Cell and Gene Therapy Market Outlook
The cell and gene therapy market size was valued at USD 17.4 billion in 2023, driven by the increasing prevalence of chronic disorders like cancer across the globe. The market size is anticipated to grow at a CAGR of 23.17% during the forecast period of 2024-2032 to achieve a value of USD 113.53 billion by 2032.
Cell and Gene Therapy: Introduction
Cell and gene therapy represents a revolutionary frontier in medical science, offering transformative potential for treating a range of genetic and acquired diseases. These innovative therapies involve modifying or replacing genetic material within a patient’s cells to combat disease at its source. Cell therapy focuses on the administration of live, often genetically altered cells, while gene therapy involves directly modifying or correcting defective genes. Recent advancements in technologies like CRISPR and CAR-T have propelled the field, promising personalized and potentially curative treatments for conditions such as cancer, genetic disorders, and rare diseases, heralding a new era of precision medicine and improved patient outcomes.
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Key Trends in the Global Cell and Gene Therapy Market
Some key trends in the global cell and gene therapy market include:
- Advancements in Gene Editing Technologies: Innovations such as CRISPR-Cas9 and other gene editing tools have revolutionized the field of gene therapy, enabling precise modification of genetic material to correct disease-causing mutations. These technologies hold promise for treating a wide range of genetic disorders more effectively and efficiently.
- Increased Investment and Funding: The cell and gene therapy market has witnessed a surge in investment from both public and private sectors, fuelling research, development, and commercialization efforts. Funding support from governments, venture capital firms, and pharmaceutical companies is driving innovation and expanding the therapeutic pipeline.
- Growing Clinical Success: Positive clinical trial results and regulatory approvals have demonstrated the therapeutic potential of cell and gene therapies across various indications, including rare genetic diseases, cancer, and autoimmune disorders. Increasing clinical success stories are boosting confidence in the efficacy and safety of these innovative treatments.
- Expansion of Indications: The scope of cell and gene therapy applications is expanding beyond traditional indications, with ongoing research exploring their potential in treating complex diseases such as cardiovascular disorders, neurodegenerative diseases, and infectious diseases. This broadening of indications is driving market growth and diversification.
- Regulatory Advancements: Regulatory agencies worldwide are adapting to the unique challenges and opportunities presented by cell and gene therapies, streamlining approval processes, and providing guidance to facilitate innovation while ensuring patient safety. Expedited pathways and regulatory incentives are accelerating product development and commercialization.
- Manufacturing Innovation: Advances in cell culture technologies, bioprocessing, and automation are improving the scalability, reproducibility, and cost-effectiveness of cell and gene therapy manufacturing. Innovative manufacturing platforms and partnerships are addressing manufacturing challenges and increasing production capacity to meet growing demand.
- Access and Affordability: Efforts to improve patient access to cell and gene therapies are underway, driven by initiatives to address reimbursement challenges, establish value-based pricing models, and enhance healthcare infrastructure. Collaborative approaches involving payers, providers, manufacturers, and patient advocacy groups aim to ensure equitable access to these transformative treatments.
- Integration with Standard of Care: Cell and gene therapies are increasingly being integrated into standard treatment algorithms and multidisciplinary care models, complementing existing therapeutic approaches and improving overall patient outcomes. Combination therapies and synergistic treatment regimens are being explored to maximize therapeutic efficacy and durability.
- International Collaboration: Collaboration among academia, industry, regulatory agencies, and healthcare stakeholders is fostering global partnerships and knowledge-sharing initiatives to advance cell and gene therapy research, standardize practices, and address common challenges. International collaboration enhances research capabilities, accelerates innovation, and expands access to cutting-edge therapies worldwide.
- Patient-Centric Focus: Patient advocacy groups and initiatives are playing a crucial role in shaping the development and delivery of cell and gene therapies, ensuring that patient perspectives, preferences, and needs are prioritized throughout the treatment journey. Patient engagement, education, and support programs empower individuals to make informed decisions and actively participate in their care.
Cell and Gene Therapy Market Segmentation
Market Breakup by Type
- Cell Therapy Types
- Autologous Cell Therapy
- Autogenic Cell Therapy
- Ex-vivo Cell Therapy
- In-vivo Cell Therapy
- Gene Therapy Types
- Somatic Cell Gene Therapy
- Germline Gene Therapy
- Ex-vivo Gene Therapy
- In-vivo Gene Therapy
Market Breakup by Indications
- Oncology
- Cardiology
- CNS
- Musculoskeletal
- Infectious Diseases
- Dermatology
- Endocrine, Metabolic, Genetic
- Immunology and Inflammation
- Ophthalmology
- Hematology
- Gastroenterology
- Others
Market Breakup by Product Type
- Yescarta
- Provenge
- Luxtura
- Kymriah
- Imlygic
- Gintuit
- MACI
- Laviv
- Gendicine
- Oncorine
- Neovasculgen
- Strimvelis
- Invossa
- Zolgenesma
- Tecartus
- Lisocel
- Zyntelego
- Others
Market Breakup by End User
- Hospitals
- Ambulatory Surgical Centres
- Wound Care Centres
- Cancer Care Centres
- Others
Market Breakup by Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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Cell and Gene Therapy Market Overview
The global cell and gene therapy market is segmented based on geographical regions, including:
North America: North America, particularly the United States and Canada, holds a significant share in the cell and gene therapy market. Factors such as advanced healthcare infrastructure, supportive regulatory environment, robust research and development activities, and high prevalence of genetic disorders contribute to the region’s market dominance.
Europe: Europe is another key market for cell and gene therapy, with countries such as Germany, the United Kingdom, France, and Switzerland leading in innovation and adoption. Well-established biotechnology and pharmaceutical industries, strong academic research institutions, and government support for healthcare innovation drive market growth in this region.
Asia Pacific: The Asia Pacific region, including countries like Japan, China, South Korea, and Australia, represents a rapidly growing market for cell and gene therapy. Factors such as increasing healthcare expenditure, rising prevalence of chronic diseases, expanding biotechnology sector, and government initiatives to promote healthcare innovation contribute to market expansion in this region.
Latin America: Latin America is an emerging market for cell and gene therapy, with countries like Brazil, Mexico, and Argentina showing significant growth potential. Improving healthcare infrastructure, rising awareness about advanced treatment options, and increasing investment in healthcare technology drive market development in this region.
Middle East and Africa: The Middle East and Africa region represent a growing market for cell and gene therapy, driven by improving healthcare infrastructure, rising healthcare spending, and increasing awareness about innovative treatment approaches. Countries such as Saudi Arabia, the UAE, South Africa, and Nigeria are key contributors to market growth in this region.
Cell and Gene Therapy Market: Competitor Landscape
The key features of the market report include patent analysis, grants analysis, clinical trial analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- Amgen, Inc.
Amgen, Inc. is a leading biotechnology company headquartered in Thousand Oaks, California, United States. Founded in 1980, Amgen is dedicated to developing innovative therapies to treat serious illnesses, with a focus on oncology, hematology, nephrology, inflammation, bone health, and cardiovascular diseases. The company’s product portfolio includes biologic medications such as Enbrel (etanercept) for autoimmune diseases, Neulasta (pegfilgrastim) for neutropenia, and Repatha (evolocumab) for hypercholesterolemia. Amgen is also involved in research and development across various therapeutic areas, including novel biologics, small molecules, and biosimilars. With a commitment to scientific innovation and patient care, Amgen continues to make significant contributions to advancing healthcare worldwide.
- Bluebird Bio, Inc.
Bluebird Bio, Inc. is a biotechnology company specializing in developing gene therapies for severe genetic diseases and cancer. Founded in 1992 and headquartered in Cambridge, Massachusetts, Bluebird Bio is known for its innovative research and development efforts in gene editing and cell therapy technologies. The company’s product pipeline includes investigational therapies targeting rare genetic diseases such as beta-thalassemia, sickle cell disease, and adrenoleukodystrophy (ALD), as well as oncology indications like multiple myeloma. Bluebird Bio is dedicated to advancing the field of gene therapy and bringing transformative treatments to patients in need.
- Castle Creek Pharmaceutical Holdings
Castle Creek Pharmaceutical Holdings is a biopharmaceutical company dedicated to developing and commercializing therapies for patients with rare and serious dermatologic conditions. Founded in 2016, the company focuses on addressing unmet medical needs in dermatology through innovative treatments. Castle Creek’s pipeline includes therapies for a range of skin disorders, including epidermolysis bullosa, vitiligo, and alopecia areata. With a commitment to research, development, and patient care, Castle Creek aims to improve the lives of individuals affected by rare dermatologic diseases. The company collaborates with healthcare professionals, patient advocacy groups, and regulatory agencies to advance its mission of delivering effective and accessible treatments to those in need.
- Kite Pharma, Inc.
Kite Pharma, Inc., a subsidiary of Gilead Sciences, is a pioneering biopharmaceutical company specializing in the development of innovative cancer immunotherapies. Founded in 2009, Kite is renowned for its groundbreaking work in chimeric antigen receptor (CAR) T-cell therapy, a revolutionary approach that harnesses the power of the immune system to target and eliminate cancer cells. Kite’s flagship therapy, YESCARTA® (axicabtagene ciloleucel), was the first CAR T-cell therapy approved for certain types of non-Hodgkin lymphoma. The company continues to advance its pipeline of CAR T-cell therapies and other immune-oncology treatments, aiming to transform the landscape of cancer care and improve patient outcomes worldwide.
- Novartis AG
Novartis AG is a global pharmaceutical and healthcare company headquartered in Basel, Switzerland. Founded in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis has established itself as one of the largest pharmaceutical companies in the world. The company operates in multiple therapeutic areas, including innovative medicines, generics, eye care, and oncology. Novartis focuses on research and development to bring breakthrough treatments and therapies to patients worldwide. With a diverse portfolio of pharmaceuticals, biologics, and cell and gene therapies, Novartis is committed to addressing unmet medical needs and improving healthcare outcomes for patients globally.
Other key players in the market include Orchard Therapeutics plc., Pfizer, Inc., Inc., Vericel Corporation Inc., Precision BioSciences, Kolon Tissuegene Inc., Takeda Pharmaceutical Company, Vertex Pharmaceuticals Inc., Sangamo Therapeutics Inc., Organogenesis Holdings Inc., and Spark Therapeutics
