Laboratory Proficiency Testing Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The Laboratory Proficiency Testing Market is Segmented by Industry Type (Clinical Diagnostics, Microbiology, Pharmaceutical & Biologics and More), by Technology (Chromatography, Spectrophotometry, Immunoassays and More), by Provider Type (Independent / Third-Party Providers, Instrument-Manufacturer Programs, and More) and Geography (North- America, Europe and More). The Market Forecasts are Provided in Terms of Value (USD).

Laboratory Proficiency Testing Market Size and Share

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Laboratory Proficiency Testing Market Analysis by Mordor Intelligence

The laboratory proficiency testing market stands at USD 1.45 billion in 2025 and is projected to advance to USD 1.98 billion by 2030, translating into a 6.5% CAGR. This trajectory reflects a shift from compliance-only participation toward strategic quality differentiation as regulators tighten analytical performance criteria and as laboratories deploy more advanced molecular and cell-based assays. Revised CLIA grading for blood alcohol and blood lead testing that took effect in January 2025 has already raised precision expectations across North American clinical laboratories [1]Source: Centers for Medicare & Medicaid Services, “QSO-25-10-CLIA,” cms.gov . Food-, water- and environmental-testing laboratories face parallel pressures under the FDA’s LAAF program and the EPA’s new PFAS methods, accelerating demand for validated external quality assessment[2]Source: U.S. Environmental Protection Agency, “Clean Water Act Methods Update Rule for the Analysis of Effluent,” epa.gov Provider preferences continue to tilt toward vendor-neutral schemes, while digital platforms begin to streamline result analytics—signals that the laboratory proficiency testing market is becoming an operational performance lever rather than a regulatory obligation.

Key Report Takeaways

  • By industry, Clinical Diagnostics led with 38.67% of laboratory proficiency testing market share in 2024; Pharmaceutical & Biologics is forecast to grow at 7.65% CAGR to 2030.
  • By technology, Cell Culture-based Assays accounted for 27.54% share of the laboratory proficiency testing market size in 2024, while PCR & Molecular Methods are advancing at a 7.23% CAGR through 2030.
  • By provider type, Independent/Third-party Providers held 54.45% of laboratory proficiency testing market share in 2024 and are expanding at an 8.12% CAGR through 2030.
  • By geography, North America commanded 42.34% revenue share in 2024, whereas Asia-Pacific is projected to record the fastest 8.34% CAGR to 2030.

Segment Analysis

By Industry: Clinical Diagnostics Dominates While Pharma Accelerates

Clinical Diagnostics held 38.67% of laboratory proficiency testing market share in 2024 as CLIA mandates coupled with rising chronic disease testing volumes sustained program enrollment. Laboratories routinely parcel the laboratory proficiency testing market size for hematology, chemistry and infectious disease panels across multiple providers, reinforcing predictable renewal revenue. Meanwhile, Pharmaceutical & Biologics posted the quickest 7.65% CAGR, propelled by stringent analytical method validation in monoclonal antibody potency and mRNA vaccine release.

The laboratory proficiency testing industry is also witnessing consistent microbiology uptake driven by dual demand from food safety and clinical bacteriology labs. Cosmetics & Personal Care inquiries grew after the FDA’s MoCRA enforcement date in July 2024, prompting new schemes for heavy metals and microbial challenge. Cannabis and psychedelics testing rounds widened the application base, indicating that differentiated external quality assessment can precede formal regulatory edicts in emerging niches.

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Note: Segment shares of all individual segments available upon report purchase

By Technology: Cell Culture Keeps Lead but Molecular Surges

Cell Culture-based Assays accounted for 27.54% of the laboratory proficiency testing market size in 2024, reflecting continued biologics potency testing and viral clearance confirmation. Yet PCR & Molecular Methods are set to outpace, expanding at 7.23% CAGR as precision oncology, pathogen genomics and wastewater-based epidemiology demand nucleic-acid accuracy benchmarking.

Chromatography and mass spectrometry rounds maintain core relevance for pharmaceutical impurity profiling and PFAS quantitation, while spectrophotometry serves routine clinical chemistry programs at scale. The laboratory proficiency testing industry increasingly integrates digital data exchange—especially for sequencing files—improving peer-comparison analytics and expanding scheme value beyond simple pass/fail metrics.

By Provider Type: Independent Providers Define Objectivity

Independent/Third-party Providers controlled 54.45% of laboratory proficiency testing market share in 2024, translating the laboratory proficiency testing market into a neutral arbiter of analytical competence across platforms. Their 8.12% growth rate reflects customer preference to decouple quality oversight from instrument vendors.

Manufacturer-affiliated schemes retain significance for highly specialized hardware but face skepticism over objectivity, while government or accreditation-body programs focus on public-health missions such as water quality and newborn screening. Several independents now bundle workflow analytics dashboards, offering laboratories real-time performance trending that enhances internal quality management systems.

Laboratory Proficiency Testing Market
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Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

North America generated 42.34% of 2024 revenues, anchored by CLIA-based compulsory enrollment of more than 260,000 U.S. laboratories and by Canada’s harmonized accreditation system. The region’s laboratory proficiency testing market also benefits from niche demand in cannabis testing as state-level legalization continues. Consolidation among commercial super-networks such as Labcorp and BioReference supports volume robustness even as unit pricing comes under negotiation.

Asia-Pacific records the fastest 8.34% CAGR to 2030, reflecting China’s CNAS accreditation requirements, Japan’s Food Sanitation Act testing obligations and India’s expanding bio-manufacturing corridor. APAC mutual recognition arrangements further enlarge cross-border acceptance, lowering redundant test costs and raising adoption of sophisticated external quality controls. Logistics constraints remain a drag in parts of South-East Asia, yet digital reporting platforms partially offset physical distribution gaps.

Europe sustains mature albeit steady growth under EN ISO/IEC 17025 implementation and evolving monographs such as the European Pharmacopoeia’s cannabis flower inclusion in July 2024. Brexit complexities marginally elevate administrative overhead but have not dampened the laboratory proficiency testing market given maintained mutual recognition agreements. Latin America and the Middle East & Africa represent long-term upside once cold-chain and customs bottlenecks resolve, with regional governments already signaling alignment with ISO norms.

Laboratory Proficiency Testing Market
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Competitive Landscape

The laboratory proficiency testing market is moderately concentrated; technical barriers, accreditation approvals and logistical infrastructure deter rapid entrant turnover. Independent providers leverage vendor-neutral credibility, while instrumentation companies integrate schemes to reinforce aftermarket services. Eurofins’ purchases of ViraCor-IBT (May 2024) and Infinity Laboratories (February 2025) showcase horizontal additions that extend infectious-disease and materials science expertise.

Strategic themes include digitalization—cloud portals now autoload analytic results into QC dashboards—and white-space expansion into psychedelics, at-home sample kits and AI-assisted histopathology. U.S. Department of Defense environmental testing standards, updated December 2023, mandate PT participation for contract eligibility, locking in baseline demand denix.osd.mil. Vendor differentiation increasingly hinges on turnaround speed, statistical depth and multi-matrix portfolio breadth rather than price alone.

Consolidation continues: Labcorp announced three asset deals between September 2024 and May 2025, strengthening oncology and women’s-health coverage. Providers without global logistics networks may exit niche schemes, potentially curbing market choice yet improving cross-round comparability where dominant players standardize metrics.

Laboratory Proficiency Testing Industry Leaders

  1. Bio-Rad Laboratories, Inc.,

  2. FAPAS

  3. LGC Limited

  4. Merck KGaA

  5. Trilogy Analytical Laboratory

  6. *Disclaimer: Major Players sorted in no particular order
Bio-Rad Laboratories, Inc., FAPAS (A Division of Fera Science Limited), LGC Limited, Merck KGaA, NSI Lab Solutions, QACS Ltd, Trilogy Analytical Laboratory and Waters Corporation
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Recent Industry Developments

  • March 2025: Labcorp announced acquisition of select BioReference Health oncology assets, broadening cancer diagnostics capabilities
  • February 2025: Eurofins completed acquisition of Infinity Laboratories, extending analytical reach in materials testing
  • January 2025: EPA approved expedited PFAS and chlorine methods under the Safe Drinking Water Act, reinforcing obligatory proficiency testing for alternative procedures

Table of Contents for Laboratory Proficiency Testing Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Stricter ISO/IEC 17025 & 17043 accreditation mandates
    • 4.2.2 Growing clinical diagnostics volume amid chronic disease burden
    • 4.2.3 Tightening food & water-safety regulations worldwide
    • 4.2.4 Biologics manufacturing boom demanding validated analytical methods
    • 4.2.5 Legalization of cannabis & psychedelics spurring niche PT schemes
    • 4.2.6 Rise of remote / at-home testing creating digital PT opportunities
  • 4.3 Market Restraints
    • 4.3.1 High subscription costs for small & mid-size laboratories
    • 4.3.2 Sample logistics & stability hurdles in emerging regions
    • 4.3.3 Consolidation-driven discontinuation of key PT programs
    • 4.3.4 Data-privacy rules limiting inter-lab data sharing analytics
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter’s Five Forces
    • 4.7.1 Threat of New Entrants
    • 4.7.2 Threat of Substitutes
    • 4.7.3 Bargaining Power of Buyers
    • 4.7.4 Bargaining Power of Suppliers
    • 4.7.5 Competitive Rivalry

5. Market Size & Growth Forecasts

  • 5.1 By Industry (Value)
    • 5.1.1 Clinical Diagnostics
    • 5.1.2 Microbiology
    • 5.1.3 Pharmaceutical & Biologics
    • 5.1.4 Food & Animal Feed
    • 5.1.5 Water & Environmental
    • 5.1.6 Commercial Beverages
    • 5.1.7 Cosmetics & Personal Care
    • 5.1.8 Others
  • 5.2 By Technology (Value)
    • 5.2.1 Chromatography
    • 5.2.2 Spectrophotometry
    • 5.2.3 Immunoassays
    • 5.2.4 PCR & Molecular Methods
    • 5.2.5 Cell Culture-based Assays
    • 5.2.6 Other Emerging Techniques
  • 5.3 By Provider Type (Value)
    • 5.3.1 Independent / Third-party Providers
    • 5.3.2 Instrument-Manufacturer Programs
    • 5.3.3 Government & Accreditation-body Schemes
  • 5.4 By Geography (Value)
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 United Kingdom
    • 5.4.2.2 Germany
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 India
    • 5.4.3.3 Japan
    • 5.4.3.4 South Korea
    • 5.4.3.5 Australia
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 South America
    • 5.4.4.1 Brazil
    • 5.4.4.2 Argentina
    • 5.4.4.3 Rest of South America
    • 5.4.5 Middle East and Africa
    • 5.4.5.1 GCC
    • 5.4.5.2 South Africa
    • 5.4.5.3 Rest of Middle East and Africa

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 College of American Pathologists (CAP)
    • 6.3.2 LGC Limited
    • 6.3.3 Bio-Rad Laboratories
    • 6.3.4 Randox Laboratories
    • 6.3.5 AOAC International
    • 6.3.6 American Proficiency Institute
    • 6.3.7 Waters ERA (Waters Corp.)
    • 6.3.8 UK NEQAS
    • 6.3.9 Fera Science (Fapas)
    • 6.3.10 Proficiency Testing Australia
    • 6.3.11 QACS Labs
    • 6.3.12 QSE GmbH
    • 6.3.13 European Proficiency Testing Service (EPTIS)
    • 6.3.14 AAFCO Proficiency Testing Program
    • 6.3.15 Inpas SL
    • 6.3.16 Bipea
    • 6.3.17 NSI Lab Solutions
    • 6.3.18 Global Proficiency Ltd.
    • 6.3.19 Phenova
    • 6.3.20 Absolute Standards Inc.
    • 6.3.21 FSS Proficiency Testing

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Laboratory Proficiency Testing Market Report Scope

As per the scope of the report, laboratory proficiency testing determines the performance of individual laboratories for specific tests or measurements and is used to monitor laboratories’  performance.

By Industry (Value) Clinical Diagnostics
Microbiology
Pharmaceutical & Biologics
Food & Animal Feed
Water & Environmental
Commercial Beverages
Cosmetics & Personal Care
Others
By Technology (Value) Chromatography
Spectrophotometry
Immunoassays
PCR & Molecular Methods
Cell Culture-based Assays
Other Emerging Techniques
By Provider Type (Value) Independent / Third-party Providers
Instrument-Manufacturer Programs
Government & Accreditation-body Schemes
By Geography (Value) North America United States
Canada
Mexico
Europe United Kingdom
Germany
France
Italy
Spain
Rest of Europe
Asia-Pacific China
India
Japan
South Korea
Australia
Rest of Asia-Pacific
South America Brazil
Argentina
Rest of South America
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
By Industry (Value)
Clinical Diagnostics
Microbiology
Pharmaceutical & Biologics
Food & Animal Feed
Water & Environmental
Commercial Beverages
Cosmetics & Personal Care
Others
By Technology (Value)
Chromatography
Spectrophotometry
Immunoassays
PCR & Molecular Methods
Cell Culture-based Assays
Other Emerging Techniques
By Provider Type (Value)
Independent / Third-party Providers
Instrument-Manufacturer Programs
Government & Accreditation-body Schemes
By Geography (Value)
North America United States
Canada
Mexico
Europe United Kingdom
Germany
France
Italy
Spain
Rest of Europe
Asia-Pacific China
India
Japan
South Korea
Australia
Rest of Asia-Pacific
South America Brazil
Argentina
Rest of South America
Middle East and Africa GCC
South Africa
Rest of Middle East and Africa
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Key Questions Answered in the Report

What is driving growth in the laboratory proficiency testing market after 2025?

Stricter ISO accreditation, expanding clinical diagnostics volumes and the rollout of new food- and water-safety regulations are lifting global demand, resulting in a projected 6.5% CAGR through 2030.

Which industry segment is expanding the fastest?

Pharmaceutical & Biologics is forecast to grow at 7.65% CAGR as biologics manufacturing and method validation intensify external quality assessment requirements.

How large is the North American share of the laboratory proficiency testing market?

North America contributed 42.34% of global revenue in 2024, supported by mandatory CLIA participation and FDA, EPA program demands.

Why are independent proficiency testing providers gaining share?

Laboratories prefer vendor-neutral programs to avoid perceived conflicts of interest and to access broader multi-platform benchmarking.

Laboratory Proficiency Testing Market Report Snapshots