The scale of generic uptake in the major markets
The International Generics Pharmaceutical Alliance (IGBA), an international network of generic medicines associations, released a report that maps the varying levels of uptake of generics medicine, and the resulting value of its share across the entire pharmaceutical market.
As can be seen in the map below, the US actually has the greatest generics penetration by volume, at 90%, but this accounts for only 22% of the overall value of the market – one of the lowest levels across the countries studied.
At the opposite end of the spectrum is South Africa, which has one of the lowest levels of volume, 69.6%, but the overall value of the generics market is close to half, at 47.5%.
Improving generic entry
To encourage the further entry of generics onto the global market, IGBA released an additional report, which looked at how the global regulatory system could facilitate this through a harmonized approach.
The report notes that many countries have developed their own regulatory good manufacturing practice (GMP) standards, which necessitates multiple countries carrying out inspections at the same company – often duplicating results.
IGBA noted that such repeated inspections are of ‘significant concern’ for the manufacturers of active pharmaceutical ingredients (APIs) and finished products. This is due to the high costs for the companies and occasionally diverging regulatory opinion.
As a result, the organization is calling for greater global harmonization through the development of mutual recognition agreements, such as that recently agreed between the US Food and Drug Administration and the European Medicines Agency.
