Financial and administrative burdens are a challenge for businesses in the generic veterinary medicines sector, according to a new study.
Generic veterinary medicines are veterinary medicines that are the same as a previously patented or licenced molecule or active substance, and where the patent for the original product has ended or expired.
Many businesses in the generic veterinary medicines sector in Europe are represented by Access VetMed, which carried out the 2024 European Market Study on Generic and Value-Added Veterinary Medicines, the results of which were published this week.
The study found that, of all veterinary medicine marketing authorisations in Europe, 50% are for generic products, and 60% of businesses that hold veterinary medicine marketing authorisations hold generic licenses.
Access VetMed members hold 64% of generic authorisations for companies with more than 500 products, which the study said demonstrates “their pivotal role in expanding market availability and accessibility”.
Generics dominate market authorisations for companion animals such as dogs and cats, while products for ruminants also show “significant strength”, according to the study.
Anti-infectives and antiparasitics emerged as the largest therapeutic categories, accounting for 57% of all generic authorisations.
However, the study also found that, while EU regulations have “improved harmonisation” in the sector, they have also been responsible for notable financial and administrative burdens, particularly for small and medium-sized enterprises (SMEs).
Access VetMed said the study emphasises the need for addressing “administrative inefficiencies and rising costs”, particularly through enhanced collaboration with the European Medicines Agency (EMA) and national authorities.
Such measures are critical to ensuring sustainable growth, especially for SMEs navigating complex regulatory landscapes, the representative organisation said.
Xavier Molins, the president of Access VetMed, said: “The data confirms that the generic veterinary medicines industry in Europe remains robust and poised for continued growth, despite emerging challenges.
“This study provides crucial insight for the sector, from identifying new market opportunities in niche areas to highlighting areas where regulatory improvements could unlock further potential,” Molins added.
Generic veterinary medicines
Generic veterinary medicines emanate from the same molecule as the originator. They are equally high quality, safe and efficient as the originators, according to Access VetMed.
Generics are assessed, authorised and regulated by relevant competent authorities before entering the market.
To operate in Europe, the generic producers have to follow manufacturing standards and quality controls known as good manufacturing practice (GMP).
Generic medicines are authorised and placed on the market after intellectual property and other protection periods associated to the originator product have expired. This may take up to 25 years.
