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Global Pharmaceutical Quality Control Market was Valued at US $ 3481.94 Mn in 2020 Owing to Increasing Investments and Product Development in the Pharmaceutical Sector

Published On 27 Aug 2021 07:26 AM


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Absolute Markets Insights (AMI) reports a robust forecast for the pharmaceutical quality control market during the 2021-2029 period. In its newly released report, AMI anticipates the market will grow at 13.85% as minimized disruption, transit time and costs are rapidly leading the market towards growth. AMI reports that the market stood at a valuation of US $ 3481.94 Mn in 2020.

Quality control and compliance in pharma is necessary so that safe therapies are carried out for patients. During the drug development procedure, the main purpose of pharmaceutical quality control is accuracy, authenticity and compliance. In 2020, the U.S. Food and Drug Administration (FDA) received over 230 applications from cell therapy developers and gene therapy developers to begin clinical trials. Although COVID-19 pandemic disrupted the world in the context of operations and procedures, the advanced therapy medicinal product (ATMP) was an industry that did not lose its pace with regards to its 2019 output.

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Along with the traditional ways of providing quality control, today ways of distributed quality control are possible where almost all routine product testing take place on the production line. This enables real-time release testing (RTRT). Equipment and robots at distributed quality check (QC) facilities have artificial-intelligence (AI)-powered capabilities. Labs continue to perform testing to determine specialty and stability. Not just in some local unity, this testing can also take place off-site in a centralized location. For a smooth shift to online testing in the future, pharmaceutical companies are considering to start collaborating with research & development (R&D) for the operations-related purposes to develop an optimal quality-control and filing strategy. For new products and manufacturing sites, this can be useful and helpful.

In addition to the growth of pharmaceutical industry, the demand in the global pharmaceutical quality control market is increasing due to the global outbreak of China-originated COVID-19. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), American firms conduct over half the world’s R&D in pharmaceuticals. The members of this association had invested US $ 79.6 billion in R&D in 2018 for establishing the biopharmaceutical sector. This increasing investments and product development are pushing the growth of the pharmaceutical industry, along with simultaneously creating the need for pharmaceutical quality control. Other factors contributing towards the market growth include better means of data integrity and contamination control. With increasing automation and instrument-based analysis, the processes for analysis with minimum human role and thus, lesser chances of human error, the data integrity can be ensured. In 2019, 23.9% of all Food and Drug Administration (FDA) 483 warning letters were related to records and reports (FDA). FDA considered data integrity violations a serious offense. According to the U.S. Centers for Disease Control and Prevention (CDC), at least 3.2% of patients fall victim to one hospital acquired infection (HAI) per day due to which demand for sterility testing as well as efforts to sterilize the hospital equipment has increased.

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Allergens, antigens, vaccines and hormones were the most applied applications in 2020

According to Absolute Market Insights report, although plasma derivative is the fastest growing category in the application segment during 2021-2029 period in the global pharmaceutical quality control market, the largest market share in this market is held by allergens, antigens, vaccines and hormones. High incidence and large economic burden caused to patients by allergic diseases is leading to the increase in the production, quality check, and supply of pharmaceutical solutions to cure allergies caused by allergens. In February 2020, Aimmune Therapeutics spent USD 10 million to in-license an experimental anti-allergenic biological drug from Xencor. 

The increasing need to produce antibodies that can fight against an infection is also accelerating the market growth. Reports from July 2021 highlight that the Pasteur Institute in Senegal would produce rapid antigen tests for diagnosing the coronavirus disease from early 2022, with the help of a new tech transfer agreement.  In another instance, Vietnam produced first batch of Russian COVID-19 vaccine which is known as Sputnik V. As vaccines are the most powerful and cost-effective way to induce immunity required to fight a particular infection, pharmaceutical companies are producing vaccines and supplying them after quality check.

Due to increasing demand for cost-effective hormone therapies, especially growth hormone therapies, there is an increase in the production, quality check, and supply of pharmaceutical solutions offering hormone-based therapies. In January 2021, using Ribosomal DNA (rDNA) technology to synthesize production of proteins and peptide hormones, a US-based early-stage biotech startup, rBIO achieved synthetic production of insulin. This breakthrough in medical research is likely to lower the cost of insulin by 30%.

GC–MS held was the most popular technique for pharmaceutical quality control in 2020

The gas chromatography mass spectrometry (GC–MS) segment held the largest market share in 2020. Rising adoption of Gas Chromatography (GC) coupled with advancements in the technology is the key factor expected to drive the growth of global pharmaceutical quality control market over the forecast period. The desire for flexibility, miniaturization, and faster results among manufacturers of pharmaceutical medicines and biopharmaceutical medicines is also driving the market growth. For example, full automatization of sample preparation and multiple detection channels due to technological advancement are helping pharmaceutical manufacturers to address the need for more specific and confident results that can be attained with shorter turnaround times. Along with the need for faster analysis, miniaturization is creating opportunities for chips technology or low thermal mass systems together with the development of new micro-detectors and mass spectrometers. Furthermore, many pharmaceutical companies have invested in production plants, especially in China, India, and Israel to lower production costs, and require routine QA/QC systems under good manufacturing practice (GMP)-regulated environments. This shows the growth of GC–MS segment in the growing global pharmaceutical quality control market.

Pharmaceutical Microbiology is expected to be a preferred method of Analysis during the Forecast Period (2021-2029)

The pharmaceutical microbiology type was the largest category in the analysis type segment of global pharmaceutical quality control market in 2020 and during the forecast period, this type is estimated to witness highest growth rate. Among the categories of pharmaceutical microbiology, sterility testing was most preferred way of testing in pharmaceutical microbiology in 2020. Sterility testing is useful for determining if the article to be tested for sterility contains elements that may interfere with the growth of microorganisms within the growth media used for the assay. This test confirms that the test material does not interfere with the organism’s growth when low numbers of microorganisms are added to the media volume containing the test material. Sterility testing includes bacteriostatic contamination and fungistatic contamination. This testing is also referred to as sterility validation, sterility verification, and sterility qualification.

In March 2021, the Oyo State government in Nigeria started to conduct sterility tests on the 127,740 doses of coronavirus vaccines developed by AstraZeneca that it received from the National Primary Healthcare Development Agency (NPHDA). In the era of pandemic, the demand and use of sterility testing can rise with growth of the global pharmaceutical quality control market during 2021-2029 period.

Advanced Medical Infrastructure have kept the market strong in the North America Region

The growing demand for patient safety was a leading cause of for the necessity of quality control in 2020. AMI reports that the global pharmaceutical quality control market in North America region was the largest regional market in 2020 due to presence of key market players, strong economy, availability of advanced medical sector infrastructure, increasing investment in R&D in pharmaceuticals industry, patient safety, and strict regulations regarding quality check. Increasing number of new ways of quality check are also boosting the market in this region.

In 2017, the FDA introduced a Drug Competition Action Plan to bring generic drugs to market. Thus, quality control for such drugs which are new is required for therapeutically active formulations. Only then, the performance of new drugs can be expected to be consistent and predictable. Hence, an increase in demand for pharmaceutical quality control is expected during the forecast period in the global pharmaceutical quality control market.

Some key players in the global pharmaceutical quality control market are Lucideon Limited, ThermoFisher Scientific, Merck KGaA, Charles River Laboratories, Eurofins Scientific, SGS Group Management SA, Toxikon Corporation, and Sartorius AG, amongst others.  

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Global Pharmaceutical Quality Control Market:

  • By Application
    • Allergens, antigens, vaccines and hormones
    • Cytokines, enzymes and human whole-blood
    • Plasma derivative
    • Immune sera, immunoglobulins and products of fermentation
    • Others (diagnostic agents for in vitro use, etc.)
  • By Offering
    • Consumables and Instruments
    • Solutions
    • Services
  • By Techniques
    • GC/MS 
    • LC/MS/ High Performance Liquid (HPLC)
    • Ultra High Performance Liquid (UHPLC)
    • Supercritical Fluid (SFC) chromatography
    •  Elemental analysis techniques
    • Others
  • By Testing Categories
    • Elemental Impurities
    • Volatile Organic Impurities
    • Extractables and Leachables
    • Semi-Volatile Organic Impurites
    • Non-Volatile Organic Impurites
    • Counterion Analysis
    • Others
  • By Analysis Type
    • Pharmaceutical Microbiology
      • Sterility Testing
      • Antimicrobial Efficacy Testing (AET)
      • Microbial Limits Testing
      • Bioburden Determination
      • Endotoxin Testing
      • Environmental Monitoring and Identification
      • Packaging Testing
      • Pharmaceutical and Biopharmaceutical  Release Testing
      • Pharmaceutical Gas Testing
      • Viral Safety Testing and Lot Release Testing
      • Others (Water Analysis and etc.)
    • Pharmaceutical Chemistry
      • Elemental Impurities
      • Volatile Organic Impurities
      • Extractables and Leachables
      • Semi-Volatile Organic Impurites
      • Non-Volatile Organic Impurites
      • Counterion Analysis
      • Others
  • By Region
    • North America
      • U.S.
      • Canada
      • Mexico
      • Rest of North America
    • Europe
      • France
      • The UK
      • Spain
      • Germany
      • Italy
      • Nordic Countries
        • Denmark
        • Finland
        • Iceland
        • Sweden
        • Norway
      • Benelux Union
        • Belgium
        • The Netherlands
        • Luxembourg
      • Rest of Europe
    • Asia Pacific
      • China
      • Japan
      • India
      • New Zealand
      • Australia
      • South Korea
      • Southeast Asia
        • Indonesia
        • Thailand
        • Malaysia
        • Singapore
        • Rest of Southeast Asia
      • Rest of Asia Pacific
    • Middle East & Africa
      • Saudi Arabia
      • UAE
      • Egypt
      • Kuwait
      • South Africa
      • Rest of Middle East & Africa
    • Latin America
      • Brazil
      • Argentina
      • Rest of Latin America

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Press Release Provided By: Absolute Markets Insights