Pharmaceutical Analytical Testing Market Size (2024 - 2029)

The pharmaceutical analytical services market is projected to experience significant growth over the forecast period, driven by an increase in clinical trials and a heightened focus on analytical testing of biologics and biosimilars. The market's expansion is further supported by the trend of outsourcing laboratory testing services and initiatives by health regulatory bodies to promote clinical trials. Strategic activities by market players, such as collaborations and partnerships, are also expected to enhance their service capabilities, contributing to market growth. However, challenges such as complex regulatory frameworks and the development of analytical techniques may pose obstacles to this growth.

Market Size of Pharmaceutical Analytical Testing Industry

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Pharmaceutical Analytical Testing Market  Summary
Study Period 2021 - 2029
Market Size (2024) USD 8.98 Billion
Market Size (2029) USD 13.43 Billion
CAGR (2024 - 2029) 8.41 %
Fastest Growing Market Asia Pacific
Largest Market North America

Major Players

Pharmaceutical Analytical Testing Market  Major Players

*Disclaimer: Major Players sorted in no particular order

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Pharmaceutical Analytical Testing Market Analysis

The Pharmaceutical Analytical Testing Market size is estimated at USD 8.98 billion in 2024, and is expected to reach USD 13.43 billion by 2029, growing at a CAGR of 8.41% during the forecast period (2024-2029).

Various factors, such as the increasing number of clinical trials, the rising focus on analytical testing of biologics and biosimilars, and the increased trend of outsourcing laboratory testing services, are expected to boost the market growth over the forecast period.

The increase in clinical trials for developing new drugs is anticipated to boost the need for pharmaceutical analytical services and contribute to market growth. For instance, in February 2024, according to clinicaltrials.gov, there were 481,599 studies from locations comprising 50 states and 223 countries. Additionally, in December 2023, Mission Therapeutics, a United Kingdom-based company, received clinical trial authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) to evaluate the MTX325 in a Phase-I study for Parkinson’s disease. Thus, with the high number of clinical trials, it is anticipated that pharmaceutical analytical services are likely to be employed and contribute to market growth.

Additionally, initiatives taken by health regulatory bodies, such as the World Health Organization, to boost clinical trial activities are expected to propel the growth of the pharmaceutical analytical services market over the forecast period. For instance, in November 2023, the World Health Organization Global Clinical Trials forum presented the global vision for developing clinical research infrastructure in various therapeutic areas such as cancer, cardiovascular disease, and metabolic and neurological disorders. It facilitates the ethics and regulatory approval process. Therefore, government initiatives for promoting clinical trials and research are anticipated to fuel the adoption of pharmaceutical analytical services, contributing to market growth.

Moreover, the growing emphasis on analytical assessments of biosimilars and biologics drives the demand for pharmaceutical analytical services and contributes to market growth. For instance, in February 2022, an article published in the Frontiers in Bioengineering and Biotechnology mentioned that analytical and biosimilarity assessments were conducted to ensure the approval of biosimilars worldwide. Thus, pharmaceutical analytical services are highly employed, with a growing focus on analytical testing to ensure the approval process and safety of the molecules, thus driving the market growth.

The market players' strategic activities, such as collaborations and partnerships, are anticipated to boost their capabilities to provide pharmaceutical analytical services, which is expected to bolster the market growth. For instance, in July 2023, Recipharm opened a new analytical laboratory in Bengaluru, India, to promote its testing capabilities for nitrosamines, extractable and leachable, and elemental impurity testing worldwide. Additionally, in December 2023, Sterling Accuris Diagnostics acquired Vaibhav Analytical Services, provider of analytical testing services based in Ahmedabad, India. With this acquisition, the company intends to expand its services to new horizons, especially in the realm of pharmaceutical analytical testing. Such developments are estimated to propel market growth over the forecast period.

Therefore, owing to the aforementioned factors, such as the rise in clinical trials, growing attention on analytical testing of biologics and biosimilars, and the rising trend of outsourcing laboratory testing services, the studied market is anticipated to grow over the forecast period. However, the complex regulatory framework for maintaining laboratories and challenges in developing proper analytical techniques will likely impede market growth.

Pharmaceutical Analytical Testing Industry Segmentation

As per the scope of the report, pharmaceutical analytical testing is majorly used in pharmaceutical and biopharmaceutical companies for a series of clinical trials on newly manufactured drugs to ensure safety. This pharmaceutical analytical testing market is segmented by service type and geography. By service type, the market is segmented into bioanalytical testing, method development & validation, stability testing, drug substances testing, and other service types. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. For each segment, the market size is provided in terms of USD value.

By Service Type
Bioanalytical Testing
Method Development & Validation
Stability Testing
Drug Substances Testing
Other Service Types
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 Size Summary

The pharmaceutical analytical services market is poised for significant growth, driven by an increase in clinical trials and a heightened focus on the analytical testing of biologics and biosimilars. The trend of outsourcing laboratory testing services is also contributing to the market's expansion. Regulatory bodies like the World Health Organization are actively promoting clinical trial activities, which is expected to further propel the market. The demand for pharmaceutical analytical services is bolstered by the need for rigorous testing to ensure the safety and efficacy of new drugs, particularly in the context of numerous ongoing clinical trials globally. Strategic initiatives by market players, such as collaborations and the establishment of new laboratories, are enhancing their capabilities and service offerings, thereby supporting market growth.

In addition to the factors driving overall market expansion, the stability testing segment is expected to see increased adoption due to government initiatives and guidelines that mandate such testing. Regulatory bodies, including the European Medicines Agency, are setting standards to ensure the stability and safety of pharmaceutical products, which is anticipated to drive segment growth. The North American region is expected to hold a significant market share, supported by substantial investments in research and development and a high number of clinical trials and drug approvals. The fragmented nature of the market, with numerous international and local players, is characterized by strategic activities like product launches and acquisitions, which are further propelling market growth.

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Pharmaceutical Analytical Testing Market Size - Table of Contents

  1. 1. MARKET DYNAMICS

    1. 1.1 Market Overview

    2. 1.2 Market Drivers

      1. 1.2.1 Increasing Number of Clinical Trials

      2. 1.2.2 Focus on Analytical Testing of Biologics and Biosimilars

      3. 1.2.3 Increased Trend of Outsourcing Laboratory Testing Services

    3. 1.3 Market Restraints

      1. 1.3.1 Complex Regulatory Framework for Maintaining Laboratories

      2. 1.3.2 Challenges in the Development of Proper Analytical Techniques

    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 by Value - USD)

    1. 2.1 By Service Type

      1. 2.1.1 Bioanalytical Testing

      2. 2.1.2 Method Development & Validation

      3. 2.1.3 Stability Testing

      4. 2.1.4 Drug Substances Testing

      5. 2.1.5 Other Service Types

    2. 2.2 Geography

      1. 2.2.1 North America

        1. 2.2.1.1 United States

        2. 2.2.1.2 Canada

        3. 2.2.1.3 Mexico

      2. 2.2.2 Europe

        1. 2.2.2.1 Germany

        2. 2.2.2.2 United Kingdom

        3. 2.2.2.3 France

        4. 2.2.2.4 Italy

        5. 2.2.2.5 Spain

        6. 2.2.2.6 Rest of Europe

      3. 2.2.3 Asia-Pacific

        1. 2.2.3.1 China

        2. 2.2.3.2 Japan

        3. 2.2.3.3 India

        4. 2.2.3.4 Australia

        5. 2.2.3.5 South Korea

        6. 2.2.3.6 Rest of Asia-Pacific

      4. 2.2.4 Middle East and Africa

        1. 2.2.4.1 GCC

        2. 2.2.4.2 South Africa

        3. 2.2.4.3 Rest of Middle East and Africa

      5. 2.2.5 South America

        1. 2.2.5.1 Brazil

        2. 2.2.5.2 Argentina

        3. 2.2.5.3 Rest of South America

Pharmaceutical Analytical Testing Market Size FAQs

The Pharmaceutical Analytical Testing Market size is expected to reach USD 8.98 billion in 2024 and grow at a CAGR of 8.41% to reach USD 13.43 billion by 2029.

In 2024, the Pharmaceutical Analytical Testing Market size is expected to reach USD 8.98 billion.

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