The European market for therapeutic monoclonal antibody products will be worth $42.4bn by 2018 thanks to 11 per cent year-on-year growth, according to a new study.
Analysts at Frost & Sullivan said market expansion will be driven by innovative new products that add to the successes of existing brands to treat rising disease incidence across the region.
Monoclonal antibodies (Mabs) are predominantly used to treat cancer, autoimmune and inflammatory diseases, where existing blockbusters include J&J/Merck & Co’s Remicade (infliximab) and Abbott’s Humira (adalimumab).
There are also Mabs in development as treatments for cardiovascular and infectious disease, as well as for use with organ transplants.
Frost & Sullivan research analyst Deepika Pramod Chopda said: “Technological development within the biotech and genomic markets triggered the use of Mabs for therapeutics.
“With the rise in disease incidence rate and deterioration in human health conditions, the need for innovative and effective cure has been in great demand.”
The analysts added that while Mabs are the fastest growing segment within the biotechnology market, their high developmental costs constitute a major barrier for mid-segment market entrants.
They have a complex production process that requires expensive biological and chemical materials and clinical trials that brings their average development costs up to $650-$750m.
Consequently this hinders the ability of small biotech companies to bring new Mabs to market and generally favours big pharma, thanks to its financial strength and capabilities.
“Alliances between big pharma and small biotech firms for developing biologics is a key trend observed in this market,” added Chopda. “Alliances with financially adept companies will help small biotech firms to develop new technologies, thus encouraging product development within this market.”
But emerging biosimilars could present a threat to the market. The European Medicines Agency (EMA) finalised guidance on biosimilar Mabs in a June move that provided regulatory guidance on showing equivalence of biosimilar Mabs to their reference products.