GLOBAL MARKETS FOR NON-HOSPITAL-BASED POINT-OF-CARE DIAGNOSTIC PRODUCTS

215 Pages | 55 Exhibits | 2016 Analysis | Forecasts Through 2020

OVERVIEW:
This analysis includes a discussion of products, current/forecast markets, competitors, and opportunities in the global market for point-of-care (POC) diagnostic products used outside of the hospital environment.

POINT-OF-CARE DIAGNOSTICS MARKET HIGHLIGHTS

  • The POC products market is comprised of many testing segments. In 2015, global total sales for these product segments were valued at $10.8 billion.
  • In 2015, the home/self-testing POC products market accounted for approximately 56% of the total global market for POC diagnostic products. The physician's office lab segment accounted for approximately 17.4% of total product sales. Sales of POC diagnostic products to alternate testing sites accounted for less than 1% of the total global products market.
  • Factors driving the expansion of the overall POC diagnostic testing products market include shortages in lab technologists to staff central labs and the growing demand for care delivery in nonā€hospital settings as a means of cutting costs and improving patient access to healthcare.
  • Leading product segments for the home and self-testing market include whole blood glucose testing and pregnancy and fertility testing, among others. For the physician office lab and alternate testing sites market, rapid infection testing, general chemistry testing, and immunochemistry testing are the leading product segments.
Topics Covered Include:
  • An overview of POC diagnostic products used in the home, physician office lab, and alternative testing site environments.
  • Discussion of up and coming products and trends in utilization.
  • Which competitors are leading the market?
  • How are country/region-specific factors affecting the market?
  • How are market environments changing and what factors are positively and negatively impacting growth?


TABLE OF CONTENTS:
EXECUTIVE SUMMARY
 
i. Self-Testing POC Diagnostics Market 
ii. Physician Office-based POC Diagnostics Market 
iii. Methodology 

Exhibit ES-1: Global POC in vitro diagnostic products market, 2015-20 
Exhibit ES-2: Global POC diagnostics market by place of service ($m), 2015-20 
Exhibit ES-3: Global home and self-testing POC products market, share by product type, 2015 
Exhibit ES-4: Global POL and alternate laboratory sites POC diagnostic products market, share by product type, 2015 

1. MARKET OVERVIEW
 
1.1 Trends in the Global Clinical Diagnostics Market 
1.2 Trends in Laboratory Restructuring and the Organization of Testing 
1.3 Factors Driving the Adoption of POC Testing 
1.4 Regulatory Trends Impacting the Use of POC Testing 
1.5 Cost and Reimbursement Issues in POC Testing 
1.6 Quality Control and Quality Assurance Issues in POC Testing 
1.7 Trends in Self-Monitoring, Disease Screening, Wellness Testing, Risk Assessment, and Preventative Testing 
1.8 Changes in the Site of Healthcare Delivery 
Bibliography 

Exhibit 1-1: Global clinical diagnostics market, by segment ($000s), 2015-20 
Exhibit 1-2: Clinical diagnostics market, by region ($000s), 2015-20 
Exhibit 1-3: Clinical chemistry market, by segment ($000s), 2015-20 
Exhibit 1-4: Hematology/coagulation testing market, by segment, 2015-20 
Exhibit 1-5: Diagnostic microbiology products market, by segment, 2015-20 
Exhibit 1-6: Trends in population aged 65 and older and health expenditures, selected countries
Exhibit 1-7: Changes to the clinical laboratory fee schedule in the US, 2000-15 
Exhibit 1-8: Number of CLIA-registered clinical laboratories by type, 2000-16 
Exhibit 1-9: Estimated surgical and non-surgical procedure volume in the US, by site, 2015 
Exhibit 1-10: Trends in CLIA-waived labs versus total labs in the US 
Exhibit 1-11: Segmentation of healthcare costs in the US 
Exhibit 1-12: Historical trends in the number of hospitals, hospital beds, hospital admissions, and average hospital stay in the US, 1992-2014 
Exhibit 1-13: Trend in the number of retail medical clinics in the US 

2. HOME AND SELF-TESTING PRODUCTS
 
2.1 Whole Blood Glucose Self-Testing Products Market 
	2.1.1 Existing whole blood glucose self-testing products 
	2.1.2 Development-stage whole blood glucose self-testing products 
		2.1.2.1 Integrated glucose testing devices 
		2.1.2.2 Implantable glucose monitors 
	2.1.3 Whole blood glucose self-testing products market analysis and forecast 
	2.1.4 Whole blood glucose self-testing product suppliers' sales and market shares 
	2.1.5 Drivers and limiters of the whole blood glucose self-testing products market 
2.2 OTC Pregnancy and Fertility Testing Products Market 
	2.2.1 Trends in home pregnancy and fertility testing 
	2.2.2 Existing products for home pregnancy and fertility testing 
	2.2.3 New products under development for home pregnancy and fertility testing 
	2.2.4 OTC pregnancy and fertility testing products market analysis and forecast 
	2.2.5 OTC pregnancy and fertility testing product suppliers' sales and market shares 
	2.2.6 Drivers and limiters of the OTC pregnancy and fertility testing products market 
2.3 Markets for Other Home and Self-Testing Products 
	2.3.1 Cholesterol self-testing 
	2.3.2 Fecal occult blood testing 
	2.3.3 Home drugs of abuse testing 
	2.3.4 Coagulation self-testing 
	2.3.5 Infectious disease self-testing 
	2.3.6 Cancer marker self-testing 
Bibliography 

Exhibit 2-1: Trends in diabetes prevalence, 2013-35 
Exhibit 2-2: Leading whole blood glucose self-testing products available in the global market 
Exhibit 2-3: Other whole blood glucose self-testing products 
Exhibit 2-4: Whole blood glucose self-testing products market, by region ($m), 2015-20 
Exhibit 2-5: Sales and market share for leading suppliers of whole blood glucose self-testing products, by region, 2015 
Exhibit 2-6: Home pregnancy and fertility testing products 
Exhibit 2-7: OTC pregnancy and fertility testing products market, by region ($m), 2015-20 
Exhibit 2-8: Number of births by region (million), 2015-20 
Exhibit 2-9: Home pregnancy and fertility testing market by product segment 
Exhibit 2-10: Sales and market share for leading suppliers of OTC pregnancy and fertility testing products, by region, 2015 
Exhibit 2-11: Cholesterol self-testing products market, by region ($m), 2015-20 
Exhibit 2-12: Sales and market share for leading suppliers of cholesterol self-testing products, by region, 2015 
Exhibit 2-13: Fecal occult blood testing products available in the global market 
Exhibit 2-14: Home drugs of abuse testing products market, by region ($m), 2015-20 
Exhibit 2-15: Sales and market share for leading suppliers of home drugs of abuse testing products, by region, 2015 
Exhibit 2-16: PT/INR self-testing products available in the global market 
Exhibit 2-17: Coagulation self-testing products market, by region ($m), 2015-20 
Exhibit 2-18: Sales and market share for leading suppliers of coagulation self-testing products, by region, 2015 

3. PHYSICIAN'S OFFICE AND OTHER ALTERNATE SITE TESTING PRODUCTS 

3.1 Types of Testing Performed in Physician's Offices and Other Alternate Sites 
3.2 Existing Physician's Office Laboratory Products 
3.3 New POL Products Under Development 
3.4 Physician's Office Laboratory Market Analysis by Segment: 
General Chemistry, Hematology, Immunochemistry, Rapid Test Kits, Urinalysis, Whole Blood Glucose, Allergy, Other 
3.5 POL Product Suppliers' Sales and Market Shares 
3.6 Drivers and Limiters of the Worldwide POL Products Market 
3.7 Other Alternate Site Testing Products and Markets 

Exhibit 3-1: Trends in CLIA-registered POLs and other selected alternate site labs in the US 
Exhibit 3-2: US POLs by certificate type and Certificate of Compliance POLs by Certificate Schedule 
Exhibit 3-3: Tests ordered by office-based physicians in the US, 2000-12 
Exhibit 3-4: Physician's office laboratory products 
Exhibit 3-5: Products in development for the POL and alternate site laboratory 
Exhibit 3-6: Worldwide POL market, by region ($m), 2015-20 
Exhibit 3-7: Worldwide POL market, by product segment ($m), 2015-20 
Exhibit 3-8: Sales and market share for leading suppliers of POL chemistry products, by region, 2015 
Exhibit 3-9: Sales and market share for leading suppliers of POL immunochemistry products, by region, 2015 
Exhibit 3-10: Sales and market share for leading suppliers of POL hematology products, 2015 
Exhibit 3-11: Sales and market share for leading suppliers of POL rapid test kits, by region, 2015 
Exhibit 3-12: Sales and market share for leading suppliers of POL urinalysis products, by region, 2015 
Exhibit 3-13: Sales and market share for leading suppliers of POL allergy testing products, by region, 2015 
Exhibit 3-14: Sales and market share for leading suppliers of POL whole blood glucose testing products, by region, 2015 
Exhibit 3-15: Sales and market share for leading suppliers of POL hemoglobin testing products, by region, 2015 
Exhibit 3-16: Sales and market share for leading suppliers of POL coagulation testing products, by region, 2015 
Exhibit 3-17: Sales and market share for leading suppliers of POL glycated hemoglobin testing products, by region, 2015 
Exhibit 3-18: Combined worldwide sales and market share for leading suppliers of POL testing products, 2015 

4. COMPETITOR ASSESSMENT
 
4.1 Overview of Companies in the Global POC Diagnostics Market 
4.2 Mergers and Partnerships to Improve Competitive Position 

Exhibit 4-1: Overview of leading companies in the POC diagnostics market 
Exhibit 4-2: Recent mergers, acquisitions, and partnerships in the global POC diagnostics market 

5. COMPANY PROFILES
 
5.1 Abaxis 
5.2 Abbott Laboratories 
5.3 Accriva Diagnostics 
5.4 Alere 
5.5 Alfa Wassermann 
5.6 Arkray 
5.7 Danaher 
	5.7.1 Beckman Coulter 
	5.7.2 HemoCue 
	5.7.3 Radiometer 
5.8 ELITech Group 
5.9 Helena Laboratories 
5.10 Instrumentation Laboratory 
5.11 Menarini Diagnostics 
5.12 Nova Biomedical 
5.13 OraSure Technologies 
5.14 Ortho Clinical Diagnostics 
5.15 Panasonic Healthcare 
5.16 Phamatech 
5.17 Princeton BioMeditech 
5.18 Quidel 
5.19 Response Biomedical 
5.20 Roche Diagnostics
5.21 Siemens Diagnostics 
5.22 Trinity Biotech 
5.23 Trividia Health 

APPENDIX: COMPANY LISTING 


COMPANIES COVERED:

  1. 77 Elektronika Kft.
  2. A. Menarini Diagnostics
  3. Abaxis Inc.
  4. Abbott Laboratories Inc.
  5. Access Bio
  6. Accriva Diagnostics
  7. AccuTech LLC
  8. ACON Laboratories
  9. Ador Diagnostics
  10. Aerscher Diagnostics
  11. Agamatrix
  12. Aggredyne
  13. Ahram Biosystems Inc.
  14. AiMedics Pty Ltd.
  15. Albertsons (unit of SUPERVALU) SUPERVALU
  16. Alere
  17. Alfa Scientific Designs
  18. Alfa Wassermann S.p.A
  19. AllMedicus
  20. Americh Massena
  21. American Biomedica Corporation
  22. American Screening Corporation
  23. Amylin Pharmaceuticals
  24. Ancestry.com
  25. Apex Biotech
  26. Applied Biosystems (unit of Thermo Fisher Scientific)
  27. Applied Proteomics
  28. Apple
  29. Apollo Medical Devices LLC
  30. Arax Co. Ltd.
  31. Arkray
  32. Arlington Scientific
  33. Assure Tech (Hangzhou) Co. Ltd.
  34. AstraZeneca PLC
  35. Astute Medical
  36. Ativa Medical
  37. Atlas Genetics
  38. Atlas Link
  39. Aventir Biotech
  40. AVL List GmbH
  41. Awareness Technology
  42. Azo Products
  43. Axis-Shield plc
  44. Babystart Ltd
  45. Bayer AG
  46. Bayer Corporation
  47. B. Braun Melsungen
  48. Beckman Coulter
  49. Becton Dickinson
  50. Beijing Unidiag Technology
  51. BeneCheck/General Life Biotechnology Co.
  52. BioHelix Corporation
  53. (Wuxi) BioHermes Biomedical Technology Co., Ltd.
  54. Biomedix
  55. Biomerica
  56. bioMerieux
  57. bioMerieux SA
  58. Bionime
  59. Bioscience (Tianjin) Biotechnology Co., Ltd. (Bioscience Diagnostic Technology)
  60. Bio-Rad Laboratories
  61. Biosite Diagnostics
  62. Biosurfit SA
  63. BioSynex
  64. BODITECH MED
  65. BodyTel
  66. Boule Diagnostics
  67. Brahms Diagnostica USA
  68. BR Pharmaceuticals
  69. Branan Medical
  70. Brucker Daltonic
  71. CA Casyso AG
  72. Cadila Pharmaceuticals Ltd.
  73. CardioGenics Inc.
  74. CARE Diagnostica
  75. Calypte Biomedical
  76. Cardinal Health
  77. Carlyle Group
  78. Cellavision
  79. Cepheid Inc.
  80. Ceragem Medisys
  81. Chembio Diagnostic Systems
  82. Cholestech
  83. Church & Dwight
  84. CH Werfen/Werfen Life Group
  85. Cipla Ltd.
  86. CLIAwaived.com
  87. CoaguSense
  88. Confirm Biosciences
  89. Conworx Technology GmbH
  90. Core Technology Co. Ltd. (Coretests)
  91. Coris Bioconcept
  92. Coyote Bioscience Co. Ltd.
  93. CTK Biotech
  94. Cue
  95. CVS Caremark
  96. Daktari Technologies
  97. Danaher
  98. Dexcom
  99. Diagnostic Test Group (Clarity Diagnostics)
  100. Diagnostic Stago
  101. Diasorin
  102. Diesse Diagnostica
  103. Drew Scientific
  104. Dr. Reddy's Laboratories Ltd.
  105. Drucker Diagnostics
  106. Echo Therapeutics
  107. Edan Instruments
  108. EDP Biotech
  109. Edwards Lifesciences
  110. EKF Diagnostics GmbH
  111. Eli Lilly and Company
  112. Elitech Group
  113. Enterix (unit of Quest Diagnostics)
  114. Entra Health Systems
  115. Epocal
  116. Epigenomics AG
  117. EPS Biotechnology
  118. Eumed Biotechnology
  119. Eurolyser Diagnostica
  120. Exact Sciences
  121. Express Diagnostics
  122. F. Hoffmann-La Roche Ltd
  123. Fairhaven Health, LLC
  124. Focus Diagnostics
  125. Fosun Pharma
  126. GDS Technology (unit of Stanbio)
  127. GE Medical Systems
  128. Genedrive plc
  129. GeneNews
  130. General Life Biotechnology Co. Ltd.
  131. Genexo Sp. z o. o.
  132. Gen-Probe
  133. Geratherm Medical AG
  134. Germaine Laboratories
  135. Getein Biotech
  136. GlaxoSmithKline
  137. GlySens
  138. Goldmag Nanobiotech Co. Ltd.
  139. Great Basin Scientific
  140. Guangzhou KOFA Biotechnology Co. Ltd.
  141. Haemonetics
  142. Hangzhou Biotest Biotech Co. Ltd.
  143. Healgen Scientific LLC
  144. Heidelberger Medical Marketing (HMM Holding AG)
  145. Helena Laboratories, Inc.
  146. Hema Diagnostic Systems
  147. HemoCue AB
  148. HemoSonics LLC
  149. Hemosure
  150. Henry Schein
  151. HiberGene Diagnostics
  152. Hitachi
  153. Hologic
  154. Home Access Health
  155. HomeDrugTestingKit.com
  156. Home Health Testing MLSC, Inc.
  157. (Shenzhen) Horron XLH Medical Electronics Co. Ltd.
  158. Horiba Ltd.
  159. Hotgen Biotech Co., Ltd.
  160. HTL-Strefa S.A.
  161. HuBit
  162. Humasis
  163. Hycor Biomedical (unit of Agilent Technologies)
  164. IDEXX Laboratories
  165. i-Health Labs (Andon Health)
  166. Immunostics
  167. iLine Microsystems
  168. Innovative Biosystems
  169. Insight Pharmaceuticals Prestige Brands
  170. Instrumentation Laboratory
  171. Intec Products
  172. IntelliGender
  173. Intuity Medical
  174. Iquum
  175. IRIS International
  176. i-sens
  177. Jannsen Pharmaceuticals
  178. Jant Pharmacal
  179. JEI Daniel Biotech Corp.
  180. J. Mitra
  181. Johnson & Johnson
  182. Kent Pharma
  183. Kohlberg Kravis Roberts
  184. Konica Minolta
  185. Laboratory Corporation of America (Labcorp)
  186. Labstix Diagnostics Pty Ltd.
  187. Labstyle Innovations
  188. DarioHealth
  189. LifeHealth LLC
  190. Life Technologies (unit of Thermo Fisher Scientific)
  191. LifeScan/Johnson & Johnson
  192. Lifotronic Technology Co. Ltd.
  193. LITE-ON Technology Corporation
  194. Lobeck Medical
  195. LSI Medience
  196. LucigenDX
  197. Lumigenex (Suzhou) Co. Ltd.
  198. Magellan Biosciences
  199. Mannkind
  200. MaybeMOM
  201. mBio Diagnostics (division of Precision Photonics)
  202. McKesson
  203. Medica Corporation
  204. Medical Automation Systems, Inc.
  205. Medi-Lab
  206. Medmira Inc.
  207. Medonic (unit of Boule Diagnostics/Boule Medical AB)
  208. Medtox Scientific Inc.
  209. Medtronic Inc.
  210. Medtronic Blood Management
  211. A. Menarini Diagnostics S.r.l.
  212. Mendor Oy
  213. Merck & Company
  214. Meridian Bioscience
  215. Mesa Biotech
  216. MH Medical Co. Ltd.
  217. Micropoint Bioscience
  218. Mindray Medical International
  219. Moore Medical
  220. MP Biomedicals
  221. Nano-Ditech
  222. Nano Entek
  223. Nanomix
  224. New Horizons Diagnostics
  225. Noble Medical
  226. Nova Biomedical
  227. Nova Century
  228. NOWDiagnostics
  229. Omega Pharma
  230. Opko Health
  231. Opti Medical
  232. OptiScan Biomedical
  233. OraSure Technologies Inc.
  234. Oratel Diagnostics
  235. Ortho Clinical Diagnostics
  236. OvaGene Oncology
  237. Oxoid (unit of Thermo Fisher Scientific)
  238. Panasonic Shikoku Electronics
  239. Pepex Biomedical
  240. Perlong Medical
  241. Permaxim
  242. Phadia
  243. Phamatech
  244. Philips Healthcare
  245. Phoenix MedCare
  246. Piramal Healthcare Ltd/Piramal Enterprises Ltd.
  247. Polymedco
  248. Portola Pharmaceuticals
  249. Precision Biosensor
  250. Princeton BioMeditech Corporation
  251. Procter & Gamble
  252. PSS World Medical (unit of McKesson)
  253. PTS Diagnostics
  254. Qualigen
  255. Quest Diagnostics
  256. Quidel, Inc.
  257. Radiometer International A/S
  258. ReLIA Biotechnologies
  259. Remel (unit of Thermo Fisher Scientific)
  260. Response Biomedical
  261. Rite-Aid
  262. Roche Diagnostics
  263. Rohto Pharmaceutical
  264. Royal Philips Electronics
  265. (Guilin) Royalyze Medical
  266. SA Scientific
  267. Sacks Medical
  268. Samsung
  269. Sanitoets Closed Corp/Sallamander Concepts
  270. Sanofi
  271. Sanwa Kaguku Kenkyusho
  272. SD Biosensor
  273. Sekisui Diagnostics
  274. Senseonics
  275. Separation Technology
  276. Seradyn
  277. Sichuan Maccura Biotechnology Co. Ltd.
  278. Siemens Healthcare Diagnostics
  279. Silicon Biodevices
  280. Sinocare
  281. Spectral Medical, Inc.
  282. Spectrum Diagnostics
  283. Stanbio Laboratory
  284. Standard Diagnostics
  285. Stem Cells Inc.
  286. Swiss Precision Diagnostics
  287. Syntron
  288. Sysmex
  289. T2 Biosystems
  290. Taidoc
  291. Takeda Pharmaceutical
  292. Target
  293. Techno Medica Co. Ltd.
  294. Teco Diagnostics
  295. Telcor
  296. TEM International
  297. Terumo
  298. Theranos
  299. Thermo Fisher Scientific Inc.
  300. Tianjin MNCHIP Technologies Co.
  301. Tianjin New Bay Bioresearch
  302. Toda Pharma
  303. Tosoh
  304. Trinity Biotech
  305. Trividia Health
  306. Tyson Bioresearch
  307. UniComs
  308. Universal Biosensors
  309. U.S. Diagnostics
  310. Ustar Biotechnologies (Hangzhou) Ltd.
  311. Visgeneer
  312. Vital Diagnostics
  313. VolitionRx
  314. Walgreen Company
  315. Walmart Stores
  316. Warburg Pincus
  317. Wells Bio, Inc. (Access Bio)
  318. W.H.P.M. Inc.
  319. Xagenic
  320. YD Diagnostics
  321. Yellow Springs Instruments, Inc.
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