【Strict regulations】Pharmaceutical companies must comply with strict regulations set by the FDA (US Food and Drug Administration), EMA (European Medicines Agency) and other national regulatory bodies. This includes extensive documentation, clinical trials and quality control measures to ensure the safety and effectiveness of the drug.

【High research and development costs】Developing new drugs is expensive, often costing billions of dollars, including the costs of research, development and clinical trials. In particular, many drugs have not been marketed, and the financial risks are great.

【Long development cycle】The process from drug discovery to market usually takes 10 to 15 years or more. This long cycle can affect a company's return on investment and requires careful planning and management.

【Innovation Challenge】Despite massive investment, discovering and developing innovative drugs remains challenging. Scientific and technical barriers can hinder progress, and the success rate of new drug discovery is relatively low.

【Patent protection lapses】Patents for drugs typically last 20 years, but the active patent period is usually shorter after market approval. After the patent expires, generic drug manufacturers can produce cheaper drugs, leading to a significant drop in revenue for the original developers.

【Patent Strategy】Companies need to develop strategies to extend patent protection through new formulations, combinations, or delivery methods. However, these strategies are not always successful and are expensive to implement.

【Cost control】Governments and healthcare systems are increasingly focused on controlling drug costs, including negotiating drug prices, imposing price caps, and promoting the use of generics and biosimilars.

【Reimbursement Challenge】Favorable reimbursement from insurance companies and government health programs is key to the marketplace's success. Companies often face the challenge of negotiating reimbursement rates and need to demonstrate the value of their drugs compared to existing treatments.

【Public scrutiny】Incidents of rising drug prices and price gouging have led to calls for public scrutiny and price regulation. Companies must manage these pressures while maintaining profitability.

【Complex Supply chain】The pharmaceutical supply chain is complex, involving raw material suppliers, manufacturers, distributors and logistics providers. Managing this complex network requires effective coordination and supervision to ensure the quality and availability of products.

【Interruption Risk】Supply chain disruptions, such as geopolitical tensions, natural disasters or epidemics, can affect the timely production and distribution of medicines. Companies need to develop contingency plans to mitigate these risks.

【Protect Sensitive data】Pharmaceutical companies handle large amounts of sensitive data, including patient information from clinical trials and proprietary research data. Protecting this data from cyber threats and unauthorized access is critical.

【Intellectual Property Risk】Protecting intellectual property rights is essential to maintaining a competitive advantage. However, intellectual property theft or unauthorized use can occur, especially in global markets. Companies must invest in strong IP protection strategies and legal measures to defend their innovations.