Pharmaceutical Analytical Testing Market

Detailed research report on the pharmaceutical analytical testing market, including market analysis, industry size, and forecast from 2024 to 2029.

The Report Covers Global Pharmaceutical Analytical Testing Outsourcing Market Trends and It is Segmented by Service Type (Bioanalytical Testing, Method Development & Validation, Stability Testing, Drug Substances Testing, and Other Service Types) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Size and Forecasts are Provided in Terms of Value (USD Million) for all the Above Segments.

Pharmaceutical Analytical Testing Market Size

Single User License

$4750

Team License

$5250

Corporate License

$8750

Book before:
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

Need a report that reflects how COVID-19 has impacted this market and its growth?

Single User License

$4750

Team License

$5250

Corporate License

$8750

Book before:

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 Market Trends

Stability Testing Segment is Expected to Exhibit a Significant Market Growth Over the Forecast Period

Stability testing is done to evaluate the capability of the drug to retain its properties throughout its shelf-life. The stability studies of pharmaceutical products are one of the most important parameters for developing new drugs and formulations. The stability testing is done based on five parameters: chemical, physical, microbiological, therapeutic, and toxicity. The degradation of any of these parameters can lead to health hazards.

Factors such as the growing government initiatives and guidelines to support stability testing, advantages of stability testing, and key strategies adopted by the market players are expected to boost the growth of the studied segment over the forecast period.

The regulatory bodies are involved in developing guidelines to ensure the stability of the testing of pharmaceutical products. For instance, in July 2023, the European Medicines Agency published guidelines on stability testing for active ingredients and pharmaceutical products to ensure their safety. These guidelines mandate pharmaceutical companies to conduct stability testing, which is expected to drive segment growth over the forecast period.

Additionally, various studies were conducted to perform stability testing with different analytical techniques for determining drug quality, efficacy, and safety. For instance, in March 2023, a study published in the Turkish Journal of Pharmaceutical Sciences reported that stability testing was conducted for the biosimilar monoclonal antibodies candidate (TUR01) with advanced analytical techniques such as isoelectric focussing on capillary electrophoresis, capillary electrophoresis-sodium dodecyl sulfate, and others.

In addition to the above context, the study showed drug stability at ≤-65°C and 5 ± 3°C at least 18 months. Thus, analytical stability testing ensures that the drugs are highly stable, which in turn is expected to propel the adoption of such techniques across drug manufacturing companies, as it provides the safety and quality of biosimilars, hence contributing to segment growth.

Key players' strategic initiatives, such as product launches, approvals, and partnerships, are expected to fuel the segment's growth. For instance, in November 2023, CatSci Ltd established a partnership with Reach Separations in which the company can leverage CatSci's expertise in analytical science covering various services, including International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability testing. 

Additionally, in July 2023, ten23 Health launched quality control services in Switzerland for product release and stability testing of clinical and commercial drugs as per the international current good manufacturing practice (cGMP) standards. Such developments are estimated to boost the segment growth during the forecast period.

Therefore, the aforementioned factors, such as government initiatives, market players' strategies, and the effectiveness of pharmaceutical product stability testing, are anticipated to drive the segment growth over the forecast period.

Pharmaceutical Analytical Testing Market :Number of Clinical Trials Registered (In Thousands), Global, 2022-2024

North America Holds a Significant Share in the Market and Expected to do Same During The Forecast Period

North America is expected to occupy a significant market share in the pharmaceutical analytical testing market owing to the increasing number of R&D activities, investments, and strategic initiatives taken by the market players in the region.

The region's need for pharmaceutical analytical services is growing due to increased clinical research activities and drug approvals. For instance, in January 2024, the United States Food and Drug Administration's Center for Drug and Evaluation approved 55 new drugs in 2023, which are indicated for treating various infectious diseases. Also, as of February 2024, about 146,311 clinical trials were registered in the United States, contributing 30% of the total registered clinical trials. Thus, the significant number of drug approvals and clinical trials in the region is anticipated to boost the market growth in the area during the forecast period.

Furthermore, growing investments in clinical research fuel the demand for pharmaceutical analytical services to develop safe and high-quality pharmaceutical products and drive market growth in the region. For instance, the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group represents the leading biopharmaceutical research companies in the United States. In 2022, its member companies' research and development (R&D) expenditure reached about USD 101 billion worldwide, in which the United States accounted for 21% of R&D investment. Therefore, significant research and development expenditures for conducting clinical trials will likely employ pharmaceutical analytical services to ensure safety at each drug development stage and are expected to propel the market growth.

The strategic initiatives, including product launches, approvals, acquisition and partnerships, not only enhance the capabilities and service offerings of key market players but also drive the broader adoption of pharmaceutical analytical services. For instance, in January 2024, Alcami Corporation acquired Pacific Pharmaceutical Services, Inc. to improve its pharma storage and services capabilities in Nevada, ensuring the stability and security of storing pre-clinical and clinical materials. Additionally, in December 2022, Pharmacopeia opened its advanced manufacturing technology lab in Richmond, Virginia, with the launch of analytical services to boost drug manufacturing activities and medication supply chain resilience. Such developments are estimated to propel market growth in the region.

Therefore, the increasing number of clinical trials, increase in research and development expenditures, and product launches are expected to boost the demand for pharmaceutical analytical testing market growth in the North American region, ensuring high-quality and safe drug development.

Pharmaceutical Analytical Testing Market - Growth Rate by Region

Pharmaceutical Analytical Testing Industry Overview

The pharmaceutical analytical testing market is fragmented in nature due to the presence of several companies globally. Various strategies are adopted by the market players such as product launches, collaborations, and acquisitions to expand their business in the market. The studied market consists of several international and local companies that hold most of the market shares and are well known. Some of the key players in the market are Steris, Intertek Pharmaceutical Services, Pace Analytical Services, SGS SA, Boston Analytical, and among others.

Pharmaceutical Analytical Testing Market Leaders

  1. Steris

  2. Intertek Pharmaceutical Services

  3. Pace Analytical Services

  4. SGS SA

  5. Boston Analytical

*Disclaimer: Major Players sorted in no particular order

Pharmaceutical Analytical Testing Market Concentration
Need More Details on Market Players and Competitors?
Download PDF

Pharmaceutical Analytical Testing Market News

  • March 2024: LGM Pharma invested over USD 2 million to expand its analytical testing services and include drug delivery suppository manufacturing capabilities by 50% in its facility in Rosenburg, Texas. 
  • January 2024: Kindeva Drug Delivery increased its analytical service capabilities by launching a new global business unit, which provides integrated and stand-alone analytical support to pharmaceutical, biopharmaceutical, and medical device companies.

Pharmaceutical Analytical Testing Market Report - Table of Contents

1. INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing Number of Clinical Trials
    • 4.2.2 Focus on Analytical Testing of Biologics and Biosimilars
    • 4.2.3 Increased Trend of Outsourcing Laboratory Testing Services
  • 4.3 Market Restraints
    • 4.3.1 Complex Regulatory Framework for Maintaining Laboratories
    • 4.3.2 Challenges in the Development of Proper Analytical Techniques
  • 4.4 Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD)

  • 5.1 By Service Type
    • 5.1.1 Bioanalytical Testing
    • 5.1.2 Method Development & Validation
    • 5.1.3 Stability Testing
    • 5.1.4 Drug Substances Testing
    • 5.1.5 Other Service Types
  • 5.2 Geography
    • 5.2.1 North America
    • 5.2.1.1 United States
    • 5.2.1.2 Canada
    • 5.2.1.3 Mexico
    • 5.2.2 Europe
    • 5.2.2.1 Germany
    • 5.2.2.2 United Kingdom
    • 5.2.2.3 France
    • 5.2.2.4 Italy
    • 5.2.2.5 Spain
    • 5.2.2.6 Rest of Europe
    • 5.2.3 Asia-Pacific
    • 5.2.3.1 China
    • 5.2.3.2 Japan
    • 5.2.3.3 India
    • 5.2.3.4 Australia
    • 5.2.3.5 South Korea
    • 5.2.3.6 Rest of Asia-Pacific
    • 5.2.4 Middle East and Africa
    • 5.2.4.1 GCC
    • 5.2.4.2 South Africa
    • 5.2.4.3 Rest of Middle East and Africa
    • 5.2.5 South America
    • 5.2.5.1 Brazil
    • 5.2.5.2 Argentina
    • 5.2.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Laboratory Testing Inc.
    • 6.1.2 Eurofins Scientific
    • 6.1.3 SGS SA
    • 6.1.4 Labcorp (Toxikon Inc)
    • 6.1.5 Pace Analytical Services
    • 6.1.6 Intertek Group Plc
    • 6.1.7 Boston Analytical
    • 6.1.8 West Pharmaceutical Services, Inc.
    • 6.1.9 Steris
  • *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments
You Can Purchase Parts Of This Report. Check Out Prices For Specific Sections
Get Price Break-up Now

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
Geography Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Geography Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Geography Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
Geography South America Brazil
Argentina
Rest of South America
Need A Different Region Or Segment?
Customize Now

Pharmaceutical Analytical Testing Market Research 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.

Steris, Intertek Pharmaceutical Services, Pace Analytical Services, SGS SA and Boston Analytical are the major companies operating in the Pharmaceutical Analytical Testing 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 Market.

In 2023, the Pharmaceutical Analytical Testing Market size was estimated at USD 8.22 billion. The report covers the Pharmaceutical Analytical Testing Market historical market size for years: 2021, 2022 and 2023. The report also forecasts the Pharmaceutical Analytical Testing Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

The regulatory requirements for Analytical Testing in the Pharmaceutical Industry are a) Compliance with Good Manufacturing Practices (GMP) b) Adherence to guidelines set by regulatory agencies

Pharmaceutical Analytical Testing Industry Report

The global pharmaceutical analytical testing services market is on a notable growth path, driven by an increasing demand for analytical testing services and a significant rise in drug approvals and clinical trials. Enhanced government efforts to bolster analytical testing capabilities, along with a growing need for vaccine testing, contribute to market expansion. The sector, with its emphasis on bioanalytical testing and method development, addresses the urgent need for meticulous drug testing to ensure new pharmaceuticals’ safety and efficacy. Despite challenges such as developing appropriate analytical techniques and a complex regulatory landscape, the market sees lucrative opportunities, especially in stability testing and the trend towards outsourcing laboratory testing services. North America’s leadership role, underscored by intense R&D activities and numerous clinical trials, signals a promising future for innovation within the healthcare analytical testing services market, ready to meet the pharmaceutical and biopharmaceutical industries' changing needs. Statistics for the 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 and historical overview. Get a sample of this industry analysis as a free report PDF download.

80% of our clients seek made-to-order reports. How do you want us to tailor yours?

Please enter a valid email id!

Please enter a valid message!

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