Table of Contents
1 Table of Contents 2
1.1 List of Tables 9
1.2 List of Figures 11
2 Introduction 13
2.1 What Is This Report About? 13
2.2 Definitions
13
2.2.1 Endoscopy Devices 13
3 Healthcare Sector Review 14
3.1
Healthcare Expenditure 14
3.2 Healthcare Infrastructure 19
3.2.1
Healthcare Personnel Data 21
3.2.2 Healthcare Facilities Data 24
4
Endoscopy Devices in United States 26
4.1 Endoscopy Devices Overall
Revenues (2000-2012) 26
4.2 Endoscopy Devices Overall Volume (2000-2012)
32
4.3 Endoscopy Devices Overall Company Shares (2005-2006) 35
4.4
Flexible Endoscope in United States 36
4.4.1 Flexible Endoscope Overall
Revenues (2000-2012) 36
4.4.2 Flexible Endoscope Overall Volume
(2000-2012) 38
4.4.3 Flexible Endoscope Average Price (2000-2012) 40
4.4.4 Flexible Endoscope Distribution Share (2005-2006) 42
4.4.5 Flexible
Endoscope Company Share (2005-2006) 43
4.5 Rigid Endoscope in United
States 44
4.5.1 Rigid Endoscope Overall Revenues (2000-2012) 44
4.5.2
Rigid Endoscope Overall Volume (2000-2012) 46
4.5.3 Rigid Endoscope
Average Price (2000-2012) 48
4.5.4 Rigid Endoscope Distribution Share
(2005-2006) 50
4.5.5 Rigid Endoscope Company Share (2005-2006) 51
5
OLYMPUS CORPORATION Company Profile 52
5.1 Company Overview 52
5.2
Business Overview 52
5.2.1 Imaging Systems Business 52
5.2.2
Information and Communication Business 53
5.2.3 Life Sciences Business
53
5.2.4 Medical Systems Business 54
5.2.5 Others 55
5.2.6 Major
Products and Services 55
5.2.7 History 56
5.3 Value Chain Analysis
58
5.3.1 Manufacturing 59
5.3.2 Product Development 59
5.3.3 Sales
and Marketing 59
5.4 SWOT Analysis 60
5.4.1 OLYMPUS CORPORATION
Strengths 60
5.4.2 OLYMPUS CORPORATION Weaknesses 61
5.4.3 OLYMPUS
CORPORATION Opportunities 61
5.4.4 OLYMPUS CORPORATION Threats 62
5.5
Financial and Operational Review 63
5.5.1 Financial Statements 63
5.5.2 Share Holding Structure 64
5.6 Locations And Subsidiaries 64
5.7
OLYMPUS CORPORATION Pipeline Products 66
5.7.1 OLYMPUS CAPSULE ENDOSCOPE
SYSTEM 66
5.7.2 Single Balloon Enteroscopy (SBE) system 67
6 KARL
STORZ GmbH & Co. KG Company Profile 68
6.1 Company Overview 68
6.2
Business Overview 68
6.2.1 Major Products and Services 68
6.2.2
History 69
6.3 Locations And Subsidiaries 69
7 PENTAX Medical Company
Profile 71
7.1 Company Overview 71
7.2 Business Overview 71
7.2.1
Major Products and Services 72
7.2.2 History 73
7.3 Locations And
Subsidiaries 73
7.3.1 Other Locations & Subsidiaries 74
8 B. Braun
Melsungen AG Company Profile 75
8.1 Company Overview 75
8.2 Business
Overview 75
8.2.1 Aesculap division 75
8.2.2 B. Braun Avitum division
76
8.2.3 Hospital Care division 76
8.2.4 Out Patient Market (OPM)
division 76
8.2.5 Major Products and Services 77
8.2.6 History 77
8.3 Value Chain Analysis 79
8.3.1 Manufacturing 79
8.3.2 Product
Development 80
8.3.3 Sales and Marketing 81
8.4 SWOT Analysis 81
8.4.1 B. Braun Melsungen AG Strengths 81
8.4.2 B. Braun Melsungen AG
Weaknesses 82
8.4.3 B. Braun Melsungen AG Opportunities 83
8.4.4 B.
Braun Melsungen AG Threats 83
8.5 Financial and Operational Review 84
8.5.1 Financial Statements 84
8.5.2 Financial Ratios 85
8.6 Locations
And Subsidiaries 85
8.7 Financial Deals Landscape 87
8.7.1 B. Braun
Signs An Agreement With Nipro 87
8.7.2 B. Braun Enters Into A Licensing
Agreement With Chartie Hospital 88
8.7.3 B. Braun Signs An Agreement With
Charite 89
8.8 Recent Developments 90
8.8.1 Mar 26, 2008: B. Braun
Reports 2007 Results 90
8.8.2 Oct 25, 2007: B. Braun Melsungen Signs
Distribution Agreement With NIPRO 92
8.8.3 May 25, 2007: B. Braun
Melsungen Enters Into Strategic Alliance With Health Robotics 93
8.8.4 Mar
28, 2007: B. Braun Melsungen Reports 2006 Results 93
8.8.5 Mar 24, 2007:
B. Braun Melsungen To Shut Its Plant In Puerto Rico 94
8.8.6 Mar 15, 2007:
B. Braun Melsungen To Invest In Medical Technology Production 94
8.8.7 Sep
19, 2005: B. Braun Medical Opens Manufacturing Facility In Suzhou 94
8.9
B. Braun Melsungen AG Pipeline Products 95
8.9.1 Coroflex Please 95
8.9.2 SeQuent Please 97
9 Fujinon Corporation Company Profile 100
9.1
Company Overview 100
9.2 Business Overview 100
9.2.1 Major Products
and Services 101
9.2.2 History 101
9.3 Locations And Subsidiaries
103
10 Regulation System 104
10.1 Medical Equipment Approval Process
104
10.1.1 Pre-market Approval Process 105
10.1.2 Intended use and
Indications for use 105
10.1.3 Predicate Device 106
10.1.4 Safe and
Effective 106
10.1.5 Other Category Devices 108
10.1.6 Post-Market
Approval Process 109
10.1.7 Compliance and Enforcement 109
10.1.8
Registration Fee 110
10.1.9 Approval Time 110
11 Pricing and
Reimbursement 111
11.1 Government Policies 111
11.2 Private Insurance
112
11.3 Diagnosis Related Groups (DRG) 113
12 Distribution Structure
114
12.1 Distribution Structure 114
13 Financial Deals Landscape
115
13.1 Acquisition 115
13.1.1 ev3 Acquires Foxhollow Technologies
115
13.1.2 Sandhill Scientific Acquires Oakfield Instruments 116
13.1.3 SAES Getters Increases The Offering Price For The Acquisition Of Memry
118
13.2 Venture Financing 120
13.2.1 USGI Medical Secures $10 Million
In Venture Financing 120
13.2.2 superDimension Secures $22.3 Million In
Venture Capital Financing 121
13.2.3 Core Essence Orthopaedics Raises $5
Million From NewSpring Capital 122
13.2.4 XLumena Raises $6.15 Million In
Venture Financing 123
13.2.5 SmartPill Corp. Secures $20 Million In
Venture Financing 124
13.2.6 Aragon Surgical Raises $25 Million In Series
B Round Of Financing 126
13.2.7 Holochip Raises $2.7 Million In Series A
Financing From ITU Ventures And ITOCHU 127
13.2.8 AngioScore Secures $30
Million In Series E Financing 129
13.2.9 Apollo Endosurgery Secures $11.5
Million In Series A Financing 131
13.3 IPO 132
13.3.1 SafeStitch
Medical Completes Private Placement Of $4 Million 132
13.3.2 EnteroMedics
Completes Initial Public Offering Of $43.92 Million 133
13.4 Debt
Offerings 134
13.4.1 Precision Optics Completes Private Placement Of $0.6
Million 134
13.5 Partnership 136
13.5.1 KARL STORZ Signs An Agreement
With EndoGastric Solutions 136
13.5.2 Covidien Signs An Agreement With
Allergan 137
14 Recent Developments 139
14.1 Strategy And Business
Planning 139
14.1.1 Sep 02, 2008: Navilyst Medical Eyes Expansion 139
14.1.2 Jul 28, 2008: CONMED Plans To Close Mohawk Valley Manufacturing
Facilities 139
14.2 Corporate Communications 140
14.2.1 Sep 09, 2008:
US Endoscopy Appoints VP Of New Product Development 140
14.2.2 Aug 19,
2008: Aragon Surgical Appoints CEO 140
14.2.3 Jul 08, 2008: Vascular
Technologies And Ultroid Technologies Appoints New CEO 141
14.2.4 Jul 07,
2008: Cellvizio Appoints Vice President Of Marketing 141
14.2.5 Jul 01,
2008: Welch Allyn Lighting Appoints Senior Management Members 141
14.2.6
Jun 03, 2008: Boston Scientific Announces Management Changes 142
14.2.7
May 27, 2008: Cantel Appoints New Board Member 143
14.2.8 May 27, 2008:
Welch Allyn Appoints Senior Vice President, General Counsel 143
14.2.9 May
21, 2008: Conmed Appoints President For Its Subsidiary 144
14.2.10 Apr 25,
2008: Cantel Announces Management Change 144
14.2.11 Apr 23, 2008: Welch
Allyn Appoints SVP, EMEA And Latin America 145
14.2.12 Apr 07, 2008:
Boston Scientific Appoints EVP, Secretary and General Counsel 145
14.3
Legal and Regulatory 145
14.3.1 Jun 11, 2008: Jury Awards Smith & Nephew
$14.7 Million In Damages 145
14.4 Government and Public Interest 146
14.4.1 May 20, 2008: Inventor Announces On Noninvasive Device For GERD,
Obesity 146
14.5 Product News 146
14.5.1 Feb 18, 2008: Given Imaging
Receives NSE Letter From The US Food And Drug Administration Regarding Its
Application To Market PillCam COLON 146
14.5.2 Nov 26, 2007: Invendo
Medical Discloses Further Clinical Data At United European Gastroenterology
Week 2007 In Paris 147
14.6 Other Significant Developments 147
14.6.1
Sep 03, 2008: CONMED Receives FDA Clearance For New Gastrointestinal Endoscopy
Products 147
15 Appendix 149
15.1 Methodology 149
15.2 Coverage
150
15.3 Secondary Research 150
15.4 Primary Research 151
15.5
Models 151
15.6 Forecasts 152
15.7 Expert Panels 152
15.8 Currency
Conversion 153
15.9 Contact Us 154
15.10 Disclaimer 154
1.1
List of Tables
Table 1: United States Healthcare Expenditure, 2003-2010
15
Table 2: United States Healthcare Expenditure by Age (per person),
2000-2003 16
Table 3: United States Healthcare Expenditure by Sex (per
person), 2000-2003 16
Table 4: United States Healthcare Expenditure by
Race (per person), 2000-2003 17
Table 5: United States Personal Healthcare
Expenditure by Type, 2000-2004 17
Table 6: United States Personal
Healthcare Expenditure by Source, 2000-2004 18
Table 7: Total Number of
Doctors in the United States, 2003-2010 21
Table 8: Number of Doctors by
Specialty in the United States, 2003-2010 22
Table 9: Doctors by Region
(Number per 10,000 Civilian Population), 2002-2004 23
Table 10: Doctors by
Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 24
Table
11: Total Hospitals in the United States, 2000-2004 24
Table 12: Community
Hospitals by Number of Beds in the United States, 2000-2004 25
Table 13:
Number of Hospital Beds in the United States, 2000-2004 25
Table 14:
Number of Hospital Beds by Range in the United States, 2000-2004 25
Table
15: Endoscopy Devices, United States, Overall Revenues ($ mn), 2000-2012
26
Table 16: Endoscopy Devices, United States, Overall Revenues ($ mn),
Historic, 2000-2007 27
Table 17: Endoscopy Devices, United States, Overall
Revenues ($ mn), Forecast, 2007-2012 28
Table 18: Endoscopy Devices,
United States, Category Revenues ($ mn), 2000-2012 29
Table 19: Endoscopy
Devices, United States, Category Revenues ($ mn), Historic, 2000-2007 30
Table 20: Endoscopy Devices, United States, Category Revenues ($ mn),
Forecast, 2007-2012 31
Table 21: Endoscopy Devices, United States,
Category Volume (Units), 2000-2012 32
Table 22: Endoscopy Devices, United
States, Category Volume (Units), Historic, 2000-2007 33
Table 23:
Endoscopy Devices, United States, Category Volume (Units), Forecast, 2007-2012
34
Table 24: Endoscopy Devices in United States, Overall, Company Share by
Revenue ($ mn), 2005-2006 35
Table 25: Flexible Endoscope, United States,
Overall Revenues ($ mn), Historic, 2000-2007 36
Table 26: Flexible
Endoscope, United States, Overall Revenues ($ mn), Forecast, 2007-2012 37
Table 27: Flexible Endoscope, United States, Overall Volume (Units), Historic,
2000-2007 38
Table 28: Flexible Endoscope, United States, Overall Volume
(Units), Forecast, 2007-2012 39
Table 29: Flexible Endoscope, United
States, Average Price ($), Historic, 2000-2007 40
Table 30: Flexible
Endoscope, United States, Average Price ($), Forecast, 2007-2012 41
Table
31: Flexible Endoscope, United States, Distribution Share by Revenue ($ mn),
2005-2006 42
Table 32: Flexible Endoscope, United States, Company Share by
Revenue ($ mn), 2005-2006 43
Table 33: Rigid Endoscope, United States,
Overall Revenues ($ mn), Historic, 2000-2007 44
Table 34: Rigid Endoscope,
United States, Overall Revenues ($ mn), Forecast, 2007-2012 45
Table 35:
Flexible Endoscope, United States, Overall Volume (Units), Historic, 2000-2007
46
Table 36: Flexible Endoscope, United States, Overall Volume (Units),
Forecast, 2007-2012 47
Table 37: Rigid Endoscope, United States, Average
Price ($), Historic, 2000-2007 48
Table 38: Rigid Endoscope, United
States, Average Price ($), Forecast, 2007-2012 49
Table 39: Rigid
Endoscope, United States, Distribution Share by Revenue ($ mn), 2005-2006
50
Table 40: Rigid Endoscope, United States, Company Share by Revenue ($
mn), 2005-2006 51
Table 41: OLYMPUS CORPORATION, SWOT Analysis, 2007
60
Table 42: OLYMPUS CORPORATION, Financial Statements, Yen Million,
2003-2007 63
Table 43: OLYMPUS CORPORATION, Share Holding Structure
64
Table 44: OLYMPUS CORPORATION, Other Locations 65
Table 45:
OLYMPUS CORPORATION, Subsidiaries 66
Table 46: KARL STORZ GmbH &
Co. KG, Other Locations 70
Table 47: PENTAX Medical Company, Other
Locations 74
Table 48: B. Braun Melsungen AG, SWOT Analysis, 2006
81
Table 49: B. Braun Melsungen AG, Financial Statements, Euro
Thousand, 2002-2006 84
Table 50: B. Braun Melsungen AG, Financial
Ratios, Euro Thousand, 2002-2006 85
Table 51: B. Braun Melsungen AG,
Subsidiaries 86
Table 52: Fujinon Corporation, Subsidiaries 103
Table 53: Medical Equipment Registration Fee in United States, 2007 110
Table 54: Medical Device Approval Time in United States, 2004 110
Table
55: Currency Conversion from USD to Local Currency at 2007 Constant Rate
153
1.2 List of Figures
Figure 1: United States, Healthcare
Expenditure by Source, 2003 15
Figure 2: United States, Healthcare
Infrastructure, Top Level View, 2007 20
Figure 3: Healthcare Expenses
Segmentation by End User, 2003 21
Figure 4: Endoscopy Devices, United
States, Overall Revenues ($ mn), 2000-2012 26
Figure 5: Endoscopy Devices,
United States, Overall Revenues ($ mn), Historic, 2000-2007 27
Figure 6:
Endoscopy Devices, United States, Overall Revenues ($ mn), Forecast, 2007-2012
28
Figure 7: Endoscopy Devices, United States, Category Revenues ($ mn),
2000-2012 29
Figure 8: Endoscopy Devices, United States, Category Revenues
($ mn), Historic, 2000-2007 30
Figure 9: Endoscopy Devices, United States,
Category Revenues ($ mn), Forecast, 2007-2012 31
Figure 10: Endoscopy
Devices, United States, Category Volume (Units), 2000-2012 32
Figure 11:
Endoscopy Devices, United States, Category Volume (Units), Historic, 2000-2007
33
Figure 12: Endoscopy Devices, United States, Category Volume (Units),
Forecast, 2007-2012 34
Figure 13: Endoscopy Devices in United States,
Overall, Company Share (%), 2006 35
Figure 14: Flexible Endoscope, United
States, Overall Revenues ($ mn), Historic, 2000-2007 36
Figure 15:
Flexible Endoscope, United States, Overall Revenues ($ mn), Forecast,
2007-2012 37
Figure 16: Flexible Endoscope, United States, Overall Volume
(Units), Historic, 2000-2007 38
Figure 17: Flexible Endoscope, United
States, Overall Volume (Units), Forecast, 2007-2012 39
Figure 18: Flexible
Endoscope, United States, Average Price ($), Historic, 2000-2007 40
Figure
19: Flexible Endoscope, United States, Average Price ($), Forecast, 2007-2012
41
Figure 20: Flexible Endoscope, United States, Distribution Share (%),
2006 42
Figure 21: Flexible Endoscope, United States, Company Share (%),
2006 43
Figure 22: Rigid Endoscope, United States, Overall Revenues ($
mn), Historic, 2000-2007 44
Figure 23: Rigid Endoscope, United States,
Overall Revenues ($ mn), Forecast, 2007-2012 45
Figure 24: Flexible
Endoscope, United States, Overall Volume (Units), Historic, 2000-2007 46
Figure 25: Flexible Endoscope, United States, Overall Volume (Units),
Forecast, 2007-2012 47
Figure 26: Rigid Endoscope, United States, Average
Price ($), Historic, 2000-2007 48
Figure 27: Rigid Endoscope, United
States, Average Price ($), Forecast, 2007-2012 49
Figure 28: Rigid
Endoscope, United States, Distribution Share (%), 2006 50
Figure 29: Rigid
Endoscope, United States, Company Share (%), 2006 51
Figure 30:
OLYMPUS CORPORATION, Value Chain Analysis 58
Figure 31: B. Braun
Melsungen AG, Value Chain Analysis 79
Figure 32: Medical Equipment
Approval Process in the United States, 2007 105
Figure 33: PMA Approval
Process in the United States, 2007 107
Figure 34: The 510(k) Approval
Process for Medical Devices in the United States, 2007 108
Figure 35:
Reimbursement Structure in the United States, 2007 113
Figure 36:
Distribution Structure of Medical Equipment in the United States, 2006 114
Figure 37: Global Markets Direct Methodology 149
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