Analytical Standards Market

Market Definition

The market involves the production and supply of high-purity compounds used to verify the accuracy of analytical measurements. These standards are essential in calibrating instruments, validating methods, and ensuring quality control across industries.

The formulation process requires strict purity control and adherence to international standards, ensuring the reliability and consistency of analytical measurements across various industries. Applications span pharmaceuticals, food safety, environmental testing, petrochemicals, and forensics.

Analytical standards are used in chromatography, spectroscopy, and titration, enabling precise identification and quantification of substances in complex chemical or biological samples. The report highlights key market drivers, major trends, regulatory frameworks, and the competitive landscape shaping the industry’s growth.

Analytical Standards Market Overview

The global analytical standards market size was valued at USD 1301.5 million in 2023 and is projected to grow from USD 1390.1 million in 2024 to USD 2315.1 million by 2031, exhibiting a CAGR of 7.56% during the forecast period.

The market is driven by the increasing adoption of chromatography and spectroscopy across pharmaceutical, food, and environmental testing sectors. Technological advancements in analytical techniques have improved detection accuracy and efficiency. This has increased the demand for reliable reference materials to maintain consistency and meet regulatory compliance in testing processes.

Major companies operating in the analytical standards industry are Merck KGaA, Agilent Technologies, Inc., Waters Corporation, LGC Limited, PerkinElmer Inc., Thermo Fisher Scientific Inc., Restek Corporation, AccuStandard Inc., GFS Chemicals Inc., RICCA Chemical Company, Alfa Chemistry, NSI Lab Solutions, Mallinckrodt Pharmaceuticals, United States Pharmacopeial Convention, and CD Bioparticles.

The  market is expanding due to increasingly rigorous global regulations governing pharmaceutical manufacturing and drug safety. Regulatory agencies require validated analytical methods to ensure product quality, batch consistency, impurity profiling, and accurate dosing.

To meet these compliance standards, pharmaceutical manufacturers are adopting certified reference materials. The growing demand for reliable drug testing across globally is reinforcing the critical role of analytical standards in pharmaceutical workflows.

• In January 2025, the U.S. Food and Drug Administration (FDA) issued draft guidance titled "Considerations for Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products." This outlines a risk-based credibility assessment framework for AI models used in regulatory processes, emphasizing the need for reliable and transparent AI applications in drug development and evaluation.

Key Highlights

1. The analytical standards industry size was valued at USD 1301.5 million in 2023.
2. The market is projected to grow at a CAGR of 7.56% from 2024 to 2031.
3. North America held a market share of 43.10% in 2023, with a valuation of USD 560.9 million.
4. The organic analytical standards segment garnered USD 748.0 million in revenue in 2023.
5. The spectroscopy segment is expected to reach USD 851.5 million by 2031.
6. The pharmaceutical and life science analysis segment secured the largest revenue share of 35.55% in 2023.
7. The bioanalytical testing is poised for a robust CAGR of 8.09% through the forecast period.
8. Asia Pacific is anticipated to grow at a CAGR of 8.83% during the forecast period.

Market Driver

"Increasing Adoption of Chromatography and Spectroscopy"

The analytical standards market is driven by the rising use of chromatography and spectroscopy techniques in laboratories. These methods require precise calibration materials to maintain data reliability.

As laboratories seek to improve reproducibility in both qualitative and quantitative analysis, demand for certified reference substances grows. This factor is reinforced by advancements in analytical instruments and growing complexity in sample testing across industries including healthcare, chemicals, and environmental monitoring.

• ​In January 2025, the U.S. Environmental Protection Agency (EPA) approved alternative testing methods for analyzing contaminants under the Safe Drinking Water Act. This approval allows laboratories to implement new analytical procedures, enhancing the accuracy and efficiency of water quality assessments. The newly approved methods include advanced techniques such as Liquid Chromatography-Tandem Mass Spectrometry (LC/MS/MS), enhancing the precision and sensitivity of contaminant detection.

Market Challenge

"Lack of Standardization Across Global Regulations"

A key challenge impacting the growth of the analytical standards market is the lack of uniform regulatory standards across regions. Differences in testing protocols, certification requirements, and quality benchmarks create complexity for manufacturers operating in multiple countries. This fragmentation slows product approvals and limits global reach.

To address this, key players are investing in regulatory expertise and expanding their compliance teams to align with region-specific guidelines. Market players are also forming strategic partnerships with accredited laboratories and regulatory bodies to co-develop standards that meet international criteria, streamlining approvals and building trust globally.

Market Trend

"Technological Advancements in Analytical Techniques"

Technological progress in analytical instruments is enhancing the capabilities of labs, which is boosting the analytical standards market. High-resolution instruments now detect and quantify substances at trace levels, requiring equally precise standards for calibration.

Automation, miniaturization, and digitalization in laboratory workflows are increasing the need for certified reference materials that match the sensitivity of new systems. The shift toward higher analytical precision and data accuracy is creating a sustained need for sophisticated analytical standards.

• In March 2025, the U.S. National Institute of Standards and Technology (NIST) introduced a certified human gut microbiome reference material designed to support analytical consistency in microbiome research. This material includes eight vials containing human fecal matter in an aqueous suspension, characterized with extensive metagenomic and metabolomic data. It serves as a benchmark for calibrating high-resolution analytical instruments used in microbiome analysis, ensuring data reproducibility across labs.

Analytical Standards Market Report Snapshot

Segmentation	Details
By Category	Organic Analytical Standards, In-organic Analytical Standards
By Technique	Spectroscopy, Chromatography, Titrimetry, Physical Property Testing
By Application	Pharmaceutical and Life Science Analysis, Environmental Analysis, Food and Beverage Analysis, Forensic Standards, Petrochemical Analysis, Veterinary Drug Analysis, Others
By Methodology	Bioanalytical Testing, Stability Testing, Raw Material Testing, Dissolution testing, Others
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation

• By Category (Organic Analytical Standards, In-organic Analytical Standards): The organic analytical standards segment earned USD 748.0 million in 2023 due to its critical role in trace-level detection of organic contaminants across pharmaceuticals, food safety, and environmental testing.
• By Technique (Spectroscopy, Chromatography, Titrimetry, and Physical Property Testing): The spectroscopy segment held 35.45% of the market in 2023, due to its widespread use in pharmaceutical quality control, food safety testing, and environmental analysis.
• By Application (Pharmaceutical and Life Science Analysis, Environmental Analysis, Food and Beverage Analysis, and Forensic Standards): The pharmaceutical and life science analysis segment is projected to reach USD 863.5 million by 2031, owing to the high demand for precise quality control, regulatory compliance, and validated testing methods in drug development and biopharmaceutical manufacturing.
• By Methodology (Bioanalytical Testing, Stability Testing, Raw Material Testing, and Dissolution testing): The bioanalytical testing segment is poised for significant growth at a CAGR of 8.09% through the forecast period, attributed to its critical role in supporting drug development, regulatory submissions, and therapeutic monitoring through precise quantification of drugs, metabolites, and biomarkers.

Analytical Standards Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

The North America analytical standards market share stood around 43.10% in 2023 in the global market, with a valuation of USD 560.9 million. North America dominates the market due to its highly stringent regulatory requirements, particularly in the healthcare and pharmaceutical sectors.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and Health Canada mandate the use of validated analytical standards in drug manufacturing, clinical trials, and quality assurance processes. 

Additionally, the growing pace of R&D activities in fields such as nanotechnology, bioengineering, and advanced materials is increasing the demand for precise and reliable analytical methods.

These developments have created a sustained need for high-purity reference materials to ensure experimental accuracy and regulatory compliance, thereby accelerating the adoption of analytical standards across North America.

• In March 2025, CPAchem launched a new range of Metallo-Organic Certified Reference Materials (CRMs) designed to support high-precision analytical techniques. These materials are tailored for laboratories engaged in advanced research and development, particularly in fields such as nanotechnology, bioengineering, and material science. The introduction of these CRMs aligns with the increasing demand for validated analytical standards in response to stringent global regulations in pharmaceutical manufacturing and drug safety.

Asia Pacific analytical standards industry is poised for significant growth at a robust CAGR of 8.83% over the forecast period. Asia Pacific’s ongoing industrialization, particularly in sectors like chemicals, pharmaceuticals, and electronics, is a significant driver for the market.

Analytical standards are crucial for ensuring product consistency, quality assurance, and regulatory compliance in high-volume manufacturing processes. The increasing demand for advanced analytical testing methods in these growing industries is fueling market growth across the region.

Furthermore, with rising concerns over food safety, especially regarding contamination from pesticides, allergens, and additives, food manufacturers and regulators require precise analytical methods. Analytical standards ensure the reliability and accuracy of food testing, enabling compliance with both local and international safety regulations.

• As of March 2024, the Food Safety and Standards Authority of India (FSSAI) had approved a total of 79 Rapid Analytical Food Testing (RAFT) kits. These kits are designed to facilitate quick and reliable on-site testing of various food contaminants, including pesticides, allergens, and additives, thereby ensuring compliance with stringent food safety regulations.

Regulatory Frameworks

• In the U.S., the Food and Drug Administration (FDA) regulates analytical standards through Title 21 of the Code of Federal Regulations (CFR)—specifically Parts 58 (Good Laboratory Practice), 210 and 211 (Current Good Manufacturing Practice), and 820 (Quality System Regulation). In addition, the Generally Recognized as Safe (GRAS) program sets conditions for food substances. The FDA's 2024 rule includes Laboratory-Developed Tests (LDTs) under its review framework.
• The European Medicines Agency (EMA) enforces analytical guidelines through the International Council for Harmonisation (ICH)—notably Q2(R1) for method validation and Q6A for specifications. The European Food Safety Authority (EFSA) governs food analysis, requiring use of certified reference standards for contaminants and additives across all member states.
• In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) governs drug testing using ICH-compliant standards, and the Ministry of Health, Labour and Welfare (MHLW) oversees food safety testing. Both bodies mandate use of analytical standards and validated testing methods in pharmaceutical and food-related quality control processes.

Competitive Landscape

Market players are increasingly adopting strategies such as collaboration to strengthen their market position. These strategic partnerships help companies enhance their research capabilities, access new technologies, and expand their product offerings.

By working together, companies are combining their expertise and resources to accelerate the development of innovative solutions, improving clinical outcomes, and meeting market demand more effectively. Such collaborations are crucial in advancing the market and ensuring that companies remain competitive in a rapidly evolving landscape.

• In October 2024, Biond Biologics Ltd. entered into a clinical trial and supply agreement with Merck KGaA to assess its immunotherapy candidate BND-35 in combination with cetuximab, Merck’s anti-EGFR monoclonal antibody. Under the agreement, Merck KGaA will provide cetuximab for the trial, which focuses on evaluating the safety and efficacy of the BND-35 and cetuximab combination. BND-35 is an innovative anti-ILT3 antibody designed to block ILT3’s interaction with extracellular matrix ligands such as fibronectin, a key element in many tumor microenvironments (TME).

List of Key Companies in Analytical Standards Market:

• Merck KGaA
• Agilent Technologies, Inc.
• Waters Corporation
• LGC Limited
• PerkinElmer Inc.
• Thermo Fisher Scientific Inc.
• Restek Corporation
• AccuStandard Inc.
• GFS Chemicals Inc.
• RICCA Chemical Company
• Alfa Chemistry
• NSI Lab Solutions
• Mallinckrodt Pharmaceuticals
• United States Pharmacopeial Convention
• CD Bioparticles

Recent Developments (Approval/Product Launch)

• In March 2025, Agilent Technologies Inc. announced that its PD-L1 IHC 28-8 pharmDx kit received two additional companion diagnostic indications under the EU In Vitro Diagnostic Regulation (IVDR1). These new approvals broaden treatment eligibility to include early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma patients.
• In June 2024, Waters Corporation introduced the Xevo MRT, its most advanced benchtop mass spectrometer (MS), establishing new benchmarks for high resolution and speed, essential for large-scale population and epidemiological studies. This new model enhances the innovative technology originally developed in the Waters SELECT SERIES MRT MS.