Pharmaceutical Analytical Testing Outsourcing Market Size (2024 - 2029)

The pharmaceutical analytical testing outsourcing market is poised for growth, driven by factors such as increased research and development expenditures, a heightened focus on regulation, safety, and quality, and the demand for biosimilars and biopharmaceutical products. The market's expansion is further supported by advancements in analytical testing techniques and strategic partnerships and acquisitions among service providers. However, challenges such as reliance on the performance of outsourced organizations, concerns over data privacy, and varying outsourcing expenditures may impede market growth.

Market Size of Pharmaceutical Analytical Testing Outsourcing Industry

Pharmaceutical Analytical Testing Outsourcing Market Summary
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

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 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 Outsourcing Market Size Summary

The pharmaceutical analytical testing outsourcing market is poised for significant growth, driven by various factors including increased research and development expenditures, a heightened focus on regulation, safety, and quality, and the demand for biosimilars and biopharmaceutical products. The COVID-19 pandemic accelerated the need for analytical testing outsourcing as regulatory agencies expedited approvals for clinical trials, fostering collaborations and agreements among key market players. These developments, along with the availability of advanced analytical testing techniques, are expected to propel market expansion. However, challenges such as reliance on unstable outsourced manufacturing organizations and concerns regarding data privacy may hinder growth.

North America is anticipated to hold a major share of the pharmaceutical analytical testing outsourcing market, supported by technological advancements, a strong presence of key market players, and increased pharmaceutical research and development funding. The region's growth is further bolstered by strategic acquisitions and expansions by companies like Pace Analytical Services and Boston Analytical. The market's competitive landscape is characterized by mergers, acquisitions, and partnerships among major players such as SGS SA, Labcorp, and Eurofins Scientific, which are expected to drive further growth. Overall, the market is set to expand, with North America leading due to its robust infrastructure and investment in clinical trials.

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Pharmaceutical Analytical Testing Outsourcing Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing focus on Regulation, Safety and Quality

      2. 1.2.2 Pricing Benefits of Outsourcing

      3. 1.2.3 Rise in the Demand for Biosimilars and Biopharmaceutical Products as well as for Analytical Drugs

    3. 1.3 Market Restraints

      1. 1.3.1 Increase in the Concerns Regarding Privacy/Theft of Confidential Data of Manufacturing Pharmaceuticals

      2. 1.3.2 Varied Outsourcing Expenditures by Companies

    4. 1.4 Porter's Five Forces Analysis

      1. 1.4.1 Threat of New Entrants

      2. 1.4.2 Bargaining Power of Buyers/Consumers

      3. 1.4.3 Bargaining Power of Suppliers

      4. 1.4.4 Threat of Substitute Products

      5. 1.4.5 Intensity of Competitive Rivalry

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

    1. 2.1 By Services

      1. 2.1.1 Bioanalytical Testing

        1. 2.1.1.1 Clinical

        2. 2.1.1.2 Non-clinical

      2. 2.1.2 Method Development and Validation

        1. 2.1.2.1 Extractable & Leachable

        2. 2.1.2.2 Impurity Method

        3. 2.1.2.3 Technical Consulting

        4. 2.1.2.4 Other Method Development and Validations

      3. 2.1.3 Stability Testing

        1. 2.1.3.1 Drug Substance

        2. 2.1.3.2 Stability Indicating Method Validation

        3. 2.1.3.3 Accelerated Stability Testing

        4. 2.1.3.4 Photostability Testing

        5. 2.1.3.5 Other Stability Testings

      4. 2.1.4 Other Services

    2. 2.2 By End-User

      1. 2.2.1 Pharmaceutical And Biopharmaceutical Companies

      2. 2.2.2 Contract Manufactuing Organizations

      3. 2.2.3 Other End-Users

    3. 2.3 Geography

      1. 2.3.1 North America

        1. 2.3.1.1 United States

        2. 2.3.1.2 Canada

        3. 2.3.1.3 Mexico

      2. 2.3.2 Europe

        1. 2.3.2.1 Germany

        2. 2.3.2.2 United Kingdom

        3. 2.3.2.3 France

        4. 2.3.2.4 Italy

        5. 2.3.2.5 Spain

        6. 2.3.2.6 Rest of Europe

      3. 2.3.3 Asia-Pacific

        1. 2.3.3.1 China

        2. 2.3.3.2 Japan

        3. 2.3.3.3 India

        4. 2.3.3.4 Australia

        5. 2.3.3.5 South Korea

        6. 2.3.3.6 Rest of Asia-Pacific

      4. 2.3.4 Middle-East and Africa

        1. 2.3.4.1 GCC

        2. 2.3.4.2 South Africa

        3. 2.3.4.3 Rest of Middle-East and Africa

      5. 2.3.5 South America

        1. 2.3.5.1 Brazil

        2. 2.3.5.2 Argentina

        3. 2.3.5.3 Rest of South America

Pharmaceutical Analytical Testing Outsourcing Market Size 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.

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