無菌検査市場：製品（キット・試薬、機器、サービス）、検査（膜ろ過、直接接種）、用途（製薬、バイオ製造、医療機器製造）、エンドユーザー（製薬、バイオテック）、地域別 - 2028年までの世界予測

Sterility Testing Market by Product (Kits & Reagents, Instrument, Services), Test (Membrane Filtration, Direct Inoculation), Application (Pharma, Biological Manufacturing, Medical Device Manufacturing), End User (Pharma, Biotech) & Region - Global Forecasts to 2028

世界の無菌検査市場は、2023年の11億米ドルから2028年には19億米ドルに達し、CARGは10.5％になると予測されています。医薬品・バイオテクノロジーの生産能力の拡大、新規バイオ医薬品の開発の増加、ライフサイエ... もっと見る

出版社	出版年月	電子版価格	ページ数	図表数	言語
MarketsandMarkets マーケッツアンドマーケッツ	2023年3月13日	US$4,950 シングルユーザライセンスライセンス・価格情報注文方法はこちら	192	213	英語

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サマリー

世界の無菌検査市場は、2023年の11億米ドルから2028年には19億米ドルに達し、CARGは10.5％になると予測されています。医薬品・バイオテクノロジーの生産能力の拡大、新規バイオ医薬品の開発の増加、ライフサイエンス研究への投資の増加などの要因が、市場成長を促進すると予想されます。しかし、シングルユース技術の採用の増加や、製品承認に関する厳しい規制ガイドラインが、市場の成長をある程度抑制すると予想されます。
「予測期間中、キット＆試薬は最も急速に成長するセグメントとなる見込みです。
製品＆サービスに基づき、無菌検査市場はキット＆試薬、機器、サービスに分けられます。予測期間中（2023-2028年）、キット＆試薬セグメントは、無菌検査市場において最も急成長しているセグメントとしても期待されています。キットは使い勝手が良いため、製薬業界やバイオテクノロジー業界で広く使用されています。さらに、保存期間が長いことから、学術機関や受託研究機関での採用が増加しています。無菌検査は、医薬品・バイオ医薬品の臨床・商業生産において必須である。製薬・バイオ企業は、コスト効率と時間効率の良さから、無菌検査用のキット・試薬を採用しています。
"2022年、用途別セグメントでは、医薬品＆バイオ医薬品が最大の市場占有率を占める"
アプリケーションに基づき、無菌検査市場は医薬品・生物製剤製造、医療機器製造、その他のアプリケーションに分けられます。2022年、無菌検査市場の用途別セグメントでは、医薬品・バイオ医薬品製造分野が最大のシェアを占めています。このセグメントの成長の要因としては、世界各地で医薬品・バイオ医薬品の生産能力が拡大、成長していることが挙げられます。
"2022年、北米はこの市場で最大の地域シェアを占めた"
2022年の無菌検査市場は、北米が支配的であった。この地域には大手製薬会社やバイオ医薬品会社の製造施設が存在し、北米の無菌性試験の膨大な需要に貢献すると考えられます。同地域では、医薬品承認率の上昇に伴い、無菌検査市場の拡大が予想されます。また、北米の医薬品・バイオ医薬品の需要は、疾病の蔓延や患者数の増加により高まっています。さらに、北米の製薬・バイオテクノロジー分野では、多額の研究開発投資が行われており、今後数年間は急速な成長が見込まれています。

予備選の内訳

本調査には、部品サプライヤーからティア1企業、OEMに至るまで、様々な業界専門家による洞察が含まれています。プライマリーの内訳は以下の通りです：

- 回答者別：供給側70％、需要側30％。
- 役職別-CXOおよびディレクター-30％、エグゼクティブ-25％、マネジャー-45
- 地域別：北米40％、欧州25％、APAC20％、RoW15％。

無菌検査市場は、Charles River Laboratories（米国）、Merck KGaA（ドイツ）、bioMérieux SA（フランス）、SGS SA（スイス）、WuXi AppTec（中国）、Nelson Laboratories, LLC（米国）、Pacific BioLabs（米国）、Sartorius AG（ドイツ）、サーモフィッシャーサイレフィック（米国）、Samsung Biologics（韓国）といった少数の世界的に確立したプレーヤーによって支配されています。本調査では、無菌検査市場におけるこれらの主要企業の会社概要、最近の開発状況、主要な市場戦略など、詳細な競合分析が含まれています。
調査対象範囲

当レポートでは、無菌検査市場を地域別（北米、欧州、アジア、その他の地域）、製品・サービス別（キット・試薬、機器、サービス）、検査タイプ別（膜ろ過、直接接種、その他の検査）、用途別（医薬品・バイオ、医療機器、その他の用途）、エンドユーザー別（医薬品企業、バイオテクノロジー企業、その他）に分類しています。また、無菌検査市場における市場促進要因、阻害要因、機会、課題、動向についても包括的にレビューしています。

レポート購入の主なメリット

本レポートは、市場全体とセグメントの収益数値の最も近い近似値に関する情報を提供し、この市場のリーダー/新規参入者を支援します。本レポートは、関係者が競争環境を理解し、より多くの洞察を得ることで、事業の位置づけを高め、適切な市場参入戦略を計画するのに役立ちます。また、本レポートは、関係者が無菌検査市場の鼓動を理解し、主要な市場促進要因、阻害要因、課題、および機会に関する情報を提供するのに役立ちます。

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1 INTRODUCTION 27
1.1 STUDY OBJECTIVES 27
1.2 MARKET DEFINITION 27
1.2.1 INCLUSIONS AND EXCLUSIONS 28
1.3 MARKET SCOPE 28
1.3.1 MARKETS COVERED 28
1.3.2 YEARS CONSIDERED 29
1.4 CURRENCY CONSIDERED 29
1.5 LIMITATIONS 29
1.6 STAKEHOLDERS 29
1.7 SUMMARY OF CHANGES 30
1.7.1 RECESSION IMPACT 30
2 RESEARCH METHODOLOGY 31
2.1 RESEARCH DATA 31
FIGURE 1 RESEARCH DESIGN 31
2.1.1 SECONDARY RESEARCH 32
2.1.1.1 Secondary sources 33
2.1.2 PRIMARY RESEARCH 34
2.1.2.1 Primary sources 34
2.1.2.2 Primary sources 35
2.1.2.3 Breakdown of primaries 35
FIGURE 2 STERILITY TESTING MARKET: BREAKDOWN OF PRIMARIES 35
2.2 MARKET SIZE ESTIMATION 36
FIGURE 3 STERILITY TESTING MARKET SIZE ESTIMATION (2022) 36
FIGURE 4 STERILITY TESTING MARKET SIZE ESTIMATION METHODOLOGY: BOTTOM-UP APPROACH 36
FIGURE 5 KEY INDUSTRY INSIGHTS 38
FIGURE 6 STERILITY TESTING MARKET: CAGR PROJECTION (2023–2028) 39
FIGURE 7 STERILITY TESTING MARKET: GROWTH ANALYSIS OF DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 39
2.3 MARKET BREAKDOWN AND DATA TRIANGULATION 41
FIGURE 8 DATA TRIANGULATION METHODOLOGY 41
2.4 RESEARCH LIMITATIONS 42
2.5 RESEARCH ASSUMPTIONS 42
2.6 RISK ANALYSIS 42
2.7 RECESSION IMPACT 43
TABLE 1 GLOBAL INFLATION RATE PROJECTION, 2021–2027 (% GROWTH) 43

3 EXECUTIVE SUMMARY 44
FIGURE 9 STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2023 VS. 2028 (USD MILLION) 44
FIGURE 10 STERILITY TESTING MARKET, BY TEST TYPE, 2023 VS. 2028 (USD MILLION) 45
FIGURE 11 STERILITY TESTING MARKET, BY APPLICATION, 2023 VS. 2028 (USD MILLION) 45
FIGURE 12 STERILITY TESTING MARKET, BY END USER, 2023 VS. 2028 (USD MILLION) 46
FIGURE 13 STERILITY TESTING MARKET: GEOGRAPHICAL SNAPSHOT 46
4 PREMIUM INSIGHTS 48
4.1 STERILITY TESTING MARKET OVERVIEW 48
FIGURE 14 RISING EXPANSION OF PHARMACEUTICAL & BIOPHARMACEUTICAL PRODUCTION CAPACITIES TO FUEL UPTAKE OF STERILITY TESTING SERVICES 48
4.2 ASIA: STERILITY TESTING MARKET, BY PRODUCT & COUNTRY (2022) 49
FIGURE 15 KITS & REAGENTS SEGMENT ACCOUNTED FOR LARGEST MARKET SHARE IN CHINA 49
4.3 STERILITY TESTING MARKET, BY REGION (2022) 50
FIGURE 16 ASIA TO WITNESS HIGHEST GROWTH RATE DURING FORECAST PERIOD 50
5 MARKET OVERVIEW 51
5.1 INTRODUCTION 51
5.2 MARKET DYNAMICS 51
FIGURE 17 STERILITY TESTING MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, & CHALLENGES 51
5.2.1 DRIVERS 52
5.2.1.1 Rising expansion of pharmaceutical & biopharmaceutical production capacities 52
5.2.1.2 Increasing development of novel biopharmaceutical products 53
TABLE 2 NOVEL DRUG APPROVALS (2022) 53
5.2.1.3 Rising investments in life sciences research 54
5.2.2 RESTRAINTS 55
5.2.2.1 Growing adoption of single-use technology 55
5.2.2.2 Stringent regulatory guidelines for product approval 55
5.2.3 OPPORTUNITIES 56
5.2.3.1 Emerging markets 56
5.2.3.2 Increasing outsourcing of services to sterility testing providers 56
5.2.4 CHALLENGES 57
5.2.4.1 Shortage of skilled professionals 57
5.3 TARIF AND REGULATION 57
5.3.1 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 57
TABLE 3 NORTH AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 57
TABLE 4 EUROPE: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 58
TABLE 5 ASIA PACIFIC: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 58
TABLE 6 REST OF THE WORLD: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 59
5.4 PORTER’S FIVE FORCES ANALYSIS 59
TABLE 7 STERILITY TESTING MARKET: PORTER’S FIVE FORCES ANALYSIS 59
5.4.1 THREAT FROM NEW ENTRANTS 60
5.4.2 THREAT FROM SUBSTITUTES 60
5.4.3 BARGAINING POWER OF BUYERS 60
5.4.4 BARGAINING POWER OF SUPPLIERS 60
5.4.5 INTENSITY OF COMPETITIVE RIVALRY 60
5.5 SUPPLY CHAIN ANALYSIS 61
FIGURE 18 STERILITY TESTING MARKET: SUPPLY CHAIN ANALYSIS 61
5.6 TECHNOLOGICAL ANALYSIS 62
5.7 INDICATIVE PRICING 62
TABLE 8 SELLING PRICE OF STERILITY TESTING PRODUCTS 62
5.8 PATENT ANALYSIS 63
FIGURE 19 STERILITY TESTING MARKET: PATENT TESTING APPLICATIONS (JANUARY 2012–DECEMBER 2022) 63
5.9 ECOSYSTEM ANALYSIS 64
TABLE 9 STERILITY TESTING MARKET: SUPPLY CHAIN ECOSYSTEM 64
5.10 KEY CONFERENCES AND EVENTS, 2023–2024 65
TABLE 10 STERILITY TESTING MARKET: CONFERENCES AND EVENTS (2023−2024) 65
5.11 KEY STAKEHOLDERS AND BUYING CRITERIA 65
5.11.1 KEY STAKEHOLDERS IN BUYING PROCESS 65
FIGURE 20 INFLUENCE OF STAKEHOLDERS ON BUYING PROCESS FOR STERILITY TESTING PRODUCTS 65
5.11.2 STERILITY TESTING MARKET: BUYING CRITERIA 66
FIGURE 21 KEY BUYING CRITERIA FOR END USERS 66
5.12 TRADE ANALYSIS 66
TABLE 11 TOP 10 IMPORTERS OF MACHINERY AND APPARATUS FOR FILTERING/PURIFYING LIQUIDS (HS CODE – 842129) 66
TABLE 12 TOP 10 EXPORTERS OF MACHINERY AND APPARATUS FOR FILTERING/PURIFYING LIQUIDS (HS CODE – 842129) 67
6 STERILITY TESTING MARKET, BY PRODUCT & SERVICE 68
6.1 INTRODUCTION 69
TABLE 13 STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 69
6.2 KITS & REAGENTS 69
6.2.1 RISING DEMAND FOR STANDARD STERILITY TESTING TO DRIVE MARKET 69
TABLE 14 STERILITY TESTING MARKET FOR KITS & REAGENTS, BY REGION, 2021–2028 (USD MILLION) 69
TABLE 15 NORTH AMERICA: STERILITY TESTING MARKET FOR KITS & REAGENTS, BY COUNTRY, 2021–2028 (USD MILLION) 70
TABLE 16 EUROPE: STERILITY TESTING MARKET FOR KITS & REAGENTS, BY COUNTRY, 2021–2028 (USD MILLION) 70
TABLE 17 ASIA: STERILITY TESTING MARKET FOR KITS & REAGENTS, BY COUNTRY, 2021–2028 (USD MILLION) 70
TABLE 18 REST OF THE WORLD: STERILITY TESTING MARKET FOR KITS & REAGENTS, BY COUNTRY, 2021–2028 (USD MILLION) 71
6.3 SERVICES 71
6.3.1 GROWING TREND OF OUTSOURCING SERVICES TO CROS TO DRIVE MARKET 71
TABLE 19 STERILITY TESTING MARKET FOR SERVICES, BY REGION, 2021–2028 (USD MILLION) 72
TABLE 20 NORTH AMERICA: STERILITY TESTING MARKET FOR SERVICES, BY COUNTRY, 2021–2028 (USD MILLION) 72
TABLE 21 EUROPE: STERILITY TESTING MARKET FOR SERVICES, BY COUNTRY, 2021–2028 (USD MILLION) 72
TABLE 22 ASIA: STERILITY TESTING MARKET FOR SERVICES, BY COUNTRY, 2021–2028 (USD MILLION) 73
TABLE 23 REST OF THE WORLD: STERILITY TESTING MARKET FOR SERVICES, BY COUNTRY, 2021–2028 (USD MILLION) 73
6.4 INSTRUMENTS 73
6.4.1 INCREASING ADOPTION OF RAPID MICROBIAL METHODS TO SUPPORT MARKET GROWTH 73
TABLE 24 STERILITY TESTING MARKET FOR INSTRUMENTS, BY REGION, 2021–2028 (USD MILLION) 74
TABLE 25 NORTH AMERICA: STERILITY TESTING MARKET FOR INSTRUMENTS, BY COUNTRY, 2021–2028 (USD MILLION) 74
TABLE 26 EUROPE: STERILITY TESTING MARKET FOR INSTRUMENTS, BY COUNTRY, 2021–2028 (USD MILLION) 74
TABLE 27 ASIA: STERILITY TESTING MARKET FOR INSTRUMENTS, BY COUNTRY, 2021–2028 (USD MILLION) 75
TABLE 28 REST OF THE WORLD: STERILITY TESTING MARKET FOR INSTRUMENTS, BY COUNTRY, 2021–2028 (USD MILLION) 75
7 STERILITY TESTING MARKET, BY TEST TYPE 76
7.1 INTRODUCTION 77
TABLE 29 STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 77
7.2 MEMBRANE FILTRATION 77
7.2.1 RISING DEMAND FOR TESTING OF DRUGS IN LIQUID DOSAGE FORMS TO FUEL ADOPTION 77
TABLE 30 STERILITY TESTING MARKET FOR MEMBRANE FILTRATION, BY REGION, 2021–2028 (USD MILLION) 78
TABLE 31 NORTH AMERICA: STERILITY TESTING MARKET FOR MEMBRANE FILTRATION, BY COUNTRY, 2021–2028 (USD MILLION) 78
TABLE 32 EUROPE: STERILITY TESTING MARKET FOR MEMBRANE FILTRATION, BY COUNTRY, 2021–2028 (USD MILLION) 78
TABLE 33 ASIA: STERILITY TESTING MARKET FOR MEMBRANE FILTRATION, BY COUNTRY, 2021–2028 (USD MILLION) 79
TABLE 34 REST OF THE WORLD: STERILITY TESTING MARKET FOR MEMBRANE FILTRATION, BY COUNTRY, 2021–2028 (USD MILLION) 79
7.3 DIRECT INOCULATION 79
7.3.1 ABILITY TO PROVIDE TESTING FOR MICROBIAL CONTAMINANTS TO DRIVE MARKET 79
TABLE 35 STERILITY TESTING MARKET FOR DIRECT INOCULATION, BY REGION, 2021–2028 (USD MILLION) 80
TABLE 36 NORTH AMERICA: STERILITY TESTING MARKET FOR DIRECT INOCULATION, BY COUNTRY, 2021–2028 (USD MILLION) 80
TABLE 37 EUROPE: STERILITY TESTING MARKET FOR DIRECT INOCULATION, BY COUNTRY, 2021–2028 (USD MILLION) 80
TABLE 38 ASIA: STERILITY TESTING MARKET FOR DIRECT INOCULATION, BY COUNTRY, 2021–2028 (USD MILLION) 81
TABLE 39 REST OF THE WORLD: STERILITY TESTING MARKET FOR DIRECT INOCULATION, BY COUNTRY, 2021–2028 (USD MILLION) 81
7.4 OTHER TEST TYPES 81
TABLE 40 STERILITY TESTING MARKET FOR OTHER TEST TYPES, BY REGION, 2021–2028 (USD MILLION) 82
TABLE 41 NORTH AMERICA: STERILITY TESTING MARKET FOR KITS & REAGENTS, BY COUNTRY, 2021–2028 (USD MILLION) 82
TABLE 42 EUROPE: STERILITY TESTING MARKET FOR OTHER TEST TYPES, BY COUNTRY, 2021–2028 (USD MILLION) 82
TABLE 43 ASIA: STERILITY TESTING MARKET FOR OTHER TEST TYPES, BY COUNTRY, 2021–2028 (USD MILLION) 83
TABLE 44 REST OF THE WORLD: STERILITY TESTING MARKET FOR OTHER TEST TYPES, BY COUNTRY, 2021–2028 (USD MILLION) 83
8 STERILITY TESTING MARKET, BY APPLICATION 84
8.1 INTRODUCTION 85
TABLE 45 STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 85
8.2 PHARMACEUTICAL & BIOLOGICS MANUFACTURING 85
8.2.1 GROWING PHARMACEUTICAL & BIOPHARMACEUTICAL PRODUCTION CAPACITIES TO DRIVE MARKET 85
TABLE 46 STERILITY TESTING MARKET FOR PHARMACEUTICAL & BIOLOGICS MANUFACTURING, BY REGION, 2021–2028 (USD MILLION) 86
TABLE 47 NORTH AMERICA: STERILITY TESTING MARKET FOR PHARMACEUTICAL & BIOLOGICS MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 86
TABLE 48 EUROPE: STERILITY TESTING MARKET FOR PHARMACEUTICAL & BIOLOGICS MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 87
TABLE 49 ASIA: STERILITY TESTING MARKET FOR PHARMACEUTICAL & BIOLOGICS MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 87
TABLE 50 REST OF THE WORLD: STERILITY TESTING MARKET FOR PHARMACEUTICAL & BIOLOGICS MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 88
8.3 MEDICAL DEVICE MANUFACTURING 88
8.3.1 RISING DEMAND FOR STERILITY TESTING OF MEDICAL DEVICES TO DRIVE MARKET 88
TABLE 51 STERILITY TESTING MARKET FOR MEDICAL DEVICE MANUFACTURING, BY REGION, 2021–2028 (USD MILLION) 88
TABLE 52 NORTH AMERICA: STERILITY TESTING MARKET FOR MEDICAL DEVICE MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 89
TABLE 53 EUROPE: STERILITY TESTING MARKET FOR MEDICAL DEVICE MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 89
TABLE 54 ASIA: STERILITY TESTING MARKET FOR MEDICAL DEVICE MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 89
TABLE 55 REST OF THE WORLD: STERILITY TESTING MARKET FOR MEDICAL DEVICE MANUFACTURING, BY COUNTRY, 2021–2028 (USD MILLION) 90
8.4 OTHER APPLICATIONS 90
TABLE 56 STERILITY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 2021–2028 (USD MILLION) 90
TABLE 57 NORTH AMERICA: STERILITY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 91
TABLE 58 EUROPE: STERILITY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 91
TABLE 59 ASIA: STERILITY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 91
TABLE 60 REST OF THE WORLD: STERILITY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 92
9 STERILITY TESTING MARKET, BY END USER 93
9.1 INTRODUCTION 94
TABLE 61 STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 94
9.2 PHARMACEUTICAL COMPANIES 94
9.2.1 GROWING EXPANSION OF PRODUCTION CAPACITIES AND STRONG PIPELINE OF NOVEL DRUGS TO DRIVE MARKET 94
TABLE 62 STERILITY TESTING MARKET FOR PHARMACEUTICAL COMPANIES, BY REGION, 2021–2028 (USD MILLION) 94
TABLE 63 NORTH AMERICA: STERILITY TESTING MARKET FOR PHARMACEUTICAL COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 95
TABLE 64 EUROPE: STERILITY TESTING MARKET FOR PHARMACEUTICAL COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 95
TABLE 65 ASIA: STERILITY TESTING MARKET FOR PHARMACEUTICAL COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 95
TABLE 66 REST OF THE WORLD: STERILITY TESTING MARKET FOR PHARMACEUTICAL COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 96
9.3 BIOTECHNOLOGY COMPANIES 96
9.3.1 RISING R&D INVESTMENTS IN BIOTECH FIRMS TO DRIVE MARKET 96
TABLE 67 STERILITY TESTING MARKET FOR BIOTECHNOLOGY COMPANIES, BY REGION, 2021–2028 (USD MILLION) 96
TABLE 68 NORTH AMERICA: STERILITY TESTING MARKET FOR BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 97
TABLE 69 EUROPE: STERILITY TESTING MARKET FOR BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 97
TABLE 70 ASIA: STERILITY TESTING MARKET FOR BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 97
TABLE 71 REST OF THE WORLD: STERILITY TESTING MARKET FOR BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2021–2028 (USD MILLION) 98

9.4 OTHER END USERS 98
TABLE 72 STERILITY TESTING MARKET FOR OTHER END USERS, BY REGION, 2021–2028 (USD MILLION) 98
TABLE 73 NORTH AMERICA: STERILITY TESTING MARKET FOR OTHER END USERS, BY COUNTRY, 2021–2028 (USD MILLION) 99
TABLE 74 EUROPE: STERILITY TESTING MARKET FOR OTHER END USERS, BY COUNTRY, 2021–2028 (USD MILLION) 99
TABLE 75 ASIA: STERILITY TESTING MARKET FOR OTHER END USERS, BY COUNTRY, 2021–2028 (USD MILLION) 99
TABLE 76 REST OF THE WORLD: STERILITY TESTING MARKET FOR OTHER END USERS, BY COUNTRY, 2021–2028 (USD MILLION) 100
10 STERILITY TESTING MARKET, BY REGION 101
10.1 INTRODUCTION 102
TABLE 77 STERILITY TESTING MARKET, BY REGION, 2021–2028 (USD MILLION) 102
10.2 NORTH AMERICA 102
FIGURE 22 NORTH AMERICA: STERILITY TESTING MARKET SNAPSHOT 103
TABLE 78 NORTH AMERICA: STERILITY TESTING MARKET, BY COUNTRY, 2021–2028 (USD MILLION) 103
TABLE 79 NORTH AMERICA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 104
TABLE 80 NORTH AMERICA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 104
TABLE 81 NORTH AMERICA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 104
TABLE 82 NORTH AMERICA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 105
10.2.1 US 105
10.2.1.1 Rising growth in medical devices industry to fuel uptake 105
TABLE 83 US: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 105
TABLE 84 US: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 106
TABLE 85 US: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 106
TABLE 86 US: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 106
10.2.2 CANADA 107
10.2.2.1 Rising demand for pharmaceutical & biologics manufacturing to support market growth 107
TABLE 87 CANADA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 107
TABLE 88 CANADA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 108
TABLE 89 CANADA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 108
TABLE 90 CANADA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 108
10.2.3 NORTH AMERICA: RECESSION IMPACT 109
10.3 EUROPE 110
TABLE 91 EUROPE: STERILITY TESTING MARKET, BY COUNTRY, 2021–2028 (USD MILLION) 110
TABLE 92 EUROPE: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 110
TABLE 93 EUROPE: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 111
TABLE 94 EUROPE: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 111
TABLE 95 EUROPE: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 111
10.3.1 GERMANY 112
10.3.1.1 Favorable R&D funding by federal & state governments to fuel uptake 112
TABLE 96 GERMANY: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 112
TABLE 97 GERMANY: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 113
TABLE 98 GERMANY: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 113
TABLE 99 GERMANY: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 113
10.3.2 UK 114
10.3.2.1 Rising development of biotechnology manufacturing firms to drive market 114
TABLE 100 UK: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 114
TABLE 101 UK: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 115
TABLE 102 UK: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 115
TABLE 103 UK: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 115
10.3.3 FRANCE 116
10.3.3.1 Rising government initiatives for biologics manufacturing to support market growth 116
TABLE 104 FRANCE: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 116
TABLE 105 FRANCE: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 117
TABLE 106 FRANCE: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 117
TABLE 107 FRANCE: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 117
10.3.4 ITALY 118
10.3.4.1 Favorable government support for establishment of biotech startups to support market growth 118
TABLE 108 ITALY: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 118
TABLE 109 ITALY: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 119
TABLE 110 ITALY: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 119
TABLE 111 ITALY: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 119
10.3.5 SPAIN 120
10.3.5.1 Increasing focus on development of APIs to fuel uptake 120
TABLE 112 SPAIN: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 120
TABLE 113 SPAIN: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 121
TABLE 114 SPAIN: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 121
TABLE 115 SPAIN: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 121
10.3.6 REST OF EUROPE 122
TABLE 116 REST OF EUROPE: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 122
TABLE 117 REST OF EUROPE: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 122
TABLE 118 REST OF EUROPE: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 123
TABLE 119 REST OF EUROPE: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 123
10.3.7 EUROPE: RECESSION IMPACT 123
10.4 ASIA 124
FIGURE 23 ASIA: STERILITY TESTING MARKET SNAPSHOT 125
TABLE 120 ASIA: STERILITY TESTING MARKET, BY COUNTRY, 2021–2028 (USD MILLION) 126
TABLE 121 ASIA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 126
TABLE 122 ASIA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 126
TABLE 123 ASIA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 127
TABLE 124 ASIA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 127
10.4.1 CHINA 127
10.4.1.1 Favorable government policies to increase drug manufacturing to drive market 127
TABLE 125 CHINA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 128
TABLE 126 CHINA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 128
TABLE 127 CHINA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 129
TABLE 128 CHINA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 129

10.4.2 JAPAN 129
10.4.2.1 Rising investments for cell & gene therapy facilities to support market growth 129
TABLE 129 JAPAN: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 130
TABLE 130 JAPAN: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 130
TABLE 131 JAPAN: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 130
TABLE 132 JAPAN: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 131
10.4.3 INDIA 131
10.4.3.1 Increasing demand for biosimilars to drive market 131
TABLE 133 INDIA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 132
TABLE 134 INDIA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 132
TABLE 135 INDIA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 132
TABLE 136 INDIA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 133
10.4.4 SOUTH KOREA 133
10.4.4.1 Significant exports of pharmaceutical drugs to fuel uptake of sterility testing services 133
TABLE 137 SOUTH KOREA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 133
TABLE 138 SOUTH KOREA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 134
TABLE 139 SOUTH KOREA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 134
TABLE 140 SOUTH KOREA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 134
10.4.5 REST OF ASIA 135
TABLE 141 REST OF ASIA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 135
TABLE 142 REST OF ASIA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 135
TABLE 143 REST OF ASIA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 136
TABLE 144 REST OF ASIA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 136
10.5 REST OF THE WORLD 136
TABLE 145 REST OF THE WORLD: STERILITY TESTING MARKET, BY REGION, 2021–2028 (USD MILLION) 137
TABLE 146 REST OF THE WORLD: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 137
TABLE 147 REST OF THE WORLD: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 137
TABLE 148 REST OF THE WORLD: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 138
TABLE 149 REST OF THE WORLD: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 138
10.5.1 SOUTH & CENTRAL AMERICA AND THE CARIBBEAN 138
10.5.1.1 Growing vaccine production to propel demand for sterility testing 138
TABLE 150 SOUTH & CENTRAL AMERICA AND THE CARIBBEAN: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 139
TABLE 151 SOUTH & CENTRAL AMERICA AND THE CARIBBEAN: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 139
TABLE 152 SOUTH & CENTRAL AMERICA AND THE CARIBBEAN: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 140
TABLE 153 SOUTH & CENTRAL AMERICA AND THE CARIBBEAN: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 140
10.5.2 PACIFIC AND OCEANIA 140
10.5.2.1 Improving investments in pharmaceutical R&D to fuel uptake 140
TABLE 154 PACIFIC AND OCEANIA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 141
TABLE 155 PACIFIC AND OCEANIA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 141
TABLE 156 PACIFIC AND OCEANIA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 141
TABLE 157 PACIFIC AND OCEANIA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 142
10.5.3 AFRICA 142
10.5.3.1 Favorable government support for healthcare infrastructure to drive market 142
TABLE 158 AFRICA: STERILITY TESTING MARKET, BY PRODUCT & SERVICE, 2021–2028 (USD MILLION) 142
TABLE 159 AFRICA: STERILITY TESTING MARKET, BY TEST TYPE, 2021–2028 (USD MILLION) 143
TABLE 160 AFRICA: STERILITY TESTING MARKET, BY APPLICATION, 2021–2028 (USD MILLION) 143
TABLE 161 AFRICA: STERILITY TESTING MARKET, BY END USER, 2021–2028 (USD MILLION) 143
11 COMPETITIVE LANDSCAPE 144
11.1 OVERVIEW 144
11.2 STRATEGIES ADOPTED BY KEY PLAYERS 144
TABLE 162 STERILITY TESTING MARKET: KEY PLAYER STRATEGIES 144
11.3 MARKET SHARE ANALYSIS 145
FIGURE 24 STERILITY TESTING MARKET: MARKET SHARE ANALYSIS OF KEY PLAYERS IN 2022 (LEADING FOUR COMPANIES) 145
TABLE 163 STERILITY TESTING MARKET: INTENSITY OF COMPETITIVE RIVALRY 146
11.4 REVENUE SHARE ANALYSIS OF KEY PLAYERS 146
FIGURE 25 STERILITY TESTING MARKET: REVENUE SHARE ANALYSIS OF KEY PLAYERS (TOP FOUR) 147
11.5 COMPANY EVALUATION QUADRANT 147
FIGURE 26 STERILITY TESTING MARKET: COMPANY EVALUATION MATRIX (2022) 148
11.5.1 STARS 149
11.5.2 EMERGING LEADERS 149
11.5.3 PERVASIVE PLAYERS 149
11.5.4 PARTICIPANTS 149
11.6 COMPANY EVALUATION QUADRANT: STARTUPS/SMES 150
FIGURE 27 STERILITY TESTING MARKET: COMPANY EVALUATION MATRIX FOR STARTUPS/SMES (2022) 150
11.6.1 PROGRESSIVE COMPANIES 151
11.6.2 STARTING BLOCKS 151
11.6.3 RESPONSIVE COMPANIES 151
11.6.4 DYNAMIC COMPANIES 151
11.7 COMPETITIVE BENCHMARKING 152
11.7.1 COMPANY PRODUCT FOOTPRINT 152
TABLE 164 STERILITY TESTING MARKET: PRODUCT PORTFOLIO ANALYSIS 152
11.7.2 COMPANY GEOGRAPHIC FOOTPRINT 153
TABLE 165 STERILITY TESTING MARKET: GEOGRAPHIC ANALYSIS 153
11.8 COMPETITIVE SCENARIO 154
TABLE 166 STERILITY TESTING MARKET: DEALS (JANUARY 2019−JANUARY 2023) 154
TABLE 167 STERILITY TESTING MARKET: OTHER DEVELOPMENTS (JANUARY 2019−JANUARY 2023) 155
12 COMPANY PROFILES 156
12.1 KEY PLAYERS 156
(Business Overview, Products/Services Offered, Recent Developments, and MnM View)*
12.1.1 MERCK KGAA 156
TABLE 168 MERCK KGAA: BUSINESS OVERVIEW 156
FIGURE 28 MERCK KGAA: COMPANY SNAPSHOT (2021) 157
12.1.2 CHARLES RIVER LABORATORIES 160
TABLE 169 CHARLES RIVER LABORATORIES: BUSINESS OVERVIEW 160
FIGURE 29 CHARLES RIVER LABORATORIES: COMPANY SNAPSHOT (2021) 161
12.1.3 BIOMÉRIEUX SA 164
TABLE 170 BIOMÉRIEUX SA: BUSINESS OVERVIEW 164
FIGURE 30 BIOMÉRIEUX SA: COMPANY SNAPSHOT (2021) 165
12.1.4 SGS S.A. 167
TABLE 171 SGS SA: BUSINESS OVERVIEW 167
FIGURE 31 SGS S.A.: COMPANY SNAPSHOT (2021) 168
12.1.5 SARTORIUS AG 170
TABLE 172 SARTORIUS AG: BUSINESS OVERVIEW 170
FIGURE 32 SARTORIUS AG: COMPANY SNAPSHOT (2022) 171

12.1.6 THERMO FISHER SCIENTIFIC INC. 173
TABLE 173 THERMO FISHER SCIENTIFIC: BUSINESS OVERVIEW 173
FIGURE 33 THERMO FISHER SCIENTIFIC INC.: COMPANY SNAPSHOT (2022) 174
12.1.7 WUXI APPTEC 176
TABLE 174 WUXI APPTEC: BUSINESS OVERVIEW 176
12.1.8 SAMSUNG BIOLOGICS 178
TABLE 175 SAMSUNG BIOLOGICS: BUSINESS OVERVIEW 178
FIGURE 34 SAMSUNG BIOLOGICS: COMPANY SNAPSHOT (2021) 179
12.1.9 GENSCRIPT 181
TABLE 176 GENSCRIPT: BUSINESS OVERVIEW 181
FIGURE 35 GENSCRIPT: COMPANY SNAPSHOT (2021) 182
12.1.10 PACIFIC BIOLABS 183
TABLE 177 PACIFIC BIOLABS: BUSINESS OVERVIEW 183
12.1.11 NELSON LABORATORIES, LLC 184
TABLE 178 NELSON LABORATORIES, LLC: BUSINESS OVERVIEW 184
* Business Overview, Products/Services Offered, Recent Developments, and MnM View might not be captured in case of unlisted companies.
12.2 OTHER PLAYERS 186
12.2.1 PACE ANALYTICAL 186
12.2.2 RAPID MICRO BIOSYSTEMS, INC. 186
12.2.3 TENTAMUS 187
12.2.4 SINGOTA SOLUTIONS 187
12.2.5 NEOPHARM LABS INC. 187
12.2.6 LEXAMED 188
12.2.7 ASTELL SCIENTIFIC LTD 188
12.2.8 HIMEDIA LABORATORIES 189
12.2.9 PALL CORPORATION (PART OF DANAHER CORPORATION) 189
12.2.10 BOSTON ANALYTICAL 190
12.2.11 SOLVIAS AG 190
12.2.12 BD 191
13 APPENDIX 192
13.1 DISCUSSION GUIDE 192
13.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 195
13.3 CUSTOMIZATION OPTIONS 197
13.4 RELATED REPORTS 197
13.5 AUTHOR DETAILS 198

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Table of Contents

Summary

The global sterility testing market is expected to reach USD 1.9 billion in 2028 from USD 1.1 billion in 2023 at a CARG of 10.5%. Factors such as expanding pharmaceutical & biotechnology production capacities, increasing development of novel biopharmaceutical products, and rising investments in life sciences research are expected to drive market growth. However, the growing adoption of single-use technology and stringent regulatory guidelines for product approval are expected to restrain market growth to a certain extent.
“During the forecast period, the kits & reagent is expected to account as the fastest-growing segment .”
Based on product & service, the sterility testing market is divided into kits & reagents, instruments, and services. During the forecast period (2023-2028), the kits & reagents segment is also expected to be the fastest-growing segment in the sterility testing market. Kits are widely used in the pharmaceutical and biotechnology industries as it is easy to use. Moreover, the long shelf life of these products is contributing to their rising adoption in academic institutions and contract research organizations. Sterility testing is mandatory during the clinical and commercial manufacturing of pharmaceutical & biopharmaceutical products. Pharmaceutical & biotechnology companies adopt kits & reagents for sterility testing as it is cost-effective and time-efficient.
“In 2022, by application segment, pharmaceutical & biologics accounted for the biggest market share”
Based on application, the sterility testing market is divided into pharmaceutical & biologics manufacturing, medical device manufacturing, and other applications. In 2022, the pharmaceutical and biologics manufacturing segment accounted for the largest share of the application segment in the sterility testing market. Factors responsible for the growth in this segment include the growing, growing pharmaceutical and biopharmaceutical production capacity across the globe.
“In 2022, North America accounted for the largest regional share in this market”
The market for sterility testing was dominated by North America in 2022. Presence of manufacturing facilities of major pharmaceutical and biopharmaceutical firms in the region will contribute for the huge demand for sterility testing in North America. The market for sterility testing is anticipated to grow in the region as drug approval rates rise. Also, the demand for pharmaceuticals and biopharmaceuticals in North America are rising due to the rising prevalence of diseases and the expanding patient population. Moreover, the pharmaceutical and biotechnology sectors in North America make substantial R&D investments and are anticipated to experience rapid growth in the coming years.

Breakdown of primaries

The study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows:

• By Respondent– Supply Side- 70%, Demand Side-30%
• By Designation— CXOs and Directors- 30%, Executives - 25%, Mangers - 45%
• By Region— North America - 40%, Europe - 25%, APAC – 20%, RoW- 15%

The sterility testing market is dominated by a few globally established players such as Charles River Laboratories (US), Merck KGaA (Germany), bioMérieux SA (France), SGS SA (Switzerland), WuXi AppTec (China), Nelson Laboratories, LLC (US), Pacific BioLabs (US), Sartorius AG (Germany), Thermofisher Scientific Inc. (US), and Samsung Biologics (South Korea). The study includes an in-depth competitive analysis of these key players in the sterility testing market with their company profiles, recent developments, and key market strategies.
Research Coverage:

The report segments the sterility testing market based on region (North America, Europe, Asia, and Rest of the World), by product & service (kits & reagents, instruments, and services), by test type (membrane filtration, direct inoculation, and other tests), by application (pharmaceuticals and biologicals, medical devices, and other applications), and by end user (pharmaceutical companies, biotechnology companies, and others ). The report also provides a comprehensive review of market drivers, restraints opportunities, challenges and trends in the sterility testing market.

Key Benefits of Buying the Report:

The report will help the leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall market and the segments. This report will help stakeholders understand the competitive landscape and gain more insights to better position their businesses and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the sterility testing market and provides them with information on key market drivers, restraints, challenges, and opportunities.

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