The global gene therapy market is growing rapidly; it is estimated to be worth USD 2.6 billion in 2023 and is anticipated to reach USD 17.3 billion by 2035. It is expected to grow at a compounded annual growth rate (CAGR) of 17.3% during the forecast period.

 

The growth of the gene therapy market is mainly attributed to the increasing demand for tailored therapies to treat diseases that occur due to genetic defects. Gene therapy is an advanced technique that enables the replacement of disease-causing genes with normal functional genes. This treatment regimen has been implemented for the correction of mutated genes in patients by utilizing molecular carriers such as viral and non-viral vectors. Owing to its therapeutic efficacy in treating the disease at the cellular level, several industrial stakeholders have increased their research and development activities for the development of next-generation gene therapies. It is worth noting here that in August 2017, Tisagenlecleucel was the first gene therapy to receive approval from the FDA to treat relapsed or refractory pediatric and young-adult B-cell acute lymphoblastic leukemia. In 2020, Libmeldy™ (an ex vivo gene therapy) received approval from the FDA to treat metachromatic leukodystrophy. At present, more than 200 gene therapies are currently being evaluated under phase II and phase III clinical studies. The ongoing advancements in gene editing tools to develop gene-based therapies and increasing research activities in the field are anticipated to drive growth during the forecast period.

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Competitive Landscape of the Gene Therapy Market

 

Currently, the market landscape features over 250 gene therapy companies that are actively engaged in the production of various early and late-stage gene therapies across the globe. Overall, the gene therapy market is well fragmented and features several industrial players and industrial stakeholders who are actively investing in research and development initiatives for the production of gene therapies. To support the growing demand, several companies developing gene therapies are currently undergoing different collaborations to advance their research for next-generation gene-based therapies. However, the primary focus of such consolidation efforts will be on expanding the existing development efforts. The ongoing collective efforts of the companies and rising demand for highly efficient single-dose gene-based therapeutics are anticipated to drive the market during the forecast period.

Gene Therapy Market Players

Examples of the key companies engaged in the gene therapy market (which have also been profiled in the market report; the complete list of the companies is also included in the full report) include:

⬝      Amgen

⬝      AnGes

⬝      Biogen

⬝      Bluebird bio

⬝      Dendreon Pharmaceuticals

⬝      Enzyvant Therapeutics 

⬝      Kite Pharma 

⬝      Novartis AG

⬝      Oxford Biomedica

⬝      UniQure NV

⬝      Spark Therapeutics, Inc

⬝      SIBONO

⬝      Shanghai Sunway Biotech 

 

In recent years, gene therapies have catered to the attention of the leading industrial players owing to their significance in the treatment of genetic disorders. Considering these significance, several gene therapy market players increase their research and development activities to enhance the development of advanced gene-based therapeutics.

⬝      In August 2023, TSHA-102, developed by Taysha Gene Therapies, received fast-track designation approval from the FDA for the treatment of patients suffering from Rett Syndrome.

⬝      In August 2023, Xcell Biosciences and LabCorp inked a collaboration deal for the development and validation of cell and gene-based therapies.

⬝      In May 2023, Ray Therapeutics successfully closed around USD 100 million in a series A funding round, and the company will utilize these funds to enhance the development of optogenetic gene therapies.

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Key Report Takeaways

Insights into the Rapidly Growing Gene Therapy Market

  • Expanding Pipeline: Over 1,150 gene therapy candidates are currently in development, targeting a wide array of disease indications. To date, 11 therapies have successfully reached commercialization.
  • Development Stages: More than 70% of these therapies are in early-stage development. Notably, nearly 80% of late-stage studies (phase II and above) rely on viral vectors for gene delivery.
  • Innovation by Start-ups: Start-ups are at the forefront of gene therapy innovation. Their valuation often hinges on industry experience and investment rather than immediate profitability.
  • Big Pharma’s Strategic Moves: Major pharmaceutical companies are leveraging proprietary product development, strategic investments, and partnerships to expand their gene therapy portfolios and capitalize on this lucrative market.
  • Mergers and Acquisitions: The growing interest in gene therapy is evident from the surge in M&A activity. Nearly 50% of these initiatives aim to access novel platforms or consolidate therapeutic areas.
  • Cost Concerns and Affordability: High treatment costs remain a significant challenge. However, evolving pricing models and reimbursement strategies are expected to address affordability in the future.
  • Commercialization Strategies: Stakeholders are exploring diverse strategies to maximize the potential of gene therapies throughout their lifecycle, from development to market launch.
  • Market Growth Forecast: The gene therapy market is poised for an impressive annualized growth rate of 18% over the next decade.
  • Broad Opportunity Distribution: Long-term market opportunities are expected to be evenly distributed across therapeutic areas, administration routes, and key geographical regions.

With a robust pipeline, strategic collaborations, and advancements in delivery technologies, the gene therapy market is set to redefine the future of medicine, offering transformative treatments for previously untreatable conditions.

 

Gene Therapy Market Geographical Region Outlook

Understanding the Global Gene Therapy Market

The gene therapy market is divided into four main geographical regions: North America, Europe, Asia-Pacific, and the Rest of the World. Here's a breakdown of how the market is performing and expected to grow in these regions:

1. North America: The Market Leader

  • North America currently holds the largest share of the gene therapy market.
  • By 2035, it is estimated that North America will maintain its dominance, accounting for 59.5% of the global market.
  • Factors contributing to this leadership include advanced healthcare infrastructure, high R&D investments, and the presence of leading gene therapy companies.

2. Asia-Pacific: The Fastest Growing Region

  • The Asia-Pacific region is experiencing rapid growth in the gene therapy market.
  • During the forecast period, it is expected to grow at a compound annual growth rate (CAGR) of 27.1%, the highest among all regions.
  • The growth is driven by increasing awareness of advanced therapies, investments in biotechnology, and supportive government policies in countries like China, Japan, and India.

3. Europe and the Rest of the World

  • While Europe also plays a significant role in the gene therapy market, its growth is steady compared to the booming Asia-Pacific region.
  • The Rest of the World region, which includes areas like Latin America and the Middle East, is gradually adopting gene therapy technologies but remains smaller in market size compared to other regions.

Key Takeaway

While North America continues to dominate the market, Asia-Pacific shows immense potential for future growth. Understanding these regional trends helps highlight where innovation and investment are driving the global gene therapy market.

Gene Therapy Market Segments

Based on the research report, Roots Analysis has been segmented based on the type of therapy, type of gene therapy delivery method, type of vector used, target therapy areas, route of administration, end user, and key geographical regions.

▪          Gene Therapy Market, Based on the Type of Therapy

⬝    Gene Augmentation

⬝    Oncolytic Viral Therapy

⬝    Immunotherapy

⬝    Others

▪          Gene Therapy Market, Based on the Type of Gene Delivery Method

⬝    Ex vivo method

⬝    In vivo method

▪          Gene Therapy Market, Based on Type of Vector Used

⬝    Adeno-associated Virus

⬝    Adenovirus

⬝    Herpes Simplex Virus

⬝    Lentivirus

⬝    Non-Viral Vectors

⬝    Retrovirus

⬝    Others

▪          Gene Therapy Market, Based on the Target Therapeutic Areas

⬝    Cardiovascular Diseases

⬝    Dermatological Diseases

⬝    Genetic Diseases

⬝    Hematological Diseases

⬝    Infectious Diseases

⬝    Metabolic Diseases

⬝    Muscle-Related Diseases

⬝    Oncological Diseases

⬝    Ophthalmic Diseases

⬝    Others

▪          Gene Therapy Market, Based on the Route of Administration

⬝    Intraarticular

⬝    Intracerebral

⬝    Intracoronary

⬝    Intradermal

⬝    Intralesional

⬝    Intramuscular

⬝    Intrapleural

⬝    Intrathecal

⬝    Intratumoral

⬝    Intravenous

⬝    Intravesical

⬝    Intravitreal

⬝    Subretinal

⬝    Topical

⬝    Others

▪          Gene Therapy Market, Based on the Geographical Region

⬝    North America

⬝    Europe

⬝    Asia-Pacific

⬝    Rest of the World

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