Report: Opportunity in Prenatal Segment For Emerging Test Products

NEW YORK, Jan. 29, 2015 /PRNewswire/ -- Kalorama Information has reported extensively on prenatal testing markets for more than a decade, but the recently there's been an increase in opportunity, as revealed in the firms latest study of Women's Health Diagnostics Markets.  Prenatal cytogenetic testing represents an important source of clinical market growth for technologies such as sequencing, microarrays, biomarker immunoassays and mass spectrometry.

Women's Health Diagnostics Markets is available at http://www.kaloramainformation.com/Women-Health-Diagnostic-8487406/.

"Family planning and coordination of care for a child born with health conditions are increasingly relevant issues for the in vitro diagnostics (IVD) community that is increasingly involved in the prenatal testing market," said Emil Salazar, analyst for Kalorama Information.  "While ethical considerations will arise with further market development, prenatal, postnatal and maternal testing are viable, promising cytogenetic screening methods that have seen ready acceptance from many insurers in at-risk populations where the prevalence of genetic disorders (especially chromosomal) justify coverage."

Kalorama notes the success of several competitors in the area: 

• The traditional market leader in neonatal, prenatal and maternal screening, PerkinElmer, has followed a course of business development for its Genetics/Genetic Screening business unit consistent with overall market development and the diversification of associated diagnostic technologies. The company's core offering is a series of assays able to be run on DELFIA immunoanalyzers able to detect biomarkers associated with aneuploidy risk (abnormal number of chromosomes associated with Down syndrome and other disorders) and even pre-eclampsia risk (maternal condition). The DELFIA Xpress, introduced in 2003, has seen placements in over 50 countries worldwide and helped fuel tremendous growth in PerkinElmer's Genetic Screening unit. The PerkinElmer business unit saw overall revenue grow from roughly $100 million in 2003 to $300 million in 2008 as DELFIA Xpress revenue grew by a CAGR of over 100% over the same period.
• Verinata is at the epicenter of a rapidly growing NIPT service market also inhabited by competitors Sequenom and Ariosa Diagnostics. In January 2013, Verinata was acquired by Illumina for $450 million. Illumina also serves as the supplier to Sequenom for sequencing reagents, consumables, and equipment. Sequenom has seen revenue from its laboratory developed tests (LDTs), led by its MaterniT21 NIPT service, increase from $119.6 million between 2012 and 2013; and $86.9 million and $114.78 on a year-to-date (YTD) basis for the first three quarters of 2013 and 2014. Service-related revenue for Illumina also have grown rapidly (50%+) in the business quarters of 2013 and 2014 proceeding its acquisition of Verinata.
• Sequenom has also cultivated a lucrative relationship with array-based NIPT service provider CombiMatrix. The Irvine, CA-based laboratory is a provider of genome-wide prenatal testing services that serve as a complement for the aneuploidy screening sequencing service offered by Sequenom. Prenatal microarray testing serves a reflex testing service to Sequenom's NGS procedure and has seen similarly robust adoption rates. CombiMatrix revenue from prenatal microarray procedures grew by more than 120% in 2013 and more than 40% year-to-date through the first half of 2014.
• The experience of CombiMatrix and the repeated validation of microarrays for application in prenatal testing are not lost on other partners. Agilent has been able to relatively stabilize its array sales through its leading position in postnatal testing. Losing significant business in gene expression research to the competitive application of next-generation sequencing (NGS), Affymetrix has also identified post- and prenatal testing as a source for future growth in its microarray business.

The technologies discussed above – immunoassay, mass spectrometry, sequencing, microarray – are found with traditional karyotyping and in situ hybridization in a multi-billion prenatal cytogenetics testing market, according to Kalorama. 

"Companies offering sequencing- and array-based NIPT services estimate the current addressable market at over $1 billion," said Salazar.  "Remaining market development will include insurers' assessment of the risk threshold for expectant mothers that will permit reimbursement for various NIPT services."

Those services include basic screening, wider genomic screening, reflex testing, and confirmation. Some labs' tests, such as Ariosa Diagnostics' Harmony test, will also permit further investigation into the efficacy and economy of platforms such as sequencing and microarrays.  Ultimately, prenatal testing represents a very probable continued growth opportunity for the multiple technologies of sequencing, microarrays and mass spectrometry still emerging in various applications within clinical diagnostics.

Kalorama Information's report, Women's Health Diagnostics Markets contains more information about opportunities in the prenatal market.  The report is available at http://www.kaloramainformation.com/Women-Health-Diagnostic-8487406/.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.

Contact:
Bruce Carlson
(212) 807-2622
[email protected]
www.KaloramaInformation.com

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