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Major Growth Driver Identified in 2025 Pharmaceutical Quality Control Market: The Rising Demand For Biosimilars Drives The Growth Of The Market Due To Patent Expirations And The Need For Rigorous Quality Control
Pharmaceutical Quality Control Market
Pharmaceutical Quality Control Market Size Valuation Forecast: What Will the Market Be Worth by 2025?
The market size for quality control in the pharmaceutical industry has been expanding swiftly over the past few years. There will be growth from $8.23 billion in 2024 to $9.08 billion in 2025, with the compound annual growth rate (CAGR) set at 10.4%. The considerable growth in the historic period can be credited to growing investments in pharmaceutical R&D, a rise in the occurrences of drug recalls, enhanced awareness around drug safety, an increase in compliance-motivated testing procedures, and a surge in global pharmaceutical trade.
Pharmaceutical Quality Control Market Size Forecast: What's the Projected Valuation by 2029?
In the coming years, the pharmaceutical quality control market is anticipated to experience robust growth, expanding to a market size of $13.29 billion in 2029 with a CAGR of 10.0%. Factors contributing to this growth in the projected period are an increased application of artificial intelligence in quality control systems, a heightened demand for precision medication testing, an increased need for quality medication, a rise in the demand for contract manufacturing services and an increased call for real-time quality monitoring systems. Key trends in this forecast period comprise the progression in AI-powered visual inspection systems, use of biosensors in advanced microbial detection technologies, creation of cloud-based quality control platforms, innovations in real-time environmental monitoring systems, and advances in digital twin technology for process simulation.
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What Are the Drivers Transforming the Pharmaceutical Quality Control Market?
The growth of the pharmaceutical quality control market is anticipated to be spurred by the increasing demand for biosimilars. Biosimilars, which are biological medicinal products highly analogous to an existing approved reference biological product with no significant variations concerning safety, purity, and potency, are in demand due to the expiry of patents on original biological drugs. This facilitates the entry of more economical alternatives in the market. Pharmaceutical quality control is instrumental in ensuring patents' safety, purity, and consistency by stringently testing them against reference biologicals, supporting regulatory compliance and market approval. As an illustration, in January 2023, Cardinal Health Inc., a healthcare firm based in the United States, indicated that as of January 2022, 33 FDA-approved biosimilar products were in the US, with 21 being marketable. By 2023, the total count of FDA-approved biosimilars increased to 40, with 25 being commercially available. Thus, the escalating demand for biosimilars underscores the growth of the pharmaceutical quality control market.
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What Long-Term Trends Will Define the Future of the Pharmaceutical Quality Control Market?
Major firms in the pharmaceutical quality control market are concentrating on technological innovation, such as cutting-edge software platforms, to increase testing precision and regulatory conformity. These software platforms utilize automation, data analysis, and artificial intelligence (AI) to augment the efficacy, precision, and regulatory compliance of the quality control processes in the pharmaceutical industry. For example, in June 2025, Dycine Pharmaceuticals Ltd., a pharmaceutical company based in India, introduced an AI-powered quality control platform aimed at elevating the standards of manufacturing and ensuring the integrity of their products. This platform employs sophisticated AI algorithms to identify discrepancies, supervise incoming real-time data, and simplify compliance processes across the pharmaceutical production sequence. This system offers critical components such as predictive analytics, automated report generation, and effortless integration with prevailing manufacturing systems, thereby reducing mistakes, boosting efficiency and ensuring uniform quality across all production lots.
Which Segments in the Pharmaceutical Quality Control Market Offer the Most Profit Potential?
The pharmaceutical quality control market covered in this report is segmented
1) By Product: Consumables, Services, Instruments
2) By Deployment Type: Cloud-Based And Web-Based, On-Premises
3) By Analysis Type: Sterility Testing, Membrane Filtration, Direct Inoculation, Bio Burden Testing, Aerobic Count Testing, Anaerobic Count Testing, Spore Count Testing, Fungi or Mold Count Testing, Endotoxin Testing, Other Analysis Types
4) By End-user: Pharmaceutical And Biotechnology Companies, Contract Development and Manufacturing Organization Or Contract Research Organization, Research Laboratories
Subsegments:
1) By Consumables: Culture Media, Reagents, Assay Kits, Filters And Membranes, Pipette Tips
2) By Services: Microbiological Testing Services, Analytical Testing Services, Stability Testing Services, Sterility Assurance Services, Validation And Qualification Services
3) By Instruments: Chromatography Systems, Spectroscopy Instruments, Particle Size Analyzers, Potential Of Hydrogen Meters And Electrical Conductivity Meters, Autoclaves And Incubators
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Which Firms Dominate the Pharmaceutical Quality Control Market by Market Share and Revenue in 2025?
Major companies operating in the pharmaceutical quality control market are Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Merck KGaA, Becton, dic*kinson and Company, McKinsey And Company Inc., SGS S.A., Eurofins Scientific SE, WuXi AppTec Co. Ltd., Charles River Laboratories International Inc., PerkinElmer Inc., Mettler-Toledo International Inc., bioMérieux SA, Shimadzu Scientific Instruments Inc., Waters Corporation, Randox Laboratories Ltd., SOLVIAS AG, Esco Micro Pte. Ltd, REMI Elektrotechnik Limited, Lucideon Limited, and BRAM-COR S.p.A.
Which Regions Offer the Highest Growth Potential in the Pharmaceutical Quality Control Market?
North America was the largest region in the pharmaceutical quality control market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the pharmaceutical quality control market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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