Cell & Gene Therapy Market by Therapy Type (Cell Therapy, Gene Therapy), Delivery Method (Intramuscular, Intravenous), Therapeutic Areas, Application, End User - Global Forecast 2025-2030

The Cell & Gene Therapy Market size was estimated at USD 14.33 billion in 2023 and expected to reach USD 16.65 billion in 2024, at a CAGR 18.98% to reach USD 48.39 billion by 2030.

Cell and gene therapy is an innovative field in biotechnology that involves altering genes or introducing new cells into a patient’s body to treat or potentially cure diseases at the genetic level. The necessity for these therapies stems from their potential to address conditions that are currently incurable, such as certain genetic disorders, some types of cancer, and rare diseases. Application of cell and gene therapy is vast, including oncology, cardiology, and neurology, offering customized solutions for previously untreatable conditions. End-use scope primarily covers healthcare facilities such as hospitals, specialized clinics, and research institutions, with an increasing role in regenerative medicine.

The market is driven by technological advances in gene editing tools like CRISPR, increased investments in research and development, and a growing prevalence of chronic and genetic disorders. Recent breakthroughs in immunotherapy, particularly CAR-T cell therapy, highlight potential opportunities for expansion in cancer treatment. Opportunities exist in developing scalable manufacturing processes, improving delivery mechanisms for therapies, and establishing robust regulatory pathways to accelerate market entry. However, challenges include high development and manufacturing costs, stringent regulatory environments, and ethical concerns raised by genetic modifications.

Key limitations affecting market growth are related to safety and efficacy issues, as well as patient accessibility due to high treatment costs. Navigating these challenges requires strategic partnerships between biotech firms and healthcare providers, as well as collaboration with regulatory agencies to refine approval processes. The best areas for innovation and research include enhancing targeted delivery systems, making therapies more affordable through novel production methods, and expanding applications in autoimmune and neurodegenerative disorders. Market nature is rapidly evolving, characterized by significant investment inflows, a competitive landscape with key players focusing on mergers and acquisitions, and an ongoing need for interdisciplinary approaches to research and commercialization. Leveraging these insights can guide businesses toward sustainable growth and impactful healthcare solutions.

The market dynamics represent an ever-changing landscape of the Cell & Gene Therapy Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

• Market Drivers
  • Increasing prevalence of genetic disorder and rare disease globally
  • Growing awareness and rising demand for personalised medicine
• Market Restraints
  • Complex production processes and quality control issues associated with cell & gene therapy
• Market Opportunities
  • Development of off-the-shelf cell therapies offers scalable solutions for large patient populations
  • Rising collaboration between biotechnology and pharmaceutical companies for enhanced research & development
• Market Challenges
  • Stringent governmental regulation & approval procedures for new gene therapies

• Therapy Type: Preference for T cell therapy to target and destroy cancer cells

  Cell therapy initiates using live cells to treat or prevent diseases. Stem cell therapies leverage the regenerative abilities of stem cells to repair damaged tissues or combat diseases. They are divided into two main types: hematopoietic stem cell therapies, which are primarily employed in treating blood-related disorders including leukemia and lymphoma by restoring healthy blood cell production, and mesenchymal stem cell therapies, which hold potential in regenerative medicine owing to their ability to differentiate into different cell types and modulate immune responses, thus showing promise in the treatment of autoimmune diseases and tissue injuries. Furthermore, T cell therapy focuses on manipulating and enhancing T cells, a crucial component of the immune system, to attack, destroy, and kill cancer cells. Chimeric antigen receptor T cell therapy (CAR T) involves genetically engineering a patient's T cells to express specific receptors that recognize and attack cancer cells with remarkable precision and efficacy, particularly in hematological cancers. Another type is T cell receptor (TCR)-based therapy, which targets a broader range of tumors by directing T cells to recognize specific antigens presented by tumor cells, offering a versatile approach to solid tumor management. In gene therapy, the main focus is on correcting defective genes to treat diseases. Ex vivo gene therapy involves the genetic modification of cells outside the patient's body, which are then transplanted back to treat disorders such as severe combined immunodeficiency (SCID). However, in vivo gene therapy directly delivers genetic material into the patient's body to rectify genetic disorders at their source, exemplified by therapies targeting inherited retinal diseases and metabolic disorders. These therapies are reshaping the medical landscape, offering curative potential and improving clinical outcomes across various conditions.

• Delivery Method: Utilization of intramuscular delivery system to reduced invasiveness

  The intramuscular delivery method injects the therapeutic agent directly into the muscle tissue. It is often preferred for its ease of administration, reduced invasiveness, and the potential requirement for fewer resources compared to other methods. This approach can contribute to localized absorption of the therapy, which is beneficial for specific applications, such as vaccines or localized treatments. Intramuscular injections typically afford a slower release of the therapeutic agent into the bloodstream, providing a steady and prolonged exposure. This is advantageous for therapies where a sustained effect is desirable. Manufacturers such as Moderna are leveraging this method in their mRNA-based vaccine technology, emphasizing its suitability for preventive and chronic treatments. However, the intravenous delivery method is particularly prominent in more complex and systemic therapeutic applications. Delivering the therapeutic agent directly into the patient's bloodstream ensures rapid and complete systemic distribution, which is essential for treatments requiring quick onset and comprehensive therapeutic coverage. This method is highly effective for advanced therapies, such as CAR T-cell therapies used in oncology, where precision and potency are paramount. However, healthcare professionals' need for administration in a clinical setting increases operational challenges and costs. With recent research and technological advancements, intramuscular and intravenous delivery systems continue to evolve to enhance therapeutic outcomes and expand their applicability across a broader range of diseases and conditions.

The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Cell & Gene Therapy Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.

The PESTLE analysis offers a comprehensive tool for understanding and analyzing the external macro-environmental factors that impact businesses within the Cell & Gene Therapy Market. This framework examines Political, Economic, Social, Technological, Legal, and Environmental factors, providing companies with insights into how these elements influence their operations and strategic decisions. By using PESTLE analysis, businesses can identify potential opportunities and threats in the market, adapt to changes in the external environment, and make informed decisions that align with current and future conditions. This analysis helps companies anticipate shifts in regulation, consumer behavior, technology, and economic conditions, allowing them to better navigate risks and capitalize on emerging trends.

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Cell & Gene Therapy Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Cell & Gene Therapy Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

• Novartis acquires Kate Therapeutics to advance gene therapies for neuromuscular diseases

  Novartis announced the acquisition of Kate Therapeutics for up to USD 1.1 billion. This acquisition aims to enhance Novartis' capabilities in addressing inherited neuromuscular disorders such as DMD, FSHD, and DM1. Kate's innovative DELIVER platform, which optimizes muscle-targeted therapies minimizing liver exposure. [Published On: November 21, 2024]

• Cellular Origins and Fresenius Kabi sign agreement for automated cell and gene therapy manufacturing

  Cellular Origins and Fresenius Kabi announced a development agreement to integrate Fresenius Kabi’s cell therapy technologies with Cellular Origins’ constellation automation platform. This aims to automate and scale up cell and gene therapy manufacturing using the Cue cell processing system, enhancing efficiency and reducing human error.  [Published On: October 16, 2024]

• Astellas and AviadoBio exclusive license agreement for AVB-101 gene therapy targeting frontotemporal dementia

  Astellas and AviadoBio entered a strategic agreement granting Astellas an exclusive option to license AviadoBio's AVB-101, an innovative AAV-based gene therapy aimed at treating frontotemporal dementia (FTD). The collaboration aims to further the development and commercialization of AVB-101, leveraging AviadoBio's expertise in gene therapy. [Published On: October 08, 2024]

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Cell & Gene Therapy Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

The report delves into recent significant developments in the Cell & Gene Therapy Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Abeona Therapeutics Inc., Adaptimmune Therapeutics PLC, AGC Inc., Alnylam Pharmaceuticals, Inc., American Gene Technologies Inc., Amgen Inc., AnGes, Inc, Astellas Pharma Inc., Becton, Dickinson and Company, Biogen Inc., Bluebird Bio, Inc., BridgeBio Pharma, Inc., Bristol-Myers Squibb Company, C.H. Boehringer Sohn AG & Co. KG, Cellectis SA, CRISPR Therapeutics AG, F. Hoffmann-La Roche AG, Gilead Sciences, Inc., Intellia Therapeutics, Inc., Ionis Pharmaceuticals, Inc., Johnson & Johnson Services Inc., Kyowa Kirin Co., Ltd., Merck KGaA, Moderna, Inc., Mustang Bio, Inc., Novartis AG, Novo Nordisk A/S, Pfizer, Inc., REGENXBIO Inc., Sangamo Therapeutics, Inc., Sarepta Therapeutics, Inc., Shoreline Biosciences, Sibiono GeneTech Co. Ltd., Syncona Limited, Thermo Fisher Scientific Inc., and Vertex Pharmaceuticals Incorporated.

This research report categorizes the Cell & Gene Therapy Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Therapy Type
  • Cell Therapy
    • Stem Cell Therapies
      • Hematopoietic Stem Cell Therapies
      • Mesenchymal Stem Cell Therapies
    • T Cell Therapy
      • CAR T Cell Therapy
      • T Cell Receptor (TCR)-based
  • Gene Therapy
    • Ex Vivo Gene Therapy
    • In Vivo Gene Therapy
• Delivery Method
  • Intramuscular
  • Intravenous
• Therapeutic Areas
  • Cardiovascular
    • Congestive Heart Failure
    • Ischemic Heart Disease
  • Metabolic Disorders
    • Diabetes
    • Obesity
  • Neurological Disorders
    • Alzheimer's Disease
    • Huntington's Disease
    • Multiple Sclerosis
    • Parkinson's Disease
    • Spinal Cord Injuries
  • Oncology
    • Hematological Malignancies
    • Lymphomas
    • Solid Tumors
  • Ophthalmology
• Application
  • Clinical Applications
    • Disease Prevention
    • Disease Treatment
  • Research & Development
• End User
  • Academic & Research Institutes
    • Private Research Labs
    • Universities
  • Hospitals & Clinics

• Region
  • Americas
    • Argentina
    • Brazil
    • Canada
    • Mexico
    • United States
      • California
      • Florida
      • Illinois
      • New York
      • Ohio
      • Pennsylvania
      • Texas
  • Asia-Pacific
    • Australia
    • China
    • India
    • Indonesia
    • Japan
    • Malaysia
    • Philippines
    • Singapore
    • South Korea
    • Taiwan
    • Thailand
    • Vietnam
  • Europe, Middle East & Africa
    • Denmark
    • Egypt
    • Finland
    • France
    • Germany
    • Israel
    • Italy
    • Netherlands
    • Nigeria
    • Norway
    • Poland
    • Qatar
    • Russia
    • Saudi Arabia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Turkey
    • United Arab Emirates
    • United Kingdom

1. Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
2. Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
3. Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
4. Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
5. Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.

1. What is the current market size and projected growth?
2. Which products, segments, applications, and regions offer promising investment opportunities?
3. What are the prevailing technology trends and regulatory frameworks?
4. What is the market share and positioning of the leading vendors?
5. What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?