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ReportLinker Find Industry reports, Company profiles and Market Statistics >> Download this market research report on Reportlinker.com United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Covering Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Published on May 2008 Report Summary United States In Vitro Diagnostics Industry Report Summary This report is an essential source for in-depth information and data relating to the USA In Vitro Diagnostics devices market. I t also offers detailed and comprehensive coverage of market revenue, volume, distribution and company share information; and latest news, financial deals and pipeline products information of each of the key sub-segments of the In Vitro Diagnostics in USA Scope ' The report provides sector information broken down into detailed categories and segments in country. ' Total revenues, products sold, end users, and average pricing.
' Market shares of all the key competitors. ' Key pipeline products that are set to shape the market, broken down by sector. ' Information on the top medical equipment companies in the sector in the country covering business description, strategic anal ysis, and financial information.
' Healthcare structure, regulatory environment, approval process, pricing ... more.
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trends and reimbursement. ' Product and brand updates, strategy changes, R&D projects, corporate expansions and contractions and regulatory changes. ' Key mergers and acquisitions, partnerships, private equity investments and IPOs.<br><br> ' Customer, hospitals and physicians data. Reasons to buy ' Gain a strong understanding of the industry at a global level, with break downs for the country ' Evaluate and compare the attractiveness of the market in the country. ' Identify growth segments and opportunities in each industry sector within the country.<br><br> ' Evaluate the pipeline of key products that will change the sector, and identify threats and opportunities before the products are launched in the country. ' Analyze the competitiveness of the market in the country and identify hotspots. ' Develop strategies based on the latest product, brand, expansion and research and development news in the country.<br><br> ' Do deals with an understanding of how competitors are financed, and the mergers and partnerships that have shaped the market in the country. ' Identify and analyze the strengths and weaknesses of the industry incumbents in the country. United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 1/12 ReportLinker Find Industry reports, Company profiles and Market Statistics Table of Content 1 Table of Contents 2 1.1 List of Tables 14 1.2 List of Figures 20 2 Introduction 25 2.1 What Is This Report About' 25 2.2 Definitions 25 2.2.1 In Vitro Diagnostics 25 3 Healthcare Sector Review 33 3.1 Healthcare Expenditure 33 3.2 Healthcare Infrastructure 38 3.2.1 Healthcare Personnel Data 40 3.2.2 Healthcare Facilities Data 44 4 In Vitro Diagnostics in United States 46 4.1 In Vitro Diagnostics Overall Revenue (2000-2012) 46 4.2 In Vitro Diagnostics Overall Company Share (2005-2006) 52 5 Clinical Chemistry Test Reagents in United States 53 5.1 Clinical Chemistry Test Reagents Overall Revenue (2000-2012) 53 5.1.1 Rapid Tests Overall Revenue (2000-2012) 57 5.1.2 Laboratory Reagents Overall Revenue (2000-2012) 59 5.1.3 Calibrators and Controls Overall Revenue (2000-2012) 61 5.2 Clinical Chemistry Test Reagents Distribution Share (2005-2006) 63 5.3 Clinical Chemistry Test Reagents Company Share (2005-2006) 64 6 Immunochemistry Test Reagents in United States 65 6.1 Immunochemistry Test Reagents Overall Revenue (2000-2012) 65 6.1.1 Disease Specific Test Reagents Overall Revenue (2000-2012) 69 6.1.2 Disease Specific Markers Overall Revenue (2000-2012) 81 6.1.3 Hormone Related Testing Reagents Overall Revenue (2000-2012) 89 6.1.4 Drug Related Testing Reagents Overall Revenue (2000-2012) 101 6.1.5 Rapid Tests Overall Revenue (2000-2012) 109 6.1.6 Calibrators and Controls Overall Revenue (2000-2012) 111 6.2 Immunochemistry Test Reagents Distribution Share (2005-2006) 113 6.3 Immunochemistry Test Reagents Company Share (2005-2006) 114 7 Blood Test Reagents in United States 115 7.1 Blood Test Reagents Overall Revenue (2000-2012) 115 7.1.1 Haematology Test Reagents Overall Revenue (2000-2012) 119 7.1.2 Hemostasis Test Reagents Overall Revenue (2000-2012) 131 7.1.3 Monoclonal Antibodies Overall Revenue (2000-2012) 141 7.1.4 Histology and Cytology Reagents Overall Revenue (2000-2012) 143 7.1.5 Tissue Typing Reagents Overall Revenue (2000-2012) 145 7.1.6 Cytokines and Immunomodulators Overall Revenue (2000-2012) 147 7.2 Blood Test Reagents Distribution Share (2005-2006) 149 7.3 Blood Test Reagents Company Share (2005-2006) 150 8 Microbiology Test Reagents in United States 151 8.1 Microbiology Test Reagents Overall Revenue (2000-2012) 151 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 2/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 8.1.1 Bacteriology Test Reagents Overall Revenue (2000-2012) 155 8.1.2 Rapid Tests Overall Revenue (2000-2012) 165 8.1.3 Calibrators and Controls Overall Revenue (2000-2012) 167 8.2 Microbiology Test Reagents Distribution Share (2005-2006) 169 8.3 Microbiology Test Reagents Company Share (2005-2006) 170 9 Infectious Immunology Test Reagents in United States 171 9.1 Infectious Immunology Test Reagents Overall Revenue (2000-2012) 171 9.1.1 Virology Overall Revenue (2000-2012) 175 9.1.2 Bacteriology Overall Revenue (2000-2012) 183 9.1.3 Parasitology Overall Revenue (2000-2012) 185 9.1.4 Calibrators and Controls Overall Revenue (2000-2012) 187 9.1.5 Rapid Tests Overall Revenue (2000-2012) 189 9.2 Infectious Immunology Test Reagents Distribution Share (2005-2006) 191 9.3 Infectious Immunology Test Reagents Company Share (2005-2006) 192 10 Genetic Test Reagents in United States 193 10.1 Genetic Test Reagents Overall Revenue (2000-2012) 193 10.2 Genetic Test Reagents Distribution Share (2005-2006) 195 10.3 Genetic Test Reagents Company Share (2005-2006) 196 11 Self Testing in United States 197 11.1 Self Testing Overall Revenue (2000-2012) 197 11.2 Self Testing Distribution Share (2005-2006) 199 11.3 Self Testing Company Share (2005-2006) 200 12 Instruments in United States 201 12.1 Instruments Overall Revenue (2000-2012) 201 12.2 Instruments Distribution Share (2005-2006) 203 12.3 Instruments Company Share (2005-2006) 204 13 Abbott Laboratories Company Profile 205 13.1 Company Overview 205 13.2 Business Overview 205 13.2.1 Products 207 13.2.2 History 208 13.3 Value Chain Analysis 212 13.3.1 Manufacturing 212 13.3.2 Product Development 212 13.3.3 Clinical Trials 213 13.3.4 Sales and Marketing 214 13.4 SWOT Analysis 214 13.4.1 Abbott Laboratories Strengths 214 13.4.2 Abbott Laboratories Weaknesses 215 13.4.3 Abbott Laboratories Opportunities 216 13.4.4 Abbott Laboratories Threats 216 13.5 Financial and Operational Review 218 13.5.1 Financial Statements 218 13.5.2 Financial Ratios 219 13.6 Locations And Subsidiaries 220 13.6.1 Head Office 220 13.6.2 Other Locations & Subsidiaries 220 13.7 Financial Deals Landscape 221 13.7.1 Luminex Enters Into A Partnership Agreement With Abbott 221 13.7.2 Evalve Secures $60 Million In Series D Financing 222 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 3/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 13.7.3 Abbott Acquires Kos Pharmaceuticals 224 13.7.4 Abbott Laboratories Enters Into An Agreement With Enanta Pharmaceuticals 226 13.7.5 Abbott Laboratories Enters Into Distribution Agreement With Verax 227 13.7.6 AstraZeneca Signs An Agreement With Abbott 229 13.7.7 Abbott Laboratories Enters Into Licensing Agreement With Advanced Life Science 231 13.7.8 Abbott Acquires Vascular Business Of Guidant From Boston Scientific 232 13.7.9 Abbott Enters Into An Agreement With Axis-Shield 234 13.7.10 Abbott Enters Into Licensing Agreement With Nephromics 236 13.7.11 Abbott Enters Into Licensing Agreement With BioCurex 237 13.7.12 Nihon Kohden And Abbott Laboratories Enter Into Commercialization Agreement 238 13.7.13 Abbott Signs An Agreement With OraSure 240 13.7.14 Abbott Enters Into Licensing Agreement With Cleveland Clinic 242 13.7.15 Chattem Acquires Selsun Blue 243 13.7.16 Abbott Terminates The Deal To Divest Its Divisions To GE Healthcare 245 13.7.17 GE Healthcare terminates the acquisition of In vitro diagnostics and Point-of-Care diagnostics businesses of Abbott 247 13.8 Recent Developments 249 13.8.1 Apr 01, 2008: Abbott To Declare Q1 2008 Results 249 13.8.2 Jan 23, 2008: Abbott Declares Q4 2007 Results 249 13.8.3 Jan 03, 2008: Abbott To Declare Q4 And Year-End 2007 Results 250 13.8.4 250 13.8.5 Dec 14, 2007: Abbott Declares Quarterly Dividend 250 13.8.6 Oct 17, 2007: Abbott Declares Q3 2007 Results 250 13.8.7 Aug 03, 2007: Abbott COO To Retire 251 13.8.8 Jul 18, 2007: Abbott Reports Q2 2007 Results 251 13.8.9 Jul 11, 2007: Abbott Announces Termination Of Contract With GE 252 13.8.10 Jun 14, 2007: Abbott Declares Quarterly Dividend 252 13.8.11 Apr 18, 2007: Abbott Declares Quarterly Dividend 252 13.8.12 Apr 18, 2007: Abbott Reports Q1 2007 Results 252 13.8.13 Apr 10, 2007: Abbott Opens New Biotechnology Manufacturing Unit in Puerto Rico 253 13.8.14 Jan 24, 2007: Abbott Declares Quarterly Dividend 254 13.8.15 Jan 24, 2007: Abbott Reports Q4 2006 Results 254 13.8.16 Jan 08, 2007: Abbott m2000' Instrument and Viral Load Tests for HIV-1 and HCV Approved in Canada 255 13.8.17 Dec 20, 2006: Abbott To Voluntarily Delist From NYSE Arca 257 13.8.18 Oct 18, 2006: Abbott Announces Share Repurchase Program 258 13.8.19 Oct 18, 2006: Abbott Declares Quarterly Dividend 258 13.8.20 Oct 18, 2006: Abbott Reports Q3 2006 Results 258 13.8.21 Jul 19, 2006: Abbott Declares Quarterly Dividend 259 13.8.22 Jul 19, 2006: Abbott Reports Q2 2006 Results 259 13.8.23 Apr 19, 2006: Abbott Declares Quarterly Dividend 259 13.8.24 Apr 19, 2006: Abbott Reports Q1 2006 Results 259 13.8.25 Jan 20, 2006: Abbott Names New Director To The Board 260 13.9 Abbott Laboratories Pipeline Products 261 13.9.1 Fully Bioabsorbable Stent 261 13.9.2 FreeStyle Navigator Continuous Glucose Monitoring System 264 13.9.3 Wallis System 266 14 Siemens Medical Solutions Company Profile 269 14.1 Company Overview 269 14.2 Business Overview 269 14.2.1 Siemens Medical 269 14.2.2 Products 270 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 4/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 14.2.3 History 270 14.3 Value Chain Analysis 271 14.3.1 Manufacturing 272 14.3.2 Product Development 272 14.3.3 Sales and Marketing 272 14.4 SWOT Analysis 273 14.4.1 Siemens Medical Solutions Strengths 273 14.4.2 Siemens Medical Solutions Weakness 274 14.4.3 Siemens Medical Solutions Opportunities 274 14.4.4 Siemens Medical Solutions Threats 274 14.5 Locations And Subsidiaries 276 14.6 Financial Deals Landscape 277 14.6.1 Siemens Medical Acquires Dade Behring 277 14.6.2 Siemens Medical Forms Joint Venture With Kameda Healthinformatics Institute 278 14.6.3 Siemens Medical Acquires Gesellschaft fur Systemforschung und Dienstleistungen im Gesundheitswesen 280 14.6.4 Siemens Medical Solutions Acquires Diagnostics Division Of Bayer Healthcare 281 14.6.5 Siemens Medical Solutions Acquires German Healthcare IT Company GSD 283 14.6.6 SonoSite And Siemens Enter Into Distribution Agreement 284 14.6.7 Siemens Medical Solutions and IMPAC Medical Systems Of Elekta Group Enter Into Distribution Agreement 286 14.6.8 Siemens Medical Acquires Sensant Corp 287 14.7 Recent Developments 289 14.7.1 Feb 28, 2008: Siemens Expects US Medical Market To Recover In 2009 289 14.7.2 Jan 31, 2008: Siemens Repots Q1 FIscal 2008 Results 289 14.8 Siemens Medical Solutions Pipeline Products 290 14.8.1 DCA Vantage Analyzer 290 14.8.2 Acuson S2000 292 14.8.3 AXIOM Luminos dRF (Enhancements) 293 14.8.4 Ysio wi-D 294 14.8.5 Syngo DynaCT 295 14.8.6 Syngo iGuide 296 14.8.7 Syngo iPilot 296 14.8.8 Siemens 7T MRI system 297 14.8.9 Siemens 11.7T MRI system 297 14.8.10 REMIND platform - REMIND Clinical Decision Support (CDS) 297 14.8.11 Virtual Touch tissue imaging 300 14.8.12 Virtual Touch tissue quantification 301 15 F.<br><br> Hoffmann-La Roche Ltd. Company Profile 304 15.1 Company Overview 304 15.2 Business Overview 304 15.2.1 Diagnostics 304 15.2.2 Pharmaceuticals 304 15.2.3 Products 305 15.2.4 History 306 15.3 Value Chain Analysis 311 15.3.1 Manufacturing 311 15.3.2 Product Development 312 15.3.3 Sales and Marketing 313 15.4 SWOT Analysis 314 15.4.1 F. Hoffmann-La Roche Ltd.<br><br> Strengths 314 15.4.2 F. Hoffmann-La Roche Ltd. Weaknesses 315 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 5/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 15.4.3 F.<br><br> Hoffmann-La Roche Ltd. Opportunities 316 15.4.4 F. Hoffmann-La Roche Ltd.<br><br> Threats 316 15.5 Financial and Operational Review 318 15.6 Locations And Subsidiaries 320 15.7 Financial Deals Landscape 322 15.7.1 Roche Acquires Ventana Medical Systems 322 15.7.2 Roche Signs An Agreement With ACEA Biosciences 323 15.7.3 Roche Signs Licensing Agreement With Ortho-Clinical Diagnostics And Novartis Vaccines & Diagnostics 324 15.7.4 Roche Acquires Nimblegen 325 15.7.5 Roche Signs An Agreement With Ipsen 327 15.7.6 Roche Signs Licensing Agreement With Alnylam Pharmaceuticals 328 15.7.7 Roche acquires BioVeris 329 15.7.8 Roche Signs An Agreement With Toyama Chemical 330 15.7.9 Roche Acquires 454 Life Sciences 331 15.7.10 Roche And Transgene Enter Into A Partnership Agreement 332 15.7.11 Roche Acquires Therapeutic Human Polyclonals 333 15.7.12 Proacta, Inc. completes $35 million series B financing 335 15.7.13 Roche Diagnostics Signs An Agreement With Multilyte 336 15.7.14 Roche Diagnostics Signs An Agreement With ThromboGenics And Geymonat 337 15.7.15 Roche Signs An Agreement With InterMune 338 15.7.16 Roche Signs An Agreement With BioCryst Pharmaceuticals 340 15.7.17 Roche Signs An Agreement With PDL BioPharma 341 15.7.18 Innogenetics Signs An Agreement With Roche Diagnostics 342 15.7.19 Roche Diagnostics Signs An Agreement With Response Biomedical 343 15.7.20 Roche Acquires GLYCART biotechnology 344 15.7.21 Roche Diagnostics Signs An Agreement With Amplimedical 345 15.7.22 Roche Diagnostics Signs An Agreement With Exiqon 346 15.7.23 Roche Signs An Agreement With 454 Life Sciences 347 15.7.24 Roche Diagnostics Signs An Agreement With bioMerieux 349 15.7.25 Roche Sells Roche Consumer Health To Bayer HealthCare 350 15.7.26 Roche Signs An Agreement With deCODE genetics 351 15.7.27 Roche Signs An Agreement With PDL BioPharma 352 15.7.28 Roche Signs An Agreement With Japan Tobacco 353 15.7.29 Roche Diagnostics Signs An Agreement With Institut Pasteur And Bio-Rad Laboratories 354 15.7.30 Roche Diagnostics Signs An Agreement With Ortho-Clinical Diagnostics 355 15.7.31 Roche Diagnostics Signs An Agreement With Inverness Medical 357 15.7.32 Roche To Sell Three Pharmaceutical Products To Actavis 358 15.8 Recent Developments 359 15.8.1 Jan 30, 2008: Roche Reports 2007 Results 359 15.8.2 Oct 23, 2007: Roche Considers Legal Options In Patent Litigation Case 360 15.8.3 Oct 16, 2007: Roche Declares First Nine Months 2007 Results 361 15.8.4 Oct 02, 2007: Roche Names New CEO For Diagnostics Division 362 15.8.5 Jul 19, 2007: Roche Reports H1 2007 Results 363 15.8.6 May 30, 2007: NorDiag Enters Distribution Agreement With Roche 365 15.8.7 Feb 07, 2007: Roche Reports Full-Year 2006 Results 365 15.8.8 Oct 17, 2006: Roche Reports Nine-Months Ended 2006 Results 367 16 Beckman Coulter, Inc. Company Profile 370 16.1 Company Overview 370 16.2 Business Overview 370 16.2.1 Cellular Systems 370 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 6/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 16.2.2 Chemistry Systems 370 16.2.3 Discovery and Automation Systems 371 16.2.4 Immunoassay Systems 371 16.2.5 Products 371 16.2.6 History 372 16.3 Value Chain Analysis 376 16.3.1 Manufacturing 376 16.3.2 Product Development 377 16.3.3 Sales and Marketing 377 16.4 SWOT Analysis 378 16.4.1 Beckman Coulter, Inc.<br><br> Strengths 378 16.4.2 Beckman Coulter, Inc. Weaknesses 379 16.4.3 Beckman Coulter, Inc. Opportunities 379 16.4.4 Beckman Coulter, Inc.<br><br> Threats 380 16.5 Financial and Operational Review 381 16.6 Locations And Subsidiaries 383 16.7 Financial Deals Landscape 385 16.7.1 AcroMetrix Enters Into A Partnership Agreement With Beckman Coulter 385 16.7.2 Beckman Coulter Enters Into Licensing Agreements For Molecular Tests With National University of Ireland 386 16.7.3 Beckman Coulter Acquires Flow Cytometry Instrumentation Business From Dako 386 16.7.4 Beckman Coulter Acquires NexGen Diagnostics 387 16.7.5 Beckman Coulter Signs An Agreement With Johns Hopkins University 388 16.7.6 Beckman Coulter Grants Sublicense To Dade Behring 389 16.7.7 Beckman Coulter Completes Private Placement Of $600 Million 390 16.7.8 Beckman Coulter Acquires Lumigen 391 16.7.9 Beckman Coulter Signs Licensing Agreement With Roche 393 16.7.10 Beckman Coulter Acquires Agencourt Bioscience 393 16.7.11 Beckman Coulter to aqcuire Biosite 395 16.8 Recent Developments 396 16.8.1 Feb 08, 2008: Beckman Names New Chairman 396 16.8.2 Feb 08, 2008: Beckman Declares Quarterly Dividend 396 16.8.3 Dec 12, 2007: Beckman Elects New Board Member 396 16.8.4 Nov 07, 2007: Beckman Signs Agreements With MedAssets 396 16.8.5 Oct 22, 2007: Beckman Declares Quarterly Dividend 396 16.8.6 Jul 26, 2007: Beckman Declares Quarterly Dividend 396 16.8.7 Jun 04, 2007: Beckman Board Member Resigns 397 16.8.8 May 03, 2007: Beckman Declares Quarterly Dividend 397 16.8.9 May 02, 2007: Beckman Q1 Revenue Up 7.8% To $613.6 Million 397 16.8.10 Apr 02, 2007: Beckman Signs Pact With Premier To Provide Core Laboratory Systems 398 16.8.11 Jan 10, 2007: Beckman Coulter Streamlines Operations 398 16.8.12 Oct 10, 2006: Beckman Coulter Appoints New Vice President and CFO 399 16.8.13 Aug 01, 2006: Beckman Announces Arbitration Results With Digene 399 16.8.14 Apr 27, 2006: Beckman Coulter Provides Information On Applera Settlement 400 16.9 Beckman Coulter, Inc. Pipeline Products 400 16.9.1 Sex Hormone Binding Globulin Test 400 16.9.2 sVEGF-R1 401 16.9.3 EPO assay 401 16.9.4 ProClot (Protein C) for ACL TOP 402 16.9.5 ProS (Protein S) for ACL TOP 403 16.9.6 Factor VIII for ACL TOP 403 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 7/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 16.9.7 Tricyclics 404 16.9.8 Ischemia Modified Albumin 404 16.9.9 ANA Screen 405 16.9.10 Product Overview 405 16.9.11 Product Description 405 16.9.12 Product Status 405 16.9.13 Soluble Transferrin Receptor 405 16.9.14 PT-Fib for ACL TOP 406 16.9.15 PT-Fib HS for ACL TOP 406 16.9.16 PT-Fib HS Plus for ACL TOP 407 16.9.17 Rubella IgM 408 16.9.18 Anti-Cardiolipin 408 16.9.19 ds DNA Ab 409 16.9.20 Inhibin A 409 16.9.21 Anti-dsDNA 410 16.9.22 Immunoassay for sepsis 410 16.9.23 Tests for hospital acquired infections 411 16.9.24 Chlamydia test 412 16.9.25 Neisseria test 413 17 Dade Behring Holdings, Inc. Company Profile 415 17.1 Company Overview 415 17.1.1 Products 415 17.2 Locations And Subsidiaries 415 17.3 Financial Deals Landscape 416 17.3.1 Siemens Medical Acquires Dade Behring 416 17.3.2 Beckman Coulter Grants Sublicense To Dade Behring 417 17.4 Recent Developments 418 17.4.1 Jul 23, 2007: Dade Behring Declares Quarterly Cash Dividend 418 17.4.2 May 08, 2007: Dade Behring Declares Quarterly Cash Dividend 418 17.4.3 Feb 13, 2007: Dade Behring Declares Quarterly Cash Dividend 418 17.5 Dade Behring Holdings, Inc.<br><br> Pipeline Products 418 17.5.1 Innovance D-DIMER 418 18 Regulation System 420 18.1 Medical Equipment Approval Process 420 18.1.1 Pre-market Approval Process 421 18.1.2 Intended use and Indications for use 421 18.1.3 Predicate Device 422 18.1.4 Safe and Effective 422 18.1.5 Other Category Devices 424 18.1.6 Post-Market Approval Process 425 18.1.7 Compliance and Enforcement 426 18.1.8 Registration Fee 426 18.1.9 Approval Time 426 19 Pricing and Reimbursement 427 19.1 Government Policies 427 19.2 Private Insurance 428 19.3 Diagnosis Related Groups (DRG) 429 20 Distribution Structure 430 20.1 Distribution Structure 430 21 APPENDIX 431 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 8/12 ReportLinker Find Industry reports, Company profiles and Market Statistics 21.1 Global Markets Direct Research Methodology 431 21.2 Coverage 432 21.3 Secondary Research 432 21.4 Primary Research 433 21.5 Models 433 21.6 Forecasts 434 21.7 Expert Panels 434 21.8 Currency Conversion 435 21.9 Contact Us 436 21.10 Disclaimer 436 1.1 List of Tables Table 1: United States Healthcare Expenditure, 2003-2010 34 Table 2: United States Healthcare Expenditure by Age (per person), 2000-2003 35 Table 3: United States Healthcare Expenditure by Sex (per person), 2000-2003 35 Table 4: United States Healthcare Expenditure by Race (per person), 2000-2003 36 Table 5: United States Personal Healthcare Expenditure by Type, 2000-2004 36 Table 6: United States Personal Healthcare Expenditure by Source, 2000-2004 37 Table 7: Total Number of Doctors in the United States, 2003-2010 40 Table 8: Number of Doctors by Specialty in the United States, 2003-2010 41 Table 9: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 42 Table 10: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 43 Table 11: Total Hospitals in the United States, 2000-2004 44 Table 12: Community Hospitals by Number of Beds in the United States, 2000-2004 44 Table 13: Number of Hospital Beds in the United States, 2000-2004 44 Table 14: Number of Hospital Beds by Range in the United States, 2000-2004 45 Table 15: In Vitro Diagnostics, United States, Overall Revenues ($ mn), 2000-2012 46 Table 16: In Vitro Diagnostics, United States, Overall Revenues ($ mn), Historic, 2000-2007 47 Table 17: In Vitro Diagnostics, United States, Overall Revenues ($ mn), Forecast, 2007-2012 48 Table 18: In Vitro Diagnostics, United States, Category Revenues ($ mn), 2000-2012 49 Table 19: In Vitro Diagnostics, United States, Category Revenues ($ mn), Historic, 2000-2007 50 Table 20: In Vitro Diagnostics, United States, Category Revenues ($ mn), Forecast, 2007-2012 51 Table 21: In Vitro Diagnostics, United States, Overall Company Share by Revenue, 2005-2006 52 Table 22: Clinical Chemistry Test Reagents, United States, Overall Revenues ($ mn), Historic, 2000-2007 53 Table 23: Clinical Chemistry Test Reagents, United States, Overall Revenues ($ mn), Forecast, 2007-2012 54 Table 24: Clinical Chemistry Test Reagents, United States, Revenue by Segment ($ mn), Historic, 2000-2007 55 Table 25: Clinical Chemistry Test Reagents, United States, Revenue by Segment ($ mn), Forecast, 2007-2012 56 Table 26: Rapid Tests, United States, Overall Revenues ($ mn), Historic, 2000-2007 57 Table 27: Rapid Tests, United States, Overall Revenues ($ mn), Forecast, 2007-2012 58 Table 28: Laboratory Reagents, United States, Overall Revenues ($ mn), Historic, 2000-2007 59 Table 29: Laboratory Reagents, United States, Overall Revenues ($ mn), Forecast, 2007-2012 60 Table 30: Calibrators and Controls, United States, Overall Revenues ($ mn), Historic, 2000-2007 61 Table 31: Calibrators and Controls, United States, Overall Revenues ($ mn), Forecast, 2007-2012 62 Table 32: Clinical Chemistry Test Reagents, United States, Distribution Share by Revenue ($ mn), 2005-2006 63 Table 33: Clinical Chemistry Test Reagents, United States, Company Share by Revenue ($ mn), 2005-2006 64 Table 34: Immunochemistry Test Reagents, United States, Overall Revenues ($ mn), Historic, 2000-2007 65 Table 35: Immunochemistry Test Reagents, United States, Overall Revenues ($ mn), Forecast, 2007-2012 66 Table 36: Immunochemistry Test Reagents, United States, Revenue by Segment ($ mn), Historic, 2000-2007 67 United States In Vitro Diagnostics Industry Report: Detailed Analysis of the Medical Equipment & Medical Devices Market Coverin g Clinical Chemistry, Immunochemistry, Infectious Immunology, Microbiology, Genetic and Blood Test Reagents, Insturments and Tes Page 9/12 ReportLinker Find Industry reports, Company profiles and Market Statistics Table 37: Immunochemistry Test Reagents, United States, Revenue by Segment ($ mn), Forecast, 2007-2012 68 Table 38: Disease Specific Test Reagents, United States, Overall Revenues ($ mn), Historic, 2000-2007 69 Table 39: Disease Specific Test Reagents, United States, Overall Revenues ($ mn), Forecast, 2007-2012 70 Table 40: Disease Specific Test Reagents, United States, Revenue by Sub-Segment ($ mn), Historic, 2000-2007 71 Table 41: Disease Specific Test Reagents, United States, Revenue by Sub-Segment ($ mn), Forecast, 2007-2012 72 Table 42: Allergy, United States, Overall Revenues ($ mn), Historic, 2000-2007 73 Table 43: Allergy, United States, Overall Revenues ($ mn), Forecast, 2007-2012 74 Table 44: Anaemia/ Vitamins, United States, Overall Revenues ($ mn), Historic, 2000-2007 75 Table 45: Anaemia/ Vitamins, United States, Overall Revenues ($ mn), Forecast, 2007-2012 76 Table 46: Rheumatoid Disease, United States, Overall Revenues ($ mn), Historic, 2000-2007 77 Table 47: Rheumatoid Disease, United States, Overall Revenues ($ mn), Forecast, 2007-2012 78 Table 48: Auto-Immune Disease, United States, Overall Revenues ($ mn), Historic, 2000-2007 79 Table 49: Auto-Immune Disease, United States, Overall Revenues ($ mn), Forecast, 2007-2012 80 Table 50: Disease Specific Markers, United States, Overall Revenues ($ mn), Historic, 2000-2007 81 Table 51: Disease Specific Markers, United States, Overall Revenues ($ mn), Forecast, 2007-2012 82 Table 52: Disease Specific Markers, United States, Revenue by Sub-Segment ($ mn), Historic, 2000-2007 83 ble 53: Disease Specific Markers, United States, Revenue by Sub-Segment ($ mn), Forecast, 2007-2012 84 Table 54: Tumour Markers, United States, Overall Revenues ($ mn), Historic, 2000-2007 85 Table 55: Tumour Markers, United States, Overall Revenues ($ mn), Forecast, 2007-2012 86 Table 56: Cardiac Markers, United States, Revenue by Sub-Segment ($ mn), Historic, 2000-2007 87 Table 57: Cardiac Markers, United States, Revenue by Sub-Segment ($ mn), Forecast, 2007-2012 88 Table 58: Hormone Related Testing Reagents, United States, Overall Revenues ($ mn), Historic, 2000-2007 89 Table 59: Hormone Related Testing Reagents, United States, Overall Revenues ($ mn), Forecast, 2007-2012 90 Table 60: Hormone Related Testing Reagents, United States, Revenue by Sub-Segment ($ mn), Historic, 2000-2007 91 Table 61: Hormone Related Testing Reagents, United States, Revenue by Sub-Segment ($ mn), Forecast, 2007-2012 92 Table 62: Specific Proteins, United States, Overall Revenues ($ mn), Historic, 2000-2007 93 Table 63: Specific Proteins, United States, Overall Revenues ($ mn), Forecast, 2007-2012 94 Table 64: Fertility and Pregnancy, United States, Overall Revenues ($ mn), Historic, 2000-2007 95 Table 65: Fertility and Pregnancy, United States, Overall Revenues ($ mn), Forecast, 2007-2012 96 Table 66: Individual/ Specified Hormones, United States, Overall Revenues ($ mn), Historic, 2000-2007 97 Table 67: Individual/ Specified hormones, United States, Overall Revenues ($ mn), Forecast, 2007-2012 98 Table 68: Specific Organ Function, United States, Overall Revenues ($ mn), Historic, 2000-2007 99 Table 69: Specific Organ Function, United States, Overall Revenues ($ mn), Forecast, 2007-2012 100 Table 70: Drug Related Testing Reagents, United States, Overall Revenues ($ mn), Historic, 2000-2007 101 Table 71: Drug Related Testing Reagents, United States, Overall Revenues ($ mn), Forecast, 2007-2012 102 Table 72: Drug Related Testing Reagents, United States, Revenue by Sub-Segment ($ mn), Historic, 2000-2007 103 Table 73: Drug Related Testing Reagents, United States, Revenue by Sub-Segment ($ mn), Forecast, 2007-2012 104 Table 74: Therapeutic Drugs, United States, Overall Revenues ($ mn), Historic, 2000-2007 105 Table 75: Therapeutic Drugs, United States, Overall Revenues ($ mn), Forecast, 2007-2012 106 Table 76: Drug of Abuse and Toxicology, United States, Overall Revenues ($ mn), Historic, 2000-2007 107 Table 77: Drug of Abuse and Toxicology, United States, Overall Revenues ($ mn), Forecast, 2007-2012 108 Table 78: Rapid Tests, United States, Overall Revenues ($ mn), Historic, 2000-2007 109 Table 79: Rapid Tests, United States, Overall Revenues ($ mn), Forecast, 2007-2012 110 Table 80: Calibrators and Controls, United States, Overall Revenues ($ mn), Historic, 2000-2007 111 Table 81: Calibrators and Controls, United States, Overall Revenues ($ mn), Forecast, 2007-2012 112 Table 82: Immunochemistry Test Reagents, United States, Distribution Share by Revenue ($ mn), 2005-2006 United States In Vitro Diagnostics Industry Report: Detailed 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