How big is the cell and gene therapy market?
The cell and gene therapy market size reached a value of USD 18.8 Billion in 2023. Looking forward, the market is expected to reach USD 60.1 Billion by 2032, exhibiting a growth rate (CAGR) of 15.66% during 2024-2032.
The market is driven by regulatory advancements, continual technological innovations, substantial investment and funding, progressive regulatory environments, considerable rise in healthcare expenditures, extensive government support, particularly in developed countries, rapid expansion of healthcare infrastructure, increasing patient awareness, significant investments in research and development (R&D) activities, and strategic academic-industry collaborations and partnerships.
Regulatory Advancements: A Key Market Driver
The field of cell and gene therapy has witnessed significant progress due to advancements in regulatory frameworks. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established comprehensive guidelines and expedited pathways to facilitate the development and approval of innovative therapies. These frameworks include initiatives like the Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S. and the Priority Medicines (PRIME) scheme in Europe, which offer accelerated review processes for promising therapies targeting unmet medical needs. Such regulatory support has reduced the time and financial burden associated with bringing cell and gene therapies to market, thereby encouraging increased investment and research activities in this sector.
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This harmonization not only ensures that therapies meet high safety and efficacy standards but also facilitates their international commercialization. Additionally, regulatory authorities are increasingly engaging with stakeholders through public consultations and advisory committees, ensuring that the changing guidelines are well-informed by scientific and industry expertise.
Over 2,900 gene therapy studies have been initiated globally, with more than 3,800 studies listed on clinicaltrials.gov, including over 1,000 currently recruiting. IND applications for gene therapy peaked at 206 in 2018, nearly double the 106 applications in 2017. The FDA approved its first gene therapy product in 2015, with three approvals in 2017 and two more in May 2019. Currently, 291 gene therapy studies are in phase III. The FDA expects to approve 40 gene therapies by 2022 and 10-20 per year by 2025, with 200 IND applications annually by 2020.
The proactive stance of regulatory bodies has also fostered collaborations between academia, industry, and government agencies. Public-private partnerships have emerged as a key strategy to address the complexities and high costs associated with cell and gene therapy development. These collaborations often receive support from government funding and grants, further mitigating the financial risks for companies involved in this innovative field. Overall, regulatory advancements have created a conducive environment for the growth of the cell and gene therapy market by streamlining the development process, reducing barriers to entry, and promoting collaborative efforts.
Continual Technological Innovations: Contributing to Market Growth
The rapid advancement of technological innovations has played a pivotal role in driving the cell and gene therapy market. Breakthroughs in gene editing technologies, such as CRISPR-Cas9, have revolutionized the ability to precisely modify genetic material, paving the way for the development of targeted and personalized therapies. These technologies enable researchers to correct genetic defects at their source, offering potential cures for a wide range of genetic disorders and diseases that were previously deemed untreatable.
The burgeoning success of hematopoietic stem/progenitor cell gene therapy (HSPC-GT) hinges on advanced viral vectors for efficient and safe gene transfer. The integration of novel site-specific gene editing technologies like CRISPR-Cas expands the potential of HSPC-GT, enabling precise genetic modifications. Clinical trials using lentiviral vectors (LVs) have shown promising results, with 400 patients treated for 14 diseases by 2020, demonstrating sustained benefits. As of 2020, 279 patients were treated with LVs across 34 trials, and HSPC-GT products are now available for conditions like β-thalassemia and cerebral adrenoleukodystrophy.
Additionally, advances in cell engineering techniques have significantly improved the efficacy and safety of cell-based therapies. For example, the development of chimeric antigen receptor (CAR) T-cell therapy has shown remarkable success in treating certain types of cancers by engineering patients’ own immune cells to recognize and attack malignant cells. Innovations in manufacturing processes, such as automated cell culture systems and bioreactors, have also enhanced the scalability and consistency of cell therapy production, addressing one of the major challenges in the field.
Moreover, the integration of artificial intelligence (AI) and machine learning (ML) in the drug discovery and development process has accelerated the identification of potential therapeutic targets and optimized clinical trial designs. AI algorithms can analyze vast amounts of biological data to predict patient responses and identify biomarkers for treatment efficacy, thereby personalizing therapy approaches and improving patient outcomes. The convergence of these technological innovations has not only expanded the therapeutic potential of cell and gene therapies but also made their development more efficient and cost-effective, driving market growth.
Considerable Rise in Investment and Funding: Propelling Market Expansion
The cell and gene therapy market has experienced a rise in investment and funding from various sources, including venture capital firms, pharmaceutical companies, and government agencies. This influx of capital has been instrumental in advancing research and development activities, supporting clinical trials, and facilitating the commercialization of innovative therapies. Venture capital investments in biotech startups specializing in cell and gene therapies have provided the necessary financial backing to translate groundbreaking scientific discoveries into viable therapeutic products.
In the US, a simulation model was developed to assess the financial impact of novel gene therapies, focusing on 109 late-stage clinical trials before January 2020. The model estimated annual spending on gene therapies at approximately $20.4 billion under conservative assumptions. The spending was decomposed by age group, revealing that half of the annual spending will be on non-Medicare-insured adults and children. As of December 2022, four gene therapies were approved in the U.S.: voretigene neparvovec, onasemnogene abeparvovec-xioi, brexucabtagene autoleucel, and etranacogene dezaparvovec. High prices per treatment, such as $425,000 per eye for voretigene neparvovec and $2.1 million per patient for onasemnogene abeparvovec-xioi, highlight affordability challenges. With an estimated 340,000 U.S. patients expected to receive gene therapy by 2030, the study concludes by exploring different payment methods and policies to ensure patient access to these therapies’ benefits while managing their high costs.
Pharmaceutical companies have acknowledged the great possibilities of cell and gene therapies and are more frequently forming strategic partnerships, acquisitions, and collaborations with biotech companies. These partnerships enable large pharmaceutical companies to take advantage of the specialized knowledge and technologies of smaller firms, speeding up the development process and broadening their range of treatments. Furthermore, government funding initiatives and grants have offered important assistance for initial research and medical trials, especially for rare diseases and orphan indications with restricted commercial incentives.
The increased trust from investors in the cell and gene therapy industry is also shown by the rise in IPOs and M&A transactions. Businesses in this sector have effectively secured large amounts of funding through IPOs, allowing them to grow their activities and progress their clinical projects. The strong financial support not only guarantees the economic viability of companies working on these treatments, but also cultivates a competitive environment that promotes creativity and speeds up the release of new treatments onto the market.
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Leading Companies in the Cell and Gene Therapy Market:
The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global cell and gene therapy market, several notable companies are expanding their production capacities and securing strategic partnerships. They are also achieving regulatory approvals and launching groundbreaking clinical trials. Some of the key players in the market include Amgen Inc., Biogen, Bluebird bio, Inc., Bristol-Myers Squibb, Gilead Science, Kolon TissueGene Inc., Orchard Therapeutics plc., Pfizer Inc, Renova Therapeutics, and Spark Therapeutics, Inc.
June 14, 2024: Amgen announced that the FDA has approved BLINCYTO® (blinatumomab) for treating CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. The approval is based on the Phase 3 E1910 clinical trial, which showed a 58% reduction in the risk of death and superior overall survival compared to chemotherapy alone. BLINCYTO®, the first Bispecific T-cell Engager (BiTE®) therapy for this indication, marks its third approved indication and redefines the standard of care for B-ALL patients.
February 23, 2024: Biogen announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending marketing authorization for QALSODY® (tofersen) to treat adults with SOD1-ALS, a rare genetic form of ALS. If approved by the European Commission, QALSODY will be the first treatment in the EU targeting a genetic cause of ALS. The CHMP’s recommendation is based on evidence from clinical trials, showing significant reductions in plasma neurofilament light chain and potential improvements in patients’ physical abilities.
June 5, 2024: Bluebird Bio, Inc. completed the first commercial cell collection for LYFGENIA, a gene therapy for sickle cell disease. The FDA approved LYFGENIA in December 2023 for patients with a history of vaso-occlusive events. Cells were collected at Children’s National Hospital, part of Bluebird’s network of over 60 Qualified Treatment Centers.
Market Analysis:
Cell and gene therapies have become pivotal in treating various indications, significantly impacting the global market. In cardiovascular disease, these therapies offer potential curative solutions by repairing damaged heart tissues and improving cardiac function, with advanced gene-editing techniques correcting genetic mutations in congenital heart conditions. Oncology disorders benefit the most, holding the largest market share. Innovative therapies like CAR-T cells and gene-editing technologies specifically target and eradicate cancer cells, leading to remission and prolonged survival rates in previously incurable cancers.
For genetic disorders, cell and gene therapies provide groundbreaking treatments by correcting genetic abnormalities at the molecular level. Techniques such as CRISPR and gene therapy vectors address conditions like cystic fibrosis and muscular dystrophy, offering hope for long-term cures. In infectious diseases, gene therapy can enhance immune responses by engineering immune cells to recognize and destroy pathogens, showing promise in combating HIV and hepatitis.
Neurological disorders also see significant advancements. Gene therapy offers potential treatments for conditions like Parkinson’s and Alzheimer’s by delivering therapeutic genes to the brain, aiming to restore function and halt disease progression. Additionally, metabolic and autoimmune diseases benefit from personalized therapies targeting genetic causes, improving patient quality of life. Overall, cell and gene therapies drive the global market by offering innovative, potentially curative treatments across a broad range of indications, transforming disease management and patient outcomes.
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Regional Analysis:
The major markets for cell and gene therapy include the North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represented the largest market.
The market for cell and gene therapy in North America is propelled by a sophisticated healthcare system and significant investment in R&D. The region is led by the United States, thanks to its strong biotech industry and favorable regulatory environment. The existence of top pharmaceutical companies and many clinical trials support the growth of the market. Moreover, substantial financial support from governmental and corporate entities helps speed up the development of groundbreaking treatments. Canada also enhances this with its robust healthcare system and government efforts to support biotechnological progress.
In Europe, the cell and gene therapy market is driven by forward-thinking regulatory environments and significant investments in biotechnology. Germany and the United Kingdom lead the way in promoting innovation through strong partnerships between academia and industry, supported by the government. The EMA offers a cohesive regulatory route, improving market entry throughout Europe. Nations such as France, Italy, and Spain play a major role by their sophisticated healthcare systems and rising patient education.
The cell and gene therapy market in the Asia Pacific region is experiencing fast expansion due to increasing healthcare spending and notable progress in biotechnology. China and Japan stand out in the region, receiving significant government backing and making substantial R&D investments. South Korea and Australia also excel in advanced medical research infrastructure and involvement in clinical trials. The market expansion is further fueled by India’s expanding pharmaceutical industry and rising occurrence of genetic disorders.
In Latin America, the growth of the cell and gene therapy market is fueled by advancements in healthcare infrastructure and rising investments in biotechnological research. Brazil and Mexico play a vital role, receiving increasing backing from governmental efforts and global partnerships. There is an increasing occurrence of chronic and genetic diseases in the area, leading to a need for advanced treatment options. Local pharmaceutical firms are more and more involved in research and development endeavors, with the backing of academic institutions.
The cell and gene therapy market in the Middle East and Africa is gradually expanding, driven by increasing healthcare investments and growing awareness of advanced medical treatments. The United Arab Emirates and Saudi Arabia are leading the region with significant government support and strategic initiatives to develop biotechnological capabilities. South Africa also plays a crucial role with its emerging biotech sector and focus on research and development.
Key information covered in the report.
Base Year: 2023
Historical Period: 2018-2023
Market Forecast: 2024-2032
Breakup Therapy Type:
- Cell Therapy
- Stem Cell
- Pluripotent Stem Cell
- Cancer Stem Cell
- Adult Stem Cell
- Non-Stem Cell
- T Cells
- Natural Killer
- Others
- Stem Cell
- Gene Therapy
Breakup by Indication:
- Cardiovascular Disease
- Oncology Disorder
- Genetic Disorder
- Infectious Disease
- Neurological Disorder
- Others
Breakup by Delivery Mode:
- In-Vivo
- Ex-Vivo
Breakup End User:
- Hospitals
- Cancer Care Centers
- Pharmaceutical & Biotechnology Companies
- Others
Breakup by Region:
- North America
- United States
- Canada
- Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Others
- Asia Pacific
- China
- Japan
- India
- South Korea
- Australia
- Indonesia
- Others
- Latin America
- Brazil
- Mexico
- Others
- Middle East and Africa
Competitive Landscape:
The competitive landscape of the cell and gene therapy market is characterized by a dynamic and rapidly evolving ecosystem. Numerous players, including pharmaceutical companies, biotechnology firms, research institutions, and startups, are actively engaged in this space. These entities strive to carve out their niche by leveraging cutting-edge technologies, developing innovative therapies, and establishing strategic partnerships.
· Amgen Inc.
· Biogen
· Bluebird bio, Inc.
· Bristol-Myers Squibb
· Gilead Science
· Kolon TissueGene Inc.
· Orchard Therapeutics plc.
· Pfizer Inc.
· Renova Therapeutics
· Spark Therapeutics, Inc.
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