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Table of Contents for Sterilization Technologies: Advancing into the 21st Century



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INTRODUCTION

XXI

REASONS FOR DOING THE STUDY

XXI

STUDY GOALS AND OBJECTIVES

XXI

CONTRIBUTION OF THE STUDY

XXI

SCOPE AND FORMAT

XXII

METHODOLOGIES AND INFORMATION SOURCES

XXII

ANALYST CREDENTIALS

XXII

RELATED BCC REPORTS

XXIII

BCC ONLINE SERVICES

XXIII

DISCLAIMER

XXIII

SUMMARY

XXIV

Summary Table:
U.S. MARKET FOR STERILIZATION EQUIPMENT BY TYPE, THROUGH 2010 ($ MILLIONS)

XXV

Summary Figure:
U.S. MARKET FOR STERILIZATION EQUIPMENT BY TYPE, 2005-2010 ($ MILLIONS)

XXV

OVERVIEW

1

STERILIZATION DEFINED

1

STERILIZATION TECHNOLOGIES

2

Figure 1 SHARE OF U.S. STERILIZATION EQUIPMENT BY TYPE, 2005 (%)

2

Table 1 U.S. MARKET FOR STERILIZATION EQUIPMENT BY TYPE, 2005 ($ MILLIONS)

3

FILTRATION STERILIZATION

3

Figure 2 SHARE OF U.S. FILTRATION STERILIZATION EQUIPMENT MARKET BY TYPE, 2005 (%)

3

Figure 2 (CONTINUED)

4

Table 2 U.S. FILTRATION STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, 2005 ($ MILLIONS)

4

HEAT STERILIZATION

4

Figure 3 SHARE OF U.S. HEAT STERILIZATION EQUIPMENT MARKET BY PROCESS, 2005 (%)

5

Table 3 U.S. HEAT STERILIZATION EQUIPMENT MARKET VALUE BY PROCESS, 2005 ($ MILLIONS)

5

Steam Heat Sterilization

6

Figure 4 SHARE OF U.S. STEAM HEAT STERILIZATION EQUIPMENT MARKET BY TYPE, 2005 (%)

6

Table 4 U.S. STEAM HEAT STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, 2005 ($ MILLIONS)

7

Dry Heat Sterilization

7

CHEMICAL STERILIZATION

7

Figure 5 SHARE OF U.S. CHEMICAL STERILIZATION EQUIPMENT MARKET BY TYPE, 2005 (%)

8

Table 5 U.S. CHEMICAL STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, 2005 ($ MILLIONS)

8

RADIATION STERILIZATION

9

Figure 6 SHARE OF U.S. RADIATION STERILIZATION EQUIPMENT MARKET BY TYPE, 2005 (%)

9

Table 6 U.S. RADIATION STERILIZATION EQUIPMENT MARKET VALUE, 2005 ($ MILLIONS)

10

Gamma

10

Electron Beam

10

X-ray

10

CONTRACT STERILIZATION SERVICES

11

Figure 7 SHARE OF U.S. CONTRACT STERILIZATION SERVICES MARKET BY TYPE, 2005 (%)

11

Table 7 U.S. CONTRACT STERILIZATION SERVICES MARKET VALUE BY TYPE, 2005 ($ MILLIONS)

12

STERILIZATION HALLMARKS

12

STERILITY VALIDATION

13

UNWANTED MICROBES

13

Table 8 PROBLEMS CAUSED BY MICROBES IN SELECTED INDUSTRIES

14

SPOILAGE

14

PATHOGENICITY

14

Table 9 ANNUAL U.S. ILLNESSES CAUSED BY SELECTED PATHOGENS

15

PHYSICAL INTERFERENCE

15

CHEMICAL IMPURITY

16

STERILIZATION TECHNIQUES EVALUATION

16

Table 10 DECISION-MAKING CRITERIA FOR SYSTEM USE

16

PHYSICAL STATES OF MATTER

17

Table 11 STERILIZATION METHODS APPLIED TO PHYSICAL STATES

17

GOVERNMENT REGULATIONS

18

FDA

18

Irradiation Regulation

19

USDA/FSIS

20

OSHA

21

EPA

21

ANSI

22

ISO

22

CEN

22

AAMI

23

THE U.S. STERILIZATION INDUSTRY AND ITS COMPETITIVE ASPECTS

24

Figure 8 BASIC STERILIZATION INDUSTRY STRUCTURE

24

INDUSTRY ENVIRONMENT

25

MARKET INFLUENCES

25

INTERNATIONAL MARKET

26

Figure 9 SHARE OF GLOBAL STERILIZATION EQUIPMENT MARKET BY REGION, 2005 (%)

26

Table 12 GLOBAL STERILIZATION EQUIPMENT MARKET VALUE BY REGION, 2005 ($ MILLIONS)

27

North America

27

Europe

27

Europe (Continued)

28

Asia

29

Others

30

IMPORTANT STRATEGIES

30

DRIVING FORCES

31

INDUSTRY LEADERS

31

Figure 10 DISTRIBUTION CHANNELS FOR U.S. STERILIZATION PRODUCTS

32

OEMS

32

Figure 11 U.S. STERILIZATION OEMS MARKET SHARE: MAJOR VS OTHER PLAYERS, 2005 (%)

33

Table 13 SALES OF MAJOR VS OTHER PLAYERS IN THE U.S. STERILIZATION OEMS MARKET, 2005 ($ MILLIONS)

33

Advanced Sterilization Products

34

Barnstead International

34

Getinge USA, Inc.

34

MDS Nordion

35

Millipore Corp.

35

3M Medical Division

36

Pall Corp.

36

Steris Corp.

36

CONTRACT SERVICE PROVIDERS

37

Figure 12 U.S. CONTRACT SERVICE PROVIDERS MARKET SHARE, 2005 (%)

37

Figure 12 (CONTINUED)

38

Table 14 SALES OF U.S. CONTRACT SERVICE PROVIDERS, 2005 ($ MILLIONS)

38

Sterigenics International, Inc.

38

Steris Corp.

39

REPROCESSORS

39

Figure 13 U.S. REPROCESSORS MARKET SHARE, 2005 (%)

40

Table 15 SALES OF U.S. REPROCESSOR COMPANIES, 2005 ($ MILLIONS)

41

Alliance Medical Corp.

41

MediSISS

41

SterilMed, Inc.

42

Vanguard Medical Concepts, Inc.

42

CONSUMABLES SUPPLIERS

42

Ethylene Oxide Usage

43

RESELLERS

43

STERILIZATION TECHNOLOGY

44

CAPITAL EQUIPMENT

44

Table 16 U.S. STERILIZATION CAPITAL EQUIPMENT MARKET VALUE BY SIZE, THROUGH 2010 ($ MILLIONS)

44

Figure 14 U.S. STERILIZATION CAPITAL EQUIPMENT MARKET VALUE BY SIZE, 2000-2010 ($ MILLIONS)

45

Large Capital Equipment

45

Table 17 U.S. LARGE STERILIZATION CAPITAL EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

46

Small Capital Equipment

46

Table 18 U.S. SMALL STERILIZATION CAPITAL EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

46

CONTRACT SERVICES

46

MARKET VALUE

47

Table 19 U.S. CONTRACT STERILIZATION SERVICES MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

47

Figure 15 U.S. CONTRACT STERILIZATION SERVICES MARKET VALUE BY TYPE, 2000-2010 ($ MILLIONS)

48

IN-HOUSE STERILIZATION

49

TREATMENT MODALITIES

50

Table 20 U.S. STERILIZATION EQUIPMENT MARKET VALUE BY TREATMENT MODALITY, THROUGH 2010 ($ MILLION)

51

Figure 16 U.S. STERILIZATION EQUIPMENT MARKET VALUE BY TREATMENT MODALITY, 2000-2010 ($ MILLIONS)

51

TERMINAL STERILIZATION

52

Table 21 U.S. TERMINAL STERILIZATION EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

52

ASEPTIC PROCESSING

53

Table 22 U.S. ASEPTIC PROCESSING EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

53

END-USES

54

Table 23 MAJOR U.S. STERILIZATION EQUIPMENT INDUSTRY SECTORS, BY PROCESS

54

Table 24 U.S. STERILIZATION EQUIPMENT MARKET VALUE BY END USE, THROUGH 2010 ($ MILLIONS)

55

Figure 17 U.S. STERILIZATION EQUIPMENT MARKET VALUE BY END USE, 2000-2010

55

POINT-OF-USE MARKET

56

Table 25 U.S. POINT-OF-USE STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

56

Market Drivers

56

Medical Device Reuse

57

Third Party Reprocessors

57

Table 26 U.S. THIRD-PARTY REPROCESSING MARKET VALUE, THROUGH 2010 ($ MILLIONS)

58

In-house Reprocessing

59

Application Limitations

59

MANUFACTURING MARKET

59

Table 27 U.S. STERILIZATION EQUIPMENT MANUFACTURING MARKET VALUE BY INDUSTRY SECTOR, THROUGH 2010 ($ MILLIONS)

60

Medical/Pharmaceutical

60

Table 28 U.S. MEDICAL/PHARMACEUTICAL STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

61

Food/Beverage

62

Table 29 U.S. FOOD/BEVERAGE STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

62

OTHER INDUSTRIES

62

Table 30 U.S. OTHER INDUSTRIES STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

63

FILTRATION STERILIZATION

64

MARKET VALUE

64

Table 31 U.S. STERILE FILTERS MARKET VALUE BY PROCESS, THROUGH 2010 ($ MILLIONS)

65

Figure 18 U.S. STERILE FILTERS MARKET VALUE BY PROCESS, 2000-2010 ($ MILLIONS)

65

LIQUID FILTRATION STERILIZATION

66

MARKET VALUE

66

Table 32 U.S. STERILE LIQUID FILTERS MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

66

Figure 19 U.S. STERILE LIQUID FILTERS MARKET VALUE BY TYPE, 2000-2010 ($ MILLIONS)

67

BATCH-TYPE STERILIZING FILTERS

67

Market Value

68

Table 33 U.S. STERILE BATCH LIQUID FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

68

IN-LINE FILTERS

69

Market Value

69

Table 34 U.S. STERILE IN-LINE LIQUID FILTERS MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

69

Water Filters

69

Market Value

69

Table 35 U.S. STERILE WATER FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

70

Syringe Filters

70

Market Value

70

Table 36 U.S. STERILE SYRINGE FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

71

Intravenous Filters

71

Market Value

71

Table 37 U.S. STERILE IV FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

72

GAS FILTER STERILIZATION

72

MARKET VALUE

72

Table 38 U.S. STERILE GAS FILTERS MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

73

Figure 20 U.S. STERILE GAS FILTERS MARKET VALUE, BY TYPE, 2000-2010 ($ MILLIONS)

73

COMPRESSED GAS FILTERS

74

Market Value

74

Table 39 U.S. STERILE COMPRESSED GAS FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

74

MEDICAL GAS FILTERS

75

Market Value

75

Table 40 U.S. STERILE MEDICAL GAS FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

75

VENT FILTERS

75

Market Value

76

Table 41 U.S. STERILE VENT FILTERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

76

END-USES

76

Table 42 U.S. STERILE FILTERS S MARKET VALUE BY END USE, THROUGH 2010 ($ MILLIONS)

77

Figure 21 SHARE OF U.S. STERILE FILTERS MARKET BY END USE, 2005 AND 2010 (%)

77

Figure 21 (CONTINUED)

78

POINT OF USE

78

Market Value

78

Table 43 U.S. STERILE FILTERS FOR POINT-OF-USE MARKET VALUE, THROUGH 2010 ($ MILLIONS)

79

MANUFACTURING

79

Market Value

79

Table 44 U.S. STERILE FILTERS FOR MANUFACTURING MARKET VALUE, BY INDUSTRY SECTOR, THROUGH 2010 ($ MILLIONS)

80

Medical and Pharmaceutical

80

Market Value

80

Table 45 U.S. STERILE FILTERS FOR MEDICAL AND PHARMACEUTICAL MARKET VALUE, THROUGH 2010 ($ MILLIONS)

80

Market Value (Continued)

81

Food and Beverage Processing

82

Table 46 U.S. STERILE FILTERS FOR FOODS AND BEVERAGES MARKET VALUE, THROUGH 2010 ($ MILLIONS)

82

Other Industries

83

Market Value

83

Table 47 U.S. STERILE FILTERS FOR OTHER INDUSTRIES MARKET VALUE, THROUGH 2010 ($ MILLIONS)

83

FILTER STERILIZATION SUPPLIERS

84

Table 48 SELECTED U.S. STERILE FILTERS SUPPLIERS

84

Figure 22 U.S. STERILE FILTERS MARKET SHARE: MAJOR VS OTHER PLAYERS, 2005 (%)

84

Figure 22 (CONTINUED)

85

Table 49 SALES OF MAJOR VS OTHER PLAYERS IN THE U.S. STERILE FILTERS SUPPLIERS MARKET, 2005 ($ MILLIONS)

85

MAJOR PLAYERS

85

Pall Corp.

85

Millipore Corp.

86

PLAYERS

86

Cuno, Inc.

86

Domnick Hunter, Inc.

87

Donaldson Co., Inc.

87

GE Water and Process Technology

87

Hydro Service and Supplies, Inc.

88

Meissner Filtration Products

88

Parker Hannifin Corp.

88

Sartorius Corp.

89

Whatman, Inc.

89

Zander, Inc.

89

HEAT STERILIZATION

90

Table 50 ANTIMICROBIAL TEMPERATURE RANGES

90

HEAT STERILIZATION TECHNOLOGIES

90

MARKET VALUE

90

Table 51 U.S. HEAT STERILIZATION EQUIPMENT MARKET VALUE BY PROCESS, THROUGH 2010 ($ MILLIONS)

91

Figure 23 U.S. HEAT STERILIZATION EQUIPMENT MARKET VALUE BY PROCESS, 2000-2010 ($ MILLIONS)

91

STEAM STERILIZATION

92

Market Value

92

Table 52 U.S. STEAM STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

92

Figure 24 U.S. STEAM STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, 2000-2010 ($ MILLIONS)

93

Autoclaving

93

Market Value

94

Table 53 U.S. AUTOCLAVING EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

94

Distillation

94

Market Value

95

Table 54 U.S. DISTILLATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

95

Vapor Distillation

96

Market Value

96

Table 55 U.S. VAPOR COMPRESSION DISTILLATION EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

96

Single-Stage Distillation

96

Market Value

97

Table 56 U.S. SINGLE STAGE DISTILLATION EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

97

Pasteurization

98

Market Value

98

Table 57 U.S. PASTEURIZATION EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

98

Retorting

99

Market Value

99

Table 58 U.S. RETORTING EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

99

Other Steam Sterilizers

100

Market Value

100

Table 59 U.S. MARKET FOR OTHER STEAM STERILIZER EQUIPMENT, THROUGH 2010 ($ MILLIONS)

100

DRY HEAT STERILIZATION

101

Market Value

102

Table 60 U.S. DRY HEAT STERILIZATION MARKET VALUE, THROUGH 2010 ($ MILLIONS)

102

END-USES

103

Table 61 U.S. HEAT STERILIZATION EQUIPMENT MARKET VALUE BY END USE, THROUGH 2010 ($ MILLIONS)

103

Figure 25 SHARE OF U.S. HEAT STERILIZATION EQUIPMENT MARKET BY INDUSTRY SECTOR, 2005 AND 2010 (%)

104

POINT OF USE

104

Market Value

105

Table 62 U.S. HEAT STERILIZATION EQUIPMENT FOR POINT-OF-USE MARKET VALUE, THROUGH 2010 ($ MILLIONS)

105

MANUFACTURING

105

Market Value

105

Table 63 U.S. HEAT STERILIZATION EQUIPMENT FOR MANUFACTURING MARKET VALUE BY INDUSTRY SECTOR, THROUGH 2010 ($ MILLIONS)

106

Medical and Pharmaceutical Manufacturing

106

Market Value

106

Table 64 U.S. HEAT STERILIZATION EQUIPMENT FOR MEDICAL AND PHARMACEUTICAL MANUFACTURING MARKET VALUE, THROUGH 2010 ($ MILLIONS)

106

Food and Beverage Processing

107

Market Value

108

Table 65 U.S. HEAT STERILIZATION EQUIPMENT FOR FOODS AND BEVERAGES MANUFACTURING MARKET VALUE, THROUGH 2010 ($ MILLIONS)

108

Other Industries

109

Market Value

109

Table 66 U.S. HEAT STERILIZATION EQUIPMENT FOR OTHER INDUSTRIES MARKET VALUE, THROUGH 2010 ($ MILLIONS)

110

HEAT STERILIZATION OEMS

110

Table 67 SELECTED U.S. HEAT STERILIZER SUPPLIERS

111

Figure 26 U.S. HEAT STERILIZER SUPPLIERS MARKET SHARE: MAJOR, MID-LEVEL AND OTHER PLAYERS, 2005 (%)

112

Table 68 SALES OF MAJOR, MID-LEVEL AND OTHER PLAYERS IN THE U.S. HEAT STERILIZER SUPPLIERS MARKET, 2005 ($ MILLIONS)

113

MAJOR PLAYERS

113

Barnstead International

113

Steris Corp.

114

MID-LEVEL PLAYERS

114

Beta Star Corp.

114

Consolidated Stills and Sterilizers

115

Feldmeier Equipment Co.

115

Getinge USA, Inc.

115

Invensys APV

116

Primus Sterilizer Co., Inc.

116

Tuttnauer USA Co., Ltd.

116

OTHER PLAYERS

117

Alfa Medical

117

Allpax Products, Inc.

117

API Heat Transfer Group

118

Barry-Wehmiller Co.

118

Despatch Industries

118

Dixie Canner Equipment Co.

119

FMC Corp.

119

Goodnature Products, Inc.

119

Hereema Co.

120

Lydon Oven Co.

120

Malo, Inc.

120

MicroThermics, Inc.

121

Sterilization Cassette Systems, Inc.

121

Water Distillers, Inc.

121

CHEMICAL STERILIZATION

122

MARKET VALUE

122

Table 69 U.S. CHEMICAL STERILIZATION EQUIPMENT MARKET VALUE BY TYPE, THROUGH 2010 ($ MILLIONS)

123

Figure 27 U.S. CHEMICAL STERILIZATION EQUIPMENT MARKET VALUE, BY TYPE, 2000-2010 ($ MILLIONS)

123

ETHYLENE OXIDE

124

MARKET VALUE

124

Table 70 U.S. ETHYLENE OXIDE STERILIZATION EQUIPMENT MARKET VALUE, THROUGH 2010 ($ MILLIONS)

125

OTHER CHEMICAL STERILIZERS

125

Table 71 U.S. OTHER CHEMICAL STERILIZERS MARKET VALUE, THROUGH 2010 ($ MILLIONS)

125

Peracetic Acid

126

Hydrogen Peroxide

126

Ozone

127

Chlorine Dioxide

128

END-USES

128

Table 72 U.S. CHEMICAL STERILIZATION EQUIPMENT MARKET VALUE BY END USE, THROUGH 2010 ($ MILLIONS)

128

Figure 28 SHARE OF U.S. CHEMICAL STERILIZATION EQUIPMENT MARKET BY END USE, 2005 AND 2010 (%)

129

POINT OF USE

130

Market Value

130

Table 73 U.S. CHEMICAL STERILIZATION EQUIPMENT POINT-OF-USE MARKET VALUE, THROUGH 2010 ($ MILLIONS)

130

MANUFACTURING

131

Market Value

131

Table 74 U.S. CHEMICAL STERILIZATION EQUIPMENT MANUFACTURING MARKET VALUE, THROUGH 2010 ($ MILLIONS)

131

Medical and Pharmaceutical Manufacturing

131

Market Value

132

Table 75 U.S. CHEMICAL STERILIZATION EQUIPMENT FOR MEDICAL AND PHARMACEUTICAL MANUFACTURING MARKET VALUE, THROUGH 2010 ($ MILLIONS)

132

Food and Beverage Processing

133

Market Value

133

Table 76 U.S. CHEMICAL STERILIZATION EQUIPMENT FOR FOODS AND BEVERAGES MARKET VALUE, THROUGH 2010 ($ MILLIONS)

133

Other Industries

133

Market Value

133

Table 77 U.S. CHEMICAL STERILIZATION EQUIPMENT FOR OTHER INDUSTRIES MARKET VALUE, THROUGH 2010 ($ MILLIONS)

134

OEM SUPPLIERS

134

Table 78 SELECTED CHEMICAL STERILIZER OEMS

135

Figure 29 U.S. CHEMICAL STERILIZER OEMS MARKET SHARE: MAJOR VS OTHER PLAYERS, 2005 (%)

135

Figure 29 (CONTINUED)

136

Table 79 SALES OF MAJOR VS OTHER PLAYERS IN THE U.S. CHEMICAL STERILIZER OEMS MARKET, 2005 ($ MILLIONS)

136

MAJOR PLAYERS

136

Advanced Sterilization Products

137

Andersen Sterilizers, Inc.

137

3M Medical Division

137

Steris Corp.

138

PLAYERS

138

Engelhard Corp.

138

Novazone, Inc.

139

Ozone Safe Food, Inc.

139

Selective Micro Technologies

139

Sterile Technologies, Inc.

140

Sterilox Technologies, Inc.

140

Vacudyne, Inc.

140

CONTRACT STERILIZATION SUPPLIERS

141

Table 80 SELECTED CONTRACT ETO SERVICES PROVIDERS

141

Figure 30 U.S. CONTRACT ETO SERVICE PROVIDERS MARKET SHARE: MAJOR VS OTHER PLAYERS, 2005 (%)

141

Figure 30 (CONTINUED)

142

Table 81 SALES OF MAJOR VS OTHER PLAYERS IN THE U.S. CONTRACT ETO SERVICE PROVIDERS MARKET, 2005 ($ MILLIONS)

142

MAJOR PLAYERS
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