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Is Molecular Diagnostics in Europe Suffering from Too Much Hype?

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At A Glance

Name: Martin Pfister

Age: 37

Title: Consultant

Education: PhD from the University of Leipzig, Germany; MS from the University of Greisfwald, Germany, and New York University

Background: External leads consultant for HBS Consulting

 

Smaller markets, tighter competition, tight government regulations, and complex reimbursement systems has made it a challenge for companies to develop and sell molecular diagnostics in Europe.

But is Europe falling farther behind the United States in the goal of developing pharmacogenomics-based molecular diagnostics? Though it is believed that Europe represents around one-third of the global molecular diagnostics marketplace, it is difficult to gauge the size of the space because it overlaps the in vitro diagnostic market and “is less well defined than the pharmaceutical or device markets,” according to a new research report published by HBS Consulting.

The report, written by Martin Pfister, speculates that 1,500 gene-based tests will eventually be available if you consider approximately 30,000 genes with an estimated diagnostic significance of about 5 percent, the report said.

“The way is paved by infectious disease testing and blood banking applications, but pharmacogenetic, predisposition diagnostics and molecular cancer diagnostics applications will follow soon and post strong numbers in the years to come,” the report reads. “Cancer for instance, represents a set of diseases with vast unmet clinical need for improved diagnostics and therapeutics.”

Pharmacogenomics Reporter caught up with Pfister this week.

The sub-title of your report, which focuses on the European molecular diagnostics market, is ‘Revolution or Hype.’ Is there really a question that the molecular diagnostics market is either one or the other? Is it more one than the other?

It depends on whom you think of. I have interviewed many companies for this report, and they think of molecular diagnostics as a revolution that will change the market. But if you look at end users [such as physicians] and patients … they still see this as hype. I think the market is not ready yet, and we don’t use these kinds of tools and techniques, because we don’t think that they are more helpful than things we already use.

Do you think the hype component poses a threat to molecular diagnostic technologies once they do become more widely available? In other words, are companies developing these tools and services doing themselves a disservice by crying wolf?

No. I think the public awareness is one of the key factors in this market. And once more tests become available, and get marketed better, consumers will begin to think of molecular diagnostics as a revolution.

What are the biggest challenges facing companies as they try to develop molecular diagnostics for the European market?

I think that one of the biggest challenges is the price of the tests [that do exist]. Another restraint is [the tests] are still complicated, so you need well-trained and skilled [technicians] to perform those tests. Another challenge, particularly for smaller companies trying to get into this field, is that it is very complicated to get into the market because most of the licenses are claimed already — especially in European countries.

What do you see as the biggest revenue drivers in Europe in the coming years? Is there a particular technology that shines, or a disease state or biomarker that most companies are focusing on?

First of all, the most promising areas within molecular diagnostics are in cancer and predisposition for diseases such a diabetes and asthma. Or disease related to the central nervous system, such as Alzheimer’s disease. I think an important tool that is still under-estimated … are microarrays. You can automate them, and that is a very important factor, so that they can become more easy to handle.

Other drivers of this business are the technical advantages that molecular diagnostics have: Fast methods, automatable, and you can decrease costs using these technologies. Also, getting back to one of your earlier questions, cost-benefit analyses should be marketed better to customers. For example, if you have more targeted therapies, or your product enables shorter hospitalization times, then you can drop costs for your hospital costs. This is a fact that is not communicated, because people see that these tests are cost-intensive. But, in the long run, I think you can save money.

Why is it that marketing, as you say, is a challenge? You’d think that this should not be an issue from companies such as Roche and Abbott.

I think it’s because this market developed much faster than knowledge about it had developed. So this market is premature, and the view that the company has is different from the view that the end user has. And if you market to laboratories, tests are more expensive, and they see these costs; they don’t see the mid-term benefits.

Does the current regulatory climate in Europe present challenges to molecular diagnostics?

It is an unsolved issue. For example, in Germany, the government recruits experts and hires commissions, and try to get a picture of the European regulatory landscape. But when they start, they’ve already fallen behind. This is a big challenge, especially to American companies that want to get access to the European market; it ‘s a big problem to get a clear picture of the regulatory issue of molecular diagnostics in Europe.

It’s different for testing certain pathogens — hepatitis C, HIV. But for other tests, such as molecular diagnostics that test for cancer predisposition, it’s difficult.

 

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