Italy is the world's second largest producer of active pharmaceutical ingredients (APIs), trailing only China. It holds nearly a 30% share in the U.S., still the largest market for branded and generic APIs.
That is the finding of a new report from the Italian Chemical Pharmaceutical Association (CPA) discussed in World Pharmaceuticals. The report says that India trails Italy and is the third largest API producer in the world but the second in Asia behind China. Indian API makers, however, have seen a growth in sales of 12.6% and export more than 70% of their production, the CPA says.
As API manufacturing has grown into a global business there are lots of changes taking place. Europe has passed a law taking effect this July requiring certification of API imports. The European Fine Chemicals Group (EFCG) has recently called for international standards and plant inspections of all API and drugmakers worldwide.
The CPA report says that while the U.S. remains the largest overall API market, China has overtaken it as a buyer of generic APIs. Further, it says the overall API market should grow by 6.5% to 7% annually over the next 5 years. The BRIC countries--Brazil, Russia, India and China--will see a combined growth rate in API use of 15% to 20% and 38% in generic API growth as their economies and middle class grow.
Other insights include that in Latin America, Mexico is the largest maker of APIs but demand for APIs in Brazil, growing faster than in any other country in that region. In Eastern Europe, Hungary leads the list of API makers.
- read the World Pharmaceuticals report (PDF)