Promise—and Problems—Signal Mixed Year Ahead for Big Pharma

Biopharmaceuticals-the major source of new medicines and a key knowledge industry for the future-faces another rough year from empowered payers as it makes its slow passage to a renewed product base. This is the main finding from Pharmaceutical Executive magazine’s annual survey of trends and issues facing the biopharma world in the year ahead. The annual outlook has run continuously in the January issue since the magazine was founded in 1981, and is based on interviews with more than 20 top opinion leaders and experts drawn from business and the clinical professions as well as the regulatory, patient, and payer communities.

“Our mission is to take the pulse of the ‘c suite’ of top management and other external decision-makers who collectively determine the future of this vital industry,” said Pharm Exec Content Director William Looney. “This is a business that develops more than 90% of medicines in current use and adds considerably to economic output in an era where the high paying jobs it generates are increasingly scarce.”

The 2013 Industry Forecast reviewed an uptick of FDA and EMA approvals over the past two years to conclude that company labs are beginning to leverage the fruits of the revolution in molecular biology and science’s successful mapping of the human genome.  A key factor is the growing ability of the industry to translate academic insights about the origins of diseases into development pathways that lead to commercialization. The best science is meaningless if it cannot lead to a medicine, vaccine or device  that is safe and effective for patient use-finally, Big Pharma is recognizing it cannot do all of this alone.

The Forecast highlights that this year marks an important difference from past cycles of discovery. “Our interviews detect far more pessimism about how quickly new innovations will be taken up in actual clinical practice,” Looney said.  “Payers, led by governments with significant budgetary cost exposures, are proving far more skeptical about the science and want more evidence that discoveries will not only benefit individual patients but deliver a broader public health outcome too.”  The forecast notes that defining such outcomes is firmly in in the eye of the beholder, which puts a premium on information that is relevant, accessible, clean and unbiased.

Delivering new products that make sense to budget conscious payers is more important than ever, as other sources of growth are under significant stress. In particular, the shine is off the so-called emerging markets of Asia and the developing world, largely because local competition to big Pharma is becoming more intense.  And while it is clear that government funders in the US, Europe and Japan are tightening their pocketbooks on drug reimbursement, less is understood about the long term implications of the failure of the these critical mainstay markets to invest in the basic infrastructure for research and wise regulation that biopharma companies depend on to remain globally productive. “More than ever, the industry has to make the case for itself, which historically is a task it has neglected-the assumption is that innovation will always be rewarded,” warns the Pharm Exec Forecast. “2013 is the year that so-called truth will be tested.”

For the full text of the 2013 Pharm Exec Industry Forecast, visit the Pharm Exec web site, pharmexec.com.

For further information on the magazine and our full range of information services, please contact Pharm Exec’s Publisher, Russ Pratt, at rpratt@advanstar.com