The market for pharmaceutical analytical testing was valued at US$ 7137.91 million in 2021 and is anticipated to grow at a CAGR of 8.2% from 2022 to 2028 to reach US$ 12,352.3 million. Due to the rising demand for analytical testing services or solutions, as well as the increase in drug approvals and clinical trials conducted globally, the market for pharmaceutical analytical testing is expanding rapidly. In addition, the COVID-19 outbreak and government initiatives to improve analytical testing capabilities are anticipated to spur market expansion. The complexity of the regulatory framework and difficulties in developing appropriate analytical methods, however, are anticipated to impede market expansion.
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Over the forecast period, the market for pharmaceutical analytical testing is anticipated to grow as a result of increasing demand for analytical testing services and products around the world. In order to characterise biologics and biosimilars, increase productivity, and provide real-time product quality control, for instance, biopharmaceutical companies conduct analytical testing. LGM Pharma announced the introduction of its Analytical Services offering in July 2021, which offers clients in the pharmaceutical industry services for analytical testing and stability. LGM is currently providing its analytical services knowledge and resources as a stand-alone contract service for clients in the pharmaceutical industry.
During the forecast period, an increase in the number of drug approvals and clinical trials conducted globally is anticipated to fuel the growth of the global pharmaceutical analytical testing market. For instance, there are now significantly more registered clinical trials than there were previously. Despite COVID-19’s ongoing effects, the FDA’s (Food and Drug Administration) approval total for last year was in line with recent trends. 50 novel therapeutics were approved by the FDA’s Center for Drug Evaluation and Research (CDER) in 2021. The average over the past five years is 51 drugs annually. 24 drugs were consumed annually ten years ago. This is then anticipated to fuel market expansion.
Initiatives by the government to improve analytical testing capabilities are anticipated to provide players in the pharmaceutical analytical testing market with lucrative growth opportunities. For instance, the Chinese government issued a notification to upgrade the quality of generic drugs, clear the backlog of drug applications, improve the quality and transparency of the review and approval process, and encourage new drug R&D in line with global development in order to improve the process of drug review and approval. For market participants, this should present lucrative growth opportunities.
The global pharmaceutical analytical testing market is predicted to see significant growth opportunities as a result of the COVID-19 outbreak. The demand for biological medicines has significantly increased as a result of the global pandemic, claims WHO. According to the WHO, 349 vaccines were in development as of April 15, 2022, which is expected to increase the demand for analytical testing services for COVID-19 vaccines that are in clinical trials. For instance, Johnson & Johnson tested Ad26.COV2.S, an investigational COVID-19 vaccine candidate, with the assistance of Eurofins Scientific.
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The need for analytical testing services and products is growing quickly along with the development of new drugs and formulations, as well as the expansion of clinical trials. Analytical testing is carried out by pharmaceutical and biopharmaceutical companies to identify biologics and biosimilars, boost productivity, and provide real-time product quality control. Over the forecast period, this trend is anticipated to persist, fueling market expansion.
Additionally, the market for pharmaceutical analytical testing is anticipated to experience significant growth in the near future due to the rise in demand for such testing and the outsourcing of it, as well as the strategic initiatives taken by market participants. Throughout the forecast period, this trend is anticipated to persist, fueling the expansion of the global market for pharmaceutical analytical testing.
The growth of the market for pharmaceutical analytical testing is anticipated to be hampered by difficulties in the development of appropriate analytical techniques. For instance, analytical services and technologies are essential to the production of biopharmaceuticals. Producing biopharmaceuticals is difficult and expensive processing and purification techniques are needed. As a result, pharmaceutical manufacturers struggle to ensure product quality.
The pharmaceutical analytical testing market is predicted to experience growth challenges due to complex regulatory framework. Every nation has its own laws governing innovation, production, drug testing, marketing, and post-marketing research. Therefore, it is anticipated that strict regulations governing laboratory upkeep, validation, and testing of pharmaceutical drugs will impede the expansion of the market for pharmaceutical analytical testing.
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The Service Type and Geography categories are used to segment the global pharmaceutical analytical testing market report.
The market is divided into Bioanalytical Testing, Method Development and Validation, Stability Testing, Drug Substances Testing, and Other Service Types based on the type of service provided. Due to the rising demand for bioanalytical testing services and/or products, the bioanalytical testing segment is anticipated to dominate the pharmaceutical analytical testing market during the forecast period. The quantitative assessment of analytes/substances in biological matrices like tissue, blood, serum, urine, or other bodily fluids is known as bioanalysis.
Due to the rise in drug use and abuse, the drug substance testing segment is also anticipated to experience rapid growth in the near future. A drug test examines a sample of urine, blood, saliva, or breath for indications of one or more prescription or illicit drugs.
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At the American Association for Cancer Research (AACR) annual meeting in March 2022, Transgene, a biotech company from France, will present a poster with fresh and encouraging preliminary Phase 1 data on TG4050, its individual Neoantigen cancer vaccine.
Health Canada had approved the importation and commercialization of nal von Minden’s NADAL COVID-19 IgG/IgM Test, according to a March 2021 announcement from Teracero Pharma Inc. and its German partner, nal von Minden GmbH.
A provider of safety and quality services to the consumer products sector, Modern Testing Service, was acquired by Eurofins in November 2021. The acquisition will quicken Eurofins Consumer Product Testing’s progress toward its objective of dominating the testing, inspection, and certification (TIC) market for consumers.
Sullivan & Nicolaides Pathology/Sonic Health Care sold the Biotech Laboratories business to Eurofins in October 2021. The acquisition will expand Eurofins’ network of food laboratories, which is already expanding throughout Australia and New Zealand.
Key Companies Insights
The market for pharmaceutical analytical testing is incredibly cutthroat. This is explained by the rise in drug approvals and clinical trials, which has led market players to concentrate on introducing novel products to the marketplace.
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. are a few of the major companies in the global pharmaceutical analytical testing market.
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