Gene Therapy Market to Grow at a CAGR of 19.25% Through 2032, Driven by Breakthroughs in Rare Disease Treatment and Personalized Medicine | DelveInsight

The global gene therapy market is on a strong upward trajectory, fueled by scientific advancements, growing approvals, and rising demand for personalized and curative treatments. With a projected CAGR of 19.25% through 2032, gene therapy is transforming the treatment paradigm for genetic disorders, rare diseases, cancers, and even select infectious and neurodegenerative conditions.

Gene therapies offer the potential for long-term or permanent cures by delivering, altering, or replacing faulty genes at the molecular level. Key platforms include in vivo (direct gene delivery) and ex vivo (cell-based modification) approaches, utilizing viral vectors (AAV, lentivirus) or non-viral delivery technologies such as CRISPR and lipid nanoparticles.

DelveInsight's Gene Therapy Market Insights, Competitive Landscape, and Market Forecast - 2032 provides an in-depth analysis of the global market across the US, EU4 (Germany, France, Italy, Spain), the UK, Japan, and other key geographies. The report covers detailed segmentation by vector type, indication, delivery method, and end-user setting. It also explores regulatory frameworks, reimbursement challenges, manufacturing scalability, and pricing strategies.

High-profile approvals like ZOLGENSMA (for spinal muscular atrophy), LUXTURNA (for inherited retinal disease), and ROCTAVIAN (for hemophilia A) have validated the commercial potential of gene therapy. Meanwhile, ongoing late-stage programs targeting sickle cell disease, beta-thalassemia, Duchenne muscular dystrophy, and various cancers are poised to further expand the market.

Key players such as Abiomed, Inc., Asahi Kasei Corporation, Abbott Laboratories, Berlin Heart GmbH, Jarvik Heart, Inc., and Medtronic Plc., are actively investing in R&D, partnerships, and manufacturing innovations to scale access and improve patient outcomes.

As gene editing and delivery technologies evolve, the gene therapy market is entering a new era-marked by precision, curative intent, and transformative impact on previously untreatable diseases.

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Key Takeaways from the Gene Therapy Market Report
• The global gene therapy market was valued at USD 8.57 billion in 2024 and is expected to grow at a CAGR of 19.25%, reaching USD 34.93 billion by 2032.
• As per DelveInsight estimates, North America is anticipated to dominate the gene therapy market during the forecast period.
• Notable gene therapy companies such as Abiomed, Inc., Asahi Kasei Corporation, Abbott Laboratories, Berlin Heart GmbH, Jarvik Heart, Inc., Medtronic Plc., Terumo Corporation, Evaheart, Inc., Calon Cardio, SynCardia Systems LLC, Cardiobridge Gmbh, LivaNova, Inc., Cirtec, CorWave SA, FineHeart, ReliantHeart Inc., and several others are currently operating in the gene therapy market.
• In June 2025, Sarepta Therapeutics (NASDAQ: SRPT) announced that the FDA granted platform technology designation to its rAAVrh74 viral vector, used in the investigational gene therapy SRP-9003 (bidridistrogene xeboparvovec) for treating limb-girdle muscular dystrophy type 2E/R4.
• In May 2025, Capsida Biotherapeutics announced that the FDA granted Fast Track designation to CAP-002, its investigational IV-administered gene therapy for STXBP1 developmental and epileptic encephalopathy (STXBP1-DEE). CAP-002 is the first IV-delivered, AAV-based gene therapy designed to cross the blood-brain barrier to enter human trials.
• In May 2025, AskBio Inc., a Bayer subsidiary, announced the publication of full Phase 1b trial results for AB-1005, a GDNF gene therapy for Parkinson's disease, in the journal Movement Disorders.
• In May 2025, Capsida Biotherapeutics announced FDA clearance of the IND for CAP-002, its first-in-class IV gene therapy for syntaxin-binding protein 1 developmental and epileptic encephalopathy (STXBP1-DEE). CAP-002 features a proprietary engineered capsid that crosses the blood-brain barrier while avoiding off-target tissues, and is manufactured in Capsida's GMP facility.
• In May 2025, MavriX Bio announced FDA clearance of its IND for MVX-220, an AAV gene therapy targeting Angelman syndrome (AS). The upcoming ASCEND-AS first-in-human trial will assess the safety and efficacy of MVX-220, designed to restore UBE3A gene function, in both adult and pediatric patients with various AS genotypes.
• In April 2025, the FDA approved Abeona Therapeutics' ZEVASKYN, a groundbreaking treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB). This approval marks the third treatment for the rare condition, highlighting progress in RDEB care. ZEVASKYN, the first autologous, cell-based gene therapy for RDEB, aims to enhance collagen VII expression at wound sites by integrating the COL7A1 gene, offering new hope and treatment options for patients and their families.
• In April 2025, Abeona Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved ZEVASKYNTM (prademagene zamikeracel), the first and only autologous cell-based gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is the only FDA-approved treatment for RDEB wounds with a single application.
• In April 2025, BlackfinBio Ltd. announced that the FDA cleared its IND application for a Phase 1/2 clinical trial of its AAV gene therapy, BFB-101, in children with Hereditary Spastic Paraplegia, Type 47 (SPG47).

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Gene Therapy Overview
Gene therapy is an innovative treatment approach that aims to correct or replace faulty genes responsible for disease development. By introducing functional genetic material into a patient's cells-either through viral vectors like AAV or lentivirus, or via non-viral platforms such as CRISPR or lipid nanoparticles-gene therapy offers the potential for long-term or even curative effects. Initially developed for rare monogenic disorders like spinal muscular atrophy and hemophilia, it is now being explored across broader therapeutic areas including oncology, neurology, and cardiovascular disease.

The field has gained momentum with the approval of therapies like ZOLGENSMA, LUXTURNA, and ROCTAVIAN, demonstrating its clinical potential. While challenges around high costs, delivery methods, and regulatory complexities persist, ongoing technological advancements are improving efficacy, safety, and scalability. As a result, gene therapy is poised to become a transformative force in modern medicine, offering targeted, durable solutions for previously untreatable conditions.

Gene Therapy Market Insights
North America is projected to lead the global gene therapy market in 2024, driven by advanced healthcare infrastructure, robust R&D, and strong investment in biopharmaceutical innovation. The region's high burden of rare and genetic disorders, presence of key players like Biogen, Novartis, and PTC Therapeutics, favorable reimbursement policies, and a well-established clinical trial landscape-particularly in the U.S.-are major contributors to market dominance.

According to the CDC (2024), Duchenne and Becker muscular dystrophy affect about 1 in 5,000 U.S. males aged 5-9. Gene therapies targeting dystrophin gene mutations with AAV vectors are gaining traction. Similarly, approximately 33,000 males in the U.S. live with hemophilia, with approved therapies like Roctavian (BioMarin) and Hemgenix (CSL Behring) driving growth by offering long-term solutions.

The market is further fueled by product approvals-such as Pfizer's BEQVEZTM for hemophilia B (FDA approved in April 2024)-strengthening North America's leadership in gene therapy advancements.

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Gene Therapy Market Dynamics
According to the Haemophilia Foundation Australia (2024), over 7,400 Australians live with bleeding disorders, while globally, haemophilia affects around 1 in 6,000-10,000 males-totaling an estimated 830,895 cases, including over 282,000 severe cases. Gene therapies like BioMarin's Roctavian (hemophilia A) and UniQure's Hemgenix (hemophilia B) offer promising, long-term alternatives to traditional factor replacement by addressing the genetic root cause, thereby significantly boosting the gene therapy market.

Additionally, over 2,500 Australians have been diagnosed with Von Willebrand Disease (VWD), though many cases remain undiagnosed. Gene therapy holds potential to treat VWD and other inherited bleeding disorders through targeted genetic correction, aided by innovations like CRISPR and the rise of personalized medicine.

The pipeline is rapidly advancing, with therapies like Pfizer's giroctocogene fitelparvovec showing positive Phase II results in 2024. Regulatory fast-tracking and novel delivery technologies further support market expansion.

However, challenges such as high treatment costs and ethical concerns around gene editing may slightly hinder growth through 2032.

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Coverage: Global
Study Period: 2022 to 2032
Gene Therapy Market CAGR: ~19.25%
Key Gene Therapy Companies: Abiomed, Inc., Asahi Kasei Corporation, Abbott Laboratories, Berlin Heart GmbH, Jarvik Heart, Inc., Medtronic Plc., Terumo Corporation, Evaheart, Inc., Calon Cardio, SynCardia Systems LLC, Cardiobridge Gmbhand, LivaNova, Inc., Cirtec, CorWave SA, FineHeart, ReliantHeart Inc., and others.

Gene Therapy Market Segmentation
Market Segmentation By Vector Type: Viral and Non-Viral.
Market Segmentation By Delivery Type: Ex Vivo and In Vivo.
Market Segmentation By Indication: Neurological, Oncological, Hematological, Ophthalmological, and others.
Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of the World.

Which MedTech key players in the gene therapy market are set to emerge as the trendsetters, explore @ https://www.delveinsight.com/report-store/gene-therapy-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Gene Therapy Market Report Introduction
2. Gene Therapy Market Executive Summary
3. Competitive Landscape
4. Regulatory Analysis
5. Gene Therapy Market Key Factors Analysis
6. Gene Therapy Market Porter's Five Forces Analysis
7. Gene Therapy Market Layout
8. Gene Therapy Market Company and Product Profiles
9. KOL Views
10. Project Approach
11. About DelveInsight
12. Disclaimer & Contact Us

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About DelveInsight
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This release was published on openPR.