There are myriad challenges that healthcare providers face today including: spiraling costs, an aging population, the rapid globalization of diseases, and diseases for which there is no treatment. A product that could solve all of these problems would be wildly successful. While there is no such silver bullet at present, vaccine products, where they exist for a disease category, come pretty close to being such a panacea.
Vaccines are cost effective—every dollar invested in vaccination returns between $7 to $20 in averted healthcare costs; they tend to be available for diseases that affect the older population more harshly; and they have the potential to be effective globally, where other treatments are not cost effective.
While sales of existing vaccines accounted for less than 2% of the world pharmaceutical market, which approached $800 billion in 2009, their growth will continue to outpace that of the broader drug market. The success of products such as Gardasil and the recent H1N1 influenza vaccine is expected to accelerate the pharmaceutical industry’s interest in vaccines.
Using a range of technologies and mechanisms of action, emerging vaccines are being designed to address both infectious and noninfectious disease. From allergies to diabetes to Ross River fever, vaccine developers are investigating a large number of indications that previously would have been considered untreatable via inoculation.
There are few effective pharmaceutical treatments for drug addiction. While many health insurers will not cover treatments such as Suboxone, the families of many drug addicts are highly motivated to do so. It is not uncommon for families to pay thousands or even hundreds of thousands of dollars out of pocket for in-patient rehabilitation therapy.
In October 2009, a study published in the Archives of General Psychiatry reported that early-stage trials sponsored by the National Institute on Drug Abuse found a 38% reduction in cocaine use among participants in a clinical trial who were vaccinated with an addiction vaccine candidate. Antibody production was reportedly sustained for another nine months following the vaccine treatment.
Anti-alcoholism vaccines are currently on the market as well. In April 2006, the FDA approved Vivitrol, a product produced by Alkermes and marketed by Cephalon. It is intended for use in combination with psychosocial support.
Dengue fever affects more than 100 million people worldwide. Mortality is high, symptoms are severe, and there are no clearly effective treatments to address the disease once it has become established.
While the need for a vaccine to prevent Dengue fever is high, the disease’s predilection for developing nations reduces potential product revenue. As a result, research into a Dengue fever vaccine is largely being pioneered by government research institutes and smaller vaccine developers. The exception is Sanofi Pasteur; its ChimeriVax is currently in Phase III studies. If ChimeriVax is approved by 2012 and other Dengue fever vaccines follow, total global sales are expected to reach $1.4 billion in 2020.
Diabetes affects more than 200 million people worldwide, with about 20 million suffering from the more serious type 1 diabetes and the rest characterized as type 2. Both forms are linked to a range of serious co-morbidities including blindness, kidney failure, and amputations.
While diabetes may be controlled with various medications including insulin (for type 1) and medicines to regulate blood glucose level (for type 2), there is essentially no cure for diabetes, and sufferers must often adhere to strict dietary and blood glucose monitoring protocols. A vaccine could address a large market need and would likely be covered by medical insurance.
Hepatitis C and E
Hepatitis C and E, which together affect almost 300 million people worldwide, are serious conditions that generally lead to death via liver disease. Vaccines for hepatitis A and B have significantly reduced the impact of these related diseases, and developers continue to seek similar means to address other hepatitis strains.
With an estimated 74.5 million people afflicted with hypertension in the U.S., and some of these unable to control their condition via lifestyle modifications or medication, the market for a vaccine that would prevent the risks of mortality and severe symptoms associated with this illness appears extremely large.
Two vaccines have moved into Phase II clinical testing. Although many product candidates at this stage fail to gain approval, other developers will build upon the pioneering work in order to gain access to this significant opportunity.
With 250 million cases each year combined with severe symptoms and relatively high mortality, malaria has long been the subject of healthcare initiatives ranging from drug and vaccine development to the deployment of mosquito nets to prevent infection.
As of late 2009, the most advanced vaccine candidate was GlaxoSmithKline’s Mosquirix, a Phase III product that is likely to be approved in 2012. When this occurs, sales are expected to rise strongly to reach nearly $2 billion in 2020.
MRSA infection is a growing problem. Although it currently affects a total of just 4 million people globally, incidence is rising and within a decade MRSA could be considerably more prevalent.
Earlier this year, Nabi Biopharmaceuticals sold its PentaStaph vaccine candidate, which is in Phase I trials, to GlaxoSmithKline Biologicals. Assuming this product is introduced in 2016, global sales are expected to rise to $650 million as awareness of the dangers of MRSA rises.
West Nile Virus
With relatively severe symptoms and a lack of standard therapies for care, West Nile Virus represents a significant threat to individuals who have been infected. However, prevalence is relatively low and confined to developing areas. Because of this, research into prophylactics and therapeutics remains limited with public funding and smaller organizations responsible for most of the initiatives.
The disease areas covered in this article are those most likely to feature approved vaccine products in the near future. As a result of recent advances, it is likely that sales of emerging vaccine products will add $9 billion to the vaccine market in six years, and that these emerging vaccines will add over $24 billion to the vaccine market in 2020. (This is in addition to the $22 billion and growing vaccine market that exists today).
This projection assumes that a good number of vaccine candidates currently in Phase III will be commercialized in 2012, several candidates in Phase II will enter the market in 2014, and some of the candidates in Phase I will launch in 2016. It is unlikely that all candidates will be approved, but assuming that vaccine candidate failures follow normal historical trends, we predict total sales of emerging vaccines will hit $25 billion in 2020.