Medical Device: Clinical Development Market Assessment

  • March 2013
  • -
  • Industry Standard Research
  • -
  • 120 pages

Over the past five years the iShares Dow Jones U.S. Medical Devices Index Fund (IHI), which tracks the largest US medical device company stock performance, is outpacing the Dow Jones Industrial Average (+37% vs. +18% for the DJIA).

Today, device manufacturers are certainly “enjoying” living among the ancient Chinese curse of “may you live in interesting times.” Recently, times have been difficult with the device tax, an almost constant stream of lawsuits, and product recalls. However, from a fundamental standpoint, the macroeconomic forces are still in place for medical device manufacturers to grow and profit. This report is intended to provide an overview of the medical device development market dynamics.

What you will learn in this report:

• Use historic Clinicaltrial.gov data to support and plan for future clinical development studies
• Benchmark study characteristics of 7,254 on-going or recently completed studies [All data are analyzed by Phase and study type (i.e. interventional, observational, and expanded access)]
- Number of trials
- Length of trials
- Trial enrollment
- Selected sponsor distribution of trials
- Funding source distribution of trials
• Quantify the industry-funded clinical development market size (2010-2015)
• Receive full profiles of select medical device companies with active development pipelines
- Financial information
- Pipeline
- Recent patent activity

Valuable for:

Medical device companies, Contract research organizations (CROs), venture capital, and other medical device service providers

Table Of Contents

Table of Contents

Copyright and Usage Guidelines 5
Methodology 6
Introduction 7
Executive Summary/ Infographic 8
Clinical Trial Activity 10
Number of clinical trials 11
Clinical trials, by phase 11
Study type distribution of medical device trials 11
Expanded Access Trials, by phase 12
Interventional Trials, by phase 12
Observational Trials, by phase 13
Industry-funded study type distribution of medical device trials 14
Industry-funded expanded access trials, by phase 14
Industry-funded interventional trials, by phase 15
Industry-funded observational trials, by phase 15
Average length of clinical trials 16
Average trial length, by phase 16
Average expanded access trial length, by phase 17
Average interventional trial length, by phase 17
Average observational trial length, by phase 18
Average industry-sponsored expanded access trial length, by phase 18
Average industry-sponsored interventional trial length, by phase 19
Average industry-sponsored observational trial length, by phase 19
Projected vs. actual ongoing trial length, by phase 20
Projected vs. actual ongoing expanded access trial length, by phase 20
Projected vs. actual ongoing interventional trial length, by phase 21
Projected vs. actual ongoing observational trial length, by phase 22
Projected vs. actual ongoing industry-sponsored expanded access trial length, by phase ……22
Projected vs. actual ongoing industry-sponsored interventional trial length, by phase 23
Projected vs. actual ongoing industry-sponsored observational trial length, by phase 24
Average clinical trial enrollment 25
Average enrollment by phase 25
Expanded access enrollment, by phase 25
Interventional enrollment, by phase 26
Observational enrollment, by phase 26
Industry-sponsored, expanded access trial enrollment, by phase 27
Industry-sponsored, interventional trial enrollment, by phase 27
Industry-sponsored, observational trial enrollment, by phase 28
Selected sponsor distribution of medical device trials 29
Total sponsor distribution of medical device trials 29
Sponsor distribution of phase I medical device trials 31
Sponsor distribution of phase II medical device trials 32
Sponsor distribution of phase III medical device trials 33
Sponsor distribution of phase IV medical device trials 34
Sponsor distribution of medical device trials classified as not having a phase 35
Funding source distribution of medical device trials 37
Total funding source distribution of medical device trials 37
Funding source distribution of phase I medical device trials 37
Funding source distribution of phase II medical device trials 38
Funding source distribution of phase III medical device trials 38
Funding source distribution of phase IV medical device trials 39
Funding source distribution of medical device trials classified as not having a phase………… 39
Industry-funded Clinical Development Market Size 40
Methodology 40
Total Industry-funded Device Development Market Size 2010-2015 42
Service Provider Addressable Market 2010-2015 43
Medical Device Company Profiles 44
Abbott Laboratories 44
Financial Information 45
High-level Pipeline 46
Recent Patent Activity 47
Baxter International Inc. 49
Financial Information 50
High-level Pipeline 51
Recent Patent Activity 51
Biomet Inc. 56
Financial Information 57
Recent Patent Activity 58
Boston Scientific Corp. 62
Financial Information 63
High-level Pipeline 64
Recent Patent Activity 65
Covidien Plc. …… 67
Financial Information 68
Recent Patent Activity 69
DENTSPLY International 70
Financial Information 71
Recent Patent Activity 72
Fresenius Medical Care AG and Co. KGAA 73
Financial Information 74
High-level Pipeline 75
Recent Patent Activity 75
General Electric 79
Financial Information 80
High-level Pipeline 81
Recent Patent Activity 81
Johnson and Johnson 82
Financial Information 83
High-level Pipeline 84
Recent Patent Activity 84
Medtronic Inc. 91
Financial Information 92
High-level Pipeline 93
Recent Patent Activity 93
Novartis AG 96
Financial Information 97
High-level Pipeline 98
Recent Patent Activity 99
Philips Electronics NV 101
Financial Information 102
High-level Pipeline 103
Recent Patent Activity 103
Siemens AG 105
Financial Information 106
High-level Pipeline 107
Recent Patent Activity 107
Smith and Nephew 111
Financial Information 112
High-level Pipeline 113
Recent Patent Activity 113
St. Jude Medical 114
Financial Information 115
Pipeline 116
Recent Patent Activity 117
About Industry Standard Research 120





Companies Mentioned

Medtronic Inc.
St. Jude Medical Inc.
Boston Scientific Corp.
Abbott Laboratories
Johnson and Johnson (including DePuy and Ethicon)
Cook
Biomet Inc.
Biotronic SE and Co. KG
Ulthera Inc.
Dentsply International Inc.
Covidien
W.L. Gore and Associates Inc.
Merck KGaA
Sorin Group
Glaukos Corportation
InSightec
Koninklijke Philips Electronics
Allergan
Coloplast
Novartis AG
Stryker
Zimmer Holdings
Edwards Lifesciences
3M
Bayer AG
Bard
General Electric
Becton Dickenson
Terumo
Hologic
Hoya
Fresenius SE and Co
Siemens
Smith and Nephew
Baxter International
Olympus
Toshiba
Varian Medical Systems

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