Cell and Gene Therapy CRO Market (4th Edition): Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Cell Therapy (CAR-NK, CAR-T, TCR-T, and Others), Type of Genetic Modification (Ex vivo and In vivo), Stage of Development (Discovery, Preclinical, and Clinical), Therapeutic Area (Blood Disorders, Cardiovascular Disorders, Dermatological Disorders, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Musculoskeletal Disorders, Neurological Disorders, Oncological Disorders, Rare Diseases, and Other disorders), End-Users (Industry Players and Non-Industry Players) and Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World)
The Cell and Gene Therapy CRO Market is valued at USD 1,653 million in 2024 growing at a CAGR of 7.1% during the forecast period 2024-2035.
Cell and gene therapy candidates have shown promising outcomes in treating rare and complex diseases, including conditions for which effective treatments are currently in development phase. It's essential to note that in cell therapy, human cells are transplanted to repair or replace damaged cells or tissues, facilitating treatment through the alteration or restoration of specific cell sets. These cells may be sourced from the patient (autologous cells) or a donor (allogeneic cells). Conversely, gene therapy aims to address underlying genetic issues to treat and prevent diseases by replacing, inactivating, or introducing genes into cells, either inside or outside the body. It's noteworthy that some therapeutic interventions can be categorized as both cell and gene therapies. The mechanism of action typically involves gene alteration in specific cell types and subsequent insertion into the patient's body.
Currently, over 90 cell and gene therapies have received global approval. Recent examples of approved therapies include Fucaso (2023; developed by IASO Bio) for treating multiple myeloma, Elvediys (2023; developed by Sarepta Therapeutics) for treating Duchenne muscular dystrophy, and Vyjuvek (2023; developed by Krystal Biotech) for treating dystrophic epidermolysis bullosa. Moreover, more than 3,500 clinical studies are underway, evaluating cell and gene therapies across 16 therapeutic areas. Besides biotechnology companies developing these therapies, other stakeholders in the market contribute to their success. Apart from Contract Research Organizations (CROs), companies providing clinical trial software solutions play a crucial role in clinical trial management. These platform providers are exploring novel platforms to facilitate decentralized/virtual clinical trials for cell and gene therapies. One such company is Jeeva Clinical Trials, based in the US, which is developing a SaaS platform aimed at reducing the travel burden for trial participants. Additionally, there are companies developing cell and gene therapy supply chain software to help drug developers and CROs manage supply chains.
With the rapidly evolving landscape of cell and gene therapy, CROs bring expertise in navigating complex regulatory frameworks, optimizing study designs, and facilitating the seamless transition from preclinical to clinical success. These factors are expected to present significant market growth opportunities for contract service providers during the forecast period.
Key Market Segments
Type of Cell Therapy
CAR-NK
CAR-T
TCR-T
Type of Genetic Modification
Stage of Development
- Discovery
- Preclinical
- Clinical
Therapeutic Area
- Blood Disorders
- Cardiovascular Disorders
- Dermatological Disorders
- Immunological Disorders
- Infectious Diseases
- Metabolic Disorders
- Musculoskeletal Disorders
- Neurological Disorders
- Oncological Disorders
- Rare Diseases
- Other Disorders
End-users
- Industry Players
- Non- Industry Players
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Rest of the World
Research Coverage:
- This introductory chapter presents insights into historical development of Contract Research Organizations (CROs), ongoing trends in outsourcing, and the array of services they offer. Beginning with a brief overview of CROs, it traces the evolution of the contract research services market. Various types of CROs and their service offerings are discussed, followed by an examination of the benefits and potential pitfalls of collaborating with these service providers. Additionally, the chapter underscores the pivotal role CROs play in advancing Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies, within the pharmaceutical landscape.
- A comprehensive examination of the contract research service provider market within the cell and gene therapy sector is conducted, based on the factors such as establishment year, company size measured by employee count, headquarters location, specialized expertise in cell therapy and gene therapy, operational scale encompassing discovery, preclinical, clinical, and commercial phases, and the range of preclinical services provided (such as toxicology studies, in-vivo testing, safety studies, PK/ADME studies, bioanalytical studies, and other preclinical services). Additionally, the assessment covers the spectrum of clinical services offered, such as clinical trial management / clinical project management, clinical research monitoring, data management, safety, and pharmacovigilance, along with other clinical services. Regulatory services provided, including legal representation, GAP analysis, Technical Dossier Submission, and IND Preparation, are also scrutinized. Moreover, the evaluation extends to general support services offered, such as consulting, training, biostatistics, post-market assessment, and reimbursement assistance.
- Comprehensive profiles are provided for cell and gene therapy CROs, major contract research organizations offering services across preclinical, clinical, and commercial scales, situated in North America, Europe, and Asia-Pacific. Each profile encompasses a concise company overview, particulars concerning their cell and gene therapy service offerings, recent advancements, and an insightful perspective on future prospects.
- An in-depth benchmark analysis is conducted to assess the strengths and capabilities of different entities operating within this sector. This evaluation focuses on the expertise of companies across a spectrum of services pertinent to cell and gene therapy development. By facilitating comparisons among peer groups, the analysis enables companies to gauge their current capabilities, identify areas for improvement, and strategize for enhanced competitiveness within the industry.
- An exhaustive examination is conducted on the partnerships forged among stakeholders within the cell and gene therapy contract research sector, considering various pertinent parameters. These include the year of partnership, type of partnership, areas of expertise involved, identification of the most prolific players based on the number of partnerships established, and the geographical distribution of partnership activity within this domain spanning the period from 2015 to 2023.
- A comprehensive analysis is conducted on the mergers and acquisitions within this sector spanning the period from 2015 to 2023, considering various pertinent parameters. These include the year of agreement, type of agreement, key value drivers underlying the deal, identification of the most prolific players based on the number of agreements signed, and the geographical locations of the involved companies. Additionally, the chapter offers insights into the financial terms of the deals, if available, to delineate the deal multiples in terms of the acquired firm's annual revenues at the time of acquisition and its years of experience in this domain.
- An in-depth examination of acquisitions within the cell and gene therapy domain is conducted, focusing on the historical trend of acquiring activity by key players since 2015. The analysis aims to provide industry stakeholders with insights to identify potential acquisition.
- An extensive examination of concluded, in-progress, and forthcoming clinical investigations into diverse cell and gene therapies. This analysis considers multiple pertinent factors, including the year of trial registration, trial status, phase of the trial, patient demographics, sponsoring entity, leading industry participants (by trial registration volume), research design, targeted therapeutic fields, and primary geographical locations.
- A thorough examination of the overall expenses incurred by large and very large contract research organizations (CROs) specializing in cell and gene therapy. This analysis focuses on the costs related to setting up and sustaining a CRO facility over both short and long durations. The chapter presents findings derived from an in-depth investigation into the total cost of ownership for cell and gene therapy CROs spanning the timeframe from Y0 to Y20.
- A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry's evolution highlighting the relative effect of each SWOT parameter on the overall cell and gene therapies research services industry.
- A comprehensive market forecast analysis has been conducted to gauge the present market size and future prospects for cell and gene therapy Contract Research Organizations (CROs) over the next decade. Drawing from various factors including anticipated adoption patterns and validated through primary research, we have developed an informed projection of market development from 2024 to 2035. The report outlines the expected distribution of current and projected opportunities within the cell and gene therapy CRO market. Additionally, to accommodate potential uncertainties and strengthen our model, we have presented three forecast scenarios - conservative, base, and optimistic - reflecting distinct trajectories for industry growth.
- Comprehensive projections of current and future cell & gene therapy CRO market across different types of cell therapy, such as CAR-NK, CAR-T, TCR-T, and others.
- Detailed projections of current and future cell and gene therapy CRO market across different types of genetic modification, such as ex vivo and in vivo.
- Comprehensive predictions of the current and future cell and gene therapy CRO industry across different stages of development, such as clinical, preclinical and discovery.
- Detailed projections of the current and future cell and gene therapy CRO market across different therapeutic area, such as blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders.
- Comprehensive projections of the current and future cell & gene therapy CRO market across different end users, namely industry players and non-industry players.
- Detailed projections of the current and future cell and gene therapy CRO industry across various geographies, namely North America, Europe, Asia-Pacific and Rest of the World.
Key Benefits of Buying this Report
- The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
- Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
- The report provides stakeholders with a pulse on the Cell and Gene Therapy CRO Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.
Leading Market Companies
CMIC
PPD
QPS
CMED
ICON