Vaccines Review and Outlook 2010

The global vaccine market is expected to achieve $34 billion in sales by 2012. With an estimated annual growth rate of 14% during the next five years, vaccines will be the fastest-growing therapeutic area, even outpacing oncology.

The recently renewed interest in the vaccine sector is attributed to advances in technology, federal liability protection for developers, increasing global demand, and premium pricing for new products. The impact of vaccines on global health and economic development is enormous. Vaccines have saved more lives than any health intervention since global access to clean drinking water. According to the CDC, a dozen deadly diseases targeted by childhood vaccinations have been eliminated or have declined more than 90% during the past century in the United States.

Despite the availability of vaccines, there is massive unmet medical need in the battles against childhood diseases in developing nations, chronic diseases such as diabetes and cancer, and other wide-spread or up-and-coming conditions such as HIV/AIDS, meningitis, and dengue. Even the seasonal influenza segment holds significant opportunities to improve market penetration, shelf stability, and delivery.

One of the most striking vaccine advances in recent years is active immunotherapies, including the April 2010 FDA approval of Dendreon's Provenge, a personalized vaccine targeting prostate cancer. Active immunotherapy stimulates the patient's immune system to fight cancer while sparing the patient most of the adverse side effects associated with chemotherapy, radiation, and other biologics that target antigens. The anti-cancer activity persists long after a course of treatment. These vaccines feature new modes of action and present opportunities for development of combination therapies to provide exceptional long-term tumor control. Therapeutic vaccines are also being researched for the treatment of HIV, hepatitis C, and more.

Novel delivery techniques will help improve access, compliance, and safety, particularly in developing nations. One such system, nanoemulsion, is an oil-based liquid placed in the nose. It has been shown to produce a strong immune response against smallpox and HIV. Virtually any bacterial or viral disease that results in an immune response is a candidate for the development of a nanoemulsion-based vaccine.

BiondVax Pharmaceuticals Ltd. is developing a proprietary, innovative Universal Influenza Vaccine with the potential to provide multi-season and multi-strain protection against both seasonal flu epidemics as well as global flu pandemics such as the Swine flu. A universal flu vaccine could be an effective public health measure to reduce the annual burden of influenza as well as spontaneous pandemics for many years and possibly decades.

Innovation among start-up companies is one of the main factors behind the renewed interest in vaccines. Top vaccine manufacturers seek collaboration with academia and small biotech firms in the early phases of development. As the industry continues to evolve, there will be many opportunities for collaboration and public-private partnerships, like the one GlaxoSmithKline established with Brazil's Oswaldo Cruz Foundation to develop and manufacture vaccines for urgent South American public health priorities. Moving forward, vaccine partners must continue to identify unmet public health needs and accelerate innovative vaccine R&D to create novel solutions.

While vaccines are less susceptible to erosion by generic competition because the cost of entry is extremely high, as vaccine formulations become more precise and defined, the vaccines sector will likely follow the lead of the biotech industry toward the production of biosimilar and biobetter vaccines. India and China are emerging as competitors in this area. Both countries have exhibited great skill in copying old vaccines and are becoming increasingly adept at copying new technology, with India having become the largest global producer of copied vaccines.