Monoclonal antibodies (mAbs) market expected to soar from $1.2bn to $24bn in six years

Published: 30-Jan-2014

Untapped US markets and low cost manufacturing in Asia Pacific and Latin America will assist growth, says F&S


The imminent entry of several companies, including Big Pharma, small biotech and generic participants, into the global biosimilars space will propel the market towards exponential growth, forecasts new research from Frost & Sullivan.

Indian groups such as Dr Reddy’s Laboratories, Biocon and Reliance Life Sciences are already making a concerted effort to enter the European market. Although they have not yet penetrated this market owing to the stringent regulatory pathway, new product launches are expected in the mid-term.

Biosimilar markets in countries such as the US and Japan are also expected to grow exponentially with more clarity on the regulatory pathway, the analyst says.

The study, Analysis of the Global Biosimilars Market, finds that the biosimilars market earned revenue of about $1.2bn in 2013 and estimates that this will reach approximately $24bn in 2019. Untapped US markets with a strong biosimilars pipeline as well as markets in Asia-Pacific and Latin America with a low cost of manufacturing will offer key growth opportunities.

'On one hand, the market is powering ahead regarding the strength of participants’ global expansion strategies, and, on the other, it is still beset by traditional patent-infringement issues,' said Frost & Sullivan's Healthcare Senior Research Analyst Srinivas Sashidhar.

'Moreover, the strategies adopted by innovator companies need to be taken into account. Johnson & Johnson, for example, has extended the European patent life of its innovator drug Remicade until February 2015, thereby delaying the launch of Hospira’s biosimilar monoclonal antibody (mAb) Inflectra and Celltrion’s biosimilar mAb Remsima.'

To reduce the time to market further, Frost & Sullivan advises companies also to explore opportunities in mergers and acquisitions and form alliances with firms that have expertise in biosimilars manufacturing and development, citing Teva’s alliance with Cephalon and Lupin Pharmaceuticals’ partnership with Neuclone as examples.

'In addition to mAbs, follitropins, interferons and low molecular weight heparins are likely to emerge in the long run,' added Sashidhar. 'However, some companies may focus on specific therapeutic classes depending on their capabilities and strategic fit.'

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