A different survey, conducted by GBI Research, reports radically different market figures. In it, biomarkers, a special subset of the metabolomics market, had a global value of $14.9 billion in 2012, up from $3.5 billion in 2004, according to Geetika Munjal, analyst for GBI Research. That amounts to a CAGR of 20.1%.
As BCC Research senior editor Chris Spivey estimates for GEN, “the current figure for the total biomarker market is at around $20 billion.” Metabolomic applications, however, are estimated at $230 million for 2012.
The difference, Spivey explains, is that, “You can have biomarkers for all sorts of things—heart failure, insulin levels, CNS breakdowns, genomics, proteomics, and, of course, metabolites. The BCC report only considers the segments for metabolomics and, within that niche, only the subset of activity around metabolomics biomarkers.”
The three most important challenges faced in developing and adopting biomarkers for personalized medicine are regulation, reimbursement, and awaren ess, according to Munjal. Differences among biopharma and diagnostic company business models and timelines also pose important hurdles as companies form partnerships to develop tests for drugs that are already approved or are in the pipeline.
“To make their alliances (with bio pharma companies) work, diagnostic companies are specializing in fewer therapeutic areas so they can focus on developing tests to fit specific treatment outcomes,” Munjal tells GEN.
Biopharma companies, meanwhile, leverage their sales forces and marketing budgets to promote companion diagnostics throughout their sales networks.
Recently, Eli Lilly & Co. and Pfizer each signed partnership agreements with Dako. Lily’s deal focuses on oncology, while Pfizer’s agreement covers its broad pipeline, Munjal notes. “Partnering is likely to continue, as it helps companies focus on their core competencies,” he adds.
Qiagen is another company to watch, Munjal says. Like Dako, it plays an important role in the personalized medicine space.
Roche and Novartis also have integrated drug and diagnostics division. “These companies understand the global regulatory guidelines for companion diagnostics and guide the partner company through all complexities of co-development,” Munjal adds.