The Rise of Cell and Gene Therapy CRO

Over 500 cell and gene therapy candidates are being investigated in different stages of clinical development across various geographies. In fact, in the past five years alone, more than 1,000 clinical trials, that are currently active, were initiated to evaluate the potential of these cell and gene therapies across multiple therapeutic indications. Due to several development challenges, such as fragile nature of cells being used, safety and efficacy issues, laborious procedures for conducting clinical studies, complex regulatory framework and exorbitant costs, it is difficult for the companies with limited expertise and finances to successfully develop these therapies in-house. The aforementioned challenges have led several players to outsource a significant part of their clinical stage research to capable cell and gene therapy CRO, which claim to offer cost-efficient solutions as well as intellectual and operational expertise.

Over 70 cell and gene therapy CROs provide a variety of early and late stage product development-related services to cell and gene therapy developers

Over 45% of the players offer clinical trial management services and preclinical safety and quality studies.

Primarily based in the US and EU, the key innovation hubs, cell and gene therapy CRO of varying sizes are offering support at both preclinical and clinical stages of product development

Cell therapies is one of the main focus areas; specifically, stem cell therapy has emerged as relatively more popular among small and mid-sized CROs

Over 1,000 active clinical trials, focused on cell therapies, have been registered across the globe in the last five years, highlighting the increasing demand for contract service providers

Close to 60% of clinical trials registered were focused on oncological disorders. Additionally, majority of the trials were registered in North Ameeica.

Companies involved in this domain are steadily expanding their capabilities to strengthen their service portfolio and align with contemporary industry benchmarks

Several partnerships over the last six years indicate the rising interest in this domain; players are actively entering into collaborations focused on diverse types of cell therapies

Various industry and non-industry players have inked deals for cell and gene therapy. Over 40% of the partnerships were signed for outsourcing agreements.

The cell and gene therapy CRO market is projected to grow at a steady pace of 8.9% annually; the opportunity is expected to be well distributed across different type of therapies, various regions and therapeutic areas

The cell and gene therapy CRO market is fragmented across different segments  including type of therapy, therapeutic area and geography.

To learn more, please click Cell and Gene Therapy CRO Market. For any queries / suggestions, please do not hesitate to contact us at You can also download the SAMPLE REPORT on cell and gene therapy CRO by Roots Analysis.

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