Ireland and Big Pharma's patent cliff
The Irish manufacturing sector moved further into contractionary territory during April, with output and new orders each declining for the second month running amid signs of deteriorating economic conditions.
The mainly US-owned pharmaceutical and medical devices sector accounts for about 60% of merchandise exports and drug patent expirations are clearly having an impact.
On the patent cliff, a problem for Big Pharma is that high spending on R&D has
been producing low returns over the past decade. The majority of sales for the
world's leading pharmaceutical companies are derived from the most mature
drugs, with the top three drugs for a company on average contributing 44% of
total sales. The testing thresholds have increased overtime with new knowledge
and litigation fears.
The patent period of 20 years for non-biotech drugs after testing etc can be about 10 years.
Pfizer's Lipitor had peak annual sales of $13bn -- a world record - - and it's hard to replace that level of revenue. Alzheimer's is a huge opportunity and the monetary cost of dementia in the United States ranges from $157bn to $215bn annually, making the disease more costly to the nation than either heart disease or cancer. In coming years, it will 'swamp' the US healthcare system according to one expert.
While approvals increased in 2011, in 2010, the US Food and Drug Administration's (FDA) drugs division approved just 21 novel medicines -- less than half the level seen in 1996 and 1997.
Roughly the same number of drugs was approved by the FDA in 2008 as were approved in 1950.
Between 2010 and 2015 products with sales of more than $142bn will face copycat competition -- from total sales in excess of $800bn.
Deutsche Bank has said that the top seven European firms spent $161bn in R&D during 2007-11 to produce drugs with a net present value of just $86bn.
About 7,000 diseases affect the human family, but only 600 have treatments. Fewer than 3% of rare diseases have an FDA approved treatment, yet one in ten Americans is affected by a rare disease.