By Ben Butkus
The global molecular diagnostics market, currently valued at about $5.9 billion, is the fastest growing segment of the approximately $52 billion global in vitro diagnostics market and is expected to reach nearly $11 billion by 2015, according to a report released this week by market research and consulting firm DeciBio.
In addition, the report found that the quantitative PCR-based technology segment, at about $2.8 billion, currently accounts for nearly half of the overall MDx market and is expected to grow at or slightly faster than the overall market in the next four years to between $5 billion and $5.9 billion.
Meantime, next-generation sequencing-based molecular testing is expected to experience the highest rate of growth over the next four years with approximately 100 percent growth per annum; while less quantitative technologies such as endpoint PCR and reverse-transcriptase PCR are expected to grow more slowly than the overall market, the report found.
DeciBio, founded in 2009 in Los Angeles, began compiling the first edition of the report, entitled "Molecular Diagnostics: Market Size, Segmentation, Growth, and Opportunities," in an attempt to address what it perceived as "a real lack of intelligence" on the life science research tools and diagnostic markets, DeciBio's Stéphane Budel told PCR Insider this week.
The company started by conducting interviews with 30 to 40 molecular diagnostic experts — mostly "really hands-on people … who use the technology regularly or who are lab directors," Budel said — then wove into subsequent editions additional comments from interview subjects, data from company presentations and regulatory filings, and publicly available information.
The most recently published report, the fourth edition, has allowed DeciBio to more accurately gauge recent trends and predict future market directions. For instance, the report noted that the MDx market, currently valued at about $5.9 billion and comprising about 11 percent of the overall IVD market, has been and should continue to be "relatively immune to macroeconomic trends."
To wit, the report noted that MDx testing has been "relatively recession-proof," and in 2009, following the global economic recession, the market experienced an estimated growth of 15 percent, "only slightly below our previous forecast of 17 percent."
Similarly, the authors reported that the MDx market is expected to grow at a rate of 15 percent per year for the next four years to reach approximately $10.9 billion by 2015, primarily due to increased incidence of chronic disease in an aging population, increased test availability, and continued adoption of pharmacogenomics and personalized medicine.
According to the report, although more than 500 companies compete in the MDx space, the majority of revenue is due to just a few large players, with eight companies controlling about 68 percent of the MDx market, led by Roche with a $1.2 billion MDx franchise. Other dominant technology vendors include Gen-Probe, Qiagen, Abbott, Myriad Genetics, Siemens/Bayer/Dade, Cepheid, and Genomic Health.
In terms of technology categories, the report identified seven areas that either currently or are expected to comprise the bulk of MDx testing. These include, in order of current market share, quantitative real-time PCR, transcription-mediated amplification, fluorescence in situ hybridization, capillary electrophoresis sequencing, hybrid capture, endpoint or RT-PCR, and next-generation sequencing.
The report notes that qPCR "is expected to remain a key technology" in MDx, growing approximately 19 percent per year in the next four years to cap at about $5.5 billion in 2015, driven by continued adoption of the technology in both single and multiplex tests.
"While other emerging technologies may have higher sensitivity and specificity (e.g. next-generation sequencing, digital PCR), interviewee feedback from users indicated that qPCR test performance is sufficient for the majority of currently marketed tests."
In contrast, the endpoint PCR and RT-PCR segment is expected to grow slightly slower than the overall MDx market in the next four years, with between 7 and 13 percent annual growth, the report stated. "While the technology is cost-effective, labs are increasingly shifting to more quantitative tests, such as qPCR, even in instances where absence/presence would suffice," the authors noted.
Along those same lines, while NGS currently comprises only a sliver of the overall MDx market, DeciBio expects the technology to experience a very high rate of growth approaching 100 percent annually, over the next few years, driven by its adoption in oncology, pre- and post-natal screening, and HIV genotyping.
However, Budel told PCR Insider that such growth is always difficult to predict for a new technology.
"If you look at NGS, it's … almost non-existent right now," Budel said. "But we project that it's going to grow to something like [between $700 million and $1.1 billion] by 2015. And it's very directional. In that case, it's very difficult to predict what's going to happen to that technology."
This is less the case with qPCR and PCR, Budel added. "A lot of these tests are pretty well-established. You can predict what's going to happen with them much better than with some of these emerging technologies. That said, it can be tricky, because if you look at a company like Genomic Health, they recently said they were considering using NGS instead of qPCR for some of their future tests. That kind of statement makes projections very difficult."
In other technology categories, transcription-mediated amplification — which is primarily offered by Gen-Probe and partner Novartis — is currently valued at about $1 billion, or around 17 percent of the overall MDx market, and is expected to grow 5 percent to 10 percent per year for the next four years.
Meantime, hybrid capture, most associated with Qiagen's Digene HPV assay, comprises about $300 million of the MDx market, and is expected to experience single-digit per-annum growth over the next four years as other technologies with potentially higher specificity, such as qPCR, are rolled out.
DeciBio also identified and grouped together several technologies that collectively comprise a significant portion of the MDx market but individually are too young or unproven to separate out.
Technologies in this "other" category included bead-based nucleic acid assays such as those offered by Luminex and Nanosphere; microarrays; digital PCR; electrochemical detection, such as GenMark Diagnostics' eSensor; and isothermal methods such as loop-mediated isothermal amplification, or LAMP; and nucleic acid sequence-based amplification, or NASBA, technology, found in BioMérieux's NucliSens clinical diagnostic assays.
These technologies, the report noted, currently comprise about $300 million of the overall MDx market, and are collectively expected to experience fast growth of approximately 25 percent to 40 percent per annum in the next four years.
Budel told PCR Insider that while it was again difficult to quantitatively predict which of these "other" technologies might grow the fastest, some anecdotally stood out.
"The technologies that … people seem excited about include the eSensor technology," he said. "We actually spoke to someone that used the GenMark system and was an early adopter, and people who use that tech are actually very excited about it.
"Meridian Biosciences uses LAMP for its HPV test," and while "LAMP is not used to a large extent right now, if that test takes off, then of course the growth of the technology will take off as well," he added.
"There are a lot of other technologies that I would not be surprised if they experienced fast growth … including BioMérieux's NASBA … and a lot of other modifications of PCR that people have done that have clinical applications. Some of those tests might not even be included in this report yet, like COLD-PCR."
Of course, MDx technology choices are in large part driven by disease and therapeutic categories, which DeciBio also teased out in its report.
According to DeciBio's research, infectious disease testing currently dominates the MDx market, representing about $3.3 billion, or just over half, of the $5.9 billion market. In addition, infectious disease testing represents about 90 percent of total test activity in terms of number of tests performed.
This market is expected to experience between 10 percent and 15 percent per-year growth for the next four years, driven primarily by HIV genotyping and hospital-acquired infections such as methicillin-resistant Staphylococcus aureus and Clostridium difficile.
The report noted that while infectious disease testing currently relies primarily on qPCR and PCR, bead-based technologies are gaining momentum for their ability to multiplex.
Meantime, oncology MDx tests represent about 18 percent of the overall market. Oncology has been an early adopter of MDx due primarily to targeted therapy development; high drug prices driving a need for more targeted therapy; disease aggressiveness; and inaccuracy and high cost of alternative tests.
Growth in this area, the report noted, is expected to be between 15 percent and 20 percent annually in the next few years, driven primarily by new tests and molecular signature tests similar to Genomic Health's Oncotype DX. DeciBio also reported that NGS-based tests will likely support an even higher growth rate within three or so years.
Other key disease areas expected to drive MDx growth include human papillomavirus testing, inherited disease testing, and prenatal testing.
Additional top-line findings from the report include the projection that MDx assays are expected to begin migrating to higher-plex formats "supported by instruments with a more straightforward workflow;" and that the field in general is expected to attract "additional scrutiny from regulators" in light of the US Food and Drug Administration's plan to regulate laboratory-developed tests.
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