Each year, IMS Health, a provider of healthcare information and business consulting, surveys the landscape to uncover developments
with the biggest potential bottom line impact on the biopharmaceutical industry. These seven Harbingers of Change should be
considered in every pharma company's plans for addressing the business and reputational environment in 2010.
Of the issues identified, reimbursement challenges in emerging markets dominate the list, with potentially game-changing initiatives
underway in Korea and China, and also—surprisingly—in Japan. Each of these can be said to draw inspiration from precedents
in other markets, so the value of thinking globally while executing locally is a theme worth teasing out from the mix. This
year's list also underscores the search for new business models, evidenced by trends around new therapeutic formulations to
serve lower income patients in developing countries, revival of the OTC segment, and the restructuring of in-house R&D operations.
In summary, the list shows how "globalized" business risks have become. Big Pharma now lives in a glass house with many doors.
All in One Equals One for All
Innovative target drug formulations for the "bottom billion"—finding profit from unmet needs of lower income consumers in
Today, process innovation is becoming as important as product innovation, because without finding better ways to promote access
to needed medicines, industry's best scientific assets can never be fully leveraged to support real gains in health outcomes.
Generics companies are now working to supply one obvious answer: a "polypill" that combines an arsenal of generic therapies
to fight the world's number one killer, cardiovascular disease.
The last year has seen growing interest in the "polypill"—a product that consists of more than two therapies designed to cover
the known landscape of treatment for a disease. Companies are now racing to plant their flags in the potentially lucrative
market for a low-cost cardiovascular medication containing three or more components—many, if not all, generics.
» Dr. Reddy's Laboratories announced plans to launch the "Red Heart" polypill in India, the trials for which were completed
in May 2008. The all-generics pill contains a beta-blocker, an ACE inhibitor, aspirin, and a cholesterol-lowering agent. Global
launch is planned for 2010 at a cost to providers and patients of about $1 a month.
» Doctors at the Wolfson Institute of Preventative Medicine in the UK have produced the first samples of a five-in-one polypill
that contains a statin, three blood pressure–lowering drugs, and folic acid. The goal is to launch within two years, and to
make the pill available to everyone in the UK over age 55 for less than $2 a day.
» Spanish researchers have started clinical tests on a three-in-one pill that the makers hope to launch globally by 2010. At
less than $10 a month, the pill contains a statin, an ACE inhibitor, and aspirin.
The polypill can be traced to 2001, when the World Health Organization proposed the use of a fixed-dose combination product
for preventing cardiovascular disease.
According to the American Heart Association, cardiovascular disease affects more people in India and China than in all economically
developed countries in the world put together. The cardiovascular polypills under development—available for a few dollars
a month—promise to have great appeal to payers, who have been lukewarm on earlier combination pills because of the pricing
strategies on patent-protected products. But given the complexity of the pills, one size will not necessarily fit all patients.
Postmarketing surveillance will help practitioners understand which dosing options work best and how the agents interact.
Assuming that the first polypills live up to their potential, R&D-based manufacturers may be well advised to view their portfolios
from a new perspective. The introductory polypills are targeting cardiovascular disease, but other diseases such as diabetes
could also be candidates for treatment with an all-in-one therapy.