L'agence de notation Fitch Ratings a publié un rapport sur l'évolution de la R&D dans l'industrie pharmaceutique au 3e trimestre 2011.
Prior Revenue Declines Reverse: There was a return to positive revenue growth derived from the human medicines offerings at Fitch-rated large pharmaceutical companies achieved in the third quarter. The industry remains under pressure from generic competition and government cost containment; however, Fitch-covered drug manufacturers saw an average weighted revenue increase of 2.1% in the third quarter after adjusting for currency changes and consolidation activities within the past 12 months.
Patent Expiration Wave Cresting: The most significant period of key drug patent expiration is upon the industry. The world’s largest pharmaceutical, Pfizer Inc.’s (Pfizer) Lipitor, lost U.S. market exclusivity in November, following Eli Lilly & Co.’s (Eli Lilly) top-selling drug, Zyprexa, which expired in October. The coming year will be the most challenging for the industry, despite a wealth of new drug approvals in 2011. Four of the industry’s 10 best-selling medicines will loss patent protection, including Bristol-Myers Squibb Co. (Bristol-Myers Squibb) and Sanofi SA’s (Sanofi) Plavix, in May.
Drug Approvals Outpace 2010: Fitch notes that total novel drug approvals to-date in 2011 have vastly outnumbered the historically low level cleared during 2010. Through November, 29 new treatments spanning both general and specialty medicines have been approved by the U.S. Food and Drug Administration (FDA), in comparison to 21 authorized for marketing in 2010. The majority of these novel therapies may reach blockbuster status.
Solid Drug Registration Activity: Pharmaceutical developers covered by Fitch have attained two-thirds of their goals for regulatory filings so far this year. Specifically, 14 of 21 new therapeutics, including vaccines, that were originally slated to be registered with drug regulatory agencies in Europe or the U.S. have been filed at the date of this report. In addition, regulatory dossiers for four more drug candidates could still be filed prior to the end of the year.
Télécharger le document