Reports - Cell and Gene Therapy Manufacturing Market
Cell and Gene Therapy Manufacturing Market Size, Share & Trends Analysis Report by Type (Cell Therapy, Gene Therapy) by Indication (Oncology Diseases, Inherited Disorders, Cardiovascular Diseases, Musculoskeletal Disorders, Neurological Diseases, Other Indications) by Application (Clinical Manufacturing, Commercial Manufacturing) by End User (Pharmaceutical & Biotechnology Companies, Contract Manufacturing Organizations (CMOs), Research Institutes & Academic Centers, Regulatory Agencies, Other End Users) by Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa) - Global Industry Assessment (2017 - 2022) & Forecast (2023 - 2030)
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2035
26.62%
North America
Asia Pacific
2019 - 2023
2023 - 2035
The final deliverable will encompass both quantitative and qualitative data, providing a comprehensive analysis of the market. The scope is customizable.
The global Cell and Gene Therapy Manufacturing Market is valued at USD 12.58 Billion in 2022 and is projected to reach a value of USD 168.6 Billion by 2030 at a CAGR (Compound Annual Growth Rate) of 26.62% between 2023 and 2030.
Premium Insights
The manufacturing of cell and gene therapies has emerged as a revolutionary area of medicine, providing hope for cures for many diseases. This quickly developing industry has undergone significant growth in recent years, making significant contributions to improvements in patient care and medical research. 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 the treatment of genetic diseases like spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD) is another noteworthy illustration of progress in the manufacturing of 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 also enhancing the quality of life for those who are 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 the use of 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 that are 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 that were 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:
Economic Insights
The market for manufacturing cell and gene therapies is being significantly impacted by numerous economic factors. 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 in order to guarantee the safety and effectiveness of these therapies. The development of the market and the ability of cell and gene therapy manufacturing to be profitable can both 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 are receiving investments from major pharmaceutical and biotechnology corporations from around the world. Gene and cell therapy are active areas of investment for major service providers, including CDMOs/CMOs and internal manufacturers.
Top Market Trends
Market Segmentation
The global Cell and Gene Therapy Manufacturing market can be categorized on the following: Therapy Type, Application, Indication, End-User, and Regions. 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). Based on Application, the market can be divided into Clinical Manufacturing and Commercial Manufacturing. By Indication, it is categorized as Oncology Diseases, Inherited Disorders, Cardiovascular Diseases, Musculoskeletal Disorders, Neurological Diseases, and other indications. Based on End-User, the market can be categorized as Pharmaceutical and Biotechnology Companies, Contract Manufacturing Organizations (CMOs), Research Institutes and 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 a number of factors, the Cell and Gene Therapy Manufacturing market is now dominated by the cell therapy category. Cell therapies have demonstrated excellent promise in the treatment of a variety of illnesses, such as cancer, cardiovascular conditions, and autoimmune diseases. For instance, CAR-T cell therapy, which genetically modifies a individuals own immune cells to target and eradicate cancerous cells, has revolutionized the treatment of specific types of leukemia and lymphomas. The aim of this treatment is to kill cancer cells by genetically modifying a patients own 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 a number of 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. In order 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 a variety of 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, which are essential to ensuring the effectiveness and safety of
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 cases of cancer that are diagnosed each year, it is a major global health concern. Regulatory agencies have been more open to approving cell and gene therapies for oncology indications compared to 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 it easier to develop and produce cell and gene therapies for cancer.
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 the manufacturing of 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 the treatment of 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 cell and
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 the presence of 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 as a result of rising interest in personalized medicine and rising 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 as a result of 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 the manufacturing of 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 a lot of time and money developing cutting-edge manufacturing facilities. To guarantee a consistent supply of their therapy, this included automated production lines, quality control measures, and capacity expansion plans.
The key players in the global Cell and Gene Therapy Manufacturing market include - Lonza (Switzerland) among others.
Recent Market Developments
Segmentation of the Global Cell and Gene Therapy Manufacturing Market
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Source: www.vantagemarketresearch.com
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Report Coverage | Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, technology landscape, patent analysis, market attractiveness analysis by segments and North America, company market share analysis, and COVID-19 impact analysis | |
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