Cell and Gene Therapy CRO Market to Cross US$ 3.5 billion by 2035 | Roots Analysis

Published: April 2024


According to a recently published report by Roots Analysis, the complexities associated with the development of cell and gene therapies necessitates specialized expertise in areas such as drug discovery, clinical evaluation, quality control and regulatory compliance, driving the demand for CRO services

Cell and Gene Therapy CRO Industry Overview

The global cell and gene therapy CRO market size is anticipated to grow at a CAGR of 7.1% from 2024-2035, reaching USD 3,513 million by 2035.

With over 90 cell and gene therapies approved globally, and more than 3,500 clinical studies currently evaluating these therapies across 16 therapeutic areas; it is safe to state that cell and gene therapy candidates have demonstrated tremendous potential with an aim to treat rare and complex diseases, including indications for which no effective treatment is currently available. Ongoing studies aim to uncover the specific mechanisms underlining these therapies, paving the way for a more targeted and effective approach to harness their potential for healthcare purposes. Given the extensive research efforts in the continuously advancing cell and gene therapy landscape, CROs bring expertise in developing a comprehensive compliance framework that encompasses all relevant regulations, optimizing study designs, and supporting seamless transition from preclinical to clinical stages. The aforementioned factors are likely to present lucrative market growth opportunities for contract service providers and this upcoming therapeutic segment is anticipated to become one of the fastest growing markets within the pharmaceutical industry in the coming years.

Browse 160+ figures and 170+ market data tables spread across 340+ pages and detailed Table of Content on “Cell and Gene Therapy CRO Market by Type of Cell Therapy, Type of Genetic Modification, Stage of Development, End-Users and Key Geographical Regions: Industry Trends and Global Forecasts, Till 2035” here: https://www.rootsanalysis.com/reports/cell-and-gene-therapy-cros-market/230.html

Market Drivers

Several factors contribute to the growth of the cell and gene therapy CRO market. The expanding pipeline of cell and gene therapies, with over 3,500 clinical trials evaluating cell and gene therapies across various developmental stages has propelled the market. This surge can be attributed to the biopharmaceutical industry's recent shift towards more efficient treatment options like ATMPs. Consequently, there is a likelihood of increased outsourcing of R&D operations to CROs due to the lack of well-equipped infrastructure and capital among smaller firms. In addition, CROs offer logistical support for cell preservation in banks during shipping, as this is crucial for maintaining product consistency and safety. Moreover, the technical expertise of CROs can optimize the supply chain process by ensuring temperature-controlled storage, enhancing product shelf-life, facilitating intermediate storage, and offering breakpoints within the drug development process. Therefore, many innovators in the cell and gene therapy industry are compelled to outsource their drug discovery and clinical research operations to contract service providers, thereby contributing to the growth of this market.

Market Restraints

One of the primary restraint of this industry is the compliance to the stringent regulatory guidelines for cell and gene therapies. In addition, these therapies are associated with exorbitant development costs as compared to conventional therapies primarily due to the fact that these therapies are highly personalized and require individualized development, as well as manufacturing processes. Moreover, the companies that have approved ATMPs in their portfolio, face significant reimbursement related challenges, where payers are unwilling to pay such high upfront treatment costs, further hindering the market growth.

Growth Factors

Despite several challenges, various growth factors continue to drive the cell and gene therapy CRO market. One of the notable growth factors is that several CROs have expanded their service portfolio to include R&D, product development and clinical research services, thereby offering a wide range of services to developers. In addition, various CROs claim to offer GCP / GLP compliant preclinical research services for cell and gene therapies. In fact, some of the players have well-established facilities for conducting in vitro and in vivo evaluation of their pipeline candidates. Additionally, a considerable increase in research and development efforts, coupled with increasing investments from both public and private sectors, has accelerated growth of this market. Moreover, collaborations among pharmaceutical companies, academic institutions, and research organizations to address unmet medical needs globally, are likely to drive considerable growth in the market.

Cell and Gene Therapy CRO Market Segments

Based on the type of cell therapy, the market is segmented into CAR-T, TCR-T, CAR-NK and Others.

  • The CAR-T segment led the cell and gene therapy CRO market, capturing the largest revenue share of 47% in 2024.
  • Further, the TCR-T segment is anticipated to witness the highest market growth rate of 8.4%, annually during the forecast period.

Based on the type of genetic modification, the market is segmented into Ex vivo and In vivo.

  • The ex vivo segment led the cell and gene therapy CRO market, capturing the largest revenue share of close to 70% in 2024.
  • The in vivo segment is anticipated to witness the highest market growth rate of around 8.5%, annually during the forecast period.

Based on the stage of development, the market is segmented into Clinical, Preclinical and Discovery.

  • Therapies in clinical stage of development led the cell and gene therapy CRO market, capturing the largest revenue share of 87% in 2024.
  • In fact, both preclinical and discovery segment is anticipated to witness a market growth rate of over T7.7%, annually during the forecast period.

Based on the therapeutic area, the market is segmented into Blood Disorders, Cardiovascular Disorders, Dermatological Disorders, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Musculoskeletal Disorders, Neurological Disorders, Oncological Disorders, Rare Diseases, and  Other disorders.

  • The oncological disorders segment has led the cell and gene therapy CRO market, capturing the largest revenue share of 25% in 2024.
  • The blood disorders segment is anticipated to witness the highest market growth rate of over 8.7%, annually during the forecast period.

Based on the end-users, the market is segmented into Industry Players and Non-Industry Players.

  • The industry players segment led the cell and gene therapy CRO market, capturing the largest revenue share of 84% in 2024.
  • Further, the non-industry players segment is anticipated to grow at an annualized rate of 5% during the forecast period.

Based on the Regional Insights, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World.

  • North America dominated the cell and gene therapy CRO market and accounted for the largest revenue share of 59% in 2024.
  • In Asia-Pacific, the cell and gene therapy CRO market is anticipated to demonstrate lucrative growth of 8.1% during the forecast period.

Key Companies Profiled

The cell and gene therapy CRO market report also includes detailed profiles of key players (listed below) that offer contract research services for cell and gene therapies:

  • Aixial
  • Altasciences
  • CMIC
  • ICON
  • Labcorp
  • Linical
  • Medpace
  • Novotech
  • PPD
  • Precision for Medicine
  • QPS
  • Syneos Health

You Can Download Free Sample PDF Copy of This Report At:
https://www.rootsanalysis.com/reports/cell-and-gene-therapy-cros-market/request-sample.html

About Roots Analysis

Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.

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