Towards Healthcare
Gene Therapy Market Size Hits USD 11.4 Billion in 2025

Gene Therapy Market in 2025 Hospitals Lead with 65% Share as R&D and Strategic Investments Drive 20% CAGR

Market insights predict the global gene therapy industry will increase from USD 9.5 billion in 2024 to USD 58.87 billion by 2034, achieving a CAGR of 20%. The gene therapy market is growing rapidly due to the growing demand for precision medicine. North America’s dominance is attributed to the rising focus on genomics & multi-omics.

Category: Therapeutic Area Insight Code: 5804 Format: PDF / PPT / Excel

Gene Therapy Market Size, Shares, Top Key Players and Strategies

The global gene therapy market size is calculated at USD 9.5 in 2024, grew to USD 11.4 billion in 2025, and is projected to reach around USD 58.87 billion by 2034. The market is expanding at a CAGR of 20% between 2025 and 2034.

Tremendous financing from both public and private entities has allowed gene therapy research to make tremendous strides in recent years. These investors want to spur market expansion by expediting the approval of innovative gene therapies.   For instance, the adoption of viral vectors, which are well known for their low toxicity and high immunological efficacy, has indicated a shift toward safer, more efficient treatment alternatives.

Ongoing technological advancements and accelerated regulatory processes are expected to mitigate these challenges and ensure consistent market growth. Small and large market players are collaborating to spur innovation and save costs by combining resources and expertise.

Gene Therapy Market Size 2024-2034

Key Takeaways

  • Gene therapy industry poised to reach USD 9.5 billion in 2024.
  • Forecasted to grow to USD 58.87 billion by 2034.
  • Expected to maintain a CAGR of 20% from 2025 to 2034.
  • North America dominated the gene therapy market with a revenue share of 45% in 2024.
  • Asia Pacific is expected to grow at the fastest CAGR during the forecast period.
  • By therapy type, the in vivo gene therapy segment held the largest revenue of 60% in 2024.
  • By therapy type, the ex vivo gene therapy segment is expected to be the fastest-growing during the forecast period.
  • By vector type, the viral vectors segment dominated the market with a revenue of 75% in 2024.
  • By vector type, the non-viral vectors segment is expected to grow at the fastest CAGR during the forecast period.
  • By gene type, the deficiency genes segment captured the largest market revenue share of ~35% in 2024.
  • By gene type, the tumor suppressor genes segment is expected to grow at the highest CAGR during the forecast period.
  • By disease indication, the cancer segment dominated the market with a revenue share of ~40% in 2024.
  • By disease indication, the genetic disorders segment is expected to grow at the fastest CAGR during the forecast period.
  • By delivery method, the intravenous (IV) segment captured the largest revenue of the market in 2024, which was 50%.
  • By delivery method, the intrathecal / Intraocular segment is expected to grow at the fastest CAGR during the forecast period.
  • By end-user, the hospitals segment dominated the market with a revenue share of 65% in 2024.
  • By end-user, the specialty clinics segment is expected to grow at the fastest CAGR during the forecast period.

Key Metrics and Overview

Metric Details
Market Size in 2025 USD 11.4 Billion
Projected Market Size in 2034 USD 58.87 Billion
CAGR (2025 - 2034) 20%
Leading Region North America share by 45%
Market Segmentation By Therapy Type, By Vector Type, By Gene Type, By Disease Indication, By Delivery Method, By End User, By Region
Top Key Players Amgen Inc., Novartis AG, F. Hoffmann-La Roche, Gilead Sciences, Inc., bluebird bio, Inc., Bristol-Myers Squibb Company, Legend Biotech., BioMarin., uniQure N.V., Merck & Co., Sarepta Therapeutics, Inc., Krystal Biotech, Inc., CRISPR Therapeutics.

Market Overview

The gene therapy market refers to the global industry involved in the development, manufacturing, and commercialization of gene therapies. Gene therapy is a cutting-edge biomedical approach that involves modifying or manipulating a person's genes to treat or prevent diseases. This can include replacing, inactivating, or introducing genes into a patient’s cells to correct genetic disorders, cancers, or other diseases caused by genetic abnormalities. The market encompasses various therapeutic modalities, delivery technologies, treatment areas, and end users, with significant research and clinical advancements driving growth.

  • In May 2025, the biotech company Stylus Medicine invested $85 million to start creating a new class of in vivo genetic drugs that do not have the production and distribution challenges associated with ex vivo gene editing therapies. (Source - Pharmaceutical)
  • In May 2024, a $54 million Series A fundraising round was launched and finished by Latus Bio, Inc. ("Latus"), a biotechnology company developing novel gene therapy alternatives for disorders of the central nervous system (CNS). (Source - Businesswire)

What is the Role of AI in the Gene Therapy Market?

Artificial Intelligence (AI) has fundamentally altered the interpretation and assessment of data in biomedical research. One of the main ways that AI is helping to create gene therapy is by evaluating big genomic databases, simulation results, and experimental outcomes.  This skill yields insights that would need a lot more time to comprehend by human researchers. Convolutional neural networks (CNNs) and recurrent neural networks (RNNs), two advanced deep learning (DL) structures, as well as more traditional machine learning methods like support vector machines, random forests, and Bayesian learning, are just a few examples of the many applications of AI algorithms.

Market Dynamics

Driver

Growing Research for Developing Novel Therapies

Ongoing research and development (R&D) initiatives are expected to have a substantial influence on gene testing technology sales. Many companies are looking to construct a gene therapy platform with an emphasis on building a transformational portfolio through internal faculty and strengthening those talents through strategic collaborations, R&D expansion, potential licensing, and merger and acquisition activities.

Restraint

High Cost

With list prices ranging from USD 373,000 to USD 4.25 million, single-dose cures put a strain on payer budgets and challenge the willingness of society to pay for curative treatments. According to providers, the primary barriers to access are prior authorization, travel distance, and deficiencies in social support. Although they still require sophisticated data exchange and long-term follow-up infrastructure, innovative compensation solutions, including outcome-based contracts, amortization models, and warranties, are gaining popularity.

Opportunity

Growing Product Pipelines & Investments

The increasing number of research initiatives and innovations in the field is expected to have a major influence on the market. The growing funding and expenditures in gene therapy research and development (R&D) are supporting the market expansion. Because of its enormous potential to address unmet medical needs and provide long-term benefits, gene therapies are attracting a lot of attention. The prognosis for the gene therapy industry is improving as a result of big pharmaceutical corporations creating their own gene therapy departments or purchasing gene therapy startups to speed up research.

Segmental Insights

Why the In Vivo Gene Therapy Segment Dominated the Market in 2024?

By therapy type, the in vivo gene therapy segment dominated the gene therapy market in 2024. Numerous fields of study have demonstrated the effectiveness of gene therapy delivered in vivo. A few of the gene treatments that are currently authorized convey genetic material in vivo. As researchers continue to improve gene delivery techniques, targeted in vivo gene therapy will develop further.

By therapy type, the ex vivo gene therapy segment is expected to grow at the fastest CAGR during the forecast period. Professionals can provide a genetically modified cellular treatment that specifically addresses the issue that needs to be fixed by merging cutting-edge technology with ex vivo gene therapy processes. New studies are exploring the application of these medicines for even more diseases and conditions that affect children and adults.

What Made the Viral Vectors Segment Dominant in the Gene Therapy Market in 2024?

By vector type, the viral vectors segment held the largest share of the market in 2024. Viral vector applications for gene therapy have seen a promising new beginning in recent years. Viral vector-based therapy is currently at the forefront of modern medicine because of significant developments in vector engineering, delivery, and safety. Numerous diseases, such as infectious diseases, cardiovascular, muscular, hematologic, ophthalmologic, metabolic, and malignancies, have been treated by viral vectors.

By vector type, the non-viral vectors segment is estimated to grow at the highest CAGR during the predicted time frame. Non-viral vectors offer a substantial safety advantage over viral techniques because to their shown reduced pathogenicity, low cost, and ease of production. The primary advantage of using non-viral vectors is biosafety. Non-viral vectors have garnered a lot of attention due to their lower immunotoxicity. 

Which Gene Type Segment Dominated the Gene Therapy Market in 2024?

By gene type, the deficiency genes segment dominated the market in 2024. In the U.S., rare diseases impact 15.5 million individuals and result in annual medical costs of USD 997 billion. Although the incidence of rare diseases is unclear globally due to diagnostic challenges, estimates place the number at over 100 million. Gene therapy is one innovative way to treat primary immune deficiencies (PIDs). For those who have genetic mutations that lead to sickness, gene therapy may be a transformative option.

By gene type, the tumor suppressor genes segment is anticipated to grow at the fastest CAGR during 2025-2034. The number of possible tumor suppressors that might be used in clinical settings to stop the spread of cancer cells is growing. Tumor suppressor gene therapy is one possible cancer treatment strategy that aims to restore or enhance the function of tumor suppressor genes in cancer cells. The goals of this treatment are to limit the spread of cancer, induce apoptosis (cell death), and inhibit tumor formation.

How Cancer Segment Dominated the Market in 2024?

By disease indication, the cancer segment held the largest share of the gene therapy market in 2024. Gene therapy is a broad field that provides a number of innovative treatments that are likely to significantly lower the number of deaths from cancer. In therapeutic trials, gene therapy has been shown to dramatically increase the life expectancy and survival rate of cancer patients. Additionally, a number of innovative therapeutic strategies, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), clustered regularly interspaced short palindromic repeats/CRISPR-associated protein 9 (CRISPR/Cas9), etc., have been developed to complement conventional cancer treatments that directly modify DNA as gene transfer technologies have progressed.

By disease indication, the genetic disorders segment is estimated to grow at the highest rate during the forecast period. Gene therapy may be used to treat a wide range of acquired and genetic human illnesses. The number of completed, ongoing, or pending gene therapy trials in the world is now above 600. In the U.S. and Europe, the majority of them are phase I safety studies for cancer treatment, with those for vascular, infectious, and monogenetic illnesses coming next.

Which Delivery Method Segment Dominated the Market in 2024?

By delivery method, the intravenous (IV) segment dominated the gene therapy market in 2024. IV medications provide several benefits and have been demonstrated to be effective in a number of clinical situations and to meet a wide range of therapeutic needs. This kind of administration is particularly helpful for providing timely, controlled treatment. The intravenous route is the fastest way to deliver medication and refill fluids because it delivers pharmaceuticals directly into the circulatory system, where they are quickly distributed throughout the body.

By delivery method, the intrathecal / Intraocular segment is anticipated to grow at the highest CAGR during the upcoming years. Intraocular and intrathecal injections offer targeted gene therapy delivery, minimizing systemic side effects and optimizing therapeutic results. Intrathecal administration, or injection into the cerebrospinal fluid, is an effective treatment for neurological illnesses because it circumvents the blood-brain barrier. Intraocular delivery, whether by injections or implants, enables the restricted treatment of eye diseases by taking advantage of the immune-privileged location and segmented structure of the eye.

What Made the Hospitals Segment Dominant in the Market in 2024?

By end-user, the hospitals segment led the gene therapy market with a revenue share of ~65% in 2024. The success of gene therapy can be greatly impacted by selecting the appropriate facility and specialist.  Selecting the appropriate hospital is essential for complete care, in addition to identifying the best expert. As this cutting-edge medical field gathers traction, several hospitals across the globe have established themselves as leaders in gene therapy research and implementation.

By end-user, the specialty clinics segment is anticipated to be the fastest growing during the forecast period. Multispecialty clinics aim to satisfy patient requests by using a single practice. A multispecialty clinic's focus on offering top-notch medical care is very beneficial to patients. One's overall medical expenses might be significantly decreased by using multispecialty clinics.

Regional Insights

Gene Therapy Market Share, By Region, 2024 (%)

Why was North America Dominant in 2024?

North America dominated the gene therapy market share by 45% in 2024. Growing cancer and rare disease occurrences and prevalence, rising product approvals for gene therapy, and favorable government funding for gene therapy are driving the North American market. Additionally, patients now have greater access to gene treatments due to insurance coverage and payments. Additional factors driving market expansion include rising healthcare costs and R&D investments.

The U.S. Gene Therapy Market Trends

The U.S. is growing significantly due to the growing cancer and rare disease cases. In the U.S., cancer is the second leading cause of death overall and the leading cause of death for people under 85. In 2025, there will likely be 618,120 cancer-related fatalities and 2,041,910 new cancer cases in the U.S. In the U.S., rare diseases are estimated to affect 25 to 30 million people, making up a significant portion of the population.

The Canada Gene Therapy Market Trends

The Canadian government is working hard to boost the nation's biomanufacturing and life sciences sectors in order to deliver safe and effective next-generation treatments. For instance, in March 2025, the Canadian federal government announced its support for the manufacture of gene and cell therapies enabled by sophisticated robotics and artificial intelligence (AI). OmniaBio's project will focus on advanced treatments for chronic diseases, including diabetes, autoimmune diseases, cancer, and neurological and cardiovascular conditions.

Rising Chronic Conditions are Driving the Asia Pacific

Asia Pacific is estimated to host the fastest-growing gene therapy market during the forecast period. The need for gene therapy is rising in the Asia Pacific region due to the rise in a variety of chronic disorders. At the same time, this is influenced by the expanding healthcare sector. Companies and organizations are also focusing on developing new gene therapies to address the increasing number of inherited diseases. As a result, industrial collaboration is increasing. Similarly, utilizing state-of-the-art technology facilitates their development. Additionally, the government is helping to lower the cost of these therapies.

The China Gene Therapy Market Trends

The fast advancement of gene therapy in China can be attributed to significant investments in research and development. Chinese researchers are at the forefront of treating genetic diseases, including hemophilia, thalassemia, and sickle cell anemia, because of cutting-edge tools like CRISPR-Cas9. Currently, gene treatment costs about $250,000 USD in China.

The India Gene Therapy Market Trends

In India, 80 million people suffer from rare diseases, 80 percent of which are inherited. Due to innovations like the Genome India Project, India is well-positioned to take the lead in customized gene treatment. Extending the successes of CAR-T cell therapy and gene therapy for hemophilia. For efficient implementation, collaboration among the government, healthcare providers, researchers, and industry is essential, as is a comprehensive program that addresses costs, regulations, infrastructure, and public opinion.

Government Initiatives are Driving Europe

Europe is expected to grow significantly in the gene therapy market during the forecast period. The European Union's 'Horizon Europe Mission on Cancer,' which was launched in September 2023 to accelerate research and innovation in cancer therapies, is one initiative that supports the region's progress. The nation is able to establish itself in the gene therapy business because of government initiatives that foster innovation.

The Germany Gene Therapy Market Trends

The German government aims to increase Germany's appeal as a center for pharmaceutical and healthcare innovation by putting in place a number of focused initiatives, including the National GCT Strategy. Following the German government's recognition of gene and cell therapies as a critical strategic industry, new laws and policies should be rapidly and firmly enacted to execute the National GCT Strategy.

The UK Gene Therapy Market Trends

The UK government shared pledges for UK-wide implementation from 2022 to 2025 as part of its ambitious goal to ensure genomics research and healthcare can flourish nationwide. £26 million for a state-of-the-art cancer effort, £105 million for a ground-breaking research project, £22 million for Genomics England to address health inequities in genetic medicine, and up to £25 million in funding led by the Medical Research Council are among them.

Top Companies in the Gene Therapy Market

Gene Therapy Market Companies

Latest Announcements by Industry Leaders

In September 2024, according to Ryan Confer, President and Chief Executive Officer at Genprex, we think our gene therapy strategy would position NewCo as an innovator in new diabetic medicines, potentially addressing the whole diabetes market," Confer added.  When insulin was initially developed more than a century ago to treat people with type 1 diabetes, it marked the most important breakthrough in the treatment of the disease.  By eliminating the requirement for GLP-1 therapies in type 2 diabetes and the daily hassle of insulin replacement therapy and blood glucose monitoring, we think our treatment has the potential to upend the diabetes business. (Source - Genprex)

Recent Developments in the Gene Therapy Market

  • In June 2025, BIRAC, the Biotechnology Industry Research Assistance Council, and Miltenyi Biotec India Pvt. Ltd. signed a strategic Letter of Intent (LoI).  A common goal of strengthening domestic capabilities in next-generation therapies is reflected in the partnership, which was established during the present BIO International Convention 2025 in Boston. (Source - E health)
  • In March 2025, Bharat Biotech established a vertically integrated facility for cell treatment, gene therapy, and virus manufacture in Hyderabad's Genome Valley.   The company asserts that its around $75 million investment is the first of its kind in the country. (Source - Moneycontrol)

Segments Covered in the Report

By Therapy Type

  • In Vivo Gene Therapy
    • Somatic Cell Gene Therapy
    • Germline Gene Therapy
    • CRISPR-based In Vivo Therapies
    • RNA-based In Vivo Therapies
    • Single-Dose Gene Replacement Therapies
    • Immune Modulating In Vivo Therapies
  • Ex Vivo Gene Therapy
    • Autologous Gene Therapy
    • Allogeneic Gene Therapy
    • CAR-T Cell Therapies
    • Gene-Edited Stem Cell Therapies
    • CRISPR-Cas9 Edited Cell Therapies

By Vector Type

  • Viral Vectors
    • Adenovirus
    • Adeno-Associated Virus (AAV)
    • Lentivirus
    • Retrovirus
    • Herpes Simplex Virus (HSV)
  • Non-Viral Vectors
    • Liposomes
    • Naked DNA
    • Electroporation
    • Nanoparticles
    • Physical Methods (e.g., microinjection, gene gun)

By Gene Type

  • Deficiency Genes
  • Receptor Genes
  • Antigen Genes
  • Cytokine Genes
  • Tumor Suppressor Genes
  • Other Genes

By Disease Indication

  • Cancer
  • Genetic Disorders
    • Hemophilia
    • Spinal Muscular Atrophy (SMA)
    • Duchenne Muscular Dystrophy (DMD)
    • β-thalassemia / Sickle Cell Disease
  • Neurological Disorders
  • Cardiovascular Diseases
  • Ophthalmic Disorders
  • Infectious Diseases
  • Others (e.g., metabolic disorders, autoimmune diseases)

By Delivery Method

  • Intravenous (IV)
  • Intrathecal / Intraocular
  • Intramuscular (IM)
  • Subcutaneous
  • Others

By End User

  • Hospitals
  • Specialty Clinics
  • Academic & Research Institutes
  • Biotech/Pharmaceutical Companies
  • Others

By Region 

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Last Updated: 04 July 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Kesiya Chacko is an accomplished market research professional with over 4+ years of experience in the healthcare industry, known for delivering actionable insights and strategic analysis that empower healthcare organizations.

Learn more about Kesiya Chacko

Aditi Shivarkar, with over 14 years of experience in consumer goods, leads research at Towards Consumer Goods, ensuring precise, actionable insights on trends, consumer preferences, and sustainable packaging for businesses.

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FAQ's

The gene therapy market is projected to reach USD 58.87 billion by 2034, growing at a CAGR of 20% from 2024 to 2034.

North America is currently leading the gene therapy market due to rising cases of chronic conditions and growing investments in multi-omics.

The gene therapy market includes seven segments such as by therapy type, by vector type, by gene type, by disease indication, by delivery method, by end-user, and by region.

Some key players include Amgen Inc., Novartis AG, F. Hoffmann-La Roche, Gilead Sciences, Inc., bluebird bio, Inc., etc.

Key trends include rising prevalence of cancer, growing demand for personalized medicine, and rising research in genomics.

By repairing the underlying genetic fault, gene therapy may provide a permanent cure for certain genetic disorders. however, the effectiveness of this treatment will vary depending on the condition, the mode of administration, and the stability of the implanted gene.

By 2036, genetic treatments are predicted to be the norm for treating uncommon genetic disorders, and they will finally be able to cure them.  Additionally, CRISPR-Cas9 is thought to be the most promising gene editing technique for replacing or repairing damaged genes within the next 15 years.

Ministry of Health and Family Welfare, Government of India, National Institutes of Health, FDA, WHO, PIB, CDC.