Drugdu.com expert's response:

The pharmaceutical industry faces numerous challenges, including:

Ⅰ.High R&D Costs: Drug development is a lengthy and expensive process, often requiring billions of dollars and many years. The risk of failure is high, with many drugs not passing clinical trials.

Ⅱ.Regulatory Pressure: Drug regulatory agencies (e.g., FDA, EMA) have increasingly stringent approval requirements for new drugs, necessitating more resources for clinical trials and data collection, thus increasing the difficulty and cost of bringing new drugs to market.

Ⅲ.Short Patent Protection Period: The patent protection period for new drugs is relatively short. Once the patent expires, generic drugs quickly enter the market, significantly reducing the market share and profits of the original drug.

Ⅳ.Intense Market Competition: The pharmaceutical market is highly competitive, not only from other innovative drugs but also from generic drugs and biosimilars.

Ⅴ.Price Pressure: Governments and the public are increasingly concerned about drug prices, especially high-priced drugs, leading to pricing pressure on pharmaceutical companies, which need to balance innovation and affordability.

Ⅵ.Supply Chain Challenges: The globalized pharmaceutical supply chain is complex and susceptible to natural disasters, political instability, trade disputes, and other factors that can cause material shortages and production disruptions.

Ⅶ.Ethical and Compliance Issues: Clinical trials and marketing activities may face ethical and compliance issues, requiring strict adherence to relevant laws and regulations to avoid legal disputes and reputational damage.

Ⅷ.Technological Change: Rapid developments in biotechnology, gene therapy, and precision medicine demand continuous innovation and adjustment in research and development direction for traditional pharmaceutical companies to stay competitive.

Ⅸ.Talent Shortage: There is a shortage of high-level research and management talent, particularly in the biopharmaceutical field, challenging the innovation capabilities and operational efficiency of pharmaceutical companies.

These challenges require the pharmaceutical industry to address them through innovation, collaboration, policy support, and other efforts to promote the industry's sustainable development and progress.