Pharmaceutical Quality Control

Global Pharmaceutical Quality Control Market to Reach US$3.6 Billion by 2030

The global market for Pharmaceutical Quality Control estimated at US$1.8 Billion in the year 2024, is expected to reach US$3.6 Billion by 2030, growing at a CAGR of 13.0% over the analysis period 2024-2030. Consumables, one of the segments analyzed in the report, is expected to record a 12.4% CAGR and reach US$2.3 Billion by the end of the analysis period. Growth in the Instruments segment is estimated at 14.7% CAGR over the analysis period.

The U.S. Market is Estimated at US$477.3 Million While China is Forecast to Grow at 17.3% CAGR

The Pharmaceutical Quality Control market in the U.S. is estimated at US$477.3 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$764.9 Million by the year 2030 trailing a CAGR of 17.3% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 9.5% and 11.5% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 10.3% CAGR.

Global Pharmaceutical Quality Control Market – Key Trends & Drivers Summarized

Why Is Quality Control Emerging as the Cornerstone of Pharmaceutical Manufacturing Success?

In the highly regulated pharmaceutical sector, quality control (QC) is fundamental to safeguarding product efficacy, safety, and regulatory compliance. It encompasses a range of activities including raw material testing, in-process sampling, finished product analysis, and environmental monitoring—ensuring that each batch meets rigorous pharmacopoeial standards and predefined specifications. As regulatory agencies tighten oversight on manufacturing practices and product quality, QC processes are being strengthened through analytical technology, risk-based protocols, and digital integration.

The complexity of modern drug products—particularly biologics, vaccines, and cell and gene therapies—demands highly sensitive and specialized QC methods to monitor critical quality attributes (CQAs). This is prompting the widespread adoption of high-performance liquid chromatography (HPLC), spectroscopy, mass spectrometry, and rapid microbiological methods in QC laboratories. Moreover, the emphasis on real-time release testing (RTRT) and continuous process verification is pushing quality control from a final checkpoint to an integrated, proactive quality assurance function across the entire production cycle.

How Are Advanced Analytical Technologies and Automation Enhancing QC Efficiency and Accuracy?

The integration of advanced analytical instruments and automated workflows is transforming pharmaceutical quality control from a labor-intensive, batch-driven model into a streamlined, high-throughput operation. Automation of sample preparation, data acquisition, and result reporting is reducing turnaround times, minimizing human error, and enhancing traceability. Robotic sampling systems, intelligent data analysis platforms, and LIMS integration are allowing laboratories to process larger volumes with greater accuracy and regulatory compliance.

Technologies such as near-infrared (NIR) spectroscopy, Raman spectroscopy, and chemometric modeling are enabling real-time, non-destructive analysis for solid dosage forms and biopharmaceuticals. Process analytical technology (PAT) tools embedded in manufacturing lines are now being used to monitor and control CQAs in real time, reducing reliance on end-point testing. These innovations are particularly crucial in continuous manufacturing and personalized medicine, where batch sizes are small, timelines are compressed, and product consistency is critical.

Why Are Global Regulations, Cost Pressures, and Digitalization Trends Reshaping QC Strategies?

Regulatory requirements from the FDA, EMA, and WHO are evolving toward quality-by-design (QbD) and lifecycle-based approaches, encouraging companies to integrate QC data with upstream and downstream process control. Authorities now expect robust documentation of testing methodologies, data traceability, and evidence of control strategies in real time. These shifts are prompting pharmaceutical firms to embed QC systems within digital quality management platforms that centralize compliance tracking and support remote audits.

Cost pressures in pharmaceutical production are also influencing QC strategy, particularly for generics and contract manufacturing operations. Companies are investing in multi-analyte platforms, centralized testing facilities, and remote data review systems to optimize resource utilization without compromising quality. Digital transformation is enabling predictive analytics, trend detection, and deviation management through AI and machine learning tools—creating a proactive and adaptive QC function that goes beyond traditional quality assurance paradigms.

What’s Driving the Global Growth of the Pharmaceutical Quality Control Market?

The growth in the pharmaceutical quality control market is driven by several factors including rising drug complexity, evolving regulatory frameworks, and the shift toward continuous and precision manufacturing. A major growth driver is the need to ensure product integrity, patient safety, and compliance in the face of global supply chain diversification and fast-paced innovation cycles.

As the industry scales up biologics, biosimilars, and advanced therapies, the demand for accurate, sensitive, and standardized QC technologies is escalating. At the same time, globalization of drug production and outsourcing trends are creating a need for harmonized, validated quality control systems across geographies. The expansion of digital quality ecosystems, automation technologies, and rapid analytical methods will continue to support the evolution of QC into a strategic function—central to risk mitigation, regulatory success, and operational excellence in pharmaceutical manufacturing worldwide.

SCOPE OF STUDY:

The report analyzes the Pharmaceutical Quality Control market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product (Consumables, Instruments, Services); Analysis Type (Sterility Testing, Bioburden Testing, Endotoxin Testing, Stability Testing, Extractable & Leachable Testing, Raw Material Testing, Other Analysis Types)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 33 Featured) -

• bioMérieux SA
• BRAM-COR SPA
• Charles River Laboratories International Inc.
• Danaher Corporation
• Esco Micro Pte. Ltd.
• Eurofins Scientific
• Lucideon Limited
• Merck KGaA
• Mettler Toledo
• Panomex Inc.
• PerkinElmer Inc.
• REMI Group
• Sartorius AG
• SGS S.A.
• Shimadzu Scientific Instruments
• Solvias AG
• Thermo Fisher Scientific Inc.
• Toxikon Corporation
• Waters Corporation
• WuXi AppTec

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks. The Publisher uses digital controls protecting against copying and printing is restricted to one full copy to be used at the same location.

The latest version of Adobe Acrobat Reader is required to view the report. Upon ordering an electronic version, the Publisher will provide a link to download the purchased report.

Prior to fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.