Gene Therapy Starting Materials Market (2025 - 2030) Size, Share & Trends Analysis Report By Product (Viral Vectors, Plasmid DNA, Cell Lines), By Development Stage, By Application, By End Use, By Region, And Segment Forecasts

Market Size & Trends

The global gene therapy starting materials market size was estimated at USD 1.90 billion in 2024 and is projected to grow at a CAGR of 19.24% from 2025 to 2030. This strong growth is driven by the rising demand for advanced treatments targeting genetic disorders, cancer, and rare diseases. As gene therapies become more common, the need for high-quality raw materials like plasmids, viral vectors, and enzymes continues to increase. In addition, investments in R&D, regulatory support, and the expansion of manufacturing capacity are helping the market grow steadily.

The COVID-19 pandemic served as a strategic accelerator for the gene therapy starting materials industry due to the rapid advancements in vaccine development and increased focus on genetic research. The urgent need for novel treatments highlighted the importance of gene-based technologies, boosting investments in related raw materials like plasmids and viral vectors. The pandemic also strengthened global collaboration, fast-tracked regulatory approvals, and encouraged biotech firms to expand production capacities. These factors created a strong foundation for long-term market growth, positioning gene therapy as a key area in future medical innovation.

Furthermore, advanced treatments targeting genetic disorders are anticipated to grow significantly over the forecast period. This is attributed to rising awareness, increasing diagnosis rates, and advancements in gene-editing technologies such as CRISPR. Supportive government initiatives, growing R&D funding, and a strong pipeline of gene therapy candidates are also contributing to this trend. As more gene therapies receive regulatory approval, the demand for high-quality starting materials is expected to rise, further driving market expansion.

In addition, investments in R&D play a key role in driving innovation in gene therapy. Increased funding from both the public and private sectors is leading to the development of safer and more effective therapies. These investments are also supporting the improvement of manufacturing processes, ensuring better scalability and quality of starting materials. As a result, companies are better equipped to meet the growing demand, accelerating the commercialization of gene-based treatments.

Robust Pipeline Progress Fuels Growth in the Global Gene Therapy Industry

The global gene therapy pipeline maintained strong growth momentum from Q1 to Q4 2024, driven by a surge in clinical activity and continued innovation in therapeutic development. The field is rapidly evolving as a core pillar of precision medicine, with gene therapies increasingly recognized for their potential to address unmet medical needs in rare diseases, oncology, and genetic disorders. Biopharmaceutical companies, research institutions, and CDMOs are collectively advancing their pipelines to capitalize on this opportunity.

Clinical-stage activity expanded steadily throughout the year. The number of therapies in Phase I and Phase II trials increased each quarter, supported by encouraging early-stage results and a growing number of Investigational New Drug (IND) applications. While Phase III remained stable, the significant rise in pre-registration programs-nearly doubling from Q3 to Q4-indicates that a growing number of gene therapies are nearing regulatory submission, a crucial milestone in commercialization.

Table 1: Number of Gene Therapy Studies by Stage and Quarter, 2024

Preclinical development also remained strong, reflecting ongoing discovery efforts and the entry of new candidates into the pipeline. This consistency points to a healthy innovation cycle, with strong upstream R&D feeding the clinical development funnel. Companies are actively investing in platform technologies, such as viral vectors and plasmid DNA, to ensure scalability and regulatory compliance.

As the pipeline advances, the demand for high-quality starting materials, advanced manufacturing technologies, and regulatory-ready infrastructure is rising. Market participants are responding by enhancing production capacity, forming strategic alliances, and adopting automation to reduce timelines and improve operational efficiency-further strengthening the industry’s commercial outlook.

Viral Vector Innovation Driving Gene Therapy Industry

The gene therapy starting materials industry is experiencing significant growth, propelled by advancements in viral vector technologies. Viral vectors, particularly adeno-associated viruses (AAVs), are essential for delivering therapeutic genes into target cells. Innovations in capsid engineering are enhancing vector specificity and efficiency, reducing required dosages and minimizing immune responses. These improvements are critical for expanding the therapeutic applications of gene therapies and improving patient outcomes.

Manufacturing scalability remains a challenge, with the production of high-quality viral vectors being complex and resource-intensive. Efforts are underway to optimize production processes, including the development of more efficient cell lines and purification methods to increase yields and reduce costs. Addressing these manufacturing hurdles is vital for meeting the growing demand for gene therapies and ensuring their commercial viability.

The market is also witnessing increased investment and collaboration among biotech firms, pharmaceutical companies, and academic institutions. These partnerships aim to accelerate research and development, streamline regulatory pathways, and expand the pipeline of gene therapy candidates. As a result, the gene therapy starting materials industry is poised for continued expansion, driven by technological advancements and a robust clinical pipeline.

Market Concentration & Characteristics

Innovation in the gene therapy starting materials industry is driven by advancements in biotechnology, automation, and manufacturing processes. These developments enable higher purity, improved yield, and faster production of key components like plasmids and viral vectors. As technologies evolve, companies can streamline workflows, reduce costs, and enhance scalability, making gene therapies more accessible and commercially viable.

The gene therapy starting materials industry is experiencing increased M&A activity, with leading companies acquiring specialized firms to bolster their portfolios, integrate end-to-end capabilities, and scale production. These strategic moves are driven by the need to meet growing clinical and commercial demand, enhance innovation pipelines, and secure a stronger foothold in the competitive gene therapy ecosystem.

Regulatory frameworks play a crucial role in product development and commercialization in the gene therapy starting materials industry. Strict guidelines ensure product safety, quality, and consistency, which are essential for gaining approval. Regulatory bodies also provide pathways for fast-track approvals and support innovation through updated policies. As global regulations evolve, companies must adapt quickly to remain compliant and competitive, making regulatory alignment a key factor in market success.

The gene therapy starting materials industry is seeing continuous product expansion as companies introduce a wide range of high-performance starting materials to meet growing demand. This includes advanced plasmids, viral vectors, and enzymes tailored for improved efficiency, safety, and scalability. Ongoing innovation is enabling better customization for specific therapeutic applications, while also supporting faster production timelines. Such developments are helping companies strengthen their market position and cater to the evolving needs of the gene therapy industry.

Leading companies in the gene therapy starting materials industry are expanding their presence across key regions to strengthen their global footprint. This includes setting up new manufacturing facilities, forming strategic partnerships, and increasing investments in emerging markets. By enhancing their regional reach, these companies aim to improve supply chain efficiency, meet local regulatory requirements, and respond more effectively to the growing global demand for gene therapy products.

Product Insights

The viral vectors segment led the market with the largest revenue share of 42.91% in 2024, driven by their essential role in facilitating the transfer of genetic material in gene therapy applications. Their high transfection efficiency, reliability, and widespread use in approved and late-stage therapies have positioned them as a preferred choice in the industry. Strong demand from biopharmaceutical companies, coupled with growing R&D investments, continues to support the segment’s dominant market position.

The plasmid DNA segment is projected to grow at the fastest CAGR of 20.13% over the forecast period, fueled by increasing demand for DNA-based therapies, vaccines, and cell and gene therapy manufacturing. Plasmid DNA serves as a critical raw material for producing viral vectors and mRNA, making it essential in upstream processes. Advancements in production technologies and growing investments in biotech research are further accelerating segment growth.

Development Stage Insights

Based on development stage, the clinical therapeutics segment led the market with the largest revenue share of 48.07% in 2024, which can be attributed to the growing number of gene therapy candidates advancing through clinical trials. Increased regulatory approvals, strong investment in therapeutic development, and rising demand for personalized treatments have further driven this segment’s growth. In addition, the expanding pipeline of therapies targeting rare and genetic diseases continues to boost the need for high-quality starting materials in clinical applications.

The pre-clinical therapeutics segment is anticipated to grow at the fastest CAGR of 19.84% during the forecast period. This is attributed to increased early-stage R&D activities, rising investments in novel gene therapy platforms, and a growing focus on rare and inherited diseases. Expanding biotech pipelines are also fueling demand for high-quality starting materials in pre-clinical development.

Application Insights

Based on application, the oncology segment led the market with the largest revenue share of 37.90% in 2024 and is anticipated to grow at the fastest CAGR over the forecast period. This is attributed to the growing adoption of gene therapies for cancer treatment. The rising global cancer burden has accelerated demand for targeted and personalized therapies, with gene therapy offering promising outcomes in hard-to-treat cancers. Increased clinical trial activity, regulatory approvals, and investment in oncology-focused gene therapies have further strengthened the segment. In addition, the development of advanced vectors and delivery systems tailored for cancer applications has enhanced treatment effectiveness, supporting the segment’s leading position in the market.

The genetic disease segment is projected to grow at a significant CAGR of 19.36% over the forecast period. Rising diagnosis rates, advancements in gene-editing technologies, and increasing availability of targeted therapies are driving the growth of the segment. Growing R&D efforts and supportive regulatory pathways for rare and inherited disorders are also accelerating development, boosting demand for high-quality starting materials in this segment.

End Use Insights

Based on end use, the biopharmaceutical and pharmaceutical companies segment led the market with the largest revenue share of 51.89% in 2024. The segment is propelled by the increasing adoption of gene therapy in drug development pipelines and the growing demand for high-quality starting materials. These companies are heavily investing in R&D, expanding manufacturing capabilities, and forming strategic collaborations to accelerate the development of innovative therapies. In addition, the rising number of clinical trials and regulatory approvals is driving the need for consistent and scalable raw material supply. The focus on treating rare and complex diseases through gene-based solutions further supports the segment’s strong market position and continued growth.

The CROs & CMOs segment is projected to grow at the fastest CAGR over the forecast period. This is driven by the increasing trend of outsourcing among biopharmaceutical and pharmaceutical companies. As gene therapy development becomes more complex and resource-intensive, companies are turning to CROs and CMOs for their specialized expertise, cost-effective solutions, and ability to accelerate timelines. These service providers offer end-to-end support, from research and development to large-scale manufacturing, helping clients meet regulatory requirements and focus on core innovation. In addition, the growing pipeline of gene therapies and demand for flexible, scalable production capabilities are further propelling growth in this segment.

Competitive Scenario Insights

The gene therapy starting materials industry is witnessing intensifying competition as both established and emerging players expand their capabilities to meet rising global demand. Leading companies such as Thermo Fisher Scientific, Inc., Lonza, and Catalent continue to dominate the landscape through robust manufacturing infrastructure, comprehensive service offerings, and end-to-end solutions that support clinical and commercial-scale gene therapy development. Their strategic focus on partnerships, acquisitions, and global footprint expansion strengthens their market leadership and sets industry standards for quality, scalability, and regulatory compliance.

Emerging players like GenScript and Revvity, Inc. are gaining traction by offering specialized solutions in plasmid DNA synthesis, cell line development, and viral vector manufacturing. Their agility in adopting advanced technologies and customizing solutions to specific therapeutic needs positions them as key collaborators in early-stage and niche markets. Meanwhile, innovation-driven companies such as Sartorius AG and Danaher are leveraging their expertise in bioprocessing, automation, and analytics to streamline upstream and downstream workflows. These players are enhancing efficiency and accelerating timelines, critical for meeting the fast-paced development cycles of gene therapies.

Companies like Charles River Laboratories, Merck KGaA, and Eurofins Scientific continue to expand their offerings in quality testing, regulatory support, and preclinical development-playing a vital role in ensuring safety and compliance across the gene therapy value chain.

Regional Insights

North America dominates the gene therapy starting materials market with the largest revenue share of 48.23% in 2024, due to the presence of a well-established biotechnology and pharmaceutical industry, advanced healthcare infrastructure, and strong investment in gene therapy research. The region benefits from early adoption of innovative technologies, a high concentration of clinical trials, and favorable regulatory frameworks that support accelerated approvals. Leading market players have significant operations across the U.S. and Canada, further strengthening supply chains and product availability. In addition, robust academic and research institutions actively collaborating with industry players contribute to continued innovation. Government support through funding and policy initiatives also plays a key role in maintaining North America’s leadership in the global gene therapy space.

U.S. Gene Therapy Starting Materials Market Trends

The gene therapy starting materials market in the U.S. leads due to strong R&D investment, a high volume of clinical trials, and a mature biopharmaceutical ecosystem. The presence of major industry players, advanced manufacturing capabilities, and supportive regulatory pathways further drive market growth. In addition, collaborations between academic institutions and biotech firms fuel innovation, reinforcing the position as a global hub for gene therapy development.

Europe Gene Therapy Starting Materials Market Trends

The gene therapy starting materials market in Europe experiences steady due to rising investments in biotechnology, supportive regulatory initiatives, and an increasing number of clinical trials across key countries. Strong academic research, government funding, and collaborations between industry and healthcare institutions further support innovation. In addition, the growing demand for advanced therapies targeting rare and genetic diseases contributes to the region’s expanding market presence.

The UK gene therapy starting material market is seeing rising adoption of gene therapy starting materials due to strong government support, growing biotech investments, and a focus on rare disease research. Advanced healthcare infrastructure and active academic-industry collaborations also contribute to the country’s expanding role in gene therapy development.

The gene therapy starting material market in Germany benefits from advanced bio-manufacturing capabilities, significant public and private R&D investments, and a growing pipeline of gene therapy projects. The country’s focus on innovation, quality standards, and academic-industry partnerships supports steady market expansion and strengthens its position within the European biotech landscape.

Asia Pacific Gene Therapy Starting Materials Market Trends

The gene therapy starting materials market in Asia Pacific exhibits rapid growth owing to increasing investments in biotechnology, expanding clinical research, and rising demand for innovative therapies targeting genetic and rare diseases. Supportive government initiatives, growing partnerships between local and global biopharma companies, and improvements in healthcare infrastructure are further driving market expansion. Key countries such as China, Japan, and South Korea are leading this growth, backed by a strong focus on R&D, regulatory advancements, and the development of large-scale manufacturing capabilities.

The China gene therapy starting materials market is expected to grow at a significant CAGR during the forecast period, due to strong government support, rising healthcare investments, and rapid advancements in biotech research. The country’s expanding clinical trial landscape, growing number of biopharma companies, and focus on rare and genetic diseases are driving demand. In addition, improvements in manufacturing infrastructure and regulatory reforms are accelerating market development.

The gene therapy starting material market in Japan is growing due to strong government support, a well-established pharmaceutical sector, and an increasing focus on regenerative medicine. Advancements in research, favorable regulatory policies, and collaborations between academic institutions and biotech companies are further driving demand and innovation in the market.

MEA Gene Therapy Starting Materials Market Trends

The gene therapy starting materials market in the Middle East and Africa is projected to grow the demand for gene therapy starting materials due to the increasing investment in healthcare infrastructure, the rising prevalence of genetic disorders, and growing awareness of advanced treatment options. Governments in the region are enhancing support for biotechnology and precision medicine initiatives, while partnerships with global pharmaceutical companies are helping to introduce cutting-edge therapies. In addition, the expansion of clinical research centers and improved access to diagnostic services are contributing to the steady development of the gene therapy landscape across these emerging markets.

The Kuwait gene therapy starting materials marketis anticipated to grow at a steady CAGR during the forecast period, due to rising interest in advanced medical technologies, increased healthcare spending, and government initiatives supporting biotech development. Growing awareness of genetic disorders and expanding diagnostic capabilities also contribute to the market’s positive outlook.

Key Gene Therapy Starting Materials Company Insights

Key players operating in the gene therapy starting materials industry are undertaking various initiatives to strengthen their market presence and increase the reach of their products and services. Strategies such as expansion activities and partnerships are key in propelling market growth.

Recent Developments

• In April 2025, ProBio launched GMP plasmid DNA manufacturing services at its Hopewell facility, offering end-to-end production from cell bank to batch release within three months. With integrated analytical testing, method development, and project management, the facility aims to accelerate the development timelines for gene and cell therapies.

• In April 2024, Cellistic launched Echo-NK, a scalable platform designed to support Off-the-Shelf allogeneic immune cell therapies. Leveraging the therapeutic potential of Natural Killer (NK) cells, the platform offers drug developers a commercially viable solution for targeting blood cancers, solid tumors, and autoimmune diseases.

• In March 2025, Bharat Biotech launched India’s first vertically integrated cell and gene therapy and viral vector production facility at Genome Valley. This purpose-built infrastructure marks the company’s expansion from vaccine innovation into advanced regenerative and personalized therapies, strengthening its position in the biopharma sector.

Gene Therapy Starting Materials Market Report Scope

Global Gene Therapy Starting Materials Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and analyzes the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global gene therapy starting materials market report based on product, development stage, application, end use, and region.

• Product Outlook (Revenue, USD Billion, 2018 - 2030)

  • Viral Vectors

    • Adenovirus

    • Retrovirus

    • Adeno-Associated Virus (AAV)

    • Lentivirus

    • Others

  • Plasmid DNA

  • Cell Lines

  • Others

• Development Stage Outlook (Revenue, USD Billion, 2018 - 2030)

  • Pre-clinical Therapeutics

  • Clinical Therapeutics

  • Marketed Therapeutics

• Application Outlook (Revenue, USD Billion, 2018 - 2030)

  • Oncology

  • Infectious Disease

  • Genetic Disease

  • Others

• End Use Outlook (Revenue, USD Billion, 2018 - 2030)

  • Biopharmaceutical & Pharmaceutical Companies

  • CROs & CMOs

  • Others

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • UAE

    • Saudi Arabia

    • Kuwait