The global pharmaceutical industry has experienced a mixed performance in the third quarter of the current fiscal year, with certain positive trends counterbalanced by other issues which hint at the challenges to come in the sector's medium-term future.
International financial analyst Fitch Ratings has published its findings on the drug manufacturing industry for the three-month period, noting a downward trend in revenue compared to the two quarters preceding it, reports PharmaTimes.
Whereas revenue levels among Fitch-monitored pharmaceutical developers saw growth of 6.2 per cent and 1.2 per cent respectively for the first and second quarters, the third was instead marked by a drop of 1.5 per cent.
Furthermore, it was demonstrated that only six of the 13 drug developers covered by Fitch saw revenue increases generated by their drug portfolios during the third quarter, with three of these registering a "very modest" sales growth.
According to Fitch, the fall in sales is indicative of a wider economic trend affecting the healthcare industry in many countries, as governments have introduced new sector reforms and austerity measures which are impacting negatively on financial bottom lines.
"As anticipated, these measures are pressuring revenues generated in European territories in the low to middle single digits," it said.
However, more encouraging trends were noted in the area of research and development and regulatory submissions, with a number of companies achieving success in their efforts to gain approval for new molecular entities (NMEs).
For example, the number of late-stage research programmes conducted by drug developers rated by Fitch has expanded by 11 during the third quarter, with five being continued from early-phase internal research programmes, while the remainder were accounted for by licensing agreements and acquisitions.
Moreover, around 50 per cent of the pharmaceutical sector's original 22 new therapeutic products have been filed as planned in 2010, while six have seen extensions to their original filing plans.
Meanwhile, data from key regulators shows that many of these treatments are being accepted for use - the US Food & Drug Administration and the European Medicines Agency each approved six NMEs during the third quarter of 2010, as did Japan's Ministry of Health, Labor and Welfare.
According to Fitch, the level of NME filings taking place globally currently equates to around three per quarter, which was described as a "modest yet steady" rate.
Nevertheless, the report also noted that further difficulties could arise for drug manufacturers in the coming months as the result of the approaching expiry of a number of important product patents.
This so-called "patent cliff" has been the topic of a number of discussions in recent months - analyst CMR International stated earlier this year that the loss of key patents will cause some companies to lose business to Chinese and Indian generic drugmakers, while AstraZeneca chief scientist Andy Dray noted that many firms are now embracing a more collaborative approach to help avoid the problem.
According to Fitch, the third quarter was "rather light" in terms of key patent expiries, with the Pfizer antidepressant Effexor-XR and the Sanofi-Aventis anticoagulant Lovenox ranking as the only two blockbuster drugs to be affected.
However, this process is set to accelerate soon - in the fourth quarter, Sanofi-Aventis' cancer drug Taxotere has lost its patent protection, while Lilly's cancer therapy Gemzar and Eisai/Pfizer's Alzheimer's compound Aricept are already facing generic competition after going off-patent.
Fitch observed that Lilly's antipsychotic Zyprexa and Pfizer's bestselling cholesterol treatment Lipitor are set to see their patents expire this year, with Amgen and Bristol-Myers Squibb also named as companies whose portfolios will be at the highest exposure as the patent cliff issue moves beyond its current modest state in the next three years.