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The Future of Cardiovascular Diagnostics
THE MARKET, TRENDS & FUTURE DIRECTIONS

Extracted on: 20 Apr 2011
Reference Code: BI00021-008
Publication Date: 02 Mar 2010
Publisher: Datamonitor

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The Future of Cardiovascular Diagnostics
THE MARKET, TRENDS & FUTURE DIRECTIONS
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THE MARKET, TRENDS & FUTURE DIRECTIONS
Summary
* The IVD market was estimated to be worth $35bn in 2008 (excluding sales of blood glucose self testing) and is growing at around 3% per annum. Over half of sales were derived from clinical chemistry and immunoassay products however, the PoC market is small but ever increasingly important. Cardiovascular IVDs accounted for around 25% of immunoassay test revenues and PoC sales. * The market is dominated by large cap companies including: Abbott Diagnostics, Beckman Coulter Inc., Becton Dickinson and Company (BD), bioMérieux, Johnson & Johnson (Ortho Clinical Diagnostics), Inverness Medical Innovations, Roche Diagnostics, and Siemens Healthcare. The market continues to be driven by advances in new biosensor technologies for use in PoC diagnostics and the identification of novel CV biomarkers (CGEN-114, galectin-3, KLP-6, GDF-15) is ripe for commercialization. * The diagnostic imaging market (excluding services) was estimated to be worth around $42bn in 2008 and is growing by around 2%-3% per annum. Of this the medical imaging market associated with clinical diagnostic and surgical procedures accounts for around $20bn sales (+3% per annum). We estimate around a quarter of medical imaging sales are spent on cardiovascular imaging diagnostics. * The diagnostic imaging market is dominated by a handful of large cap healthcare companies - GE Healthcare, Hitachi, Philips, Siemens, and Toshiba - which market a range of imaging platforms; no single imaging technology dominates the market. The usage of CT and MRI continues to increase due to new product launches (e.g. dual source CT scanners) which offer rapid and high resolution imaging and a reduction in ionizing radiation and contrast agents - changing the way CV disease is diagnosed.
Market analysis
The IVD market
The in vitro diagnostic (IVD) market was estimated to be worth $35bn in 2008 (excluding sales of blood glucose self testing) and is growing at around 3% per annum with a forecast compound average growth rate 2008 to 2012 of 7.4%. The US accounts for around a third of IVD sales, the majority of which are generated through Physician Office Laboratory (POL) testing (54.5%), hospital labs (4.5%) and independent labs (2.7%); highlighting the importance of POLs particularly as the number of labs continues to grow, thereby driving future sales.
Figure 26: The IVD market – geographic split (2008)

Source: bioMérieux
China is the second largest Asia-Pacific market after Japan and is growing at 15%-20% annually and this along with other emerging markets has attracted considerable investment from IVD companies during the last few years. It is estimated that by 2016 the emerging economies will account for two thirds of global gross domestic product (GDP; Figure 27).
In 2008 over half of diagnostic sales were derived from clinical chemistry and immunoassay products however, the PoC market is small but becoming increasingly important. It is currently estimated to be worth around $2.4bn but growing by up to 11% per annum and will become an important focus for future IVD development.
Figure 27: The IVD market – segments (2008)

Source: Axis-Shield
Growth in IVDs has been driven by a number of factors, namely the needs of an ageing population, advances in ‘omic technologies and companion diagnostics and an increased biological understanding of diseases; all have made a positive impact on the market which in turn has helped to offset the impact of ongoing pricing pressures.
Overall there has been considerable consolidation within the industry (see later) and companies have been keen to empower patients by decentralizing testing and expanding PoC diagnostics. Meanwhile advances in automation and immunochemistry technologies have lead to improvement in screening throughput from high to ultra high, providing greater speed with accuracy while reducing costs. In addition, there has been increased awareness of emergency testing and the emergence of companion diagnostics and theranostics.
The leading players include: Abbott Diagnostics, Beckman Coulter Inc., Becton Dickinson and Company (BD), bioMérieux, Johnson & Johnson (Ortho Clinical Diagnostics), Inverness Medical Innovations, Roche Diagnostics and Siemens Healthcare; together these companies account for up to two thirds of global sales revenue (Figure 28).
Figure 28: The IVD market – market leaders (2008)

Source: Company websites
In addition, the IVD market has attracted investment from a plethora of medical device manufacturers as well as a variety of reagent and technology suppliers which support this growing and dynamic industry (Table 21 and Table.22).
Table 21: Medical Device Manufacturers & Suppliers in IVD AcroMetrix Corp. | Adaltis Inc. | AdnaGen AG | Aethlon Medical, Inc. | Affymetrix, Inc. | Agilent Technologies Inc | Akonni Biosystems Inc | Alfa Scientific Designs, Inc. | Alpha Innotech Corp. | AMAG Pharmaceuticals, Inc | Ambion, Inc. AMDL, Inc | American Bio Medica Corp | Amgen Inc. | Amic AB | Aperio Technologies, Inc. | Applied Biosystems Group | Applied Imaging Corp | Applied NeuroSolutions, Inc | Arcxis Biotechnologies Inc | ARKRAY, Inc. | AspenBio Pharma, Inc. | Assay Designs, Inc. | Asuragen, Inc. | Aurelium BioPharma Inc | Avitar, Inc. | Axis-Shield plc | Ayanda Biosystems S.A. | B•R•A•H•M•S Aktiengesellschaft | Baxter International Inc | Biocompatibles Int plc | Biomerica, Inc | Bionostics, Inc. | Bio-Rad Laboratories, Inc. Bio- | Reference Laboratories, Inc. | Biosite Inc | Biotage AB | Biotest AG | BioTime, Inc | Biotron Limited | Biovest International, Inc. | Black Ridge Mining Ltd | Boehringer Ingelheim GmbH | Bristol-Myers Squibb Company | Bruker Daltonics Inc | Calypte Biomedical Corp | Celerus Diagnostics, Inc | Celsis International plc | Cepheid | Chembio Diagnostic, Inc. | China Medical Technologies | IncChina Sky One Medical, Inc | Clinical Data, Inc. | CollTech Australia Limited | CombiMatrix Corp | Concateno plc | Corgenix, Inc | Correlogic Systems, Inc. | Covance Inc. | Covidien plc C | Cozart Bioscience Ltd | CytoCore, Inc. | Cytogen Corp. | Cytori Therapeutics, Inc | Cytyc Corp. | Daxor Corp. | deCODE genetics, Inc | diaDexus, Inc. | DiaGenic ASA | DiaSorin S.p.A | Diazyme Laboratories | Digene Corp | DNAPrint Genomics, Inc | DRAXIS Health Inc | ECI Biotech Inc | Eckert & Ziegler Strahlen- und | Mdizintechnik AG | Eiken Chemical Co.,Ltd | Emergent BioSolutions Inc | Epigenomics AG | Epinex Diagnostics Inc | Escalon Medical Corp. | eXagen DIAGNOSTICS, Inc | Exiqon A/S | ExonHit Therapeutics SA | F. Hoffmann-La Roche Ltd | Fermiscan Holdings Limited | Foundation for Innovative New | Diagnostics (FIND) | Gene Express, Inc | Genesis Genomics Inc. Genetix | Group plc | Genomic Health, Inc | Genosis PLC | Gen-Probe Inc | Genzyme Corp. | Glycominds Ltd. | g-Nostics Ltd. | GRANT Life Sciences, Inc | Grifols, S.A. | Haemonetics Corp. | Hai Kang Life Corp. Ltd | HealthLinx Limited | Helicos BioSciences Corp | HemoSense, Inc. | I-Flow Corp. | Illumina, Inc. | ImmuCell Corp. | Immucor, Inc. | Immunicon Corp. | Innogenetics NV | Innova Biotechnology Co. Ltd | IntelligentMDx | InterGenetics Inc | Interleukin Genetics Inc | International Isotopes Inc. | Ion Beam Applications S.A | IRIS International, Inc. | Kyowa Hakko Kirin Co., Ltd. | LabNow, Inc. | Laboratory Corp. of America | LabTech Systems Limited | LifeAssays AB | Luminex Corp. |

Source: Medical Devices Business Review
Table 22: Medical Device Manufacturers & Suppliers in IVD (contd) Malaysian Bio-Diagnostics | Research Sdn Bhd | Medarex, Inc. | Med-Direct International Ltd | MedTox Scientific, Inc. | Menarini Group | Meridian Bioscience, Inc. | Micromet, Inc. | Milagen, Inc. | Millipore Corp. | Mindray Medical International Limited | | Miraculins Inc. | Misonix, Inc. | MND DIAGNOSTIC LTD. | Monogram Biosciences, Inc. | Nabi Biopharmaceuticals | Nanogen, Inc. | Nektar Therapeutics | Neogen Corp. | Nihon Kohden Corp. | NorDiag ASA | Novo Nordisk A/S | OLYMPUS CORP. | Omrix Biopharmaceuticals, Inc. | Onconome, Inc. | Optherion, Inc. | OraSure Technologies, Inc. | Orion Genomics | Ortho-Clinical Diagnostics Inc. | Osmetech plc | Otsuka Pharmaceutical Co. Ltd | | Oxford Nanopore Technologies Ltd | Oxonica plc | Pacific Edge Biotechnology Ltd | Panbio Limited | PerkinElmer, Inc. | Phadia AB | Photocure ASA | Power3 Medical Products, Inc. | PreMD Inc. | Progentech USA, Inc. | Qiagen N.V. | QLT Inc. | Quadraspec, Inc. | Quidel Corp. | Quotient Diagnostics Ltd | Response Biomedical Corp | Rosetta Genomics, Ltd. | SaNGOmo BioSciences, Inc. Satoris, Inc. | | Seattle Genetics, Inc. | Seegene, Inc. | SEIKAGAKU CORP. | SenoRx, Inc. | SensiGen, LLC. | Sequella, Inc. | Sequenom, Inc. | SeraCare Life Sciences, Inc. | Shimadzu Corp. | Shionogi & Co., Ltd. | Sigma-Aldrich Corp. | Singulex, Inc. | Span Diagnostics Ltd. | SQI Diagnostics Inc. | SurModics, Inc. | Sysmex Corp. | Target Discovery, Inc. | Targeted Diagnostics & Therapeutics, Inc. | | Techno Medica Co., Ltd. | Tethys Bioscience, Inc. | Thermo Fisher Scientific Inc. | Third Wave Technologies, | Thoratec Corp. | Trinity Biotech Plc | Tristan Technologies, Inc. | Tyrian Diagnostics Limited | United Therapeutics Corp. | Universal Biosensors, Inc. | Vasogen Inc. | Ventana Medical Systems, Inc. Verax Biomedical, Inc | | Vical Inc | Viragen, Inc. | VIRxSYS Corp. | Vivacta Limited | Warnex Inc. | Waters Corp. | Xenomic | | |

Source: Medical Devices Business Review
The cardiovascular IVD market
Cardiovascular diagnostics incorporate: cardiovascular disease risk assessment (cholesterol and lipid profile apolipoproteins B and A-1; lipoprotein (a)) cardiac inflammatory biomarkers (e.g. CRP, Lp-PLA2), cardiac markers of necrosis (e.g. CK-MB, myoglobin and troponin), coagulation markers (e.g. D-Dimer, prothrombin) and genetic markers of CVD (e.g. factor V Leiden, prothrombin 20210 G/A 210 and C677T MTHT).
In 2008, sales of cardiovascular IVDs accounted for around 25% of immunoassay test revenues, generating around $2.1bn and growing at around 10% per annum. In the PoC segment, cardiovascular diagnostics account for around $0.7bn in sales through cardiac biomarker monitoring and coagulation markers. The majority of sales are generated through cardiac disease risk tests (e.g. cholesterol testing, lipoproteins).
Figure 29: Cardiovascular Diagnostics – Market Segments (2008)

Source: Pharmavision.co.uk estimates
By 2015 we estimate the global cardiovascular diagnostic market will generate nearly US$6.6bn, primarily driven by growth in clinical biomarkers, the development of targeted therapies and associated companion diagnostics, the discovery and validation of genetic markers of cardiovascular risk and reimbursement of pharmacogenomic tests and prognostic tests.
This market continues to be driven by biomarker discovery and advances in new technologies which have lead to the: * Clinical validation of new biomarkers e.g. homocysteine, Apo A&B; * Development of companion diagnostic and theranostics; * Expansion of screening panels in a single test cassette providing a more comprehensive risk assessment; * Enhanced diagnostics such as high sensitivity CRP and BNP increasing their clinical utility; * Decentralization of hospital testing; * Migration to rapid testing and PoC to increase speed, diagnosis and treatment; * An increase in patient self testing, at home monitoring for therapy maintenance e.g. anticoagulant treatment.
Whilst many of the large IVD companies have been active within the cardiovascular diagnostics market, several smaller companies have specialized in this arena and identified cardiovascular biomarkers ripe for commercialization or company acquisitions. The following Tables (23 and .24) summarize some of these innovative small cap companies.
Table 23: Cardiovascular focused IVD companies Company | Profile, Cardiovascular Diagnostics, Pipeline & Alliances | Atherotech, Birmingham, UK www.atherotech.com | Atherotech is a privately held cardio-diagnostic company focusing on direct measurement of the comprehensive lipid profile using the company's VAP (Vertical Auto Profile) Technology The company provides its unique testing services to physicians, hospitals, clinics, and other laboratories. The VAP Test measures 15 separate components of blood cholesterol, also offers hsCRP and homocysteine tests. Atherotech has agreements with Any Lab Test Now, Source Scientific, LLC, Resverlogix Corp. and HealthCheckUSA. | Axis-Shield Plc, Dundee, UK (www.axisheild.com) | Axis-Shield Plc develops and manufactures IVDs for use in clinical laboratories and at the PoC specializing proprietary markers for diagnosis and management of critical illnesses e.g. cardiovascular disease. It operates in laboratory based IVD and PoC. It has a wide range of automated systems (Afinion system), immunoassay and proprietary markers which includes homocysteine. Expect to generate $10 million in 2009. It markets Axis-Shield enzymatic homocysteine assay, Homocysteine EIA and the AxSYM xtra D-dimer. It has forged alliances with Abbott Laboratories, Bayer Ag, Siemens (formerly Diagnostic Products Corporation), Quest Diagnostics Inc and Response Biomedical Corporation. | BG Medicine (formerly Beyond Genomics) (www.bg-medicine.com) | Discover and develop molecular diagnostics using high-throughput mass spectrometry, chromatography, and spectroscopy and multiplexed assay technologies for metabolic profiling and is y involved in biomarker discovery. It is developing Galectin-3 for HF and post MI (Abbott, Corgenix Medical Corp), AMD predict for acute atherothrombosis and LipiDx for lipid disorders. BG has collaborations with Abbott labs, AstraZeneca, Cordex Pharma, Corgenix Medical Corporation, ACS Biomarker and Philips. | Celera, Maryland, US (www.celera.com) | Develops and manufactures molecular diagnostic products for hospitals and clinical laboratories. In 2007 it acquired Atria Genetics and Berkeley HeartLab (BHL). BHL is a CLIA certified laboratory which offers 35 clinical diagnostic tests including assays for lipid profiling. BHL posted sales of around $100 million for 2008. Berkley lab provides laboratory testing in LDL, HDL, Lp(a) Apo A1 & B, hsCRP, fibrinogen, Lp-PLA2, homocysteine, ApoE and KIF6 genetic testing. Celera is developing KIF6 a market for CV risk and statin benefit, LPA for aspirin benefit, stroke and DVT biomarkers. Celera has alliances with Abbott Laboratories, Bayer Ag and other pharma companies. |

Source: Medtrack (accessed 2/2/10)
Table 24: Cardiovascular focused IVD companies (contd): Company | Profile, Cardiovascular Diagnostics, Pipeline & Alliances | Compugen Ltd, Tel Aviv Israel (www.cgen.com) | Compugen is a drug and diagnostic product candidate discovery company. It has developed a Diagnostic Biomarkers program utilizing predictive technologies, experimental processes and an integrated computational platform to discover and validate novel diagnostic biomarkers associated with cancer, cardiovascular disease, drug-induced nephrotoxicity and other conditions. It offers its products in the areas of Immunoassay Diagnostics, Drug-induced Toxicity, Biomarkers, Genomic Markers and Nucleic Acid Diagnostics. It has identified CGEN-114 an novel variant of Troponin I. Compugen has collaborations with Biosite, Medarex, Inc., Merck & Co., Inc., Ortho-Clinical Diagnostics, Roche, Siemens Healthcare Diagnostics and Teva Pharmaceutical Industries. | PGx Health, CT, US (www.pgxhealth.com) | PGxHealth is a division of Clinical Data and focuses on biomarker discovery. The company has developed biomarkers for cardiovascular disease. Its tests available include: 1) FAMILION tests detect mutations that can cause cardiac channelopathies and cardiomyopathies, rare, and Long QT Syndrome (LQTS). PGxHealth has collaborations with Lab21, Deutsches Herzzentrum Munchen Hospital, University of Pittsburgh, Blue Cross and Blue Shield Association. | PrognostiX Inc, OH, US (www.Prognostix.com) | A specialty laboratory and diagnostic company that develops and markets CV disease diagnostic products. It is spin out of the Cleveland Clinic Foundation. It markets CardioMPO in patients at risk for major adverse cardiac events, including MI, need for revascularization, or death. PrognostiX has partnerships with Inverness Medical Innovations Inc. | Response Biomedical Corporation Columbia, Canada (www.responsebio.com) | RBC develops, manufactures and markets rapid on-site diagnostic tests for use with its portable RAMP Platform – a portable scanning fluorescence reader and single-use, disposable Test Cartridges - for quantitative measurement of cardiac markers in the clinical setting. It markets RAMP cardiac panel includes NT-proBNP, Troponin I, Troponin, CK-MB, Myoglobin. It has alliances with Roche Diagnostics Corp, Cardio Medical Products, Inc, LXU Healthcare, Inc and 3M Co. |

Source: Medtrack (accessed 2/2/10)
The diagnostic imaging market
Diagnostic imaging refers to technologies that allow doctors to look inside the body for clues about a medical condition. The diagnostic imaging market (excluding services) was estimated to be worth around $42bn in 2008 and is growing by around 2%-3% per annum, with a forecast compound annual growth rate 2008-2012 of 2.9%.
Medical imaging is a technique or process used to create images of the human body for clinical purposes i.e. for a medical procedure such as stent implant, or to diagnose or examine the course of a disease such as atherosclerosis, a contributing factor for CVD. Around $20bn diagnostic imaging sales (+3% per annum) were derived from medical imaging around a quarter of which were spent on imaging diagnostics related to cardiovascular conditions, namely, acute coronary syndromes and stroke (for more details on medical imaging see RBI report).
The diagnostic imaging market is dominated by a handful of large cap healthcare companies which market a range of imaging modalities to aid the prevention and early detection of disease. Several companies such as Philips Healthcare and Siemens Healthcare have IVD divisions enabling them to provide “a one-stop shop” diagnostic service. Figure 30 summarizes the leading players and revenue stream for 2008.
Figure 30: Leading diagnostic imaging companies (2008)

Source: Company websites
No single imaging technology dominates the market although the usage of CT and MRI have increased during the last few years due to new product launches (e.g. dual source CT scanners) and growth in the emerging economies. There has been a significant growth in cardiovascular X-ray due to the introduction of new high performance, flexible platforms such as those from Philips (Allura Xper FD) and Toshiba (Infinix-I Series) and companies focusing on offering integrated Cath lab facilities.
Overall the imaging market is forecast to deliver low single-digit growth (2-4%) over the next five years due to increased prevalence of chronic diseases (cancer and cardiovascular disease), advances in new technologies, and their application, leading to an increase in productivity and a decrease in cost. Increasingly, companies will position themselves as a “one stop shop” offering a range of services from prevention, screening, diagnostics, treatment management, and surveillance. In addition, growth and investment in the emerging economies including China, India, Latin America and South Korea, will continue to drive sales allowing companies to focus on local market needs at affordable prices. These drivers will help to offset issues associated with pricing pressures and reimbursement changes and limited capital access of customers due to prevailing market conditions.
Figure 31: Leading diagnostic imaging – market segments (2008)

Source: Ruschowski, Philips Healthcare, May 2009
Aside from the large healthcare players numerous small to mid cap companies provide specialist services in imaging and supportive information technologies, some of which are tabulated in.
Table 25: Medical device manufacturers & suppliers in imaging 4-D Neuroimaging | Accelerator Nordic AB | Accuray Inc. | Advanced BioPhotonics Inc. | Advanced Diagnostics, Inc. | Agfa-Gevaert N.V. | Air Products and Chemicals Inc | Alfresa Holdings Corp. | Alliance Healthcare Services. | Aloka Co., Ltd. | Alpine Biomed Corp. | Alseres Pharmaceuticals, Inc. | Analogic Corp. | Arrow International, Inc. | ASKA Pharmaceutical Co., | ART Advanced Research Technologies, Inc. | Avid Radiopharmaceuticals, | | Bayer Schering Pharma AG | Biofield Corp. | BioImagene, Inc. | Bruker Corp. | BSN medical GmbH | Caliper Life Sciences Inc. | Carestream Health, Inc. | Ceradyne, Inc. | CIVCO Medical Solutions | CML Healthcare Income Fund | CompuMed, Inc. | Confirma Inc. | Cook Medical Inc. | Danaher Corp. | Del Global Technologies Corp. | Diagnosticos da America S.A. | Digirad Corp. | Dynatomics Ltd. | Elbit Imaging Ltd. | Endologix, Inc. | EP Limited | ESAOTE S.p.A. | Falco Biosystems Ltd. | FemSuite LLC. | FMI Technologies, Inc. | Fonar Corp. | FUJIFILM Holdings Corp. | FUJIFILM Medical Syst USA | Fukuda Denshi Co., Ltd. | Given Imaging Ltd. | Guerbet Group | Hologic, Inc. | IDEXX Laboratories, Inc. | Imaging Diagnostic Systems Inc. Imalux Corp. | IMMUNOMEDICS, INC | | InSightec Ltd. | Ivens S.A. | Konica Minolta Holdings, Inc. | LightLab Imaging, Inc. | Magna-Lab Inc. | MedCath Corp. | Mediscience Technology Corp. | Merit Medical Systems, Inc. | Michelson Diagnostics Ltd | Mindray Medical Int. Ltd | Mochida Pharmaceutical Co Ltd | MR Instruments, Inc. | Molecular Insight Pharmaceuticals, Inc. | Neoprobe Corp. | | Olympus Corp. | ONI Medical Systems, Inc. | Oxford Instruments plc | Paradigm Medical Industries Inc. Perceptronix Medical Inc. | PerkinElmer, Inc. | | Pindi Products, Inc. | Planar Systems, Inc. | Planmed Oy | Quantel Medical SA | RadNet, Inc. | Sectra AB | Shimadzu Corp. | SonoSite, Inc. | Spine Surgical Innovation | SuperSonic Imagine, SA | Swissray International, Inc. | Techniscan Medical Systems | Texas Instruments Inc | The Medipattern Corp. | Tomophase Corp. | TomoTherapy Inc. | Ultrasonix Medical Corp. | U-Systems, Inc. | Varian Medical Systems, Inc. | VCA Antech Inc | Viatronix Inc. | Viking Systems, Inc. | Vision RT Limited | Visual Pathways, Inc. | Vital Images, Inc. | Volcano Corp. | Wellstar International, Inc. | XCounter AB | Xoft Inc. | Zecotek Photonics Inc. | ZONARE Medical Systems, Inc. | | |

Source: Company websites
Leading IVD & imaging companies
Abbott, Illinois, US
Abbott (www.abbott.com) was founded in 1888 and has emerged as one of the most diverse healthcare companies in the world. It has three divisions: Medical Products, Nutrition Products and Pharmaceuticals, the Medical products division accounts for around 23% of global sales revenues ($7.2bn in 2008) and includes vascular devices (stents & cauterization products), PoC (i-Stat system for cardiac biomarkers etc), laboratory and molecular diagnostics (hospital, labs & clinics including blood screening and hematology platforms) and diabetes care.
Abbott has a comprehensive portfolio of cardiac tests including biomarkers to diagnose heart failure and myocardial infarction and provides blood screening instruments and tests to hospitals and reference laboratories using its laboratory based ARCHITECT, i1000SR and i2000SR platforms and as point of care and near-patient testing using its handheld i-STAT technology. In November 2009, Abbott and BG Medicine signed an agreement to develop and commercialize galectin-3, a novel biomarker for the detection of heart failure for analysis on i100SR and i2000SR instruments. In 2009 it acquired Solvay Pharmaceutical to expand its diagnostic franchise.
Beckman Coulter, California, US
Beckman Coulter (www.beckmancoulter.com) develops, manufacturers and markets biomedical testing products for the hospitals and critical care setting as well as life science research. Hospital laboratories remain its core clinical diagnostic customers and it has an installed base of more than 200,000 clinical and research systems in laboratories around the world.
In 2008, it recorded $3.1bn annual revenue from clinical diagnostics of which 78% was generated from consumable supplies (including reagent test kits), service and lease payments. In February 2009, BC acquired a lab-based diagnostic business from Olympus Corporation for approximately $800m to expand its chemistry and immunoassay automation technology platforms; allowing it access to high and ultra high throughput technologies AU480, AU680, and AU5400.
Becton Dickinson & Company, NJ, US
Becton Dickinson and Company (www.bd.com) was founded in 1897 and is a leading supplier of medical, biosciences and diagnostic products to healthcare institutions, life science researchers, clinical laboratories, industry and the general public. In the diagnostics arena it has become one of the leading providers of products for the safe collection and transport of diagnostic specimens, as well as instruments and reagent systems to accurately detect a broad range of infectious diseases, healthcare-associated infections and cancers.
Becton Dickinson has partnerships with Fujirebio, HyperBranch Medical Technology, Inc, LiDCO Group Plc, Health Canada, Arbor Vita Corporation, U.S. Genomics, Ivera Medical Corporation, 3DM, Inc, 3-D Matrix, Ltd., Ivera Medical Corporation and Accelr8 Technology. In 2006, the company acquired GeneOhn Sciences Inc for its rapid diagnostic technology, TriPath Imaging, to expand its geographical distribution, followed by Handylab in November 2009. bioMérieux, Marcy L’Etoile, France bioMérieux (www.biomerieux.com) provides IVDs for medical and industrial applications in microbiology, immunodiagnostics’ (including cardiac biomarkers) and molecular diagnostics for physicians and biologists. In 2008, it generated sales of €1.11bn with immunoassays contributing around 27% of sales (€304 million growing by +5.7% per annum). bioMérieux has extensive expertise in the development of biological assays of cardiovascular and infectious disease markers. It has developed a range of manual rapid immunoassay systems and reagents for emergency diagnostics (VIDAS and miniVIDAS), medium sized labs (VIDIA) and markets VIDAS emergency panel to assess cardiac markers of necrosis Troponin1, myoglobin, CK-MB and NT-proBNP for the diagnosis of ACS, the VIDAS D-Dimer exclusion which excludes DVT, PE and VTE.
In January 2010, it formed a strategic alliance with Philips to develop automated handheld devices to improve diagnosis and disease management in the critical care hospital setting, including emergency and coronary units. In the same month it acquired Meikang Biotech to expand its PoC diagnostic capabilities in the emerging markets and aims to position it to take advantage of future growth in theranostics. It has collaborations with Applied Biosystems, Inc., ProteoSys AG, The Foundation for Innovative New Diagnostics (FIND), University of Sunderland, Hitachi High-Technologies Corporation, Sequenom Center for Molecular Medicine, Inc. (formerly Center for Molecular Medicine), Shanghai Kehua Bio-Engineering Company Ltd and the Quidel Corporation.
GE Healthcare, New York, US
General Electric (GE) Healthcare (www.ge.com) was founded in 1915 and has become one of the leading healthcare providers in the world. It is a global leader in diagnostics and offers a suite of imaging technologies including X-ray, digital mammography, Computed Tomography (CT), Magnetic Resonance (MR) and Molecular Imaging technologies. In 2009 it generated $16bn in global revenues of which $9bn was generated in its healthcare division. It spent over $1bn on innovative research which enables it to maintain cutting edge research in novel neurological diagnostics (e.g. stroke) and is building a prominent leadership in clinical software.
It states its primary mission as the “early detection and prevention of disease and over the next few years the company expects to increase shareholder value by focusing on cost savings, improving access to its technologies and improving the quality of the services it offers by reducing medical error, improving diagnostic capability, providing remote medicine and monitoring and enhancing early disease detection.
In the cardiovascular arena GE has developed its integrated cardiac solution, helping doctors to predict, diagnose, inform and treat heart disease including cath lab technology, diagnostic ECGs, cardiac imaging (digital cardiac X-ray, echocardiography, CT, RMI and nuclear), cardiovascular information management systems and telemetry products.
In September 2008, it initiated an R&D program in heart disease imaging agents with the National Cancer Institute and National Institute of Health, the US Department of Health and Human services. Since 2009 it established co-marketing agreements in the CardioArena and Centricity Cardiology with TomTec and Innova Cardiovascular X-ray Systems with Boston Scientific and LightLab Imaging.
Hitachi Medical Corporation, Tokyo, Japan
Hitachi Medical Corporation (HMC; www.hitachimed.com) is headquartered in Japan and supplies diagnostic and medical imaging products throughout the world including MRI, CT, US, X-ray and Optical topography. Hitachi Medical Systems America (HMSA) was established in 1989 and markets and sells HMCs technology in the US. It is a leading developer of Open MRI (e.g. Oasis Echelon AIRIS and VOSI technology) and also offers Hi-resolution Ultrasound (e.g. EUB-405 and EUB-8500) and Computed Tomography products (e.g. ECLOS16).
It also markets multi-slice CT system Presto, The helical CT system Pronto and Digital X-ray products with the relevant software requirements. The company's Optical Topography measures and images dynamically the hemoglobin levels in the brain during functional activity whilst its MRI technology can provide high resolution brain ischemia assessment (NeuroSuite). In October 2008 Hitachi Medical signed a letter of intent with TomoTherapy to distribute the Hi Art cancer treatment system in Japan.
Inverness Medical Innovations, Inc., MA, US
Inverness (www.invernessmedical.com) develops, manufactures and markets consumer medical diagnostic products for the over-the-counter pregnancy and fertility/ovulation test market and the rapid point of care diagnostics, focusing on cardiology, infectious diseases, oncology, drugs of abuse and women's health. It also manufactures and markets a wide variety of vitamins and nutritional supplements.
The company generated sales of $1.67bn in 2008 of which 34% was generated from cardiology based products. Inverness provides ELISA, IFA and serology test for the laboratory and hospital use including well known brands: Cholestech LDX for complete lipid profiling and high sensitivity C-reactive protein (hsCRP); INRatio to monitor prothrombin time (PT) for oral coagulation management and the Triage System which includes cardiovascular tools (BNP, CK-MB, myoglobin, troponin, D-dimer) to aid in the diagnosis and assessment of heart failure and acute myocardial infarction and in risk stratification in acute coronary syndromes and heart failure or thromboembolic events including pulmonary embolism (PE) and DVT.
In 2009, it acquired Concateno plc and in January 2010 made a bid for Standard Diagnostics, a rapid diagnostic company in Korea. It has formed alliances with Epocal, the developer of SmartCard Technology for Blood Analysis. It has clinical trials under way for at-home BNP testing for CHF population using wireless enabled features to transmit data.
Johnson & Johnson, NJ, US
J&J (www.jnj.com) operates three divisions: consumer health, pharmaceuticals and medical devices and diagnostic. Its medical devices & diagnostics segment focus’ on products which target: blood glucose monitoring and insulin delivery, sutures, wound care, diagnostics, spinal care and sports medicine. In 2009 the company generated global revenue of $61.9bn of which 38% was generated from its medical device and diagnostics division ($23.6 bn, +1.9%).
Ortho Clinical Diagnostics (revenues $1.5bn, +9%) and Cordis (Biosense Webster revenues $2bn, +11%) are J&J companies which operate in the diagnostic arena. Ortho Clinical Diagnostics has developed high throughput and ultra high throughput immunoassay platform technology, VITROS 3600 and 5600 systems and continues to expand its array of assays through the acquisition of new biomarkers.
J&J continues to expand its franchise through acquisition which included Accalrent, Finsbury orthopedics and Gloster Europe during 2009 and expanded its R&D capabilities in China and India and manufacturing facilities in Brazil, China and India whilst offering surgical training centers in all the BRIC countries. The Company also announced that it had received FDA clearance for marketing the CARTO3 System, an advanced 3D imaging technology for use by electrophysiologists in treating cardiac arrhythmias. In June 2008, Nordic AB (a J&J company) acquired Amic, a privately held Swedish developer of IVDs for use in PoC and near patient testing, for around $40 million.
Philips Healthcare, Amsterdam, the Netherlands
Royal Philips Electronics (www.healthcare.philips.com) of the Netherlands is a diversified health and well-being company and through the integration of technology and design it has become one of the market leaders in cardiac care, acute care and home healthcare. Philips Healthcare division accounts for approximately 34% of global sales revenues (€7.84bn in 2009, +2%) and focuses on disease prevention from screening and diagnosis, through to treatment, monitoring and health management, both at home and in the clinical setting.
Philips Imaging Systems generated 32% of sales offering a suite of imaging modalities including: CT, MRI, PET, SPECT, US and X-Ray as well as mixed modalities (e.g. SPECT/CT; BrightView XCT), preclinical imaging solutions (e.g. MOSAIC HP; NanoSPECT/CT) and access to its novel Magnetic Particle Imaging (MPI) technology.
Philips’ current portfolio includes a full range of diagnostic tools (e.g. medical imaging, ECG and vital function monitoring) to support healthcare providers in identifying high-risk cardiac patients during the early stages of disease from MR angiography, and cardiac CT through to an integrated Cathlab and EP lab solutions. Since 2007 it has been working with Imarx Therapeutics on a co-develop research program on the development of cardiovascular drugs to treat stroke. In January 2010 the company established a partnership with bioMérieux to develop and market handheld diagnostic solutions for PoC diagnostics in emergency departments, coronary units and ICU – novel products from this alliance are anticipated by 2013.
Roche, Basel, Switzerland
Roche (www.roche.com) is focused on two healthcare areas, pharmaceuticals and diagnostics. In 2009 it generated sales of CHF 10.1bn and invested over CHF1bn in R&D, it is the worlds largest IVD Company with around 20% share of the IVD market generated by a broad portfolio of products for early detection and diagnosis. Roche Diagnostics' segments include professional diagnostics (45%), diabetes care (29%), molecular diagnostics (12%), applied science (9%) and tissue diagnostics (5%).
It markets a range of point-of-care products including: Accu-Chek for diabetes care, CoaguChek Systems for blood coagulation monitoring as well as high throughput technology platforms using its Cobas AmpliScreen System for the screening of blood products. It has established collaborations with Fujirebio Diagnostics, Inc. (formerly Centocor Diagnostics, Inc.), NorDiag ASA, Exiqon A/S, The National Jewish Medical and Research Center, AGOWA, LGC Limited (Laboratory of the Government Chemist) and Agilent Technologies Inc.
In April 2009 it acquired Innovatis AG, an automated cell analysis solutions company and Swisslab GmbH, a laboratory information system company in December 2008. It continues to improve its operational efficiency and has expanded its range of decentralized tests including, coagulation monitoring products for health professionals and patients and its cardiac troponin test to detect MI in heart attack patients.
In August 2009 it began to roll out its Cobas 8000 series for high throughput analysis in Europe and launched four new blood glucose monitoring systems. Meanwhile it continues to expand its molecular diagnostic blood screening portfolio as a future growth area.In September, Roche licensed GDF-15 from St Vincents Hospital Sydney as a potential new biomarker for cardiac dysfunction to support its expansion into the cardiac diagnostic arena.
Siemens Healthcare, Berlin & Munich, Germany
Siemens (www.siemens.com) is headquartered in Germany (Berlin and Munich) and offers diversified services throughout the world in building, energy and automation, healthcare and other businesses. Its healthcare division supports a range of diagnostic imaging and therapy products including: CT, MRI, PET and US, as well as specialized imaging technologies such as angiography, mammography, molecular imaging and surgical C-arms and navigation and their respective IT software.
Through the strategic acquisition of Diagnostic Products Corporation in April 2006, Bayer Healthcare Diagnostics in June 2006 and Dade Behring in July 2007, the company now offers an integrated imaging, laboratory diagnostics, therapy and IT solution to the healthcare service. Siemens Healthcare accounts for around 15 percent of global Siemens sales and reported revenues of €11.9bn in 2009 with €7.15bn derived from its imaging and IT division and invested over €700 million in R&D to continue to deliver innovative technologies in the marketplace.
During 2009 it launched its 3D/4D Acuson X300 ultrasound system to improve the detection of fetal cardiac anomalies for better clinical prognosis and the Acuson SC2000 for volume imaging ultrasound. In 2009 it generated revenues of €3.49bn from its diagnostics division and spent €300m on R&D from the sale of its Stratus CS range (include cardiac biomarkers) and launched the Innovance Antithrombin, a new test for determining congenital and acquired antithrombin deficiency, expanding its cardiac testing platforms which include Innovance D-Dimer and CardioPhase hsCRP. It renewed its agreement with Sysmex on the global distribution of anticoagulation test products and expanded its RAPIDpoint blood gas analyzer platforms.
Toshiba Medical Systems Corporation, Tokyo, Japan
Toshiba medical Systems Corporation (www.toshiba-medical.co.jp) is headquartered in Tokyo, Japan and is a world leader in high technology equipment including information and communication, household appliances and healthcare equipment. Toshiba America Medical Systems markets, sells, distributes and services diagnostic imaging services in the US. It is a leading developer of CT systems (Aquillon Series), MRI (Vantage Series), Ultrasound (Aplio, Viamo) and X-ray (Infinix series) as well as image management systems and dual detector systems (Radrex-I radiographic system). In recent years the company has launched a variety of cardiovascular imaging devices, including Aplio Artida, for 4D cardiac ultrasound imaging, a five-axis cardiovascular X-Ray system and its Vantage magnetic resonance system, which provides a contrast-free solution to MR angiography. In December 2009 it showcased its Aquilion ONE, a dynamic volume CT system for monitoring stroke patients
M&A activity
Despite tough market conditions there has been considerable M&A activity within the diagnostic arena as companies reposition themselves in growth areas (e.g. emerging markets, molecular diagnostics & imaging) and take advantage of new technologies (diagnostic biomarkers, theranostics) and additional diagnostic modalities (MRI, X-ray).
During the last few years there has been considerable consolidation within the diagnostic industry following the acquisition of Diagnostic Products Corporation in 2006 and Bayer Diagnostics and Dade Behring in 2008 by Siemens Healthcare, Roche’s acquisition of Ventana Medical Systems (2008) and Beckman Coulter’s acquisition of Olympus Corporation (2009), Inverness Medical Innovations of Biosite (2007), ACON Labs (2009) and Standard Diagnostics (2009).
Table 26 summarizes recent M&A activity in the cardiovascular diagnostic field and highlights recent acquisitions throughout the globe from leading IVD players and imaging companies.
In the IVD arena, companies such as bioMérieux, Beckman Coulter, PerkinElmer, Inverness Medical Innovations and Siemens Healthcare, have expanded their global footprint to take advantage of double digit growth in the emerging economies including China, India, Japan, Singapore and South Korea.
Conversely, others have acquired assets and technologies to expand their product repertoire such as Quidel Corp/Diagnostic Hybrids, Qiagen/DxS, LabCorp/Monogram Biosciences, Lab21/Plasmatec Lab Products, Inverness Medical Innovations/ACON Labs lateral flow technology, Quest Diagnostics/Pathway Diagnostic Corp, Veridex/Immunicon Corporation, DiaSorin/Biotrin, bioMerieux/Ab Biodisk and J&J/Amic AB.
Advances in rapid testing and biosensor technologies have attracted investor from IVD manufacturers to complement their existing platforms and these include Becton Dickinson’s acquisition of Handylab and Lab21’s acquisition of Biotec Labs, which increased their exposure in the rapid testing PoC market.
Meanwhile diagnostic imaging companies have made strategic purchases in novel technology platforms GE Healthcare/ONI Medical Systems, Philips/Meditronics, Philips/AlphaX-ray Technologies and Bruker AXS/SIS GmbH.
Given the economic environment and healthcare reforms, it seems likely that diagnostic orientated companies will continue to look for investment opportunities within the healthcare industry to support and expand their business strategies, providing a more holistic approach to diagnostics.
Table 26: Recent M&A activity in the cardiovascular diagnostic arena Date | Acquirer | Target | Summary | Jan-2010 | bioMérieux SA | Meikang Biotech | bioMérieux SA has acquired Meikang Biotech, a China-based manufacturer of rapid diagnostic tests, and Meikang’s large production site in Shanghai. | Jan-2010 | Quidel Corporation | Diagnostic Hybrids, Inc. | Quidel Corporation, a provider of PoC diagnostic tests, has entered into a definitive agreement to acquire Diagnostic Hybrids, Inc., a developer, manufacturer and marketer of cellular and molecular diagnostic kits, for a cash consideration of approximately $130 million. | Nov-2009 | GE Healthcare | ONI Medical Systems | GE Healthcare, a UK-based provider of medical technologies and services, has acquired MRI technology platform from ONI Medical Systems, Inc., a US-based developer of MRI systems. | Nov-2009 | Becton, Dickinson & Co | HandyLab, Inc. | BD has acquired HandyLab, Inc., a developer and manufacturer of molecular diagnostic assays and automation platforms, for $275 million. | Oct-2009 | Thermo Fisher Scientific | B R A H M S Aktiengesellschaft | Thermo Fisher Scientific, Inc. has acquired all issued shares of B.R.A.H.M.S Aktiengesellschaft from Switzerland-based venture capital firm HBM BioVentures and B.R.A.H.M.S management team for EUR330 million in cash. | Sep-2009 | QIAGEN N.V. | DxS, Ltd. | Qiagen N.V., a Netherlands-based provider of sample and assay technologies, has acquired all of the outstanding share capital in DxS, Ltd., a UK-based personalized medicine company, for approximately $130 million. | Sep-2009 | PerkinElmer SiNGOpore Pte., Ltd. | Sym-Bio LifeScience Co Ltd. Inc., | PerkinElmer Singapore Pte., Ltd., a Singapore-based subsidiary of PerkinElmer, has acquired all of the outstanding shares in Sym-Bio LifeScience Co., Ltd., a China-based diagnostic product company. | Aug-2009 | SonoSite, Inc. | CardioDynamics International Corporation | SonoSite, Inc., acquired all of the outstanding shares of CardioDynamics International Corp a developer, manufacturer, and marketer of ICG sensors. The transaction is valued at approximately $12.3 million, including assumption of approximately $2.3 million of net debt. |

Source: Medtrack (accessed 02/02/10)
Table 27: Recent M&A activity in the cardiovascular diagnostic arena (contd) Date | Acquirer | Target | Summary | Aug-2009 | Laboratory Corporation of America Holdings | Monogram Biosciences, Inc (formerly ViroLogic, Inc.) | LabCorp acquired all the outstanding shares of Monogram Biosciences, Inc which develops molecular diagnostic products for the treatment of infectious diseases, cancer, and other diseases. The transaction is valued at approximately $106.7 million | Aug-2009 | Inverness Medical Innovations Inc | Standard Diagnostics, Inc | IMI commenced a cash tender offer to acquire up to 75.79% of the issued shares of Standard Diagnostics, Inc., a South Korea-based manufacturer and distributor of pharmaceutical products, at a price of KRW30,000 ($24.65) per share. Inverness Medical launched a tender offer to acquire a 40.45% stake in Standard Diagnostics for a consideration of KRW97,080 million ($79.8 million). | Aug-2009 | Beckman Coulter, Inc. | Olympus Corporation | BC acquired the lab-based diagnostics business of Olympus Corporation for a cash consideration of approximately JPY76,000 million ($803.09 million). Olympus is a Japan-based manufacturer and marketer of precision machineries and instruments. | May-2009 | Royal Philips Electronics | Traxtal Inc | Philips acquires Canada-based Traxtal Inc developer of minimally-invasive instruments and software for image-guided intervention and therapy (IGIT) | May-2009 | Lab21, Ltd. | Plasmatec Laboratory Products | Lab21, Ltd. acquired Plasmatec Laboratory Products, Ltd., from Axis-Shield plc | May-2009 | ELITech Group | Nanogen, Inc | The Elitech Group, a French diagnostics company, acquired the assets of IVD developer Nanogen, Inc. The transaction is valued at $25.7 million. | Mar-2009 | Inverness Medical Innovations Inc. | ACON Laboratories, Inc | IM Innovations signed a definitive agreement acquire ACONs lateral flow immunoassay and PoC technology. The transaction was value at approximately $200 million | Mar-2009 | Lab21, Ltd. | Biotec Laboratories Limited | Lab21, Ltd., acquired a majority stake in Biotec Laboratories Limited, a rapid diagnostics business | Feb-2009 | GE Healthcare | Dynamic Imaging | GE acquired Dynamic Imaging to expand its imaging informatics business | Feb-2009 | Beckman Coulter, Inc. | Olympus Corporation | Beckman Coulter receives Federal Trade Commission approval to acquire | Jan-2009 | Abbott Laboratories | Ibis Biosciences, Inc. | Abbott Laboratories acquires remaining 81.4% stake in Ibis Biosciences from Isis Pharmaceuticals | Dec-2009 | Quest Diagnostics Inc | Pathway Diagnostics Corp | Quest Diagnostics Incorporated acquired Pathway Diagnostics Corporation biomarker assay development, validation, and testing services |

Source: Datamonitor
Table 28: Recent M&A activity in the cardiovascular diagnostic arena (contd) Date | Acquirer | Target | Summary | Nov-2008 | Philips Electronics | Meditronics | Royal Philips Electronics acquired Meditronics, an India-based manufacturer of X-Ray systems. | Sep-2008 | GE Healthcare | Varian Inc | Varian Inc. and GE Healthcare ink medical imaging deal | Sep-2008 | Siemens Healthcare Diagnostic | Dade Behring. Diagnostic India Pvt., Ltd | Siemens Healthcare Diagnostics acquire dDade Behring Diagnostic India Pvt., Ltd for an estimated price of INR430 million ($9.44 million) | Sep-2008 | Philips Electronics | Alpha X- Ray Technologies (I) Pvt., Ltd. | Royal Philips Electronics, signed an agreement to acquire Alpha X-Ray Technologies, an India-based manufacturer of cardiovascular X-Ray systems. | Aug-2008 | Bruker AXS GmbH | S.I.S. Surface Imaging System GmbH | Bruker AXS GmbH, acquired S.I.S. Surface Imaging Systems GmbH (S.I.S.), a Germany-based manufacturer and distributor of atomic force/scanning probe microscopy systems. S.I.S. would be renamed as Bruker Nano GmbH. | Jul-2008 | Alliance HealthCare | Medical Outsourcing Services | Alliance Imaging, Inc., acquired Medical Outsourcing Services, LLC a | | Services, Inc. | | radiation therapy services, has a mobile provider of PET/CT, for approximately $20 million in cash and assumed indebt. | Jul-2008 | DiaSorin S.p.A. | Biotrin International | DiaSorin S.p.A., signed an agreement to acquire Biotrin International, a diagnostics company. The overall payment, totally financed by existing credit lines, amounts to about EUR25 million. | Jul-2008 | St. Jude Medical, Inc. | EP MedSystems, Inc. | St. Jude Medical, Inc., acquired EP MedSystems, Inc., a developer and marketer of cardiac electrophysiology (EP) products. | Jun-2008 | Liponex, Inc. | ImaSight, Inc. | Liponex, Inc., a biopharmaceutical research company, has acquired all of the issued and outstanding shares of ImaSight, Inc., a developer and supplier of digital radiography solutions for human and animal healthcare. | Jun-2008 | bioMérieux SA | AB BIODISK | bioMérieux sa acquired AB BIODISK, a vitro diagnostics company that develops and manufactures products for antimicrobial susceptibility testing. | Jun-2008 | J&J Nordic AB | Amic AB | Johnson & Johnson Nordic AB, acquired Amic AB, a developer of IVD technologies, from Venture capital firms InnovationsKapital and Investor Growth Capital. |

Source: Medtrack (accessed 02/02/10)
Recent collaborations & agreements
During the last 18 months diagnostic companies have been keen to collaborate with leading institutes on the discovery and development of cardiovascular biomarkers for diagnostic commercialization, including galectin-3, kinesin-like protein 6 (KLP-6) and growth-differentiation factor-15 (GDF-15) in a variety of CV conditions. Others have pursued research programs to determine genetic variants that are associated with specific CV conditions such as atrial fibrillation, cardiomyopathy and stroke (Table.28).
Several biomarkers are ripe for commercialization and deals have been struck with leading players in order to optimize their market exposure, this includes BG Medicine’s agreement with Abbott on galectin-3 and Response Biomedical Corporation’s agreement with Roche on NT-proBNP tests. Biomarker research is likely to remain high on the agenda for all IVD players now and for the foreseeable future; continuing to fuel strategic alliances with academia, biomarker discovery companies and diagnostic developers.
In diagnostic imaging, industry leading companies have forged strategic alliances with IT companies to improve data acquisition and workflow between imaging modalities, such as LightLab and GE Healthcare or to co-develop new products such as Toshiba’s and Vital images Aquilion ONE CT scanner. Abbott and Angioblast are also involved with developing new catheters for stem cell delivery.
Several companies have re-established distribution deals with numerous outlets to improve the global exposure of leading brands such as GE Healthcare with TomTec with its Innova Cardiovascular X-ray system. Interestingly in January 2010 Philips and bioMérieux entered into a partnership to develop PoC diagnostics for hospital, emergency department, coronary unit and ICU. They will combine their expertise in cardiac care, biomarker discovery and technology platforms (VIDAS and Magnotech biosensor platform) to gain a foothold in the rapidly growing PoC market (+10% per annum). The companies anticipated launching their first PoC product by 2013.
Table 29: Recent collaborations in the cardiovascular arena Date | Source | Partner(s) | Area of Interest | Jan-2010 | bioMérieux | Philips | Partnership to develop and market handheld diagnostic solution for PoC diagnostics in emergency, coronary units and ICU. | Nov-2009 | BG Medicine, Inc. | Abbott Laboratories | Commercialization and development of Galectin-3 a biomarker for heart failure | Oct-2009 | Berkeley HeartLab, Inc. | Proven Diagnostics | Berkeley HeartLab and Proven Diagnostics to co-market cardiovascular tests Kinesin-like protein 6 (KIF6) | Sep-2009 | Athera Biotechnologies | AB ALPCO Diagnostics | Distribution of cardiovascular disease biomarker, CVDefine | Sep-2009 | St Vincent's Hospital Sydney Ltd | Roche Holding AG | Acquired IP for cardiovascular diseases on growth-differentiation factor-15 (GDF-15) | Jul-2009 | BOUTY | Tor Vergata University | Development of the Loxin test, a genomic marker for atherosclerosis | Jun-2009 | Roche NimbleGen, Inc. | University of Miami | Research project on genetic variants associated with dilated cardiomyopathy | Apr-2009 | Perlegen Sciences, Inc. | Celera Group | License genetic diagnostic IP for coronary heart disease | Apr-2009 | deCODE genetics | Celera Group | License genetic markers for heart attack, atrial fibrillation, stroke, Type II diabetes | May-2009 | LightLab Imaging | GE Healthcare | Collaborate to improve workflow between Innova cardiovascular X-ray system | Mar-2009 | BG Medicine, Inc. Boston University NIH | NHLBI, NGO The US DHHS | Co development and research program on biomarker discovery studies for Heart diseases, metabolic syndrome | Jan-2009 | Sysmex | Siemens Healthcare | Renewed agreement on global distribution of anticoagulation test products | Jan-2009 | TomTec imaging | GE Healthcare | Establish co-marketing agreements with GE’s Innova Cardiovascular X-ray systems Centricity Cardiology | Jan-2009 | Hannover Medical | School Roche Holding AG | Acquisition of cardiovascular diseases of Growth-Differentiation factor-15 | Jan-2009 | -- | Toshiba Corporation Vital Images Inc | Co development license for AquilionONE CT scanner for heart disease |

Source: Medtrack (accessed 02/02/10)
Table 30: Recent collaborations in the cardiovascular diagnostic arena (contd) Date | Source | Partner(s) | Area of Interest | Dec-2008 | Newfound Genomics Inc. | Clinical Data Inc PGxHealth | Marketing of Arrhythmogenic Right Ventricular Cardiomyopathy test | Dec-2008 | Protagen AG | Bayer HealthCare AG | Development agreement on Atrial Fibrillation using UNIarray Technology | Sep-2008 | NCI/NIH | GE Healthcare | Initiated a R&D program in heart disease imaging agents | Sep-2008 | OmniSonics Medical Technologies, Inc | Boston Scientific Corp | Codevelopment license for OmniWave technology for thromboembolics | Aug-2008 | Corgenix Medical Corp | BG Medicine, Inc. | Supply IgG Anti-AtherOx Kit Diagnostic kits for Myocardial infarction | Jul-2008 | Inverness Medical Innovations Inc | Thermo Fisher Scientific Inc. | Distribution agreement for cardiology tests cardiology tests | Jun-2008 | Response Biomedical Corp | Roche Holding AG | Commercialization of RAMP NT-proBNP Test, Troponin I (TnI) assay to diagnose heart failure and myocardial infarction | Mar-2008 | Vermillion, Inc. | Stanford University | Biomarker panel for commercialization & development of a PAD blood test | Feb-2008 | Interleukin Genetics Inc | Alticor Inc Access Business Group LLC | Development of cardiovascular disease genetic tests | Feb-2008 | Angioblast Systems, Inc. | Abbott Laboratories | Collaboration on catheter-based cell therapy for heart failure catheter-based cell therapy | Feb-2008 | ACS Biomarker b.v. | BG Medicine, Inc. | Commercialization of diagnostic technology for acute atherothrombosis |

Source: Medtrack (accessed 02/02/10)
Recent product launches & trends
Cardiovascular in vitro diagnostics
The use of IVDs continues to grow due to physician demands for more rapid and effective diagnostics for acute and chronic cardiovascular conditions resulting in a more comprehensive risk assessment and diagnosis. Technological advances in immunoassays have improved the sensitivity and specificity of first generation tests leading to the development of high sensitivity tests, CRP and troponin, which have greater clinical utility. This in turn has lead to improvements in patient outcomes whilst reducing healthcare costs.
Table 31: Recent product launches in cardiovascular IVDs Company | Product launches | BioMérieux | High performance VIDAS troponin I ultra | diaDeux | PLAC test | Roche Diagnostic’s | hsElecsys Troponin T and Troponin I assay for heart attack and cardiac risk stratificationCardiac pro-BNP testCobas h232 portable cardiac marker systemCobas 8000 analyzer for high throughput large labsCobas 6000 analyzer for mid size labsTwo new clinical chemistry modules c701 & c 502Expand immunochemistry menu to include: PlGF/SFlt1 & IL-6 | Siemens (Dade Behring) | CardioPhase hsCRP test for multiple testing platformsHomocysteine test on BN SystemhsTroponin I assayInnovace Antithrombin testHigh throughput integrated systems Dimension Vista 5000 and Dimension ExLHigh throughput immunoassay Immulite 2000 XPi and ADVIA Centaur CP |

Source: Company website
Companies continue to upgrade laboratory based immunoassay technologies migrating from high throughput to ultra throughput to reduce sample size, reagent volumes and reduction price per test. (e.g. Roche’s cobas 8000 analyzer and Siemens Dimensions Vistas 5000). Meanwhile the adoption of new biosensor technologies has driven innovation within the PoC diagnostics segment to meet the ever increasing demand for portable, self-testing devices (e.g. Siemens CardioPhase) as patients take a more active role in monitoring risk factors and maintaining coagulation therapy. The identification of new cardiac biomarkers (e.g. PLAC) has lead to their incorporation into new test panels as companies perform cost benefit analysis to ensure uptake and reimbursement.
Cardiovascular diagnostic imaging
During the last year many new diagnostic imaging platforms and software programs have been launched onto the market to aid in the detection and diagnosis of a host of diseases including cardiovascular diseases. Table 31 summarizes some of these recent product launches from leading healthcare companies.
Advances have been made in all imaging modalities, particularly in MRI, CT and ultrasound where the instrumentation and software has enabled more rapid and high resolution imaging. GE Healthcare launched Discovery NM/CT 670 using its new cadium zinc telluride and Alcyone technology and Philips Brightview XCT, SPECT –CT hybrid systems. Whilst the installation base for this technology is still small Dr Marc Gheerart, International BL Director Nuclear Medicine, Philips Healthcare believes;
“that over the next 2-5 years this technology has the potential to reduce surgical intervention and improve diagnosis ultimately providing a complete diagnosis guide therapy solution.”
Many systems have become more portable and miniaturized improving their utility both in the clinic and the hospital setting this is particularly true for ultrasound and ECG technologies, which have witnessed a new lease of life due to high tech algorithms and the adoption of wireless technology (e.g. GE’s MAC 800 and MAC 1600).
Increasingly, companies have made improvements in the patient care and management cycle providing the technology and workflow platforms to enable the smooth transition between point of contact with the patient, ambulance, admission and diagnosis through to surgical intervention. For example Siemens and Philips have designed hybrid operating rooms enabling a patient to undergo rapid diagnosis and treatment in a single suite.
There are several examples where cardiovascular instrumentation has been developed which is “fit for purpose,” for example, the development of a 3D transeosophageal echocardiogram probe from Philips offers considerable advantages over existing fluoroscopy technologies and according to Dr Joris van den Hurk Vice President Cardiology Programs, Philips Healthcare;
“this instrument will revolutionize structural intervention procedures (e.g. heart valve replacements), due to its exquisite image quality and ability to detect aortic leakage.”
Table 32: Recent product launches in diagnostic imaging Company | Product launches | GE Healthcare | | Feb-10 | VScan pocket sized visualization PoC testing | Jan-10 | Discovery Nm 530c a new cadium zinc telluride cardiology camera with Alcyone reconstruction technology | Dec-09 | Digital X-ray Discovery XR650 & Optima XR 460 | Dec-09 | 3D multimodality workstations | Oct-09 | Discovery NM/CT 670 new slim line hybrid CT-SPECT system | Apr-09 | Lightspeed VCT provide 70% lower exposure in Cath Lab | Apr-09 | New cardiac CT unveiled at ACC | Apr-09 | Portable ECG innovation MAC 800 and MAC 1600. | Mar-09 | New portable ECG with medical texting | Philips | | Dec-09 | Interventional vascular X-ray Allura Xper FD20 & DoseAware | Sep-09 | Philips and Maquet integrated solutions for minimally invasive surgery | Sep-09 | ‘3D Heart Navigator’ interventional tool; | Oct-09 | HYPERimage advances PET-MR scanner | Aug-09 | ECG PageWriter TC50 cardiograph | Jul-09 | Mobile C-arm with flat detector for surgical X-ray procedures | Jun-09 | BrightView XCT a SPECT/CT Hybrid | Jun-09 | 3D transeosophageal echocardiogram probe | Mar-09 | Philips Heartstart MRx Support Fast Triage of Stemi Patients | Mar-99 | Philips Utilization Services' optimize workflow | Mar-09 | Achieva 3.0T TX | Siemens | | Feb-10 | New functional imaging cerebral blood flow | Dec-09 | Acuson Sc2000 echocardiography system | Nov-09 | Magnetom Skyra 3T scanner | No 2009 | New PACS system | Oct-09 | Somatom Definition Flash CT | Oct-09 | Hybrid operating rooms | Sep-09 | SurgiVision MRI guided cardiac electrophysiology | Aug-09 | SyNGO Dyna CT Cardiac 3D imaging | Jun-09 | Dual source Somaton Definition CT | May-09 | syNGO iFlow digital subtraction angiography | Toshiba Medical Corporation America | | Feb-10 | Viamo US system cleared by FDA | Jan-10 | Install first vascular X-ray | Dec-09 | New hybrid catheritization table 55-axis X –ray line | Dec-09 | Aquilion one advanced capabilities for Stroke | Nov-09 | Ultra portable US with new laptop system | Nov-09 | 3T mR system | Oct-09 | Mid-sized US system | Sep-09 | CV-3D for infinix CV |

Source: Company websites

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