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Understanding the market dynamics of biosimilars
Biosimilars represent an attractive market opportunity in the pharmaceutical industry. In order to understand the underlying market dynamics and to identify the success factors of the biosimilars market, a PEST (political, economic, social, technological) analysis was conducted based on desk research and expert interviews with market participants and stakeholders. The regulatory environment for biosimilars seems to be well established and both the required manufacturing technology and the necessary analytical capabilities for biosimilar development are available. The potential market is expected to grow due to the overall dynamics in the biologics market and the patent expiration of blockbuster drugs. The perspective of the scientific community towards biosimilars has changed from skeptical to rather positive in the last 10 years, probably reflecting the evolution of regulatory guidelines and technological progress. However, physicians, responsible for the prescription of drugs, are still rather skeptical about biosimilars and need to be better informed in order to increase the currently low market penetration of biosimilars. Taken together, the biosimilars industry is expected to step out of its infancy stage and now enter the growth phase.