Pharmaceutical Analytical Testing Outsourcing Market- Growth, Trends, Covid-19 Impact, and Forecasts (2022 - 2027)

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 Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Pharmaceutical Analytical Testing Outsourcing Market Size
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 8.7 %

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Market Overview

The Pharmaceutical Analytical Testing Outsourcing Market is expected to register a CAGR of 8.7% during the forecast period, 2022-2027.

COVID-19 has 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 the 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 has seen a shift in site permissions from local to centralized. Previously, a prospective clinical trial location had to be approved by the local government. In other circumstances, the transition to a more centralized approval framework allowed more locations to be accepted for clinical trial testing more rapidly, cutting the period for site approval from months to days. 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, 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 the 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, according to the study published in the Iranian Journal of Medical Sciences in August 2021, titled "Expected Impact of Biosimilars on the Pharmaceutical Companies," 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 the 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.

Scope of the Report

As per the scope of this report, 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 the outsourcing companies that are focussed 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 Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments. 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 million) for the above segments.

By Services
Bioanalytical Testing
Clinical
Non-clinical
Method Development and Validation
Extractable & Leachable
Impurity Method
Technical Consulting
Others
Stability Testing
Drug Substance
Stability Indicating Method Validation
Accelerated Stability Testing
Photostability Testing
Others
Other Services
By End User
Pharmaceutical And Biopharmaceutical Companies
Contract Manufactuing Organizations
Others
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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Key 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 rise in product development activities, growing research and development expenditures by the 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 Trends

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 that require services throughout the drug development process, as well as contribute experience in drug-device combo products and extended-release injectable technologies. Such developments in the United States will lead to increased adoption of pharmaceutical analytical testing outsourcing services in this region, thereby driving the 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 2021, the funding in the United States for clinical trials and supportive activities for 2018, 2019, and 2020 was USD 5,207 million, USD 6,058 million, and USD 6,637 million, respectively. Therefore, the rise in research funding for such activities will lead to increased adoption of pharmaceutical analytical testing outsourcing services, driving the 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 Analysis

Competitive Landscape

The market for pharmaceutical analytical testing outsourcing is moderately competitive. The market is expected to drive due to the rise in key market strategies by the market players, such as partnerships with the pharmaceutical and biopharmaceutical companies, the rise in mergers and acquisitions among the market players, among others. 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.

Recent Developments

In 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.

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.

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 million)

    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 Others

      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 Others

      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 Others

    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

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global Pharmaceutical Analytical Testing Outsourcing Market market is studied from 2019 - 2027.

The Global Pharmaceutical Analytical Testing Outsourcing Market is growing at a CAGR of 8.7% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

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

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