Cell and Gene Therapy Market Size, Share, Growth, and Industry Analysis, By Type (Rare Diseases, Oncology, Hematology, Cardiovascular, Ophthalmology, Neurology, Other Therapeutic Classes), By Application (Pharmaceutical and Biotechnology Companies, Research and Academic Institutions, Contract Research Organizations (CROs), Hospital, Others), and Regional Forecast to 2033

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CELL AND GENE THERAPY MARKET REPORT OVERVIEW

The global cell and gene therapy market size is forecasted to reach USD 75 billion by 2033 from USD 20 billion in 2024, growing at a steady CAGR of 15.70% during forecast period 2025-2033.

The Cell and Gene Therapy (CGT) market is a revolutionary step in modern medicine where living biological products can be used to treat, prevent, or cure disease by attacking their source. Cell therapy aims at replacing lost or damaged cells, tissues or organ, a process of transplanting cells, tissues or organs while gene therapy targets genes to cure diseases. The development of biotechnology is accelerating owing to the higher level of support from numerous regulatory authorities and a higher level of investment. These are due to growth in the incidence and prevalence of chronic as well as genetic diseases, increase in the use of personalized medicine and new technique like CAR-T cell therapy. Despite such challenges as high costs and complicated manufacturing, the industry has high potential to revolutionize healthcare and be the hope for most untreatable diseases. Indeed, there has been a blend between independence and collaboration as healthcare stakeholders in Biopharm firms, research centers, and regulatory agencies work hand in hand to both hasten and open access to the resultant innovations.

COVID-19 IMPACT

"Cell and Gene Therapy market Had a Negative Effect Due to Disruption in Supply Chain and Consumer Demand during COVID-19 Pandemic"

The global COVID-19 pandemic has been unprecedented and staggering, with the market experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden market growth reflected by the rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The emergence of COVID-19 impacted the Cell and Gene Therapy market share in terms of research on the therapy, clinical trials, and supply chain. Laboratory limitations and problems of patients reach for trials resulted in such slow movements of products. The hard-going manufacturing industry compounded with logistic delivery problems denied the supply of raw materials and effective therapies. Rug regulatory reviews got delayed which in turn affected the approvals and commercialization of medical products. Although certain funding was spent on COVID-19 vaccine and treatment, there were limitations to the funding of other projects. However, the pandemic introduced advanced therapies as necessary; the sector leveraged digital tools and developed sustainable supply chain models to permit future disruptions.

LATEST TREND

"Integration of Advanced Electrochemical Cleaning Technology Enhancing Efficiency and Sustainability to Drive Market Growth"

In the Cell and Gene Therapy (CGT) market, allergenic products have had the focus in development differs from autologous cell therapies that can take up to several weeks to prepare, or even longer for patients in remote areas. Compared to autologous therapies which need individual patient’s own cells, allergenic products can in theory be replicated relatively cheaply and made available more quickly. New technologies like CRISPR-Cas9 are guiding the innovation in this sector through producing the universal donor cells. This trend correlates with the growth of need for ways to solve large patient numbers and complicated pathologies, making it the primary area for research and funding.

CELL AND GENE THERAPY MARKET SEGMENTATION

By Type

Based on Type, the global market can be categorized into Rare Diseases, Oncology, Hematology, Cardiovascular, Ophthalmology, Neurology, Other Therapeutic Classes

• Rare Diseases: Tackling genetic or metabolic conditions such as muscular dystrophy – Duchene kind, providing a lifetime improvement.

• Oncology: Making head waves in the treatment of cancer with CAR-T cell therapy and gene editing.

• Hematology: Treating blood disorders such as sickle cell anaemia, and haemophilia through some of these innovative therapies.

• Cardiovascular: Heart Disease: The Process of Developing the Treatment to Regenerating the Tissues of the Heart Muscles.

• Ophthalmology: The emerging gene therapy potential in the treatment of inherited retinal diseases.

• Neurology: Focusing on neurodegenerative and genetic diseases of the brain such as Parkinson’s and Alzheimer’s diseases, as well as ALS.

• Other Therapeutic Classes: On metabolic, immune and infectious diseases patient population respectively.

By Application

Based on application, the global market can be categorized into Pharmaceutical and Biotechnology Companies, Research and Academic Institutions, Contract Research Organizations (CROs), Hospital, Others

• Pharmaceutical and Biotechnology Companies: Directing the innovation process and the commercialization of primary CGT products.

• Research and Academic Institutions: Promoting new drug finding and early-stage therapeutic development.

• Contract Research Organizations (CROs): As consultants advising in trials and regulation compliance.

• Hospital: The process of implementing treatments at individual patients and the performance of clinical research.

• Others: Including funding bodies, distribution network and other auxiliary service providers of the targeted CGT market.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factors

"Rising Prevalence of Chronic and Genetic Disordersto Boost the Market"

The rising cases of chronic and genetic diseases remain key catalysts for the development of the Cell and Gene Therapy (CGT) industry. Many ailments such as cancer, haemophilia, cystic fibrosis and muscular dystrophy do not respond well to conventional treatment hence the need for new treatment methods. Gene therapies can be promising in treating intellectual disabilities because these approaches can directly target a disease’s source – a subject’s mutated genes. Likewise, cell therapies like stem cell are transplants that offer a means of replacing tissues that has been damaged. Increased geriatric population and inherited diseases also add more pressure on inherited diseases hence making the providers to search for a solution that is strong and final hence pushing the market for CGT. This change is backed up by the patient advocacy groups and governments focusing on providing and funding research on rare and chronic diseases propelling the market forward..

"Advancements in Biotechnology and Precision Medicine to Expand the Market"

Technological advancement particularly in the biotechnology industry is gradually influencing the market for CGT hence high and steady growth. Cell and gene therapies fit well with the strategy of precision medicine aimed at targeting individual genetic characteristics to provide an adequate response. Shifts in the method of gene editing, better delivery systems, and better ways of producing therapies at scale are being made by advancing technologies such as CRISPR-Cas9. Besides, the evolution of bioinformatics and genomics is helping in the discovery of new opportunities for treatment. These advancements are causing shorter time to market and costs, better access and improved outcomes in clinical trials. The sharing of ideas between businesses involved in developing biopharmaceuticals, and technology advancement organizations is ensuring that research on different products is brought into practice, therefore making advanced biotechnology as a key category, even more, important.

Restraining Factor

"High Costs of Therapy Development and Delivery Impede Market Growth"

The Cell and Gene Therapy (CGT) market entails one major moderating factor; the enormous costs involved in therapy development, manufacturing as well as delivery of patients. Expert systems, like Gene editing and CAR-T cell engineering solutions will need big funding in research, clinical trials, and compliances. Also, the production process of these therapies is quite intensive, especially where autologous are required, as every patient requires their own production. Cold chain logistics services, skilled health care professionals add on the costs even more by the kind of infrastructure needed for storage of the vaccines. These cost challenges remain an issue for the wider implementation of CGT and remain firmly entrenched in low and middle-income countries, thus constraining patient access to CGT and therefore reducing the overall market growth capability.

Opportunity

"Expanding Applications in Rare and Orphan Diseases to Create Opportunity for the Product in the Market"

The Cell and Gene Therapy market presents a vast potential of meeting needs for the treatment of rare and orphan diseases that still have no adequate cure. There are certain guidelines which include Orphan Drug Act in United States of America and more in various countries across the world which offers benefits like market control exclusively and monetary aid for the developers working in the field of CGT focusing in such diseases. Such diseases offer very attractive targets since with the increased scale and application of genomics and bioinformatics potential therapeutic agents are easily disclosed. Having the promise to provide solution-based results for patient demographic that often lacks adequate service makes CGT as transformative. This not only boosts various surrounding academic institutions, biotech companies, and governments to step up sensitization in enhancing market variety but also increases cooperation between all these parties.

Challenge

"Navigating Regulatory and Manufacturing Complexities Could Be a Potential Challenge "

There are major issues that impact the Cell and Gene Therapy market, such as; high levels of regulations and advanced techniques of production. Some regulatory bodies require many tests on these new treatments for medical reasons and this delays approval. Challenges in manufacturing include several aspects specific to single-cell therapies: the problem of selectively isolating target cells; making genetic alterations to cells; and the potential difficulty of rapidly scaling up production, while maintaining product quality, particularly for autologous therapies. The others are increase consistency in outcomes, sterility, and logistics such as cold chain storage. Addressing these challenges requires substantial investment in infrastructure, knowledge, and cooperation by relevant stakeholders to increase efficiency, standardization and match the speed of development of innovative therapies.

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CELL AND GENE THERAPY MARKET REGIONAL INSIGHTS

• North America

North America leads the Cell and Gene Therapy market due to a powerful framework of healthcare, strong advancement in Biotechnology research, and significant investment. The leading country today is, however, the U.S. Cell and Gene Therapy market, accounting for the largest number of FDA approved therapies and clinical trials. There is governmental encouragement of research regarding specific disorders represented by such legislation as the Orphan Drug Act. Also, highly visible major global and regional Biopharm firms, active research institutes, and venture capital support advance innovation in the sector. It also enjoys a pool of literate and skilled human resource and productive research partnership between the academic institutions and business organizations. High demand for healthcare products and services, healthy regulatory policies, and higher healthcare are spending place North America at the forefront in the CGT market.

• Europe

Europe holds a strategic place in the Cell and Gene Therapy market because of the region’s stringent regulatory regime and strong research associations. Some organizations like EMA offers some guidelines on how to approve the advanced therapies offering developers confidence. Major cosmetic countries such as Germany, the UK and France have fairly large investment in the biotechnology industry and especially in rare disease. PPPs and funds of Horizon Europe contribute to optimizing the R&D department in order to increase its effectiveness. As more dedicated manufacturing sites and programs for cross-border clinical trials are established across Europe, this region should remain an important contributor to the development of CGT.

• Asia

In term of geographical, Cell and Gene Therapy market is also gradually becoming a regional market with significant growth potential due to the improved investment in biotechnology and healthcare in Asia. Asia Pacific specifically China, Japan and South Korea continue to enjoy support from their government policies coupled with increased Research & Development Investments. China has prospects because of its increased efforts in developing clinical trial infrastructure and a relatively short and growing list of CGT products. Japan’s PMDA has implemented measures to bring expeditious regulatory review processes in the approval of regenerative medicine. Furthermore, Asia enjoys competitive factors including low cost of manufacturing and a large population of potential patients, and so it is ideal for Biopharm international players interested in expanding CGT services.

KEY INDUSTRY PLAYERS

"Key Industry Players Shaping the Market through Innovation and Market Expansion"

Key enterprise gamers in the Cell and Gene Therapy market consist of Novartis, Gilead Sciences, Bristol Myers Squibb, Pfizer, Bluebird Bio, Spark therapeutics, Kite Pharma and CRISPR Therapeutics. These companies set a tone of innovation, strong pipelines, and careful relationships. There are young companies that are already developing and innovating the technologies such as Editas Medicine and Sangamo Therapeutics. Unfortunately, academic institutions and most CROs add a lot of values by offering to help in trials and products development. Working closely with regulatory authorities also affords them the ability to supply safe and effective treatments around the world which makes these players invaluable to this market.

List of Top Cell and Gene Therapy Companies

• Amgen Inc. (U.S.)
• Bluebird bio, Inc. (U.S.)
• Dendreon Pharmaceuticals LLC. (U.S.)
• Fibrocell Science, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS

October 2024: Kite Pharma, Company of Gilead sciences declared the growth of the LA CAR-T cell therapy manufacturing in Amsterdam. This development is focused on leveraging production capacity with the aim of satisfying increasing demand for our therapies worldwide.

REPORT COVERAGE

The Cell and Gene Therapy market is an exciting sub-sector of healthcare, driving innovative, transformative therapies for patients with chronic, genetic, or rare diseases. The influences of invaluable hi-tech traits such as gene-editing technologies, personalized medicine, and bio manufacturing have fueled the growth of the market at a very high rate. Still, risks include high costs, regulation, and manufacturing issues; however, advances keep making and scaling solutions feasible. The growth is anchored on numerous strategic partnerships such as inter-hemispheric between drug developers and manufacturers, academic institutions, and governments around major geographical zones like North America, Europe, and Asia. Therefore, the CGT market is expected to increase at an astounding growth rates and has the potential to transform patient management and treat several unmet medical indications across all therapeutic zones.