Cell and Gene Therapy Market Size to Worth USD 82,240 Million by 2032 | Precedence Research

OTTAWA, ON, Nov. 21, 2023 /PRNewswire/ -- The global cell and gene therapy market size surpassed USD 15,460 million in 2022 and is estimated to be worth around USD 82,240 million by 2032, growing at a healthy CAGR of 18.3% between 2023 and 2032.

The global cell and gene therapy market size accounted for USD 18,120 million in 2023. Some of the major factors that drive the growth of the cell and gene therapy market are growing interest in oncology treatments, evolution in the biopharmaceutical industry, and increased overall funding in the cell and gene therapy market.

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Cell and Gene therapy are overlapping fields of biomedical research and treatment. Both treatments aim to reduce the underlying causes of acquired and genetic diseases and treat, prevent, or possibly cure diseases. Cell therapy uses specific cell types to repair or modify tissues with disease or cells for transferring a therapeutic agent throughout the body. Before being injected into the patient, cells are grown or altered outside of the body in cell therapy. The cells may originate from a donor (allogeneic cells) or the patient (autologous cells).

Gene therapy, which is used ex vivo or in vivo, replaces, inactivates, or offers genes into cells to treat diseases. Specific treatments are classified as gene or cell therapies. These treatments deliver different gene variants into the body through cell types.

The cell and gene therapy market is segmented based on therapy type, therapeutic class, delivery method, end-users, and region. Factors such as significant investments in research and development, technological advancements, successful results in clinical trials, and a shift to allogeneic products are driving the growth of the market. However, high development and manufacturing costs, complex regulatory landscapes, and the constraints to ensure therapies' long-term safety and efficacy are expected to hinder the market. Furthermore, emerging therapeutic applications, genetic engineering advancements, and next-generation delivery technologies are expected to provide ample opportunities in the cell and gene therapy market.

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Regenerative Medicine

Regenerative medicines are used to repair, replace, and regenerate tissues and organs affected by injury, disease, or natural aging process. These medicines restore the functionality of cells & tissues and are used in several degenerative disorders such as dermatology, neurodegenerative diseases, cardiovascular, and orthopedic applications. Stem cells are capable of proliferation and differentiation, which increase their importance in this field.

The Regenerative medicine is a rapidly growing field that has the potential to revolutionize healthcare by restoring or regenerating damaged tissues and organs. Here are some of the latest market trends in regenerative medicine:

• Growing Market Size: The global regenerative medicine market size is projected to reach USD 49.41 billion by 2025, growing at a CAGR of 23.8% from 2020 to 2025. This growth is driven by the increasing prevalence of chronic diseases, rising demand for organ transplantation, and technological advancements in regenerative medicine.
• Increasing Investment: The regenerative medicine industry is attracting significant investment from both public and private sectors. In 2020, venture capital funding for regenerative medicine companies reached a record high of $5.5 billion, up from $3.5 billion in 2019. This funding is being used to support research and development of new regenerative therapies, as well as to expand manufacturing and commercialization capabilities.
• Emergence of Gene Therapy: Gene therapy is an emerging field that is being integrated into regenerative medicine. Gene therapies involve modifying a patient's genes to treat or cure a disease. There have been significant advancements in gene therapy in recent years, and it is expected to have a major impact on the regenerative medicine market.
• Focus on Stem Cell Therapy: Stem cell therapy is a key area of focus in regenerative medicine. Stem cells have the unique ability to differentiate into a variety of cell types, making them a promising tool for repairing damaged tissues and organs. The market for stem cell therapies is expected to grow at a significant rate in the coming years.
• Advancements in 3D Printing: 3D printing technology is being increasingly used in regenerative medicine to create scaffolds and structures that support tissue growth. Advancements in 3D printing technology are making it possible to create more complex and precise structures, which is expected to have a positive impact on the regenerative medicine market.

Key Insights:

• North America has generated a revenue share of around 49.65% in 2022.
• The gene therapy segment has held a revenue share of 13.37% in 2022.
• The cell therapy segment has accounted revenue share of 86.63% in 2022.

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Market Dynamics

Drivers: Growing awareness of genetics disease and abnormalities

According to WHO, genetic disorders and congenital abnormalities occur in about 2%-5% of all live births, accounting for up to 30% of Paediatric hospital admissions, and cause about 50% of childhood deaths in industrialized countries. Moreover, according to a study, 225 out of 560 of the diseases studied, roughly 40% percent were linked to genetic disorders. Additionally, the study was carried out to assess awareness, attitude towards genetic diseases, and acceptability of genetic interventions among pregnant women in Burera district, Rwanda. This cross-sectional study was conducted among 664 pregnant women in six selected health centers in Burera district using a detailed questionnaire.

The findings from this study showed that among participants, adequate awareness was at 29.5%, inadequate awareness at 70.5%, positive attitudes at 87.1%, negative attitudes at 12.9%, high acceptability at 97.1%, and low acceptability at 2.9%. Participants with positive attitudes towards genetic diseases were more likely to develop a high level of acceptability and willingness to use genetic interventions. Increasing insights into the genetic basis of diseases have identified new targets for cell and gene therapies. Therefore, the growing awareness of genetics allows for the development of more targeted and personalized therapeutic interventions, boosting the growth of the cell and gene therapy market.

Restraints

Cell and Gene Therapy Manufacturing costs limiting access

The cost of cell and gene therapy is higher due to producing, handling, and controlling the cells or viral vectors required to make them, which is more complicated than working with chemicals used to make conventional pharmaceuticals and biopharmaceuticals. According to an analysis of the Institute for Clinical and Economical Review (ICER), the average cost of gene therapy is between $1 million and $2 million per dose; similarly, cell therapy cost differs more widely depending on the indication and the type of product, the average cost per treatment is $1 million which limits patient access to cell and gene therapies.

For instance, FDA Approved first Gene therapy Hemgenix, developed by CSL Behring, is priced at roughly $3.5 million for adults with hemophilia B. Skysona developed by bluebird bio plans to follow $3 million treatment. The drug treats active cerebral adrenoleukodystrophy (CALD) in males between 4 and 17. ZYNTELGO developed by Bluebird Bio's s roughly $2.8 million for a one-time treatment, not accounting for hospital stays and follow-up care.

Opportunities

Technological advancements in manufacturing processes and personalized treatments

The recent approved cell and gene therapy products benefit the limited number of patients annually, and manufacturing procedures acquired from simpler biologics are costly and inefficient. However, innovation is impacting the industry, with large multinational corporations and an increasing group of start-ups and small to medium-sized enterprises (SMEs) attempting to improve every step of CGT manufacturing.

From new nucleic acid formats and viral biosynthesis methods to non-viral gene therapy printers and personalized cell therapies, these advancements aim to produce better-defined biochemical entities, resulting in more precise medicines with lower costs and time to market. This advancement reforms the manufacturing infrastructure and indicates a shift toward personalized treatments in the CGT market. As the industry sets up for the manufacture of numerous drug candidates for clinical trials and potentially new drugs on a larger scale, ongoing improvements in both product quality and manufacturing processes are expected to be critical for realizing the full potential of CGT across diverse therapeutic areas such as oncology, genetic disorders, and immune conditions.

Technological advancements, particularly in gene-editing technologies like CRISPR/Cas9, have played a pivotal role in shaping the landscape of cell and gene therapy. These tools enable precise modifications to genes, opening up new possibilities for targeted and personalized treatments. Concurrently, improvements in manufacturing processes, including automation and scale-up technologies, contribute to enhanced efficiency and scalability of production.

Regional Snapshot

Cell & Gene Therapy Market Share, by Region (2022-2032)

Europe is expected to grow significantly during the forecast period owing to the collaborative research environment, robust healthcare infrastructure, and favorable regulatory frameworks. The European Medicines Agency (EMA) offers a centralized approval process, expediting review procedures and offering incentives for orphan drug designations, creating a favorable environment for the development and commercialization of these advanced therapies Europe is rising to the top of cell and gene therapy innovation due to the region's commitment to collaborative efforts, investments in healthcare infrastructure, and a tradition of research excellence.

• The Europe cell and gene therapy market size was valued at USD 5,241.43 million in 2022 and is estimated to reach around USD 27,049.17 million by 2032, growing at a CAGR of 17.9% from 2023 to 2032.
  
  
• The North America cell and gene therapy market size was reached USD 7,678.32 million in 2022 and is estimated to reach around USD 41,243.83 million by 2032, expanding at a CAGR of 18.4% from 2023 to 2032.
  
  
• The Asia Pacific cell and gene therapy market size surpassed USD 1,941.01 million in 2022 and is projected to hit around USD 11,123.21million by 2032, expanding at a CAGR of 19.2% from 2023 to 2032.

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Therapy Type Insights:

Global Cell & Gene Therapy Market Snapshot, By Therapy Type 2022-2032 ($ Million)

The gene therapy segment is growing rapidly due to integrating scientific, technological, and clinical breakthroughs. The development of intense gene-editing technologies, specifically CRISPR/Cas9, has transformed the precision and efficiency with which genes can be modified, thus increasing the therapeutic possibilities of gene therapy. Practical clinical trials in gene-based interventions, particularly CAR-T cell therapy, and mRNA vaccines, have proven the tangible benefits and feasibility of gene-based interventions, developed confidence, and promoted interest in the field. The growing understanding of the genetic basis of diseases, enabled by advances in genomics and molecular biology, has identified new targets for gene therapy across a wide range of conditions.

The field has made significant progress in addressing rare genetic disorders and providing targeted and personalized treatments. Improved delivery systems, such as advanced viral vectors and nanoparticles, have increased the efficiency and safety of transporting therapeutic genes to target cells. The influx of investment and funding from both the public and private sectors has accelerated efforts to conduct research and development. Regulatory support, which includes accelerated approval processes for gene therapies by agencies such as the FDA and EMA, has highlighted the transformative potential of these treatments.

Therapeutic Class Insights

Based on therapeutic class, the ophthalmology class is expected to grow significantly owing to its development in gene therapies targeting retinal disorders, specifically inherited retinal diseases (IRDs). These conditions, such as retinitis pigmentosa and Leber congenital amaurosis, often result from genetic mutations affecting the function of retinal cells. Gene therapy in ophthalmology involves introducing functional genes into the retina to correct or compensate for these mutations. Significant advancements involve the development of gene therapies that utilize adeno-associated viruses (AAVs) as vectors to deliver therapeutic genes to retinal cells.

Delivery Method Insights

The ex vivo gene therapy segment is expected to grow rapidly owing to several factors that illustrate its precision, control, and adaptability in therapeutic applications. A significant benefit is the precise manipulation of cells outside the body, which allows for detailed and complex genetic corrections in a controlled laboratory setting. This amount of control improves the accuracy of genetic modifications and ensures thorough quality assurance using stringent assessments before reintroducing the modified cells into the patient. Ex vivo methods are beneficial when multiple genetic corrections or specific cell types require modification. The in vitro growth of modified cells addresses the need for a sufficient quantity, which is critical in treating various disorders.

Cancer treatments use ex vivo gene therapy, particularly in developing CAR-T cell therapies, in which T cells are extracted, genetically modified ex vivo, and then reinfused to target and eliminate cancer cells. Ex vivo modifications are growing more efficient and precise as gene-editing technologies such as CRISPR/Cas9 have advanced. With increasing clinical trials analyzing ex vivo gene therapies and regulatory support for these new strategies, the ex vivo segment is expected to grow faster. 

End-User Insights

The hospital segment dominated the market in 2022, holding a significant market share owing to the widespread adoption of gene-based treatments. Hospitals have advanced infrastructure and facilities necessary for managing the complexities of gene therapy, such as specialized laboratories and advanced imaging technologies. The multidisciplinary nature of gene therapy, which necessitates collaboration among various medical professionals, corresponds to the diversity of expertise found in hospitals.

In gene therapy, strict regulatory standards and safety protocols are required to be followed, and hospitals that are used to navigating and adhering to regulatory requirements ensure that procedures meet ethical and safety standards. Hospitals operate as centers for clinical trials, research studies, and ongoing education, developing a skilled workforce capable of delivering advanced gene therapy treatments due to their diverse patient population and central role in medical education and training.

Browse More Insights:

• Sickle Cell Disease Treatment Market:  The global market size was estimated at USD 2.5 billion in 2022 and is expected to hit around USD 50.45 billion by 2032, poised to grow at a CAGR of 35.1% during the forecast period from 2023 to 2032.
• Cell Penetrating Peptide Market: The global market size was estimated at USD 1.6 billion in 2022 and is projected to be worth around USD 7.15 billion by 2032, poised to grow at a CAGR of 16.2% during the forecast period from 2023 to 2032.
• Allogeneic Cell Therapy Devices Market: The global market size was estimated at USD 260.14 million in 2022 and is expected to reach around USD 2,476.57 million by 2032, registering a CAGR of 25.28% during the forecast period from 2023 to 2032.
• Mammalian Cell Fermentation Technology Market: The global market size was estimated at USD 42.66 billion in 2022 and it is expected to hit around USD 100.25 billion by 2032, expanding at a CAGR of 8.92% during the forecast period 2023 to 2032.
• Gene Editing Market: The global market size was estimated at USD 6.94 billion in 2022 and it is expected to surpass around USD 29.93 billion by 2032, growing at a CAGR of 15.73% during the forecast period 2023 to 2032.
• Engineered T Cells Market: The global market size was reached at USD 20.21 billion in 2022 and it is expected to hit around USD 348.9 billion by 2032, expanding at a CAGR of 32.96% during the forecast period 2023 to 2032.
• T-cell Therapy Market: The global market size was reached at USD 4.12 billion in 2022 and it is expected to hit around USD 87.49 billion by 2032, growing at a CAGR of 35.74% during the forecast period from 2023 to 2032.
• Cancer Gene Therapy Market: The global market size was estimated at USD 2.37 billion in 2022 and is projected to hit around USD 15.2 billion by 2032, poised to grow at a CAGR of 20.42% during the forecast period from 2023 to 2032.
• Gene Editing Market: The global market size was estimated at USD 6.94 billion in 2022 and it is expected to surpass around USD 29.93 billion by 2032, growing at a CAGR of 15.73% during the forecast period 2023 to 2032.
• Cell and Gene Therapy Clinical Trials Market:  The global market size reached USD 10.05 billion in 2022 and is expected to hit around USD 40.98 billion by 2032, growing at a CAGR of 15.09% from 2023 to 2032.

Recent Developments

• In Oct 2023, BioNTech presented data from a rejigged formula for the CAR-T therapy BNT211 at the European Society for Medical Oncology (EMSO) Monday, showing that the therapy had signs of clinical efficacy with an overall response rate of 45% in 38 of 44 evaluable patients.
• In Oct 2023, Forge Biologics, a genetic medicines manufacturing specialist, joined a California-backed organization to boost the development of adeno-associated adenovirus (AAV) gene therapies.
• In Oct 2023, Bayer announced its opening of its first cell therapy launch facility in Berkeley, which is expected to create capacity to bring cell therapies to patients worldwide.

Market Key Players:

• Alnylam Pharmaceuticals Inc.
• Amgen Inc.
• Biogen Inc.
• CORESTEM Inc.
• Dendreon Pharmaceuticals LLC.
• Helixmith Co. Ltd.
• JCR Pharmaceuticals Co. Ltd.
• Kolon TissueGene Inc.
• Novartis AG
• Pfizer Inc.

Market Segmentations:

By Therapy Type

• Cell Therapy
• Stem Cells
• T Cells
• Dendritic Cells
• NK Cells
• Tumor Cells
• Gene Therapy

By Therapeutic class

• Cardiovascular Disease
• Cancer
• Genetic Disorder
• Rare Diseases
• Oncology
• Hematology
• Ophthalmology
• Infectious Disease
• Neurological Disorders

By Delivery Method

• In Vivo
• Ex vivo

By End-Users

• Hospitals
• Cancer Care Centers
• Wound Care Centers
• Others

By Region 

• North America
• Europe
• Asia Pacific
• Latin America
• MEA

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