Global Cell and Gene Therapy Market, By Therapy Type (Cell Therapy (Stem Cells, T Cells, Dendritic Cells, and NK Cells) and Gene Therapy (Germline Gene Therapy and Somatic Gene Therapy)), By Application (Dermatology, Musculoskeletal, Oncology, Immunology, Cardiology & Neurology, and Others (Urinary Problems, Infectious Disease, Ophthalmic, Diseases, Retinal Diseases, And Others)), By End User (Hospitals, Clinics, and Others (Research Institutes, Academic Institutes, etc.)) and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) is estimated to be valued at US$ 22.7 billion in 2023 and is expected to exhibit a CAGR of 28.7% during the forecast period (2023-2030), as highlighted in a new report published by Coherent Market Insights.
The increasing number of cell and gene therapy patients is the major factors driving the growth of the cell and gene therapy market. Cell and gene therapy is a leading field in the medical science, which promises new treatment development for patients suffering from various diseases. For instance, Adeno-associated AAV2 vectors carrying therapeutic gene (RPE65) intra-retinal injection lead to improved vision of individuals suffering from Leber’s Congenital Amaurosis. Several clinical trials are being conducted on cell and gene therapy that are focused on potential diseases such as cancer and others. There is an increase in investments in drug development and commercialization of these therapies in order to meet significant medical needs. Genetic markers are associated with complex diseases, and therefore, it is important to study about genetic information and its clinical application in designing clinical trials and cell and gene therapy product manufacturing.
Global Cell and Gene Therapy Market – Impact of Coronavirus (COVID-19) Pandemic
The World Health Organization (WHO) designated the illness caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), which first appeared in Wuhan (province of Hubei, China) in the last months of 2019 as "coronavirus disease 2019" or COVID-19. This virus spreads quickly and had a serious negative impact on the economies, social behaviors, and healthcare of every country in the world.
COVID-19 affected the economy in three main ways: by directly affecting production and demand, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to the lockdown, several countries, such as India, China, Brazil, and others faced problems with regard to the transportation of drugs from one place to another.
COVID-19 had a mixed impact on the global cell and gene therapy market, as research programmes and preclinical operations have been affected across the Cell and Gene Therapies (CGTs) sector as businesses have restricted the number of individuals working on-site to keep them safe and comply with regulatory instructions. For instance, in March 2021, according to the report published in the National Center for Biotechnology Information, more than half of the CGT (Cell and Gene Therapies) businesses informed that it's difficult to recruit patients and the enrolment in trials have been halted in order to avoid COVID-19 exposure. As a result, new trial activation has been delayed, and new trials have been postponed. Therefore, there is a need to limit patient risk and support participation in clinical trials. Innovation and proper use of existing available technologies are essential to adapt to this new paradigm.
On the other hand, initiatives taken by research institutes with the market players for COVID-19 infection using gene therapy platforms increased the demand for cell and gene therapy during the pandemic. For instance, in November 2020, a new University of Pennsylvania (Penn) research collaborated with Regeneron Pharmaceuticals, Inc., a pharmaceutical company, to investigate whether Regeneron’s casirivimab and imdevimab investigational antibody cocktail can prevent COVID-19 infection when delivered intranasally via Adeno-Associated Virus (AAV) vectors (Gene Therapy Platform). Regeneron’s antibody cocktail (casirivimab and imdevimab administered together) was being studied in clinical trials for the treatment and prevention of COVID-19 and was granted an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) in certain high-risk patients with mild to moderate COVID-19 during the pandemic.
Global Cell and Gene Therapy Market: Key Developments
In November 2021, Sanofi S.A., a life sciences company, committed up to US$ 60 billion to Gyroscope Therapeutics, a clinical-stage biotech whose lead program could become the first gene therapy for a particular vision loss disorder
In March 2021, Novartis AG, a healthcare company, received Singapore Health Sciences Authority (HSA) approval for Kymriah (tisagenlecleucel) as the first commercial chimeric antigen receptor T-cell (CAR-T) therapy in Singapore under the new cell, tissue, and gene therapy products (CTGTP) regulatory framework
Novartis AG, a healthcare company, entered into a grant agreement with the Bill & Melinda Gates Foundation in 2021. This agreement aims to address the disparity in access to treatments and to prioritize populations that bear the greatest burden of sickle cell disease in the search for curative therapies. Furthermore, Novartis expands its therapeutic pipeline and a holistic approach to diagnosis, treatment, and management of sickle cell disease in sub-Saharan Africa.
In June 2020, Regeneron Pharmaceuticals, Inc. announced that the company is expanding its existing collaboration with Intellia Therapeutics, Inc., a genome editing company, to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and develop potential products for the treatment of hemophilia A and B.
Browse 45 Market Data Tables and 36 Figures spread through 247 Pages and in-depth TOC on “Global Cell and Gene Therapy Market”, By Therapy Type (Cell Therapy (Cell Therapy, Stem Cells, T Cells, Dendritic Cells, and NK Cells) and Gene Therapy (Germline Gene Therapy and Somatic Gene Therapy)), By Application (Dermatology, Musculoskeletal, Oncology, Immunology, Cardiology & Neurology, and Others (Urinary Problems, Infectious Disease, Ophthalmic, Diseases, Retinal Diseases, And Others)), By End User (Hospitals, Clinics, and Others (Research Institutes, Academic Institutes, etc.)), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)
Key Takeaways of the Global Cell and Gene Therapy Market:
- The global cell and gene therapy market is expected to exhibit a CAGR of 28.7% during the forecast period, owing to significant research and development activities in cell and gene therapy by the market players. For instance, in December 2022, according to data published by the Journal of Gene Medicine, approximately 1,500 gene therapy clinical trials are ongoing, have been completed, or have been approved in 36 countries. Countries where the trials were conducted include Australia, China, France, Japan, Switzerland, the Netherlands, and others. Moreover, diseases targeted by cell and gene therapies include cardiovascular diseases, cancer, inflammatory and infectious diseases, Hemophilia A and B, Severe Combined Immunodeficiency (SCID), ocular diseases, neurological diseases, and others.
- Among therapy types, the cell therapy segment is expected to be a dominant in the global cell and gene therapy market, owing to increasing therapy approvals from regulatory authorities such as the U.S. Food and Drug Administration (FDA) for new cell therapies by the market players. For instance, in April 2020, researchers from National Defense Medical Center, Taiwan, reported the use of DNA microarray gene expression profiles in research to assess the immunofunctionomes of ovarian clear cell carcinoma in early and advanced stages.
- Among regions, North America is expected to be the dominant region in the global cell and gene therapy market, owing to the increasing adoption of inorganic growth strategies such as collaboration and others by the market players. For instance, in December 2022, GSK plc., a pharmaceutical company, and Wave Life Sciences Ltd., a clinical-stage genetic medicines company, announced a strategic collaboration to advance oligonucleotide therapeutics, including Wave’s preclinical RNA editing programme targeting alpha-1 antitrypsin deficiency (AATD), WVE-006. The collaboration has an initial four-year research term. It combines GSK’s unique insights from human genetics, as well as its global development and commercial capabilities, with Wave’s proprietary discovery and drug development platform, PRISMTM.
- Major players operating in the global cell and gene therapy market include Novartis International AG, Pfizer, Inc., Sanofi S.A., Amgen, Inc., Regeneron Pharmaceuticals, Inc., Bluebird Bio, Inc. (Celgene Corporation), Biogen Inc., uniQure N.V., JCR Pharmaceuticals Co. Ltd., Gene Biotherapeutics, Kolon TissueGene, Inc., Horama S.A., MeiraGTx Limited, Gilead Sciences, Inc., Organogenesis, Inc., Orchard Therapeutics Plc., Freeline Therapeutics Ltd., Bristol-Myers Squibb Company, PTC Therapeutics, Inc., Spark Therapeutics, Inc., and Biomarin Pharmaceutical Inc.