Pharmaceutical analytical testing market

The global pharmaceutical analytical testing market was valued at US$ 7137.91 Mn in 2021 and is forecast to reach a value of US$ 12,352.3 Mn by 2028 at a CAGR of 8.2% between 2022 and 2028. The global pharmaceutical analytical testing market is experiencing strong growth owing to the rising demand for analytical testing services or solutions and rise in number of drug approvals and clinical trials across the world. Moreover, outbreak of COVID-19 and government initiatives to strengthen analytical testing capabilities expected to boost the growth of the market. However, challenges in the development of proper analytical techniques and complex regulatory framework are expected to hamper the growth of the market.

Global Pharmaceutical Analytical Testing Market: Regional Insights

Based on geography, the global pharmaceutical analytical testing market is segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market during the forecast period owing to the increasing number of clinical trials, increasing focus on regulation, safety, and quality, and outbreak of COVID-19 in the region. For instance, the number of registered clinical trials has increased significantly in recent years. According to the United States National Library of Medicine, ClinicalTrials.gov listed over 433,444 studies with locations in all 50 States and in 221 countries. Moreover, according to the World Health Organization (WHO), the United States of America had the highest total number of trials registered during 1999-2021 (157,618), followed by China (80,333) and Japan (57,754).

Asia Pacific is also expected to witness significant growth in the global pharmaceutical analytical testing market owing to the increasing demand for efficient healthcare and the rapid growth of the pharmaceutical industry in the region. For instance, according to India Brand Equity Foundation (IBEF), India’s domestic pharmaceutical market stood at US$ 42 billion in 2021 and is expected to reach US$ 65 billion by 2024 and to reach US$ 120-130 billion by 2030. Moreover, Indian drug & pharmaceutical exports stood at US$ 2,119.08 million in June 2022. This in turn is expected to aid in the growth of the global pharmaceutical analytical testing market.

Figure 1. Global Pharmaceutical Analytical Testing Market Share (%), by Region, 2022

Global Pharmaceutical Analytical Testing Market Drivers:

Growing demand for analytical testing services/solutions across the globe is expected to boost the growth of the pharmaceutical analytical testing market over the forecast period. For instance, bio-pharmaceutical companies do analytical testing to characterize biologics and biosimilars, improve productivity, and provide real-time product quality control. In July 2021, LGM Pharma announced the launch of Analytical Services offering that provides analytical testing and stability services to pharmaceutical industry clients. LGM is now offering its analytical services expertise and facilities as a standalone contract service for pharmaceutical industry clients.

Increase in number of drug approvals and clinical trials around the world is expected to augment the growth of the global pharmaceutical analytical testing market during the forecast period. For instance, the number of registered clinical trials has increased significantly in the recent years. The FDA's (Food and Drug Administration’s) approval count last year was in line with recent trends, despite the continued impact of COVID-19. The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel therapeutics in 2021. The five-year average sits at 51 drugs per year. A decade ago, it was 24 drugs per year. This in turn is expected to drive market growth.

Global Pharmaceutical Analytical Testing Market Opportunities:

Government initiatives to strengthen analytical testing capabilities are expected to offer lucrative growth opportunities for players in the pharmaceutical analytical testing market. For instance, to improve the process of drug review and approval, the government of China issued a notification to upgrade the quality of generic drugs, remove backlog of drug applications, improve the quality and transparency of the review and approval process, and encourage new drug R&D (research and development) in line with global development. This in turn is expected to offer lucrative growth opportunities for players in the market.

The outbreak of COVID-19 is expected to provide significant growth opportunities for players in the global pharmaceutical analytical testing market. According to WHO, the global pandemic has significantly increased the demand for biological medicines such as vaccines. As per to WHO, as of April 15, 2022, around 349 vaccines were being developed, which is expected to increase the demand for analytical testing services for COVID-19 vaccines under clinical trials. For instance, Eurofins Scientific supported the testing of Ad26.COV2.S, an investigational COVID-19 vaccine candidate by Johnson & Johnson.

Global Pharmaceutical Analytical Testing Market Trends:

With the increase in development of new drugs and formulations, as well as increase in number of clinical trials, the demand for analytical testing services and solutions is also increasing with the rapid pace. Pharmaceutical and biopharmaceutical companies do analytical testing to characterize biologics & biosimilars, improve productivity, and provide real-time product quality control. This trend is expected to continue over the forecast period, driving the market growth.

Moreover, owing to the rise in demand for pharmaceutical analytical testing and its outsourcing of the same along with the strategic initiatives taken by the players of the market, the pharmaceutical analytical testing market is expected to witness significant growth in the coming future. This trend is expected to continue during the forecast period, driving the growth of the global pharmaceutical analytical testing market.

Global Pharmaceutical Analytical Testing Market Restraints:

Challenges in the development of proper analytical techniques are expected to hamper the growth of the pharmaceutical analytical testing market. For instance, analytical services and technologies play a vital role in the biopharmaceutical manufacturing. Biopharmaceuticals are challenging to manufacture and require specialized & expensive processing and purification methods. Therefore, pharma manufacturers face challenges while ensuring product quality and patient safety.

Complex regulatory framework is expected to hamper the growth of the pharmaceutical analytical testing market. Every country has its own regulations which apply to innovation, manufacturing, drug testing, marketing, and post marketing studies. Thus, stringent regulations associated with the laboratory maintenance and validation, and testing of pharmaceutical drugs are anticipated to hinder growth of the pharmaceutical analytical testing market.

Figure 2. Global Pharmaceutical Analytical Testing Market Share (%), by Service Type, 2022

Global Pharmaceutical Analytical Testing Market Segmentation:

The global pharmaceutical analytical testing market report is segmented into Service Type and Geography.

Based on Service Type, the market is segmented into Bioanalytical Testing, Method Development and Validation, Stability Testing, Drug Substances Testing, and Other Service Types. Of which, Bioanalytical Testing Segment is expected to dominate the pharmaceutical analytical testing market during the forecast period and this is attributed to the increase in demand for bioanalytical testing services and/or solutions. Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids.

Drug Substances Testing Segment is also expected to witness robust growth in the near future and this is owing to the increase in drug use and misuse. A drug test looks for signs of one or more illegal or prescription drugs in a sample of urine, blood, saliva, hair, or sweat.

Global Pharmaceutical Analytical Testing Market: Key Developments

In March 2022, Transgene, a biotech company from France will be presenting a poster with new and promising preliminary Phase 1 data on TG4050, its individual Neoantigen cancer vaccine, at the American Association for Cancer Research (AACR) annual meeting 2022.

In March 2021, Teracero Pharma Inc. and its German partner, nal von Minden GmbH announced that Health Canada had issued an authorization for importation and commercialization of nal von Minden’s NADAL COVID-19 IgG/IgM Test.

In November 2021, Eurofins announced the acquisition of Modern Testing Service), a safety and quality services provider for the consumer product industry. The acquisition will accelerate the pursuit of the Eurofins Consumer Product Testing goal of becoming a top leader in the testing, inspection and certification (TIC) industry for the consumer products industry.

In October 2021, Eurofins acquired Biotech Laboratories business from Sullivan & Nicolaides Pathology/Sonic Health Care. The acquisition will add to Eurofins' growing network of Food Laboratories across Australia and New Zealand.

Global Pharmaceutical Analytical Testing Market: Key Companies Insights

The global pharmaceutical analytical testing market is highly competitive. This is attributed to the increase in number of drug approvals and clinical trials, as a result, market players are focusing on launching novel products in the market.

Some of the key players in the global pharmaceutical analytical testing market are Steris PLC, West Pharmaceutical Services Inc., Boston Analytical, Intertek Pharmaceutical Services, Pace Analytical Services, Labcorp (Toxikon Inc.), SGS SA, Eurofins Scientific, and Laboratory Testing Inc., among others.

*Definition: biopharmaceutical manufacturing industry uses analytical testing services/solutions to improve productivity, characterize biologics and biosimilars, optimize and monitor processes, and provide real-time product quality control.

Detailed Segmentation:

• Global Pharmaceutical Analytical Testing Market, By Service Type:
  • Bioanalytical Testing
  • Method Development and Validation
  • Stability Testing
  • Drug Substances Testing
  • Other Service Types
• Global Pharmaceutical Analytical Testing Market, By Geography:
  • North America
  • Europe
  • Asia-Pacific
  • Middle East and Africa
  • South America