Report states IVD companies are focusing on core lab, seeking China FDA approval, and targeting urgent care
Several of the same powerful trends reshaping healthcare and clinical laboratory services are having equally significant influence on in vitro diagnostics (IVD) manufacturers. In particular, the consolidation of hospitals and physicians, as well as the emergence of new sites of service—such as urgent care centers and retail clinics—are motivating IVD companies to tailor new diagnostic systems to the unique needs of these entities.
Kalorama, a division of MarketResearch.com, has released its list of Top-Trends that will affect IVD developers in 2017. IVDs are at the heart of the medical laboratory industry. Thus, these reports are critical to keeping clinical laboratory managers and pathology groups informed on anything that could affect the production, voracity, and availability of diagnostic testing.
In the white paper, “Top Five IVD Trends to Watch in 2017,” Kalorama identifies the IVD market trends that most affected clinical laboratories in 2016, and specifies which of them will most likely continue to do so in 2017.
Top IVD Trends for 2017
According to Kalorama, the top-5 trends affecting the IVD test market are:
1. Healthcare Organization Consolidation: This has renewed focus on the core lab;
2. Ascent of China’s Food and Drug Administration (CFDA): It’s helping China become a top player in the IVD market, just behind the US and Japan;
3. US Developers of Laboratory Developed Tests (LDTs) Penetrate the European Union (EU) Market: This region’s stable and unified regulatory regime supports increased demand for advanced LDT services;
4. Growth in Urgent Care Center and Retail Clinic Markets: Encourages IVD firms to prioritized focus on workflows that support these systems of healthcare;
5. More Companies Seek to Acquire Technology through Partnerships, Mergers, and Acquisitions: These business collaborations reveal a “distinct move for globalization of IVD knowledge.”
Consolidation and the Core Medical Laboratory Marketplace
As healthcare organizations consolidate, IVD companies are looking at core lab markets and automation systems that target big accounts, noted a Kalorama news release. Two examples of such IVD companies are Abbott Laboratories (which recently acquired St. Jude Medical) and Siemens Healthineers.
Abbott (NYSE:ABT) issued a statement announcing a new diagnostic platform for clinical laboratories, clinicians, and medical institutions called Alinity. It’s a “harmonized” platform of immunoassay, clinical chemistry, point-of-care, hematology, blood and plasma screening, and molecular diagnostics systems.
Siemens Healthineers also introduced a new solution to automate core lab testing call Atellica. This is an immunoassay/clinical chemistry solution with patented bi-directional magnetic sample-transport technology that, according to the press release, is 10 times faster than conventional conveyors, is scalable across configurations and locations, and enables simplification of lab operations, streamlined inventory control, and consistent testing results.
China FDA’s Seal of Approval
Along with US Food and Drug Administration (FDA) approval, and European CE marking, China FDA (CFDA) approval also is highly sought and widely touted by IVD companies, noted Kalorama.
For example, in a news release, Swiss multinational pharmaceuticals and diagnostics company Roche (VTX:ROG), announced that the CFDA had approved its CINtec PLUS Cytology test. This test is designed to improve the detection and early intervention of pre-cancerous cervical disease. About 62,000 new cases of cervical cancer are reported annually in China, and about 30,000 women in China annually die from the disease, according to Roche.
“Most surprising in the Chinese market’s ascent has been the prominence of its cancer diagnostics space. Advanced cancer testing is not associated with middle-income countries, but China’s research prowess in sequencing, and globally significant patient populations in urban markets, have created considerable opportunities for overseas IVD companies,” noted the Kalorama researchers, who added that next-generation sequencing is the highest area of activity in Chinese cancer diagnostics.
US LDT Companies Cross the Pond
Kalorama researchers labeled the penetration of the European Union (EU) market by cancer-focused American LDT companies as an “emerging dynamic.” Among those companies introducing LDTs to the EU are:
• Foundation Medicine; and
Kalorama’s research notes that Genomic Health has a substantial European LDT business, and that 14% of the company’s 2015 revenue came from international markets.
Urgent Care is Key Market for IVD Initiatives
About 7,100 urgent care centers operate in the US, according to the Urgent Care Association of America (UCAOA), which defines urgent care centers as those that include full-service urgent care medicine, clinical laboratory, and X-ray services.
Urgent care centers, along with 1,200 retail clinics (generally installed in retail settings, smaller than urgent care centers, and offer fewer services), have led IVD companies to prioritize services specific to the centers’ workflows, according to Kalorama.
For example, Kalorama researchers noted Roche’s cobas Liat System is designed specifically for the centers. According to Roche, the system:
• Automates the testing process;
• Simplifies workflow; and
• Enables healthcare workers to quickly offer molecular testing in a variety of settings.
Also, Roche’s cobas Influenza A/B test, used at retail clinics to test for the flu, recently received a certificate of waiver (CoW) under the Clinical Laboratory Improvement Amendment (CLIA), according to a Roche news release. This test and system uses the Roche cobas Liat PCR (polymerase chain reaction) technology.
Pace of IVD Brand Mergers ‘Brisk’
In addition to the ongoing consolidation of hospitals and healthcare systems, merger and acquisition activity involving IVD companies is “brisk,” Kalorama found.
Here are deals sealed and launched in 2016, according to Kalorama research:
• LabCorp (NYSE:LH) purchased Sequenom, an American molecular and genetic testing technology company based in San Diego;
• Abbott announced its intent to buy Alere, a developer of point-of-care (POC) rapid diagnostics technologies. However, this acquisition did not succeed and resulted in Abbott declaring “full-scale war” on Alere, according to a New York Times article;
• Danaher purchased molecular diagnostics developer Cepheid;
• Bio-Techne acquired ACD, a developer of molecular pathology and diagnostic tests for personalized medicine;
• Oxford Immunotec (Nasdaq:OXFD) acquired most of the assets of Imugen, a clinical laboratory located in Norwood, Mass., that specializes in the testing of clinical specimens for tick-borne diseases; and
• Luminex acquired Nanosphere, a developer of molecular microbiology and molecular diagnostics.
Strategic Planning at Clinical Labs Can Acknowledge Kalorama’s Trends
As Dark Daily has previously reported, Kalorama keeps close tabs on what’s trending in IVD. (See Dark Daily, “Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016, March 4, 2016.)
Thus, pathologists and clinical laboratory leaders are encouraged to review Kalorama’s new report and note any implications that will impact the short- and long-term plans of their medical laboratories and anatomic pathology groups.
—Donna Marie Pocius
The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 10th Edition
Top Five IVD Trends to Watch in 2017
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Despite Slowdown Fears, No Change in China IVD Forecast
Abbott Unveils Alinity, Its Unified Family of Innovative Next-Generation Diagnostics Systems
Siemens Healthineers Unveils Game-changing Atellica Solution at AACC 2016
Roche Receives China Food and Drug Administration (CFDA) Approval for Cintec PLUS Cytology Test to Help Prevent Women from Developing Cervical Cancer
Roche Receives FDA CLIA Waiver for Flu A/B Test for Use on Its cobas Liat PCR System
Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016 Reveals Rapid Technology Advances Intended to Give Clinical Laboratories New Diagnostic Tools