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.
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.
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.
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.
Details on these and other findings are contained in a new Freedonia industry study, “Biologics”, which presents historical demand data (2000, 2005, 2010) plus forecasts for 2015 and 2020 by product and application. This study also considers market environment factors, evaluates company market share and profiles US industry competitors.