Cell and Gene Therapy Manufacturing Market Size, Share, By Therapy Type (Cell Therapy, Gene Therapy), By Mode of Manufacturing (In-House Manufacturing, Contract Manufacturing), By Application (Oncology, Cardiovascular Diseases, Neurological Disorders, Orthopedic Diseases, Infectious Diseases, Rare Diseases, Ophthalmology, Others), By Workflow (Upstream Processing, Downstream Processing), and By Region - Trends, Analysis and Forecast till 2034

Cell and Gene Therapy Manufacturing Market Size was valued at USD 10.81 Billion in 2024 and is expected to reach USD 91.00 Billion by 2034, growing at a CAGR of 26.4%

The cell and gene therapy industry's focus on technologies has been vast due to the newer biotechnologies and emergent need for customized and newly transformative therapeutics. This fast-growing discipline involves developing and manufacturing biological therapeutics for targeting particular cellular and genetic pathways toward treating or even curing multiple diseases. Often personalized to the individual patient level, such therapies allow hope for conditions considered untreatable or difficult to manage. Cell therapies involve living cells, mainly stem cells or immune cells, in treating diverse diseases. Sometimes, these types of cells may be engineered to perform functions such as regenerating damaged tissues, killing cancer cells, and treating autoimmune diseases.

An example is the treatment with stem cells. In this way, it very much helps for Parkinson's diseases, stuff like spinal cord injuries, and diabetes. Immune cell therapies, such as CAR-T cell therapy, are revolutionizing the treatment of some cancers by enlisting the patient's immune system in fighting tumor cells. In contrast, gene therapy involves adding genetic material to cells to replace the defective ones or to introduce new functions. This technology is up-and-coming and can be applied to treat genetic diseases, infectious diseases, and even cancer. Gene therapy can broadly be classified into somatic gene therapy, targeting non-reproductive cells, and germline gene therapy, targeting reproductive cells. Whereas somatic gene therapy has shown much promise, this latter variety has many ethical issues and is currently debated.

In contrast, the requirements for manufacturing cell and gene therapies are quite different. These therapies are typically of very high complexity, very stringent in terms of quality requirements, and dependent on facilities dedicated to the purpose. Purity requirements for living cells and genetic material require special containment, guaranteeing a sterile environment and careful handling within those environments to ensure the final product's viability and potency. In addition, because of the personalized nature of the products, the production processes for these therapies are less flexible to scaling up than those of traditional drugs. The current evolving state of the cell and gene therapy manufacturing market has research efforts in place to tackle these issues and set the stage for the broader availability of these truly disruptive therapies. By overcoming these hurdles, the field has the potential to revolutionize healthcare and improve the quality of life for millions of patients worldwide.

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Key Drivers of Target Market:

Increasing Prevalence of Chronic and Rare Diseases

• The growing number of victims of chronic types of diseases, like cancer, heart diseases, and nervous system disorders, has expanded the cell and gene therapy manufacturing sector. In addition, the increasing awareness and diagnosis of rare genetic disorders indicate a necessity for treating operations to be more tailored and selective.

Advancements in Biotechnology and Genomics

• Breakthrough technologies like CRISPR gene editing, next-generation sequencing, and stem cell research have significantly accelerated the development and manufacturing of cell and gene therapies. These innovations unlock opportunities for increasingly precise, efficient, and lower-cost treatments.

Favorable Regulatory Environment

• Regulatory authorities like the FDA in the USA and the EMA in Europe show growing support for cell and gene therapies. Advancements such as expedited approval paths, orphan drug designations, and regulatory incentives place investments in such advanced therapies high on the list of biotech companies.

Restrains:

Reimbursement and Access Issues

• High-cost cell and gene therapies are difficult to reimburse. As such, many healthcare systems and insurers do not like to cover those treatments, eventually influencing patient access and slowing down the market's growth. Additionally, the skyrocketing prices of such treatments raise concerns over equal access.

Opportunities:

Development of Next-Generation Therapies

• Next-generation cell and gene therapies are emerging from significant R&D in gene editing, iPSCs, and synthetic biology. These have the potential to make intervention more effective and accessible, further enlarging the market.

The market is segmented based on Therapy Type, Mode of Manufacturing, Application, and Region.

Therapy Type Insights:

• Cell Therapy: This segment involves the treatment of diseases through the administration of living cells. In this regard, cell therapy takes the form of a broad spectrum that includes, among other things, stem cell therapy, T-cell therapy, and chimeric antigen receptor T-cell therapy. Its applications are increasingly being adopted, with a large part being focused on oncology. These treatments involve repairing, replacing, or modifying cells to improve their biological functions. Extensive development in stem cell research, regenerative medicine, and immunotherapy further catalyzes this segment.
• Gene therapy: Gene therapy, as I said already, is the method of treating or preventing any diseases by insertion, removal, or alteration of genetic material in the cells of the patients. This would assist in separating the genes working defectively and responsible for the development of a disease, or otherwise aid in bolstering the body's defense mechanism against the invasion of the pathogens. The gene therapy segment has grown tremendously since several gene therapies were approved for these life-threatening genetic disorders and rare diseases. Technologies such as CRISPR and other gene-editing tools only further drive this innovation.

Mode of Manufacturing insights:

• In-house Manufacturing: In-house manufacturing refers to when a pharmaceutical or biotechnology company makes its own product in its own manufacturing facility. Through in-house manufacturing, a pharmaceutical or biotechnology company has more control over manufacturing quality, cost, and timing. However, this sets a high entry barrier because it is expensive to create and maintain the in-house facilities needed for manufacturing such a product. Companies with existing processes and large capital bases prefer this approach to manufacturing.
• Contract Manufacturing: Contract manufacturing organizations mainly produce goods for other companies. This is very appealing to a company that wants to ease capital expenditures and keep its focus on the Department of Research and Development. The experience in manufacturing processes, regulatory compliance, and scalability brought by a CMO cannot be underestimated. In the increasingly developing field of cell and gene therapies, contract manufacturing is increasingly used by small biotech companies and startups.

Application insights:

• Oncology: One of the largest applications currently being worked on is oncology in cell and gene therapies. These target cancers of virtually all types—from hematologic malignancies to solid tumors. It is with blood cancers, especially, that CAR-T cell therapy has been a game-changer in the manner in which cancer will be treated. Gene therapies are also in trials to deliver the genes that fight cancer inside the tumor cells. With cancer as one of the leading causes of death in the world, innovative treatments in oncology continue to drive the growth of the market segment.
• Cardiovascular Diseases: Cell and gene therapy for cardiovascular diseases can help in the mending of the tissue of the heart, the growth of blood vessels, and enhancement in heart performance. It encompasses heart failure, myocardial infarction, and ischemic heart disease. Currently, stem cell or gene therapies in treatment for heart conditions are at a relative infancy stage, but if this sector develops more, it will cater to vast and grave treatment opportunities for patients with all kinds of cardiovascular diseases.
• Neurological Disorders: The application of cell and gene therapy elicits high interest in the application for diseases like Parkinson's, Alzheimer's, and spinal cord injuries. Such treatments strive for neural cell replacement, reconstitution of lost cells, mitigation of inflammation, and promotion of improved neural function. Gene therapy targeting the genetic mutations underlying these neurological diseases is being studied. The central nervous system is complex, so there are challenges with these developments, but the potential for a breakthrough in treating neurodegenerative disorders is what drives research.
• Orthopedic Diseases: Treat musculoskeletal disorders like osteoarthritis, bone fractures, and cartilage injuries through cell and gene therapy. Therapies using stem cells are being developed for tissue regeneration and repair in orthopedic disorders. They are supposed to restore mobility, diminish pain levels, and improve patients' quality of life who suffer from chronic orthopedic diseases.
• Infectious Diseases: Cell and gene therapies are being developed for the treatment of infectious diseases, including HIV, hepatitis, and COVID-19. The treatments either augment immunity against the infection or target the pathogen itself. For example, gene therapies induce genes that increase resistance to viral infections or disrupt and remove the latent viral reservoirs.
• Rare Diseases: Gene therapy applications lean toward rare diseases, usually caused by genetic mutations. These diseases, affecting only a small percentage of the population, have in the past been under-recognized by usual and conventional drug development. Gene therapies will allow the correction of underlying genetic defects in these rare diseases, offering a ray of hope where no treatment options exist.
• Ophthalmology gene therapies are advancing therapeutic approaches in the treatment of inherited retinal diseases and other disorders of vision. They aim to restore vision by replacing retinal cells with healthy gene copies. One such classic example is Luxturna, one of the first FDA-approved gene therapies.
• Others: This segment involves cell and gene therapy applications that do not feature in any of the above-mentioned segments. It covers a broad range of disorders or conditions, such as autoimmune diseases, metabolic disorders, and skin diseases. As research continues, new applications for these therapies will emerge, and thus, the segment will continue to grow.

Regional insights:

• North America: Being dominated by the United States, North America leads this cell and gene therapy manufacturing market. Factors attributed to this region's market dominance include a strong biotech sector, hefty investment in R&D, and stringent regulatory reform action. Further, the big pharma players, along with their CMOs, are supporting the market growth in this region. The U.S. FDA has also proactively approved these innovative therapies that have pushed market expansion.
• Europe: Europe represents another key market for the manufacturing of cell and gene therapies, driven by strong research institutions, government support, and increasing demand for advanced treatments. The European Medicines Agency (EMA) had approved many cell and gene therapies, raising the confidence in the market. Countries like Germany, the UK, and France are leading in the research, development, and commercialization of these therapies.
• Asia Pacific: The Asia Pacific is one of the booming regions for cell and gene therapy manufacturing. The geographical area comprising China, Japan, and South Korea makes high investments in biotechnology and overall healthcare infrastructural growth. Governmental initiatives for promoting advanced therapies and a growing patient pool primarily drive demand emanating from this region. Notably, China is fast emerging as a major cell therapy clinical trial and manufacturing hub.
• Latin America: The Latin America cell and gene therapy manufacturing market, although in its early stage, is expected to grow at a relatively higher CAGR. Countries such as Brazil, Mexico, and Argentina are at the helm of this spurt due to maximum healthcare spending and the bootstrapping of the national biotech system. Inadequate infrastructure, regulatory complexities, and a lack of specialized expertise in this region have retarded the adoption of advanced therapies. However, the efforts to build healthcare access and promote research and development would be observable as opportunities take shape.
• Middle East and Africa (MEA): This is an infant cell and gene therapy manufacturing region. Market opportunities in this region result from growing healthcare needs and infrastructural limitations. However, some countries within the Middle East, especially those of the Gulf Cooperation Council—the United Arab Emirates, Saudi Arabia, and Qatar—are pouring heavy investments into modernizing healthcare, including biotechnology and advanced therapies.

Cell and Gene Therapy Manufacturing Market Report Scope:

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2024 to 2034. For the purpose of this study segmented the target market report based on Therapy Type, Mode of Manufacturing, Application, and Region.

Segmentation:

By Therapy Type:

• Cell Therapy
•  Gene Therapy

By Mode of Manufacturing:

• In-House Manufacturing
• Contract Manufacturing

By Application:

• Oncology
• Cardiovascular Diseases
• Neurological Disorders
• Orthopedic Diseases
• Infectious Disease
• Rare Disease
• Ophthalmology
• Others

By Region:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • Israel
  • South Africa
  • Rest of Middle East & Africa

The key players operating the Cell and Gene Therapy Manufacturing Market include Novartis AG, Pfizer Inc., Gilead Sciences, Inc. (Kite Pharma), Bluebird Bio, Inc., Bristol-Myers Squibb Company, Sangamo Therapeutics, Inc., CRISPR Therapeutics, Vertex Pharmaceuticals Incorporated, Thermo Fisher Scientific Inc., Lonza Group AG, WuXi AppTec, Catalent, Inc., Fujifilm Diosynth Biotechnologies, Sartorius AG, Cognate BioServices, Inc.

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• In June 2024, the U.S. FDA approved other highly innovative cell and gene therapies, including additional CAR-T cell therapy for cancer and gene therapies against rare genetic disorders. These therapies have continued to bolster the market by validating their clinical effectiveness and opening up new treatment options to patients.
• In July 2024, CRISPR Therapeutics declared that the results of its early-phase clinical trial showed the potential to cure sickle cell disease and beta-thalassemia patients with investigational CRISPR-based gene therapy. This is breakthrough news for CRISPR technology in using gene editing for future therapy to cure most genetic diseases.
• In May 2024, Pfizer entered into a strategic manufacturing collaboration with Thermo Fisher Scientific to strengthen cell and gene therapy manufacturing capacities. Thermo Fisher will help increase manufacturing capability, shorten new therapy timelines, and boost production.

• Novartis AG
• Pfizer Inc.
• Gilead Sciences, Inc. (Kite Pharma)
• Bluebird Bio, Inc.
• Bristol-Myers Squibb Company
• Sangamo Therapeutics, Inc.
• CRISPR Therapeutics
• Vertex Pharmaceuticals Incorporated
• Thermo Fisher Scientific Inc.
• Lonza Group AG
• WuXi AppTec
• Catalent, Inc.
• Fujifilm Diosynth Biotechnologies
• Sartorius AG
• Cognate BioServices, Inc.