Biologics

Countries covered: United States US demand to exceed $100 billion by 2015 Demand for biologics will exceed $100 billion in 2015, experiencing continuing strong growth following a decade of double-digit annual increases. Continued growth will be driven by dramatic shifts in production technology and expansion of targeted diseases, and challenged by the introduction of biosimilar products following patent expiry of major biologic products. Monoclonal antibodies to benefit from biotech boom Biologics such as insulin and red blood cell stimulants have been available for many years, but since the introduction of recombinant DNA technology, manufacturers have developed a wide range of new products with very specific applications. Monoclonal antibodies are a prime example of this important shift. Proteins that destroy targeted antigens can now be purified, cloned and introduced into patients to instigate immune responses. These products have quickly established themselves as effective therapies for many forms of cancer, rheumatoid arthritis, macular degeneration and other conditions. New antibodies are under intensive investigation, and will be introduced to market within the forecast period. Routine immunizations to boost vaccines demand Biologics are also being targeted for a wider range of diseases and population segments. Biologics are complex materials that must be produced by living cells, and their producers have targeted small, niche populations with rare or difficult to treat conditions. However, as the market has grown and matured, many new applications are being found for these products. Vaccines, for example, were once focused on a small number of infectious diseases of early childhood. The number of recommended immunizations has grown significantly over the past decade, however, and since 2006, the Centers for Disease Control has encouraged adolescent and adult boosters and new immunizations, including one against the human papilloma virus associated with cervical cancer. Influenza shots are now recommended not only for the immunocompromised, but for all adults and young children, and investigation is well underway for vaccines that can protect against several core strains, effectively offering herd immunity against widespread pandemic infection. Several new vaccines are available or in late-stage clinical trials for use both as preventives and as therapies against several forms of cancer. Biosimilar products offer good opportunities Impending expiry of patents for a number of biopharmaceuticals and consumer demand to reduce treatment costs are encouraging a global market for biosimilar products. Biosimilars are made by new sponsors innovating biopharmaceuticals that reference the original drug. Manufacturers will have access to the original, commercialized products, but not to the original molecular clones and cell banks, fermentation and purification processes, or active drug substances. Biosimilars are subject to careful regulation. Europe has led the global regulatory process, requiring a strict demonstration that the “similar” product is highly comparable to the original. In the US, the FDA has allowed only a few biosimilars for sale following procedures for small molecule generics, but new regulations are under development and biosimilars are expected to become a dominant force by 2020. Please Note: Freedonia requires that, for PDF orders, clients sign a confidentiality agreement prior to fulfillment of PDF email delivery.

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PRESS RELEASE

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 are presented in 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.

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