According to DelveInsight, the Gene Therapy Market is projected to grow at a CAGR of 19.25% through 2032.

Gene Therapy Market by Vector Type (Viral and Non-Viral), Delivery Type (Ex Vivo and In Vivo), Indication (Neurological, Oncological, Hematological, Ophthalmological, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of genetic and rare diseases, rapid expansion of the gene therapy pipeline, and increasing strategic activities among the key players across the globe.
Valued at USD 8,570.28 million in 2024, the market is expected to reach USD 34,933.71 million by 2032.

The rapid growth of the market is driven by the rising prevalence of genetic and rare diseases, which is fueling demand for innovative and curative treatment approaches. The expanding pipeline of gene therapies-including a growing number of clinical trials addressing previously untreatable disorders-continues to strengthen market prospects. Furthermore, strategic collaborations, mergers, acquisitions, and partnerships among key biopharmaceutical players are accelerating research, development, and commercialization, thereby stimulating innovation and expanding global market reach.

Technological advancements-such as the integration of artificial intelligence (AI), automation, and improved delivery platforms-are enhancing precision, safety, and clinical outcomes, further encouraging adoption. Additionally, ongoing innovation and new product launches by leading companies are broadening therapeutic applications and driving accessibility. Collectively, these trends are set to sustain the strong growth trajectory of the global gene therapy market over the forecast period.

DelveInsight's Gene Therapy Market Insights report delivers a comprehensive analysis of current and projected market trends, competitive landscape, key drivers and barriers, and company-specific market shares, offering an in-depth understanding of the evolving gene therapy ecosystem.

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Key Takeaways from the Gene Therapy Market Report

The Gene Therapy Market is expected to witness steady growth at a moderate CAGR between 2025 and 2032. According to DelveInsight's estimates, North America is projected to remain the leading region in the global gene therapy market throughout the forecast period.

Several key players are actively contributing to market expansion, including F. Hoffmann-La Roche Ltd., Novartis AG, Ferring B.V., bluebird bio, Inc., CSL, Ultragenyx Pharmaceutical Inc., PTC Therapeutics, BioMarin, Biogen, Prevail Therapeutics, Sarepta Therapeutics, Inc., Kriya Therapeutics, Affinia Therapeutics, Caribou Biosciences, and Pfizer Inc., among others.

Recent regulatory milestones underscore the sector's momentum:

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In November 2024, PTC Therapeutics received FDA approval for its gene therapy KEBILIDI Trademark (eladocagene exuparvovec-tneq), indicated for both children and adults with AADC deficiency.

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In June 2023, Sarepta Therapeutics, Inc. announced that the U.S. FDA had granted accelerated approval for ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy designed for ambulatory pediatric patients aged 4-5 years with Duchenne muscular dystrophy (DMD) caused by a confirmed DMD gene mutation.

These advancements highlight the growing regulatory support and therapeutic innovation driving progress in the global gene therapy landscape.

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Gene Therapy Overview

The global gene therapy market is experiencing strong growth, fueled by the increasing incidence of rare and genetic disorders across the world. Gene therapy provides a transformative approach by addressing diseases at their genetic origin, introducing or replacing functional genes to correct underlying defects. Ongoing advancements in viral vector delivery systems, CRISPR-based gene editing, and personalized medicine are significantly improving the accuracy, safety, and therapeutic effectiveness of these treatments.

Gene Therapy Market Insights

North America is expected to capture the largest share of the global gene therapy market in 2024. This leadership is supported by the region's well-developed healthcare infrastructure, strong research and development ecosystem, and substantial investments in innovative biopharmaceuticals. The rising prevalence of rare and genetic disorders, along with the presence of key industry players such as Biogen, Novartis, and PTC Therapeutics, further strengthens the region's position. Additionally, favorable government initiatives, supportive reimbursement frameworks, and the rapid adoption of advanced gene therapy technologies contribute significantly to market growth. The United States, in particular, benefits from an extensive clinical trial network and a higher incidence of genetic diseases, which continue to drive demand for gene therapy solutions.

According to the Centers for Disease Control and Prevention (CDC, 2024), about 1 in every 5,000 males aged 5-9 in the United States is affected by Duchenne or Becker muscular dystrophy (DBMD)-conditions caused by mutations in the dystrophin gene, leading to progressive muscle weakness and loss of function. Gene therapy offers a promising approach to address the underlying cause by delivering functional dystrophin genes or micro-dystrophin constructs through adeno-associated viral (AAV) vectors, a key factor further stimulating the growth of the gene therapy market in North America.

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Gene Therapy Market Dynamics

According to the Haemophilia Foundation Australia (2024), more than 7,400 individuals in Australia have been diagnosed with bleeding disorders. Globally, haemophilia affects approximately 1 in every 6,000-10,000 males, with haemophilia A occurring in about 1 in 6,000 males and haemophilia B in 1 in 26,000 males. It is estimated that around 830,895 people worldwide live with haemophilia, including approximately 282,266 with severe forms of the disease.

Gene therapy offers a transformative approach to treating haemophilia by addressing its underlying genetic cause. By delivering functional genes that enable the body to produce missing clotting factors-Factor VIII for haemophilia A and Factor IX for haemophilia B-this therapy has the potential to provide long-term or even permanent benefits. Approved treatments such as BioMarin's Roctavian (for haemophilia A) and UniQure's Hemgenix (for haemophilia B) have shown the ability to reduce or eliminate dependence on factor replacement therapy, enhance quality of life, and correct the underlying genetic defect. As a result, the high global prevalence of haemophilia is expected to be a major driver of growth in the gene therapy market worldwide.

Furthermore, the Haemophilia Foundation Australia (2024) reported that over 2,500 Australians have been diagnosed with Von Willebrand disease (VWD), an inherited bleeding disorder that affects individuals of all genders and ethnicities-though many cases are likely underdiagnosed. Because VWD impacts both males and females, and numerous cases remain undetected, the demand for innovative and durable therapies continues to rise. Gene therapy presents a potential long-term or curative solution by correcting or replacing faulty genes responsible for the condition. Additionally, the increasing focus on personalized medicine and advances in gene-editing technologies, such as CRISPR, are accelerating the development of gene therapy candidates for bleeding disorders like VWD, further expanding therapeutic possibilities in this field.

Gene Therapy Market Drivers:

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Rising prevalence of genetic and rare diseases

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Rapid expansion of the gene therapy pipeline

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Increasing strategic activities among the key players across the globe

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Scope of the Gene Therapy Market Report:

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Coverage: Global

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Study Period: 2022 to 2032

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Key Gene Therapy Companies: F. Hoffmann-La Roche Ltd., Novartis AG, Ferring B.V., bluebird bio, Inc., CSL, Ultragenyx Pharmaceutical Inc., PTC Therapeutics, BioMarin, Biogen, Prevail Therapeutics, Sarepta Therapeutics, Inc., Kriya Therapeutics, Affinia Therapeutics, Caribou Biosciences, Pfizer Inc., and others.

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About DelveInsight

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Our expert healthcare consulting services offer in-depth market analysis, helping businesses accelerate growth and navigate challenges with actionable, results-driven strategies.

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