives
8.3.5. Yourway
8.3.5.1. Company Overview
8.3.5.2. Financial Performance
8.3.5.3. Service Benchmarking
8.3.5.4. Strategic Initiatives
8.3.6. Almac Group
8.3.6.1. Company Overview
8.3.6.2. Financial Performance
8.3.6.3. Service Benchmarking
8.3.6.4. Strategic Initiatives
8.3.7. Catalent, Inc
8.3.7.1. Company Overview
8.3.7.2. Financial Performance
8.3.7.3. Service Benchmarking
8.3.7.4. Strategic Initiatives
8.3.8. Quick International Courier (QuickStat (Kuehne + Nagel Company)
8.3.8.1. Company Overview
8.3.8.2. Financial Performance
8.3.8.3. Service Benchmarking
8.3.8.4. Strategic Initiatives
Chapter 9. Kol Commentary/Recommendations

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