Strategies for Biopharma Market Expansion

Biopharma companies are increasingly targeting international markets for growth, driven by the looming "patent cliff" and the need to expand patient access, with potential revenue of US$120 billion outside the US by 2028 according to IQVIA. However, diverse regulatory regimes, reimbursement schemes, and tax considerations pose significant challenges. Success requires prioritizing countries based on potential and regulatory environment, tailoring entry models to each market, and developing robust cross-functional capabilities. Large companies might establish a direct presence through subsidiaries or joint ventures, while smaller firms may opt for licensing distributors. Navigating regulatory pressures, anti-bribery laws, and sanctions necessitates thorough due diligence and infrastructure investment. Understanding expedited approval options and unique market-specific processes is crucial for timely and efficient product launches. Ultimately, a clear, tailored international expansion plan enhances the likelihood of success, reaching more patients and increasing revenue opportunities.

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