(MENAFN- GlobeNewsWire - Nasdaq) The gene therapy market presents key opportunities in addressing genetic disorders by targeting the root cause through therapies like gene augmentation. North America leads in market share, with notable growth expected due to increasing demand for personalized medicine, single-dose treatments, and innovation driven by start-ups and substantial investor interest.

Dublin, Dec. 05, 2025 (GLOBE NEWSWIRE) -- The "Gene Therapy Market Industry Trends and Global Forecasts to 2035: By Therapeutic Area, Type of Vector, Type of Therapy, Type of Gene Delivery Method, Route of Administration, Geographical Region, Leading Market Players and Sales Forecast" has been added to ResearchAndMarkets's offering.

The gene therapy market is forecasted to grow from USD 2.4 billion in 2025 to USD 16.5 billion by 2035, exhibiting a CAGR of 19.25% during this period.

Gene therapies address a wide range of disorders, inclusive of genetic, oncological, autoimmune, and neurological conditions. With WHO data indicating over 70 million individuals affected by genetic disorders, leading to significant infant mortality, gene therapy emerges as a beacon of hope. Notably, over 1,100 clinical trials for gene therapies have been registered recently, pointing to an uptick in scientific research. The USFDA anticipates 10 to 20 therapies to gain market access annually till 2025, heralding a strong growth trajectory driven by collaborative industry efforts.

Currently, 345 global entities are focused on developing gene therapies, with more than 50% based in the US. Phase III trials see 70% of gene therapies as gene augmentation efforts, with a notable percentage achieving fast-track designation. The intellectual property landscape is thriving, marked by over 500 gene editing patents filed in the past five years.

High investor interest is evident, with USD 36.4 billion poured into over 560 funding rounds. Start-ups, pivotal in innovation, aren't valued solely on profits but on potential and previous investments. Major pharmaceutical entities are expanding via proprietary product development and strategic investments, addressing the burgeoning demand, especially as personalized medicine gains traction.

Regionally, North America is anticipated to capture a 65% market share by 2035, though Europe is poised for a higher CAGR growth rate.

Key Market Segments

Therapeutic areas cover cardiovascular, dermatological, genetic, hematological, metabolic, muscular, oncological, and ophthalmic disorders. AAV vectors dominate the vector category, owing to their efficacy and specificity. Gene augmentation represents the largest segment by type of therapy, while in vivo methods and intravenous administration are expected to lead delivery methods.

Market Insights and Projections

The gene therapy sector's expansion is supported by favorable clinical trial outcomes, significant patent filings, and increasing mergers and acquisitions. The annualized demand for gene therapies is projected to grow over 11.67% by 2035. Moreover, continuous innovations and strategic movements by key players will further tailor this market landscape.

Key Players Profiled in the Report

• Amgen
• BioMarin Pharmaceutical
• bluebird bio
• CRISPR Therapeutics
• Novartis
• Spark Therapeutics

Strategic insights drawn from discussions with industry experts, such as former executives from companies like Orchard Therapeutics and Vivet Therapeutics, enrich this study. The analysis details company overviews, financial info, and commercialization strategies, offering a navigational tool for stakeholders.

Reasons to Buy the Report

• Comprehensive analysis of revenue projections and competitive dynamics
• Insight into market drivers, barriers, and opportunities
• Understanding of key segments and strategies for market leaders

Key Topics Covered:

1. Preface

2. Research Methodology

3. Market Dynamics

4. Economic Considerations

5. Executive Summary

6. Introduction

7. Gene Delivery Vectors

8. Regulatory Landscape And Reimbursement Scenarios

9. Market Landscape

10. Developer Landscape

11. Company Profiles

12. Marketed Gene Therapies

13. Key Commercialization Strategies

14. Late-Stage Gene Therapies

15. Patent Analysis

16. Mergers And Acquisitions

17. Funding And Investments

18. Clinical Trial Analysis

19. Cost Price Analysis

20. Start-Up Valuation

21. Big Pharma Initiatives

22. Demand Analysis

23. Market Impact Analysis: Drivers, Restraints, Opportunities And Challenges

24. Global Gene Therapy Market

25. Gene Therapies Market, By Therapeutic Area

26. Gene Therapies Market, By Type Of Vector

27. Gene Therapies Market, By Type Of Therapy

28. Gene Therapies Market, By Type Of Gene Delivery Method

29. Gene Therapies Market, By Route Of Administration

30. Gene Therapies Market, By Geographical Regions

31. Gene Therapies Market, By Leading Players

32. Gene Therapies Market, Sales Forecast Of Therapies

33. Gene Therapy Market: Emerging Technologies

34. Vector Manufacturing For Gene Therapies

35. Case Study: Gene Therapy Supply Chain

36. Executive Insights

37. Conclusion

38. Appendix I: Tabulated Data

39. Appendix II: List Of Companies And Organizations

• Amgen
• Artgen Biotech
• BioMarin Pharmaceutical
• bluebird bio
• CRISPR Therapeutics
• CSL Behring
• Ferring Pharmaceuticals
• Kolon TissueGene
• Krystal Biotech
• Novartis
• Orchard Therapeutics
• Pfizer
• PTC Therapeutics
• Sarepta Therapeutics
• Shanghai Sunway Biotech
• Sibiono GeneTech
• Spark Therapeutics

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