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バイオプロセス(生体処理)認証市場:試験タイプ毎(溶出物評価、誠実度テスト、微生物検査)、プロセスコンポーネント毎(フィルタ素子、バイオリアクタ・生体触媒)、エンドユーザ毎(CDMO、バイオ・医薬品企業) - 2024年までの世界市場予測

Bioprocess Validation Market by Test Type (Extractables and Leachables, Integrity Testing, Microbiology Testing), Process Component (Filter Element, Bioreactors), End-User (CDMO, Biotechnology & Pharmaceutical Companies) - Global Forecast to 2024

 

出版社 出版年月電子版価格 ページ数図表数
MarketsandMarkets
マーケッツアンドマーケッツ
2019年8月US$4,950
シングルユーザライセンス
195 172

サマリー

幅広い市場に関する調査レポートを出版しているマーケッツアンドマーケッツ(MarketsandMarkets)のバイオプロセス(生体処理)認証市場に関する調査レポートです。

“The bioprocess validation market is estimated to grow at a CAGR of 14.6%”

The global bioprocess validation market is exceeded USD 180 million in 2019 and is projected to be valued over USD 360 million by 2024, at a CAGR of 14.6% during the forecast period. The growth of the bioprocess validation services market is driven primarily by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries. This has also stimulated the demand for the outsourcing of bioprocess validation services. The rising R&D spending in the life science industry has contributed to this demand significantly, while the growing demand for bioprocess validation in emerging countries and patent expiries have ensured steady market growth. However, the issues related to extractable and leachable testing affect market growth to a certain extent during the forecast period.

 “Extractables/leachables testing services segment to witness the highest growth during the forecast period”
 
The combination systems segment is estimated to grow at the highest CAGR during the forecast period. This can primarily be attributed to increasing outsourcing of testing services by biopharmaceutical manufacturers; the presence of regulatory mandates and guidelines regarding the testing of extractables & leachables; and growing product safety, identity, purity, and quality; and the increasing risk of product adulteration related requirement.  

“Filter elements segment to grow at the highest CAGR in the bioprocess validation market, by process component”

The major factors driving the demand for filter elements in bioprocess validation are stringent regulations and industry standards for biopharmaceutical products; increasing usage of a variety of filters in bioprocessing; and the high demand for the evaluation of specific filter elements and their impact on the final drug product owing to the factors such as safety and efficacy of biopharmaceutical products.

“APAC market to witness the highest growth during the forecast period”

The Asia Pacific is estimated to be the fastest-growing regional market for bioprocess validation during the forecast period. The growing biopharmaceutical manufacturing capabilities in Asian countries, increasing demand for outsourcing bioprocess validation, growing life science research specific to biologics, increasing investments by pharmaceutical & biotechnology companies, rising awareness about the advantages of biopharmaceutical drugs, increasing number of CROs & CDMOs, and the favorable government initiatives to promote the growth of the pharmaceutical & biotechnology industries in several APAC countries are some of the major factors driving the growth of this market.

A breakdown of the primary participants in this report is provided below:

- By Company Type: Tier 1-46%, Tier 2-33%, and Tier 3-21%
- By Designation: C-level-43%, Director Level-35%, and Others-22%
- By Region: North America-34%, Europe-26%, Asia Pacific-19%, Latin America-11%, and the Middle East & Africa-10%

The prominent players operating in the global bioprocess validation market are Merck KGaA (Germany), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Sartorius Stedim Biotech (France), Pall Corporation (US), Cobetter Filtration Equipments Co., Ltd. (China), Toxikon Corporation (US), DOC S.r.l. (Italy), MEISSNER FILTRATION PRODUCTS, INC. (US), and Thermo Fisher Scientific (US).

Research Coverage:

This report analyzes the market for various bioprocess validation and their adoption patterns. It aims at estimating the size and future growth potential of the global bioprocess validation market as well as its segments (by test type, process component, end-user, and region). The report also includes an in-depth competitive analysis of key market players along with their company profiles, service offerings, and recent developments.

Reasons to Buy the Report

This report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them garner a greater share. Firms purchasing the report could use one, or any combination of the below mentioned five strategies for strengthening their market presence.

- Market Penetration: Comprehensive information on the service portfolios offered by the top players in the global bioprocess validation market
- Service Development/Innovation: Detailed insights on the upcoming trends, R&D activities, and service launches in the global bioprocess validation market
- Market Development: Comprehensive information on the lucrative emerging regions
- Market Diversification: Exhaustive information about new services, growing geographies, and recent developments in the global bioprocess validation market
- Competitive Assessment: In-depth assessment of services offered, market shares, growth strategies, and revenue analysis of leading players in the global bioprocess validation market



目次

1 INTRODUCTION 19
1.1 OBJECTIVES OF THE STUDY 19
1.2 MARKET DEFINITION 19
1.3 MARKET SCOPE 20
1.3.1 MARKETS COVERED 20
1.3.2 YEARS CONSIDERED FOR THE STUDY 21
1.4 CURRENCY 21
1.5 LIMITATIONS 22
1.6 STAKEHOLDERS 22

2 RESEARCH METHODOLOGY 23
2.1 RESEARCH DATA 23
2.1.1 SECONDARY DATA 24
2.1.1.1 Key data from secondary sources 25
2.1.2 PRIMARY DATA 25
2.1.2.1 Key data from primary sources 27
2.1.2.2 Key industry insights 28
2.2 MARKET SIZE ESTIMATION 29
2.3 MARKET BREAKDOWN AND DATA TRIANGULATION 31
2.4 ASSUMPTIONS FOR THE STUDY 32

3 EXECUTIVE SUMMARY 33

4 PREMIUM INSIGHTS 38
4.1 BIOPROCESS VALIDATION SERVICES: MARKET OVERVIEW 38
4.2 ASIA PACIFIC: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER (2018) 39
4.3 GEOGRAPHICAL SNAPSHOT OF THE BIOPROCESS VALIDATION SERVICES MARKET 40
4.4 REGIONAL MIX: BIOPROCESS VALIDATION SERVICES MARKET 41
4.5 BIOPROCESS VALIDATION SERVICES MARKET: DEVELOPING VS. DEVELOPED COUNTRIES 41

5 MARKET OVERVIEW 42
5.1 INTRODUCTION 42
5.2 MARKET DYNAMICS: IMPACT ANALYSIS 42
5.2.1 DRIVERS 42
5.2.1.1 Stringent safety and quality regulations 42
5.2.1.2 Increasing demand for biopharmaceuticals 43
5.2.1.3 Increasing demand for outsourcing bioprocess validation 43
5.2.1.4 Rising life science R&D expenditure 43
5.2.2 RESTRAINTS 44
5.2.2.1 Issues related to extractables & leachables 44
5.2.3 OPPORTUNITIES 45
5.2.3.1 Growth opportunities in Asia Pacific and Latin American countries 45
5.2.3.2 Patent expiry 45
5.2.4 CHALLENGES 46
5.2.4.1 Waste disposal 46
5.2.4.2 Development of new validation methods for next generation bioproducts 47

6 INDUSTRY INSIGHTS 48
6.1 INDUSTRY TRENDS 48
6.1.1 AUTOMATION IN BIOPROCESS VALIDATION SERVICES 48
6.1.2 GEOGRAPHIC EXPANSIONS BY MARKET PLAYERS 48
6.2 REGULATORY GUIDELINES FOR BIOPROCESS VALIDATION 49

7 BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE 51
7.1 INTRODUCTION 52
7.2 EXTRACTABLES/LEACHABLES TESTING SERVICES 53
7.2.1 SPECIFICATIONS AND GUIDELINES FOR EXTRACTABLES/ LEACHABLES TESTING HAVE ENSURED THE CONTINUED DEMAND FOR THESE SERVICES 53
7.3 MICROBIOLOGICAL TESTING SERVICES 55
7.3.1 LARGE-SCALE EUKARYOTIC CELL CULTURE TESTING SERVICES 57
7.3.1.1 North America shows the highest demand for large-scale eukaryotic cell culture testing services 57
7.3.2 VIRUS PRODUCTION & PURIFICATION TESTING SERVICES 58
7.3.2.1 Increased concerns of viral contaminant presence in raw materials are driving the adoption of testing services 58
7.3.3 ELECTRON MICROSCOPY TESTING SERVICES 59
7.3.3.1 Electron microscopy provides high-resolution images of specimens present in bioprocesses 59
7.4 PHYSIOCHEMICAL TESTING SERVICES 60
7.4.1 NEED FOR DETECTION AND CHARACTERIZATION OF IMPURITIES IN THE FINAL PRODUCT IS DRIVING MARKET GROWTH 60
7.5 INTEGRITY TESTING SERVICES 62
7.5.1 INTEGRITY TESTING IS VITAL TO DETECT WEAR AND TEAR AND PRESSURE-CAUSED DAMAGE 62
7.6 COMPATIBILITY TESTING SERVICES 63
7.6.1 DEMAND FOR EVALUATING PROCESS COMPONENT-FORMULATION INTERACTION HAS NECESSITATED COMPATIBILITY TESTING 63
7.7 OTHER TESTING SERVICES 65
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8 BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT 66
8.1 INTRODUCTION 67
8.2 FILTER ELEMENTS 68
8.2.1 STRINGENT REGULATIONS FOR BIOPHARMACEUTICAL PRODUCTS ARE DRIVING THE GROWTH OF THIS SEGMENT 68
8.3 MEDIA CONTAINERS AND BAGS 69
8.3.1 VALIDATION AND QUALIFICATION OF MEDIA CONTAINERS AND BAGS IS NECESSARY TO MAINTAIN THE SAFETY OF THE FINAL
BIOPHARMACEUTICAL PRODUCT 69
8.4 FREEZING AND THAWING PROCESS BAGS 71
8.4.1 THE HIGH RISK OF SEAL LEAKS IN THE PRE-FREEZING AND THAWING STAGE IS DRIVING MARKET GROWTH 71
8.5 MIXING SYSTEMS 72
8.5.1 GROWING NEED TO MEET FDA AND OTHER REGULATORY GUIDELINES DURING THE MIXING OF INGREDIENTS TO MAINTAIN PRODUCT QUALITY
IS A KEY DRIVER 72
8.6 BIOREACTORS 73
8.6.1 BIOPHARMACEUTICAL COMPANIES ARE INCREASINGLY ADOPTING BIOPROCESS VALIDATION SERVICES FOR BIOREACTORS TO LOWER
THE RISK OF CROSS-CONTAMINATION 73
8.7 TRANSFER SYSTEMS 75
8.7.1 THE NECESSITY TO MAINTAIN STERILE CONDITIONS DURING TRANSFER IS DRIVING THE MARKET 75
8.8 OTHER PROCESS COMPONENT 76

9 BIOPROCESS VALIDATION SERVICES MARKET, BY END USER 77
9.1 INTRODUCTION 78
9.2 PHARMACEUTICAL COMPANIES 79
9.2.1 INCREASING PRODUCTION VOLUME HAS ENABLED PHARMA COMPANIES TO DOMINATE THE END-USER MARKET 79
9.3 CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATIONS 80
9.3.1 EMERGING COUNTRIES HAVE BECOME KEY HUBS FOR THE OUTSOURCING OF PRODUCTION AND VALIDATION PROCESSES 80
9.4 BIOTECHNOLOGY COMPANIES 82
9.4.1 NEED FOR REGULATORY COMPLIANCE HAS DRIVEN THE DEMAND FOR BIOPROCESS VALIDATION IN BIOTECH COMPANIES 82
9.5 OTHER END USERS 84

10 BIOPROCESS VALIDATION SERVICES MARKET, BY REGION 85
10.1 INTRODUCTION 86
10.2 NORTH AMERICA 87
10.2.1 US 91
10.2.1.1 US dominated the North American bioprocess validation services market in 2018 91
10.2.2 CANADA 94
10.2.2.1 Growing investments in the Canadian biopharmaceuticals sector to support market growth during the forecast period 94
10.3 EUROPE 97
10.3.1 GERMANY 101
10.3.1.1 Germany accounted for the largest share of the European bioprocess validation services market in 2018 101
10.3.2 FRANCE 104
10.3.2.1 High demand for biologics and implementation of favorable government initiatives to drive the demand for bioprocess validation services in France 104
10.3.3 UK 107
10.3.3.1 Growing demand for outsourcing compliance-related testing services in biopharmaceutical production to support market growth in the UK 107
10.3.4 ITALY 110
10.3.4.1 Growing biopharmaceutical manufacturing to drive the adoption of bioprocess validation services in Italy 110
10.3.5 SPAIN 113
10.3.5.1 High consumption of biologics to support the growth of
the bioprocess validation services market in Spain 113
10.3.6 REST OF EUROPE 116
10.4 ASIA PACIFIC 119
10.4.1 CHINA 123
10.4.1.1 China is one of the most-preferred destinations for leading biopharmaceutical companies for biologics production 123
10.4.2 JAPAN 126
10.4.2.1 Japan is one of the largest and most established markets for pharmaceutical products in the Asia Pacific 126
10.4.3 INDIA 129
10.4.3.1 Rising volume of biopharmaceutical production to drive market growth in India 129
10.4.4 REST OF ASIA PACIFIC 132
10.5 LATIN AMERICA 135
10.5.1 BRAZIL 138
10.5.1.1 Growing investments in biopharmaceutical research to drive market growth in Brazil 138
10.5.2 MEXICO 141
10.5.2.1 Strong presence of global pharmaceutical companies in the country to support market growth 141
10.5.3 REST OF LATIN AMERICA 144
10.6 MIDDLE EAST & AFRICA 146
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11 COMPETITIVE LANDSCAPE 149
11.1 OVERVIEW 149
11.2 MARKET SHARE ANALYSIS 152
11.3 COMPETITIVE LEADERSHIP MAPPING, 2018 153
11.4 VENDOR INCLUSION CRITERIA 153
11.5 VENDOR DIVE 153
11.5.1 VISIONARY LEADERS 154
11.5.2 INNOVATORS 154
11.5.3 EMERGING COMPANIES 154
11.5.4 DYNAMIC DIFFERENTIATORS 154
11.6 COMPETITIVE SITUATIONS AND TRENDS 156
11.6.1 ACQUISITIONS 157
11.6.2 COLLABORATIONS, PARTNERSHIPS, AND AGREEMENTS 158
11.6.3 SERVICE LAUNCHES 160
11.7 SERVICE PORTFOLIO ANALYSIS 160
11.7.1 SERVICE PORTFOLIO ANALYSIS 161

12 COMPANY PROFILES 162
(Business overview, Services offered, Recent developments, MNM view, SWOT analysis)*
12.1 MERCK KGAA 162
12.2 PALL CORPORATION (A PART OF DANAHER CORPORATION) 165
12.3 SARTORIUS STEDIM BIOTECH S.A. 167
12.4 SGS S.A. 170
12.5 EUROFINS SCIENTIFIC 173
12.6 COBETTER FILTRATION EQUIPMENT CO., LTD. 177
12.7 TOXIKON CORPORATION 178
12.8 DOC S.R.L. 180
12.9 MEISSNER FILTRATION PRODUCTS, INC. 181
12.10 THERMO FISHER SCIENTIFIC, INC. 182
12.11 ADDITIONAL COMPANY PROFILES 184
12.11.1 PORVAIR PLC 184
12.11.2 BIOZEEN 184
12.11.3 TIANSHAN (TS FILTER) PRECISION FILTER MATERIAL CO., LTD. 185
12.11.4 HANGZHOU ANOW MICROFILTRATION CO., LTD. 185
12.11.5 ALMAC GROUP 185
*Business overview, Services offered, Recent developments, MNM view, SWOT analysis might not be captured in case of unlisted companies.
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13 APPENDIX 186
13.1 INSIGHTS OF INDUSTRY EXPERTS 186
13.2 DISCUSSION GUIDE 187
13.3 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 191
13.4 AVAILABLE CUSTOMIZATIONS 193
13.5 RELATED REPORTS 193
13.6 AUTHOR DETAILS 194

 

LIST OF TABLES

TABLE 1 STANDARD CURRENCY CONVERSION RATES 21
TABLE 2 BIOPROCESS VALIDATION SERVICES MARKET SNAPSHOT, 2019 VS. 2024 33
TABLE 3 TYPICAL EXTRACTABLES FOR ACCEPTABLE MATERIALS USED IN DISPOSABLE BIOPROCESS MANUFACTURING SYSTEMS 44
TABLE 4 COMPARISON OF BIOPROCESSING SYSTEM DISPOSAL OPTIONS 46
TABLE 5 MAJOR EXPANSIONS IN THE BIOPROCESS VALIDATION SERVICES MARKET
(2016-2019) 49
TABLE 6 REGULATIONS & STANDARDS GOVERNING BIOPROCESS VALIDATION 50
TABLE 7 BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 52
TABLE 8 KEY PROVIDERS OF EXTRACTABLES/LEACHABLES TESTING SERVICES 53
TABLE 9 EXTRACTABLES/LEACHABLES TESTING SERVICES MARKET , BY COUNTRY,
2017-2024 (USD MILLION) 54
TABLE 10 KEY PROVIDERS OF MICROBIOLOGICAL TESTING SERVICES 56
TABLE 11 MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 56
TABLE 12 MICROBIOLOGICAL TESTING SERVICES MARKET, BY COUNTRY,
2017-2024 (USD MILLION) 57
TABLE 13 LARGE-SCALE EUKARYOTIC CELL CULTURE TESTING SERVICES MARKET,
BY COUNTRY, 2017-2024 (USD MILLION) 58
TABLE 14 VIRUS PRODUCTION & PURIFICATION TESTING SERVICES MARKET, BY COUNTRY, 2017-2024 (USD MILLION) 59
TABLE 15 ELECTRON MICROSCOPY TESTING SERVICES MARKET, BY COUNTRY,
2017-2024 (USD MILLION) 60
TABLE 16 KEY PROVIDERS OF PHYSIOCHEMICAL TESTING SERVICES 61
TABLE 17 PHYSIOCHEMICAL TESTING SERVICES MARKET , BY COUNTRY,
2017-2024 (USD MILLION) 61
TABLE 18 KEY PROVIDERS OF INTEGRITY TESTING SERVICES 62
TABLE 19 INTEGRITY TESTING SERVICES MARKET, BY COUNTRY, 2017-2024 (USD MILLION) 63
TABLE 20 KEY PROVIDERS OF COMPATIBILITY TESTING SERVICES 64
TABLE 21 COMPATIBILITY TESTING SERVICES MARKET , BY COUNTRY,
2017-2024 (USD MILLION) 64
TABLE 22 OTHER TESTING SERVICES MARKET, BY COUNTRY, 2017-2024 (USD MILLION) 65
TABLE 23 BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT,
2017-2024 (USD MILLION) 67
TABLE 24 BIOPROCESS VALIDATION SERVICES MARKET FOR FILTER ELEMENTS,
BY COUNTRY, 2017-2024 (USD MILLION) 69
TABLE 25 BIOPROCESS VALIDATION SERVICES MARKET FOR MEDIA CONTAINERS AND BAGS, BY COUNTRY, 2017-2024 (USD MILLION) 70
TABLE 26 BIOPROCESS VALIDATION SERVICES MARKET FOR FREEZING AND THAWING PROCESS BAGS, BY COUNTRY, 2017-2024 (USD MILLION) 71
TABLE 27 BIOPROCESS VALIDATION SERVICES MARKET FOR MIXING SYSTEMS, BY COUNTRY, 2017-2024 (USD MILLION) 73
TABLE 28 BIOPROCESS VALIDATION SERVICES MARKET FOR BIOREACTORS, BY COUNTRY, 2017-2024 (USD MILLION) 74
TABLE 29 BIOPROCESS VALIDATION SERVICES MARKET FOR TRANSFER SYSTEMS,
BY COUNTRY, 2017-2024 (USD MILLION) 75
TABLE 30 BIOPROCESS VALIDATION SERVICES MARKET FOR OTHER PROCESS COMPONENTS, BY COUNTRY, 2017-2024 (USD MILLION) 76
TABLE 31 BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 78
TABLE 32 BIOPROCESS VALIDATION SERVICES MARKET FOR PHARMACEUTICAL COMPANIES, BY COUNTRY, 2017-2024 (USD MILLION) 80
TABLE 33 BIOPROCESS VALIDATION SERVICES MARKET FOR CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION, BY COUNTRY, 2017-2024 (USD MILLION) 81
TABLE 34 BIOPROCESS VALIDATION SERVICES MARKET FOR BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2017-2024 (USD MILLION) 83
TABLE 35 BIOPROCESS VALIDATION SERVICES MARKET FOR OTHER END USERS,
BY COUNTRY, 2017-2024 (USD MILLION) 84
TABLE 36 BIOPROCESS VALIDATION SERVICES MARKET, BY REGION,
2017-2024 (USD MILLION) 87
TABLE 37 NORTH AMERICA: BIOPROCESS VALIDATION SERVICES MARKET,
BY COUNTRY, 2017-2024 (USD MILLION) 89
TABLE 38 NORTH AMERICA: BIOPROCESS VALIDATION SERVICES MARKET,
BY TEST TYPE, 2017-2024 (USD MILLION) 89
TABLE 39 NORTH AMERICA: MICROBIOLOGICAL TESTING SERVICES MARKET,
BY TYPE, 2017-2024 (USD MILLION) 90
TABLE 40 NORTH AMERICA: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 90
TABLE 41 NORTH AMERICA: BIOPROCESS VALIDATION SERVICES MARKET,
BY END USER, 2017-2024 (USD MILLION) 91
TABLE 42 US: KEY MACROINDICATORS 92
TABLE 43 US: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 92
TABLE 44 US: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 93
TABLE 45 US: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 93
TABLE 46 US: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 94
TABLE 47 CANADA: KEY MACROINDICATORS 95
TABLE 48 CANADA: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 95
TABLE 49 CANADA: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 96
TABLE 50 CANADA: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 96
TABLE 51 CANADA: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 97
TABLE 52 EUROPE: BIOPROCESS VALIDATION SERVICES MARKET, BY COUNTRY,
2017-2024 (USD MILLION) 99
TABLE 53 EUROPE: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 99
TABLE 54 EUROPE: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 100
TABLE 55 EUROPE: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 100
TABLE 56 EUROPE: BIOPROCESS VALIDATION SERVICES MARKET,
BY END USER, 2017-2024 (USD MILLION) 101
TABLE 57 GERMANY: KEY MACROINDICATORS 102
TABLE 58 GERMANY: BIOPROCESS VALIDATION SERVICES MARKET,
BY TEST TYPE, 2017-2024 (USD MILLION) 102
TABLE 59 GERMANY: MICROBIOLOGICAL TESTING SERVICES MARKET,
BY TYPE, 2017-2024 (USD MILLION) 103
TABLE 60 GERMANY: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 103
TABLE 61 GERMANY: BIOPROCESS VALIDATION SERVICES MARKET,
BY END USER, 2017-2024 (USD MILLION) 104
TABLE 62 FRANCE: KEY MACROINDICATORS 105
TABLE 63 FRANCE: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 105
TABLE 64 FRANCE: MICROBIOLOGICAL TESTING SERVICES MARKET,
BY TYPE, 2017-2024 (USD MILLION) 106
TABLE 65 FRANCE: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 106
TABLE 66 FRANCE: BIOPROCESS VALIDATION SERVICES MARKET,
BY END USER, 2017-2024 (USD MILLION) 107
TABLE 67 UK: KEY MACROINDICATORS 108
TABLE 68 UK: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 108
TABLE 69 UK: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 109
TABLE 70 UK: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 109
TABLE 71 UK: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 110
TABLE 72 ITALY: KEY MACROINDICATORS 111
TABLE 73 ITALY: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 111
TABLE 74 ITALY: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 112
TABLE 75 ITALY: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 112
TABLE 76 ITALY: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 113
TABLE 77 SPAIN: KEY MACROINDICATORS 114
TABLE 78 SPAIN: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 114
TABLE 79 SPAIN: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 115
TABLE 80 SPAIN: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 115
TABLE 81 SPAIN: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 116
TABLE 82 ROE: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 117
TABLE 83 ROE: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 117
TABLE 84 ROE: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 118
TABLE 85 ROE: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 118
TABLE 86 APAC: BIOPROCESS VALIDATION SERVICES MARKET, BY COUNTRY,
2017-2024 (USD MILLION) 121
TABLE 87 APAC: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 121
TABLE 88 APAC: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 122
TABLE 89 APAC: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 122
TABLE 90 APAC: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 123
TABLE 91 CHINA: KEY MACROINDICATORS 124
TABLE 92 CHINA: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 124
TABLE 93 CHINA: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 125
TABLE 94 CHINA: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 125
TABLE 95 CHINA: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 126
TABLE 96 JAPAN: KEY MACROINDICATORS 127
TABLE 97 JAPAN: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 127
TABLE 98 JAPAN: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 128
TABLE 99 JAPAN: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 128
TABLE 100 JAPAN: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 129
TABLE 101 INDIA: KEY MACROINDICATORS 130
TABLE 102 INDIA: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 130
TABLE 103 INDIA: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 131
TABLE 104 INDIA: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 131
TABLE 105 INDIA: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 132
TABLE 106 ROAPAC: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 133
TABLE 107 ROAPAC: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 133
TABLE 108 ROAPAC: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 134
TABLE 109 ROAPAC: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 134
TABLE 110 LATIN AMERICA: BIOPROCESS VALIDATION SERVICES MARKET, BY COUNTRY, 2017-2024 (USD MILLION) 135
TABLE 111 LATIN AMERICA: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE, 2017-2024 (USD MILLION) 136
TABLE 112 LATIN AMERICA: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 136
TABLE 113 LATIN AMERICA: BIOPROCESS VALIDATION SERVICES MARKET,
BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 137
TABLE 114 LATIN AMERICA: BIOPROCESS VALIDATION SERVICES MARKET,
BY END USER, 2017-2024 (USD MILLION) 137
TABLE 115 BRAZIL: KEY MACROINDICATORS 138
TABLE 116 BRAZIL: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 139
TABLE 117 BRAZIL: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 139
TABLE 118 BRAZIL BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 140
TABLE 119 BRAZIL: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 140
TABLE 120 MEXICO: KEY MACROINDICATORS 141
TABLE 121 MEXICO: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 142
TABLE 122 MEXICO: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 142
TABLE 123 MEXICO: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 143
TABLE 124 MEXICO: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 143
TABLE 125 ROLA: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 144
TABLE 126 ROLA: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 145
TABLE 127 ROLA: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 145
TABLE 128 ROLA: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 146
TABLE 129 MEA: BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2017-2024 (USD MILLION) 147
TABLE 130 MEA: MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2017-2024 (USD MILLION) 147
TABLE 131 MEA: BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT, 2017-2024 (USD MILLION) 148
TABLE 132 MEA: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2017-2024 (USD MILLION) 148
TABLE 133 GROWTH STRATEGY MATRIX (2015-2018) 151
TABLE 134 EXPANSIONS, 2016-2019 157
TABLE 135 ACQUISITIONS, 2016-2019 158
TABLE 136 COLLABORATIONS, PARTNERSHIPS, AND AGREEMENTS, 2016-2019 159
TABLE 137 SERVICE LAUNCHES, 2016-2019 160

 

LIST OF FIGURES

FIGURE 1 RESEARCH DESIGN 23
FIGURE 2 PRIMARY SOURCES 26
FIGURE 3 BREAKDOWN OF PRIMARY INTERVIEWS (SUPPLY SIDE): BY COMPANY TYPE, DESIGNATION, AND REGION 28
FIGURE 4 BREAKDOWN OF PRIMARY INTERVIEWS (DEMAND SIDE):
BY END USER AND REGION 29
FIGURE 5 BOTTOM-UP APPROACH 29
FIGURE 6 TOP-DOWN APPROACH 30
FIGURE 7 DATA TRIANGULATION METHODOLOGY 31
FIGURE 8 BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE,
2019 VS. 2024 (USD MILLION) 34
FIGURE 9 MICROBIOLOGICAL TESTING SERVICES MARKET, BY TYPE,
2019 VS. 2024 (USD MILLION) 35
FIGURE 10 BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT,
2019 VS. 2024 (USD MILLION) 35
FIGURE 11 BIOPROCESS VALIDATION SERVICES MARKET, BY END USER,
2019 VS. 2024 (USD MILLION) 36
FIGURE 12 GEOGRAPHICAL SNAPSHOT OF THE BIOPROCESS VALIDATION SERVICES MARKET 37
FIGURE 13 INCREASING NUMBER OF STRINGENT SAFETY AND QUALITY REGULATIONS IN
THE BIOPHARMACEUTICAL INDUSTRY IS DRIVING MARKET GROWTH 38
FIGURE 14 PHARMACEUTICAL COMPANIES COMMANDED THE LARGEST SHARE OF
THE APAC BIOPROCESS VALIDATION SERVICES MARKET IN 2018 39
FIGURE 15 CHINA IS ESTIMATED TO GROW AT A HIGHEST CAGR DURING
THE FORECAST PERIOD 40
FIGURE 16 ASIA PACIFIC MARKET TO WITNESS THE HIGHEST GROWTH IN
THE FORECAST PERIOD 41
FIGURE 17 DEVELOPING COUNTRIES TO REGISTER HIGHER GROWTH DURING
THE FORECAST PERIOD 41
FIGURE 18 US: BIOLOGICS GOING OFF-PATENT IN THE COMING YEARS 46
FIGURE 19 EXTRACTABLES/LEACHABLES TESTING SERVICES TO WITNESS HIGH GROWTH IN THE BIOPROCESS VALIDATION SERVICES MARKET DURING THE FORECAST PERIOD 52
FIGURE 20 LARGE-SCALE EUKARYOTIC CELL CULTURE SERVICES TO WITNESS HIGH
GROWTH IN THE BIOPROCESS VALIDATION SERVICES MARKET DURING
THE FORECAST PERIOD 55
FIGURE 21 FILTER ELEMENTS SEGMENT TO WITNESS THE HIGHEST GROWTH IN THE BIOPROCESS VALIDATION SERVICES MARKET DURING THE FORECAST PERIOD 67
FIGURE 22 PHARMACEUTICAL COMPANIES TO WITNESS THE HIGHEST GROWTH DURING
THE FORECAST PERIOD 78
FIGURE 23 GEOGRAPHIC SNAPSHOT: MARKETS IN ASIA PACIFIC ARE EMERGING HOTSPOTS 86
FIGURE 24 NORTH AMERICA: BIOPROCESS VALIDATION SERVICES MARKET SNAPSHOT 88
FIGURE 25 EUROPE: BIOPROCESS VALIDATION SERVICES MARKET SNAPSHOT 98
FIGURE 26 APAC: BIOPROCESS VALIDATION SERVICES MARKET SNAPSHOT 120
FIGURE 27 KEY DEVELOPMENTS OF MAJOR PLAYERS BETWEEN JANUARY 2016 AND FEBRUARY 2019 150
FIGURE 28 BIOPROCESS VALIDATION SERVICES MARKET SHARE ANALYSIS,
BY KEY PLAYER, 2018 152
FIGURE 29 COMPETITIVE LEADERSHIP MAPPING, BIOPROCESS VALIDATION SERVICES MARKET (2019) 155
FIGURE 30 EXPANSIONS WAS THE KEY GROWTH STRATEGY ADOPTED BY MAJOR PLAYERS BETWEEN 2016 & 2019 156
FIGURE 31 MERCK KGAA: COMPANY SNAPSHOT 162
FIGURE 32 SARTORIUS STEDIM BIOTECH S.A.: COMPANY SNAPSHOT 167
FIGURE 33 SGS S.A.: COMPANY SNAPSHOT 170
FIGURE 34 EUROFINS SCIENTIFIC: COMPANY SNAPSHOT 173
FIGURE 35 THERMO FISHER SCIENTIFIC: COMPANY SNAPSHOT 182

 

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