Global Cell and Gene Therapy Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In October 2022, Alexion's genomic medicines announced the acquisition of LogicBio's technology. Through this acquisition, they aimed to incorporate a knowledgeable team for preclinical development and research on rare diseases. LogicBio had developed several technical systems for gene delivery and insertion to address genetic disorders, along with a platform to improve the creation of viral vectors.

• In October 2022, Moderna disclosed that Merck (MSD) had exercised its $250 million option to co-develop and commercialize PCV mRNA-4157/V940. The vaccine was being tested in a phase II clinical trial as adjuvant therapy for patients with high-risk melanoma, in combination with pembrolizumab, Merck's PD-1 antibody.

Cell therapy involves the use of living cells to restore or modify cellular functions, allowing the body to better fight diseases. This can include therapies such as stem cell transplants or the engineering of specific immune cells to combat cancer. Gene therapy, on the other hand, focuses on altering or repairing genes within a patient’s cells to correct or mitigate the effects of genetic disorders. This method can involve adding new or modified genes to help fight disease or to compensate for faulty ones. Both therapy types have made significant strides in treating previously untreatable conditions and are paving the way for personalized treatment strategies.

The indication segmentation in the Global Cell and Gene Therapy Market highlights the wide range of diseases targeted by these advanced therapies. Conditions such as cancer, genetic disorders, and blood-related diseases like leukemia and lymphoma are primary focus areas for both cell and gene therapies. The development of targeted treatments for specific genetic conditions has also gained traction, with therapies aimed at diseases like cystic fibrosis, muscular dystrophy, and sickle cell anemia. The growing emphasis on precision medicine has propelled these therapies to the forefront of medical research and treatment, offering hope to patients with limited options.

When it comes to end users, the market includes a variety of healthcare providers and institutions. Hospitals are major contributors as they have the infrastructure, medical expertise, and resources needed for complex therapies. Research institutions are also pivotal, as they conduct the foundational studies and clinical trials that help advance treatment methodologies and bring them to market. Specialized clinics that focus on regenerative and genetic treatments cater to patients who seek targeted therapies and personalized care. Additionally, biotechnology companies involved in the development of cell and gene therapy products play a crucial role, driving innovation and bringing new therapies through clinical trials and regulatory approvals.

The Geography segmentation in the Global Cell and Gene Therapy Market underscores the varying adoption and development rates across different regions. North America and Europe have been leaders in implementing these therapies, supported by advanced healthcare infrastructure, regulatory frameworks, and substantial investments in research and development. Meanwhile, regions such as Asia-Pacific are showing significant growth due to improving healthcare systems and increasing research initiatives. Emerging markets are also gradually adopting these therapies as technology becomes more accessible and cost-effective. The geographic distribution of the market demonstrates both the opportunities and challenges that different regions face in integrating cell and gene therapies into their healthcare systems.

Global Cell and Gene Therapy Segment Analysis

In this report, the Global Cell and Gene Therapy Market has been segmented by Therapy Type, Indication, End User, and Geography.

Global Cell and Gene Therapy Market, Segmentation by Therapy Type

The Global Cell and Gene Therapy Market has been segmented by Therapy Type into Cell Therapy and Gene Therapy.

Cell therapy is a significant aspect of cancer treatment that includes various types of immune cells used to fight cancer more effectively. Stem cell therapy involves the use of stem cells to regenerate or repair damaged tissues, potentially enhancing the body's ability to fight cancer. Stem cells are unique for their ability to transform into various types of cells, making them a powerful tool for targeted treatment. T cell therapy is another prominent approach, particularly in the form of CAR-T cell therapy, where T cells are modified to better recognize and attack cancer cells. This method has shown promising results in treating certain blood cancers like leukemia and lymphoma.

Dendritic cell therapy is a type of cell-based immunotherapy where dendritic cells are used to stimulate the immune system to recognize and destroy cancer cells more effectively. These cells play a crucial role in presenting antigens and initiating the immune response, making them pivotal in targeted cancer treatments. NK (Natural Killer) cell therapy also holds significant promise due to NK cells' inherent ability to kill cancer cells without the need for prior sensitization, offering an advantage over other cell types. Lastly, tumor cell therapy involves using modified cancer cells or tumor antigens to boost the immune response against cancer, providing an additional method for mobilizing the body’s natural defense mechanisms.

Gene therapy represents another groundbreaking approach in the cancer immunotherapy market. This therapy involves the modification of a patient’s genes to improve or restore the immune system's ability to recognize and destroy cancer cells. Gene therapy can be used to enhance the expression of specific proteins that strengthen the immune system or to modify immune cells so they are better equipped to fight cancer. This approach can also be combined with cell therapy for even greater effectiveness, as seen in techniques where genes are inserted into T cells to create more powerful and targeted treatments.

Global Cell and Gene Therapy Market, Segmentation by Indication

The Global Cell and Gene Therapy Market has been segmented by Indication into Cardiovascular Disease, Cancer, Genetic Disorder, Infectious Disease, Neurological Disorders, and Others.

The Global Cell and Gene Therapy Market is undergoing a paradigm shift with its segmentation by indication, reflecting the diverse array of diseases and conditions targeted by these innovative therapies. Cardiovascular Disease emerges as a pivotal area of focus, promising groundbreaking interventions for conditions such as heart failure, ischemic heart disease, and inherited cardiac disorders. Through harnessing the regenerative potential of cells or manipulating genetic mechanisms, researchers are exploring novel avenues to address the complex pathophysiology of cardiovascular ailments, offering renewed hope for patients worldwide.

Cancer stands as a cornerstone within the segmented landscape of the cell and gene therapy market, representing a multifaceted challenge that demands innovative approaches. From hematological malignancies to solid tumors, researchers are leveraging immunotherapy and gene editing technologies to devise precision-guided therapies. These advancements hold the potential to revolutionize cancer treatment paradigms by empowering the immune system or directly targeting cancer cells, paving the way for more effective and less toxic therapeutic options across a spectrum of cancer types.

The segmentation by indication extends beyond cardiovascular disease and cancer to encompass a diverse spectrum of conditions, including Genetic Disorders, Infectious Diseases, Neurological Disorders, and Others. From rare genetic diseases with limited treatment options to infectious diseases like HIV and neurological disorders such as Parkinson's disease, cell and gene therapies offer targeted interventions that address the underlying mechanisms of disease. This segmentation underscores the transformative potential of cell and gene therapies across a wide range of therapeutic areas, heralding a new era of precision medicine and personalized healthcare tailored to the unique needs of individual patients.

Global Cell and Gene Therapy Market, Segmentation by End User

The Global Cell and Gene Therapy Market has been segmented by End User into Hospitals, Cancer Care Centers, and Others.

Hospitals are among the primary end-users, serving as critical hubs for comprehensive cancer care. With access to specialized medical equipment, highly trained oncologists, and advanced technology, hospitals are well-positioned to offer a wide range of cancer treatments, including immunotherapy. Hospitals are equipped to handle complex cases that require integrated care and often serve as the main point of treatment for patients undergoing advanced therapies such as cell and gene therapy.

Cancer care centers are another important segment within the end-user category. These specialized facilities are dedicated to the diagnosis, treatment, and management of cancer, providing a focused environment for comprehensive cancer care. Unlike general hospitals, cancer care centers often have dedicated teams of oncologists, radiologists, and cancer treatment specialists who work together to deliver personalized treatment plans. They are equipped with the latest technology and often lead the way in clinical trials, research, and the implementation of innovative therapies, including immunotherapy. The growth in the number of cancer care centers and their expanding capabilities are significant drivers for the uptake of cancer immunotherapy treatments.

Others in the end-user segment include research institutions, diagnostic laboratories, and specialized outpatient clinics. Research institutions play a critical role in advancing the field of cancer treatment by conducting clinical trials and studies that evaluate the effectiveness of new immunotherapy approaches. These institutions contribute to the development and refinement of treatment protocols and provide a foundation for regulatory approvals. Diagnostic laboratories also support the end-user ecosystem by offering diagnostic services that help identify suitable candidates for specific immunotherapy regimens. Outpatient clinics that specialize in oncological services also contribute to the market by providing accessible treatment options for patients who do not require hospitalization but still need specialized care.

Global Cell and Gene Therapy Market, Segmentation by Geography

In this report, the Global Cell and Gene Therapy Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Cell and Gene Therapy Market Share (%), by Geographical Region, 2024

Segmentation of the Global Cell and Gene Therapy Market by Scale of Operation into In-house and Outsourced reflects the strategic approaches adopted by industry players to navigate the complex landscape of therapeutic development and commercialization. In-house operations denote companies that choose to establish comprehensive capabilities for research, development, and manufacturing of cell and gene therapies within their organizations. This approach offers companies greater control over the entire product lifecycle, from early-stage discovery to commercialization, enabling them to optimize processes, protect intellectual property, and maintain a competitive edge in the market.

Outsourced operations entail partnerships with contract development and manufacturing organizations (CDMOs) or other third-party service providers to augment capabilities and streamline operations. By leveraging the expertise and infrastructure of external partners, companies can accelerate program timelines, mitigate risks, and access specialized technologies or facilities that may not be feasible to develop in-house. Outsourcing also provides flexibility in resource allocation, allowing companies to scale operations based on fluctuating demand and prioritize core competencies while outsourcing non-core activities.

The segmentation by Scale of Operation underscores the dynamic interplay between internal capabilities and external collaborations in driving innovation and commercialization within the cell and gene therapy market. As the industry continues to evolve, companies are likely to adopt hybrid models that combine in-house expertise with strategic partnerships to maximize efficiencies and accelerate the translation of scientific discoveries into clinically impactful therapies. By embracing a diversified approach to operations, stakeholders can navigate the complexities of the cell and gene therapy landscape and position themselves for long-term success in this rapidly advancing field.

This report provides an in depth analysis of various factors that impact the dynamics of Global Cell and Gene Therapy Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers:

• Increasing Investment
• Favorable Regulatory Environment

• Rising Prevalence of Chronic Diseases - The rising prevalence of chronic diseases is a significant driver reshaping the landscape of the global cell and gene therapy market. Chronic diseases, such as cardiovascular disorders, cancer, diabetes, and neurological conditions, are imposing an increasing burden on healthcare systems worldwide. Factors such as aging populations, sedentary lifestyles, and changing dietary habits contribute to the escalating incidence of these conditions, creating a pressing need for innovative therapeutic solutions.

  Cell and gene therapies offer a promising avenue for addressing the underlying causes of chronic diseases by targeting genetic mutations, dysfunctional cells, or aberrant pathways. These advanced treatments have the potential to provide long-lasting or even curative benefits, transforming the management of chronic conditions from symptomatic relief to disease modification. As a result, they represent a beacon of hope for millions of patients grappling with the lifelong burden of chronic illnesses.

  The rise of chronic diseases underscores the urgency of advancing precision medicine approaches tailored to individual patients' genetic makeup, lifestyle factors, and disease characteristics. Cell and gene therapies epitomize the personalized medicine paradigm by offering bespoke treatments designed to address the unique molecular signatures and pathophysiological mechanisms underlying each patient's condition. Through continuous innovation and collaboration across the healthcare ecosystem, stakeholders can harness the full potential of cell and gene therapies to combat the rising tide of chronic diseases and improve outcomes for patients worldwide.

Restraints:

• High Treatment Costs
• Limited Reimbursement Policies

• Scalability Challenges - Scalability challenges pose a significant obstacle to the widespread adoption and commercialization of cell and gene therapies, limiting their ability to meet the growing demand for these transformative treatments. Unlike traditional pharmaceuticals, which can be mass-produced using established manufacturing processes, cell and gene therapies involve complex and labor-intensive production methods that often rely on living cells or genetic materials. As a result, scaling up production to meet market demand while maintaining product quality, consistency, and safety presents formidable technical and logistical challenges for industry stakeholders.

  One of the primary scalability challenges in cell and gene therapy manufacturing is achieving reproducibility and consistency across large-scale production batches. Variability in cell quality, genetic modification efficiency, and culture conditions can significantly impact therapeutic efficacy and safety, necessitating stringent quality control measures throughout the manufacturing process. Additionally, the specialized infrastructure and equipment required for cell expansion, gene editing, and vector production further complicate scaling efforts, often requiring substantial capital investment and expertise.

  The intricate nature of cell and gene therapy manufacturing processes poses logistical challenges related to supply chain management, logistics, and regulatory compliance. From sourcing raw materials and reagents to navigating complex regulatory requirements governing cell and gene therapy manufacturing and distribution, stakeholders must navigate a highly regulated and dynamic landscape to ensure product quality, safety, and compliance at every stage of the supply chain. Failure to address scalability challenges effectively can result in production delays, supply shortages, and increased costs, ultimately hindering patient access to these life-saving therapies.

  Addressing scalability challenges in cell and gene therapy manufacturing requires a multifaceted approach that integrates advances in bioprocessing technologies, automation, and data analytics with strategic partnerships, regulatory harmonization efforts, and investment in infrastructure and workforce development. By fostering collaboration and innovation across the industry, academia, and regulatory agencies, stakeholders can overcome scalability barriers and unlock the full potential of cell and gene therapies to address unmet medical needs and improve patient outcomes on a global scale.

Opportunities:

• Development of Novel Therapies
• Collaborations and Partnerships

• Patient Advocacy and Education - Patient advocacy and education play a pivotal role in shaping the trajectory of the global cell and gene therapy market, empowering patients to make informed decisions, access innovative treatments, and advocate for their healthcare needs. As cell and gene therapies continue to revolutionize the treatment landscape for a wide range of diseases and conditions, patient advocacy organizations serve as powerful catalysts for raising awareness, driving policy changes, and amplifying patient voices within the healthcare ecosystem.

  Patient advocacy groups serve as invaluable resources for individuals affected by rare diseases, chronic conditions, and genetic disorders, offering support, information, and community networks to navigate their healthcare journeys. By providing access to educational materials, peer support programs, and advocacy initiatives, these organizations empower patients and caregivers to become informed advocates for their own health and actively participate in shared decision-making processes with healthcare providers and researchers.

  Patient advocacy efforts are instrumental in fostering collaboration and dialogue among stakeholders across the cell and gene therapy ecosystem, including patients, caregivers, healthcare professionals, industry partners, and regulatory agencies. Through patient-centered initiatives, such as patient advisory boards, community engagement events, and advocacy campaigns, stakeholders can co-create solutions that prioritize patient perspectives, preferences, and needs throughout the drug development lifecycle, from research and clinical trials to regulatory approval and post-market access.

  By elevating patient voices, driving awareness, and advocating for equitable access to cell and gene therapies, patient advocacy organizations contribute to a more patient-centric healthcare system that prioritizes individualized care, shared decision-making, and improved outcomes for all. As the field of cell and gene therapy continues to advance, patient advocacy and education will remain essential pillars in ensuring that innovative treatments reach those who need them most and that patients are empowered to play active roles in their own healthcare journeys.