Gene Therapy Global Market is Projected to Grow at a CAGR of ~19% by 2028

The gene therapy market is witnessing significant momentum as advancements in genetic medicine continue to transform the treatment landscape for several serious and rare diseases. The increasing burden of genetic disorders such as spinal muscular atrophy, hemophilia, and inherited retinal diseases, coupled with growing clinical research activity, is creating substantial opportunities for gene therapy developers. Improvements in gene editing technologies, vector engineering, manufacturing capabilities, and targeted delivery approaches are further supporting market expansion. According to DelveInsight, the global gene therapy market is projected to grow at a CAGR of approximately 19% during the forecast period from 2023 to 2028.

DelveInsight’s Gene Therapy Market Insights report provides a comprehensive assessment of the current and future market landscape, covering market trends, growth drivers, barriers, competitive developments, leading companies, and regional dynamics. The report also examines the evolving pipeline and therapeutic applications that are shaping the future of gene-based medicine.

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Gene Therapy Market: Key Developments and Industry Landscape

North America is expected to maintain a prominent position in the global gene therapy market during the forecast period. The region benefits from an established healthcare ecosystem, strong research infrastructure, substantial investments in biotechnology, and the presence of several leading pharmaceutical and biotechnology companies. The growing focus on rare diseases and innovative treatment modalities is also contributing to the development of gene therapy programs.

Several prominent companies are actively involved in the gene therapy landscape, including Novartis AG, F. Hoffmann-La Roche Ltd., Ferring B.V., bluebird bio, Inc., Ultragenyx Pharmaceutical Inc., PTC Therapeutics, BioMarin, Biogen, Prevail Therapeutics, and CSL, among others.

The gene therapy sector also experienced several notable developments in January 2024. Vertex Pharmaceuticals announced that CASGEVY™ (exagamglogene autotemcel), a CRISPR/Cas9 gene-edited therapy, received marketing authorization from the Saudi Food and Drug Authority for sickle cell disease and transfusion-dependent beta thalassemia.

During the same period, Precision BioSciences entered into an agreement with TG Therapeutics involving the development of azercabtagene zapreleucel for potential applications beyond oncology, particularly autoimmune diseases. Kriya Therapeutics also outlined plans to advance its gene therapy programs into clinical development, highlighting the growing pipeline of next-generation genetic medicines.

Bayer AG and Asklepios BioPharmaceutical announced the completion of 18-month data collection from a Phase Ib study evaluating AB-1005 (AAV2-GDNF), an investigational gene therapy being developed for Parkinson’s disease. Meanwhile, MeiraGTx announced a financial transaction involving its remaining interest in an eye-disease treatment collaboration with Johnson & Johnson.

Genascence Corporation also initiated a Phase Ib clinical study of GNSC-001 for knee osteoarthritis. These developments demonstrate the expanding application of gene therapy beyond traditional rare genetic disorders into neurological, ophthalmological, autoimmune, and musculoskeletal conditions.

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Gene Therapy Overview and Therapeutic Potential

Gene therapy is an advanced therapeutic approach designed to treat disease by introducing, removing, replacing, or modifying genetic material within a patient’s cells. Unlike conventional therapies that primarily manage symptoms or disease progression, gene therapy seeks to address underlying genetic mechanisms responsible for disease development.

The approach has become increasingly important across inherited disorders, hematological conditions, neurological diseases, ophthalmological disorders, and certain cancers. Depending on the therapeutic strategy, genetic material may be delivered directly into the patient’s body or cells may be modified outside the body before being administered back to the patient.

Viral vectors remain an important delivery technology, while non-viral approaches are also being investigated to improve safety, scalability, and targeting. Gene-editing technologies such as CRISPR/Cas9 have further expanded the possibilities for precise modification of disease-associated genes.

Despite its therapeutic promise, gene therapy development remains complex. High manufacturing costs, delivery challenges, durability of treatment effects, potential safety concerns, and ethical considerations can influence development and commercialization. Continued research and regulatory experience are expected to play an important role in addressing these challenges.

Gene Therapy Market Insights and Regional Growth

North America accounted for the largest share of the gene therapy market in 2022. Its market position was supported by factors including the growing population affected by genetic disorders, increasing cancer incidence, advanced healthcare infrastructure, extensive research activity, and the presence of established pharmaceutical and biotechnology organizations.

The region has also benefited from an active regulatory environment supporting the development of innovative therapies. In 2019, the US Food and Drug Administration projected substantial growth in gene therapy product approvals and investigational applications, reflecting the expected expansion of the development pipeline.

The increasing number of clinical-stage programs and investments in genetic medicine continues to strengthen North America’s role in the global market. Growing research into rare diseases, inherited disorders, cancer, and neurological conditions is expected to create additional opportunities for gene therapy developers.

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Gene Therapy Market Dynamics and Growth Drivers

The increasing prevalence and diagnosis of genetic and rare diseases represents a major factor supporting the expansion of the gene therapy market. Conditions such as hemophilia, spinal muscular atrophy, inherited retinal disorders, and other genetic diseases have created significant demand for therapies capable of addressing underlying disease mechanisms.

The approval and commercialization of gene therapies for conditions such as hemophilia B have demonstrated the potential of genetic medicines to provide long-term therapeutic benefits. At the same time, continued innovation in vector technology and gene-editing platforms is encouraging developers to explore broader therapeutic applications.

The expanding clinical pipeline is another important contributor to market growth. Investigational programs are increasingly targeting neurological, ophthalmological, musculoskeletal, hematological, and autoimmune diseases, broadening the potential addressable population for gene therapy.

However, several challenges may restrict market expansion. The high cost associated with research, manufacturing, and administration of gene therapies can create accessibility concerns. In addition, ethical considerations, regulatory complexity, long-term safety monitoring, and challenges associated with delivering genetic material to specific tissues may affect development timelines and commercialization.

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Gene Therapy Market Segmentation and Assessment

The global gene therapy market can be assessed across several key dimensions. By vector type, the market is segmented into viral and non-viral approaches. By delivery type, gene therapies are categorized into ex vivo and in vivo approaches. Based on indication, the market includes neurological, oncological, hematological, ophthalmological, and other therapeutic areas.

Geographically, the market is evaluated across North America, Europe, Asia-Pacific, and the Rest of the World. Comprehensive market assessments also incorporate product profiles, case studies, Porter’s Five Forces analysis, key opinion leader perspectives, and analyst insights to provide a broader understanding of the competitive and commercial environment.

Gene Therapy Market Outlook

The global gene therapy market is entering an important phase of development as scientific innovation, clinical progress, and regulatory advancements continue to expand its therapeutic applications. Growing investment in gene editing, vector technologies, and manufacturing infrastructure is supporting the development of increasingly sophisticated treatments. Although high treatment costs, safety considerations, manufacturing complexity, and ethical questions remain important challenges, continued innovation may broaden access and therapeutic opportunities. The expanding pipeline across rare diseases, cancer, neurological disorders, ophthalmology, and other conditions is expected to remain a key contributor to market growth through the forecast period. DelveInsight’s market analysis provides stakeholders with insights into emerging trends, competitive developments, regional dynamics, and future opportunities within this rapidly evolving therapeutic landscape.

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