Robust CGT pipeline with growing number of product approvals, strong support from large pharma and biotech, and consistent investor enthusiasm (~$20 bn raised in 2020) is set to boost the demand for CGT services. A growing pipeline of therapies are nearing regulatory decisions. Out of 1,220 ongoing clinical trials in 2020, 152 were in Phase 3 â€” FDA and EMA predict approval of 10-20 cell and gene therapies each year by 2025.
Rising Demand for Full-service/One-stop-shop CDMOs
Full-service CDMOs that can assist with both development and manufacturing are in utmost demand. Much of the CGT development as of late has been from smaller biotech companies or research universities who rely on CDMOs from preclinical development through packaging.
â€œThere is growing demand for Cell and Gene Therapy CTDMOs who can offer integrated development, manufacturing, and testing services. For CGT companies, outsourcing manufacturing and testing operations to a capable CTDMO can reduce development timelines, provide supplementary capacity, and ultimately control costs.â€ – Senior Director, Tier 1 CGT CDMO, United States
Substantial Outsourcing in Cell and Gene Therapy CDMO Market due to Lack of Internal Capabilities
The current level of outsourcing in CGT exceeds 60% which is far above the level of outsourcing seen in overall pharma/biologics field. Cell & Gene Therapy is a complex field requiring high level of expertise. Also, it has costly production and different manufacturing process/infrastructure requirements as compared to traditional small molecules. Big pharma currently lacks production-ready infrastructure and are increasingly looking for CGT CDMOs to enter/expand their presence in fast-growing CGT market. Moreover, rising influx of small biotechs in the market with limited/no manufacturing capabilities and/or development expertise further provides growth opportunities for the Cell and Gene Therapy CDMO market.
Regional Snapshot: Cell and Gene Therapy CDMO Market
North America is expected to witness fastest growth and continue its dominance in the coming 5 years owing to growing manufacturing capacity for CGTs, favorable regulatory approval process, growing CGT approvals per year, and strong product pipeline of CGTs in the United States.
Competitive Landscape Analysis: Cell and Gene Therapy CDMO Market
The global Cell and Gene Therapy CDMO market is marked by the presence of both established players and several small and mid-sized players. Some of the leading players operating in the market are Lonza, Catalent, Patheon, Wuxi Advanced Therapies and Charles River Laboratories. Other promising players in the market are Vive Biotech, SK Bioscience, Fujifilm, Vibalogics, Exothera, Takara, Oxford Biomedica, Viralgen and AGC Biologics, among several others.
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