ROCKVILLE, Md., Nov. 3, 2016 /PRNewswire/ -- Kalorama Information announces ten companies, outside of the top four in vitro diagnostics (IVD) competitors, that should be noted for innovation, fast growth and/ or positioning for future trends. The market research firm has analyzed the IVD market for over a decade and reviews testing segment markets on a regular basis. While most IVD revenues are earned by just four companies (Roche, Abbott, Siemens, Danaher), the firm says future growth will be driven by a larger group of competitors. Kalorama Information's report, The Worldwide Market for In Vitro Diagnostics, 10th Edition, profiles hundreds of companies in the industry. The report can be found at: http://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-10206771/.
Kalorama notes the following companies based on recent revenue growth, product development and distribution deals. The firm did not rank these companies and implies no order in the list:
- Established in 1999, San-Diego based DexCom, Inc. markets technologies for the continuous monitoring of glucose in people with diabetes. The company quadrupled IVD sales since 2012. In 2015, Google announced a collaboration with DexCom to combine its technology platform with DexCom's sensor technology, resulting in a small, disposable bandage sensor connected to the cloud for real-time diabetes control.
- Critical care and core lab expert Nova Biomedical's tests are designed for rapid measurement of blood gases, co-oximetry, metabolites, electrolytes, and hematology. The design of their systems has given the company an entry into core labs, where Kalorama estimates the company has earned eight percent revenue growth since 2012. Last year, the company's Stat Profile Prime, a blood gas analyzer that combines micro-electronics of the consumer world with Nova's proprietary smaller and faster cartridge technology was FDA cleared for point-of-care (POC) use, allowing non-laboratory, POC personnel to perform bedside, critical care testing with lab-quality results.
- NanoString Technologies (Seattle, WA) has developed the nCounter Analysis System which provides highly multiplexed, direct profiling of individual molecules in a single reaction without amplification.
The company established a diagnostics business unit to commercialize its PAM50 Breast Cancer Intrinsic Subtyping Assay. The test incorporates an array of 50 genes, which can be used to classify breast cancer patients into four distinct subpopulations with varying degrees of disease severity. Watch companion testing efforts with this company - Their recent nCounter microarray platform with 20-gene expression panel from tissue samples for Enzalutamide (Astellas Pharma) for triple-negative breast cancer, and the Modified Prosigna Breast Cancer microarray on the nCounter platform for the REVLIMID (Celgene Coporation) are examples of CDx efforts. The company grew to an estimated $60 million in IVD revenue from $23 million in 2012.
- Quidel - Until recently Quidel's business depended heavily on the annual flu season and on its pregnancy test business. But influenza can be an unstable partner and it's fair to say the company has received the wakeup call. Quidel accelerated a product diversification strategy that was already in place. Quidel's products aid in the detection and diagnosis of many critical conditions, including: influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel provides a broad spectrum of FDA-cleared Strep A diagnostic assays that cover the full spectrum of market needs for this pathogen, including two assays on the Sofia platform (one CLIA-waived), three different assays on the QuickVue platform (two CLIA-waived), and two new molecular assays – AmpliVue Strep A Assay and Lyra Direct Strep Assay (for Streptococcus pathogens of Groups A and C&G). Quidel's Specialty Products Group (SPG) develops research products in the fields of oncology and bone health.
- Beddord, MA-based Hologic continues to lead in infectious disease and women's health. The company ramped up its offerings when in June 2013, Quest Diagnostics agreed to offer Hologic's APTIMA family of products, as well as to co-develop and promote advanced diagnostic solutions to improve women's health. Under the five-year non-exclusive agreement with an initial term of five years, Quest Diagnostics will promote Hologic's FDA-approved or cleared assays for HPV, HPV genotyping, chlamydia, gonorrhea and trichomonas vaginalis. In addition, Quest Diagnostics will continue to utilize Hologic's ThinPrep liquid-based cytology products. An increase in Molecular Diagnostics products, and in particular the Aptima family of assays was primarily due to increased volumes due to an increased in the installed base of Panther instruments, and increased sales volumes of the HPV screening assay, which was FDA approved for use on the Panther system.
- Wako Diagnostics of Osaka, Japan grew revenues at a compound average of 9% between 2013 and 2016, according to Kalorama's estimates. Wako's line of diagnostics reagents includes special and esoteric general chemistry reagents and immunoassay reagents for the diagnosis of cancer, diabetes and infectious diseases used primarily in reference and research labs. Wako offers the lectin-reactive alpha-fetoprotein (AFP-L3) and des-gammacarboxy prothrombin (DCP) liver cancer marker tests on the μTASWako i30. They are intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of liver cancer. The AFP-L3 and DCP tests obtained FDA clearance for in vitro diagnostic use in February 2011 and are currently offered at most major Reference Laboratories in the U.S. The tests are also available for clinical use in Japan, South Korea and the European community.
- GenMark Diagnostics provides automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark's proprietary eSensor detection technology, GenMark's eSensor XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact workstation and self-contained, disposable test cartridges. In addition to the Respiratory panel tests, the Carlsbad, CA-based company markets four tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Respiratory Viral Panel, Thrombophilia Risk Test, and Warfarin.
- Netherlands-based QIAGEN is already a large player, a leading global provider of sample and assay technologies. Last year, QIAGEN reported the company surpassed its 2015 goal of more than 1,500 cumulative placements of its QIAsymphony platform. QIAGEN launched seven new CE-IVDtests for detection of various infectious diseases. Kalorama believes the activities to watch is their moves in the companion diagnostics space: RT-PCR test for detection of AR-VY gene expression (RNA) in CTCs on Rotor Gene Q Mdx platform for Glesatinib (Mirati Therapeutics) for NSCLC with oncogenic MET gene alterations, their NRAS PCR on Rotor-Gene Q Mdx platform for Binimetinib (Array Biopharma) for melanoma.
- Bethlehem, PA-based OraSure has developed a niche for unique saliva-based collection for molecular testing. Its molecular collection systems and HCV product lines continue to be the primary growth drivers: the company reported that interest in saliva based molecular tests is demonstrated by increases in the company's molecular collection systems subsidiary, DNA Genotek, which doubled IVD sales between 2012 and 2015. Among other offerings, the company sells the OraQuick In-Home HIV Test, the first rapid HIV test approved by the U.S. Food and Drug Administration for sale to the consumer over-the-counter market in the U.S.
- Mindray is the best known China-headquartered globally operating IVD company, with global headquarters are in Shenzhen, China, and U.S. headquarters in Mahwah, New Jersey has a global presence for competitive analyzers. Mindray's IVD products include: hematology analyzers and reagents, chemistry analyzers and reagents, urinalysis, and microplate systems. Mindray reported it will develop a more advanced biochemistry analyzer, an upgraded hematology analyzer, other biochemistry analyzers and several reagents, as well as a number of upgraded urine sediment analyzers. The company's BS-2000M is a competitive chemistry analyzers, with throughput of up to 2000 photometric tests per hour and 600 tests per hour for ISE, the large capacity of 140 positions for reagent kits and 140 positions of independent sample carousel can support the large daily sample tests.
About the Report
Kalorama Information's report, The Worldwide Market for In Vitro Diagnostics, 10th Edition ranks companies by revenue and provides detailed analysis of competitive moves of the top companies in IVD. The report also contains hundreds of profiles of innovator IVD companies in various segments, including molecular testing, microbiology, histology, immunoassays, blood banking and other fields. Detailed market estimates and forecast for each test segment are included, as well as a discussion of trends and company activities behind the numbers. The report can be found on our company website.
Please link any media or news references to our reports or data to http://www.kaloramainformation.com/.
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. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.
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