US Demand for Biologics to Reach $102 billion in 2015

US demand for biologics is expected to grow 6.5 percent per year to $102 billion in 2015, driven by dramatic shifts in production technology and an expansion in the number of targeted diseases.  New biologics are being developed for the treatment of cancer, diabetes and other serious medical conditions, many of which are seeing their incidence rise in the US population.  While growth in market value will slow from the double-digit advances registered during the past decade, this is primarily a function of restrained pricing which will mask to some extent continued robust gains in market penetration.  The introduction of biosimilars into the US market is expected to contribute to both of these trends.  These and other trends, including market share and product segmentation, are presented in US Biologics, a new study from The Freedonia Group, Inc., a Cleveland-based industry research firm.

Biologics such as insulin, vaccines and various blood products have been available for many years. However, the more recent introduction of recombinant DNA technology has allowed manufacturers to develop a wide range of new products with very specific applications. Of more than 40 brand-named monoclonal antibodies currently available in the US, 26 have received FDA approval since 2000, and 15 of the 26 since 2005.  These products have quickly established themselves as effective therapies for many forms of cancer, macular degeneration, rheumatoid arthritis and other diseases.  New antibodies are under intensive investigation, and are expected to be introduced to market during the forecast period.

A growing global market for biosimilars (also known as follow-on biologics) is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs.  Europe has led the global regulatory process to make biosimilars available but to date US approvals have lagged behind those in the international community.  The FDA has allowed only a few biosimilars for sale in the US, generally following procedures for small molecule generics. However, the FDA has announced plans to release new regulatory guidelines by the end of 2011 which will clarify the approval process for follow-on biologics.  Once biosimilars can be approved for US sale, they are expected to make lower-cost biologic treatments more widely available, presenting a challenge to some longstanding proprietary products.

The Freedonia Group is a leading international business research company, founded in 1985, that publishes more than 100 industry research studies annually. This industry analysis provides an unbiased outlook and a reliable assessment of an industry and includes product segmentation and demand forecasts, industry trends, demand history, threats and opportunities, competitive strategies, market share determinations and company profiles.