Cell and Gene Therapy Manufacturing Market

The global Cell and Gene Therapy Manufacturing Market is valued at USD 12.58 Billion in 2024 and is projected to reach a value of USD 168.6 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 26.62% between 2025 and 2035.

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Manufacturing cell and gene therapies have emerged as a revolutionary area of medicine, providing hope for cures for many diseases. This quickly developing industry has grown significantly in recent years, significantly contributing to patient care and medical research improvements. The successful development and commercialization of CAR-T (Chimeric Antigen Receptor T-cell) therapies, which have completely changed the lives of patients with specific types of blood cancer, is one of the most outstanding achievements in this field. With CAR-T therapy, cancer cells are targeted and destroyed by the patients own immune cells, resulting in long-term remission rates that were previously unheard of with conventional therapies. The most recent advancement in treating genetic diseases like spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD) is another noteworthy illustration of progress in manufacturing cell and gene therapies. Clinical trials have shown how effectively gene therapy can correct genetic mutations and offer patients with these crippling conditions significant clinical benefits. These advancements have opened up new treatment options for rare diseases while enhancing the quality of life for those affected.

The ratio of clinically successful cellular and gene-modified therapy products to the number of clinical trials has improved over the last few years, as seen in the healthcare sector. This is due to improved scientific and clinical knowledge of the safety risks associated with using these products. 329 cell and gene therapies were undergoing clinical trials as of May 2022, and the number is anticipated to rise sharply in the ensuing years. In addition, 13 new cell or gene therapies could be approved by the end of 2023. Patients can now choose from six CAR-T cell therapies that received approval from the FDA to treat different types of blood cancers. They are just one of many promising cell and gene therapies being developed to treat both common and rare diseases. Moreover, three new therapies for treating rare diseases and one for treating bladder cancer were approved in 2022, setting a record for the approval of never before authorized gene therapies. Five treatments already approved in the US or Europe were also approved for the first time in a new region or for a different indication. But this is only the waves first wave of swell.

Key Takeaways

• The cell therapy manufacturing segment dominated the market with a revenue share of 60.1% in 2024.
• The commercial-scale manufacturing segment is projected to have the highest CAGR during the forecast period.
• North America had the highest revenue share of 48.20% in 2024.

Economic Insights

Numerous economic factors significantly impact the market for cell and gene therapy manufacturing. The high cost of making these therapies is one important determinant. Complex and expensive techniques used in the development and manufacturing processes, like gene editing and cell culture, call for cutting-edge technology and qualified personnel. Because of this, producing these therapies continues to be expensive, making them unaffordable for many patients and healthcare systems. Additionally, the time and expense of manufacturing are frequently increased by the strict guidelines that regulatory bodies impose to guarantee the safety and effectiveness of these therapies. The development of the market and Cell and Gene Therapy Manufacturing s ability to be profitable can be hampered by these regulatory barriers. On the other hand, gene therapy businesses have received investments totaling about USD 2.3 billion. This remarkably high sum demonstrates that major gene therapy companies receive investments from major pharmaceutical and biotechnology corporations worldwide. Gene and cell therapy are active investment areas for major service providers, including CDMOs/CMOs and internal manufacturers.

Top Market Trends

1. Humanized and Personalized Cell Treatment is Receiving More Attention: The production of cell and gene therapies has seen rapid expansion in recent years, with a growing emphasis on humanized and personalized cell treatment. The need for medicines that can be customized to meet the needs of specific patients as well as the likelihood that these therapies will better patient outcomes, lower treatment costs, and increase patient satisfaction, are driving this movement. As a result, a wide range of illnesses, from rare genetic abnormalities to malignancies, are targeted by cell and gene treatment research and development. Major market participants are also investing in automated systems and technical breakthroughs to enhance the manufacturing of these medicines.
2. Increased Adoption of Automation and Robotics: Manufacturers are using automation and robotics to boost productivity and lower the risk of human error due to the rising demand for cell and gene therapies. This trend is anticipated to persist as businesses work to improve productivity and streamline the manufacturing process.
3. Modern Bioprocessing Techniques: The production of cell and gene therapies is increasingly dependent on bioprocessing techniques like closed systems and single-use systems. With the aid of these technologies, manufacturers can guarantee product sterility and preserve its integrity throughout the manufacturing process. The manufacturing market is expected to expand in the upcoming years due to the development of novel bioprocessing technologies.
4. Increasing Manufacturing Activity Outsourcing: As the cell and gene therapy market keeps growing, many businesses are choosing to outsource their manufacturing to specialized contract manufacturing organizations (CMOs). This trend enables businesses to concentrate on their core competencies while utilizing the skills and resources of CMOs to quicken the development and manufacturing of their therapeutics.

Market Segmentation

The global Cell and Gene Therapy Manufacturing market can be categorized on the following: Therapy Type, Application, Indication, End-User, and Region. Based on the Therapy Type, the market can be categorized into Gene Therapy (Non-viral Vectors and Viral Vectors) and Cell Therapy (Allogeneic, Autologous, and Viral Vector). Furthermore, based on the Application segment, the market can be divided further into Clinical Manufacturing and Commercial Manufacturing. Moreover, based on Indication, it is categorized as Oncology Diseases, Inherited Disorders, Cardiovascular Diseases, Musculoskeletal Disorders, Neurological Diseases, and Other Indications. In addition, based on the segment End-User, the market can be categorized further into Pharmaceutical & Biotechnology Companies, Contract Manufacturing Organizations (CMOs), Research Institutes & Academic Centers, Regulatory Agencies, and Other End-Users. Likewise, based on Region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Based on the Therapy Type

The success of CAR-T Cell Treatment Has Fuelled the Growth of the Cell and Gene Therapy Manufacturing Market

Due to several factors, the Cell and Gene Therapy Manufacturing market is now dominated by the cell therapy category. Cell therapies have demonstrated excellent promise in treating various illnesses like cancer, cardiovascular conditions, and autoimmune diseases. For instance, CAR-T cell therapy, which genetically modifies an individuals own immune cells to target and eradicate cancerous cells, has revolutionized the treatment of specific types of leukemia and lymphomas. This treatment aims to kill cancer cells by genetically modifying a patients immune cells, known as T-cells, to produce chimeric antigen receptors (CARs) on their surface. The development of the Cell and Gene Therapy Manufacturing Market has been fueled by the success of CAR-T cell therapy, which resulted in the regulatory agencies' approval of many medications.

Based on Application

Commercial Manufacturing Enables Regulated and Standardized Procedures to Guarantee the Reliability and Security of Cell and Gene Therapies

Commercial manufacturing dominates the application segment of the market for manufacturing cells and genes for therapies. To mass produce and distribute cell and gene therapies and serve a larger patient population, commercial manufacturing is, first and foremost, necessary. These treatments are used to treat various illnesses, including cancer, genetic disorders, and autoimmune diseases. They frequently involve genetically altered living cells. Commercial manufacturing is therefore required to meet the rising demand and guarantee the accessibility of these treatments on a larger scale. Commercial producers follow stringent Good Manufacturing Practise (GMP) standards and regulatory guidelines, essential to ensuring effectiveness and safety.

Based on Indication

Cell and Gene Therapies have Shown Significant Results in Treating Various Types of Cancer.

The dominance of oncology in the Cell and Gene Therapy Manufacturing market is largely due to the prevalence of cancer. Considering the millions of new cancer cases diagnosed yearly, it is a major global health concern. Regulatory agencies have been more open to approving cell and gene therapies for oncology indications than other therapeutic areas because of the high demand for effective cancer treatments, which has stimulated investment in Cell and Gene Therapy Manufacturing, particularly in oncology indications. This supportive regulatory environment has made developing and producing cell and gene therapies for cancer easier.

Based on End-User

Pharmaceutical and Biotechnology Companies are the Dominating End-Users in the Cell and Gene Therapy Manufacturing Market.

Pharmaceutical and biotechnology companies predominately control the end-user segment in manufacturing cell and gene therapies. These businesses are essential in advancing the research and development initiatives meant to provide patients with cutting-edge therapies. Pharmaceutical and biotechnology companies have been actively investing in Cell and Gene Therapy Manufacturing to take advantage of the enormous potential of these therapies. These companies have extensive experience in drug discovery and development. For instance, Kymriah, a CAR-T cell therapy developed by Novartis, a renowned pharmaceutical company, has been given regulatory approval in numerous nations for treating specific types of cancer. To ensure the large-scale production of this therapy, the company has heavily invested in developing manufacturing capabilities, demonstrating its dedication to cells.

Based on Region

North America to Lead Global Sales Owing to the Growing Need for Personalised Treatment

The region with the biggest market share in the manufacturing of cell and gene therapies is North America. Due to numerous top biotech and pharmaceutical companies, the region is predicted to experience tremendous growth in the manufacturing of cell and gene therapies. The market expansion in the North American region is primarily due to the United States. High healthcare costs, a robust regulatory environment for the production of cell and gene therapies, and rising investments in biotechnology research & development are a few of the reasons fueling the markets expansion in the area. In addition, the area has a strong infrastructure and qualified healthcare workers who contribute to the markets expansion. The regions market is expected to increase due to rising interest in personalized medicine and demand for cutting-edge treatments for chronic illnesses like cancer and genetic abnormalities. Moreover, the regions demand for Cell and Gene Therapy Manufacturing is rising as chronic diseases like cancer and genetic abnormalities become more common. The market in the area is growing due to the presence of well-known businesses like Pfizer Inc., Novartis International AG, and Incyte Corporation, among others. Due to favorable government regulations, rising financing, and technological breakthroughs in the biotechnology industry, the North American area is anticipated to maintain its position as the global leader in manufacturing cell and gene therapies.

Competitive Landscape

Numerous international and regional actors compete fiercely on the global market. Major corporations engage in strategic alliances, mergers & acquisitions, and joint ventures to acquire a market advantage. In addition, manufacturers concentrate on capacity expansions and R&D for new product development to offer consumers products that are on trend. One notable example is Novartis, a top pharmaceutical company that gained notoriety when its CAR-T cell therapy, Kymriah, was approved. This ground-breaking therapy was the first CAR-T therapy for specific types of leukemia and lymphoma to receive FDA approval. To meet the rising demand for CAR-T therapies, Novartis spent much time and money developing cutting-edge manufacturing facilities. This included automated production lines, quality control measures, and capacity expansion plans to guarantee a consistent supply of their therapy.

The key players in the global Cell and Gene Therapy Manufacturing market include - Lonza (Switzerland) among others.

Recent Market Developments

• July 13, 2023: The $30 M Series A financing for CoJourney Inc., a leading manufacturer and developer of cell and gene therapies, has been completed. The company is also expanding its US organization and commercial manufacturing capabilities. Legend Star Investment Management, Lake Bleu Capital, GL Ventures, and Legend Capital all contributed to this funding round. To support end-to-end custom development and manufacturing for genetic medicines, including plasmids, viral vectors, and mRNA, CoJourney has created high-efficiency processes.
• June 7, 2023:The Cell and Gene Therapy Catapult (CGT Catapult) opened new labs at the University of Edinburghs Institute of Regeneration and Repair, its first location in Scotland. The labs are located in the Edinburgh BioQuarter. CGT Catapult hopes to offer knowledge, resources, and technology to assist cell therapy developers in improving their manufacturing processes and navigating the intricate regulatory requirements associated with bringing these therapies to market with its new 350m2 high-specification laboratory space.
• May 25, 2023: To develop its technological platforms and accelerate the creation, manufacturing, and development of cell and gene therapies, ElevateBio has raised $401 million in a Series D financing round.

Segmentation of the Global Cell and Gene Therapy Manufacturing Market