Cell and Gene Therapy Manufacturing Market Set for $27 Billion Surge

The global market for cell and gene therapy (CGT) manufacturing services is on track to experience significant growth, with a projected value of USD 27 billion by 2032. According to a recent study by P&S Intelligence, the market was valued at USD 8.1 billion in 2024 and is expected to expand at a compound annual growth rate (CAGR) of 16.4%. This upward trend is driven by an increase in clinical trials, regulatory approvals, and investments in personalized medicine, marking a pivotal shift in advanced therapeutic development.

The escalating incidence of cancer and genetic disorders is reshaping treatment approaches globally. The World Health Organization reported nearly 10 million cancer-related deaths in 2020, underscoring a critical demand for innovative CGT solutions. As biopharmaceutical companies turn to specialized contract development and manufacturing organizations (CDMOs) for complex production processes, the sector is witnessing notable advancements in viral vector production, cell culture optimization, and scalable bioprocessing technologies.

Market Drivers and Segmentation

Several key factors are propelling the CGT manufacturing market forward. Outsourcing is becoming increasingly prevalent, with over 65% of CGT manufacturing activities being outsourced, compared to approximately 35% for traditional biologics. Small biotechnology firms, which are responsible for two-thirds of innovations in this field, are leveraging CDMOs to reduce time-to-market while gaining access to specialized infrastructure and regulatory expertise.

The clinical pipeline is expanding rapidly, with more than 1,975 clinical trials currently underway worldwide, including 360 CAR-T focused trials. This growth is particularly pronounced in oncology and emerging central nervous system (CNS) therapies. Furthermore, regulatory support, including expedited approval pathways and initiatives like the U.S. Cell and Gene Therapy Access Model, is fostering investment in manufacturing infrastructure, bolstering confidence in the commercialization of groundbreaking therapies.

Market segmentation reveals that cell therapies currently dominate the field, accounting for 65% of the market share. Gene therapies are anticipated to grow the fastest, driven by advancements in viral vector production and breakthrough approvals. Cancer treatments represent the largest category at 55%, while CNS disorders constitute the fastest-growing indication due to innovations in gene editing technologies and the pressing need for effective treatments.

Regional Insights and Competitive Landscape

Regionally, North America leads the market with a projected 45% share in 2024, bolstered by a high concentration of biotech firms, advanced research and development capabilities, and substantial government support. The U.S. market is expected to grow at a CAGR of 17.1% through 2032. In contrast, the Asia-Pacific region is set to achieve the fastest growth rate at 17.5% CAGR, fueled by increasing investments, regulatory reforms, and strategic partnerships, with countries like China, Japan, and India emerging as key players.

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 industry giants are investing heavily in facility expansions and platform technologies to meet the surging demand for complex therapies.

Recent developments indicate a vibrant market landscape. In September 2024, ScaleReady USA and Bio-Techne introduced optimized ProPak GMP Cytokines to enhance efficiency in CGT manufacturing. Additionally, in July 2024, Genezen Laboratories acquired uniQure’s commercial gene therapy operations, further bolstering manufacturing capacity. Notable FDA approvals, such as those for bluebird bio’s Lyfgenia and Vertex’s Casgevy in December 2023, marked significant milestones in the treatment of sickle cell disease through cell-based gene therapies.

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