Pharmaceutical Quality Control Market Size, Share, and Industry Analysis, By Product Type (Reagents & Consumables, Instruments, and Services), By Analysis Type (Physical Testing, Chemical Testing, and Microbial Testing), By End-user (Pharmaceutical Companies, Contract Research Organizations, and Others), and Regional Forecast, 2025-2032

Pharmaceutical quality control (QC) is a crucial process in the pharmaceutical industry that ensures the quality of drugs by testing and inspecting them at the various stages of production. The primary objective of quality control (QC) is to verify that the drugs meet the predetermined specifications and regulatory standards.

It involves several steps, such as raw materials testing, in-process testing, and final product testing. Quality control is essential in the pharmaceutical industry to ensure patient safety, compliance with regulations, and protection of the company's reputation. It involves detailed documentation of the inspection results for record-keeping and serves as a feedback loop for future process enhancements.

The growth of the pharmaceutical quality control market is attributed to the rise in complications and diseases across the globe. This increasing prevalence of several diseases and complications drives the demand for pharmaceutical quality control to ensure the efficacy and safety of drugs. This is expected to boost the market growth during the forecast period.

• For instance, in February 2024, the Centers for Disease Control and Prevention reported that an estimated 129 million individuals in the U.S. are currently suffering from at least one major chronic disease.

Moreover, the constant innovations and advancements in technologies by the market players are improving the quality of healthcare and contributing to the demand for pharmaceutical quality control products. This is anticipated to surge the market growth in the forthcoming years.

The COVID-19 pandemic significantly increased the demand for robust pharmaceutical quality control systems to ensure the safety and efficacy of essential medical products, vaccines, and therapies in response to supply chain disruptions and the urgent need to develop and manufacture treatments rapidly. Furthermore, several governments and pharmaceutical industries adopted quality control products during the pandemic. This propelled the market growth in 2020.

Segmentation

Key Insights

The report covers the following key insights:

• Technological Advancements in the Pharmaceutical Quality Control Market
• Key Industry Developments By Key Players
• Guidelines for Pharmaceutical Quality Control Laboratories
• Impact of COVID-19 on the Market

Analysis by Product Type

Based on product type, the market is segmented into reagents & consumables, instruments, and services. The instruments segment is expected to account for a significant market share during the forecast period. This growth is attributed to the rising demand for advanced and specialized equipment, which ensures high-quality testing and analysis for pharmaceutical products. To fulfill this rising demand, prominent players are launching various instruments, such as HPLC and particle size analyzers, increasing global availability and accessibility. This is expected to fuel the segment's growth in the coming years.

• For instance, in April 2024, Waters Corporation launched a New Alliance iS Bio high-performance liquid chromatography (HPLC) system to help biopharmaceutical quality control laboratories improve efficiency and eradicate up to 40.0% of common errors.

On the other hand, the services segment is expected to expand at a significant CAGR in the forthcoming years. Several pharmaceutical companies lack the in-house expertise and resources to perform complex quality control tests, leading them to outsource these services. This trend of outsourcing quality control activities to specialized service providers is contributing to the growth of the services segment.

Regional Analysis

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The global market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to hold a significant share of the pharmaceutical quality control market during the forecast period. The region’s pharmaceutical industry is subject to strict regulations and quality standards imposed by regulatory bodies, such as the U.S. FDA. Compliance with these regulations drives the demand for robust quality control measures. Furthermore, the increasing demand for biologics and biosimilars, which require rigorous quality control measures, is also expected to propel the growth of pharmaceutical quality control products in the region.

Asia Pacific is projected to grow at a significant CAGR during the forecast timeframe. The key countries in the region, such as India, have introduced good manufacturing practices (GMP) standards for all manufacturers and bioequivalence data for generics to improve quality regulatory standards and increase international competitiveness. Furthermore, the Indian government provides various tax benefits, funds, and grants to entitled companies to stimulate drug innovation. This is significantly driving the demand for pharmaceutical quality control products in the region. Furthermore, the growing reputation of countries such as India due to its export of pharmaceutical products is also contributing to the increasing demand for quality control in the region. This is anticipated to boost the market growth during the projection period.

• For instance, according to the Economic Times, India’s pharmaceutical products exports surged by 9.67% in 2023-24.

Key Players Covered

The market consists of significant players, such as WuXi AppTec, BIOMÉRIEUX, Thermo Fisher Scientific Inc., Merck KGaA, SGS Société Générale de Surveillance SA., Eurofins Scientific, Lucideon Limited, and Sartorius AG.

Key Industry Developments

• In March 2024, Element Materials Technology launched a rapid-response pharmaceutical testing service from its Manchester Life Sciences laboratory to support pharmaceutical companies by delivering advanced and complete testing solutions.
• In October 2023, Ennov partnered with ION Pharma B.V. to enhance quality management in the life sciences sector.
• In July 2023, Coriolis Pharma entered into a collaboration with RHEAVITA to extend its service portfolio by integrating RheaVita’s single vial unit (SVU) technology. This integration was done for continuous and controlled freeze-drying to stabilize new modalities as part of biologics drug product development for its customers.