Biosimilar Drug Revenues to reach $9.2bn in 2018, according to the new study on ASDReports

Monday 30 June 2014, Amsterdam

A new report, now available on ASDReports, forecasts the world market for biosimilars will rise by more than 20% in 2014. That progress follows similar growth in the market in 2013. Double-digit revenue growth is forecasted for that drugs market to 2024. Biosimilar drug revenues overall will reach $9.2 billion in 2018. That sales forecast and others appear in Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024, published in May 2014.

That study finds biosimilar EPO therapies - epoetin alpha, epoetin beta and darbepoetin alpha - accounted for the largest share of the biosimilars market in 2013, with revenues in excess of $0.50bn. Biosimilar epoetin alpha and beta were first launched in the EU more than five years ago and achieved EU market penetration of up to 33% in 2013. In India more than 20 companies market epoetin alpha biosimilars. In China 3SBio’s EPIAO holds a national submarket share of 40%. Higher treatment uptake is found in the EU for biosimilar G-CSF, with more than 80% of prescriptions in the UK and Germany filled with biosimilars.

Richard Lang, a pharmaceutical industry analyst, said: “Biologics form a vital part of the treatment portfolio for many serious chronic disorders, including cancer, diabetes, hepatitis and autoimmune diseases. Expanding patient populations and improved diagnosis stimulate demand from healthcare payers for more-affordable treatments for those conditions. With biosimilars able to offer discounts of 25% and 50%, demand for these follow-on biologics will rise fast in the coming 10 years.

“In 2014 the greatest interest in the biosimilars market is in development of biosimilar monoclonal antibodies (mAbs). With six original-branded antibody therapies achieving revenue in excess of $5bn last year, the potential exists for blockbuster biosimilar revenues there in the coming 10 years. Targets for competition include Roche’s Rituxan (rituximab) and AbbVie’s Humira (infliximab). The launch of Hospira and Celltrion’s infliximab biosimilars, Inflectra and Remsima, in major EU markets in 2015 will offer an indication of the potential for biosimilar antibody therapies in the future.”

Despite high revenues achieved by insulin analogues, such as Sanofi’s Lantus (insulin glargine), comparatively few companies report clinical biosimilar development programmes in treating diabetes. The first biosimilar insulin glargine will launch in the EU in 2015 and US in 2016, though, driving revenue growth for the biosimilar insulin submarket to 2024. Between 2013 and 2024 the biosimilar insulin sector will grow with a CAGR of 25%, the study finds.

The new report forecasts the overall world market for biosimilars to 2024, also giving revenue predictions and discussions for submarket segments, including data on leading molecules and R&D:

• Monoclonal antibodies (mAbs) and fusion proteins (FPs) – including rituximab, infliximab, trastuzumab, adalimumab and etanercept
• Insulin – including the submarkets of biosimilar human insulins and insulin analogues, as well as insulin glargine and insulin lispro
• Erythropoietins (EPO) and granulocyte colony-stimulating factors (G-CSF)
• Interferons – including interferon alpha and interferon beta
• Growth hormones (hGH, somatropin) and fertility hormones.

That study also analyses the regional breakdown of biosimilar revenues in 2013 and forecasts leading national submarket revenues for 2014-2024. The investigation discusses commercial and regulatory trends for biosimilar therapies from 2014. Those countries are the US, Japan, Germany, France, UK, Spain and Italy (EU5), as well five emerging markets - China, India, Brazil, Russia (BRIC) and South Korea.

Three of the five largest national markets for biosimilars in 2013 were developing countries, with China being the largest for number of biosimilars approved and revenues achieved. More than 100 biosimilars are available there, although most products achieve revenues below $5m. Leading players in the Chinese biosimilars submarket include insulin manufacturers Shanghai Fosun Pharmaceutical, Gan & Lee and Tonghua Dongbao. The US will be the fastest-growing national submarket for biosimilars between 2014 and 2024. Many companies aim to launch biosimilar mAbs there from 2014.

Biosimilars and Follow-On Biologics: World Industry and Market Prospects 2014-2024 gives quantitative and qualitative analyses of developments and trade in biosimilars. It also contains interviews with authorities in that industry. That report adds to the range of published studies on biopharmaceuticals and other healthcare industries.