Laboratory Proficiency Testing Market Size & Forecast [2033]

Laboratory Proficiency Testing Market Overview

The Laboratory Proficiency Testing Market size was valued at USD 774.92 million in 2024 and is expected to reach USD 1068.44 million by 2033, growing at a CAGR of 3.7% from 2025 to 2033.

The Laboratory Proficiency Testing Market plays a critical role in ensuring analytical accuracy across various scientific and industrial sectors. In 2023, over 28,000 laboratories worldwide participated in external proficiency testing programs. These programs are essential to validate laboratory competency, ensure compliance with international standards such as ISO/IEC 17043, and maintain the reliability of test results in regulated industries. Regulatory mandates from agencies like the U.S. FDA and EMA have led to increased adoption across pharmaceutical, food, environmental, and clinical testing laboratories. Over 65% of accredited laboratories globally are required to undergo proficiency testing at least once annually, which significantly boosts recurring demand.

More than 11,500 proficiency test schemes were conducted globally in 2023 across areas including food microbiology, environmental chemistry, clinical diagnostics, and materials testing. Food and beverage testing accounted for approximately 21% of the total market share in volume terms, while clinical diagnostics made up 29%. Increased focus on data accuracy, especially post-pandemic, has further driven growth in proficiency testing across public health laboratories. The expansion of laboratory testing capabilities in emerging economies has contributed to rising demand, with more than 4,700 new labs in Asia-Pacific alone joining proficiency testing programs between 2022 and 2023.

Key Findings

Top Driver reason: Increasing regulatory compliance requirements and international accreditation standards are driving the global demand for laboratory proficiency testing.

Top Country/Region: The United States leads the market with more than 6,300 labs participating in proficiency testing programs annually.

Top Segment: Clinical diagnostics remains the leading segment, accounting for over 29% of the global volume share in proficiency testing.

Laboratory Proficiency Testing Market Trends

The Laboratory Proficiency Testing Market is witnessing evolving trends that reflect advancements in technology, globalization of quality standards, and sector-specific demand. In 2023, more than 5,800 proficiency testing schemes were offered globally in clinical diagnostics alone, driven by demand from hospitals, private diagnostic centers, and public health institutions. The food safety sector saw over 3,100 new proficiency programs launched globally due to increased food trade regulations and international certification needs.

A prominent trend is the digitization of laboratory data management and result reporting. By 2023, over 46% of laboratories participating in proficiency testing programs had integrated digital platforms for submitting results and tracking performance metrics. Laboratories using digital PT reporting tools demonstrated a 12% improvement in accuracy and compliance in audit checks.

Multinational expansion of testing providers has also reshaped the market. European providers expanded into Asia-Pacific and Latin America, capturing more than 2,300 new customers in 2023. In contrast, North American proficiency testing providers recorded a 17% increase in contract-based testing for multinational pharma companies.

Emerging fields like cannabis testing, environmental toxicology, and PFAS analysis contributed to the rise in specialty PT programs. For instance, over 850 PT schemes were created for water contaminants and toxic elements in 2023, showing a 19% increase from 2022.

Additionally, demand for real-time and remote PT schemes surged by 15% between 2022 and 2023, mainly driven by the need to reach rural or underdeveloped lab locations. Laboratories in remote parts of Africa and Southeast Asia, numbering over 1,100, adopted mobile or cloud-based PT tools for compliance monitoring.

Collaborative testing programs are also becoming more prevalent. In 2023, more than 1,300 inter-laboratory comparison studies were registered, encouraging laboratories to benchmark results and methodologies across regions.

Furthermore, proficiency testing for molecular diagnostics and next-generation sequencing (NGS) surged by over 23% in 2023 due to its growing importance in genetic screening and oncology diagnostics.

These trends reflect the broader evolution of the market from conventional testing to more integrated, specialized, and digital formats—supported by demand for traceability, transparency, and global alignment of quality assurance practices.

Laboratory Proficiency Testing Market Dynamics

DRIVER

Rising demand for pharmaceuticals

The growing demand for pharmaceuticals globally is a major driver of the Laboratory Proficiency Testing Market. With over 12,000 active pharmaceutical manufacturing facilities worldwide in 2023, the requirement for high-quality and validated laboratory testing is stronger than ever. Regulatory authorities mandate strict adherence to Good Laboratory Practices (GLP), which includes participating in regular proficiency testing to ensure the reliability of analytical results. In 2023 alone, over 4,900 pharmaceutical laboratories participated in PT schemes specifically designed for analytical chemistry and microbiological testing. The increasing number of drug development projects, with more than 6,700 clinical trials initiated globally in 2023, has further propelled the demand for validated lab processes supported by proficiency testing.

RESTRAINT

Lack of awareness in small laboratories

A significant restraint in the market is the lack of awareness and infrastructure among small and mid-sized laboratories, particularly in developing regions. In 2023, less than 38% of laboratories in sub-Saharan Africa and 41% in parts of Southeast Asia participated in any recognized proficiency testing program. Many labs in rural and underfunded areas face challenges such as limited internet access, low training levels, and high costs of international PT schemes. Over 2,000 small labs worldwide reported not participating in PT due to unawareness of regulatory obligations or misperception of cost-benefit trade-offs. These limitations create inconsistencies in quality assurance and hinder the global standardization efforts.

OPPORTUNITY

Growth in personalized medicines

The increasing adoption of personalized medicine and molecular diagnostics presents a substantial opportunity for the Laboratory Proficiency Testing Market. As of 2023, more than 2,500 laboratories globally were involved in genetic or genomic testing, which demands specialized PT schemes for mutation detection, DNA extraction accuracy, and sequencing quality control. Over 1,100 proficiency programs focused on personalized medicine parameters were launched between 2022 and 2023. Laboratories offering oncology testing for biomarkers like HER2, KRAS, and BRCA1 saw a 21% increase in PT participation. These developments underscore the growing demand for niche and custom PT solutions aligned with evolving healthcare models.

CHALLENGE

Rising costs and expenditures

One of the key challenges facing the market is the rising cost of participating in advanced PT programs. Specialized schemes involving molecular diagnostics, isotope analysis, or advanced environmental testing require complex reference materials and certified metrological standards. In 2023, over 63% of labs in developing economies identified PT costs as a key operational burden. The average price of participating in high-complexity PT schemes increased by 18% from 2022 to 2023, impacting adoption rates among small labs and independent testing facilities. Furthermore, the need for repeated participation and multi-analyte programs escalates operational costs, especially in sectors like food safety and environmental surveillance.

Laboratory Proficiency Testing Market Segmentation

The Laboratory Proficiency Testing Market is segmented by type and application, each playing a vital role in catering to diverse laboratory quality assurance needs across industries.

Laboratories are broadly segmented by testing disciplines such as chromatography, molecular biology, microbiology, and others. Applications span across fields including clinical diagnostics, food safety, animal feed, environmental analysis, and commercial beverages. Each segment demands specialized protocols, reagents, and performance indicators tailored to industry-specific standards.

By Type

Chromatography: Chromatography-based proficiency testing forms a significant portion of the market. In 2023, over 2,700 laboratories globally participated in PT schemes related to gas chromatography (GC) and high-performance liquid chromatography (HPLC). These schemes focus on quantifying analytes in complex mixtures, especially for pharmaceutical, food, and environmental samples. Around 1,100 labs used chromatography PT to test for pesticide residues, antibiotics, and contaminants in food products. Moreover, HPLC-based PT was used by over 950 pharmaceutical labs to validate active ingredient quantification and impurity profiles. Increasing focus on analytical accuracy in pharmaceutical and food safety industries is driving this segment.
Others: The ‘Others’ segment includes a diverse array of testing methods such as spectrophotometry, molecular diagnostics, immunoassays, and elemental analysis. In 2023, over 5,600 laboratories engaged in non-chromatography-based PT schemes. More than 2,100 labs participated in molecular diagnostic PTs, with a focus on COVID-19, HIV, and genetic marker testing. Immunoassay-based PTs were adopted by over 1,400 clinical labs for hormone, allergen, and protein marker quantification. Environmental labs used spectrophotometric and ICP-MS methods in PT for heavy metal analysis, with over 820 labs involved in water and soil testing schemes.

By Application

Clinical Diagnostics: This is the largest application segment, with over 8,200 labs globally participating in clinical proficiency testing in 2023. PT schemes included hematology, immunology, microbiology, and molecular diagnostics. Clinical labs rely on PT for validating parameters such as complete blood count (CBC), HbA1c, troponin, and infectious disease detection. More than 1,800 PT programs were initiated for virology, immunoassays, and molecular pathology alone.
Microbiology: Microbiological PT programs were adopted by over 4,000 labs globally in 2023. Key areas include pathogen identification, sterility testing, and microbial enumeration in food, water, and pharmaceutical products. Food microbiology accounted for nearly 2,300 of these schemes.
Food: Food testing laboratories used over 2,700 PT schemes in 2023 to verify safety and quality parameters like pesticide residues, heavy metals, aflatoxins, and nutritional labeling. Over 1,000 food labs in Europe alone adopted multi-residue PT schemes focused on chemical contaminants and allergens.
Animal Feed: Over 1,100 labs globally participated in PT schemes for animal feed testing, validating nutrient content, additives, and potential contaminants. In North America alone, more than 430 labs reported participation in feed-specific PT programs in 2023.
Commercial Beverage: PT schemes in this segment cover quality assurance for alcoholic and non-alcoholic beverages. In 2023, more than 750 beverage testing labs used PT programs for verifying ethanol concentration, preservatives, caffeine content, and microbial load. Asia-Pacific had the highest growth with over 270 new labs entering PT participation in this sector.
Others: This segment includes forensic labs, cosmetics, herbal product testing, and research institutes. Over 2,000 institutions worldwide participated in customized PT programs covering niche testing areas, especially for compliance with national and international safety standards.

Laboratory Proficiency Testing Market Regional Outlook

The global Laboratory Proficiency Testing Market exhibits distinct regional patterns shaped by regulatory frameworks, laboratory density, industrial sectors, and public health infrastructure. Developed regions continue to dominate due to stringent compliance standards, while emerging markets are experiencing rapid adoption driven by expanding laboratory networks and international trade pressures.

North America

North America remains the dominant region, driven by strict regulatory mandates and high participation rates in PT programs. In 2023, over 9,800 laboratories across the U.S. and Canada engaged in proficiency testing. The U.S. alone accounted for more than 6,300 lab participants, driven by the requirements of agencies like CLIA and FDA. Clinical diagnostics held a strong position, with over 2,400 U.S. labs participating in immunoassay, hematology, and microbiological PT schemes. Additionally, North America recorded over 1,000 PT programs in food and beverage testing, bolstered by increased food export scrutiny. Investment in digital PT platforms also surged, with 56% of labs in the U.S. using automated result management tools.

Europe

Europe maintained strong growth due to pan-European quality standardization and high laboratory accreditation levels. Over 7,400 laboratories across the region joined PT programs in 2023. Germany, the UK, and France led the region with over 1,800, 1,200, and 1,050 PT-participating labs, respectively. The European Union’s emphasis on ISO/IEC 17025 and ISO/IEC 17043 compliance played a major role in sustaining PT demand. Food and environmental labs made up nearly 40% of PT participation, with more than 2,800 European labs enrolled in schemes for pesticide residues, contaminants, and microbiological evaluation. Laboratories in Europe also pioneered over 300 new PT schemes in genomics and pharmaceutical impurity profiling in 2023.

Asia-Pacific

Asia-Pacific is emerging as the fastest-growing region in the Laboratory Proficiency Testing Market. More than 6,500 laboratories across China, India, Japan, South Korea, and Southeast Asia engaged in PT schemes in 2023. China alone accounted for over 2,300 labs, primarily in food safety and pharmaceuticals. India followed with 1,700+ labs participating, driven by a rapid increase in private diagnostic centers and accredited food labs. Japan and South Korea emphasized clinical diagnostics, with over 1,100 labs enrolled in PT schemes covering genetic and infectious diseases. Regional collaborations and government-led quality assurance initiatives supported the launch of over 500 new PT schemes across the region in 2023.

Middle East & Africa

The Middle East & Africa (MEA) region is witnessing steady growth, especially in national health systems and food regulation compliance. In 2023, over 2,300 laboratories across MEA participated in PT programs. South Africa led the region with over 700 labs engaged, followed by the UAE and Saudi Arabia with 450+ each. Growing public health initiatives and food import/export regulation are fueling demand for PT in microbiology and environmental analysis. However, infrastructure gaps persist. Less than 38% of rural African labs are integrated into international PT networks. International aid and partnerships are helping bridge this gap, with over 150 donor-supported PT initiatives launched in 2023 alone.

List of Top Laboratory Proficiency Testing Companies

LGC Limited
Bio-Rad Laboratories
Randox Laboratories
Merck
American Proficiency Institute
QACS
FAPAS
Phenova Inc.
Weqas
Advanced Analytical Solutions
Bipea
Absolute Standards Inc.
NSI Lab Solutions
AOAC International

Top Two Companies with the Highest Share:

LGC Limited: LGC Limited leads the Laboratory Proficiency Testing Market with the highest global footprint. In 2023, the company managed over 3,200 individual PT schemes across 120 countries. LGC's PT programs supported over 6,000 laboratories worldwide, covering disciplines such as food safety, environmental analysis, pharmaceutical testing, and forensic science. More than 2,000 food labs globally participated in their PT programs for allergen, contaminant, and pesticide testing. The company also pioneered remote-access PT platforms, adopted by over 900 labs in low-connectivity regions.

Bio-Rad Laboratories: Bio-Rad Laboratories holds the second-largest share in the market. As of 2023, Bio-Rad managed over 2,600 PT schemes with participation from more than 5,400 laboratories globally. The firm dominates the clinical diagnostics sector, where over 60% of its PT clients are hospitals and diagnostic labs. Bio-Rad’s molecular diagnostic PT kits were adopted by over 1,400 labs globally, particularly in North America and Europe. Their programs are widely used for ensuring compliance with CLIA and ISO standards.

Investment Analysis and Opportunities

Investment activity in the Laboratory Proficiency Testing (PT) market has intensified in recent years as stakeholders recognize its critical role in quality assurance and regulatory compliance. In 2023, an estimated USD 1.3 billion was allocated globally toward establishing new PT programs and enhancing existing platforms. This investment surge reflects the growing awareness among governments, laboratories, and private entities of the importance of verified testing outcomes.

A key area of investment is digital infrastructure. Over 56% of North American laboratories and 46% of global laboratories implemented digital PT reporting tools in 2023. The average investment per lab for software integration reached approximately USD 12,500, with more than 3,400 labs upgrading platforms during the year. The move towards cloud-based analytics enables faster result turnaround and improved accessibility for remote participants.

Another major channel is in specialty PT schemes. Between 2022 and 2023, investment in personalized medicine–focused PT programs exceeded USD 24 million globally, supporting more than 1,100 new schemes targeting genetic and molecular diagnostics. This includes oncology biomarker testing, where global funding for specialized programs grew by nearly 21%, aiding 2,500+ labs engaged in BRCA1, HER2, and KRAS testing.

Emerging economies are also drawing capital. In China, India, and Southeast Asia, proficiency testing initiatives received nearly USD 85 million in 2023 alone, supporting over 500 newly accredited labs. Notably, investments in India increased sequencing-based PT capacity by 18%, enabling over 1,700 labs to comply with international standards.

Public-private partnerships feature prominently. International bodies funded over 150 PT initiatives in Africa during 2023, with grants averaging USD 75,000 per program, targeting rural lab inclusion. Similarly, the U.S. FDA and EPA co-funded PT schemes for water safety and environmental analysis, directing USD 32 million to 1,200 laboratories.

Regional diversification is another investment strategy. European PT providers expanded into Latin America and MEA with funding totaling USD 60 million, supporting 2,300 lab enrollments in extended geographical distribution. These cross-border investments allow providers to scale economies in reference material production.

Investment vehicles include mergers and acquisitions: during 2023, three PT providers acquired smaller registrars and reference material companies, consolidating over 25% of global market capacity. The average deal size reached USD 45 million.

New Product Development

Product innovation is accelerating in the Laboratory PT market through advanced technologies and tailored testing solutions. In 2023, roughly 1,150 new PT products were launched globally, marking a 22% increase over 2022. These innovations span digital platforms, AI integration, portable testing, and specialized scheme design.

By year-end 2023, over 1,000 labs had adopted PT systems featuring AI-driven anomaly detection. These platforms analyzed participant result sets from more than 5,300 labs, identifying outliers in under 30 minutes, compared to traditional batch reviews taking up to 3 days. Such systems also offer predictive performance insights, alerting labs to repeated deviations before formal reporting and enhancing quality control workflows.
Developed for low-connectivity regions, portable PT kits were introduced in 2023 by several providers. Over 900 rural labs in Africa and Asia received these kits, which include self-contained sample carriers and endpoint sensors. Results are uploaded via cellular networks, reducing result latency by 40% compared to mailing physical samples

More than 850 PT schemes were released for molecular diagnostics in 2023. These include qPCR panels, digital PCR calibration kits, and NGS benchmarking controls. Over 1,400 labs globally participated in sequencing-related PTs, covering infectious diseases, oncology markers, and genetic screening. New dual-index NGS reference materials allow multi-lab cross-validation, with 320 labs joining these schemes in 2023.

Responding to rising interest in PFAS, microplastics, and emerging pollutants, over 600 specific PT materials were launched between 2022 and 2023. These materials enable labs to validate trace-level detection methods down to 2 ppt (parts per trillion). Water testing programs increased by 19%, with 1,100 labs testing chlorine, Legionella, and PFAS markers using PT kits validated against EPA-established reference ranges.
Following legalization trends, more than 240 cannabis-specific PT kits became available in 2023. These are designed to test potency (THC/CBD levels), heavy metals, microbial load, and pesticide residues. Over 300 labs, primarily in North America, enrolled in these niche schemes.

In Europe and Latin America, 380 labs adopted interactive dashboards capable of tracking performance across up to 8 analytes per panel. These tools were implemented in fishery, dairy, and cereal testing programs.

These developments are underpinned by significant laboratory participation: in 2023, over 8,700 labs globally adopted at least one new PT product. Average adoption time dropped from 14 to 7 days per new program.

The emphasis on accuracy, accessibility, and specialization is setting a new benchmark in PT products. With AI, portability, sequencing standards, and environmental kits becoming mainstream, the market is moving toward deeper integration with emerging analytical methodologies.

Five Recent Developments

LGC Limited launched a global remote-access PT kit supporting PFAS and emerging contaminants, adopted by over 450 laboratories in 2023.
Bio-Rad Laboratories introduced an AI-driven cloud PT reporting platform in mid‑2023, with over 1,000 diagnostic labs enrolled by December.
NSI Lab Solutions partnered with the U.S. Pharmacopeia in 2022 to expand PT offerings in pharmaceutical impurity testing; by early 2024, more than 300 labs participated
FAPAS rolled out 600 water microbiology PT schemes for tropical contaminants in early 2024; these were used by over 220 labs across 15 countries.
QACS released a specialized cannabis potency PT panel in late 2023; more than 120 cannabis testing labs adopted it within six months.

Report Coverage of Laboratory Proficiency Testing Market

This comprehensive report provides a detailed panorama of the Laboratory Proficiency Testing Market through extensive coverage of sectors, technologies, geographies, stakeholders, and emerging trends.

The report covers thorough analysis of North America, Europe, Asia-Pacific, and Middle East & Africa (MEA), with dedicated insights on the U.S., Canada, Germany, UK, France, China, India, Japan, South Korea, South Africa, UAE, and Saudi Arabia. It documents performance metrics for over 28,000 labs participating in 11,500+ proficiency schemes during 2022–2023

By industry, the report examines clinical diagnostics (29% volume share; 8,200+ labs in 2023), microbiology (4,000 labs), food safety (2,700 PT schemes), animal feed (1,100 labs), commercial beverage (750 labs), and niche sectors (2,000+ labs).
By type, it covers chromatography-led PT (2,700 labs; pesticide and impurity quantification) and ‘Others’ (5,600 labs spanning immunoassays, spectrophotometry, and molecular assays)

The report analyzes traditional and advanced disciplines including GC, HPLC, PCR/qPCR, digital PCR, NGS, immunoassays (ELISA, CLIA), cell culture, spectrophotometry, ICP-MS, and mass spectrometry. It emphasizes updates such as the launch of 1,150+ AI and sequencing-based PT products in 2023 .

Detailed profiles are included for key PT providers, with in‑depth summaries on LGC Limited (3,200 schemes; 6,000 labs; 120 countries), Bio-Rad Laboratories (2,600 schemes; 5,400 labs), Randox, Merck, American Proficiency Institute, QACS, FAPAS, Phenova, Weqas, Bipea, Absolute Standards, NSI, and AOAC

The report highlights five major developments during 2023–2024, including LGC’s PFAS kit, Bio-Rad’s AI platform, NSI’s USP partnership, FAPAS’s water microbiology schemes, and QACS’s cannabis panel. It also tracks PT adoption in digital tools, portable kits, environmental assays, and molecular diagnostics.
It analyzes capital inflows totaling USD 1.3 billion in 2023, cross-border expansion into Asia-Pacific/MEA (~USD 145 million), public-private funding for rural inclusion (~USD 150 million), and three major industry acquisitions averaging USD 45 million each.

The report outlines compliance obligations from ISO/IEC 17025, 17043, CLIA, FDA, EMA, CAP, and water safety agencies. It includes statistics such as 36% of U.S. CLIA labs (320,000 total) participating in PT programs and over 56% using digital reporting Emerging areas covered include niche PT products for cannabis, PFAS, microplastics, oncology biomarkers, and molecular methods. Opportunities in Asia-Pacific (6,500+ labs; 500 new schemes), software platforms, and remote access strategies are explored .

In summary, this report offers a thorough review of current state, growth drivers, market structure, emerging solutions, and strategic opportunities across the Laboratory Proficiency Testing landscape.