Research and Markets: PharmaSphere: Global Biosimilars Strategy - Regulatory Landscape, Key Drivers, Markets and Trends in 2013

Thu Jun 13, 2013 4:32am EDT

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Research and Markets: PharmaSphere: Global Biosimilars Strategy - Regulatory Landscape, Key Drivers, Markets and Trends in 2013

Research and Markets ( has announced the addition of the "PharmaSphere: Global Biosimilars Strategy - Regulatory Landscape, Key Drivers, Markets and Trends in 2013" report to their offering.

Biosimilars have stated their intention of being here to stay, as recent events show an increasing trend in efforts by companies to enter and/or enhance their position in the biosimilars industry. Indeed, biosimilars are becoming crucial features of governments' plans to reduce healthcare expenditures and increase foreign investment.

Various factors, including financial austerity measures due to increasing budget deficits and debt, slowed economic growth in countries such as the US, an increasing aging population and an associated increase in the demand for healthcare in other countries like Japan, are some of the key drivers of initiatives to encourage biosimilars.

Furthermore, the recent intensification of efforts to establish frameworks under which biosimilars can be effectively regulated, by various regulatory bodies including the US Food Drug and Administration (FDA), point to a future influx of biosimilars into significantly untapped markets, as companies continue to actively position themselves strategically.

Interestingly, pharmaceutical and biotech companies are not the only ones getting into the biosimilars business, but also Contract Manufacturing Organizations (CMOs) such as Lonza and Celltrion, Contract Research Organizations (CROs) like Quintiles and Paraxel, and multi-industry conglomerates such as Samsung and LG - all companies that fancy a significant payday from being involved in the development and sale of biosimilars.

Although biosimilars will deliver some healthcare cost savings, the discount percentages earlier expected have been significantly reduced. Biosimilars are expected to be marketed at between 70% and 80% of the cost of the branded biologic, thereby delivering only a 20%-30% reduction in cost. For instance, Celltrion's recently approved Remsima - a biosimilar to Merck's Remicade (infliximab) - is expected to sell for 70% the price of Remicade in South Korea. This is in sharp contrast to generic small-molecule drugs, some of which sell for up to only 10% of the price of the innovator drug.

However, the expensive nature of biologics, some of which sell for as much as hundreds of thousands of dollars for a year's treatment, makes even a 20% price reduction quite significant. In fact, it is estimated that enabling generic options on just the top 12 categories of biologic treatments with expired patents would save the US $67 billion-$108 billion over the first 10 years, and $236 billion-$378 billion over 20 years - an average of about $31 billion a year (Shapiro, 2008). This would significantly aid the government's efforts to stabilize the economy and reduce its budget deficit.

Branded Biologics Sales Will Grow through 2017

The growing dependence on biologics to provide significant benefits in the effective treatment of chronic diseases such as rheumatoid arthritis, psoriasis, cancer, Crohn's Disease and similar conditions has resulted in the continued increase in sales, generating over $128 billion in 2012 alone. This trend is expected to continue in the short term, growing by a Compound Annual Growth Rate (CAGR) of about 5.6% to reach over $168 billion by 2017.

Afterwards, patent expirations and the existence of clearer regulatory frameworks for biosimilars will result in an upsurge of biosimilars in key biologics markets such as the US, having an adverse effect on global branded biologic sales. Furthermore, the uptake of biosimilars is also expected to increase in other markets outside the US as physicians and other stakeholders get more comfortable with their substitution - capturing market share from branded biologics.

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Research and Markets
Laura Wood, Senior Manager.
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Sector: Pharmaceuticals

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