North America Bioanalytical Testing Services Market Forecast to 2030 - Regional Analysis - by Services ; Disease Indication ; and End User

Description

List of Tables

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.

Product Code: BMIRE00029563

Table of Content

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