Abeona Therapeutics IncFDA approval of Zevaskyn, a first-in-class gene therapy, is a regulatory milestone for Abeona.
The global regenerative medicine market is projected to reach approximately USD 162 billion by 2034, growing at a compound annual growth rate of around 16% from a 2025 size of about USD 41 billion, according to a report by DelveInsight. North America held the largest share at roughly 42% in 2025, driven by advanced healthcare infrastructure and strong R&D investment, while the Asia-Pacific region is expected to be one of the fastest-growing markets. Key companies in the space include Novartis AG, Gilead Sciences, Bristol-Myers Squibb, Johnson & Johnson, and Krystal Biotech, among others. Recent developments include the European Commission's approval of Krystal Biotech's gene therapy Vyjuvek in April 2025 and the U.S. FDA's approval of Abeona Therapeutics' Zevaskyn, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa. Growth is fueled by advances in stem cell and gene therapies, rising chronic disease prevalence, and supportive regulatory pathways.
Abeona Therapeutics IncFDA approval of Zevaskyn, a first-in-class gene therapy, is a regulatory milestone for Abeona.
Krystal Biotech IncEuropean Commission approval of Vyjuvek gene therapy is a regulatory win for Krystal Biotech.
Bristol-Myers Squibb Company
Gilead Sciences Inc
Johnson & Johnson
Novartis AG