Global Cell and Gene Therapy Manufacturing Market to Hit $27B by 2032

The global cell and gene therapy (CGT) manufacturing services market is on track for significant growth, projected to increase from a valuation of USD 8.1 billion in 2024 to USD 27.0 billion by 2032. This surge represents a compound annual growth rate (CAGR) of 16.4%, driven by a variety of factors including a rise in clinical trials, expanding regulatory approvals, and heightened investments in personalized medicine.

The escalating prevalence of cancer and genetic disorders is reshaping treatment paradigms. According to the World Health Organization, nearly 10 million lives were lost to cancer in 2020, intensifying the demand for innovative CGT solutions. As biopharmaceutical companies increasingly turn to specialized contract development and manufacturing organizations (CDMOs) for complex production processes, the market is witnessing remarkable advancements in areas such as viral vector production and scalable bioprocessing technologies.

Key Drivers of Market Growth

One of the primary factors influencing the market is the rising trend of outsourcing. More than 65% of cell and gene therapy manufacturing is currently outsourced, compared to around 35% for traditional biologics. Small biotechnology firms, which are responsible for two-thirds of innovations in this field, leverage CDMOs to accelerate their time-to-market while gaining access to specialized infrastructure and regulatory expertise.

The expanding clinical pipeline also plays a crucial role, with over 1,975 clinical trials underway globally, including 360 CAR-T focused trials. The need for clinical and commercial manufacturing capabilities is growing, particularly in oncology and emerging central nervous system (CNS) therapies. Furthermore, regulatory support through expedited approval pathways and government initiatives, such as the U.S. Cell and Gene Therapy Access Model, is stimulating investment in manufacturing infrastructure, enhancing confidence in the commercialization of breakthrough therapies.

Market Segmentation and Regional Insights

In terms of market segmentation, cell therapies currently dominate, accounting for 65% of the market. Gene therapies are anticipated to experience the fastest growth, propelled by advancements in viral vector production and breakthrough approvals. Cancer remains the largest indication, representing 55% of the market, while CNS disorders are emerging as the fastest-growing category due to advancements in gene editing technologies.

Commercial manufacturing leads the application segment at 75%, with clinical manufacturing experiencing the highest growth due to an expanding early-phase trial pipeline. Contract manufacturing commands a dominant 70% market share, although in-house manufacturing is rapidly gaining traction as larger pharmaceutical firms invest in internal capabilities.

Regionally, North America leads the global market with a 45% share in 2024, driven by a high concentration of biotechnology firms, advanced research and development capabilities, and robust government support. In contrast, the Asia-Pacific region is set to record the fastest growth rate of 17.5% CAGR, bolstered by increasing investments, regulatory reforms, and strategic partnerships, with countries like China, Japan, and India emerging as key players.

The competitive landscape of the CGT manufacturing market is moderately consolidated, with leading companies such as Lonza Group Ltd., Catalent Inc., Thermo Fisher Scientific, WuXi AppTec, and Oxford Biomedica plc controlling approximately 70% of the market. These companies are heavily investing in facility expansions, platform technologies, and strategic partnerships to meet the growing demand for complex therapies.

Recent industry developments include the launch of optimized ProPak GMP Cytokines by ScaleReady USA and Bio-Techne in September 2024, aimed at enhancing efficiency in cell and gene therapy manufacturing. Additionally, in July 2024, Genezen Laboratories acquired uniQure’s commercial gene therapy operations to expand its manufacturing capacity. Significant FDA approvals for therapies such as bluebird bio’s Lyfgenia and Vertex’s Casgevy in December 2023 marked major milestones in the field.

With a robust clinical pipeline, accelerating regulatory approvals, and increasing outsourcing trends, the cell and gene therapy manufacturing services market is poised for unprecedented growth. As biopharmaceutical companies continue to innovate, the sector is set to redefine the future of personalized medicine and advanced therapeutics on a global scale.