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 Across the Atlantic, the European Medicines Agency recommended 93
new products, including generics, up from 82 in 2014.
But despite the rosy statistics and the prospect for further
progress in 2016, the pharmaceuticals industry faces challenges,
with increased political focus on drug pricing having punctured both
biotech and specialty pharma valuations in recent months.
The prospect of Hillary Clinton becoming U.S. president could
further undermine confidence in the sector's profitability in 2016,
given her pledge to rein in drug costs. But any changes in the U.S.
pricing model are likely to be gradual, according to Bernstein
analyst Tim Anderson.
Big pharmaceutical companies, meanwhile, are still struggling to get
a decent return on the billions of dollars spent annually on
research and development, since many new medicines are forecast to
yield relatively modest sales.
Moreover, securing a strong launch for new drugs, which must compete
with a growing roster of cheap generics, is often an uphill battle
as healthcare providers push back against the high prices being
charged.
Modern cancer drugs can cost more than $10,000 a month, placing a
heavy financial burden on governments, insurers and patients.
The rapid pace of new approvals reflects accelerated review times by
regulators, who want to get life-saving treatments to patients,
especially in cancer, as well as an improved scientific
understanding of diseases.
That will continue in 2016, analysts believe, with further advances
in cancer treatments that work by boosting the immune system, and
significant progress in drugs for autoimmune diseases.
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Switzerland's Roche, the world's largest cancer drug company, could
be a notable winner on both counts, with its cancer immunotherapy
atezolizumab on track for potential fast approval in 2016.
Roche may also be the first company with a drug to treat the
progressive form of multiple sclerosis and some analysts already
forecast annual sales for ocrelizumab of $5 billion.
Plenty of other companies also have promising new products waiting
in the wings for a variety of cancers, as well as disorders
including psoriasis, rheumatoid arthritis, hepatitis C and chronic
lung disease.
Full drug pipelines at many companies suggest the strong rate of new
drug launches is likely to continue for a while yet, with IMS Health
forecasting a total of 225 new drug approvals between 2016 and 2020.
(Editing by Tom Heneghan)
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