Advancing Gene Therapy Commercialization: Challenges and Opportunities in Biopharmaceutical Markets

Abstract

Gene therapy is the ultimate technological breakthrough in medicine because of its promising approach to the treatment of monogenic diseases, cancers, and other chronic conditions. However, there are key question marks that mark the journey to its successful commercialization: There are unique risks and opportunities here. The principal barriers examined in this paper are regulatory issues, scale-up manufacturing, high cost of development, acceptance by the market, and ethical issues. They reveal biopharmaceutical firms' economic and operational challenges in providing affordable and reachable drugs. As for the opportunities, the enhanced CRISPR-based editing and non-viral delivery systems and uses of artificial intelligence are evolving the market, whereas new economical collaborative models and value-based approaches are changing the strategies. Additional advantages include regulatory rewards for rare disease therapeutic research and broadening indications into more common diseases. With these difficulties being addressed in terms of investment, partnerships and patient-centered models, gene therapy provides a unique value proposition to change the face of biopharmaceuticals in healthcare.