October 18, 2018

The Rise of Cell and Gene Therapy CROs

By Arun Gupta Cell Therapies, Contract Research Organizations, Gene Therapy 0 Comments

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 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 contract research organizations (CROs), which claim to offer cost-efficient solutions as well as intellectual and operational expertise.

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

Primarily based in the US and EU, the key innovation hubs, CROs 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 therapies have 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

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

The 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