As the debate over biosimilars heats up in the USA, a new report notes that success for drugmakers in this field is reliant on getting access to a market that will totally dominant all others in the world.

The study, from Datamonitor, notes that with Japan poised to receive its first biosimilar and the US moving ever closer to the establishment of an approval pathway, the market is set for “imminent expansion”. It should be worth over $2 billion across the seven major markets by 2014, following key patent expires for epoetin alfa, filgrastim, interferon beta 1a, interferon alpha, human growth hormone and insulin-glargine, the report says.

Datamonitor argues that while many of these drugs “represent the low-hanging fruit of the biologics world and are unlikely to provide the monetary gains of more complex drugs”, they offer firms the opportunity to position themselves within the biosimilars sector, ahead of “more lucrative targets”. It adds that the level of biosimilar uptake “will have as much to do with the outcome of the public relations battle between the pro- and anti-biosimilar parties as more tangible absolutes”, such as price and performance.

Just which companies are selling biogenerics will have an impact on uptake across all markets, “and especially those that are traditionally brand loyal”, says Datamonitor analyst Pam Narang. “Given that large and established pharma companies are ideally positioned to succeed, “it is unsurprising that so many are looking to enter [the market], with Merck & Co and AstraZeneca numbering among these,” she notes.

The report notes that a proven track record will be invaluable in promoting uptake, “rendering the ostensibly unprofitable first-generation biologics an attractive prospect”. Ms Narang adds that the decline in market size forecast beyond 2014 by Datamonitor “is for the most part due to the incursion of second-generation biosimilars”.

The report goes on to note that the extent and rate of biosimilars uptake “will be greatest in those markets where the balance of power lies with the payer – Germany, USA and the UK – compared to those in which physician prescribing power and brand loyalty hold sway”, ie France, Italy, Spain and Japan. Europe, especially Germany, has emerged as the testing ground for biosimilars, but it will be the USA where the big bucks will be made.

The USA market is forecast to constitute nearly 90% of biogeneric market volume in the seven major markets in 2014, Ms Narang says, adding that its size, “combined with the voracious generic erosion that characterises it, makes it an attractive prospect for would-be biosimilars makers”. However, this is dependent on the establishment of a biosimilars approval pathway, which Datamonitor anticipates could be in place by 2010, paving the way for market entry from 2013.