DataM Intelligence has released the comprehensive report titled “Advanced Therapy Medicinal Product (ATMP) Market – Growth Rate, Industry Insights, and Forecast 2024-2031.” The study underscores a period of accelerated expansion in ATMPs — spanning gene therapies, cell/somatic therapies, and tissue-engineered medicines — driven by rising disease burdens, R&D investment, and regulatory momentum. The market, valued at US$ YY million in 2023, is projected to achieve US$ YY million by 2031, advancing at a robust CAGR over the forecast period.

Market Segmentation Insights

The ATMP market is structured around three principal therapy types: gene therapy medicines, somatic cell therapy medicines, and tissue-engineered medicines. Gene therapy leads in share (nearly half of the market), reacting to increasing incidence of genetic disorders and the promise of precise correction at a molecular level. By disease indication, segments include cancer; cardiovascular diseases; musculoskeletal disorders; immune system & inflammation; neurology; and others. Cancer and neurology are significant drivers given their unmet needs and high research intensity.

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Regional Insights

North America remains the largest region in terms of market share, supported by strong clinical infrastructure, well-established biotech sectors, and favorable regulatory frameworks that facilitate ATMP development and approvals. Asia-Pacific is forecast as the fastest growing region, propelled by increasing healthcare investments, expanding biotech capabilities, growing disease burden, and improving regulatory environments. Europe, Latin America, Middle East & Africa also contribute, though growth rates in those regions are more moderate, influenced by regulatory, reimbursement or infrastructure constraints.

Industry Trends & Recent Developments

  • Innovation is accelerating in gene therapy, especially platforms like CRISPR, plasmid DNA, antisense technology, and RNA-based gene correction, gaining momentum in both cancer and rare genetic disease treatment.

  • Somatic cell therapy and tissue engineering are experiencing increased investment in manufacturing scale-up, quality control improvements, and combination therapies.

  • Regulatory guidance is tightening, with authorities stressing safety, non-clinical data, clinical trial design, and post-market surveillance for ATMPs.

  • New product approvals and clinical trial milestones are occurring: in 2025 several novel ATMPs have received regulatory designations or accelerated paths in North America and Europe for inherited disorders or rare diseases (for example, a gene therapy for an inherited retinal disease getting FDA accelerated approval).

Competitive Landscape: Key Players

The ATMP market features a mix of specialized biotech firms and large pharmaceutical players. Firms like Orchard Therapeutics plc, Kite Pharma EU B.V., Novartis, Amgen, Bristol-Myers Squibb, Mukocell GmbH, BioTissue Technologies GmbH and others are leading in research, therapeutic development, manufacturing, and commercialization. These companies are leveraging strong R&D pipelines, clinical trial expertise, partnerships, and regulatory strategy to gain advantage. Emerging players in Asia-Pacific are also entering the market, particularly in cell therapy and tissue engineering, to take advantage of growing demand and more supportive regulatory environments.

Strategic Outlook

Looking toward 2031, growth in the ATMP market is expected to be shaped by several strategic imperatives: scaling manufacturing & supply chain for cell- and gene-based therapies, ensuring cost containment, advancing regulatory harmonization, increasing access to treatment via reimbursement models, and emphasizing safety and long-term efficacy. Personalized medicine will continue to be a key trend, as well as collaboration between biotech firms, CDMOs, governments, and academic institutions to share risk, reduce time to market, and broaden patient access.

Research Process

This report is based on rigorous methodology combining primary research (interviews with industry leaders, researchers, clinicians, regulatory experts) and secondary research (company reports, peer-reviewed literature, regulatory filings, and market databases). Forecasts are built using both top-down and bottom-up approaches to ensure accuracy in market size, segmentation, and outlooks.

Benefits of the Report

Stakeholders including biotech companies, pharmaceutical firms, CDMOs, investors, and policy makers will find this report useful for understanding therapy type trends, regional growth potential, disease indication demands, and regulatory landscape shifts. It provides actionable insights for R&D prioritization, investment allocation, market entry strategy, and partner identification in the ATMP space.

Conclusion

The Advanced Therapy Medicinal Products market is positioned for strong growth through 2031, supported by scientific innovation, increasing disease prevalence, and regulatory support. While challenges such as regulatory complexity, manufacturing scale-up, safety concerns, and cost remain, companies able to navigate these obstacles stand to capture significant opportunity. With North America leading in scale and Asia-Pacific rising fastest, the global landscape for ATMPs looks increasingly hopeful for patients and stakeholders alike.

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