Pharmaceutical Analytical Testing Outsourcing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Pharmaceutical Analytical Testing Outsourcing Market Report is Segmented by Services (Bioanalytical Testing, Method Development and Validation, Stability Testing, and Other Services), End User (Pharmaceutical and Biopharmaceutical Companies, Contract Manufacturing Organizations, and Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The Market values are Provided (in USD million) for the above segments.

Pharmaceutical Analytical Testing Market Size

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Pharmaceutical Analytical Testing Outsourcing Market Summary
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Study Period 2019 - 2029
Base Year For Estimation 2023
CAGR 8.70 %
Fastest Growing Market Asia-Pacific
Largest Market North America
Market Concentration Medium

Major Players

Pharmaceutical Analytical Testing Outsourcing Market Major Players

*Disclaimer: Major Players sorted in no particular order

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Pharmaceutical Analytical Testing Market Analysis

The pharmaceutical analytical testing outsourcing market has a market size of 7.1 billion in the base year and is expected to register a CAGR of 8.7% during the forecast period.

  • COVID-19 significantly impacted pharmaceutical analytical testing outsourcing due to the rise in the testing process to develop novel therapies for the disease. This has led to a rise in approvals from regulatory agencies on clinical trial sites by decreasing the time for the approval process. For instance, according to the article published in the European Pharmaceutical Review by Dr. Ronan Brow in March 2021, during the outbreak, the pharmaceutical sector and regulatory authorities worked closely together to create and provide diagnostic tests, treatments, and vaccinations at breakneck speed. In addition, the sector had seen a shift in site permissions from local to centralized. 
  • Similarly, the initiative by key market players, such as agreements, was expected to increase market growth. For instance, in November 2021, Alcami Corporation, Inc. signed a master laboratory services agreement with Novavax. With this agreement, Novavax immediately secured full-time equivalent (FTE) resources to provide analytical testing support for its recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. Thus, all these factors are likely to have a positive impact on the market growth over the pandemic phase.
  • Further, the factors driving the growth of this market include a rise in research and development expenditures, increasing focus on regulation, safety, and quality, pricing benefits of outsourcing, and a rise in the demand for biosimilars and biopharmaceutical products as well as for analytical drugs, availability of advanced analytical testing techniques such as hyphenated techniques; kinetic method of analysis, electrochemical techniques, among others.
  • Rising acquisitions and partnerships among pharmaceutical analytical testing outsourcing providers will drive the growth of this market. For instance, in December 2021, PharmaLex Group, a provider of specialist services for the pharmaceutical, biotech, and MedTech sectors, merged with Pharmasol, a life sciences corporation specializing in pharmacovigilance IT and business support. In addition, in December 2021, SGS SA acquired Quay Pharmaceuticals Limited (Quay Pharma), a UK-based provider of innovative formulation research and development services. With this acquisition, SGS will add Quay Pharmaceuticals services to its comprehensive portfolio of analytical services.
  • Furthermore, the rising demand for biosimilars and biopharmaceuticals will drive the market's growth significantly. For instance, the study published in the Iranian Journal of Medical Sciences in September 2021 stated that it is expected that the development of new biosimilars would save consumers up to USD 250 billion and make biological therapies more accessible to an extra 1.2 million patients by 2025. This increases the availability of such products to patients with chronic conditions and provides a more affordable option for those who previously had to discontinue therapy or rely on less effective medications. Such an increase in biosimilar manufacturing will increase the outsourcing of drug testing services, thereby boosting market growth. Therefore, owing to the aforementioned factors, the market is expected to grow over the forecast period.
  • However, a rise in the reliance on the performance of unstable outsourced manufacturing organizations, an increase in the concerns regarding the privacy/theft of confidential data for manufacturing pharmaceuticals, and varied outsourcing expenditures by companies, among others, are expected to hamper the growth of the market studied.

Pharmaceutical Analytical Testing Market Trends

Pharmaceutical and Biopharmaceutical Companies Segment is Expected to Garner a Major Share During the Forecast Period

  • By end user, the pharmaceutical and biopharmaceutical companies segment is expected to hold a significant share in the market studied over the forecast period. Factors such as the rise in product development activities, growing research and development expenditures by companies, and the need to develop novel therapies, among others, are expected to drive the growth of this segment.
  • In addition, rising mergers and acquisitions among the key market players are further expected to drive the growth of this segment studied.
  • For instance, in February 2022, Personal Genome Diagnostics Inc. (PGDx), a key player in cancer genomics with a range of complete liquid biopsy and tissue-based solutions, was acquired by Labcorp. PGDx's technology complements and accelerates Labcorp's current liquid biopsy capabilities, as well as expands Labcorp's leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities. This puts Labcorp at the forefront of improving patient outcomes in oncology.
  • Furthermore, in December 2021, Eurofins Scientific entered into a share purchase agreement with Transgenic Inc. to acquire Genetic Lab Co., Ltd., a molecular biology-based testing provider for diagnostics, biomarker development, and drug discovery. With this acquisition, the Eurofins network will further strengthen its position in the Japanese market by extending its service offering in biopharmaceutical services and clinical testing in Japan.
  • Therefore, owing to the above-mentioned factors, the segment is expected to witness significant growth over the forecast period.
Pharmaceutical Analytical Testing Outsourcing Market: Estimated Number Clinical Trials, by Location, Global, 2023

North America Holds a Major Share and Expected to do Same in the Forecast Period

  • North America holds a major share in the pharmaceutical analytical testing outsourcing market during the forecast period.
  • The factors contributing to the growth of this region include advancements in technologies, the strong foothold of key market players, the rise in chronic cases, and the rise in pharmaceutical research and development and funding, among others.
  • For instance, in October 2021, Pace Analytical Services, LLC acquired Velesco Pharmaceutical Services, Inc. Velesco is a CDMO that specializes in liquid, semi-solid, and oral solid dose product development. This acquisition adds significant experience and expertise in the development of liquid, semi-solid, and oral solid dose products for pre-clinical and clinical use, allowing Pace to support a growing number of clients throughout the drug development process.
  • In addition, in July 2021, Pace Analytical Services acquired Drug Delivery Experts, LLC (DDE). DDE, also a CDMO, specializes in complex injectable drug formulations and combination drug-device product development. As a result of the acquisition, Pace will be able to assist a growing number of clients who require services throughout the drug development process, as well as contribute experience in drug-device combo products and extended-release injectable technologies. 
  • Similarly, in January 2021, Boston Analytical, a cGMP-compliant analytical laboratory headquartered in Salem, NH, is now opening its second location in Morrisville, North Carolina. Services provided at this location will be sampling and testing services. Such developments in the United States will lead to increased adoption of pharmaceutical analytical testing outsourcing services in this region, thereby driving market growth. 
  • Furthermore, a rise in research funding for clinical trials and supportive activities in the United States is also expected to contribute to the market growth over the forecast period. For instance, according to the National Institute of Health (NIH) data published in June 2022, the funding in the United States for clinical trials and supportive activities for 2021 and 2022 were USD 45 billion and USD 51 billion, respectively. Therefore, the rise in research funding for such activities will lead to increased adoption of pharmaceutical analytical testing outsourcing services, driving regional market growth. 
  • Therefore, owing to the aforementioned factors, the market is anticipated to grow in the North American region.
Pharmaceutical Analytical Testing Outsourcing Market - Growth Rate by Region

Pharmaceutical Analytical Testing Industry Overview

The market for pharmaceutical analytical testing outsourcing is moderately competitive. The market is expected to grow due to factors such as a rise in key market strategies by the market players, such as partnerships with pharmaceutical and biopharmaceutical companies and mergers and acquisitions among the players. Some of the major players operating in this market include SGS SA, Labcorp (Toxikon, Inc.), Eurofins Scientific, Pace Analytical Services, Inc., Intertek Group Plc, WuXi AppTec, and Boston Analytical, among others.

Pharmaceutical Analytical Testing Market Leaders

  1. SGS SA

  2. Labcorp (Toxikon, Inc)

  3. Eurofins Scientific

  4. Pace Analytical Services, Inc.

  5. Intertek Group Plc

*Disclaimer: Major Players sorted in no particular order

Pharmaceutical Analytical Testing Outsourcing Market Concentration
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Pharmaceutical Analytical Testing Market News

  • April 2022: Bruker Corporation acquired Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology (PAT), pharma manufacturing automation, and Quality Assurance (QA) software and systems integration based in the United Kingdom.
  • February 2022: The Center for Breakthrough Medicines (CBM) formed a strategic alliance with BioAnalysis LLC (BIA) to provide CBM's clients with direct access to BIA's advanced testing capabilities, including characterization of viral vectors using BIA's proprietary sedimentation velocity approach to analytical ultracentrifugation, as well as other advanced biophysical methods and analytics.

Pharmaceutical Analytical Testing Market Report - Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing focus on Regulation, Safety and Quality

      2. 4.2.2 Pricing Benefits of Outsourcing

      3. 4.2.3 Rise in the Demand for Biosimilars and Biopharmaceutical Products as well as for Analytical Drugs

    3. 4.3 Market Restraints

      1. 4.3.1 Increase in the Concerns Regarding Privacy/Theft of Confidential Data of Manufacturing Pharmaceuticals

      2. 4.3.2 Varied Outsourcing Expenditures by Companies

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market size in USD)

    1. 5.1 By Services

      1. 5.1.1 Bioanalytical Testing

        1. 5.1.1.1 Clinical

        2. 5.1.1.2 Non-clinical

      2. 5.1.2 Method Development and Validation

        1. 5.1.2.1 Extractable & Leachable

        2. 5.1.2.2 Impurity Method

        3. 5.1.2.3 Technical Consulting

        4. 5.1.2.4 Other Method Development and Validations

      3. 5.1.3 Stability Testing

        1. 5.1.3.1 Drug Substance

        2. 5.1.3.2 Stability Indicating Method Validation

        3. 5.1.3.3 Accelerated Stability Testing

        4. 5.1.3.4 Photostability Testing

        5. 5.1.3.5 Other Stability Testings

      4. 5.1.4 Other Services

    2. 5.2 By End-User

      1. 5.2.1 Pharmaceutical And Biopharmaceutical Companies

      2. 5.2.2 Contract Manufactuing Organizations

      3. 5.2.3 Other End-Users

    3. 5.3 Geography

      1. 5.3.1 North America

        1. 5.3.1.1 United States

        2. 5.3.1.2 Canada

        3. 5.3.1.3 Mexico

      2. 5.3.2 Europe

        1. 5.3.2.1 Germany

        2. 5.3.2.2 United Kingdom

        3. 5.3.2.3 France

        4. 5.3.2.4 Italy

        5. 5.3.2.5 Spain

        6. 5.3.2.6 Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. 5.3.3.1 China

        2. 5.3.3.2 Japan

        3. 5.3.3.3 India

        4. 5.3.3.4 Australia

        5. 5.3.3.5 South Korea

        6. 5.3.3.6 Rest of Asia-Pacific

      4. 5.3.4 Middle-East and Africa

        1. 5.3.4.1 GCC

        2. 5.3.4.2 South Africa

        3. 5.3.4.3 Rest of Middle-East and Africa

      5. 5.3.5 South America

        1. 5.3.5.1 Brazil

        2. 5.3.5.2 Argentina

        3. 5.3.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 SGS SA

      2. 6.1.2 Labcorp (Toxikon, Inc)

      3. 6.1.3 Eurofins Scientific

      4. 6.1.4 Pace Analytical Services, Inc.

      5. 6.1.5 Intertek Group Plc

      6. 6.1.6 Thermofischer Scientific (Pharmaceutical Product Development, LLC )

      7. 6.1.7 WuXi AppTec

      8. 6.1.8 Boston Analytical

      9. 6.1.9 Charles River Laboratories International, Inc

      10. 6.1.10 West Pharmaceutical Services Inc.

      11. 6.1.11 Element Group (Exova Group PLC)

      12. 6.1.12 Merck KGaA

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Pharmaceutical Analytical Testing Industry Segmentation

Pharmaceutical analytical testing outsourcing encompasses all aspects of the pharmaceutical and therapies manufacturing, testing, and validation processes. This includes verifying pharmaceutical ingredients, compounds, and manufacturing procedures needed for medication development. These outsourcing services are provided by outsourcing companies that are focused on such services.

The pharmaceutical analytical testing outsourcing market is segmented by services (bioanalytical testing, method development and validation, stability testing, and other services), end-user (pharmaceutical and biopharmaceutical companies, contract manufacturing organizations, and other end-users), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD) for the above segments.

By Services
Bioanalytical Testing
Clinical
Non-clinical
Method Development and Validation
Extractable & Leachable
Impurity Method
Technical Consulting
Other Method Development and Validations
Stability Testing
Drug Substance
Stability Indicating Method Validation
Accelerated Stability Testing
Photostability Testing
Other Stability Testings
Other Services
By End-User
Pharmaceutical And Biopharmaceutical Companies
Contract Manufactuing Organizations
Other End-Users
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America
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Pharmaceutical Analytical Testing Market Research FAQs

The Pharmaceutical Analytical Testing Outsourcing Market is projected to register a CAGR of 8.70% during the forecast period (2024-2029)

SGS SA, Labcorp (Toxikon, Inc), Eurofins Scientific, Pace Analytical Services, Inc. and Intertek Group Plc are the major companies operating in the Pharmaceutical Analytical Testing Outsourcing Market.

Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).

In 2024, the North America accounts for the largest market share in Pharmaceutical Analytical Testing Outsourcing Market.

The report covers the Pharmaceutical Analytical Testing Outsourcing Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Pharmaceutical Analytical Testing Outsourcing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Pharmaceutical Analytical Testing Industry Report

Statistics for the 2023 Pharmaceutical Analytical Testing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Pharmaceutical Analytical Testing analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.

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Pharmaceutical Analytical Testing Outsourcing Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)