Pharma companies that adopt diagnostics-led strategies need to address three issues. First, they need to shift marketing resources
from promoting specific products to promoting diagnostic testing. Second, they must time the development of the diagnostic
to coincide optimally with the development of the therapeutic. And third, they must develop business models that will motivate
physicians and diagnostics providers to participate. Of these three, shifting promotional resources should be the easiest,
because it is fully within the company's control.
Timing the diagnostic investment is slightly more complicated. Companies can delay developing the diagnostic until the therapeutic
is approved, or close to being approved, or they can choose to develop the diagnostic in parallel with the therapeutics. The
decision about when to begin diagnostic work requires weighing its risks, rewards, and complexity. A decision to delay development
of the diagnostic can reduce the risk that the diagnostic will have to be abandoned because of failure of the therapeutic.
But it increases the risk that the diagnostic will not be available during product launch, which would have a negative effect
on the drug's revenues. Developing a diagnostic to be launched in parallel with a drug therapy requires R&D and commercial
units to come together at an early stage to formulate and execute a dual development strategy.
Reimbursement is the trickiest issue. Ideally, the public-health benefits of additional testing will be so readily apparent
that private and government payers will find it difficult to refuse reimbursement. Absent such a compelling argument, the
industry will need to find alternative funding mechanisms without running afoul of fraud and antikickback statutes. The disease-management
efforts some companies are exploring may be useful in this regard. Cost reductions resulting from new "lab on a chip" technologies
may also aid this effort.
Who Calls the Shots
To date, the industry has been amply rewarded for dispensing therapies and has not needed to devote much effort to developing
and promoting diagnostics as a way of promoting therapeutics. But as blockbusters become harder to find, undiagnosed populations
represent significant untapped revenues. A subset of them may never become an attractive market, but many are good potential
customers. The industry can no longer afford to ignore them.
Keep It Simple
The single-pill strategy seeks to simplify the lives of those who are already taking multiple medications. Specifically, it
seeks to address the needs of millions of patients who have been diagnosed with multiple concurrent conditions and take multiple
drug therapies, as well as the needs of those who take multiple drugs for a single condition. Today, physicians mix and match
products from different companies to arrive at "combination" therapies, one patient at a time. Although the benefit of such
an approach is that it results in therapies tailored to the needs of individuals, the downside is that it requires thousands
of physicians to experiment with their patients to determine which combination of drugs delivers the best results. It also
requires patients to take several drugs, possibly at different times during the day, which reduces patient compliance.
The solution is a single-pill therapy in which several drugs, previously independently marketed, are combined into one. This
approach may not be economical for all possible combinations of diseases, but many diseases coexist frequently enough to make
it worthwhile. Areas that may be worth investing in include high blood pressure and high LDL (low density lipoproteins) or
high blood pressure and low HDL (high density lipoproteins) or dyslipidemia, which is also characterized by elevated glucose
and triglycerides. A systematic review of co-morbidities, patient demographics, the preferences of prescribing physicians,
and other related data, within and across therapeutic areas, will reveal many interesting and attractive patient segments
for the single-pill approach. (See "The Single-Pill Solution,")
The single-pill strategy raises many interesting possibilities and a whole raft of questions for marketers: Could a company
increase revenues by combining a second-tier product with a market leader? Would two market leaders completely knock out the
competition if combined in a single pill? What about a combination of two strong number-two or -three products in their respective
indications? How can market leaders and underdogs, respectively, exploit this strategy, and whom will it favor?