Pharmaceutical Quality Control Market Report 2025

The pharmaceutical quality control market size has grown rapidly in recent years. It will grow from $8.23 billion in 2024 to $9.08 billion in 2025 at a compound annual growth rate (CAGR) of 10.4%. The growth during the historic period can be attributed to increasing investments in pharmaceutical research and development, a rise in drug recall incidents, growing awareness of drug safety, expanded compliance-driven testing protocols, and the rising international trade of pharmaceutical products.

The pharmaceutical quality control market size is expected to see rapid growth in the next few years. It will grow to $13.29 billion in 2029 at a compound annual growth rate (CAGR) of 10%. The growth in the forecast period can be attributed to the rising adoption of artificial intelligence in quality control processes, an increasing need for precision medicine testing, growing demand for high-quality pharmaceuticals, expansion of contract manufacturing services, and a heightened focus on real-time quality monitoring systems. Key trends during this period include advancements in AI-powered visual inspection systems, innovative microbial detection technologies using biosensors, development of cloud-based quality control platforms, innovations in real-time environmental monitoring systems, and progress in digital twin technology for process simulation.

The rising demand for biosimilars is expected to drive growth in the pharmaceutical quality control market. Biosimilars are biologic medical products that are highly similar to an approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. The demand for biosimilars is increasing due to patent expirations on original biologics, which allow more affordable alternatives to enter the market. Pharmaceutical quality control plays a critical role in ensuring that biosimilars meet strict safety, purity, and consistency standards by rigorously comparing them against reference biologics, supporting regulatory compliance and market approval. For example, Cardinal Health Inc., a US-based healthcare company, reported that the number of FDA-approved biosimilars in the US rose from 33 in January 2022 (with 21 commercially available) to 40 in 2023, with 25 commercially available. This trend highlights the growing need for quality control solutions in biosimilar production.

Companies in the pharmaceutical quality control market are increasingly adopting technological innovations such as AI-powered software platforms to improve testing accuracy, efficiency, and regulatory compliance. Intelligent software platforms use automation, data analytics, and artificial intelligence to detect anomalies, monitor real-time data, and streamline compliance throughout the pharmaceutical production process. For instance, in June 2025, Dycine Pharmaceuticals Ltd., an India-based company, launched an AI-driven quality control platform that leverages predictive analytics, automated reporting, and seamless integration with existing manufacturing systems to reduce errors, improve efficiency, and ensure consistent product quality across production batches.

In October 2024, the United States Pharmacopeial Convention (USP), a US-based independent scientific organization, acquired Stratix Labs, a provider of advanced microbiological testing solutions. This acquisition enables USP to expand its microbiological testing and contamination control capabilities, reduce microbial contamination risks, and address gaps in pharmaceutical contamination control strategies, thereby ensuring safer, higher-quality products reach patients.

Major players in the pharmaceutical quality control market are Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Merck KGaA, Becton, Dickinson 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.

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 pharmaceutical quality control market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the pharmaceutical quality control market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Pharmaceutical quality control (QC) is a structured process designed to verify the identity, strength, purity, and consistency of pharmaceutical products. It involves thorough testing of raw materials, in-process samples, and finished products to ensure compliance with established standards, thereby guaranteeing the safety and efficacy of medicines before they reach patients.

The primary products in pharmaceutical quality control include consumables, services, and instruments. QC consumables consist of essential materials and supplies such as culture media, reagents, assay kits, filters, and pipette tips used during laboratory testing to maintain the quality, safety, and regulatory compliance of pharmaceutical products. These consumables can be deployed via cloud-based, web-based, or on-premises methods. The analytical processes include sterility testing, membrane filtration, direct inoculation, bioburden testing, aerobic and anaerobic count testing, spore count testing, fungi or mold count testing, endotoxin testing, and more. Pharmaceutical QC products and services are used by pharmaceutical and biotechnology companies, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), and research laboratories.

The pharmaceutical quality control market research report is one of a series of new reports that provides pharmaceutical quality control market statistics, including pharmaceutical quality control industry global market size, regional shares, competitors with a pharmaceutical quality control market share, detailed pharmaceutical quality control market segments, market trends and opportunities, and any further data you may need to thrive in the pharmaceutical quality control industry. This pharmaceutical quality control market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pharmaceutical quality control market consists of revenues earned by entities by providing services such as analytical testing services, microbiological testing services, stability testing services, sterility assurance services, and validation and qualification services. The market value includes the value of related goods sold by the service provider or included within the service offering. The pharmaceutical quality control market also includes sales of reagents and assay kits, filters and membranes, sterility testing systems, and chromatography columns and consumables. Values in this market are ‘factory gate’ values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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