Analyze The Future Development Direction Of The API Industry

For the majority of pharmaceutical companies, the latest developments in the API market and the development direction of the API industry directly affect the future planning of enterprises, so we must pay attention to them at any time. Today, I will take you to understand the future development direction of the API industry, and hope to bring you help!

1. High-end characteristic APIs
European companies are the main suppliers of specialty APIs, but due to environmental and cost pressures, specialty APIs are beginning to shift to the Asian market. With the improvement of domestic GMP management level, process development ability and international certification experience, China has the conditions for the development of characteristic APIs.
Since the profit of a single variety of featured APIs does not have long-term growth, enterprises need more product reserves. This requires enterprises to have high R&D strength and strategic foresight, constantly reserve projects, and seize the market after the expiration of patents.

2. Small varieties of APIs
Bulk APIs are highly competitive and overcapacity. However, some small varieties of drugs with high profits and small scale still have good market space. In the research and development of chemical drugs, the possibility of large drugs is becoming smaller and smaller, and with the popularity of precision treatment, small drugs (high-efficiency drugs) are increasingly being introduced. This part is mainly antineoplastic drugs, prostate drugs and certain hormone drugs. In particular, tumor drugs with selective targeting characteristics. At present, about 80% of the world's small drugs (high-efficiency drugs) APIs are patented drugs.

3. One-stop service from patented APIs to CRO
Bulk APIs and specialty APIs are usually operated by API manufacturers in the form of self-production and self-sale after the patent expires. Patented APIs are often produced by the patented drug manufacturer itself, or the patent holder entrusts the API manufacturer to produce and operate the API manufacturer in a contract customized manner.
Patented APIs refer to pharmaceutical active ingredients used in the manufacture of original drugs (patented drugs), which mainly meet the needs of innovative drugs of original multinational pharmaceutical companies and emerging biopharmaceutical companies in the stages of clinical research, registration approval and commercial sales of drugs, including advanced intermediates used in the production of the API but under the supervision of regulatory authorities. With the global industrial division of labor and the transformation of the business model of multinational pharmaceutical companies, the outsourcing market of patented APIs will further expand.
Established pharmaceutical companies abandoned the original full-industry chain model, separated R&D and production links through outsourcing, and shifted their focus to product layout and global operations. CRO services mainly involve four stages: preclinical research, clinical trials, post-marketing patent drug sales and original drug sales after patent expiration. From the nature of the products provided by the enterprise, it can be classified as API starting materials (non-GMP), GMP intermediates, APIs and preparations. CRO advantages: lower cost, guaranteed quality, conducive to process improvement.

4. API enterprises cooperate with large international companies
Due to China's personnel advantages and cost advantages, international large companies and domestic enterprises to establish stable cooperative relations, there are two main models: domestic API companies, and the mode of cooperation with international large companies, which can reduce the export threshold; Domestic API enterprises cooperate with large international companies in the form of commissioned processing, patent transfer and joint venture production.