North America Bioanalytical Testing Services Market 2022-2031 by Molecule Type (Small, Large), Application (Bioavailability and Bioequivalence, PK, PD, ADME), Test Type (Cell-based, Virology, SINA, MDOV, Biomarker), Workflow Process (Sample Preparation, Sample Analysis, Others), Therapeutic Area (Oncology, Neurology, Infectious Diseases, Gastroenterology, Cardiology), End User (Pharma and Biopharma Companies, CDMOs, CROs), and Country: Trend Forecast and Growth Opportunity
- Report ID: 29919
- Date: Jun, 2022
- Pages: 130
- Category: Healthcare & Pharmaceuticals
North America bioanalytical testing services market is projected to grow by 8.3% annually in the forecast period and reach $ 3,232.3 million by 2031, driven by the rising demand for analytical testing of biologics and biosimilars amid COVID-19 pandemic, increasing preference for outsourcing analytical testing, growing R&D expenditure in the pharmaceutical and biopharmaceutical industries, and the rising adoption of the Quality by Design (QbD) approach.
Highlighted with 29 tables and 75 figures, this 130-page report “North America Bioanalytical Testing Services Market 2021-2031 by Molecule Type (Small, Large), Application (Bioavailability and Bioequivalence, PK, PD, ADME), Test Type (Cell-based, Virology, SINA, MDOV, Biomarker), Workflow Process (Sample Preparation, Sample Analysis, Others), Therapeutic Area (Oncology, Neurology, Infectious Diseases, Gastroenterology, Cardiology), End User (Pharma and Biopharma Companies, CDMOs, CROs), and Country: Trend Forecast and Growth Opportunity” is based on a comprehensive research of the entire North America bioanalytical testing services market and all its sub-segments through extensively detailed classifications.
Profound analysis and assessment are generated from premium primary and secondary information sources with inputs derived from industry professionals across the value chain. The report is based on studies on 2018-2021 and provides forecast from 2022 till 2031 with 2021 as the base year.
(Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
In-depth qualitative analyses include identification and investigation of the following aspects:
• Market Structure
• Growth Drivers
• Restraints and Challenges
• Emerging Product Trends & Market Opportunities
• Porter’s Fiver Forces
The trend and outlook of North America market is forecast in optimistic, balanced, and conservative view by taking into account of COVID-19. The balanced (most likely) projection is used to quantify North America bioanalytical testing services market in every aspect of the classification from perspectives of Molecule Type, Application, Test Type, Workflow Process, Therapeutic Area, End User, and Country.
Based on Molecule Type, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2021-2031 included in each section.
Small Molecules
Large Molecules
LC-MS Studies
Immunoassays
Other Large Molecule Tests
Based Application, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2021-2031 included in each section.
Bioavailability and Bioequivalence Studies
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Absorption, Distribution, Metabolism, Excretion (ADME)
Other Applications
By Test Type, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2021-2031 included in each section.
Cell-based Assays
Bacterial Cell-based Assays
Viral Cell-based Assays
Virology Testing
In Vitro Virology Testing
In Vivo Virology Testing
Species-Specific Viral PCR Assays
Serology, Immunogenicity, and Neutralizing Antibodies (SINA)
Bacterial Serology, Immunogenicity, and Neutralizing Antibodies
Viral Serology, Immunogenicity, and Neutralizing Antibodies
Method Development Optimization and Validation (MDOV)
Biomarker Testing
Pharmacokinetic Testing
Other Test Types
By Workflow Process, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2021-2031 included in each section.
Sample Preparation
Protein Precipitation
Liquid-liquid Extraction (LLE)
Sample Analysis
Hyphenated Technique
Chromatographic Technique
Electrophoresis
Ligand Binding Assay
Mass Spectrometry
Nuclear Magnetic Resonance
Other Workflow Processes
By Therapeutic Area, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2021-2031 included in each section.
Oncology
Neurology
Infectious Diseases
Gastroenterology
Cardiology
Other Therapeutic Areas
By End User, the North America market is segmented into the following sub-markets with annual revenue ($ mn) for 2021-2031 included in each section.
Pharma and Biopharma Companies
Contract Development and Manufacturing Organizations (CDMOs)
Contract Research Organizations (CROs)
Geographically, the following national/local markets are fully investigated:
• U.S.
• Canada
• Mexico
For each key country, detailed analysis and data for annual revenue ($ mn) are available for 2021-2031. The breakdown of national markets by Application, Workflow Process, and Therapeutic Area over the forecast years are also included.
The report also covers current competitive scenario and the predicted trend; and profiles key vendors including market leaders and important emerging players.
Selected Key Players:
Charles River Laboratories International Inc.
Covance Inc.
Eurofins Scientific
ICON PLC
Intertek Group PLC
IQVIA Holdings, Inc.
Laboratory Corporation of America Holdings
Medpace Holdings, Inc.
Pace Analytical Services LLC.
Parexel International Corporation
PPD Inc.
SGS SA
Syneos Health, LLC
Toxikon Corporation
WuXi Apptech Co., Ltd.
(Please note: The report will be updated before delivery so that the latest historical year is the base year and the forecast covers at least 5 years over the base year.)
1 Introduction 8
1.1 Industry Definition and Research Scope 8
1.1.1 Industry Definition 8
1.1.2 Research Scope 9
1.2 Research Methodology 12
1.2.1 Overview of Market Research Methodology 12
1.2.2 Market Assumption 13
1.2.3 Secondary Data 13
1.2.4 Primary Data 13
1.2.5 Data Filtration and Model Design 14
1.2.6 Market Size/Share Estimation 15
1.2.7 Research Limitations 16
1.3 Executive Summary 17
2 Market Overview and Dynamics 20
2.1 Market Size and Forecast 20
2.1.1 Impact of COVID-19 on World Economy 21
2.1.2 Impact of COVID-19 on the Market 23
2.2 Major Growth Drivers 28
2.3 Market Restraints and Challenges 31
2.4 Emerging Opportunities and Market Trends 34
2.5 Porter’s Fiver Forces Analysis 38
3 Segmentation of North America Market by Molecule Type 42
3.1 Market Overview by Molecule Type 42
3.2 Small Molecules 44
3.3 Large Molecules 45
3.3.1 LC-MS Studies 46
3.3.2 Immunoassays 47
3.3.3 Other Large Molecule Tests 48
4 Segmentation of North America Market by Application 49
4.1 Market Overview by Application 49
4.2 Bioavailability and Bioequivalence Studies 51
4.3 Pharmacokinetics (PK) 52
4.4 Pharmacodynamics (PD) 53
4.5 Absorption, Distribution, Metabolism, Excretion (ADME) 54
4.6 Other Applications 55
5 Segmentation of North America Market by Test Type 56
5.1 Market Overview by Test Type 56
5.2 Cell-based Assays 58
5.2.1 Bacterial Cell-based Assays 59
5.2.2 Viral Cell-based Assays 60
5.3 Virology Testing 61
5.3.1 In Vitro Virology Testing 62
5.3.2 In Vivo Virology Testing 63
5.3.3 Species-Specific Viral PCR Assays 64
5.4 Serology, Immunogenicity, and Neutralizing Antibodies (SINA) 65
5.4.1 Bacterial Serology, Immunogenicity, and Neutralizing Antibodies 66
5.4.2 Viral Serology, Immunogenicity, and Neutralizing Antibodies 67
5.5 Method Development Optimization and Validation (MDOV) 68
5.6 Biomarker Testing 69
5.7 Pharmacokinetic Testing 70
5.8 Other Test Types 71
6 Segmentation of North America Market by Workflow Process 72
6.1 Market Overview by Workflow Process 72
6.2 Sample Preparation 74
6.2.1 Protein Precipitation 75
6.2.2 Liquid-liquid Extraction (LLE) 76
6.2.3 Solid Phase Extraction (SPE) 77
6.3 Sample Analysis 78
6.3.1 Hyphenated Technique 80
6.3.2 Chromatographic Technique 81
6.3.3 Electrophoresis 82
6.3.4 Ligand Binding Assay 83
6.3.5 Mass Spectrometry 84
6.3.6 Nuclear Magnetic Resonance 85
6.4 Other Workflow Processes 86
7 Segmentation of North America Market by Therapeutic Area 87
7.1 Market Overview by Therapeutic Area 87
7.2 Oncology 89
7.3 Neurology 90
7.4 Infectious Diseases 91
7.5 Gastroenterology 92
7.6 Cardiology 93
7.7 Other Therapeutic Areas 94
8 Segmentation of North America Market by End User 95
8.1 Market Overview by End User 95
8.2 Pharma and Biopharma Companies 97
8.3 Contract Development and Manufacturing Organizations (CDMOs) 98
8.4 Contract Research Organizations (CROs) 99
9 North America Market 2021-2031 by Country 100
9.1 Overview of North America Market 100
9.2 U.S. 103
9.3 Canada 106
9.4 Mexico 108
10 Competitive Landscape 110
10.1 Overview of Key Vendors 110
10.2 New Product Launch, Partnership, Investment, and M&A 113
10.3 Company Profiles 114
Charles River Laboratories International Inc. 114
Covance Inc. 116
Eurofins Scientific 117
ICON PLC 118
Intertek Group PLC 119
IQVIA Holdings, Inc. 120
Laboratory Corporation of America Holdings 121
Medpace Holdings, Inc. 122
Pace Analytical Services LLC. 123
Parexel International Corporation 124
PPD Inc. 125
SGS SA 126
Syneos Health, LLC 127
Toxikon Corporation 128
WuXi Apptech Co., Ltd. 129
RELATED REPORTS 130
List of Tables
Table 1. Snapshot of North America Bioanalytical Testing Services Market in Balanced Perspective, 2021-2031 18
Table 2. World Economic Outlook, 2021-2031 22
Table 3. World Health Spending by Region, $ bn, 2013-2020 27
Table 4. Main Product Trends and Market Opportunities in North America Bioanalytical Testing Services Market 34
Table 5. North America Bioanalytical Testing Services Market by Molecule Type, 2021-2031, $ mn 42
Table 6. North America Bioanalytical Testing Services Market: Large Molecules Testing by Technology, 2021-2031, $ mn 45
Table 7. North America Bioanalytical Testing Services Market by Application, 2021-2031, $ mn 49
Table 8. North America Bioanalytical Testing Services Market by Test Type, 2021-2031, $ mn 56
Table 9. North America Bioanalytical Testing Services Market: Cell-based Assays by Type, 2021-2031, $ mn 58
Table 10. North America Bioanalytical Testing Services Market: Virology Testing by Type, 2021-2031, $ mn 61
Table 11. North America Bioanalytical Testing Services Market: Serology, Immunogenicity, and Neutralizing Antibodies (SINA) by Type, 2021-2031, $ mn 65
Table 12. North America Bioanalytical Testing Services Market by Workflow Process, 2021-2031, $ mn 72
Table 13. North America Bioanalytical Testing Services Market: Sample Preparation by Method, 2021-2031, $ mn 74
Table 14. North America Bioanalytical Testing Services Market: Sample Analysis by Technology, 2021-2031, $ mn 79
Table 15. North America Bioanalytical Testing Services Market by Therapeutic Area, 2021-2031, $ mn 87
Table 16. North America Bioanalytical Testing Services Market by End User, 2021-2031, $ mn 95
Table 17. North America Bioanalytical Testing Services Market by Country, 2021-2031, $ mn 101
Table 18. U.S. Bioanalytical Testing Services Market by Application, 2021-2031, $ mn 105
Table 19. U.S. Bioanalytical Testing Services Market by Workflow Process, 2021-2031, $ mn 105
Table 20. U.S. Bioanalytical Testing Services Market by Therapeutic Area, 2021-2031, $ mn 105
Table 21. Canada Bioanalytical Testing Services Market by Application, 2021-2031, $ mn 107
Table 22. Canada Bioanalytical Testing Services Market by Workflow Process, 2021-2031, $ mn 107
Table 23. Canada Bioanalytical Testing Services Market by Therapeutic Area, 2021-2031, $ mn 107
Table 24. Mexico Bioanalytical Testing Services Market by Application, 2021-2031, $ mn 109
Table 25. Mexico Bioanalytical Testing Services Market by Workflow Process, 2021-2031, $ mn 109
Table 26. Mexico Bioanalytical Testing Services Market by Therapeutic Area, 2021-2031, $ mn 109
Table 27. Charles River Laboratories International Inc.: Company Snapshot 114
Table 28. Charles River Laboratories International Inc.: Business Segmentation 115
Table 29. Charles River Laboratories International Inc.: Product Portfolio 115
List of Figures
Figure 1. Research Method Flow Chart 12
Figure 2. Bottom-up Approach and Top-down Approach for Market Estimation 15
Figure 3. North America Market Forecast in Optimistic, Conservative and Balanced Perspectives, 2021-2031 17
Figure 4. North America Bioanalytical Testing Services Market, 2021-2031, $ mn 20
Figure 5. Impact of COVID-19 on Business 23
Figure 6. Leading Causes of Death in the World, 2019-2020, million 25
Figure 7. Worldwide Geriatric Population (60 years and above) by Regions, 2015 & 2030, million 26
Figure 8. World Population 65 and Over, % of Total Population, 1950-2060 26
Figure 9. Primary Drivers and Impact Factors of North America Bioanalytical Testing Services Market 28
Figure 10. Primary Restraints and Impact Factors of North America Bioanalytical Testing Services Market 31
Figure 11. Investment Opportunity Analysis 35
Figure 12. Porter’s Fiver Forces Analysis of North America Bioanalytical Testing Services Market 38
Figure 13. Breakdown of North America Bioanalytical Testing Services Market by Molecule Type, 2021-2031, % of Revenue 43
Figure 14. North America Addressable Market Cap in 2022-2031 by Molecule Type, Value ($ mn) and Share (%) 43
Figure 15. North America Bioanalytical Testing Services Market by Molecule Type: Small Molecules, 2021-2031, $ mn 44
Figure 16. North America Bioanalytical Testing Services Market by Molecule Type: Large Molecules, 2021-2031, $ mn 45
Figure 17. North America Bioanalytical Testing Services Market by Large Molecules: LC-MS Studies, 2021-2031, $ mn 46
Figure 18. North America Bioanalytical Testing Services Market by Large Molecules: Immunoassays, 2021-2031, $ mn 47
Figure 19. North America Bioanalytical Testing Services Market by Large Molecules: Other Large Molecule Tests, 2021-2031, $ mn 48
Figure 20. Breakdown of North America Bioanalytical Testing Services Market by Application, 2021-2031, % of Sales Revenue 50
Figure 21. North America Addressable Market Cap in 2022-2031 by Application, Value ($ mn) and Share (%) 50
Figure 22. North America Bioanalytical Testing Services Market by Application: Bioavailability and Bioequivalence Studies, 2021-2031, $ mn 51
Figure 23. North America Bioanalytical Testing Services Market by Application: Pharmacokinetics (PK), 2021-2031, $ mn 52
Figure 24. North America Bioanalytical Testing Services Market by Application: Pharmacodynamics (PD), 2021-2031, $ mn 53
Figure 25. North America Bioanalytical Testing Services Market by Application: Absorption, Distribution, Metabolism, Excretion (ADME), 2021-2031, $ mn 54
Figure 26. North America Bioanalytical Testing Services Market by Application: Other Applications, 2021-2031, $ mn 55
Figure 27. Breakdown of North America Bioanalytical Testing Services Market by Test Type, 2021-2031, % of Sales Revenue 57
Figure 28. North America Addressable Market Cap in 2022-2031 by Test Type, Value ($ mn) and Share (%) 57
Figure 29. North America Bioanalytical Testing Services Market by Test Type: Cell-based Assays, 2021-2031, $ mn 58
Figure 30. North America Bioanalytical Testing Services Market by Cell-based Assays: Bacterial Cell-based Assays, 2021-2031, $ mn 59
Figure 31. North America Bioanalytical Testing Services Market by Cell-based Assays: Viral Cell-based Assays, 2021-2031, $ mn 60
Figure 32. North America Bioanalytical Testing Services Market by Test Type: Virology Testing, 2021-2031, $ mn 61
Figure 33. North America Bioanalytical Testing Services Market by Virology Testing: In Vitro Virology Testing, 2021-2031, $ mn 62
Figure 34. North America Bioanalytical Testing Services Market by Virology Testing: In Vivo Virology Testing, 2021-2031, $ mn 63
Figure 35. North America Bioanalytical Testing Services Market by Virology Testing: Species-Specific Viral PCR Assays, 2021-2031, $ mn 64
Figure 36. North America Bioanalytical Testing Services Market by Test Type: Serology, Immunogenicity, and Neutralizing Antibodies (SINA), 2021-2031, $ mn 65
Figure 37. North America Bioanalytical Testing Services Market by Serology, Immunogenicity, and Neutralizing Antibodies (SINA): Bacterial Serology, Immunogenicity, and Neutralizing Antibodies, 2021-2031, $ mn 66
Figure 38. North America Bioanalytical Testing Services Market by Serology, Immunogenicity, and Neutralizing Antibodies (SINA): Viral Serology, Immunogenicity, and Neutralizing Antibodies, 2021-2031, $ mn 67
Figure 39. North America Bioanalytical Testing Services Market by Test Type: Method Development Optimization and Validation (MDOV), 2021-2031, $ mn 68
Figure 40. North America Bioanalytical Testing Services Market by Test Type: Biomarker Testing, 2021-2031, $ mn 69
Figure 41. North America Bioanalytical Testing Services Market by Test Type: Pharmacokinetic Testing, 2021-2031, $ mn 70
Figure 42. North America Bioanalytical Testing Services Market by Test Type: Other Test Types, 2021-2031, $ mn 71
Figure 43. Breakdown of North America Bioanalytical Testing Services Market by Workflow Process, 2021-2031, % of Revenue 73
Figure 44. North America Addressable Market Cap in 2022-2031 by Workflow Process, Value ($ mn) and Share (%) 73
Figure 45. North America Bioanalytical Testing Services Market by Workflow Process: Sample Preparation, 2021-2031, $ mn 74
Figure 46. North America Bioanalytical Testing Services Market by Sample Preparation: Protein Precipitation, 2021-2031, $ mn 75
Figure 47. North America Bioanalytical Testing Services Market by Sample Preparation: Liquid-liquid Extraction (LLE), 2021-2031, $ mn 76
Figure 48. North America Bioanalytical Testing Services Market by Sample Preparation: Solid Phase Extraction (SPE), 2021-2031, $ mn 77
Figure 49. North America Bioanalytical Testing Services Market by Workflow Process: Sample Analysis, 2021-2031, $ mn 78
Figure 50. North America Bioanalytical Testing Services Market by Sample Analysis: Hyphenated Technique, 2021-2031, $ mn 80
Figure 51. North America Bioanalytical Testing Services Market by Sample Analysis: Chromatographic Technique, 2021-2031, $ mn 81
Figure 52. North America Bioanalytical Testing Services Market by Sample Analysis: Electrophoresis, 2021-2031, $ mn 82
Figure 53. North America Bioanalytical Testing Services Market by Sample Analysis: Ligand Binding Assay, 2021-2031, $ mn 83
Figure 54. North America Bioanalytical Testing Services Market by Sample Analysis: Mass Spectrometry, 2021-2031, $ mn 84
Figure 55. North America Bioanalytical Testing Services Market by Sample Analysis: Nuclear Magnetic Resonance, 2021-2031, $ mn 85
Figure 56. North America Bioanalytical Testing Services Market by Workflow Process: Other Workflow Processes, 2021-2031, $ mn 86
Figure 57. Breakdown of North America Bioanalytical Testing Services Market by Therapeutic Area, 2021-2031, % of Revenue 88
Figure 58. North America Addressable Market Cap in 2022-2031 by Therapeutic Area, Value ($ mn) and Share (%) 88
Figure 59. North America Bioanalytical Testing Services Market by Therapeutic Area: Oncology, 2021-2031, $ mn 89
Figure 60. North America Bioanalytical Testing Services Market by Therapeutic Area: Neurology, 2021-2031, $ mn 90
Figure 61. North America Bioanalytical Testing Services Market by Therapeutic Area: Infectious Diseases, 2021-2031, $ mn 91
Figure 62. North America Bioanalytical Testing Services Market by Therapeutic Area: Gastroenterology, 2021-2031, $ mn 92
Figure 63. North America Bioanalytical Testing Services Market by Therapeutic Area: Cardiology, 2021-2031, $ mn 93
Figure 64. North America Bioanalytical Testing Services Market by Therapeutic Area: Other Therapeutic Areas, 2021-2031, $ mn 94
Figure 65. Breakdown of North America Bioanalytical Testing Services Market by End User, 2021-2031, % of Revenue 95
Figure 66. North America Addressable Market Cap in 2022-2031 by End User, Value ($ mn) and Share (%) 96
Figure 67. North America Bioanalytical Testing Services Market by End User: Pharma and Biopharma Companies, 2021-2031, $ mn 97
Figure 68. North America Bioanalytical Testing Services Market by End User: Contract Development and Manufacturing Organizations (CDMOs), 2021-2031, $ mn 98
Figure 69. North America Bioanalytical Testing Services Market by End User: Contract Research Organizations (CROs), 2021-2031, $ mn 99
Figure 70. Breakdown of North America Bioanalytical Testing Services Market by Country, 2021 and 2031, % of Revenue 101
Figure 71. Contribution to North America 2022-2031 Cumulative Market by Country, Value ($ mn) and Share (%) 102
Figure 72. U.S. Bioanalytical Testing Services Market, 2021-2031, $ mn 104
Figure 73. Canada Bioanalytical Testing Services Market, 2021-2031, $ mn 106
Figure 74. Bioanalytical Testing Services Market in Mexico, 2021-2031, $ mn 108
Figure 75. Growth Stage of North America Bioanalytical Testing Services Industry over the Forecast Period 110
Research methodology is mainly referring to the practical how of any offered piece of research. More specifically, it’s all about how a researcher systematically designs a study in order to assure extremely valid as well as reliable results that ultimately address the targets and objectives of the research.
In any formal research including academic journal, article, dissertation and so on, there will be a special section on a research methodology that mainly describes what, by whom, how to gather as well as how to evaluate the data are provided.
This research methodology has been segmented into following types:
Primary Research:
It is said to be original information that the researchers collect for the crucial purposes of answering the research questions of readers with the help of surveys, observations and experiments.
Secondary Research:
The secondary research is the data that has already been collected by various other researchers in the form of government analysis or scientific studies.
Qualitative Research:
It is descriptive and subjective method irrespective of facts. Both observation and description are essential in this type of research methodology. Its main vision is to analyze knowledge, attitudes, behaviours as well as opinions of people related to the topic of any research. This method has been operated through grounded research, case study and actionable research.
Quantitative Research:
It contains several laboratory experiments, basic surveys, mathematical calculations, simulations and so on. The possible measurement, quantity or amount is considered to be a major factor in the quantitative research methodology.
Clients
