1. Regulatory environment: strict regulations and lengthy approval processes can increase costs and limit market access.
2. Intellectual property: protecting and defending intellectual property is crucial to the success of pharmaceutical companies, but can be costly and time-consuming.
3. Competition: intense competition among pharmaceutical companies can drive down prices and reduce profit margins.
4. R&D costs: the high cost of research and development, including clinical trials, can pose a significant financial risk to pharmaceutical companies.
5. Patents expiration: when patents on major drugs expire, sales can plummet, resulting in significant revenue losses.
6. Government price controls: government intervention and price controls can affect profitability and limit the ability of companies to set prices based on market demand.
7. Market access: access to markets in developing countries can be challenging, with regulatory hurdles and infrastructure limitations.
8. Counterfeit drugs: counterfeit drugs pose a serious threat to patient safety, and can damage the reputation of pharmaceutical companies.
9. Drug pricing: concerns around drug affordability and access have led to increased scrutiny around drug pricing practices.
10. Data privacy and security: pharmaceutical companies must comply with strict regulations around data privacy and security in order to protect sensitive patient information.