Although vaccines only represent two percent of the overall
pharmaceutical market, they have become the darling of many drug manufacturers’
portfolios over the past few years. Several major events and technological
innovations—from the H1N1 “swine flu” pandemic of 2009 to the development of
the first cancer vaccine Gardasil—have focused a great deal of attention on
vaccines by the media and manufacturers alike.

Currently there are over 20 diseases
that can be prevented with vaccines. The market for these is growing through
the expansion of programs to immunize populations, as well as the growth and
aging of the population. But there are also exciting new vaccines in
development both prophylactic and therapeutic, which will treat or prevent a
host of diseases that up until today have not had any corresponding vaccines.

SIZE AND GROWTH OF THE MARKET

With vaccines continuing to be the big
success story for the pharmaceutical industry, the world market for
preventative vaccines reached $22.1 billion in 2009, up from $19 billion in
2008. Kalorama Information predicts the market will increase at a compound
annual rate of 9.7% during the next five years, reaching $35 billion by 2014,
as new product introductions continue and the use of current products expands
further.

 

Vaccines are a powerful tool in the
campaign to reduce healthcare costs. It is estimated that every dollar invested
in vaccinations returns between $7 and $20 in averted healthcare costs associated
with vaccine-preventable diseases.

PEDIATRIC AND ADULT MARKETS

Vaccines are commonly segmented into
two target markets, adult and pediatric. The pediatric vaccine market is
larger, accounting for 52.2% of the total market in 2009. Pediatric vaccines
are also growing at a faster rate than adult vaccines and this is expected to
continue over the next five years, at 11.0% and 8.2% per year, respectively. 

Pfizer’s pneumococcal vaccine
Prevnar and “combination” DTaP vaccines are driving growth in the pediatric
sector, while influenza and hepatitis vaccine products are driving sales in the
adult segment of the market. Future growth in adult vaccines will be
driven by the increased acceptance of vaccines as an important healthcare tool and
by the introduction of new products. 

In 2009, influenza vaccines
generated $4.8 billion in revenues, up 49.2% from 2008 sales of $3.2 billion
with the introduction of new H1N1 swine flu vaccine. Revenues in this segment
of the adult vaccine market are expected to grow at a compound annual growth
rate of 8.0% between 2009 and 2014 with the rising utilization of influenza
vaccines, particularly in the United
States.

Several developers have since
introduced other vaccines that prevent against H1N1 and GlaxoSmithKline launched
pandemic and a pre-pandemic vaccine products. This contributed to very strong growth
of influenza vaccines during 2009.

Adult immunization is an important,
but frequently overlooked, part of patient care. Vaccination programs typically
focus on children, yet adults in industrialized countries are more likely than
children to die as a result of vaccine-preventable diseases.

Vaccination protects not only
individuals, but also entire communities from diseases spread by
person-to-person transmission. For example, it can prevent about 50% of deaths
from pneumococcal disease and 80% of deaths from influenza-related
complications in the elderly. Pharmacoeconomic studies have demonstrated the
value of influenza and pneumococcal vaccines, yet immunization rates for these
diseases continue to be low in elderly populations.

COMPETITORS

The worldwide vaccine market is
dominated by five major competitors: Merck & Co, GlaxoSmithKline, Sanofi Pasteur,
Pfizer, and Novartis, which together held 83.7% of the market in 2009. All but
Pfizer and Merck posted strong double digit growth. These companies have
made earning a greater share of the vaccine market part of their marketing and
research strategies. 

GlaxoSmithKline is in the lead with
nearly a quarter of the world market in 2009, largely due to its influenza
products Fluvarix and Hiberix. Sanofi Pasteur followed with an 18.9% market
share based on continued strong growth, particularly in influenza vaccines.
Merck, which led the market in 2008, took third place with a 16.4% share.
Pfizer, which offered just one product, was fourth with a 13.1% share, while
Novartis was fifth with 10.8% of the market.

KEY TRENDS AND ISSUES

Vaccine shortages and delays have plagued the U.S. and other
countries for years, and continue to do so. Such shortages can occur for many
reasons including a limited number of manufacturers in the vaccine market,
manufacturing or production problems, insufficient stockpiles, and (in
developing nations) greater medical need than ability to pay for vaccines.

In early 2009, for example, at
least six unvaccinated children in Southeastern Pennsylvania were infected and
two died in the largest recent outbreak of Haemophilus influenzae type b (HIB)
in the United States.
While HIB was virtually eradicated in the United States about 20 years ago,
the recent outbreak has been tied to a vaccine shortage that removed enough of
the protective effect of widespread immunizations to make unvaccinated children
more vulnerable. In December 2007, Merck withdrew 1.2 million doses of
PedvaxHIB because of a possible contamination of its equipment in West Point, Pennsylvania.

Many vaccine manufacturers have
abandoned the field over recent years, leaving only the above mentioned five
major vaccine manufacturers to produce the world’s vaccine supply. The general
consensus is that future vaccine shortages could be avoided by amending current
regulatory policies that discourage companies from investing aggressively to
develop new vaccines.

Bioterrorist threats are being addressed by a small number of
developers working on vaccines to combat potential bioterrorist threats. These
include products that prevent against infection by anthrax, smallpox and
tularemia. Leading developers of alternative products now include PharmAthene.
In September 2008, the company received $83.9 in NIAID funding to develop
SparVax. Phase I and II clinical trials, involving more than 700 healthy human
subjects, have shown SparVax to be well tolerated and induce an immune response
to anthrax with only three doses. As of mid 2010, testing was ongoing. Bavarian
Nordic is also conducting preclinical evaluations of an anthrax vaccine
candidate.

Needle-free vaccines are being developed by researchers around the
world and it is likely that at least one new delivery system will be introduced
commercially in the next five years. Edible vaccines, mucosally delivered vaccines,
intranasal vaccines, vaccine patches and vaccine chips are all under development,
with the latter expected to be commercialized within the next several years. Chips
are a novel method of vaccine administration, having been pioneered by
scientists at Kyoto Pharmaceutical University
in Japan.
In early 2010, researchers there announced that the new chip delivery system
was expected to become available in Japan by 2012.

Production techniques
are an important but overlooked area of vaccine development, as improvements in
production methods can significantly impact both speed to market and cost.
Tobacco plants, insects and nanoparticle systems all offer a means to produce
vaccines more quickly and cost effectively than using chicken eggs. Of these,
tobacco plants offer the greatest immediate potential, with production scale up
expected within the next five years.

Kalorama Information forecasted a
high growth rate for vaccines over the past few years and market events have
matched these predictions. The vaccine business is not without its risks, but
for some companies, vaccines were the only bright spot in their portfolio in
2009. It’s not a surprise therefore that development is heavy in this
sector, and we can expect a flow of novel vaccines to enter the market over the
next few years, some of which will target diseases that have not been treated
with vaccines before. All in all, it is a very exciting time in the market for
vaccines.