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

The global cell and gene therapy (CGT) manufacturing services market is set to experience significant growth, reaching an estimated value of USD 27 billion by 2032 from USD 8.1 billion in 2024. A recent study by P&S Intelligence highlights a robust compound annual growth rate (CAGR) of 16.4%. This surge is attributed to an increase in clinical trials, expanding regulatory approvals, and a growing emphasis on personalized medicine.

The escalating incidence of cancer and genetic disorders worldwide is reshaping treatment approaches. According to the World Health Organization, nearly 10 million deaths were attributed to cancer in 2020, fueling demand for innovative CGT solutions. As biopharmaceutical companies increasingly outsource complex production processes to specialized contract development and manufacturing organizations (CDMOs), the sector is witnessing notable innovations in viral vector production, cell culture optimization, and scalable bioprocessing technologies.

Key Drivers of Market Growth

Several factors are contributing to the growth of the CGT manufacturing market:

– **Outsourcing Trends**: About 65% of CGT manufacturing is outsourced, a significant increase compared to 35% for traditional biologics. Smaller biotechnology firms, which drive approximately two-thirds of innovation in this industry, are leveraging CDMOs to expedite time-to-market and gain access to specialized infrastructure and regulatory expertise.

– **Expanding Clinical Pipeline**: Currently, there are over 1,975 clinical trials ongoing worldwide, including 360 CAR-T focused trials. This increase in clinical activity, particularly in oncology and emerging central nervous system (CNS) therapies, escalates demand for both clinical and commercial manufacturing capabilities.

– **Regulatory Support**: Initiatives like the U.S. Cell and Gene Therapy Access Model, which provide expedited approval pathways, are enhancing investment in manufacturing infrastructure and boosting confidence in the commercialization of groundbreaking therapies.

Market Segmentation Insights

The CGT manufacturing market can be broken down into several key segments:

– **Therapy Type**: Cell therapies currently dominate the market, accounting for 65%. Meanwhile, gene therapies are expected to exhibit the fastest growth, propelled by advancements in viral vector production and recent breakthrough approvals.

– **Indications**: Cancer represents the largest category, comprising 55% of the market, while CNS disorders are the fastest-growing indication, driven by innovations in gene editing technologies and a pressing need for effective treatments.

– **Application Modes**: Commercial manufacturing leads the market at 75%, although clinical manufacturing is experiencing rapid growth, driven by an expanding early-phase trial pipeline.

– **Manufacturing Models**: Contract manufacturing holds a substantial 70% market share, while in-house manufacturing is on the rise as larger pharmaceutical companies invest in developing internal capabilities.

– **Workflow Segments**: Process development is currently the largest segment, while vector production is the fastest-growing segment, reflecting the increasing demand for gene therapy manufacturing.

– **End Users**: Pharmaceutical and biotechnology companies hold 55% of the market share, with academic and research institutions emerging as a key growth area in early-stage development.

Regional dynamics also play a crucial role in the market’s trajectory. North America currently leads the global market with a 45% share, bolstered by a high concentration of biotech firms and robust government support. The U.S. market is projected to grow at a CAGR of 17.1% through 2032. In contrast, the Asia-Pacific region is anticipated to record the fastest growth at 17.5% CAGR, driven by increasing investments and strategic partnerships, with countries like China, Japan, and India emerging as significant players.

Competitive Landscape and Recent Developments

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 firms are making substantial investments in facility expansions, platform technologies, and strategic partnerships to meet the growing demand for complex therapies.

Recent industry developments further highlight the market’s dynamism. In September 2024, ScaleReady USA and Bio-Techne launched optimized ProPak GMP Cytokines aimed at enhancing cell and gene therapy manufacturing efficiency. In July 2024, Genezen Laboratories expanded its capabilities by acquiring uniQure’s commercial gene therapy operations. Additionally, December 2023 marked significant milestones with FDA approvals for bluebird bio’s Lyfgenia and Vertex’s Casgevy, both pivotal in developing cell-based gene therapies for sickle cell disease.

The cell and gene therapy manufacturing services market is entering a period of remarkable growth, driven by robust clinical pipelines, increasing regulatory approvals, and a trend toward outsourcing. As biopharmaceutical companies continue to innovate, this sector is poised to redefine the landscape of personalized medicine and advanced therapeutics on a global scale.