Diagnostics & Imaging Week

ATLANTA – The molecular diagnostics market has a rags-to-riches theme to it and the riches are only going to continue to grow, according to a panel held at BIO 2009, the annual meeting of the Biotechnology Industry Organization (Washington) at the Georgia World Congress Center.

Nearly 100 people packed themselves into a conference room for a session on molecular diag during the BIO event, which ended last week.

Amy Butler, VP at Care Life Technologies (Vancouver, British Columbia); Alicia Loffler, director of the Kellog Center for Biotech at Northwestern University (Evanston, Illinois); and Joel McComb VP, Lifesciences Division of Illumina (San Diego), were the panelists and were asked to discuss the past present and future of the molecular diagnostics field.

Irwin Goverman, principal of Deloitte Consulting (New York), was the moderator.

"The growth of this market has been relatively recent," Goverman told the audience. "We've seen that the market is slow to take off."

But the market did anything but stay in neutral. In 2006 the market clocked in at about $2.3 billion, grew to $2.7 billion in 2007 and began to see substantial gains in 2009 and currently stands at $3.5 billion. In 2010 it's expected to reach $4 billion.

He added that growth is spurred by advances in functional genomics and proteomics coupled with the development of more advanced applications.

"One of the primary motivators for Care Life moving into this space was because it is a nice revenue generator," Butler said.

She said the potential for increasing revenue still exists and to see further gains companies must focus on the marketing aspect of their product in addition to the science.

"Entry into the new molecular diagnostics market would require improved capabilities in sales and marketing, such as building new sales channels and developing better relationships with the medical community," Goverman said.

Goverman displayed a slide showing what part of each space molecular diagnostics comprised. At the top of the list – this came as no surprise to the audience – was the Infectious Disease market which took on nearly 40% of the market share.

"Clearly the first and most effective is infectious disease testing," Goverman said noting that it was profitable and has gained much attention through headlines with the H1N1 outbreaks that have been occurring.

Also on the list were Pharmocogenic products at 28%; Gene Chromosomes at 13%; blood banking at 10%; and oncology at 9%.

The panel agreed that there probably wouldn't be any dramatic shifts in the market share breakdown. But if one were to occur it would probably go towards inflating infectious disease testing.

The panel also was asked which disease state diagnostics would play the greatest role in over the next few years.

"Cancer ... that's going to be a disease state that's going to have the most emphasis," Butler said, adding that there are still a great deal of unmet needs in this area."

"Sequencing will definitely play a role," McComb said.

Loffler argued that it was too soon to make such a guess.

"The market is fragmented, and I don't believe there will be a clear market for some time," she said.

One of the main concerns for the market however, was the impact that President Barack Obama's healthcare package could have on innovation.

"The Obama administration is laying the groundwork that could help strengthen molecular diagnostics and its ability to determine which treatment path patients should go down," Butler said. "The increased funding the administration has promised could benefit the diagnostics field and make the devices more effective."

"At the end of the day you have to look at the cost effectiveness that comes from the products you put on the market," McComb said. "It wasn't until reimbursements came from glucose strips and their effectiveness was monitored more closely ... glucose monitor sales sky rocketed."

But to truly capture innovation Loffler said that diagnostics companies need to mirror medical devices to capture innovation and capitalize off of upcoming legislation.

"There's a lot [that] diagnostics companies could learn from the medical device industry," Loffler said.