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生物製剤の安全性試験市場ー業界洞察、主要プレーヤー・企業別、成長機会別、最新傾向別、開発別、主要な成長ドライバー別、主要な課題別によってセグメンテーション、予測 2022年


[ 英語タイトル ] Biologics Safety Testing Market by Product (Instruments, Services, Kits & Reagents), Test (Endotoxin, Sterility Test, Cell Line Authentication, Bioburden), Application (Vaccine Development, Blood Products, Stem Cell Research) - Global Forecast to 2022


Product Code : MNMHC00108507
Survey : MarketsandMarkets
Publish On : August, 2021
Category : Healthcare and Pharmaceuticals
Study Area : Global
Report format : PDF
Sales price option (consumption tax not included)
Single User USD5650 / Question Form
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Enterprise User USD10000 / Question Form

[Report Description]

The biologics safety testing market was valued at USD 2.75 billion in 2017 and expected to grow at a CAGR of 12.2% to a USD 4.90 billion market by 2022. Growth in pharmaceutical and biotechnology industry driven by government support, the positive trend of R&D investment in the life science industry, and an increase in the number of new drug launches are factors driving the growth of this market. On the other hand, the time-consuming approval process for new drugs is considered a restraint for the market.

“Kits & reagents segment is expected to register the highest CAGR during the forecast period”
The biologics safety testing market is classified on the basis of product & service into kits & reagents, services, and instruments. The kits & reagents segment is expected to register highest growth rate during the forecast period. This growth can be attributed to the reoccurring purchase of kits & reagents, which is required for running tests.
“Endotoxin tests segment is accounted for largest share in the market”
The biologics safety testing market is classified by test type into endotoxin tests, sterility tests, cell line authentification and characterization tests, residual host contamination detection tests, adventitious agent detection tests, bioburden tests, and other tests. The endotoxin tests segment is expected to register the highest growth rate during the forecast period. This growth can be attributed to the increase in the number of drug launches.
“Increase initiative for immunization, increase company investment in vaccines development drives growth of the vaccines and therapeutics development segment”
By application, the biologics safety testing market is segmented into vaccine and therapeutics development; blood and blood-related products testing; cellular and gene therapy; tissue and tissue-related products testing; and stem cell research. The vaccine and therapeutics development segment are expected to register highest CAGR during the forecast period. The growth in this segment primarily attributed to initiatives for immunization and increased company investment in the development of vaccines.
“North America is account for the largest regional segment in the market”
Geographically, the biologics safety testing market is dominated by North America, followed by Europe. The North American region is estimated to account for the largest share of the market in 2017 and the trend is expected to continue during the forecast period. The growth in this market can be attributed to the presence of major key players in the region, a strong trend in R&D in life science industry and an increase in drug approvals.
The primary interviews conducted for this report can be categorized as follows:
• By Company Type - Tier 1 – 43%, Tier 2 – 14% and Tier 3 – 43%
• By Designation – C level – 14%, Director level – 43%, Others – 43%
• By Region – North America - 29%, Europe – 14%, APAC – 43%, RoW – 14%

Key players operating in the biologics safety testing market include Lonza Group LTD. (Switzerland), Charles River Laboratories (U.S.), Merck KGaA (Germany), SGS SA (Switzerland), WuXi Apptec (China), Thermo Fisher Scientific Inc. (U.S.), Sartorius AG (Germany), Cytovance Biologics, Inc. (U.S.), Pace Analytical Services Inc. (U.S.), and Toxikon Corporation (U.S.).
Study Coverage:
The report analyses the biologics safety testing market by product & service, test type, applications, and regions. Apart from comprehensive geographic and product & service analysis and market sizing, the report also provides the competitive landscape that covers the growth strategies adopted by industry players over the last three years. In addition, the report profiles companies with developments, and strategies adopted by key players to maintain and increase their shares in the market. The market research data, market size, and forecast of the future trends will help key market players and new entrants to make the necessary decisions to be successful in the market.
Benefits of Buying this Report:
This report will enable both established firms as well as new entrants/smaller firms gauge the pulse of the market, which in turn will help these firms garner greater market shares. Firms purchasing the report can use any one or a combination of the five strategies mentioned below to strengthen their market shares.

The report provides insights on the following strategies:

• Market Penetration: The report analyzes the biologics safety testing market by product & service, test type and application
• Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the biologics safety testing market
• Market Development: Comprehensive information about emerging markets. This report analyzes the market for various biologics safety testing product & service across geographies
• Market Diversification: Exhaustive information about new products and services, untapped geographies, recent developments, and investments in the biologics safety testing market

TABLE OF CONTENTS

1 INTRODUCTION 13
1.1 OBJECTIVES OF THE STUDY 13
1.2 MARKET DEFINITION 13
1.2.1 MARKETS COVERED 14
1.2.2 YEARS CONSIDERED FOR THE STUDY 14
1.3 CURRENCY 15
1.4 LIMITATIONS 15
1.5 STAKEHOLDERS 15
2 RESEARCH METHODOLOGY 16
2.1 RESEARCH APPROACH 16
2.2 RESEARCH DATA 17
2.2.1 SECONDARY SOURCES 17
2.2.1.1 Key data from secondary sources 17
2.2.2 PRIMARY SOURCES 18
2.2.2.1 Key data from primary sources 18
2.2.2.2 Breakdown of primary interviews 19
2.3 MARKET SIZE ESTIMATION 19
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 21
2.5 RESEARCH ASSUMPTIONS 22
3 EXECUTIVE SUMMARY 23
4 PREMIUM INSIGHTS 27
4.1 BIOLOGICS SAFETY TESTING: MARKET OVERVIEW 27
4.2 GEOGRAPHIC ANALYSIS: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE (2017) 28
4.3 GEOGRAPHIC SNAPSHOT OF THE BIOLOGICS SAFETY TESTING MARKET 29
4.4 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 2017 VS 2022 30
5 MARKET OVERVIEW 31
5.1 INTRODUCTION 32
5.2 MARKET DYNAMICS 32
5.2.1 DRIVERS 33
5.2.1.1 Growth in pharmaceutical and biotechnology industries driven by government support 33
5.2.1.2 Positive trend of R&D investments in life science 33
5.2.1.3 Increase in number of drug launches 34
5.2.1.4 High incidence and large economic burden of chronic diseases 34
5.2.2 OPPORTUNITIES 34
5.2.2.1 Emerging Markets 34
5.2.2.2 Increasing pharmaceutical outsourcing 35
5.2.3 CHALLENGE 35
5.2.3.1 Dearth of skilled professionals 35
6 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT AND SERVICE 36
6.1 INTRODUCTION 37
6.2 KITS & REAGENTS 38
6.3 SERVICES 38
6.4 INSTRUMENTS 39
7 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE 40
7.1 INTRODUCTION 41
7.2 ENDOTOXIN TESTS 42
7.3 STERILITY TESTS 43
7.4 CELL LINE AUTHENTICATION AND CHARACTERIZATION TESTS 43
7.5 BIOBURDEN TESTS 44
7.6 RESIDUAL HOST CONTAMINANT DETECTION TESTS 45
7.7 ADVENTITIOUS AGENT DETECTION TESTS 45
7.8 OTHER TESTS 46
8 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 47
8.1 INTRODUCTION 48
8.2 VACCINE & THERAPEUTICS DEVELOPMENT 49
8.3 BLOOD AND BLOOD-RELATED PRODUCTS TESTING 50
8.4 CELLULAR AND GENE THERAPY 50
8.5 TISSUE AND TISSUE-RELATED PRODUCTS TESTING 51
8.6 STEM CELL RESEARCH 52
9 BIOLOGICS SAFETY TESTING MARKET, BY REGION 53
9.1 INTRODUCTION 54
9.2 NORTH AMERICA 56
9.2.1 U.S. 59
9.2.2 CANADA 61
9.3 EUROPE 63
9.3.1 GERMANY 66
9.3.2 U.K. 67
9.3.3 FRANCE 69
9.3.4 ITALY 70
9.3.5 SPAIN 72
9.3.6 REST OF EUROPE (ROE) 73
9.4 ASIA 75
9.4.1 CHINA 79
9.4.2 JAPAN 80
9.4.3 INDIA 82
9.4.4 REST OF ASIA 83
9.5 REST OF THE WORLD 85
9.5.1 SOUTH AMERICA, CENTRAL AMERICA, AND THE CARIBBEAN 87
9.5.2 PACIFIC AND OCEANIA 89
9.5.3 AFRICA 90
10 COMPETITIVE LANDSCAPE 91
10.1 OVERVIEW 91
10.1.1 VISIONARY LEADERS 91
10.1.2 INNOVATORS 91
10.1.3 DYNAMIC DIFFERENTIATORS 91
10.1.4 EMERGING COMPANIES 91
10.2 COMPETITIVE BENCHMARKING 93
10.2.1 STRENGTH OF PRODUCT PORTFOLIO 93
10.2.2 BUSINESS STRATEGY EXCELLENCE 94
10.3 MARKET SHARE ANALYSIS 95

*Top 25 companies analyzed for this studies are - Sartorius AG (Germany), SGS SA (Switzerland), Thermo Fisher Scientific, Inc. (U.S.), Lonza Group LTD (Switzerland), Charles River Laboratories, Inc. (U.S.), Merck KGaA (Germany), Eurofins Scientific SE (Luxembourg), Source BioScience (U.K.), F. Hoffmann-La Roche Ltd. (Switzerland), Cytovance Biologics (U.S.), Toxikon Corporation (U.S.), Avance Biosciences Inc. (U.S.), Pace Analytical Services LLC. (U.S.), WuXi Apptec (China), BioMérieux SA (France), Sterigenics International LLC (U.S.), Clean Cells (France), BSL Bioservice Scientific Laboratories Munich GmbH (Germany), North American Science Associates Inc. (U.S.), PromoCell GmbH (Germany), GenScript (China), Gibraltar Laboratories (U.S.), InvivoGen (U.S.), Neopharm Labs Inc. (Canada), ViruSure GmbH (Austria)

11 COMPANY PROFILES 97
(Overview, Products Offered, Product Offering Scorecard, Business Strategy Scorecard, Recent Developments)*
11.1 CHARLES RIVER LABORATORIES INTERNATIONAL, INC. 97
11.2 MERCK KGAA 100
11.3 LONZA GROUP LTD. 104
11.4 SGS S.A. 107
11.5 THERMO FISHER SCIENTIFIC INC. 110
11.6 WUXI APPTEC 113
11.7 SARTORIUS AG 116
11.8 CYTOVANCE BIOLOGICS, INC. 119
11.9 PACE ANALYTICAL SERVICES INC. 121
11.10 TOXIKON CORPORATION 123
11.11 EUROFINS SCIENTIFIC SE 124
11.12 AVANCE BIOSCIENCES INC. 127
11.13 SOURCE BIOSCIENCE 128

*Details on MarketsandMarkets view, Overview, Products Offered, Product Offering Scorecard, Business Strategy Scorecard, and Recent Developments might not be captured in case of unlisted companies.
12 APPENDIX 131
12.1 INSIGHTS OF INDUSTRY EXPERTS 131
12.2 DISCUSSION GUIDE 132
12.3 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 134
12.4 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 136
12.5 AVAILABLE CUSTOMIZATIONS 137
12.6 RELATED REPORTS 138
12.7 AUTHOR DETAILS 139

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