TRENDS IN API PRODUCTION
Figures released by API Production companies time and again reveal that the budget and time frame of developing APIs is very high.
There are strict bottlenecks in the industry with many small companies being squeezed into tight corners by a variety of factors.
What are the current and possible future trends in API Production?
Due to complexity of emerging diseases as well as tough inspection measures by drug inspection agencies such as The FDA (Food and Drug Agency) in the U.S.A, manufacturing APIs and getting them approved has proven real tedious for manufacturers. This means that the process is also very expensive. One good example is a drug that takes approximately 10 years to develop and another 5 years negotiating approval. To cover for the risk of a long manufacturing period and extremely high budget, as well as competition from other similar generics in the markets, API Production companies have to increase prices of their products. These prices are in fact likely to keep on rising.
Meanwhile, fees for applications for generics’ approval keep rising. This means API production companies especially the relatively small ones are squeezed so hard financially to an extent of being eliminated especially if they attempt to raise costs of their products as a compensatory measure. This is bad news for competition and innovation.
Some governments are also not very supportive of foreign inspections. The China government for example has been known to bar FDA inspections, limiting their companies’ products approval for export.
The inspection strain falls very heavily on small API Production companies. Their attempts to raise cost of their products simply to remain in the market may pave way for their elimination from the market.
Other pressing issues emerging in APIproduction include:
- Lack of enough qualified labor in the dynamic API market
- Dwindling competition and innovation
- Increased regulatory scrutiny
It is not a surprise some API Production companies are opting for outsourcing in place of manufacturing. The constraints in the market seem to be getting too hard on them.