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

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    Report

  • 127 Pages
  • June 2022
  • Region: Global
  • Mordor Intelligence
  • ID: 5305882
The global pharmaceutical analytical testing market is estimated to be USD 7,137.92 million in 2021. It is expected to reach USD 11,387.35 million by 2027, registering a CAGR of 8.20% from 2022 to 2027.

While the sudden outbreak of the COVID-19 pandemic has negatively impacted most business sectors, the pharmaceutical analytical testing market has shown consistent growth in 2020 and 2021 due to the increase in demand for the development of new drugs candidates and vaccines to control the spread of the Coronavirus disease. The demand for pharmaceutical analytical testing increased during the pandemic because analytical testing is required at all phases of drug development to monitor accuracy, efficiency, and safety. Due to the uncontrolled and sudden increase in covid-19 cases, the development of biosimilars, combination molecules, and other innovative vaccines and medicines have grown, which has resulted in an increased demand for significant bioanalytical testing such as electrophoresis, electrochemical and titrimetric assays, and immunoassays.

Approximately 1,279 drugs are recalled every year globally, and 94% of Food and Drug Administration (FDA) drug recalls have been in the United States, followed by 4% of FDA drug recalls in Canada, according to the FDA Drug Recall Statistics posted on July 2021. From 2012 to 2021, the FDA issued 12,028 drug recalls in the United States. This emerges the need to test the products and ensure public safety before they are marketed. Medicines are intended for a better outcome in humans and animals as the poor quality of medicines would affect the health of the patients and the funding systems. Therefore, analytical testing holds an important role in ensuring the safety and efficacy of the drugs.

An increase in R&D activities, collaborations, and strategic partnerships is expected to drive market growth. For instance, in November 2021, Alcami Corporation, Inc. announced that it 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.

Key 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 or drugs are one of the most important parameters for the development of new drugs and new formulations. The stability testing is done based on five parameters: chemical, physical, microbiological, therapeutic, and toxicity. The degradation with respect to any of these parameters can lead to health hazards. According to the study published by the Journal of Industrial Microbiology & Biotechnology, almost 300 biopharmaceuticals have been patented over the last three decades.

The prediction of shelf-life is vital for the pharmaceutical product development of all the dosage forms. It is also utilized to determine the storage conditions and suggest label instructions. The stability testing of pharmaceutical products ensures the maintenance of product quality, safety, and efficacy throughout the shelf life which are considered a prerequisite for the acceptance and approval of any pharmaceutical products. And these studies are required to follow the guidelines of the world health organizations. According to the World Health Organization, in 2019, the number of registered trials was around 92% in SouthEast Asia and around 66% in the Eastern Mediterranean region. Hence, these factors are expected to drive the segment growth.



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


North America is expected to be a dominant region in the Pharmaceutical Analytical Testing market owing to the increasing number of R&D activities and investments. Around 293,321 studies were registered during the start of 2019, and around 32,523 studies were registered at the end of 2019 in the United States as per clinicaltrials.gov. In 2019, approximately 48 novel drugs were approved as per the data provided by the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). Among the total 53 drugs approved worldwide in 2020, most of them were approved in the United States before any other country in the world as per FDA.

In 2019, the R&D expenditure by biopharmaceutical companies was around USD 79.6 billion in the United States. Most of the pharmaceutical companies spent about one-quarter of their revenues on average on R&D expenses, which is near twice as large a share of revenues as they spent in 2000, according to the Congressional Budget Office report in April 2021.

These increasing number of clinical trials, number of drug approvals, and major companies’ involvement in increased R&D expenditures are expected to boost the demand for pharmaceutical analytical testing market growth in the North American region.



Competitive Landscape


The pharmaceutical analytical testing market is fragmented in nature due to the presence of a number of companies globally. The studied market consists of several international and local companies that hold the majority of the market shares and are well known, including Laboratory Testing Inc., Eurofins Scientific, SGS SA, Toxikon Inc., Pace Analytical Services. Intertek Pharmaceutical Services, Boston Analytical, West Pharmaceutical Services Inc., and Steris.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY3 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 million)
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 & Africa
5.2.4.1 GCC
5.2.4.2 South Africa
5.2.4.3 Rest of Middle East & 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 Phamaceutical Services
6.1.7 Boston Analytical
6.1.8 West Pharmaceutical Services Inc.
6.1.9 Steris
7 MARKET OPPORTUNITIES AND FUTURE TRENDS

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Laboratory Testing Inc.
  • Eurofins Scientific
  • SGS SA
  • Labcorp (Toxikon Inc)
  • Pace Analytical Services
  • Intertek Phamaceutical Services
  • Boston Analytical
  • West Pharmaceutical Services Inc.
  • Steris

Methodology

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