Several challenges must be addressed in order to expand the market for vaccine therapies, starting with the high cost of developing new vaccines. There also are risks of severe allergic reactions and lingering concerns about autism that have spurred activism against vaccinations and exacerbated public distrust of vaccines. While these hurdles may restrain robust market growth, global revenue for vaccines exceeded $25 billion in 2015.
The increasing global demand for novel and personalized vaccines will be a major driver for vaccine therapies in the next several years, as will the preference for generic vaccines across a spectrum of diseases.
Several challenges, however, must be addressed in order to expand the market for vaccine therapies, starting with the high cost of developing new vaccines. There also are risks of severe allergic reactions and lingering concerns about autism that have spurred activism against vaccinations and exacerbated public distrust of vaccines.
While these hurdles may restrain robust market growth, global revenue for vaccines exceeded $25 billion in 2015. North America was the leader in vaccinations, followed by a number of European nations. This is reflected in the location of major developers of vaccines, such as Pfizer and Merck & Co. of the United States, GlaxoSmithKline of the United Kingdom, and Sanofi of France.
Personalized Cancer Vaccines
Vaccines are moving beyond infectious diseases, most notably toward personalized cancer vaccines. This follows the trend for developing individualized therapies to treat cancer for better outcomes.
Cancer vaccine technologies received a boost with the U.S. Food and Drug Administration’s approval of Imlygic, or talimogene laherparepvec, which is a viral cancer therapy developed by Amgen of Thousand Oaks, Calif. This is fostering the development of other personalized cancer therapies such as messenger ribonucleic acid (mRNA)-based therapies that control the intracellular expression of proteins to prevent diseases.
A leading effort in mRNA-based cancer vaccines is the collaboration between Merck and Moderna Therapeutics of Cambridge, Mass., which will combine Merck’s Keytruda (pembrolizumab) therapy—based on cell cycle checkpoint inhibition—with Moderna's mRNA-based vaccine methodology to jointly develop a personalized cancer vaccine therapy. The Merck-Moderna partnership illustrates the high cost of vaccine development: the latter company will receive an upfront cash payment of $200 million from Merck.
RNA-based Vaccines Growing in Popularity
Other RNA-based vaccines have a greater market potential than traditional vaccination therapies because they elicit a stronger immune response. This advantage is being exploited by a team of scientists at the Massachusetts Institute of Technology (MIT) that developed a novel nanoformulation of RNA dendrimers demonstrated to be effective against H1N1 influenza, Toxoplasma gondii, and Ebola in mice.
Specifically, the MIT platform consists of a spherical nanoparticle formulation of the RNA-dendrimer vaccine containing the amplification sequences that are needed to enhance its efficacy and induce a stronger—and more desirable—immune response. During laboratory testing in mice, the MIT vaccine was able to stimulate a T cell and an antibody response.
The MIT nanoformulation platforms can be used to develop vaccines within seven days—a valuable capability in managing sudden outbreaks of disease. In addition, the RNA vaccines made by nanoformulation can be customized to make them more effective to certain ages, body types, and the like. The MIT team is exploring adapting its nanoformulation platforms to develop cancer vaccines.
Inactivated Viral Therapies
Researchers have used killed or inactivated viruses to make effective vaccines against hepatitis A and polio. Scientists at Sanofi and the Walter Reed Army Institute of Research in Bethesda, Md., are taking this approach to develop a vaccine to treat the mosquito-borne Zika virus that causes fever, pain and, in many cases, death. Walter Reed is a biomedical research lab managed by the U.S. Department of Defense and is interestingly named after the U.S. Army doctor who first posited that yellow fever was spread by mosquitoes.
Walter Reed brings its technology platform using purified, inactivated Zika virus to that table, and provides the immunoassay data to monitor responses that are related to the infection and vaccination. Sanofi will provide the regulatory strategy and clinical material needed for phase II testing of the vaccine.
Interest in this vaccine is keen in the World Health Organization and the United Nations International Children’s Emergency Fund, which will be primary users of the Zika vaccine.
Although North America has the largest vaccine market, China leads the patents for vaccine technologies, with the United States second and European nations third. Among the proprietary pursuits in this space are vaccination techniques for the clinical management of infectious diseases, such as influenza and streptococcal infections. Other research includes vaccine engineering platforms to treat diseases caused by misfolded proteins. Leading vaccine companies pursuing patents include MedImmune LLC of Gaithersburg, Md. (now owned by AstraZeneca of Cambridge, England); Minervax ApS of Copenhagen, Denmark; Novavax Inc. of Rockville, Md.; and AC Immune SA of Lausanne, Switzerland.
The Road Ahead
There are alternatives to injecting vaccines. Intranasal vaccine delivery systems are being developed by companies that include MedImmune and Mystic Pharmaceuticals of Austin, Texas. While now only used to inoculate patients against the flu, there is a solid pipeline of intranasal sprays that, if successful, could dramatically expand this delivery market after 2019.
Another painless method of delivering vaccines is by transdermal means. This is an important consideration for the elderly, children, and those who have difficulty swallowing or suffer from emesis or nausea.
However, as has been the case for many years (and to the dismay of children), injection has been the most widely used vaccination method and is likely to remain so for at least the next five years. There may be a shift from conventional syringes filled by clinicians to pre-filled syringes to address safety concerns.
Another future trend could involve greater emphasis on adult immunization. Pediatric vaccination has dominated this branch of medicine, but as the U.S. Centers for Disease Control and Prevention has noted, adults also die of influenza and its complications. Large pharmaceutical firms including Pfizer and Merck are supporting immunization initiatives aimed at adults, which would open new market opportunities for vaccines within five to 10 years.
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