임상 검사 기능 시험 시장(2025-2034년) : 기회, 성장 촉진요인, 산업 동향 분석, 예측

The Global Laboratory Proficiency Testing Market was valued at USD 1.4 billion in 2024 and is estimated to grow at a CAGR of 5.8% to reach USD 2.5 billion by 2034. A significant driver behind this expansion is the rising demand for robust quality control in laboratory settings, as well as increased usage of proficiency testing across a range of sectors. With growing regulatory scrutiny and more laboratories seeking accreditation, the market is experiencing a boost in participation. The expansion of clinical diagnostics labs and heightened focus on precision testing to manage chronic and infectious diseases are further strengthening market momentum.

As chronic health issues and communicable diseases continue to surge, the reliance on accurate diagnostics has grown substantially. To uphold international standards and reduce the risk of misdiagnosis, proficiency testing programs are being adopted more widely. These quality assurance programs are becoming critical due to the broader application of advanced diagnostic technologies like genetic and molecular testing. Public and private stakeholders alike are investing in strengthening laboratory infrastructure to meet these evolving standards. Compliance requirements from organizations such as CLIA, ISO, and CAP now mandate routine proficiency evaluations to sustain certifications and meet global quality benchmarks.

The clinical diagnostics segment reached USD 462 million in 2024, accounting for the largest share in the market. This dominance stems from the critical role accurate diagnostic testing plays in managing patient health outcomes. With the growing burden of chronic illness, there is a higher dependency on diagnostic accuracy, which makes proficiency testing non-negotiable for high-volume labs. Facilities conducting extensive panels in microbiology, molecular testing, and hematology are placing an even greater emphasis on alignment with international frameworks like ISO 15189. As advanced diagnostics see greater adoption across medical institutions, the need for rigorous proficiency assessment continues to rise, ensuring reduced error rates and improved patient outcomes.

The cell culture testing segment is set to grow at a CAGR of 5.3%, reaching USD 688.7 million by 2034. Cell culture is foundational to the production of biologics, vaccines, and various cell-based therapeutics. To maintain consistency and prevent contamination, laboratories must regularly assess their techniques and materials through proficiency testing. Labs operating under GMP guidelines, particularly those in biologics and regenerative medicine, depend on these evaluations to ensure process reliability and regulatory compliance. Furthermore, as new therapies like stem cell treatments and tissue engineering gain momentum, demand for standardized lab practices and reliable results through proficiency testing is expected to escalate.

United States Laboratory Proficiency Testing Market was valued at USD 476.3 million in 2024 and is forecast to grow at a CAGR of 4.9% from 2025 to 2034. The country leads the global market due to its strong regulatory foundation and robust diagnostics infrastructure. Strategic funding initiatives have further fueled progress in lab accuracy. Investments totaling USD 1.7 billion were dedicated to expanding testing capacity, particularly in the areas of infectious disease detection and molecular diagnostics. Federal health programs are also pushing for higher participation in proficiency evaluations, with nearly full coverage of public health labs as of 2024, which significantly supports market growth in the region.

Prominent industry players in the Laboratory Proficiency Testing Market include Aashvi PT, BIO-RAD, LGC, American Proficiency Institute, COLLEGE of AMERICAN PATHOLOGISTS, QACS LAB, FAPAS, FLUXANA, AOAC INTERNATIONAL, RANDOX, MERCK, Trilogy, WEQAS, Waters, and ABSOLUTE STANDARDS. This include strengthening their service portfolios through expansion into specialized testing areas such as molecular biology, microbiology, and toxicology. Firms are also investing in digital platforms to streamline proficiency test result submissions and automate data analysis. Custom-designed PT schemes tailored to emerging diagnostic technologies have become a central focus, while partnerships with regulatory bodies are helping these companies align with evolving global quality standards. Additionally, strategic mergers, collaborations with diagnostic laboratories, and geographic expansion into emerging economies help increase their competitive footprint and meet the growing demand for accredited testing services.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Industry trends
  • 2.2.3 Technology trends
  • 2.2.4 Application trends
• 2.3 CXO perspectives: Strategic imperatives
  • 2.3.1 Key decision points for industry executives
  • 2.3.2 Critical success factors for market players

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Stringent safety and quality regulations for food and pharmaceuticals products
    • 3.2.1.2 Increasing demand for water testing
    • 3.2.1.3 Proficiency testing is a necessary pre-requisite for laboratory's operational excellence
    • 3.2.1.4 Legalization of medical cannabis and increasing number of cannabis testing laboratories
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Dearth of skilled professionals
    • 3.2.2.2 Requirement of high-capital investments for advance testing facilities
  • 3.2.3 Market opportunities
    • 3.2.3.1 Technological advancements in testing industry
    • 3.2.3.2 Increasing adoption of proficiency tests to prevent food adulteration
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 U.S.
  • 3.4.2 Europe
• 3.5 Technology landscape
• 3.6 Gap analysis
• 3.7 Porter's analysis
• 3.8 PESTEL analysis
• 3.9 Policy landscape
• 3.10 Future market trends

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
  • 4.3.1 By Region
    • 4.3.1.1 North America
    • 4.3.1.2 Europe
    • 4.3.1.3 Asia Pacific
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard
• 4.7 Key developments
  • 4.7.1 Mergers and acquisitions
  • 4.7.2 Partnerships and collaborations
  • 4.7.3 New services launches
  • 4.7.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Industry, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Clinical diagnostics
• 5.3 Microbiology
• 5.4 Pharmaceuticals
• 5.5 Food and beverages
• 5.6 Biologics
• 5.7 Other industries

Chapter 6 Market Estimates and Forecast, By Technology, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Cell culture
• 6.3 Immunoassays
• 6.4 Polymerase chain reaction
• 6.5 Spectrometry
• 6.6 Chromatography
• 6.7 Other technologies

Chapter 7 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Pathogen detection
• 7.3 Molecular infectious disease testing
• 7.4 Blood chemistry and hematology panels
• 7.5 Sterility assurance
• 7.6 Endotoxin and pyrogen testing
• 7.7 Residual solvent and contaminant analysis
• 7.8 Other applications

Chapter 8 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 Aashvi PT
• 9.2 ABSOLUTE STANDARDS
• 9.3 American Proficiency Institute
• 9.4 AOAC INTERNATIONAL
• 9.5 BIO-RAD
• 9.6 COLLEGE of AMERICAN PATHOLOGISTS
• 9.7 FAPAS
• 9.8 FLUXANA
• 9.9 LGC
• 9.10 MERCK
• 9.11 QACS LAB
• 9.12 RANDOX
• 9.13 Trilogy
• 9.14 Waters
• 9.15 WEQAS