Global spending on biosimilars is expected to reach between $2 and $2.5 billion by 2015, up from $311 million in 2010, according to an IMS forecast. Total spend on biologics is expected to climb as high as $200 billion.
On a call with reporters yesterday, Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, said adoption rates for biosimilars are challenged by manufacturing complexity, patent exclusivity periods and an untested regulatory pathway in the U.S., plus a reticence “of providers and patients to accept biosimilars in place of original brands.” Current U.S. law allows for 12 years of patent exclusivity for new biologic drugs, although the Obama Administration’s proposed budget for 2012 would shorten that period to seven years, and prohibit the practice of “evergreening,” or making minor changes to a drug in order to extend patent exclusivity.
“We’re not expecting the U.S. regulatory pathway to be cleared, such that biosimilars can enter the U.S. market until 2014,” said Aitken. “We’ve been watching this in the European market, and we’ve seen a pattern where for the first two or three years, the penetration was relatively low, but it’s begun to take off, especially in Germany,” although not all European markets have been keen to adopt biosimilars. “I think it’s fair to say that we expect in the 2015 to 2020 period, biosimilars will see a high rate of growth and share of the market,” said Aitken on the call.
Total spending, globally, on all medicines is expected to cross the trillion dollar threshold by 2015. That figure represents a slowdown, from 6.2% growth over the last five years, to between 3%-6% estimated growth between 2010 and 2015, according to the forecast. By 2015, emerging markets will represent 28% of worldwide spending, up from 18% in 2010. IMS’s designated emerging markets include China, Brazil, India, Russia, Mexico, Turkey, Poland,Venezuela, Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam. Spending rates in China are expected to grow by 19-22%, more than any other country. Spending in China increased by 23.9%, to $41.1 billion, between 2005 and 2010.
The top three therapeutic classes in 2015, according to the forecast, are likely to be oncology ($75-80 billion), antidiabetics ($43-48 billion) and respiratory products ($41-46 billion).
Aitken noted on the call that off-invoice drug discounts,increasingly offered to payers in the U.S., France and Germany, were not reflected in IMS’ forecast. The estimated amount of such discounts in 2010 is $60-65 billion, he said.
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