Regulatory Frameworks for Biopharmaceutical Exports: Comparative Analysis Across Major Markets

Abstract

Biopharmaceutical medications made up an increasing portion of the global pharmaceutical business in 2016, with worldwide sales of US$ 228 billion. A shift in market shares, a revision of company strategies, and the attraction of new players to the biopharmaceutical market are all possible outcomes of the loss of patent protection and other exclusivity rights for many of these biopharmaceutical products. Additionally, non-innovator versions of these molecules, known as biosimilars, may now enter the market. Biosimilars provide a more affordable option to pricey biopharmaceutical treatments because of reduced R&D expenses and increased competition. Overall research found that directly and significantly link in between major markets. Health care systems may increase patient access, provide doctors more treatment options, and have a new tool to manage rising health care costs by using biosimilars. In order to compete in the finding and documenting the investment and development methods used by industry participants in the global biopharmaceutical business is the goal of this original research paper. In light of this, we differentiate between different approaches to investment and development and provide examples of these approaches for the top 25 pharmaceutical businesses. With the use of three case studies, identified various companies operating in the biosimilar sector and their key competencies for entering this market. As far as the authors are aware, our analysis is the first to offer a thorough overview of the biopharmaceutical and biosimilar market's industrial landscape as of December 2016. However, it should be acknowledged that the landscape is changing quickly.