Cell and Gene Therapy Manufacturing Market Set to Surge to $27 Billion by 2032

(MENAFN- P&S Intelligence) According to the latest market research study published by P&S Intelligence, the global cell and gene therapy (CGT) manufacturing services market is poised for transformative growth, valued at USD 8.1 billion in 2024 and projected to surge at a remarkable CAGR of 16.4% to reach USD 27.0 billion by 2032. This growth is fueled by a surge in clinical trials, expanding regulatory approvals, and increasing investments in personalized medicine, signaling a new era in advanced therapeutic development.

The escalating prevalence of cancer and genetic disorders worldwide is fundamentally reshaping treatment paradigms. According to the World Health Organization, nearly 10 million lives were lost to cancer in 2020 alone, creating unprecedented demand for innovative CGT solutions. As biopharmaceutical companies increasingly outsource complex production processes to specialized contract development and manufacturing organizations (CDMOs), the manufacturing services market is witnessing remarkable innovation in viral vector production, cell culture optimization, and scalable bioprocessing technologies.

Key Market Drivers

• Outsourcing on the Rise: More than 65% of cell and gene therapy manufacturing is outsourced, compared to approximately 35% for traditional biologics. Small biotechnology firms, responsible for two-thirds of innovation in this space, leverage CDMOs to accelerate time-to-market while accessing specialized infrastructure and regulatory expertise.
• Expanding Clinical Pipeline: With over 1,975 clinical trials underway globally—including 360 CAR-T focused trials—the demand for clinical and commercial manufacturing capabilities continues to grow, particularly in oncology and emerging CNS therapies.
• Regulatory Support: Expedited approval pathways and government initiatives, such as the U.S. Cell and Gene Therapy Access Model, are stimulating investment in manufacturing infrastructure, building confidence in the commercialization of breakthrough therapies.

Market Segmentation Highlights

• Therapy Type: Cell therapies currently dominate, representing 65% of the market, while gene therapies are expected to achieve the fastest growth due to advancements in viral vector production and breakthrough approvals.
• Indication: Cancer remains the largest category (55%), while CNS disorders represent the fastest-growing indication, driven by advances in gene editing technologies and the urgent need for effective treatments.
• Application: Commercial manufacturing leads at 75%, with clinical manufacturing experiencing the highest growth due to the expanding early-phase trial pipeline.
• Mode: Contract manufacturing holds a dominant 70% market share, though in-house manufacturing is growing rapidly as larger pharma firms invest in internal capabilities.
• Workflow: Process development is the largest segment, whereas vector production is the fastest-growing segment, reflecting increasing demand for gene therapy manufacturing.
• End Users: Pharmaceutical and biotechnology companies account for 55% of market share, while academic and research institutions are emerging as a fast-growing force in early-stage development.

Regional Insights

• North America: Leading the global market with 45% share in 2024, driven by high concentration of biotech firms, advanced R&D capabilities, and robust government support. The U.S. market is expected to grow at a CAGR of 17.1% through 2032.
• Asia-Pacific: Set to record the fastest growth at 17.5% CAGR, supported by increasing investments, regulatory reforms, and strategic partnerships, with China, Japan, and India emerging as key players.

Competitive Landscape

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

Recent Industry Highlights

• September 2024: ScaleReady USA and Bio-Techne launched optimized ProPak GMP Cytokines for efficient cell and gene therapy manufacturing.
• July 2024: Genezen Laboratories acquired uniQure’s commercial gene therapy operations, expanding strategic manufacturing capacity.
• December 2023: FDA approvals for bluebird bio’s Lyfgenia and Vertex’s Casgevy marked major milestones in cell-based gene therapies for sickle cell disease.

With robust clinical pipelines, accelerating regulatory approvals, and increasing outsourcing trends, the cell and gene therapy manufacturing services market is entering a period of unprecedented growth. As biopharma companies continue to innovate, the sector is poised to redefine the future of personalized medicine and advanced therapeutics worldwide.

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