The European generics market is expected to boom to $35.9bn (€26.1bn) in 2013, according to a Frost & Sullivan report.
The generic explosion, rising from last year's $17.18bn market, would follow the raft of blockbuster drugs coming off patent within the next few years. But the report - Blockbusters Going off Patent: Opportunities for Generics - also claimed an aging population and escalating drug prices would also drive the growth of generics in the European market. "Patent expiries, pro-generic reforms in certain countries and need for cheap, effective medicines are the key factors driving growth in the European generics market," Frost & Sullivan research analyst Sumanth Kambhammettu said. "Various studies have indicated the cost savings obtained from generics and several governments in Europe are actively promoting generics."
However, generic manufacturers would be up against severe pricing pressures, reference pricing and parallel trading. Likewise, technological and biological advances for drug reformulations and increased efficiency in drug delivery would always be in the background as companies looked to extend the patent life-cycle of their products. This move was becoming increasingly common, as found in a report published last month by research group Cutting Edge Information According to the authors of that report: "New formulations, when launched at the proper time and in the right sequence, can effectively stymie the market share erosion typically caused by generic competition."
According to data provided by the pharma companies surveyed in the report, the average new formulation strategy can protect a brand franchise's market share for almost 27 months. If there is no product re-launch, a branded product, depending on the number of generics waiting in the wings, can easily lose 50-80 per cent of its annual revenue within a year of patent expiry, the Cutting Edge Information report stated. However, the threat of generics as patents expired has been said to increase innovation and research and development in the pharmaceutical industry. According to the Frost & Sullivan report, generics providers would increasingly aim to leverage low cost contract manufacturing facilities in countries such as India and China to speed their time to market with strategic agreements developing between participants.
Currently, more than 50 per cent of all US prescriptions have filled with a generic product.
Patents due to expire between now and 2009 include: Zyrtec (cetirizine), an antihistamine from Pfizer; Advair (fluticasone and salmeterol), an anti-inflammatory from GlaxoSmithKline; Casodex (bicalutamide), hormone therapy to treat prostate cancer from Bristol-Myers Squibb; Avandia (rosiglitazone), for diabetes by GSK; and Xenical (orlistat) a weight loss drug from Roche.