Gene Therapy Starting Materials Market Expands Rapidly Toward USD 7.53 Billion by 2032 | SNS Insider

The Gene Therapy Starting Materials Market, valued at USD 1.85 billion in 2024, is projected to reach USD 7.53 billion by 2032, growing at a strong CAGR of 19.21% over the forecast period of 2025–2032. The rapid expansion of gene therapy pipelines, rising demand for high-quality plasmids and viral vectors, and expanding GMP-certified manufacturing capacity are the primary forces driving market acceleration. As the gene therapy sector evolves from small-scale trials to large-scale commercialization, companies increasingly prioritize purity, scalability, and regulatory alignment of starting materials, fueling long-term market growth and innovation.

One of the major industry trends is the shift from laboratory-grade materials to GMP-grade, customizable, and highly scalable raw materials that support both early-stage research and downstream commercial manufacturing. In 2025, Aldevron reported a 28% annual increase in plasmid DNA service demand, highlighting the rising global need for dependable gene therapy inputs. Such advancements continue to strengthen the supply chain while reducing implementation risks for biotechnology companies and clinical developers.

The United States remains a dominant regional market, valued at USD 750.45 million in 2024 and forecasted to reach USD 3040.49 million by 2032. Strong federal support, world-class R&D capabilities, and advanced manufacturing facilities contribute to its leadership position. In 2025, the U.S. government allocated USD 3.5 billion under the National Biotechnology Initiative to advance domestic production of gene therapy starting materials, further intensifying growth momentum across the nation.

Download a Free Sample PDF @ https://www.snsinsider.com/sample-request/8260     

Market Dynamics

• Drivers: The COVID-19 pandemic significantly reshaped the gene therapy starting materials landscape by highlighting global supply shortages, increasing automated manufacturing, and strengthening regulatory pathways. As companies sought to secure supply continuity, investments surged in high-quality viral vectors, plasmids, and raw materials. Since 2020, CGT manufacturing capacity increased by 40%, driven by greater demand for plasmids and viral vectors used in gene therapy development. These advancements reinforce the long-term stability, scalability, and competitiveness of the global supply chain.
• Restraints: Despite strong growth, the market faces critical challenges, particularly workforce shortages and stringent regulatory demands. More than half of CGT manufacturing companies reported shortages of skilled GMP manufacturing and quality control personnel in early 2025. The complexity of global regulatory frameworks adds further constraints, delaying production timelines and increasing compliance expenses. These obstacles limit quick scale-up while slowing the introduction of gene therapies into global markets.

Segmentation Analysis

• By Product: Viral vectors dominate the market with 43.94% of revenue in 2024 due to their highly efficient gene delivery capabilities and established use in approved therapies such as Zolgensma and Luxturna. Continuous advancements in vector engineering and rising demand for AAV and lentiviral vectors further strengthen their leadership. Meanwhile, plasmid DNA is emerging as the fastest-growing product segment with a CAGR of 19.82%. It serves as a critical foundation for viral vector manufacturing and non-viral gene therapies, particularly as mRNA-based treatments gain momentum. Increasing requirements for high-purity GMP plasmids continue to boost demand globally.
• By Stage: Clinical therapeutics accounted for 46.76% of the market in 2024, driven by growing approvals for gene therapies targeting rare and genetic disorders. The expansion of late-stage pipelines and higher GMP-grade raw material demand reinforce segment dominance. Pre-clinical therapeutics represent the fastest-growing stage segment as biotech companies, universities, and research institutions invest heavily in exploratory studies, early-stage programs, and innovation grants. Rising venture capital funding supports development of advanced plasmid DNA and viral vector starting materials intended for future clinical translation.
• By Application: Oncology held a significant market share of 38.40% in 2024 as cancer-focused gene therapies such as CAR-T and oncolytic viruses require advanced starting materials. Increasing cancer prevalence, combined with a strong pipeline of novel cellular and genetic therapies, strengthens this segment’s leadership. Meanwhile, genetic diseases represent the fastest-growing application segment with a CAGR of 20.21%. Increasing diagnostic capabilities, genomic testing, and rare disease funding are accelerating the development of gene therapies targeting inherited disorders, further driving demand for high-quality plasmids and viral vectors.
• By End-User: Biopharmaceutical and pharmaceutical companies remain the largest end-user segment due to their financial strength, manufacturing capabilities, and integration of advanced technologies. Their ability to support global supply chains, maintain GMP standards, and expand production capacity continues to reinforce leadership. CROs and CMOs are the fastest-growing end-users, benefiting from expanded outsourcing by biopharma companies seeking efficiency and flexibility. Expertise in complex viral vector and plasmid manufacturing positions them as essential partners for accelerating commercialization.

Regional Analysis

North America dominated the global market in 2024, holding a 47.60% market share. The region benefits from robust biotechnology ecosystems, advanced research institutions, and favorable regulatory support. Strong demand for high-quality viral vectors and plasmids, combined with new clinical trials and industry partnerships, continues to support market leadership. The U.S. maintains extensive CGT manufacturing capacity and a strong pipeline of FDA-approved therapies.

Europe is emerging as a powerful regional contributor supported by strong regulatory frameworks such as the EMA PRIME initiative. Countries including Germany, the U.K., and France lead in innovation, supported by expanding CRO/CMO facilities and increased rare disease funding. Public-private partnerships continue to accelerate research and development throughout the region.

Asia Pacific is the fastest-growing market with a CAGR of 20.15%. Increasing biotech investments, favorable government initiatives, and expansion of gene therapy research infrastructure contribute to rapid growth. China, Japan, and South Korea are making large strides in plasmid DNA and viral vector manufacturing. Rising patient populations and competitive manufacturing costs further strengthen the region’s market position.

Latin America shows moderate but steady growth, driven by developing healthcare systems and rising biotech activity in Brazil and Mexico. Meanwhile, the Middle East & Africa remains the slowest-growing region due to limited resources, low R&D spending, and restricted access to gene therapy technologies.

Buy Full Research Report @ https://www.snsinsider.com/checkout/8260

Key Players

Major companies in the gene therapy starting materials market include Thermo Fisher Scientific, Sartorius AG, Merck KGaA, Catalent Inc., Aldevron, WuXi Advanced Therapies, Charles River Laboratories, Lonza Group AG, AGC Biologics, Oxford Biomedica, Brammer Bio, GenScript Biotech, Takara Bio, VGXI Inc., VIVEbiotech, Touchlight Genetics, Andelyn Biosciences, MilliporeSigma, and others. These companies collectively strengthen global supply chains, enhance GMP capabilities, and support the growth of advanced therapies worldwide.

Recent Developments

In May 2024, Aldevron launched an ultra-pure research-grade plasmid DNA platform that enables smoother transitions from early-stage development to commercial-grade manufacturing. In April 2024, Touchlight Genetics partnered with OXGENE to develop scalable AAV gene therapy manufacturing using dbDNA technology, improving efficiency and regulatory readiness for future therapies.

Related Reports

Gene Therapy Market

Cell & Gene Therapy Manufacturing Services Market

Gene Therapy Platform Market

DNA Manufacturing Market

Gene Editing Market

About Us:

S&S Insider is one of the leading market research and consulting agencies that dominates the market research industry globally. Our company’s aim is to give clients the knowledge they require in order to function in changing circumstances. In order to give you current, accurate market data, consumer insights, and opinions so that you can make decisions with confidence, we employ a variety of techniques, including surveys, video talks, and focus groups around the world.

Contact Us:

Rohan Jadhav – Principal Consultant

Phone: +1-315 636 4242 (US) | +44- 20 3290 5010 (UK)

Email: info@snsinsider.com