U.S. Cell And Gene Therapy Clinical Trial Services Market Size & Share Report, 2033
The U.S. cell and gene therapy clinical trial services market size was valued at USD 7.19 billion in 2023 and is projected to surpass around USD 56.53 billion by 2033, registering a CAGR of 22.9% over the forecast period of 2024 to 2033.
The growth of the U.S. cell and gene therapy clinical trial services market is fueled by several key factors. Firstly, advancements in technology have enabled more precise and efficient manipulation of cells and genes, leading to the development of increasingly sophisticated therapies. Secondly, there has been a surge in investment from both public and private sectors, driven by the recognition of the immense potential of cell and gene therapies to revolutionize healthcare. Thirdly, favorable regulatory policies, such as expedited review pathways like the RMAT designation, have streamlined the development and approval process, encouraging companies to invest in innovative research. Additionally, growing collaborations between industry stakeholders, including contract research organizations, academic institutions, and biotechnology companies, are fostering a supportive ecosystem for the advancement of cell and gene therapies. These factors, combined with increasing demand for novel treatment options for a wide range of diseases, are driving the growth of the U.S. cell and gene therapy clinical trial services market.
| Report Attribute | Details |
| Market Size in 2024 | USD 8.84 Billion |
| Market Size by 2033 | USD 56.53 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 22.9% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Service, phase, therapeutic areas, therapy type |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Novartis AG; Takeda Pharmaceutical Company Limited.; Gilead Sciences, Inc.; Amgen Inc.; bluebird bio, Inc.; Regeneron Pharmaceuticals Inc.; CRISPR Therapeutics; Pfizer; Biocair; Modality Solutions LLC; BioLife Solutions, Inc.; Marken; Yourway; Almac Group; Catalent, Inc; Quick International Courier (QuickStat (Kuehne + Nagel Company) |
The growing prevalence of cancer, the expanding cell and gene therapy (CGT) pipeline, and the rising number of biotechnology & pharmaceutical companies outsourcing their clinical trial services are expected to drive market growth during the forecast period. In addition, U.S. cell & gene therapy clinical trial services are backed by increasing investments and R&D funding, growing adoption of novel technologies across clinical research & supply chains, and the surge in mergers & acquisitions activities in the cell and gene therapy industry.
The COVID-19 pandemic has impacted the U.S. cell & gene therapy clinical trial services industry 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. One of the main factors responsible is the general lack of demand forecast and feasibility planning. Logistics and transportation became primary concerns due to lockdowns and restrictions in the early stages of the pandemic. Clinical trials were delayed and temporarily suspended due to concerns regarding the safety of patients enrolled in trials and staff safety. As the pandemic stretched, with delays continuing for months, clinical trials that were in progress were disrupted as any inventory redundancies built into their supply chains eroded. Constant changes in regulatory policies related to clinical trial supplies adversely impacted the market.
However, the industry soon overcame the obstacles led by the outbreak of the COVID-19 pandemic, as the pandemic has accelerated certain new models in the clinical trial supplies industry to ease the crisis and cope with changing trends. Virtual trials gradually started gaining popularity and are expected to grow considerably in the coming years, which has significantly helped the industry to rebound revenues. Some of the major advantages of virtual trials are as follows:
The regulatory services segment held the largest revenue share of 21.34% in 2023. The cell and gene therapy industry's regulatory services provide guidance for enhancing the value of clinical trials throughout the product journey. This has led to a high demand for clinical trial services in the U.S., rapidly growing the segment. In March 2022, the FDA released draft guidance documents to support sponsors developing CGT products. The first draft is Human Gene Therapy Products Incorporating Human Genome Editing, which provides recommendations on the information to include in IND filings for the therapies, including safety, study design, and manufacturing. The second draft guidance is Considerations for Chimeric Antigen Receptor T Cell Products Development. Hence, such initiatives to support the development of CGT products support the market growth, simultaneously augmenting the demand for regulatory services.
The supply and logistic services segment is anticipated to register a considerable CAGR of 23.3% over the forecast period. The segment has been further sub-categorized to include specific supply & logistic services, including logistics & distribution, storage & retention, packaging, labeling and blinding, manufacturing, comparator sourcing, and others. The segment is anticipated to witness a surge in demand owing to the growing number of clinical trials in the CGT space that require exclusive logistics and storage services for extremely delicate CGT materials. For instance, by evaluating several authentic sources such as the Alliance for Regenerative Medicine (ARM), U.S. FDA, Clinicaltrials.gov, and a few others, it can be inferred that as of 2022, the worldwide number of clinical trials for cell and gene therapy stands at around 2,354, exhibiting substantial growth in the past few years, as depicted below:
The phase II segment held the largest revenue share of 48.19% in 2023. This is due to increasing generic product launches pertaining to cancer treatment. The expanding pipeline of cell and gene therapy candidates necessitates more Phase II trials to assess their safety and efficacy in diverse patient populations. Phase II clinical trials have emerging projects, and this trend is expected to continue owing to increasing investments in R&D by industry and nonindustrial sponsors. A growing number of industry-sponsored and non-industry-sponsored clinical trials in phase II, the complexity associated with phase II clinical trials, and the globalization of clinical trials are expected to boost the growth of the market, supporting the growth of the phase II segment.
On the other hand, the phase I segment is anticipated to register the fastest CAGR of 23.2% during the forecast period. Phase I study assesses the safety of a device or drug and involves evaluation of the tolerability and pharmacokinetics of molecules. It determines the effect of a device or drug on humans, including how it is absorbed, metabolized, and emitted. It also examines the side effects of the drug in case of increased dosage levels. The segment is anticipated to witness a lucrative growth rate across the analysis period owing to the rise in the clinical pipeline of CGT therapeutics. For instance, as per the U.S. FDA, around 13 new cell and gene therapies could secure approval in the U.S. and Europe by the end of 2023. Moreover, the U.S. FDA also stated that around 10 to 20 new cell and gene therapies will be approved by 2025.
The oncology segment held the largest revenue share of 56.9% in 2023. This is due to increasing generic product launches pertaining to cancer treatment. Oncology is one of the most explored areas in terms of CGT product development. This is due to the increasing number of cancer cases across the U.S. and primarily the surge in oncology-related rare diseases. To curb the cancer burden, several pharmaceutical and biopharmaceutical companies are focusing on developing novel CGT therapeutics, thus supporting segmental growth. For instance, as per the American Society of Gene & Cell Therapy (ASGCT), in 2021, 75 new clinical trials have commenced in the field of CGT, with the top 10 diseases chosen for commencing trials all belonging to the field of oncology, with the leading three being related to blood cancers including nonHodgkin’s lymphoma (NHL), multiple myeloma, acute lymphocytic leukemia (ALL).
The central nervous system (CNS) disorders segment is anticipated to register the fastest CAGR of 24.7% during the forecast period. This is due to the rising prevalence of neurological diseases across the globe, including the U.S. Alzheimer’s disease, degenerative diseases, Huntington’s disease, Parkinson’s disease, expressive aphasia, and multiple sclerosis are some of the most common neurological diseases affecting people worldwide. Clinical trials & regulatory guidelines are boosting the entry of new products into the market. These drugs are monitored for dosage, formulation, efficacy, and aftereffects. For instance, in June 2022, the U.S. FDA nominated CNS Pharmaceuticals’ Berubicin, an orphan drug for treating malignant gliomas, a brain/CNS tumor. The major drivers of cell and gene therapy for CNS diseases are newer gene-editing tools, the introduction of safe & effective vectors, and huge unmet medical needs.
The cell therapy segment held the largest revenue share of 40.65% in 2023. This is due to increasing generic product launches pertaining to cancer treatment. Cell therapy services are vital in advancing regenerative medicine & personalized medicine. Demand for the therapy is rising across various diseases, including cancer, autoimmune conditions, neurological diseases, and more. Different specialized facilities, research institutions, and healthcare professionals with experience in cell-based therapies frequently provide cell therapy services. Cell therapy comprises various services, including logistics & distribution, to ensure that the therapy's components are safely kept, transported, and supplied to clinical sites. Along with a growing cell therapy pipeline, the increasing prevalence of diseases and novel innovations are expected to propel market expansion over the forecast period.
The gene-modified cell therapy segment is expected to register the fastest CAGR of 23.6% during the forecast period. In gene-modified cell therapy, specific cells are modified genetically outside the body to cure the disease. These therapies ideally modify cells, which are then returned to the patient to treat their disease. The segment has been further sub-categorized to include CAR T-cell therapies, TCR-T cell therapy, CAR-NK cell therapy, and others. Chimeric Antigen Receptor T-cell therapy is a gene-modified cell therapy used for blood cancers such as leukemia & lymphoma. Gene-modified stem cell therapy involves modifying stem cells, which have the potential to develop into various cell types, to treat conditions like inherited genetic disorders, blood disorders, and neurodegenerative diseases. Ex vivo gene therapy cells are removed from the patient, modified outside the body, and reintroduced. The increasing demand for gene-modified cell therapy creates a rising demand for clinical trial services supporting medical innovation.
The key players focus on expanding their facilities, product/service launches, collaborations, partnerships, and mergers and acquisitions. These are the key strategic initiatives influencing the industry dynamics. For instance, in January 2022, AmerisourceBergen and TrakCel launched the integrated platform to enhance access to prescribed cell & gene therapies, delivering complete visibility during the treatment. The two platforms are TrakCel’s advanced therapy orchestration platform, OCELLOS, and Fusion, a customer relationship management & patient support platform. Some prominent players in the U.S. cell and gene therapy clinical trial services market (Amalgamation of service providers by sponsor companies and logistic providers) are:
Key Cell And Gene Therapy (CGT) Clinical Trial Sponsors Companies:
Key Cell And Gene Therapy (CGT) Supply & Logistic Providers Companies:
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Cell And Gene Therapy Clinical Trial Services market.
By Service
By Phase
By Therapeutic Areas
By Therapy Type
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. nova one advisor. 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, 2021 to 2033
4.3.2. Patient Recruitments
4.3.2.1. Patient Recruitments U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
4.3.3. Laboratory Services
4.3.3.1. Laboratory Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
4.3.4. Regulatory Services
4.3.4.1. Regulatory Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
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, 2021 to 2033
4.3.5.2. Logistics & Distribution
4.3.5.2.1. Logistics & Distribution U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
4.3.5.3. Storage & Retention
4.3.5.3.1. Storage & Retention U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
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, 2021 to 2033
4.3.5.5. Manufacturing
4.3.5.5.1. Manufacturing U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
4.3.5.6. Comparator Sourcing
4.3.5.6.1. Comparator Sourcing U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
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, 2021 to 2033
4.3.5.8. Other Services
4.3.5.8.1. Other Services U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
4.3.6. Others
4.3.6.1. Others U.S. Cell and Gene Therapy Clinical Trial Services Market, 2021 to 2033
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 2021 to 2033
5.3.2. Phase II
5.3.2.1. Phase II U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
5.3.3. Phase III
5.3.3.1. Phase III U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
5.3.4. Phase IV
5.3.4.1. Phase IV U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
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 2021 to 2033
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 2021 to 2033
6.3.3. Cardiovascular Diseases
6.3.3.1. Cardiovascular Diseases U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
6.3.4. Infectious Diseases
6.3.4.1. Infectious Diseases U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
6.3.5. Musculoskeletal
6.3.5.1. Musculoskeletal U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
6.3.6. Others
6.3.6.1. Others U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
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 2021 to 2033
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 2021 to 2033
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 2021 to 2033
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 2021 to 2033
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 2021 to 2033
7.3.2.5. Others
7.3.2.5.1. Others U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
7.3.3. Cell Therapy
7.3.3.1. Cell Therapy U.S. Cell and Gene Therapy Clinical Trial Services Market 2021 to 2033
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
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
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Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers