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North America Tissue Engineered - Skin Substitutes Market Outlook to 2020

GDMECR0232DB / Published October 2014

© GlobalData. This report is a licensed product and is not to be copied,

reproduced, shared or resold in any form

North America Tissue Engineered - Skin

Substitutes Market Outlook to 2020

Reference Code: GDMECR0232DB

Publication Date: October 2014





1 Table of Contents

1 Table of Contents .............................................................................................................................................. 2

1.1 List of Tables ................................................................................................................................................. 5

1.2 List of Figures ................................................................................................................................................ 6

2 Introduction........................................................................................................................................................ 8

2.1 What Is This Report About? ........................................................................................................................... 8

2.2 Tissue Engineered - Skin Substitutes Market Segmentation ........................................................................... 8

2.3 Definitions of Markets Covered in the Report ................................................................................................. 9

3 Tissue Engineered - Skin Substitutes Market, North America ....................................................................... 10

3.1 Tissue Engineered - Skin Substitutes Market, North America, Revenue ($m), 2005-2020 ............................ 10

3.2 Tissue Engineered - Skin Substitutes Market, North America, Category Comparison by Revenue ($m), 2005-2020 12



3.5 Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), 2005-2020............................ 18



3.8 Tissue Engineered - Skin Substitutes Market, North America, Company Share by Revenue ($m), 2012-2013 23

4 Tissue Engineered - Skin Substitutes Market, Canada .................................................................................. 25

4.1 Tissue Engineered - Skin Substitutes Market, Canada, Revenue ($m), 2005-2013....................................... 25

4.2 Tissue Engineered - Skin Substitutes Market, Canada, Revenue ($m), 2013-2020....................................... 27

4.2.1 Biologic Skin Substitutes Market, Canada, Revenue ($m), by Segment, 2005-2013 .............................. 29

4.2.1.1 Allograft Market, Canada, Revenue ($m), by Sub Segment, 2005-2013 ......................................... 31

4.2.2 Biologic Skin Substitutes Market, Canada, Revenue ($m), by Segment, 2013-2020 .............................. 33

4.2.2.1 Allograft Market, Canada, Revenue ($m), by Sub Segment, 2013-2020 ......................................... 35

4.3 Tissue Engineered - Skin Substitutes Market, Canada, Volume (Units), 2005-2013...................................... 37

4.4 Tissue Engineered - Skin Substitutes Market, Canada, Volume (Units), 2013-2020...................................... 39

4.4.1 Biologic Skin Substitutes Market, Canada, Volume (Units), by Segment, 2005-2013 ............................. 41

4.4.1.1 Allograft Market, Canada, Volume (Units), by Sub Segment, 2005-2013 ........................................ 43

4.4.2 Biologic Skin Substitutes Market, Canada, Volume (Units), by Segment, 2013-2020 ............................. 45

4.4.2.1 Allograft Market, Canada, Volume (Units), by Sub Segment, 2013-2020 ........................................ 47

4.5 Tissue Engineered - Skin Substitutes Market, Canada, Average Price ($), 2005-2020 ................................. 49

4.6 Tissue Engineered - Skin Substitutes Market, Canada, Distribution Share by Revenue ($m), 2012-2013 ..... 51

4.7 Tissue Engineered - Skin Substitutes Market, Canada, Company Share by Revenue ($m), 2012-2013 ........ 52

5 Tissue Engineered - Skin Substitutes Market, Mexico ................................................................................... 54

5.1 Tissue Engineered - Skin Substitutes Market, Mexico, Revenue ($m), 2005-2013 ........................................ 54

5.2 Tissue Engineered - Skin Substitutes Market, Mexico, Revenue ($m), 2013-2020 ........................................ 56

5.2.1 Biologic Skin Substitutes Market, Mexico, Revenue ($m), by Segment, 2005-2013................................ 58

5.2.1.1 Allograft Market, Mexico, Revenue ($m), by Sub Segment, 2005-2013 .......................................... 60

5.2.2 Biologic Skin Substitutes Market, Mexico, Revenue ($m), by Segment, 2013-2020................................ 62





5.2.2.1 Allograft Market, Mexico, Revenue ($m), by Sub Segment, 2013-2020 .......................................... 64

5.3 Tissue Engineered - Skin Substitutes Market, Mexico, Volume (Units), 2005-2013 ....................................... 66

5.4 Tissue Engineered - Skin Substitutes Market, Mexico, Volume (Units), 2013-2020 ....................................... 68

5.4.1 Biologic Skin Substitutes Market, Mexico, Volume (Units), by Segment, 2005-2013............................... 70

5.4.1.1 Allograft Market, Mexico, Volume (Units), by Sub Segment, 2005-2013 ......................................... 72

5.4.2 Biologic Skin Substitutes Market, Mexico, Volume (Units), by Segment, 2013-2020............................... 74

5.4.2.1 Allograft Market, Mexico, Volume (Units), by Sub Segment, 2013-2020 ......................................... 76

5.5 Tissue Engineered - Skin Substitutes Market, Mexico, Average Price ($), 2005-2020 ................................... 78

5.6 Tissue Engineered - Skin Substitutes Market, Mexico, Distribution Share by Revenue ($m), 2012-2013 ...... 80

5.7 Tissue Engineered - Skin Substitutes Market, Mexico, Company Share by Revenue ($m), 2012-2013 ......... 81

6 Tissue Engineered - Skin Substitutes Market, United States ........................................................................ 83

6.1 Tissue Engineered - Skin Substitutes Market, United States, Revenue ($m), 2005-2013 .............................. 83

6.2 Tissue Engineered - Skin Substitutes Market, United States, Revenue ($m), 2013-2020 .............................. 85

6.2.1 Biologic Skin Substitutes Market, United States, Revenue ($m), by Segment, 2005-2013 ...................... 87

6.2.1.1 Allograft Market, United States, Revenue ($m), by Sub Segment, 2005-2013 ................................ 89

6.2.2 Biologic Skin Substitutes Market, United States, Revenue ($m), by Segment, 2013-2020 ...................... 91

6.2.1.2 Allograft Market, United States, Revenue ($m), by Sub Segment, 2013-2020 ................................ 93

6.3 Tissue Engineered - Skin Substitutes Market, United States, Volume (Units), 2005-2013 ............................. 95

6.4 Tissue Engineered - Skin Substitutes Market, United States, Volume (Units), 2013-2020 ............................. 97

6.4.1 Biologic Skin Substitutes Market, United States, Volume (Units), by Segment, 2005-2013 ..................... 99

6.4.1.1 Allograft Market, United States, Volume (Units), by Sub Segment, 2005-2013 ............................. 101

6.4.2 Biologic Skin Substitutes Market, United States, Volume (Units), by Segment, 2013-2020 ................... 103

6.4.1.2 Allograft Market, United States, Volume (Units), by Sub Segment, 2013-2020 ............................. 105

6.5 Tissue Engineered - Skin Substitutes Market, United States, Average Price ($), 2005-2020 ....................... 107

6.6 Tissue Engineered - Skin Substitutes Market, United States, Distribution Share by Revenue ($m), 2012-2013 109

6.7 Tissue Engineered - Skin Substitutes Market, United States, Company Share by Revenue ($m), 2012-2013 110

7 Overview of Key Companies in North America Tissue Engineered - Skin Substitutes Market .................. 112

7.1 Organogenesis, Inc. .................................................................................................................................. 112

7.1.1 Company Overview ............................................................................................................................. 112

7.2 Shire Plc .................................................................................................................................................... 112


7.3 Kinetic Concepts, Inc. ................................................................................................................................ 112


7.4 Integra LifeSciences Holdings Corporation................................................................................................. 113


7.5 Smith & Nephew Plc .................................................................................................................................. 113


7.6 Covidien plc ............................................................................................................................................... 113






7.7 Molnlycke Health Care AB ......................................................................................................................... 114


7.8 BSN medical GmbH .................................................................................................................................. 114


8 Appendix ........................................................................................................................................................ 115

8.1 Research Methodology .............................................................................................................................. 116

8.1.1 Coverage ............................................................................................................................................ 116

8.1.2 Secondary Research........................................................................................................................... 116

8.1.3 Primary Research ............................................................................................................................... 117

8.1.4 Market Modeling and Forecasting ....................................................................................................... 118

8.1.5 Company Share Analysis .................................................................................................................... 121

8.1.6 Distribution Share Analysis ................................................................................................................. 122

8.2 Expert Panel .............................................................................................................................................. 122

8.3 GlobalData Consulting ............................................................................................................................... 123

8.4 Disclaimer ................................................................................................................................................. 123





1.1 List of Tables

Table 1: Tissue Engineered - Skin Substitutes Market, Cross Country Comparison, North America, Revenue ($m), USD

Constant, 2005-2020 ................................................................................................................................................................ 11

Table 2: Tissue Engineered - Skin Substitutes Market, North America, Category Comparison by Revenue ($m), USD Constant,

2005-2020 ................................................................................................................................................................................ 13

Table 3: Tissue Engineered - Skin Substitutes Market, North America, Revenue ($m), Historic, USD Constant, 2005-2013 ....... 15

Table 4: Tissue Engineered - Skin Substitutes Market, North America, Revenue ($m), Forecast, USD Constant, 2013-2020 ..... 17

Table 5: Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), 2005-2020 ........................................... 18

Table 6: Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), Historic, 2005-2013 .............................. 20

Table 7: Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), Forecast, 2013-2020 ............................ 22

Table 8: Tissue Engineered - Skin Substitutes Market, North America, Company Share by Revenue ($m), USD Constant, 2012-

2013 ........................................................................................................................................................................................ 24

Table 9: Tissue Engineered - Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Historic, 2005-2013 ................. 26

Table 10: Tissue Engineered - Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Forecast, 2013-2020 ............. 28

Table 11: Biologic Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Historic, 2005-2013 .................................. 30

Table 12: Allograft Market, Canada, Revenue ($m), USD Constant, Historic, 2005-2013........................................................... 32

Table 13: Biologic Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Forecast, 2013-2020 ................................ 34

Table 14: Allograft Market, Canada, Revenue ($m), USD Constant, Forecast, 2013-2020 ......................................................... 36

Table 15: Tissue Engineered - Skin Substitutes Market, Canada, Volume (Units), Historic, 2005-2013 ...................................... 38

Table 16: Tissue Engineered - Skin Substitutes Market, Canada, Volume (Units), Forecast, 2013-2020 .................................... 40

Table 17: Biologic Skin Substitutes Market, Canada, Volume (Units), Historic, 2005-2013 ........................................................ 42

Table 18: Allograft Market, Canada, Volume (Units), Historic, 2005-2013 ................................................................................. 44

Table 19: Biologic Skin Substitutes Market, Canada, Volume (Units), Forecast, 2013-2020....................................................... 46

Table 20: Allograft Market, Canada, Volume (Units), Forecast, 2013-2020 ............................................................................... 48

Table 21: Tissue Engineered - Skin Substitutes Market, Canada, Average Price ($), Historic, 2005-2013 .................................. 49

Table 22: Tissue Engineered - Skin Substitutes Market, Canada, Average Price ($), Forecast, 2013-2020 ................................ 50

Table 23: Tissue Engineered - Skin Substitutes Market, Canada, Distribution Share by Revenue ($m), USD Constant, 2012-2013

................................................................................................................................................................................................ 51

Table 24: Tissue Engineered - Skin Substitutes Market, Canada, Company Share by Revenue ($m), USD Constant, 2012-2013

................................................................................................................................................................................................ 53

Table 25: Tissue Engineered - Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Historic, 2005-2013 ................ 55

Table 26: Tissue Engineered - Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Forecast, 2013-2020 .............. 57

Table 27: Biologic Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Historic, 2005-2013 ................................... 59

Table 28: Allograft Market, Mexico, Revenue ($m), USD Constant, Historic, 2005-2013 ............................................................ 61

Table 29: Biologic Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Forecast, 2013-2020 ................................. 63

Table 30: Allograft Market, Mexico, Revenue ($m), USD Constant, Forecast, 2013-2020 .......................................................... 65

Table 31: Tissue Engineered - Skin Substitutes Market, Mexico, Volume (Units), Historic, 2005-2013 ....................................... 67

Table 32: Tissue Engineered - Skin Substitutes Market, Mexico, Volume (Units), Forecast, 2013-2020 ..................................... 69

Table 33: Biologic Skin Substitutes Market, Mexico, Volume (Units), Historic, 2005-2013 .......................................................... 71

Table 34: Allograft Market, Mexico, Volume (Units), Historic, 2005-2013 .................................................................................. 73

Table 35: Biologic Skin Substitutes Market, Mexico, Volume (Units), Forecast, 2013-2020 ........................................................ 75

Table 36: Allograft Market, Mexico, Volume (Units), Forecast, 2013-2020 ................................................................................ 77

Table 37: Tissue Engineered - Skin Substitutes Market, Mexico, Average Price ($), Historic, 2005-2013 ................................... 78





Table 38: Tissue Engineered - Skin Substitutes Market, Mexico, Average Price ($), Forecast, 2013-2020 ................................. 79

Table 39: Tissue Engineered - Skin Substitutes Market, Mexico, Distribution Share by Revenue ($m), USD Constant, 2012-2013

................................................................................................................................................................................................ 80

Table 40: Tissue Engineered - Skin Substitutes Market, Mexico, Company Share by Revenue ($m), USD Constant, 2012-2013 82

Table 41: Tissue Engineered - Skin Substitutes Market, United States, Revenue ($m), USD Constant, Historic, 2005-2013 ....... 84

Table 42: Tissue Engineered - Skin Substitutes Market, United States, Revenue ($m), USD Constant, Forecast, 2013-2020 ..... 86

Table 43: Biologic Skin Substitutes Market, United States, Revenue ($m), USD Constant, Historic, 2005-2013 ......................... 88

Table 44: Allograft Market, United States, Revenue ($m), USD Constant, Historic, 2005-2013 .................................................. 90

Table 45: Biologic Skin Substitutes Market, United States, Revenue ($m), USD Constant, Forecast, 2013-2020 ....................... 92

Table 46: Allograft Market, United States, Revenue ($m), USD Constant, Forecast, 2013-2020 ................................................ 94

Table 47: Tissue Engineered - Skin Substitutes Market, United States, Volume (Units), Historic, 2005-2013 ............................. 96

Table 48: Tissue Engineered - Skin Substitutes Market, United States, Volume (Units), Forecast, 2013-2020 ........................... 98

Table 49: Biologic Skin Substitutes Market, United States, Volume (Units), Historic, 2005-2013 .............................................. 100

Table 50: Allograft Market, United States, Volume (Units), Historic, 2005-2013 ....................................................................... 102

Table 51: Biologic Skin Substitutes Market, United States, Volume (Units), Forecast, 2013-2020 ............................................ 104

Table 52: Allograft Market, United States, Volume (Units), Forecast, 2013-2020 ..................................................................... 106

Table 53: Tissue Engineered - Skin Substitutes Market, United States, Average Price ($), Historic, 2005-2013 ....................... 107

Table 54: Tissue Engineered - Skin Substitutes Market, United States, Average Price ($), Forecast, 2013-2020 ..................... 108

Table 55: Tissue Engineered - Skin Substitutes Market, United States, Distribution Share by Revenue ($m), USD Constant, 2012-

2013 ...................................................................................................................................................................................... 109

Table 56: Tissue Engineered - Skin Substitutes Market, United States, Company Share by Revenue ($m), USD Constant, 2012-

2013 ...................................................................................................................................................................................... 111

Table 57: Total Number of Primary Research Participants, Wound Care Management, by Country ......................................... 118

1.2 List of Figures

Figure 1: Tissue Engineered - Skin Substitutes Market, Cross Country Comparison, North America, Revenue ($m), USD

Constant, 2005-2020 ................................................................................................................................................................ 10

Figure 2: Tissue Engineered - Skin Substitutes Market, North America, Category Comparison by Revenue ($m), USD Constant,

2005-2020 ................................................................................................................................................................................ 12

Figure 3: Tissue Engineered - Skin Substitutes Market, North America, Revenue ($m), Historic, USD Constant, 2005-2013 ...... 14

Figure 4: Tissue Engineered - Skin Substitutes Market, North America, Revenue ($m), Forecast, USD Constant, 2013-2020 .... 16

Figure 5: Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), 2005-2020 .......................................... 18

Figure 6: Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), Historic, 2005-2013 ............................. 19

Figure 7: Tissue Engineered - Skin Substitutes Market, North America, Volume (Units), Forecast, 2013-2020 ........................... 21

Figure 8: Tissue Engineered - Skin Substitutes Market, North America, Company Share (%), 2013 .......................................... 23

Figure 9: Tissue Engineered - Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Historic, 2005-2013 ................ 25

Figure 10: Tissue Engineered - Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Forecast, 2013-2020 ............ 27

Figure 11: Biologic Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Historic, 2005-2013................................. 29

Figure 12: Allograft Market, Canada, Revenue ($m), USD Constant, Historic, 2005-2013 ......................................................... 31

Figure 13: Biologic Skin Substitutes Market, Canada, Revenue ($m), USD Constant, Forecast, 2013-2020 ............................... 33

Figure 14: Allograft Market, Canada, Revenue ($m), USD Constant, Forecast, 2013-2020 ....................................................... 35

Figure 15: Tissue Engineered - Skin Substitutes Market, Canada, Volume (Units), Historic, 2005-2013 ..................................... 37

Figure 16: Tissue Engineered - Skin Substitutes Market, Canada, Volume (Units), Forecast, 2013-2020 ................................... 39





Figure 17: Biologic Skin Substitutes Market, Canada, Volume (Units), Historic, 2005-2013 ....................................................... 41

Figure 18: Allograft Market, Canada, Volume (Units), Historic, 2005-2013 ................................................................................ 43

Figure 19: Biologic Skin Substitutes Market, Canada, Volume (Units), Forecast, 2013-2020 ..................................................... 45

Figure 20: Allograft Market, Canada, Volume (Units), Forecast, 2013-2020 .............................................................................. 47

Figure 21: Tissue Engineered - Skin Substitutes Market, Canada, Company Share (%), 2013 .................................................. 52

Figure 22: Tissue Engineered - Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Historic, 2005-2013 ............... 54

Figure 23: Tissue Engineered - Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Forecast, 2013-2020 ............. 56

Figure 24: Biologic Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Historic, 2005-2013 .................................. 58

Figure 25: Allograft Market, Mexico, Revenue ($m), USD Constant, Historic, 2005-2013........................................................... 60

Figure 26: Biologic Skin Substitutes Market, Mexico, Revenue ($m), USD Constant, Forecast, 2013-2020 ................................ 62

Figure 27: Allograft Market, Mexico, Revenue ($m), USD Constant, Forecast, 2013-2020 ......................................................... 64

Figure 28: Tissue Engineered - Skin Substitutes Market, Mexico, Volume (Units), Historic, 2005-2013 ...................................... 66

Figure 29: Tissue Engineered - Skin Substitutes Market, Mexico, Volume (Units), Forecast, 2013-2020 .................................... 68

Figure 30: Biologic Skin Substitutes Market, Mexico, Volume (Units), Historic, 2005-2013 ........................................................ 70

Figure 31: Allograft Market, Mexico, Volume (Units), Historic, 2005-2013 ................................................................................. 72

Figure 32: Biologic Skin Substitutes Market, Mexico, Volume (Units), Forecast, 2013-2020....................................................... 74

Figure 33: Allograft Market, Mexico, Volume (Units), Forecast, 2013-2020 ............................................................................... 76

Figure 34: Tissue Engineered - Skin Substitutes Market, Mexico, Company Share (%), 2013.................................................... 81

Figure 35: Tissue Engineered - Skin Substitutes Market, United States, Revenue ($m), USD Constant, Historic, 2005-2013 ..... 83

Figure 36: Tissue Engineered - Skin Substitutes Market, United States, Revenue ($m), USD Constant, Forecast, 2013-2020.... 85

Figure 37: Biologic Skin Substitutes Market, United States, Revenue ($m), USD Constant, Historic, 2005-2013 ........................ 87

Figure 38: Allograft Market, United States, Revenue ($m), USD Constant, Historic, 2005-2013 ................................................. 89

Figure 39: Biologic Skin Substitutes Market, United States, Revenue ($m), USD Constant, Forecast, 2013-2020 ...................... 91

Figure 40: Allograft Market, United States, Revenue ($m), USD Constant, Forecast, 2013-2020 ............................................... 93

Figure 41: Tissue Engineered - Skin Substitutes Market, United States, Volume (Units), Historic, 2005-2013 ............................ 95

Figure 42: Tissue Engineered - Skin Substitutes Market, United States, Volume (Units), Forecast, 2013-2020 .......................... 97

Figure 43: Biologic Skin Substitutes Market, United States, Volume (Units), Historic, 2005-2013 ............................................... 99

Figure 44: Allograft Market, United States, Volume (Units), Historic, 2005-2013 ...................................................................... 101

Figure 45: Biologic Skin Substitutes Market, United States, Volume (Units), Forecast, 2013-2020 ........................................... 103

Figure 46: Allograft Market, United States, Volume (Units), Forecast, 2013-2020 .................................................................... 105

Figure 47: Tissue Engineered - Skin Substitutes Market, United States, Company Share (%), 2013 ........................................ 110

Figure 48: GlobalData Epidemiology-Based Forecasting Model ............................................................................................. 120

Figure 49: GlobalData Capital Equipment-Based Forecasting Model ...................................................................................... 121

Figure 50: Primary Interviews by Participant Type (%) ........................................................................................................... 122





2 Introduction

Medical Equipment Market Reports are the ideal guide for anyone wishing to understand their market better in terms

of revenues, unit sales, distributors and competitors.

2.1 What Is This Report About?

This report provides an overview and the following information related to the country, region, various categories,

distribution share and competitive landscape in the market:

1. Comprehensive data related to the market revenue, unit sale, average price, company share and

distribution share.

2. Corporate-level profiles of key companies operating in the Tissue Engineered - Skin Substitutes market,

which includes a brief overview of the company. The selection of the companies is based on their

operational presence.

3. A list of key products under development by different companies. The selection of this list is based on the

territory in which these products are being clinically investigated.

4. Key news and deals related to the Tissue Engineered - Skin Substitutes market.

2.2 Tissue Engineered - Skin Substitutes Market Segmentation

Tissue Engineered - Skin Substitutes market is segmented as described below, in this report:

Tissue Engineered - Skin Substitutes includes segments such as

1. Synthetic Skin Substitutes

2. Biosynthetic Skin Substitutes

3. Biologic Skin Substitutes

Biologic Skin Substitutes includes sub-segments such as Allograft and Xenograft.

o Allograft includes sub-segments such as Allograft Cellular and Allograft Acellular.

o Xenograft include sub-segment such as Xenograft Acellular.





2.3 Definitions of Markets Covered in the Report

Tissue Engineered - Skin Substitutes

Tissue engineering for wound care management is the use of mechanical and chemical processing of materials to

manufacture products that may substitute or replace all or some components that make up a normal skin (e.g.

epidermis and/or dermis, cells and matrix). They can be derived from human tissue (Autologous or Allogenic), non-

human tissue (Xenographic), and a composite or Synthetic material. Acellular or cellular, Synthetic or Biological and

may consist of a synthetic epidermis and a collagen-based dermis to encourage formation of new tissue. In products

that have a synthetic epidermis, this may be a temporary wound covering. This category covers all types of skin

substitutes mentioned above. This category consists of Synthetic skin substitutes, Biosynthetic skin substitutes, and

Biological skin substitutes.

Synthetic Skin Substitutes

Synthetic skin substitutes are the Tissue engineered products which consist of biocompatible polymer matrix. One

unit of Synthetic skin substitute refers to 100 sq. cm.

Biosynthetic Skin Substitutes

Tissue Engineered Biosynthetic skin substitutes products are a combination of biological and biocompatible polymer

matrix. One unit of Biosynthetic skin substitute refers to 100 sq. cm

Biologic Skin Substitutes

Tissue Engineered products for wound care management which are Biological in origin; includes Autograft, Allograft,

and Xenograft. One unit of Biological skin substitute refers to 100 sq. cm

Allograft

Tissue Engineered Allografts are the transplanted cells or tissues sourced from a genetically non-identical member of

the same species. These are typically available in the form of surgical grafts or matrix. Allograft can be acellular or

cellular. Acellular products (i.e., cadaveric human dermis in which cellular material is removed) have a matrix or

scaffold made of materials such as hyaluronic acid, collagen, and fibronectin. Cellular Allograft products have living

cells of fibroblasts and keratinocytes embedded in matrix.

Tissue Engineered Allografts include Allograft Cellular and Allograft Acellular

Xenograft Acellular

Tissue Engineered Xenografts are derived from animal sources. The tissue material is processed to remove the cells.

The products derived may consist of tissue scaffold or may be combined with synthetic material to create a composite

product. Both biological and biosynthetic Xenografts, having either permanent or temporary application, are tracked

under this segment. We have tracked only Xenograft Acellular and not Xenograft Cellular, as Xenograft Cellular are

rarely used because of severe rejections and infections.





3 Tissue Engineered - Skin Substitutes Market, North America

3.1 Tissue Engineered - Skin Substitutes Market, North America, Revenue ($m), 2005-2020

Figure 1: Tissue Engineered - Skin Substitutes Market, Cross Country Comparison, North America, Revenue ($m), USD

Constant, 2005-2020

Source: GlobalData





Table 1: Tissue Engineered - Skin Substitutes Market, Cross Country Comparison, North America, Revenue ($m), USD

Constant, 2005-2020

Country Name 2005 2013 2020 CAGR 05-13 CAGR 13-20 CAGR 05-20

United States

Canada

Mexico

Total

Source: GlobalData





3.2 Tissue Engineered - Skin Substitutes Market, North America, Category Comparison by Revenue ($m), 2005-2020

Figure 2: Tissue Engineered - Skin Substitutes Market, North America, Category Comparison by Revenue ($m), USD

Constant, 2005-2020

Source: GlobalData





Table 2: Tissue Engineered - Skin Substitutes Market, North America, Category Comparison by Revenue ($m), USD

Constant, 2005-2020

Category 2013 CAGR 05-13 CAGR 13-20

Biologic Skin Substitutes

Biosynthetic Skin Substitutes

Synthetic Skin Substitutes

Source: GlobalData





Page 115

8 Appendix

The data and analysis within this report are driven by Medical eTrack. Medical eTrack gives you the key information

required to drive sales, investment and deal-making activity in your business. It includes the following:

15,000+ data tables showing market size across more than 780 medical equipment segments and 15 countries,

from 2005 and forecast to 2020

6,000+ primary expert interviews, conducted annually to ensure data and report quality

1,100+ medical equipment conference reports

1,000+ industry-leading reports per annum, covering growing sectors, market trends, investment opportunities

and competitive landscape

600+ analysis reports, covering market and pipeline product analysis, by indication; medical equipment trends

and issues, and investment and M&A trends worth over $3m

50,000+ medical equipment company profiles

2,000+ private, emerging and technology start-up company profiles

4,000+ company profiles of medical equipment manufacturers in China and India

2,000+ company profiles of medical equipment manufacturers in Japan

825+ companies’ revenue splits and market shares

1,100+ quarterly and annual medical equipment company financials

700+ medical equipment company SWOTs

14,900+ pipeline product profiles

18,700+ marketed product profiles

27,600+ clinical trials

20,000+ trial investigators

20,600+ new product patents

3,700+ reports on companies with products in development

21,500+ reports on deals in the medical equipment industry

1,300+ surgical and diagnostic procedures by therapy area

50+ key healthcare indicators by country

For more information or to receive a free demonstration of the service, please visit:

http://www.medicaletrack.com/ContactUs.aspx?Id=RequestDemo





Page 116

8.1 Research Methodology

GlobalData’s dedicated research and analysis teams consist of experienced professionals with advanced statistical

expertise and marketing, market research and consulting backgrounds in the medical devices industry.

GlobalData adheres to the codes of practice of the European Pharmaceutical Marketing Research Association

(http://www.ephmra.org/).

All GlobalData databases are continuously updated and revised.

8.1.1 Coverage

The objective of updating GlobalData’s coverage is to ensure that it represents the most up-to-date vision of the

industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and

competitor sources.

Company coverage is based on three key factors: revenue; product and media attention; and innovation and market

potential.

The estimated revenue of all major companies, both private and public, are gathered and used to prioritize coverage.

GlobalData aims to cover all major news events and deals in the medical devices industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional input from GlobalData’s expert panel.

8.1.2 Secondary Research

The research process begins with extensive secondary research using internal and external sources to gather all

relevant data and information pertaining to a particular market model for a particular country. The secondary research

sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings

Industry trade journals, scientific journals and other technical literature

Association and healthcare organization websites

PubMed, Medscape and other relevant services which compile extensive reviews of clinical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market





Page 117

8.1.3 Primary Research

GlobalData conducts interviews with industry participants and commentators in order to validate its data and analysis.

A typical research interview fulfills the following functions:

Provides first-hand information on market size, market trends, growth trends, competitive landscape and

future outlook

Helps to validate and strengthen secondary research findings

Further develops the analysis team’s expertise and market understanding

Primary research involves email correspondence, telephone interviews and face-to-face interviews for each market,

category, segment and sub-segment across a range of geographies.

The participants who typically take part in such a process include, but are not limited to:

o Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and

national sales managers

o Distributors, paramedics and representatives from hospital stores, laboratories and pharmacies

o Outside experts: investment bankers, valuation experts and research analysts that specialize in specific

medical equipment markets

o Key opinion leaders: physicians and surgeons that specialize in the therapeutic areas in which the

medical device is used

The market data was validated based on the inputs from 1,725 primary research participants. The primary research

participants included stakeholders from demand side such as Nurses, Surgeons, Paramedics and Physicians as well

as participants from the supply side such as the Marketing Managers, Sales Managers and Product Managers of

companies manufacturing/marketing wound care products.





Page 118

Table 57: Total Number of Primary Research Participants, Wound Care Management, by Country

Country Total Number of Primary Research Participants

United States 172

Brazil 143

India 140

United Kingdom 128

Italy 120

Australia 118

Canada 114

Germany 111

France 111

Spain 108

Russia 101

Mexico 99

China 94

South Korea 90

Japan 76

Total 1,725

Source: GlobalData

8.1.4 Market Modeling and Forecasting

GlobalData uses an epidemiology-based treatment flow model and capital equipment-based model to estimate and

forecast market size.

Epidemiology-Based Market Model and Forecasting

The epidemiology-based forecasting model uses epidemiology data gathered from research publications and primary

interviews with physicians to establish the target patient population and treatment flow pattern for individual diseases

and therapies. The data covers prevalence, incidence, diseased population, diagnosed population, and treatment

population.

The market forecast begins with the general population, the size of which varies depending on the indication.

Prevalence is the percentage of the total population that suffers from a particular disease or condition.

Incidence is the number of new cases of a condition, symptom, death or injury that develop during a specific

time period, such as one year.

The diseased population is the population suffering from a particular disease or condition.

The diagnosed population is the population that has been diagnosed with a particular disease or condition,

expressed as a percentage of the prevalence population.





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The treatment population is the percentage of the population that has been diagnosed with a particular

disease or condition.

Device uptake is the percentage of the treatment population using a particular device, determined based on

the primary responses and the information available in secondary sources.

The epidemiology-based forecasting model for a medical device is used to:

Determine the patient segment using a particular device or procedure

Determine the frequency of usage of a particular device depending on the patient type, which further helps to

determine the absolute unit sales of a device in a year

The market for any medical device is directly proportional to the volume of units sold and the price per unit.

Market size = volumes of units sold X ASP (Average Selling Price)

The volume of units sold is calculated from the number of patients using or that has been implanted with the device.

Data on treatment rate, diagnosis and surgical treatment rate, if unavailable from research publications, is gathered

from interviews with physicians and used to estimate the patient volume for the disease under consideration.

The ASP of a device is mostly gathered from primary and secondary sources. ASP is the price at which a device is

available in a target country to an end-user. For capital equipment, the end-user is typically considered to be the

healthcare setting. For implants and consumables purchased by patients, the end-user is the patient.

Factors such as company share, reimbursement, company type (local/domestic or multinational) are taken into

consideration during ASP analysis, which uses the following sources:

Company websites

Annual reports/industry reports

Press releases





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Epidemiology-Based Forecasting Model

Capital Equipment-Based Market Model and Forecasting

The capital equipment-based forecasting model is based on the installed base, replacements and new sales of a

specific type of capital equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. The

installed base is calculated from the average number of units per facility. Sales for a particular year are arrived at by

calculating the number of replacement units and new units (additional and first-time purchases). Secondary sources

and interviews with supply-side participants and key opinion leaders from healthcare facilities are used to arrive at

installed base and unit sales for a particular year. The factors typically affecting the forecast growth rates are:

Growth in the number of healthcare facilities

Healthcare spending and government programs and initiatives

Migration from low-end equipment to high-end equipment

Growth in the diagnosed population and treatment population

Figure 48: GlobalData Epidemiology-Based Forecasting Model

Source: GlobalData





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Capital Equipment-Based Forecasting Model

8.1.5 Company Share Analysis

Company shares are calculated by analyzing a company’s sales in a particular market. In the case of public

companies, annual reports and regulatory filings, investor presentations, earnings call transcripts and broker reports

are used to determine a company’s revenue in a particular market and in a particular geography.

In the case of the private companies, company share data is gathered mostly from primary interviews and secondary

sources. Company share analysis is based on primary interviews with:

Supply side (manufacturers)

Procurement side

Distributors

Hospital purchasing groups

Demand side (surgeons/specialists)

Figure 49: GlobalData Capital Equipment-Based Forecasting Model

Source: GlobalData





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The benefits of this approach are:

High number of respondents to validate and from which to derive accurate company shares

Broad view from the supply, demand, and procurement side

Prevents biased opinions being reproduced

Demand-side interviews with key opinion leaders help to understand their preferences for the devices of

specific companies, strengthening company share estimates

Primary Interviews by Participant Type

Figure 50: Primary Interviews by Participant Type (%)

The final company share data is based on input from the supply side, the procurement side and the demand side, as

well as secondary sources. Please note that market share for companies that are included under the ‘Others’

category is not tracked on an individual basis.

8.1.6 Distribution Share Analysis

Distribution share information is gathered using a combination of secondary and primary research. It is supported by

primary interviews because the availability of secondary data is limited in most cases.

8.2 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData’s expert panel comprises marketing managers, product specialists, international sales managers from

medical device companies, academics from research universities, key opinion leaders from hospitals, consultants

from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GlobalData’s expert panel for feedback and adjusted accordingly

50

25

25

Procurement side Supply side Demand side





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8.3 GlobalData Consulting

We hope that the data and analysis in this brief will help you to make informed and imaginative business decisions. If

you have further requirements, GlobalData’s consulting team may be able to help you. GlobalData offers tailor-made

analytical and advisory services to drive your key strategic decisions

8.4 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means,

electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher,

GlobalData.

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