Analytical Standards Market

Market Overview

The global analytical standards market size was valued at USD 1.5 billion in 2023 and is projected to reach  USD 3.3 billion by 2032, registering a CAGR of 9.2% during the forecast period (2024-2032). The growing demand for testing in the pharmaceutical, environmental monitoring, and food and beverage industries contributes to the analytical standard market growth. 

Analytical standards, also known as reference materials or calibration standards, are substances or materials with well-established qualities used to calibrate instruments, validate analytical processes, and ensure the precision and dependability of analytical results. These standards are necessary across numerous industries where precise and accurate measurements are vital for quality control, regulatory compliance, and research objectives.

The convergence of forces has resulted in dynamic movements in the analytical standards industry. Technological advancements are critical since discoveries in analytical tools and procedures demand new and diverse standards. The market responds to laboratories' and industries' ongoing desire for enhanced measurement precision and accuracy by generating a steady stream of new reference materials. Tight regulations are a crucial driving force in many companies, particularly the pharmaceutical and environmental monitoring sectors. Approved analytical standards must be utilized to ensure product quality and safety and comply with these rules, promoting industrial growth. International trade and globalization both have an impact on market dynamics. 

Furthermore, global standardization encourages worldwide cooperation and commerce, resulting in increased use of standardized reference materials. Economic considerations are also important because changes in industrial production, research funding, and healthcare spending can all affect the market's growth.

Highlights

• Organic accounts for the largest market share by category.
• Spectroscopy is the major technique used in the market.
• Pharmaceutical and life science analysis is the most common application in the market.
• Bioanalytical Testing dominates the market by method.

Market Dynamics

Global Analytical Standards Market Drivers

Stringent Regulatory Requirement

Pharmaceutical products must meet stringent quality, safety, and efficacy standards set by regulatory organizations such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requires the use of validated analytical methods and certified reference materials (CRMs) throughout the drug development and manufacturing processes. A pharmaceutical business producing a new drug must conduct extensive analytical testing to ensure its safety, potency, and purity. This covers applying analytical standards to method validation, impurity profiling, and stability testing. Failure to comply with regulatory criteria may delay drug approval or potentially regulatory punishment. 

Furthermore, to streamline and rationalize the sampling procedure and maintain a centralized monthly database, the Central Drugs Standard Control Organisation (CDSCO) has released the final version of the regulatory guidelines for drug, cosmetic, and medical device sampling by Central and State drug inspectors. The guideline is primarily focused on utilizing available information and identified risks for sample selection and location to cover a wide range of drugs, cosmetics, and medical devices moving into the market from manufacturing facilities, wholesale outlets, retail outlets, government distribution channels, and so on. Sterling Accuris Diagnostics, a leading network of NABL-accredited pathology laboratories, has announced the purchase of Ahmedabad-based Vaibhav Analytical Services, a major provider of analytical testing services such as pharmaceutical/drug testing. With this acquisition, Sterling Accuris (also based in Ahmedabad) has expanded its service offerings to include pharmaceutical analytical testing.

Moreover, public health worries regarding the influence of environmental pollution on respiratory ailments, cancer, and neurological problems have fueled the demand for analytical standards for emissions testing. The Indian government has announced the transition to Bharat Stage VI (BS VI) emissions standards for two, three, and four-wheeled vehicles beginning April 1, 2020. The new standards closely follow European vehicle emissions laws. The RDE requirements will impose greater compliance and enforcement, and manufacturers may be required to undertake a recall or take other corrective actions to bring a vehicle back into conformity if it is proven to emit more pollution than laws allow.

Global Analytical Standards Market Restraints

Limited Availability of Specialized Standards

As environmental concerns grow, there is a greater need to monitor developing toxins such as pharmaceuticals, personal care products, and microplastics in water, soil, and the air. For instance, microplastics, or microscopic plastic particles, have emerged as a major environmental problem due to their extensive prevalence in aquatic environments. Microplastics in environmental samples must be analyzed using reference materials with well-defined particle size distributions and polymer compositions. However, standardized CRMs for microplastic analysis are currently in development, reducing the precision and comparability of measurements.

Similarly, medications in water bodies have aroused concerns about potential environmental and human health hazards. Specialized reference materials with approved concentrations are required to analyze trace quantities of pharmaceutical substances. However, the supply of CRMs for developing pharmaceutical pollutants in water is frequently limited.

Furthermore, the rapid advancement of materials science and nanotechnology has created new materials with distinct features and applications. Nevertheless, these sophisticated materials' characterization and quality control frequently necessitate specialized analytical standards, which may not be easily available. The production of reference materials for nanomaterial characterization confronts several challenges, including the need for well-established methodologies and reference materials to enhance nanosafety research and material characterization. 

Global Analytical Standards Market Opportunity

Environmental Monitoring and Sustainability Initiatives

Growing concerns about environmental pollution, climate change, and sustainability have increased the demand for analytical standards for measuring air quality, water quality, soil contamination, and greenhouse gas emissions. Suppliers can use this opportunity by providing CRMs and proficiency testing services to support environmental monitoring programs and regulatory compliance activities. Water quality monitoring is critical for maintaining public health and ecosystems and assuring access to clean water resources.

In addition, analytical standards are critical for correctly measuring and monitoring pollutants in water, such as heavy metals, organic compounds, minerals, and pathogens. The World Health Organization (WHO) estimates that 26% of the world's population, or 2 billion people, will lack access to safe drinking water by 2023. This includes safe and contaminant-free drinking water at home. According to the World Health Organization, 3.6 billion people, or 46% of the global population, lack safe sanitation. This involves access to a restroom or toilet where manure can be safely disposed of or treated. Thus, waterborne infections from contaminated sources offer serious health hazards, especially in low- and middle-income nations.

Conversely, air pollution threatens human health, ecosystems, and climatic stability. According to the World Health Organization (WHO), air pollution causes 6.7 million premature deaths yearly, with 3.2 million deaths attributed to household air pollution. This includes the impacts of both outdoor and indoor air pollution. Analytical standards are required to measure and monitor air pollutants such as particulate matter (PM), nitrogen oxides (NOx), sulfur dioxide (SO2), volatile organic compounds (VOCs), and heavy metals.

Regional Analysis

The global analytical standards market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global analytical standards market shareholder and is estimated to grow at a CAGR of 8.9% over the forecast period. North America dominated the market in 2023, accounting for 45% of total revenue, owing to stringent regulatory requirements, technological advances, and significant market competitors. Regulatory authorities such as the FDA and EPA require analytical criteria to ensure the quality and safety of pharmaceutical, food, and environmental samples. Technological improvements, such as the development of high-performance analytical instruments, are increasing the demand for more advanced analytical standards. Furthermore, the presence of leading market players in North America, such as Agilent Technologies, Merck KGaA, and Waters Corporation, adds to regional market growth by driving innovation and offering diverse products to suit market demand.

Asia-Pacific is anticipated to exhibit a CAGR of 9.4% over the forecast period owing to increased industrialization, expanding pharmaceutical and biotechnology sectors, and a growing emphasis on food safety and environmental monitoring. The region provides considerable prospects for market expansion, especially in nations such as China, India, and Japan, which are experiencing tremendous economic growth and technical advancement. Furthermore, the region's market expansion is driven by the increasing usage of modern analytical techniques and a significant population base. The Asia-Pacific market is primed for substantial expansion, with lucrative prospects for market participants.

The European analytical standards market was identified as a profitable region in this industry. The region's market growth can be due to rising demand for food safety testing, stringent pharmaceutical laws, and an increased emphasis on environmental monitoring. The analytical standards market in the United Kingdom is expected to grow at the fastest CAGR during the forecast period, owing to rising demand for high-quality analytical measurements in the pharmaceutical and environmental sectors, stringent regulatory requirements, and increased adoption of advanced analytical techniques.

Segmental Analysis

The global analytical standards market is segmented based on category, technique, application, and method.

The market is further segmented by category into Organic and inorganic.

The organic analytical standards segment dominated the market, accounting for 55% of total revenue. Organic analytical standards are critical to assuring the precision and reliability of analytical measures in various industries, including pharmaceuticals, environmental testing, and food and beverage. The increasing complexity of organic substances employed in multiple sectors is a driving force behind the usage of organic analytical standards. For example, in the pharmaceutical business, discovering new medicinal molecules necessitates precision analysis, increasing the demand for organic analytical standards for calibration and validation. 

Furthermore, the increased emphasis on environmental protection has necessitated the development of organic analytical standards for detecting pollutants and toxins in air, water, and soil. This trend will continue to fuel demand for organic analytical standards in the future. 

The inorganic analytical standards segment is expected to increase at a consistent CAGR during the projection period. The inorganic category of the analytical standards market includes reference materials for inorganic compounds without carbon-hydrogen bonds. This category comprises elements, metal ions, minerals, acids, bases, and salts frequently found in industrial processes, environmental samples, and geological materials. 

Based on technique, the market is fragmented into Spectroscopy, Chromatography, Titrimetry, and Physical Property Testing.

The spectroscopy segment led the market with a 45% revenue share in 2023 and is expected to increase at the quickest CAGR throughout the forecast period. The increased implementation of advanced spectroscopic techniques in pharmaceuticals, environmental testing, and food and beverage industries drives the segment's growth. One motivator is the need for accurate and reliable analysis in pharmaceutical research, where spectroscopy plays an essential role in medication formulation and quality control.

For example, in the pharmaceutical business, high-performance liquid chromatography (HPLC) combined with mass spectrometry is used to analyze medicinal components, necessitating certified reference materials (CRMs) to ensure accurate and reliable analytical results. Furthermore, the growth of the food and beverage industry and strict food safety requirements are increasing the demand for spectroscopic analysis and, by extension, analytical standards. For example, in September 2023, PepsiCo said it would establish a new food production factory in India. Such capacity expansions are anticipated to drive up market demand. 

The physical property testing category is expected to develop at a high CAGR over the forecast period. As industries strive for higher-quality products, effective quality control and assurance measures become increasingly important. Physical property testing ensures that materials and products satisfy specific criteria, which helps businesses maintain consistency and dependability.

The market can be bifurcated by application into Pharmaceutical and Life Science Analysis, Environmental Analysis, Food and Beverage Analysis, Forensic Standards, Petrochemical Analysis, and Veterinary Drug Analysis.

The pharmaceutical and life science category dominated the market, accounting for 25% of total revenue. Analytical standards are essential in pharmaceutical and life science research and development. They are required to provide measurement accuracy and dependability, which is vital for drug development and testing. Analytical standards, for example, are employed during the development of a novel drug to determine the purity and potency of the active pharmaceutical ingredient (API).

The food and beverage analysis segment is expected to increase at a lucrative CAGR throughout the forecast period. The growing complexity of global food supply chains and rigorous quality control requirements have increased the demand for analytical standards in the food and beverage industry. Accurate measurement and verification of ingredients, pollutants, and nutritional content are required to maintain regulatory compliance and meet consumer expectations for safety and transparency. Such compliances are projected to boost demand in the coming years.

Based on method, the market is sub-segmented into Bioanalytical Testing, Stability Testing, Raw Material Testing, and Dissolution Testing.

The bioanalytical testing segment dominated the market, accounting for 35% of total revenue. Bioanalytical testing is essential to drug development and pharmacokinetic research, relying significantly on analytical standards to produce precise and consistent data. One reason for using analytical standards in bioanalytical testing is the necessity for uniform and repeatable measurements to verify drug safety and efficacy. For example, analytical standards are used in pharmacokinetic investigations to calibrate instruments and validate methodologies for quantifying medicines and their metabolites in biological samples.

The stability testing segment is expected to have the fastest CAGR during the projection period. Regulatory regulations and the need to maintain product quality are key motivators. For example, instability testing and analytical standards are used to track the degradation of medications over time. The process entails subjecting samples to various stress conditions before assessing them using chromatography or spectroscopy. The stability testing market is predicted to grow at one of the fastest rates due to increased medication research and regulatory requirements.

Recent Developments

• April 2024- Merck launched the first all-in-one genetic stability assay to accelerate biosafety testing.
• April 2024- Waters Corporation (NYSE: WAT) unveiled the Alliance iS Bio HPLC System, which has additional capabilities to solve the operational and analytical difficulties of biopharma quality control (QC) laboratories. The new HPLC system combines superior bio-separation technology with built-in instrument intelligence features. It is intended to help biopharma QC analysts increase efficiency and remove up to 40% of frequent errors, saving time spent investigating the source of failed runs and out-of-spec results.
• April 2024- Agilent launched a new advanced dilution system to improve lab efficiency.