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レポート概要
当調査資料は生物学的安全性試験のグローバル市場について調査・分析したレポートです。種類別(機器、サービス、キット、試薬)市場規模、用途別(ワクチン開発、血液製剤、幹細胞研究)市場規模、地域別(北米、米国、カナダ、ヨーロッパ、ドイツ、フランス、イギリス、イタリア、ロシア、アジア、日本、中国、韓国、インド、オーストラリア、台湾、中南米、メキシコ、ブラジル、アルゼンチン、中東・アフリカ、トルコ、サウジアラビア、UAE等)市場規模データ、主な企業情報と企業別市場シェア等が収録されています。 ・調査範囲 ・エグゼクティブサマリー ・企業別生物学的安全性試験の競争状況、市場シェア ・世界の生物学的安全性試験市場:種類別市場規模 2015年-2020年(機器、サービス、キット、試薬) ・世界の生物学的安全性試験市場:種類別市場規模予測 2021年-2026年(機器、サービス、キット、試薬) ・世界の生物学的安全性試験市場:用途別市場規模 2015年-2020年(ワクチン開発、血液製剤、幹細胞研究) ・世界の生物学的安全性試験市場:用途別市場規模予測 2021年-2026年(ワクチン開発、血液製剤、幹細胞研究) ・北米の生物学的安全性試験市場分析:米国、カナダ ・ヨーロッパの生物学的安全性試験市場分析:ドイツ、フランス、イギリス、イタリア、ロシア等 ・アジアの生物学的安全性試験市場分析:日本、中国、韓国、インド、オーストラリア、台湾等 ・中南米の生物学的安全性試験市場分析:メキシコ、ブラジル、アルゼンチン等 ・中東・アフリカの生物学的安全性試験市場分析:トルコ、サウジアラビア、UAE等 ・企業情報(企業概要、製品概要、販売量、企業動向) - 掲載企業(変更可能性あり):Thermo Fisher Scientific、Charles River Laboratories International、Merck、Lonza Group、Avance Biosciences、SGS、Toxikon、NuAire ・地域別市場規模予測(2021年-2026年):北米市場、ヨーロッパ市場、アジア市場、中南米市場、中東・アフリカ市場 ・市場機会、課題、リスク、環境分析 ・バリューチェーン、販売チャネル分析 ・調査の結論 |
Biological safety testing is carried out to ensure non-contamination of biopharmaceuticals and vaccines and to comply with regulations regarding the same. It is a major step towards the launch of innovative biopharmaceutical products. Biological safety testing is essential to ensure product safety, and ensure the quality of biopharmaceutical products. It is conducted to ensure that the drug-producing microbes or cells are free from microbial or viral pathogens, for process validation of virus inactivation, clearance capability during biopharmaceutical production, and to test these biological materials during biopharmaceutical production for verifying the identity and characteristics. In addition, it is also used to ensure the purity, sterility, and genetic stability of the production cell bank. Bioburden testing, sterility testing, adventitious agent’s detection test, cell line authentication and characterization tests, endotoxin tests, and residual host contaminant detection tests are the major biological safety tests. Biological safety testing is used in vaccine, cellular, and gene therapy products, blood and blood products, tissue and tissue products, and stem cell products. It is performed by contract testing laboratories on the behalf of drug developers. These laboratories are confronted with a number of ethical issues and tasked with maintaining confidentiality in handling the results.
Rising need for biologics has resulted in unprecedented growth in number of biopharmaceutical companies. This increasing competition to develop therapeutically advanced drugs on a large scale has compelled manufacturers to improve on aspects such as productivity, cost efficiency, and deviations. Companies are thus implementing good manufacturing practices involving thorough biological testing at various levels of production cycles, thereby contributing toward market growth. Rising number of government initiatives to promote biological safety testing products is anticipated to drive overall market growth over the coming years. High microbial contamination rates and bioburden during pharmaceutical and biologics manufacturing are expected to drive government and private organizations to improve underlying biological safety practices. Moreover, presence of regulatory authorities to enforce significant safety standards is anticipated to provide boost adoption of testing tools. Stringent guidelines and recommendations laid down by these authorities increases incorporation of these tools by quality assurance technicians, thus providing a significant boost to the overall industry.
Market Analysis and Insights: Global Biological Safety Testing Market
The global Biological Safety Testing market size is projected to reach US$ 2860.4 million by 2026, from US$ 2582.3 million in 2020, at a CAGR of 10.0%% during 2021-2026.
Global Biological Safety Testing Scope and Market Size
Biological Safety Testing market is segmented by Type, and by Application. Players, stakeholders, and other participants in the global Biological Safety Testing market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by Type and by Application in terms of revenue and forecast for the period 2015-2026.
The key players covered in this study
Thermo Fisher Scientific
Charles River Laboratories International
Merck
Lonza Group
Avance Biosciences
SGS
Toxikon
NuAire
Market segment by Type, the product can be split into
Instruments
Services
Kits & Reagents
Market segment by Application, split into
Vaccine Development
Blood Products
Stem Cell Research
Market segment by Regions/Countries, this report covers
North America
Europe
China
Japan
Southeast Asia
India
1 Report Overview
1.1 Study Scope
1.2 Key Market Segments
1.3 Players Covered: Ranking by Biological Safety Testing Revenue
1.4 Market by Type
1.4.1 Global Biological Safety Testing Market Size Growth Rate by Type: 2020 VS 2026
1.4.2 Instruments
1.4.3 Services
1.4.4 Kits & Reagents
1.5 Market by Application
1.5.1 Global Biological Safety Testing Market Share by Application: 2020 VS 2026
1.5.2 Vaccine Development
1.5.3 Blood Products
1.5.4 Stem Cell Research
1.6 Study Objectives
1.7 Years Considered
2 Global Growth Trends
2.1 Global Biological Safety Testing Market Perspective (2015-2026)
2.2 Global Biological Safety Testing Growth Trends by Regions
2.2.1 Biological Safety Testing Market Size by Regions: 2015 VS 2020 VS 2026
2.2.2 Biological Safety Testing Historic Market Share by Regions (2015-2020)
2.2.3 Biological Safety Testing Forecasted Market Size by Regions (2021-2026)
2.3 Industry Trends and Growth Strategy
2.3.1 Market Top Trends
2.3.2 Market Drivers
2.3.3 Market Challenges
2.3.4 Porter’s Five Forces Analysis
2.3.5 Biological Safety Testing Market Growth Strategy
2.3.6 Primary Interviews with Key Biological Safety Testing Players (Opinion Leaders)
3 Competition Landscape by Key Players
3.1 Global Top Biological Safety Testing Players by Market Size
3.1.1 Global Top Biological Safety Testing Players by Revenue (2015-2020)
3.1.2 Global Biological Safety Testing Revenue Market Share by Players (2015-2020)
3.1.3 Global Biological Safety Testing Market Share by Company Type (Tier 1, Tier 2 and Tier 3)
3.2 Global Biological Safety Testing Market Concentration Ratio
3.2.1 Global Biological Safety Testing Market Concentration Ratio (CR5 and HHI)
3.2.2 Global Top 10 and Top 5 Companies by Biological Safety Testing Revenue in 2019
3.3 Biological Safety Testing Key Players Head office and Area Served
3.4 Key Players Biological Safety Testing Product Solution and Service
3.5 Date of Enter into Biological Safety Testing Market
3.6 Mergers & Acquisitions, Expansion Plans
4 Market Size by Type (2015-2026)
4.1 Global Biological Safety Testing Historic Market Size by Type (2015-2020)
4.2 Global Biological Safety Testing Forecasted Market Size by Type (2021-2026)
5 Market Size by Application (2015-2026)
5.1 Global Biological Safety Testing Market Size by Application (2015-2020)
5.2 Global Biological Safety Testing Forecasted Market Size by Application (2021-2026)
6 North America
6.1 North America Biological Safety Testing Market Size (2015-2020)
6.2 Biological Safety Testing Key Players in North America (2019-2020)
6.3 North America Biological Safety Testing Market Size by Type (2015-2020)
6.4 North America Biological Safety Testing Market Size by Application (2015-2020)
7 Europe
7.1 Europe Biological Safety Testing Market Size (2015-2020)
7.2 Biological Safety Testing Key Players in Europe (2019-2020)
7.3 Europe Biological Safety Testing Market Size by Type (2015-2020)
7.4 Europe Biological Safety Testing Market Size by Application (2015-2020)
8 China
8.1 China Biological Safety Testing Market Size (2015-2020)
8.2 Biological Safety Testing Key Players in China (2019-2020)
8.3 China Biological Safety Testing Market Size by Type (2015-2020)
8.4 China Biological Safety Testing Market Size by Application (2015-2020)
9 Japan
9.1 Japan Biological Safety Testing Market Size (2015-2020)
9.2 Biological Safety Testing Key Players in Japan (2019-2020)
9.3 Japan Biological Safety Testing Market Size by Type (2015-2020)
9.4 Japan Biological Safety Testing Market Size by Application (2015-2020)
10 Southeast Asia
10.1 Southeast Asia Biological Safety Testing Market Size (2015-2020)
10.2 Biological Safety Testing Key Players in Southeast Asia (2019-2020)
10.3 Southeast Asia Biological Safety Testing Market Size by Type (2015-2020)
10.4 Southeast Asia Biological Safety Testing Market Size by Application (2015-2020)
11 India
11.1 India Biological Safety Testing Market Size (2015-2020)
11.2 Biological Safety Testing Key Players in India (2019-2020)
11.3 India Biological Safety Testing Market Size by Type (2015-2020)
11.4 India Biological Safety Testing Market Size by Application (2015-2020)
12 Central & South America
12.1 Central & South America Biological Safety Testing Market Size (2015-2020)
12.2 Biological Safety Testing Key Players in Central & South America (2019-2020)
12.3 Central & South America Biological Safety Testing Market Size by Type (2015-2020)
12.4 Central & South America Biological Safety Testing Market Size by Application (2015-2020)
13 Key Players Profiles
13.1 Thermo Fisher Scientific
13.1.1 Thermo Fisher Scientific Company Details
13.1.2 Thermo Fisher Scientific Business Overview
13.1.3 Thermo Fisher Scientific Biological Safety Testing Introduction
13.1.4 Thermo Fisher Scientific Revenue in Biological Safety Testing Business (2015-2020))
13.1.5 Thermo Fisher Scientific Recent Development
13.2 Charles River Laboratories International
13.2.1 Charles River Laboratories International Company Details
13.2.2 Charles River Laboratories International Business Overview
13.2.3 Charles River Laboratories International Biological Safety Testing Introduction
13.2.4 Charles River Laboratories International Revenue in Biological Safety Testing Business (2015-2020)
13.2.5 Charles River Laboratories International Recent Development
13.3 Merck
13.3.1 Merck Company Details
13.3.2 Merck Business Overview
13.3.3 Merck Biological Safety Testing Introduction
13.3.4 Merck Revenue in Biological Safety Testing Business (2015-2020)
13.3.5 Merck Recent Development
13.4 Lonza Group
13.4.1 Lonza Group Company Details
13.4.2 Lonza Group Business Overview
13.4.3 Lonza Group Biological Safety Testing Introduction
13.4.4 Lonza Group Revenue in Biological Safety Testing Business (2015-2020)
13.4.5 Lonza Group Recent Development
13.5 Avance Biosciences
13.5.1 Avance Biosciences Company Details
13.5.2 Avance Biosciences Business Overview
13.5.3 Avance Biosciences Biological Safety Testing Introduction
13.5.4 Avance Biosciences Revenue in Biological Safety Testing Business (2015-2020)
13.5.5 Avance Biosciences Recent Development
13.6 SGS
13.6.1 SGS Company Details
13.6.2 SGS Business Overview
13.6.3 SGS Biological Safety Testing Introduction
13.6.4 SGS Revenue in Biological Safety Testing Business (2015-2020)
13.6.5 SGS Recent Development
13.7 Toxikon
13.7.1 Toxikon Company Details
13.7.2 Toxikon Business Overview
13.7.3 Toxikon Biological Safety Testing Introduction
13.7.4 Toxikon Revenue in Biological Safety Testing Business (2015-2020)
13.7.5 Toxikon Recent Development
13.8 NuAire
13.8.1 NuAire Company Details
13.8.2 NuAire Business Overview
13.8.3 NuAire Biological Safety Testing Introduction
13.8.4 NuAire Revenue in Biological Safety Testing Business (2015-2020)
13.8.5 NuAire Recent Development
14 Analyst’s Viewpoints/Conclusions
15 Appendix
15.1 Research Methodology
15.1.1 Methodology/Research Approach
15.1.2 Data Source
15.2 Disclaimer
15.3 Author Details
Table 1. Biological Safety Testing Key Market Segments
Table 2. Key Players Covered: Ranking by Biological Safety Testing Revenue
Table 3. Ranking of Global Top Biological Safety Testing Manufacturers by Revenue (US$ Million) in 2019
Table 4. Global Biological Safety Testing Market Size Growth Rate by Type (US$ Million): 2020 VS 2026
Table 5. Key Players of Instruments
Table 6. Key Players of Services
Table 7. Key Players of Kits & Reagents
Table 8. Global Biological Safety Testing Market Size Growth by Application (US$ Million): 2020 VS 2026
Table 9. Global Biological Safety Testing Market Size by Regions (US$ Million): 2020 VS 2026
Table 10. Global Biological Safety Testing Market Size by Regions (2015-2020) (US$ Million)
Table 11. Global Biological Safety Testing Market Share by Regions (2015-2020)
Table 12. Global Biological Safety Testing Forecasted Market Size by Regions (2021-2026) (US$ Million)
Table 13. Global Biological Safety Testing Market Share by Regions (2021-2026)
Table 14. Market Top Trends
Table 15. Key Drivers: Impact Analysis
Table 16. Key Challenges
Table 17. Biological Safety Testing Market Growth Strategy
Table 18. Main Points Interviewed from Key Biological Safety Testing Players
Table 19. Global Biological Safety Testing Revenue by Players (2015-2020) (Million US$)
Table 20. Global Biological Safety Testing Market Share by Players (2015-2020)
Table 21. Global Top Biological Safety Testing Players by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Biological Safety Testing as of 2019)
Table 22. Global Biological Safety Testing by Players Market Concentration Ratio (CR5 and HHI)
Table 23. Key Players Headquarters and Area Served
Table 24. Key Players Biological Safety Testing Product Solution and Service
Table 25. Date of Enter into Biological Safety Testing Market
Table 26. Mergers & Acquisitions, Expansion Plans
Table 27. Global Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 28. Global Biological Safety Testing Market Size Share by Type (2015-2020)
Table 29. Global Biological Safety Testing Revenue Market Share by Type (2021-2026)
Table 30. Global Biological Safety Testing Market Size Share by Application (2015-2020)
Table 31. Global Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 32. Global Biological Safety Testing Market Size Share by Application (2021-2026)
Table 33. North America Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 34. North America Key Players Biological Safety Testing Market Share (2019-2020)
Table 35. North America Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 36. North America Biological Safety Testing Market Share by Type (2015-2020)
Table 37. North America Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 38. North America Biological Safety Testing Market Share by Application (2015-2020)
Table 39. Europe Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 40. Europe Key Players Biological Safety Testing Market Share (2019-2020)
Table 41. Europe Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 42. Europe Biological Safety Testing Market Share by Type (2015-2020)
Table 43. Europe Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 44. Europe Biological Safety Testing Market Share by Application (2015-2020)
Table 45. China Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 46. China Key Players Biological Safety Testing Market Share (2019-2020)
Table 47. China Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 48. China Biological Safety Testing Market Share by Type (2015-2020)
Table 49. China Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 50. China Biological Safety Testing Market Share by Application (2015-2020)
Table 51. Japan Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 52. Japan Key Players Biological Safety Testing Market Share (2019-2020)
Table 53. Japan Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 54. Japan Biological Safety Testing Market Share by Type (2015-2020)
Table 55. Japan Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 56. Japan Biological Safety Testing Market Share by Application (2015-2020)
Table 57. Southeast Asia Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 58. Southeast Asia Key Players Biological Safety Testing Market Share (2019-2020)
Table 59. Southeast Asia Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 60. Southeast Asia Biological Safety Testing Market Share by Type (2015-2020)
Table 61. Southeast Asia Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 62. Southeast Asia Biological Safety Testing Market Share by Application (2015-2020)
Table 63. India Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 64. India Key Players Biological Safety Testing Market Share (2019-2020)
Table 65. India Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 66. India Biological Safety Testing Market Share by Type (2015-2020)
Table 67. India Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 68. India Biological Safety Testing Market Share by Application (2015-2020)
Table 69. Central & South America Key Players Biological Safety Testing Revenue (2019-2020) (Million US$)
Table 70. Central & South America Key Players Biological Safety Testing Market Share (2019-2020)
Table 71. Central & South America Biological Safety Testing Market Size by Type (2015-2020) (Million US$)
Table 72. Central & South America Biological Safety Testing Market Share by Type (2015-2020)
Table 73. Central & South America Biological Safety Testing Market Size by Application (2015-2020) (Million US$)
Table 74. Central & South America Biological Safety Testing Market Share by Application (2015-2020)
Table 75. Thermo Fisher Scientific Company Details
Table 76. Thermo Fisher Scientific Business Overview
Table 77. Thermo Fisher Scientific Product
Table 78. Thermo Fisher Scientific Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 79. Thermo Fisher Scientific Recent Development
Table 80. Charles River Laboratories International Company Details
Table 81. Charles River Laboratories International Business Overview
Table 82. Charles River Laboratories International Product
Table 83. Charles River Laboratories International Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 84. Charles River Laboratories International Recent Development
Table 85. Merck Company Details
Table 86. Merck Business Overview
Table 87. Merck Product
Table 88. Merck Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 89. Merck Recent Development
Table 90. Lonza Group Company Details
Table 91. Lonza Group Business Overview
Table 92. Lonza Group Product
Table 93. Lonza Group Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 94. Lonza Group Recent Development
Table 95. Avance Biosciences Company Details
Table 96. Avance Biosciences Business Overview
Table 97. Avance Biosciences Product
Table 98. Avance Biosciences Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 99. Avance Biosciences Recent Development
Table 100. SGS Company Details
Table 101. SGS Business Overview
Table 102. SGS Product
Table 103. SGS Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 104. SGS Recent Development
Table 105. Toxikon Company Details
Table 106. Toxikon Business Overview
Table 107. Toxikon Product
Table 108. Toxikon Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 109. Toxikon Recent Development
Table 110. NuAire Business Overview
Table 111. NuAire Product
Table 112. NuAire Company Details
Table 113. NuAire Revenue in Biological Safety Testing Business (2015-2020) (Million US$)
Table 114. NuAire Recent Development
Table 115. Research Programs/Design for This Report
Table 116. Key Data Information from Secondary Sources
Table 117. Key Data Information from Primary Sources
List of Figures
Figure 1. Global Biological Safety Testing Market Share by Type: 2020 VS 2026
Figure 2. Instruments Features
Figure 3. Services Features
Figure 4. Kits & Reagents Features
Figure 5. Global Biological Safety Testing Market Share by Application: 2020 VS 2026
Figure 6. Vaccine Development Case Studies
Figure 7. Blood Products Case Studies
Figure 8. Stem Cell Research Case Studies
Figure 9. Biological Safety Testing Report Years Considered
Figure 10. Global Biological Safety Testing Market Size YoY Growth 2015-2026 (US$ Million)
Figure 11. Global Biological Safety Testing Market Share by Regions: 2020 VS 2026
Figure 12. Global Biological Safety Testing Market Share by Regions (2021-2026)
Figure 13. Porter's Five Forces Analysis
Figure 14. Global Biological Safety Testing Market Share by Players in 2019
Figure 15. Global Top Biological Safety Testing Players by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Biological Safety Testing as of 2019
Figure 16. The Top 10 and 5 Players Market Share by Biological Safety Testing Revenue in 2019
Figure 17. North America Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 18. Europe Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 19. China Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 20. Japan Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 21. Southeast Asia Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 22. India Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 23. Central & South America Biological Safety Testing Market Size YoY Growth (2015-2020) (Million US$)
Figure 24. Bottom-up and Top-down Approaches for This Report
Figure 25. Data Triangulation
Figure 26. Key Executives Interviewed