• by bcarlson@marketresearch.com
  • January 5 2016

Five IVD Market Trends to Watch for in 2016

Five IVD Market Trends to Watch for in 2016

Emerging infectious disease threats, progress on sequencing in clinical medicine, near patient DNA testing are among the trends that   manufacturers and investors should be on the lookout for   in vitro diagnostic (IVD) testing in 2017.   We recently released the tenth edition of its IVD market report, which provides coverage of many of these trends.

Make sure to visit our In Vitro Diagnostics page, Kalorama's all-in-one resource covering the IVD market

1. Core Labs an IVD Market  Focus Amid Consolidation

Healthcare organizations are consolidating, it will continue to happen in 2017 with reimbursement changes, and the IVD market is adjusting to this trend. Healthcare consolidation requires a renewed approach to core lab markets and automation systems targeting the big accounts There is increasing demand among integrated health networks for greater centralization of diagnostic testing to streamline workflows and steer better healthcare information to professionals, Major IVD companies launched products this year to enhance workstations. Siemens Healthineers used the AACC Annual Meeting this year to unveil its Atellica Solution for automated core lab testing. Abbott Diagnostics unveiled its Alinity line of “harmonized systems” across the core lab (clinical chemistry and immunoassays), hematology, point-of-care (POC) diagnostics, blood screening, and molecular diagnostics.

2. CFDA IVD Market Approvals Rise in Prestige

In the past five years, China has solidified its place as an IVD market just behind the United States, European Union, and Japan. Outside of U.S. Food and Drug Administration (FDA) approval or European CE marking, China FDA (CFDA) approval has been the next most heralded product development for many IVD companies. Roche issued a 2016 press release for the CFDA approval of its CINtec PLUS Cytology test or immunocytochemistry assay for the detection of human papillomavirus (HPV). Roche also markets a molecular HPV assay that may find greater usage in emerging markets in the coming years after being approved by the U.S. FDA as a first-line HPV screening tool. Qiagen has also targeted the Chinese HPV test market with its CFDA-approved careHPV platform for low-resource settings.
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. Cancer diagnostic specialist Epigenomics of Germany has relied upon China as a principal market for its liquid biopsy colorectal cancer (CRC) test, Epi ProColon. In May 2016, the test was included in Chinese government-administered guidelines for the screening of early CRC. Epigenomics is expected to commence Chinese clinical trials during 2016 to support CFDA approval of its liquid biopsy assay for lung cancer using the methylated SHOX2 gene biomarker. Epi ProColon and other advanced molecular assays for cancer have been designated as innovative products by the CFDA, which can expedite approval processes. Next-generation sequencing (NGS) is the highest area of activity in the Chinese cancer diagnostics market. Driven foremost by demand for non-invasive prenatal testing (NIPT), the clinical sequencer base in China now includes over 40 hospitals in China and other testing institutions that serve at least 70 other hospitals and clinical clients. Cancer testing is the second-largest clinical application of NGS in China.

3. Esoteric LDT Companies Prosper in the IVD Market

An emerging dynamic is major cancer-focused U.S. LDT companies’ penetration of the EU market. Myriad Genetics, Genomic Health and Foundation Medicine have pursued different strategies to introduce their LDTs to the EU market. Foundation Medicine has a strategic partnership with Roche for the international sales and marketing of the FoundationOne and other comprehensive genomic profiling (CGP) tests. The company will also begin operations at a centralized lab for its European market LDTs in Penzburg, Germany. Myriad Genetics complemented their reference lab in Munich, Germany with the acquisition of a German clinic known as an MVZ or multi-disciplined ambulatory care center. Operating an MVZ, Myriad Genetics will be able to open direct reimbursement negotiations with insurance providers and contract with physician network and hospital clients. Genomic Health has an appreciable LDT business in Europe (international markets were 14% of the company’s 2015 revenue), but performs all testing at its Redwood City, CA facility from its CE-marked sample collection kit. The rising profile of LDTs in the EU market may limit growth opportunities for the EU molecular cancer diagnostics market. Wider availability of CE-marked molecular cancer kits has not translated to robust growth in the IVD market segment in recent years. The outlook for the regional market segment is improved, however, by returned political stability to the region, more favorable economic conditions, and rising demand for advanced LDT services (in turn driving sales of related reagents and instrumentation). Globally a high-growth market segment, molecular cancer diagnostics in the EU is expected to grow at approximately only 4% due to market maturity (relative to ROW markets) and reimbursement limitations (relative to the U.S. market with its more diversified payer system).

4. Watch Urgent Care, Retail Clinics 

The proliferation of urgent care centers (10,000+) in the US, as well as retail clinics (1,200+), per the chart next, have made systems that can deal with the workflows associated with these clinics a priority. Urgent Care Centers provide walk-in, extended hour access for acute illness and injury care that is either beyond the scope or availability of the typical primary care practice. UCC’s differ from traditional physicians’ offices with procedure rooms for lacerations and fractures, radiology department for x-ray services, and in some cases a laboratory. High visibility and adequate parking is part of their business model, thus centers are usually located in freestanding buildings, though they can be located in strip malls and in some cases they may be within a hospital complex but with a separate entrance, Convenient hours are a key strength of urgent care centers. Retail clinics differ from urgent care centers in that they are smaller, are encased within a retail setting, provide a limited menu of services and usually are staffed by one practitioner or two. Alere is present in this marketplace. Roche’s cobas Liat, a PCR point of care platform, which recently received CLIA –waived status for Flu A/B and RSV, is designed with these clinics in mind.

5. No Slowdown in In Vitro Diagnostics Market for M&A and Activities

Companies need many parts to succeed in IVD, and so we expect merger activity, as well as partnerships and other arrangements to be robust in 2017. It was in 2016. Some M&As allow larger companies to acquire new technologies but there is a distinct move for globalization of IVD knowledge. LabCorp purchased Sequenom. Abbott announced its intention to buy Alere, Sunnyvale, CA-based Cepheid was purchased by Danaher corporation. Bio-Techne acquired ACD for $250 million, marking Bio-Techne’s entry into the genomics field and market. ACD’s technology, RNA-ISH is a technology facilitating and improving the monitoring of gene expression patterns at the single cell level––while retaining the morphological context of the tissue being analyzed. Oxford Immunotec Global PLC, a global, high-growth diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, acquired substantially all of the assets of Imugen, Inc., a Massachusetts-based clinical laboratory focused on developing and performing specialized testing for tick-borne diseases. Luminex acquired Nanosphere and their Verigene platform and seeks to benefit from their broad menu, and strong presence in the molecular microbiology market. According to the companies. Nanosphere’s Verigene technology leads in the high-growth bloodstream infection segment and complements Luminex’s current infectious disease portfolio.

This Kalorama Information report, The Worldwide Market for In Vitro Diagnostic Tests, has been updated for two decades in ten editions, keeping readers informed about developments in all areas of the ivd industry, around the world, in one volume.  The 1,600-page report provides market size estimates and projections for the entirety of the clinical diagnostics testing market.  It also tracks hundreds of competitors, notes significant partnerships, distribution deals and acquisitions and defines the market share situation for the in vitro diagnostic market and competitive analysis for many segments.

Kalorama Information's The Worldwide Market for In Vitro Diagnostic Tests, 10th Edition

Important Testing Segment Markets in the In Vitro Diagnostic Market

Published every two years, this report estimates the current in vitro diagnostics market size and forecasted market size to 2021 for defined segments of the IVD market and various sub-segments, including:
  • Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
  • Clinical Chemistry and "Core Lab" Markets (including sub segment revenues for General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)
  • Point-of-Care Testing (POC), (Professional and Self-Testing, Glucose Testing, Pregnancy Tests, drugs of abuse, HIV, H. pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other)
  • Microbiology and Virology by Test Type (Immunoassays, ID/AST, Infectious Diseases - DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies)
  • Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
  • Tissue-Based Testing - Histology and Cytology (Pap, ISH, IHC, HPV)
  • Infectious Disease Immunoassay Testing  (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)
  • Hematology
  • Molecular Tests in Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others
  • Non-Infectious Disease Immunoassay Sales by Analyte Type (Cardiac markers, Tumor markers, Diabetes/HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic drugs, Tox/Drugs of abuse, Vitamin D)
  • Coagulation Tests (Lab-Based, POC, Genetic Markers)
  • Sequencing and Flow Cytometry
No other report provides similar understanding of the world diagnostics market.  For each of the listed   segments, 2016 market size, 2021 projection and compound annual growth rate is provided, as well as   significant companies in the market and product innovations.  The market data is put into a context with   real-world industry and medical practice trends.  Shara Rosen (MBA, RT),  has authored ten editions of   this superior work intended to provide IVD market coverage in a world perspective.  The report has been   called "The Bible of the IVD Industry" by customers, which include top IVD firms.  Using Kalorama Information's report ensures that your firm will have the perspective and data of others in the industry and those that track the industry and invest in it.