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North America Bioanalytical Testing Services Market Forecast to 2030 - Regional Analysis - by Services (Pharmacokinetics, Biomarkers, Immunogenicity, Virology Testing, Cell-based assays, and Others); Disease Indication (Cardiovascular, Neurological Disorders, Metabolic Disorders, Autoimmune Disorders, Respiratory Diseases, Oncology, Sexual Health, Bone Disease, and Others); and End User [Pharmaceutical and Biopharmaceutical Companies, Contract Research Organization (CRO), Contract Development And Manufacturing Organization (CDMO), and Others]

February 2024 | 110 pages | ID: NEF168B4975DEN
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The North America bioanalytical testing services market was valued at US$ 1,798.03 million in 2022 and is expected to reach US$ 3,971.42 million by 2030; it is estimated to grow at a CAGR of 10.4% from 2022 to 2030.

Increasing Outsourcing of R&D Activities by Pharmaceutical Companies fuel the North America Bioanalytical Testing Services Market

Pharmaceutical companies outsource research & development activities that are not core to their internal structure. Outsourcing miscellaneous activities allows them to efficiently focus on their internal core competencies for making the drug development process better and more cost effective. Moreover, outsourcing manufacturing activities, along with R&D, benefits them by lowering the turnaround period, adding to their expertise, and eliminating the need for large capital investments. According to the Survey of Biopharmaceutical Manufacturing Capacity and Production by BioPlan Associates, analytical testing/bioassay was the most outsourced service in 2022, followed by toxicity testing, validation services, product characterization, and others. While developing nations are the largest contributors to the demand for bioanalytical testing services through contract manufacturing, the US remains a potential outsourcing destination. 39.6% of non-US respondents in the survey preferred outsourcing to US-based facilities. Thus, the practice of outsourcing is gaining popularity worldwide, especially in developing countries, thereby favoring the growth of the bioanalytical testing services market. Pharmaceutical businesses are widely implementing the quality-by-design (QbD) concept, which is further propelling the adoption of outsourcing services by pharmaceutical companies to increase the robustness of their production processes and ensure optimal product quality and manufacturing productivity. QbD is supported by regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The concept has gained traction in the pharmaceutical industry over the years with the publication of ICH Q9 (Quality Risk Management), ICH Q8 (R2, Pharmaceutical Development), and ICH Q10 (Pharmaceutical Quality System). According to the ICH Q10 guidelines, analytical methods are essential to the pharmaceutical quality system. Analytical QbD (AQbD) implementation in manufacturing ensures product quality and performance. Outsourcing bioanalytical testing services helps pharmaceutical businesses reduce business risks by avoiding major investments in analytical equipment and skilled professionals, especially while the product is in the early phase of development. Due to the availability of specialized analytical testing service providers with crucial competencies to quickly provide excellent results, pharmaceutical companies are increasingly considering outsourcing bioanalytical testing services to third-party service providers, which fuels the market growth.

North America Bioanalytical Testing Services Market Overview

North America holds the largest share of the bioanalytical testing services market, with the US, Canada, and Mexico being the major contributors to the market growth in this region. The uninterrupted growth of the pharmaceuticals industry, the increasing need for developing novel drugs due to an upsurge in the incidences of various diseases, rising healthcare expenditure by governments, and a growing preference for outsourcing activities for the quality assurance of pharmaceutical products are the factors favoring the growth of the bioanalytical testing services market in North America.

North America Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Million)

North America Bioanalytical Testing Services Market Segmentation

The North America bioanalytical testing services market is segmented based on test type, disease indication, end user, and country.

Based on test type, the North America bioanalytical testing services market is segmented into pharmacokinetics, biomarkers, immunogenicity, virology testing, cell-based assays, and others. The cell-based assays segment held the largest market share in 2022.

Based on disease indication, the North America bioanalytical testing services market is segmented into cardiovascular, neurological disorders, metabolic disorders, respiratory diseases, autoimmune disorder, oncology, sexual health, bone disease, and others. The oncology segment held the largest market share in 2022.

Based on end user, the North America bioanalytical testing services market is segmented into pharmaceutical and biopharmaceutical companies, contract research organization (CRO), contract development and manufacturing organization (CDMO), and others. The pharmaceutical and biopharmaceutical companies segment held the largest market share in 2022.

Based on country, the North America bioanalytical testing services market is segmented into the US, Canada, and Mexico. The US dominated the North America bioanalytical testing services market share in 2022.

SGS SA, Pharmaron Beijing Co Ltd, Element Materials Technology Group Ltd, CD BioSciences Inc, Charles River Laboratories International Inc, Eurofins Scientific SE, Labcorp Drug Development Inc, Syneos Health Inc, KCAS Bioanalytical and Biomarker Services LLC, ICON Plc, and Intertek Group Plc are some of the leading companies operating in the North America bioanalytical testing services market.
1. INTRODUCTION

1.1 The Insight Partners Research Report Guidance
1.2 Market Segmentation

2. EXECUTIVE SUMMARY

2.1 Key Insights

3. RESEARCH METHODOLOGY

3.1 Coverage
3.2 Secondary Research
3.3 Primary Research

4. NORTH AMERICA BIOANALYTICAL TESTING SERVICES MARKET LANDSCAPE

4.1 Overview
4.2 PEST Analysis
  4.2.1 North America PEST Analysis

5. NORTH AMERICA BIOANALYTICAL TESTING SERVICES MARKET - KEY INDUSTRY DYNAMICS

5.1 Key Market Drivers:
  5.1.1 Increasing Outsourcing of R&D Activities by Pharmaceutical Companies
  5.1.2 High Demand for Analytical Testing of Biosimilars and Biologics
5.2 Key Market Restraints:
  5.2.1 Challenges in Development and Validation of Bioanalytical Methods
5.3 Key Market Opportunities
  5.3.1 Uninterrupted Growth of Pharmaceuticals Industry
5.4 Future Trends
  5.4.1 Rising Drug Discovery and Development Activities for Emerging and Rare Diseases
5.5 Impact Analysis:

6. BIOANALYTICAL TESTING SERVICES MARKET - NORTH AMERICA MARKET ANALYSIS

6.1 Bioanalytical Testing Services Market Revenue (US$ Mn), 2022 - 2030

7. NORTH AMERICA BIOANALYTICAL TESTING SERVICES MARKET - REVENUE AND FORECAST TO 2030 - BY SERVICES

7.1 Overview
7.2 Bioanalytical Testing Services Market Revenue Share, by Services 2022 & 2030 (%)
7.3 Pharmacokinetics
  7.3.1 Overview
  7.3.2 Pharmacokinetics: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
7.4 Biomarkers
  7.4.1 Overview
  7.4.2 Biomarkers: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
7.5 Immunogenicity
  7.5.1 Overview
  7.5.2 Immunogenicity: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
7.6 Virology Testing
  7.6.1 Overview
  7.6.2 Virology Testing: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
    7.6.2.1 In-Vitro Virology Testing
      7.6.2.1.1 Overview
    7.6.2.2 In-Vitro Virology Testing: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
  7.6.3 In-Vivo Virology Testing
    7.6.3.1 Overview
    7.6.3.2 In-Vivo Virology Testing: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
7.7 Cell-Based Assays
  7.7.1 Overview
  7.7.2 Cell-Based Assays: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
7.8 Others
  7.8.1 Overview
  7.8.2 Others: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)

8. NORTH AMERICA BIOANALYTICAL TESTING SERVICES MARKET - REVENUE AND FORECAST TO 2030 - BY DISEASE INDICATION

8.1 Overview
8.2 Bioanalytical Testing Services Market Revenue Share, by Disease Indication 2022 & 2030 (%)
8.3 Cardiovascular
  8.3.1 Overview
  8.3.2 Cardiovascular: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.4 Neurological Diseases
  8.4.1 Overview
  8.4.2 Neurological Diseases: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.5 Autoimmune Disorders
  8.5.1 Overview
  8.5.2 Autoimmune Disorders: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.6 Respiratory Diseases
  8.6.1 Overview
  8.6.2 Respiratory Diseases: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.7 Metabolic Disorders
  8.7.1 Overview
  8.7.2 Metabolic Disorders: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.8 Oncology
  8.8.1 Overview
  8.8.2 Oncology: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.9 Sexual Health
  8.9.1 Overview
  8.9.2 Sexual Health: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.10 Bone Disease
  8.10.1 Overview
  8.10.2 Bone Disease: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
8.11 Others
  8.11.1 Overview
  8.11.2 Others: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)

9. NORTH AMERICA BIOANALYTICAL TESTING SERVICES MARKET - REVENUE AND FORECAST TO 2030 - BY END USER

9.1 Overview
9.2 Bioanalytical Testing Services Market Revenue Share, by End User 2022 & 2030 (%)
9.3 Pharmaceutical and Biopharmaceutical Companies
  9.3.1 Overview
  9.3.2 Pharmaceutical and Biopharmaceutical Companies: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
9.4 Contract Research Organization (CRO)
  9.4.1 Overview
  9.4.2 Contract Research Organization (CRO): Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
9.5 Contract Development and Manufacturing Organization (CDMO)
  9.5.1 Overview
  9.5.2 Contract Development and Manufacturing Organization (CDMO): Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
9.6 Others
  9.6.1 Overview
  9.6.2 Others: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)

10. NORTH AMERICA BIOANALYTICAL TESTING SERVICES MARKET - COUNTRY ANALYSIS

10.1 North America Bioanalytical Testing Services Market, Revenue And Forecast To 2030
  10.1.1 Overview
    10.1.1.1 North America Bioanalytical Testing Services Market, by Country
    10.1.1.2 US
      10.1.1.2.1 Overview
      10.1.1.2.2 US Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
      10.1.1.2.3 US Bioanalytical Testing Services Market, by Services
        10.1.1.2.3.1 US Bioanalytical Testing Services Market, by Virology Testing
      10.1.1.2.4 US Bioanalytical Testing Services Market, by Disease Indication
      10.1.1.2.5 US Bioanalytical Testing Services Market, by End User
    10.1.1.3 Canada
      10.1.1.3.1 Overview
      10.1.1.3.2 Canada Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
      10.1.1.3.3 Canada Bioanalytical Testing Services Market, by Services
        10.1.1.3.3.1 Canada Bioanalytical Testing Services Market, by Virology Testing
      10.1.1.3.4 Canada Bioanalytical Testing Services Market, by Disease Indication
      10.1.1.3.5 Canada Bioanalytical Testing Services Market, by End User
    10.1.1.4 Mexico
      10.1.1.4.1 Overview
      10.1.1.4.2 Mexico Bioanalytical Testing Services Market Revenue and Forecast to 2030 (US$ Mn)
      10.1.1.4.3 Mexico Bioanalytical Testing Services Market, by Services
        10.1.1.4.3.1 Mexico Bioanalytical Testing Services Market, by Virology Testing
      10.1.1.4.4 Mexico Bioanalytical Testing Services Market, by Disease Indication
      10.1.1.4.5 Mexico Bioanalytical Testing Services Market, by End User

11. BIOANALYTICAL TESTING SERVICES MARKET INDUSTRY LANDSCAPE

11.1 Overview
11.2 Growth Strategies in the Bioanalytical Testing Services Market
11.3 Inorganic Growth Strategies
  11.3.1 Overview
11.4 Organic Growth Strategies
  11.4.1 Overview

12. COMPANY PROFILES

12.1 SGS SA
  12.1.1 Key Facts
  12.1.2 Business Description
  12.1.3 Products and Services
  12.1.4 Financial Overview
  12.1.5 SWOT Analysis
  12.1.6 Key Developments
12.2 Pharmaron Beijing Co Ltd
  12.2.1 Key Facts
  12.2.2 Business Description
  12.2.3 Products and Services
  12.2.4 Financial Overview
  12.2.5 SWOT Analysis
  12.2.6 Key Developments
12.3 Element Materials Technology Group Ltd
  12.3.1 Key Facts
  12.3.2 Business Description
  12.3.3 Products and Services
  12.3.4 Financial Overview
  12.3.5 SWOT Analysis
  12.3.6 Key Developments
12.4 CD BioSciences Inc
  12.4.1 Key Facts
  12.4.2 Business Description
  12.4.3 Products and Services
  12.4.4 Financial Overview
  12.4.5 SWOT Analysis
  12.4.6 Key Developments
12.5 Charles River Laboratories International Inc
  12.5.1 Key Facts
  12.5.2 Business Description
  12.5.3 Products and Services
  12.5.4 Financial Overview
  12.5.5 SWOT Analysis
  12.5.6 Key Developments
12.6 Eurofins Scientific SE
  12.6.1 Key Facts
  12.6.2 Business Description
  12.6.3 Products and Services
  12.6.4 Financial Overview
  12.6.5 SWOT Analysis
  12.6.6 Key Developments
12.7 Labcorp Drug Development Inc
  12.7.1 Key Facts
  12.7.2 Business Description
  12.7.3 Products and Services
  12.7.4 Financial Overview
  12.7.5 SWOT Analysis
  12.7.6 Key Developments
12.8 Syneos Health Inc
  12.8.1 Key Facts
  12.8.2 Business Description
  12.8.3 Products and Services
  12.8.4 Financial Overview
  12.8.5 SWOT Analysis
  12.8.6 Key Developments
12.9 KCAS Bioanalytical and Biomarker Services LLC
  12.9.1 Key Facts
  12.9.2 Business Description
  12.9.3 Products and Services
  12.9.4 Financial Overview
  12.9.5 SWOT Analysis
  12.9.6 Key Developments
12.10 ICON Plc
  12.10.1 Key Facts
  12.10.2 Business Description
  12.10.3 Products and Services
  12.10.4 Financial Overview
  12.10.5 SWOT Analysis
  12.10.6 Key Developments
12.11 Intertek Group Plc
  12.11.1 Key Facts
  12.11.2 Business Description
  12.11.3 Products and Services
  12.11.4 Financial Overview
  12.11.5 SWOT Analysis
  12.11.6 Key Developments

13. APPENDIX

13.1 About Us
13.2 Glossary of Terms

LIST OF TABLES

Table 1. North America Bioanalytical Testing Services Market Segmentation
Table 2. US Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Services
Table 3. US Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Virology Testing
Table 4. US Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Disease Indication
Table 5. US Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - End User
Table 6. Canada Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Services
Table 7. Canada Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Virology Testing
Table 8. Canada Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Disease Indication
Table 9. Canada Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - End User
Table 10. Mexico Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Services
Table 11. Mexico Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Virology Testing
Table 12. Mexico Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - Disease Indication
Table 13. Mexico Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn) - End User
Table 14. Recent Inorganic Growth Strategies in the Bioanalytical Testing Services Market
Table 15. Recent Organic Growth Strategies in the Bioanalytical Testing Services Market
Table 16. Glossary of Terms, North America Bioanalytical Testing Services Market

LIST OF FIGURES

Figure 1. North America Bioanalytical Testing Services Market Segmentation, By Country
Figure 2. North America - PEST Analysis
Figure 3. North America Bioanalytical Testing Services Market - Key Industry Dynamics
Figure 4. Impact Analysis of Drivers and Restraints
Figure 5. North America Bioanalytical Testing Services Market Revenue (US$ Mn), 2022 - 2030
Figure 6. North America Bioanalytical Testing Services Market Revenue Share, by Services 2022 & 2030 (%)
Figure 7. Pharmacokinetics: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 8. Biomarkers: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 9. Immunogenicity: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 10. Virology Testing: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 11. In-Vitro Virology Testing: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 12. In-Vivo Virology Testing: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 13. Cell-Based Assays: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 14. Others: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 15. North America Bioanalytical Testing Services Market Revenue Share, by Disease Indication 2022 & 2030 (%)
Figure 16. Cardiovascular: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 17. Neurological Diseases: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 18. Autoimmune Disorders: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 19. Respiratory Diseases: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 20. Metabolic Disorders: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 21. Oncology: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 22. Sexual Health: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 23. Bone Disease: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 24. Others: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 25. North America Bioanalytical Testing Services Market Revenue Share, by End User 2022 & 2030 (%)
Figure 26. Pharmaceutical and Biopharmaceutical Companies: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 27. Contract Research Organization (CRO): Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 28. Contract Development and Manufacturing Organization (CDMO): Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 29. Others: Bioanalytical Testing Services Market - Revenue and Forecast to 2030 (US$ Million)
Figure 30. North America Bioanalytical Testing Services Market, by Country - Revenue 2022 ($Mn)
Figure 31. North America Bioanalytical Testing Services Market, By Key Countries, 2022 And 2030 (%)
Figure 32. US Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn)
Figure 33. Canada Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn)
Figure 34. Mexico Bioanalytical Testing Services Market Revenue And Forecast to 2030 (US$ Mn)
Figure 35. Growth Strategies in the Bioanalytical Testing Services Market


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