Absolute Markets Insights (AMI) reports a robust forecast for the pharmaceutical quality control market during the 2021-2030 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.
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.
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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