NA Pharmaceutical Isolator Market - Industry Trends and Forecast to 2029
- Published Date: 2022-12-22
- Report ID: 143024
- Pages: 225
-
Format:
Short Description
North America Pharmaceutical Isolator Market, By Type (Aseptic Isolators, Containment Isolators, Bio Isolators, Sampling And Weighing Isolators, Active Pharmaceutical Ingredient (API) Manufacturing Isolators, Radiopharmaceutical Isolators, Production Isolators, Others), System Type (Closed System, Open System), Pressure (Positive Pressure, Negative Pressure), Configuration (Floor Standing, Modular, Mobile, Compact, Table Top, Portable, Others), Application (Sterility Testing, Manufacturing , Sampling/ Weighing/ Distribution , Medical Device Manufacturing, Others), End User (Hospitals, Diagnostic Laboratories, Academic And Research Institutes, Pharmaceutical And Biotechnology Companies, Contract Research Organizations, Others), Distribution Channel (Direct Tender, Retail Sales, Third Party Distributors) Industry Trends and Forecast to 2029.
Market Definition
The isolation concept is quite known in the pharmaceutical industry, protects the process from the Operator and or the operator from the process, while protecting the environment. The key to containment, is minimal exposure. By controlling the exposure range below the hazard level set for the compound, the Operator and the environment are properly protected. Hence, the product is protected and therefore a key regulatory issue is addressed. A pharmaceutical isolator is a sealed bacterial enclosure used in the pharmaceutical surrounding for aseptic filling and toxic process. It is made of a perfectly sterile main isolator where the products are handled, stored or packaged using shoulder-high gloves placed on one of the walls. The pharmaceutical isolator enables the control and containment of pharmaceutical processes. The conditions required for working of a pharmaceutical isolator are sterile environment and free of viable microorganisms. A pharmaceutical isolator ensures that production area and aseptic environment are placed in separate positions.
A pharmaceutical industry isolator is cost effective and efficient, in comparison to cleanrooms for the pharmaceutical industry in an aseptic environment. It creates a controlled atmosphere during the microbial and drug production process by adjusting with the different standards certification standard required for isolators and restricted access barriers. It ensures the protection of the product, the operators and the environment at the same time.
The abundant applications of pharmaceutical isolators, vary for production and control purposes. It is used while handling, transferring or packing solid semi-solid or powder pharma drugs, handling and filing solutions and infusions. The pharmaceutical isolators are applied in sterility testing, aseptic handling of tissues or biological production systems or pathogenic samples, etc. It can be used for the production and control of drugs and pharmaceutical products.
The surge in demand for the isolators across pharmaceutical and biotechnology industry, along with low operational cost, high maintenance of aseptic condition in the production of pharmaceutical products and growing demand of biopharmaceutical industry are the factors expected to drive the market growth, in the forecast period.
Also, strategic initiatives by market players, technological progressions in pharmaceutical isolators, high sterility assurance and increasing investment for healthcare infrastructure. These factors increase in the demand for pharmaceutical isolators market.
Market Segmentation
The North America pharmaceutical isolator market is categorized into seven notable segments, which are by type, system type, pressure, configuration, application, end user and distribution channel.
On the basis of type, the North America pharmaceutical isolator market is segmented into aseptic isolators, containment isolators, bio isolators, sampling and weighing isolators, active pharmaceutical ingredient (API) manufacturing isolators, radiopharmaceutical isolators, production isolators and others.
On the basis of system type, the North America pharmaceutical isolator market is segmented into closed system, open system.
On the basis of pressure type, the North America pharmaceutical isolator market is segmented into positive pressure, negative pressure.
On the basis of configuration, the North America pharmaceutical isolator market is segmented into floor standing, modular, mobile, compact, table top, portable, others.
On the basis of configuration, the North America pharmaceutical isolator market is segmented into floor standing, modular, mobile, compact, table top, portable, others.
On the basis of application, the North America pharmaceutical isolator market is segmented into sterility testing, manufacturing , sampling/ weighing/ distribution , medical device manufacturing, others.
On the basis of end user, the North America pharmaceutical isolator market is segmented into hospitals, diagnostic laboratories, academic and research institutes, pharmaceutical and biotechnology companies, contract research organizations, others.
On the basis of distribution channel, the North America pharmaceutical isolator market is segmented direct tender, retail sales, third party distributors
Market Players
Some of the major players operating in the North America pharmaceutical isolator market are:
Getinge AB
cytiva (A subsidiary of Danaher Corporation)
Azbil Corporation
Chiyoda corporation
Hosokawa micron Ltd
Bioquell, An Ecolab Solution (A subsidiary of ecolab
chamunda pharma machinery
COMECER S.p.A. (A subsidiary of ats automation tools)
Envair technology
Esco Micro Pte. Ltd
Fedegari Autoclavi S.P.A
Germfree Laboratories, Inc.
Gelman Singapore
Hect Technologie Gmbh
Iso Tech Design
Iteco Srl
Jacomex
LAF Technologies
MBRAUN.
Nuaire
Steriline
Schematic Engineering Industry
Skan Ag
Tema Sinergie S.P.A
TABLE OF CONTENTS
1 INTRODUCTION 36
1.1 OBJECTIVES OF THE STUDY 36
1.2 MARKET DEFINITION 36
1.3 OVERVIEW OF THE NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET 37
1.4 CURRENCY AND PRICING 39
1.5 LIMITATIONS 39
1.6 MARKETS COVERED 39
2 MARKET SEGMENTATION 44
2.1 MARKETS COVERED 44
2.2 GEOGRAPHICAL SCOPE 45
2.3 YEARS CONSIDERED FOR THE STUDY 46
2.4 DBMR TRIPOD DATA VALIDATION MODEL 47
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 50
2.6 MULTIVARIATE MODELLING 51
2.7 MARKET APPLICATION COVERAGE GRID 52
2.8 SOURCE LIFELINE CURVE 53
2.9 DBMR MARKET POSITION GRID 54
2.10 VENDOR SHARE ANALYSIS 56
2.11 SECONDARY SOURCES 57
2.12 ASSUMPTIONS 57
3 EXECUTIVE SUMMARY 58
4 PREMIUM INSIGHT 61
4.1 PESTEL ANALYSIS 62
4.2 PORTERS FIVE FORCES 63
4.3 INDUSTRIAL INSIGHTS: 64
5 NORTH AMERICA PHARMACEUTICAL ISOLATORS MARKET: REGULATIONS 66
6 MARKET OVERVIEW 70
6.1 DRIVERS 72
6.1.1 GROWING DEMAND FOR THE PHARMACEUTICAL ISOLATORS ACROSS BOOMING PHARMACEUTICAL 72
6.1.2 LOW OPERATIONAL COST OF PHARMACEUTICAL ISOLATORS 72
6.1.3 HIGH MAINTENANCE OF ASEPTIC CONDITIONS IN THE PRODUCTION OF PHARMACEUTICAL PRODUCTS 73
6.1.4 LOW OPERATING COST OF PHARMACEUTICAL ISOLATORS & GROWING DEMAND IN THE BIOPHARMACEUTICAL INDUSTRY 73
6.2 RESTRAINTS 74
6.2.1 STRINGENT GOVERNMENTAL REGULATIONS 74
6.2.2 HIGH COST OF INSTALLATION & LIMITED ADOPTION OF RABS 74
6.3 OPPORTUNITIES 75
6.3.1 STRATEGIC INITIATIVES BY MARKET PLAYERS 75
6.3.2 TECHNOLOGICAL ADVANCEMENTS IN PHARMACEUTICAL ISOLATORS 75
6.3.3 HIGH STERILITY ASSURANCE 76
6.4 CHALLENGES 76
6.4.1 LACK OF SKILLED EXPERTISE 76
6.4.2 ENGINEERING CHALLENGES FACED WHILE DESIGNING THE PHARMACEUTICAL ISOLATORS 77
7 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY TYPE 78
7.1 OVERVIEW 79
7.2 ASEPTIC ISOLATOR 82
7.3 ACTIVE PHARMACEUTICAL INGREDIENT (API) MANUFACTURING ISOLATORS 82
7.4 CONTAINMENT ISOLATORS 83
7.5 BIO ISOLATORS 83
7.6 SAMPLING AND WEIGHING ISOLATORS 84
7.7 RADIOPHARMACEUTICAL ISOLATORS 84
7.8 PRODUCTION ISOLATORS 85
7.9 OTHERS 85
8 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY SYSTEM TYPE 86
8.1 OVERVIEW 87
8.2 OPEN SYSTEM 90
8.3 CLOSED SYSTEM 90
9 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY PRESSURE 91
9.1 OVERVIEW 92
9.2 POSITIVE PRESSURE 95
9.3 NEGATIVE PRESSURE 95
10 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY CONFIGURATION 96
10.1 OVERVIEW 97
10.2 FLOOR STANDING 100
10.3 MODULAR 100
10.4 MOBILE 101
10.5 COMPACT 101
10.6 TABLE TOP 102
10.7 PORTABLE 102
10.8 OTHERS 103
11 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY APPLICATION 104
11.1 OVERVIEW 105
11.2 STERILITY TESTING 108
11.3 MANUFACTURING 108
11.4 SAMPLING/WEIGHING/DISTRIBUTION 109
11.5 MEDICAL DEVICE MANUFACTURING 109
12 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY DISTRIBUTION CHANNEL 110
12.1 OVERVIEW 111
12.2 DIRECT TENDER 114
12.3 RETAIL SALES 114
12.4 THIRD PARTY DISTRIBUTORS 115
13 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY END USER 116
13.1 OVERVIEW 117
13.2 PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES 120
13.2.1 STERILE FILTERING 120
13.2.2 AMPULE FILLING 120
13.2.3 SYRINGE FILLING 121
13.2.4 SAMPLING 121
13.2.5 SAMPLE TESTING 121
13.2.6 STERILITY TESTING 121
13.2.7 PACKAGING 121
13.2.8 OTHERS 121
13.3 CONTRACT RESEARCH ORGANIZATION 121
13.3.1 STERILE FILTERING 122
13.3.2 AMPULE FILLING 122
13.3.3 SYRINGE FILLING 122
13.3.4 SAMPLING 122
13.3.5 SAMPLE TESTING 122
13.3.6 STERILITY TESTING 122
13.3.7 PACKAGING 123
13.3.8 OTHERS 123
13.4 ACADEMIC AND RESEARCH INSTITUTES 123
13.4.1 STERILE FILTERING 124
13.4.2 AMPULE FILLING 124
13.4.3 SYRINGE FILLING 124
13.4.4 SAMPLING 124
13.4.5 SAMPLE TESTING 124
13.4.6 STERILITY TESTING 124
13.4.7 PACKAGING 124
13.4.8 OTHERS 124
13.5 HOSPITALS 125
13.5.1 STERILE FILTERING 125
13.5.2 AMPULE FILLING 125
13.5.3 SYRINGE FILLING 126
13.5.4 SAMPLING 126
13.5.5 SAMPLE TESTING 126
13.5.6 STERILITY TESTING 126
13.5.7 PACKAGING 126
13.5.8 OTHERS 126
13.6 DIAGNOSTIC LABORATORIES 126
13.6.1 STERILE FILTERING 127
13.6.2 AMPULE FILLING 127
13.6.3 SYRINGE FILLING 127
13.6.4 SAMPLING 127
13.6.5 SAMPLE TESTING 127
13.6.6 STERILITY TESTING 127
13.6.7 PACKAGING 127
13.6.8 OTHERS 128
13.7 OTHERS 128
14 NORTH AMERICA PHARMACEUTICAL ISOLATOR MARKET, BY REGION 129
14.1 NORTH AMERICA 130
14.1.1 U.S. 139
14.1.2 CANADA 144
14.1.3 MEXICO 149
15 NORTH AMERICA PHARMACEUTICAL ISOLATORS MARKET: COMPANY LANDSCAPE 154
15.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 154
16 SWOT ANALYSIS 155
17 COMPANY PROFILE 156
17.1 GETINGE AB 156
17.1.1 COMPANY SNAPSHOT 156
17.1.2 REVENUE ANALYSIS 156
17.1.3 COMPANY SHARE ANALYSIS 157
17.1.4 PRODUCT PORTFOLIO 157
17.1.5 RECENT DEVELOPMENT 157
17.2 CYTIVA (A SUBSIDIARY OF DANAHER CORPORATION) 158
17.2.1 COMPANY SNAPSHOT 158
17.2.2 REVENUE ANALYSIS 158
17.2.3 COMPANY SHARE ANALYSIS 159
17.2.4 PRODUCT PORTFOLIO 159
17.2.5 RECENT DEVELOPMENT 159
17.3 AZBIL CORPORATION 160
17.3.1 COMPANY SNAPSHOT 160
17.3.2 REVENUE ANALYSIS 160
17.3.3 COMPANY SHARE ANALYSIS 161
17.3.4 PRODUCT PORTFOLIO 161
17.3.5 RECENT DEVELOPMENTS 161
17.4 CHIYODA CORPORATION 162
17.4.1 COMPANY SNAPSHOT 162
17.4.2 REVENUE ANALYSIS 162
17.4.3 COMPANY SHARE ANALYSIS 163
17.4.4 PRODUCT PORTFOLIO 163
17.4.5 RECENT DEVELOPMENT 163
17.5 HOSOKAWA MICRON LTD 164
17.5.1 COMPANY SNAPSHOT 164
17.5.2 COMPANY SHARE ANALYSIS 164
17.5.3 PRODUCT PORTFOLIO 165
17.5.4 RECENT DEVELOPMENTS 165
17.6 BIOQUELL, AN ECOLAB SOLUTION (A SUBSIDIARY OF ECOLAB) 166
17.6.1 COMPANY SNAPSHOT 166
17.6.2 REVENUE ANALYSIS 166
17.6.3 PRODUCT PORTFOLIO 167
17.6.4 RECENT DEVELOPMENT 167
17.7 CHAMUNDA PHARMA MACHNIERY 168
17.7.1 COMPANY SNAPSHOT 168
17.7.2 PRODUCT PORTFOLIO 168
17.7.3 RECENT DEVELOPMENTS 168
17.8 COMECER S.P.A. (A SUBSIDIARY OF ATS AUTOMATION TOOLS) (2021) 169
17.8.1 COMPANY SNAPSHOT 169
17.8.2 REVENUE ANALYSIS 169
17.8.3 PRODUCT PORTFOLIO 170
17.8.4 RECENT DEVELOPMENT 172
17.9 ENVAIR TECHNOLOGY 173
17.9.1 COMPANY SNAPSHOT 173
17.9.2 PRODUCT PORTFOLIO 173
17.9.3 RECENT DEVELOPMENTS 173
17.10 ESCO MICRO PTE. LTD 174
17.10.1 COMPANY SNAPSHOT 174
17.10.2 PRODUCT PORTFOLIO 174
17.10.3 RECENT DEVELOPMENT 175
17.11 FEDEGARI AUTOCLAVI S.P.A 177
17.11.1 COMPANY SNAPSHOT 177
17.11.2 PRODUCT PORTFOLIO 177
17.11.3 RECENT DEVELOPMENTS 177
17.12 GERMFREE LABORATORIES, INC. 178
17.12.1 COMPANY SNAPSHOT 178
17.12.2 PRODUCT PORTFOLIO 178
17.12.3 RECENT DEVELOPMENT 180
17.13 GELMAN SINGAPORE 181
17.13.1 COMPANY SNAPSHOT 181
17.13.2 PRODUCT PORTFOLIO 181
17.13.3 RECENT DEVELOPMENTS 182
17.14 HECT TECHNOLOGIE GMBH (2021) 183
17.14.1 COMPANY SNAPSHOT 183
17.14.2 PRODUCT PORTFOLIO 183
17.14.3 RECENT DEVELOPMENT 183
17.15 ISO TECH DESIGN 184
17.15.1 COMPANY SNAPSHOT 184
17.15.2 PRODUCT PORTFOLIO 184
17.15.3 RECENT DEVELOPMENTS 184
17.16 ITECO SRL 185
17.16.1 COMPANY SNAPSHOT 185
17.16.2 PRODUCT PORTFOLIO 185
17.16.3 RECENT DEVELOPMENT 185
17.17 JACOMEX 186
17.17.1 COMPANY SNAPSHOT 186
17.17.2 PRODUCT PORTFOLIO 186
17.17.3 RECENT DEVELOPMENT 186
17.18 LAF TECHNOLOGIES 187
17.18.1 COMPANY SNAPSHOT 187
17.18.2 PRODUCT PORTFOLIO 187
17.18.3 RECENT DEVELOPMENTS 187
17.19 MBRAUN.(2021) 188
17.19.1 COMPANY SNAPSHOT 188
17.19.2 PRODUCT PORTFOLIO 188
17.19.3 RECENT DEVELOPMENT 188
17.20 NUAIRE (A SUBSIDIARY OF GENUIT GROUP PLC) 189
17.20.1 COMPANY SNAPSHOT 189
17.20.2 REVENUE ANALYSIS 189
17.20.3 PRODUCT PORTFOLIO 190
17.20.4 RECENT DEVELOPMENTS 190
17.21 STERILINE (2021) 191
17.21.1 COMPANY SNAPSHOT 191
17.21.2 PRODUCT PORTFOLIO 191
17.21.3 RECENT DEVELOPMENTS 191
17.22 SCHEMATIC ENGINEERING INDUSTRY 192
17.22.1 COMPANY SNAPSHOT 192
17.22.2 PRODUCT PORTFOLIO 192
17.22.3 RECENT DEVELOPMENTS 192
17.23 SKAN AG 193
17.23.1 COMPANY SNAPSHOT 193
17.23.2 REVENUE ANALYSIS 193
17.23.3 PRODUCT PORTFOLIO 194
17.23.4 RECENT DEVELOPMENT 194
17.24 TEMA SINERGIE S.P.A 195
17.24.1 COMPANY SNAPSHOT 195
17.24.2 PRODUCT PORTFOLIO 195
17.24.3 RECENT DEVELOPMENTS 196
18 QUESTIONNAIRE 198
19 RELATED REPORTS 202
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