Gene Therapy Starting Materials Market Size & Growth Analysis to 2030

The global gene therapy starting materials market size was accounted at around USD 2 billion in 2024 and anticipated to register a significant CAGR of around 20% during the forecast period from 2025 to 2030. The market is a rapidly expanding segment of the biotechnology industry, driven by the growing demand for advanced therapeutic solutions to treat genetic disorders, cancers, and rare diseases. Starting materials, including plasmids, viral vectors, oligonucleotides, and enzymes, play a crucial role in the development and manufacturing of gene therapies. With the increasing number of clinical trials and FDA-approved gene therapies, there is a significant need for high-quality, GMP-compliant starting materials to ensure safety, efficacy, and regulatory compliance. This surge in gene therapy innovation, supported by government funding and private investments, is fueling the market’s growth.

Technological advancements in vector engineering, cell culture systems, and bioprocessing techniques are further enhancing the production efficiency and scalability of these starting materials. The market is also witnessing a trend toward outsourcing and partnerships between biopharmaceutical companies and specialized contract development and manufacturing organizations (CDMOs) to streamline the supply chain and reduce costs. North America dominates the market due to strong R&D infrastructure, while the Asia-Pacific region is emerging rapidly due to increasing investments and a growing patient pool. As the gene therapy landscape continues to evolve, the demand for robust, scalable, and regulatory-compliant starting materials is expected to rise significantly.

Market Snapshot:

Market Drivers:

The global gene therapy starting materials market is experiencing significant growth, propelled by advancements in gene-editing technologies, increased regulatory support, and a rising prevalence of genetic disorders. The approval of CRISPR-based therapies, such as the FDA’s late 2023 authorization of a treatment for sickle cell disease, underscores the expanding clinical adoption of gene therapies. This development has heightened the demand for high-quality starting materials like plasmids, viral vectors, and enzymes essential for manufacturing these therapies. Additionally, the growing incidence of genetic conditions like Duchenne muscular dystrophy and cystic fibrosis is driving the need for innovative treatments, further fueling the market’s expansion.​

Technological innovations are also playing a crucial role in market growth. The integration of artificial intelligence (AI) in gene therapy development is enhancing the discovery process, optimizing vector design, and accelerating clinical trial success rates. Moreover, advancements in vector engineering and bioprocessing techniques are improving the efficiency and scalability of gene therapy production. These technological strides, combined with supportive regulatory frameworks and increased investment in research and development, are expected to continue driving the demand for gene therapy starting materials in the foreseeable future.

Market Trends:

Increased Investment in Research & Development (R&D)

One of the most prominent trends is the surge in funding and investment across the gene therapy value chain. Biotechnology and pharmaceutical companies are allocating substantial resources toward the development of advanced gene therapy platforms, with a specific focus on the quality and scalability of starting materials like plasmid DNA, viral vectors, and enzymes. These investments are not only aimed at new drug development but also at enhancing manufacturing processes and ensuring regulatory compliance, especially as more gene therapies move from clinical trials to commercial use.

Advances in Gene Editing Technologies

The emergence and rapid adoption of cutting-edge gene-editing tools, such as CRISPR-Cas9, TALENs, and ZFNs, are revolutionizing the field of gene therapy. These technologies have increased the precision and scope of gene modification, making it possible to correct mutations at their source. As a result, there’s a growing demand for specialized starting materials that are compatible with these tools. This trend is expanding the market not only in terms of volume but also in diversity, as new applications in oncology, hematology, and rare genetic disorders continue to emerge.

Outsourcing to Contract Development and Manufacturing Organizations (CDMOs)

The complexity of producing GMP-compliant gene therapy starting materials has led many biopharma companies to partner with CDMOs. These organizations offer expertise, infrastructure, and regulatory know-how, which helps gene therapy developers focus on R&D while ensuring a reliable supply of high-quality materials. This outsourcing trend is gaining momentum as it provides flexibility, cost-efficiency, and scalability—critical factors in a highly dynamic and regulated market.

Customization and Innovation in Viral Vectors and Plasmids

There’s a strong focus on the customization of viral vectors (especially AAV, lentivirus, and retrovirus) and plasmids to improve transduction efficiency, tissue targeting, and safety profiles. Researchers and manufacturers are designing vectors that can be tailored to specific therapeutic needs, such as treating central nervous system disorders or hematological diseases. Custom plasmids, with optimized promoters and regulatory elements, are also gaining traction as they allow more effective gene expression. These innovations are essential to enhancing treatment outcomes and minimizing off-target effects.

Supportive Regulatory Frameworks and Approvals

Regulatory bodies, particularly in the U.S. and Europe, are playing a crucial role in accelerating the gene therapy landscape. Agencies like the FDA have not only fast-tracked several gene therapies but have also introduced streamlined pathways such as the RMAT (Regenerative Medicine Advanced Therapy) designation. These frameworks are encouraging greater participation from developers and investors alike, thereby boosting demand for starting materials that meet stringent quality and safety standards.

Market Opportunities:

The global gene therapy starting materials market is witnessing significant opportunities, particularly with the approval of groundbreaking therapies. In December 2023, the U.S. FDA approved Casgevy (exagamglogene autotemcel), developed by Vertex Pharmaceuticals and CRISPR Therapeutics, marking the first CRISPR/Cas9 gene-edited therapy authorized for treating sickle cell disease. This milestone not only validates the potential of gene-editing technologies but also underscores the increasing demand for high-quality starting materials such as plasmids and viral vectors essential for manufacturing these advanced therapies. ​

Furthermore, companies like Autolus are expanding the market’s scope by developing innovative CAR-T therapies. Autolus’s Aucatzyl, approved by the FDA in November 2024 for treating acute lymphoblastic leukemia, exemplifies advancements in personalized cancer treatments. The therapy’s design aims to reduce side effects by shortening the binding duration to cancer cells, highlighting the need for specialized starting materials tailored to such precise mechanisms. These developments indicate a growing opportunity for suppliers of gene therapy starting materials to cater to the evolving requirements of next-generation therapies.

Market Segment Insights:

The global gene therapy starting materials market is bifurcated into product, development stage, application, end-use, and geography. On the basis of application., the oncology is the dominant segment in the global market, accounting for the largest revenue share of over 1/3 of the global market in 2024 due to the high global incidence of cancer and the rapid advancement of gene-based cancer treatments. Therapies such as CAR-T (Chimeric Antigen Receptor T-cell) have revolutionized the way hematologic cancers are treated by using a patient’s own modified immune cells to target tumors. These therapies require a variety of starting materials like plasmids, viral vectors, and transfection reagents in large volumes and high quality to ensure safety and efficacy. The success of products such as Kymriah and Yescarta, coupled with the recent FDA approval of Autolus’s Aucatzyl for acute lymphoblastic leukemia in November 2024, reflects both the clinical relevance and commercial potential of gene therapies in oncology.

Furthermore, the oncology segment benefits from strong R&D investments, robust clinical pipelines, and strategic collaborations between biotech firms and pharmaceutical giants. Companies are increasingly focusing on developing personalized cancer therapies, which demand highly specialized starting materials tailored to specific cancer types and patient profiles. As more solid tumor indications are explored and addressed through gene-based approaches, the need for custom plasmid constructs, high-titer viral vectors, and other critical materials is expected to surge. These trends firmly position oncology as the growth engine of the gene therapy starting materials market for the foreseeable future.

The gene therapy starting materials market research report presents the analysis of each segment from 2020 to 2030 considering 2023 as the base year for the research. The compounded annual growth rate (CAGR) for each respective segment is calculated for the forecast period from 2025 to 2030.

Historical & Forecast Period

• 2020-23 – Historical Year
• 2024 – Base Year
• 2025-2030 – Forecast Period

Market Segmentation:

By Product:

• Viral Vectors
  • Adenovirus
  • Retrovirus
  • Adeno-Associated Virus (AAV)
  • Lentivirus
  • Others
• Plasmid DNA
• Cell Lines
• Others

By Development Stage:

• Pre-clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics

By Application:

• Oncology
• Infectious Disease
• Genetic Disease
• Others

By End-Use:

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Others

By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

Regional Analysis:

Geographically, the North America stands as the dominant region in the global gene therapy starting materials market, contributing 1/2 of the global market share as of 2024. This leadership is attributed to the region’s advanced healthcare infrastructure, substantial investments in research and development, and a favorable regulatory environment. The United States, in particular, plays a pivotal role, accounting for approximately 89% of the North American gene therapy market. The presence of major pharmaceutical companies, research institutions, and a robust pipeline of gene therapy products has positioned North America as a global leader in this field. The region benefits from substantial healthcare spending, increased investment in biotechnology, and growing awareness about genetic disorders.​

A notable example of North America’s dominance is the FDA’s expanded approval of Sarepta Therapeutics’ gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD) in June 2024. This approval allows the therapy’s use in a broader patient population, covering approximately 90% of U.S. DMD patients. Such developments underscore the region’s capacity to lead in gene therapy innovations and the corresponding demand for high-quality starting materials necessary for manufacturing these advanced therapies. The combination of scientific advancement, regulatory support, and market readiness solidifies North America’s position at the forefront of the Gene Therapy Starting Materials Market.

Competitive Landscape:

Some of the leading market players operating in the global gene therapy starting materials market are Thermo Fisher Scientific, Lonza Group, Merck KGaA, Catalent Inc., and Charles River Laboratories. Companies are exploring markets by expansion, new investment, the introduction of new services, and collaboration as their preferred strategies. Players are exploring new geography through expansion and acquisition to gain a competitive advantage through joint synergy.

Key Companies:

• Thermo Fisher Scientific
• Lonza Group
• Merck KGaA
• Catalent Inc.
• Charles River Laboratories
• GenScript Biotech
• Eurofins Scientific
• Danaher
• Revvity, Inc.
• Sartorius AG

Key Questions Answered by Gene Therapy Starting Materials Market Report

• Global gene therapy starting materials market forecasts from 2025-2030
• Regional market forecasts from 2025-2030 covering Asia-Pacific, North America, Europe, Middle East & Africa, and Latin America
• Country-level forecasts from 2025-2030 covering 15 major countries from the regions as mentioned above
• Gene therapy starting materials submarket forecasts from 2025-2030 covering the market by product, development stage, application, end-use, and geography
• Various industry models such as SWOT analysis, Value Chain Analysis about the market
• Analysis of the key factors driving and restraining the growth of the global, regional, and country-level gene therapy starting materials markets from 2025-2030
• Competitive Landscape and market positioning of top 10 players operating in the market