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Home healthcare is defined by the U.S. Centers of Disease Control and Prevention's (CDC) National Center for Health Statistics as, "healthcare provided to individuals and families in their places of residence for the purpose of promoting, maintaining, or restoring health or for maximizing the level of independence while minimizing the effects of disability and illness, including terminal illness." Last year, an estimated 18 million people received home healthcare in the U.S., and most of these individuals also used associated home care products. With the aging of the "baby boom" generation and the increase in patient life spans--a trend not limited to the U.S.--the numbers of home care patients will continue to grow. As patient life spans are extended with more sophisticated medical care and new technologies, and home care becomes an increasingly important and accepted means to contain healthcare costs for managed care providers, this market segment is poised for significant growth in the near future. The purpose of this TriMark Publications report is to describe the specific segment of the home medical testing devices markets, with particular emphasis on the United States market. The U.S. market for home care products, testing, devices and equipment continues to post steady gains, primarily as a result of: 1) the aging population, 2) a growing trend to out-patient care and the corresponding shift of chronic care patients from hospitals, and 3) extended care facilities to the home. In other areas of the world, the results vary depending on the economies of the country and the health sophistication of the consuming public. This analysis presents an overview of the home medical testing devices market with the latest information regarding emerging new products, new markets for older products/technologies and industry trends.

1. 1. Introduction 4
2. 1.1 Statement of Report 4
3. 1.2 Objectives of this Report 4
4. 1.3 Scope of the Report 6
5. 1.4 Methodology 6
6. 1.5 Executive Summary 7
8. 2. Home Medical Testing Devices Markets 9
9. 2.1 Overview 9
11. 3. Home Medical Testing Devices Market Segments 10
12. 3.1 Overview 10
13. 3.2 World Markets 10
14. 3.2.1 Major Markets for the Home Medical Testing Devices Segment 10
15. 3.2.2 Global Trends 10
16. 3.3 The U.S. Market 11
17. 3.4 World Markets 12
18. 3.4.1 Asia/Southeast Asia 12
19. 3.4.1.1 Japan 13
20. 3.4.1.2 China 14
21. 3.4.1.3 Taiwan 14
22. 3.4.1.4 India 14
23. 3.4.2 Australia/New Zealand 16
24. 3.4.3 Western Europe 16
25. 3.4.4 Eastern Europe 21
26. 3.4.5 Middle East 23
28. 4. Technology Issues 24
29. 4.1 Component Issues 24
30. 4.2 Production Methods 24
31. 4.3 cGMPs in Use 24
32. 4.4 Testing 24
33. 4.5 Shipping/Handling/Storage Environment Concerns 24
34. 4.6 Use Environment-Unique Issues 25
35. 4.6.1 IFUs 25
36. 4.6.2 Electro Magnetic Compatibility 25
37. 4.6.3 Product Support-Helpline 25
38. 4.6.4 Preventive Maintenance 25
39. 4.6.5 Back-up 25
40. 4.6.6 Family Support 26
41. 4.6.7 Medical Review 26
42. 4.7 EMI/EMC 26
43. 4.8 Risk Management (ISO 14971:2007) 26
44. 4.9 Categories of Products 28
45. 4.9.1 Alcohol Test Kits 28
46. 4.9.2 Allergy Test Kits 28
47. 4.9.3 Amniotic Fluid Leak Detectors 30
48. 4.9.4 Anemia Meters 30
49. 4.9.5 Apnea Therapy Equipment 31
50. 4.9.6 Asthma Monitors 31
51. 4.9.7 Blood Pressure Monitors 32
52. 4.9.8 Breast Self-Examination Tools 34
53. 4.9.9 Blood Typing Kits 38
54. 4.9.10 Chlamydia 38
55. 4.9.11 Cholesterol Tests 38
56. 4.9.12 Defibrillators (Patient Use) 39
57. 4.9.13 Diabetes Test Kits 40
58. 4.9.14 Drugged Drink Test Kits 40
59. 4.9.15 Electro Cardiogram 40
60. 4.9.16 Gonorrhea Test 41
61. 4.9.17 Hepatitis C Test 41
62. 4.9.18 HIV (AIDS) 42
63. 4.9.19 Influenza (Flu) Test Kits 44
64. 4.9.20 Infusion Pumps 44
65. 4.9.21 Kidney Dialysis 46
66. 4.9.22 Kidney Disease Test Kits 47
67. 4.9.23 Occult (Stool) Blood Screening Test Kits 47
68. 4.9.24 Paternity (DNA) Test Kits 48
69. 4.9.25 Pregnancy and Fertility Diagnostics 48
70. 4.9.26 Pressure Pump and Pad System (for Bed Sores) 49
71. 4.9.27 Prostate Cancer Screening Test Kit 50
72. 4.9.28 Remote Monitoring Services 50
73. 4.9.29 Spirometers 51
74. 4.9.30 Thermometers 51
75. 4.9.31 Thyroid Test Kits 51
76. 4.9.32 Urinalysis Test Kit 51
77. 4.9.33 Vaginal Infections 51
78. 4.9.34 Wheelchairs 52
79. 4.10 Future Directions 56
80. 4.10.1 New Diabetes Testing Technologies 56
81. 4.10.2 Quick Cholesterol Testers 57
82. 4.10.3 Adsorbers 57
83. 4.10.4 Remote Health Monitoring/Screening 57
85. 5. Business Trends 58
86. 5.1 Market Drivers 58
87. 5.1.1 Medical/Clinical Studies 59
88. 5.1.2 Sports 59
89. 5.1.3 Demographics 59
90. 5.1.4 Market Restraints 60
91. 5.2 Market Prospects 60
92. 5.3 Marketing and Distribution 60
93. 5.4 Competitive Landscape 61
94. 5.5 Business Developments 61
95. 5.6 Acquisitions and Partnerships 61
97. 6. Home Medical Testing Kits and Devices, Regulation and Reimbursement 63
98. 6.1 Market Segments 63
99. 6.1.1 Test Kits/Diagnostics 63
100. 6.1.2 Devices 63
101. 6.1.3 Equipment 63
102. 6.2 Customer Needs 63
103. 6.3 Competitor Analysis 63
104. 6.4 Pricing Pressures (Based on the U.S. Model) 64
105. 6.4.1 "Big Box" Retailing 64
106. 6.4.2 Internet 64
107. 6.4.3 Mail Order 64
108. 6.4.4 Chain Retail Outlets (Grocery, Dedicated) 64
109. 6.4.5 "Mom and Pop" (Stand Alone) Health (Food) Stores 65
110. 6.4.6 MLM (Multi Level Marketing) 65
111. 6.5 BSE and Gelatin-based Ingested (or Body Fluid Contact) Products 65
112. 6.6 Home Care Providers 66
113. 6.7 Medicare-certified Agencies 66
114. 6.8 Types of Home Healthcare Organizations 66
115. 6.9 Non-Medicare-certified Agencies 67
116. 6.9.1 Medicare Home Health Prospective Payment 67
117. 6.9.2 U.S. Medicaid Home Care 67
118. 6.9.3 Managed Care 67
119. 6.10 Third-Party Reimbursement 69
120. 6.11 Regulation Trends 69
121. 6.11.1 U.S. FDA Policy 69
122. 6.11.2 GMPs 70
123. 6.11.3 Current Progress 73
124. 6.11.4 Future Regulatory Trends 73
125. 6.11.5 Key Issues 74
126. 6.11.6 Labeling Requirements 75
127. 6.12 Market Trends 75
129. 7. Corporate Profiles 77
130. 7.1 Abbott Laboratories 77
131. 7.2 Apria Healthcare 77
132. 7.3 Baxter International, Inc. 77
133. 7.4 Braun 78
134. 7.5 Del Mar Reynolds Medical Ltd. 79
135. 7.6 Fresenius Medical Care 79
136. 7.7 Gambro AB 81
137. 7.8 Graham-Field Health Products 82
138. 7.9 Gentiva Health Services, Inc. 83
139. 7.10 General Nutrition Centers, Inc. 85
140. 7.11 Invacare Corporation 86
141. 7.12 Kimberly-Clark Corporation 87
142. 7.13 Lincare 87
143. 7.14 Matria Healthcare 89
144. 7.15 Respironics 92
145. 7.16 Sunrise Medical 94
147. Appendix 1: Overview of the U.S. FDA Good Manufacturing Practices (GMP)/Quality System (QS) Regulation (21 CFR Part 820) 96
148. Appendix 2: The U.S. FDA GMPs, 21 CFR Part 820 102
149. Appendix 3: FDA Guidelines for Device Use in the Home 117
150. Appendix 4: ISO 14971 Medical Device Risk Management 119
153. INDEX OF TABLES
155. Table 3.1: Comparison of Procedure Costs-U.S. and Overseas, 2006 and 2007 12
156. Table 5.1: Market Drivers 59
157. Table 5.2: Market Restraints 60