Cell and Gene Therapy Manufacturing Market by Therapy Type (Gene Therapy, Cell Therapy, Combination Therapies), Technology (Viral Vector Manufacturing, Non-Viral Vector Manufacturing, Cell Expansion and Culturing Technologies), Application (Oncology, Genetic Disorders, Cardiovascular Diseases, Neurological Disorders), End-User (Biopharmaceutical Companies, CDMOs, Research Institutes), Process Type (Autologous Manufacturing, Allogeneic Manufacturing); Global Insights & Forecast (2024 – 2030)

As per Intent Market Research, the Cell and Gene Therapy Manufacturing Market was valued at USD 6.5 billion in 2023 and will surpass USD 34.0 billion by 2030; growing at a CAGR of 26.7% during 2024 - 2030.

The cell and gene therapy manufacturing market has been experiencing significant growth, driven by innovations in biotechnology, a rising global demand for personalized treatments, and increasing investment in the development of novel therapies. These therapies offer groundbreaking solutions for previously untreatable diseases, particularly genetic disorders, cancers, and cardiovascular conditions. As the market expands, advancements in manufacturing technologies, including viral vector production, cell expansion, and culturing techniques, play a pivotal role in making these therapies scalable and cost-effective. Furthermore, the market is characterized by various segments, including therapy type, technology, application, end-users, and process type, each contributing to the overall evolution of the industry.

Gene Therapy Segment is Largest Owing to Growing Demand for Targeted Treatments

Gene therapy represents the largest segment in the cell and gene therapy manufacturing market. The increasing number of genetic disorders and rare diseases is driving the demand for gene therapies that can target the root causes of these conditions. These therapies often involve the introduction, alteration, or removal of genes within a patient’s cells to treat or prevent diseases. Advancements in gene editing technologies, such as CRISPR, have further fueled the potential for gene therapies to become mainstream treatments. Moreover, regulatory approvals from global agencies, such as the FDA and EMA, have led to a growing portfolio of approved gene therapies, including those for rare genetic disorders like spinal muscular atrophy and hemophilia. As a result, the gene therapy manufacturing segment is set to continue its dominance in the market.

Viral Vector Manufacturing is Fastest Growing Technology Segment Due to Its Essential Role in Gene Delivery

Among the various technologies in the cell and gene therapy manufacturing market, viral vector manufacturing is the fastest-growing. Viral vectors are crucial for delivering genetic material into a patient's cells, making them indispensable for gene therapy production. The growth of viral vector manufacturing is being driven by the increased demand for viral vector-based gene therapies and the scalability of this technology for clinical and commercial production. As more gene therapies enter clinical trials and achieve regulatory approval, the need for efficient and high-quality viral vector production has grown substantially. Companies are increasingly investing in the development of advanced viral vector manufacturing technologies to meet these demands, ensuring purity, yield, and safety in gene therapy production.

Oncology Application is Largest Owing to Rising Cancer Prevalence and Research Investment

The oncology application segment is the largest within the cell and gene therapy manufacturing market. Cancer remains one of the most prevalent and challenging health conditions globally, and innovative gene and cell therapies have shown promise in treating various forms of cancer. CAR-T cell therapies, which genetically modify a patient’s T cells to target cancer, have gained significant traction in oncology. As cancer therapies continue to evolve, the demand for cell and gene therapy manufacturing increases to meet the needs of clinical trials and commercialization. With ongoing research investments and clinical successes, oncology is expected to remain the primary application driving the demand for cell and gene therapy manufacturing solutions.

Biopharmaceutical Companies are Largest End-User in Cell and Gene Therapy Manufacturing

Biopharmaceutical companies are the largest end-users of cell and gene therapy manufacturing services. These companies are at the forefront of developing, testing, and commercializing novel gene and cell therapies. Biopharmaceutical companies partner with Contract Development and Manufacturing Organizations (CDMOs) to scale up production, ensuring that therapies are manufactured to meet regulatory standards and supply the global market. The rapid growth in biopharmaceutical investments and the increasing number of therapeutic candidates in the gene therapy pipeline continue to drive demand for specialized manufacturing services. As these companies expand their portfolios of cell and gene therapies, they remain a crucial segment for driving growth in the market.

Allogeneic Manufacturing Process is Fastest Growing Owing to Scalability and Cost-Efficiency

The allogeneic manufacturing process is the fastest-growing process type within the cell and gene therapy manufacturing market. Allogeneic manufacturing involves the use of donor cells to produce therapies, as opposed to autologous manufacturing, which requires the patient’s own cells. Allogeneic therapies offer significant advantages, including the ability to produce large batches of cells for multiple patients, making them more scalable and cost-effective compared to autologous therapies. The ability to create "off-the-shelf" therapies that can be distributed to various patients without the need for individualized production has contributed to the increasing adoption of allogeneic manufacturing processes, which is expected to continue to rise as gene therapies become more widespread.

North America is the Largest Region Owing to Robust Research and Regulatory Support

North America, particularly the United States, holds the largest market share in the cell and gene therapy manufacturing market. The region is a global leader in biotechnology and pharmaceutical research, with a high concentration of research institutions, biopharmaceutical companies, and healthcare providers. In addition to significant private and public investments in cell and gene therapy research, North America benefits from a favorable regulatory environment, with agencies like the FDA providing guidance and approvals for new therapies. The presence of advanced manufacturing facilities and infrastructure, along with strong reimbursement policies, further boosts the demand for gene and cell therapy manufacturing services in the region. North America is expected to maintain its leadership position due to continued research advancements and the rapid commercialization of gene and cell therapies.

Leading Companies and Competitive Landscape

The competitive landscape of the cell and gene therapy manufacturing market is dominated by key players such as Lonza Group, WuXi AppTec, Samsung Biologics, Gilead Sciences, Novartis, and Boehringer Ingelheim, among others. These companies are focusing on expanding their manufacturing capacities, particularly in viral vector production and cell line development, to meet the growing demand for gene and cell therapies. Strategic partnerships, mergers, and acquisitions have become common in the industry, as companies seek to strengthen their portfolios and improve manufacturing capabilities. Companies are also investing heavily in advanced technologies such as automated manufacturing platforms, cryopreservation, and bioreactor systems to ensure the efficient and scalable production of gene and cell therapies. With increasing regulatory approvals and clinical successes, these industry leaders are well-positioned to drive the growth of the market in the coming years

Recent Developments:

• Lonza Group announced the expansion of its viral vector manufacturing capabilities to support the growing demand for gene therapies. This expansion includes a new facility in Switzerland aimed at accelerating production for clinical and commercial gene therapy products.
• WuXi AppTec has partnered with Lifecore Biomedical to develop advanced manufacturing solutions for gene therapies, enhancing their ability to support viral vector production for both clinical trials and commercial scale-up.
• Gilead Sciences (Kite Pharma) received FDA approval for its latest CAR-T cell therapy, expanding its portfolio of gene therapy offerings. The approval positions Kite Pharma as a leader in the oncology gene therapy space.
• Novartis has expanded its AveXis manufacturing facility in North Carolina, significantly increasing its capacity for producing gene therapies for spinal muscular atrophy (SMA), which is a rare genetic disorder.
• Boehringer Ingelheim entered a strategic partnership with Oxford Biomedica, aiming to increase its capabilities in viral vector production to meet the increasing global demand for gene and cell therapies, particularly for oncology treatments

List of Leading Companies:

• Lonza Group
• WuXi AppTec
• Samsung Biologics
• Gilead Sciences (Kite Pharma)
• Novartis (AveXis)
• Catalent
• Sartorius AG
• MilliporeSigma
• Bayer AG
• Boehringer Ingelheim
• Regeneron Pharmaceuticals
• Bristol-Myers Squibb
• Vertex Pharmaceuticals
• Cytiva (Danaher Corporation)
• Oxford Biomedica

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