Gene Therapy Market is Grow at a CAGR of 14.50% to reach US$ 12.92 billion by 2031

According to The Insight Partners, Global Gene Therapy Market size is projected to reach US$ 12.92 billion by 2031 from US$ 5.06 billion in 2024. The market is expected to register a CAGR of 14.50% during 2025–2031.

The global gene therapy market is experiencing a transformative phase driven by remarkable advancements in biotechnology, increasing investments, and growing acceptance of genetic-based treatments across healthcare systems. From curing inherited genetic disorders to tackling cancer and rare diseases, gene therapy stands at the epicenter of a medical revolution that redefines how diseases are treated and, ultimately, prevented.

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Transforming Modern Medicine

Gene therapy involves the introduction, alteration, or removal of genetic material in a patient’s cells to address a disease at its genetic root. Unlike conventional treatments that only manage symptoms, gene therapy aims for a permanent cure by correcting defective genes or replacing them with functional ones. This novel therapeutic approach is gaining global traction as clinical success stories—like those involving CRISPR-based therapies—make their way to commercialization and regulatory approvals across regions.

As we move further into the 2030s, the gene therapy market continues to expand rapidly, bolstered by a robust research pipeline, strong R&D funding, and favorable regulatory environments in North America, Europe, and Asia-Pacific. Pharmaceutical giants such as Novartis, Gilead Sciences, Biogen, and CRISPR Therapeutics are spearheading innovation with next-generation treatments addressing oncology, neurology, and rare genetic disorders.

Market Growth Dynamics

A significant driving force behind the expanding gene therapy ecosystem lies in the increasing prevalence of genetic diseases and chronic illnesses. According to 2025 industry reports, over 7,000 rare diseases globally affect nearly 400 million people, with around 80% of these conditions having a genetic basis. This urgent need has spurred enormous investment from public and private sectors to accelerate commercialization timelines and expand clinical applications.

Furthermore, patient-centric healthcare approaches and technological advancements such as AI-driven drug discovery and next-generation sequencing are enhancing precision and lowering development timelines. The result is a fast-evolving landscape characterized by rapid approvals, innovative delivery mechanisms, and increased affordability in the long term.

Key Market Developments

Recent industry updates highlight global acceleration in gene therapy adoption. Regulatory agencies, including the U.S. FDA and EMA, continue to approve new therapies addressing previously untreatable conditions. For example, in early 2025, new partnerships between biotech firms and pharmaceutical manufacturers were announced to strengthen viral vector production capacity, a crucial element in scalable gene therapy development.

ZEO ScientifiX recently expanded its operations in the U.S., focusing on personalized genetic treatments while leveraging Florida’s new stem cell market infrastructure. Similarly, biotech companies are exploring AI integration to optimize clinical trials and improve treatment efficacy across cancer, ophthalmology, and musculoskeletal disorder segments.

Global and Regional Insights

North America remains the most dominant region, primarily due to its advanced healthcare infrastructure, high R&D investments, and favorable regulatory support. The region is home to the majority of clinical trials and commercial launches, led by U.S.-based innovators such as bluebird bio, Sarepta Therapeutics, and Biogen.

In Europe, supportive health policies and strategic collaborations between academic institutions and biotechnology firms are paving the way for broader gene therapy adoption. The European Medicines Agency has streamlined procedures for advanced therapy medicinal products, which encourages innovation and market entry for emerging players.

The Asia-Pacific region exhibits the fastest growth trajectory, driven by an expanding patient base, increasing healthcare expenditure, and growing biopharma capabilities. Countries like Japan, with its strong regenerative medicine ecosystem, and India, with growing healthcare investments and awareness, are becoming critical hubs for clinical studies and cost-effective gene therapy production. China’s focus on establishing large-scale genomic medicine infrastructure further accelerates regional expansion.

Industry Trends Shaping the Future

• Shift toward non-viral delivery methods that reduce safety concerns associated with traditional viral vector techniques.
• Increasing use of AI and machine learning in therapy design and clinical trial optimization.
• Expansion of public-private partnerships to foster gene therapy commercialization globally.
• Growth in patient-specific therapies enabled by CRISPR and other gene-editing technologies.
• Focus on integrating gene therapy with cell-based regenerative therapies for enhanced therapeutic outcomes.

Market Size, Share, Trends, Analysis, and Forecast (Through 2031)

• Expanding research collaborations and partnerships driving commercialization across therapeutic categories.
• Growing demand for personalized treatment in oncology, neurology, and rare genetic conditions.
• Increasing prevalence of rare genetic disorders accelerating long-term adoption.
• North America leading global share, with rapid expansion in Asia-Pacific and Europe.
• Outlook through 2031 shows sustained growth driven by technology evolution, government incentives, and breakthrough therapies entering markets.
• Significant improvements anticipated in affordability and accessibility through scalable production and regulatory harmonization.
• Strengthened intellectual property and innovation pipelines anticipated to protect commercialization efforts through 2031.

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Future Outlook

The coming decade will see gene therapy evolve from experimental medicine into a mainstream treatment modality. Integration with big data analytics, personalized genomics, and AI-based precision medicine platforms will redefine how genetic conditions are managed. As governments increase their commitment to healthcare innovation, patient access to cutting-edge therapies will expand significantly.

According to a recent 2025 report, global momentum continues to build with expanding clinical successes and technological breakthroughs marking a new era in human health. The forecast through 2031 envisions a world where genetic disorders are no longer lifelong burdens but curable conditions—making gene therapy one of the most revolutionary chapters in the story of modern medicine.

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