실험실 능력 검증 시장 크기 및 공유 2025 – 2034

Laboratory Proficiency Testing Market Size

The global laboratory proficiency testing market was valued at USD 1.4 billion in 2024. The market is expected to reach from USD 1.5 billion in 2025 to USD 2.5 billion in 2034, growing at a CAGR of 5.8% during the forecast period. The high market growth is attributed to the growing demand for quality assurance in laboratory operations, the rising adoption of proficiency testing across various industries, surging stringent regulatory and accreditation requirements, and expansion of clinical diagnostic laboratories, among other contributing factors.
 

The growing prevalence of chronic conditions alongside infectious diseases has increased the need for precise laboratory diagnostics. Proficiency testing programs help ensure that laboratories comply with international benchmarks, reducing the chances of diagnostic errors. Further, there is a growing need for advanced diagnostic instruments, including molecular diagnostics and genetic testing, which require strict quality control processes such as proficiency testing. Both government and non-government institutions are enhancing laboratories to improve the overall patient safety and treatment outcomes. For instance, developed and emerging countries are adopting proficiency testing, which is aiding in expanding the market.
 

Moreover, organizations such as ISO (the International Organization for Standardization), CAP (the College of American Pathologists), and CLIA (the Clinical Laboratory Improvement Amendments) have put stricter policies in place that require laboratories to undergo quality audits and proficiency testing in order to adhere to pre-established standards. Laboratories must undertake proficiency testing on a regular basis in order to sustain their accreditations. Emerging markets, along with increasing awareness of advanced testing methodologies, are now contributing to enhanced laboratory proficiency testing, thus fostering expansion in this segment.
 

Laboratory proficiency testing is defined as an external quality audit where the testing methodology is assessed to determine the precision and accuracy of various laboratories which is compared to each other. This guarantees conformity to international frameworks while enforcing uniformity and enhancement cycles. Proficiency testing is vital in sustaining the integrity of diagnostics, particularly in clinical, pharmaceutical, and industrial fields.
 

Laboratory Proficiency Testing Market Trends

The market is shifting with the new advancements in testing methodologies, automation, and the use of digital technologies. A growing shift towards analyzing proficiency test results using AI and ML has also been noted. These technologies help in making assessments more accurate by detecting anomalies and assessing patterns far beyond human capabilities.
 

• Additionally, remote and digital platforms for proficiency testing are becoming more widely accepted such that geographically distant laboratories can now engage in overseas testing programs without the need for physical sample transport. As per the data by College of American Pathologists (CAP), digital proficiency testing participation increased by 45% between 2021 and 2023. WHO reported that more than 2,500 laboratories in 120 countries were using digital proficiency testing in 2023, marking a 60% increase from 2021 numbers.
   
• In addition, there is an increasing number of interlinked laboratories from different countries which has led to the development of international proficiency testing systems. For example, the WHO and CDC are working together to implement standardized proficiency testing on all global laboratories to evaluate their pandemic preparedness and response capabilities. With the increasing adoption of high-throughput tested technologies by laboratories, the proficiency testing provider is also expanding workload-optimized scalable solutions, thereby further increasing the market.
   

Laboratory Proficiency Testing Market Analysis

Based on industry, the market is segmented as clinical diagnostics, microbiology, pharmaceuticals, food and beverages, biologics, and other industries. The clinical diagnostics segment generated revenue of USD 462 million in 2024.
 

• Clinical diagnostics holds the largest share in the market, as accurate test results are vital for patient diagnosis and management. As reported by the World Health Organization (WHO), cancer claimed around 10 million deaths worldwide in 2022, whereas diabetes impacted 537 million adults aged 20 and 79 years.
   
• Similarly, CDC shows that cardiovascular diseases accounted for 1 in every 5 deaths in the U.S. as of 2021. The International Diabetes Federation is expecting the cases of diabetes to rise to 570 million by 2024. Owing to these reasons, there has been a consistent increase in chronic health conditions. This also means a greater reliance on diagnostic testing, thus making proficiency testing imperative to sustaining laboratory standards.
   
• In addition, laboratories that have high volumes of tested blood panels, microbiology cultures as well as molecular assays have a sharper focus on compliance with international standards such as iso 15189 and CLIA due to the nature of these tests. Moreover, other healthcare facilities are increasingly adopting advanced diagnostics which in turn enhances the need of proficiency testing which in turn refine error margins and enhance outcomes for patients, thereby leading to the segmental growth in the market.
   

Based on technology, the laboratory proficiency testing market is segmented as cell culture, immunoassays, polymerase chain reaction, spectrometry, chromatography, and other technologies. The cell culture segment is expected to drive business growth and expand at a CAGR of 5.3%, reaching over USD 688.7 million by 2034.
 

• Cell culture remains critical in creating biologics such as monoclonal antibodies, vaccines, and cell-based therapies. As the biopharma industry expands, laboratories must maintain reproducibility in cultured cell lines. To ensure cell viability, contamination control, and media quality, Proficiency Testing (PT) can confirm key parameters. There is always a need for validated processes created by regulatory authorities which biologics cell culture based labs have, thus increasing the need for PT. This is particularly important for GMP compliant facilities.
   
• The use of cell cultures is also found in the development of stem cell therapies and in tissue engineering and personalized medicine. Proficiency testing ensures standardization which decreases the variability and risk for human cell handling. With a sharp increase in the demand for advanced therapies, there has also been a focus on developing proficiency testing monitoring area of cell morphology, contamination detection, and cell line authentication.
   
• Cell culture is employed extensively in preclinical drug screening and in vitro toxicology due to the reduced need for animal models. These assays need to be reproducible and biologically relevant, which makes PT crucial for validating assay performance. Labs participate in PT programs to maintain accuracy in cell, cytotoxicity, and proliferation assays. Furthermore, the expansion of high-throughput screening accelerates the need for proficiency testing.
   

Based on application, the market is segmented as pathogen detection, molecular infectious disease testing, blood chemistry and hematology panels, sterility assurance, endotoxin and pyrogen testing, residual solvent and contaminant analysis, and other applications. The pathogen detection segment dominated the market with a revenue share of 28% in 2024.
 

• Foodborne pathogens such as Salmonella, Listeria, and E. coli and others are increasingly being considered as public health concerns as they prompt the need for better and enhanced food safety regulations. Laboratories that deal with food and agriculture are required by the regulatory bodies to take part in PT Chekcing Systems to ensure accuracy and trustworthiness in pathogen testing. Compliance Motivation is fostered by HACCP, FSMA (U.S.), and worldwide export obligations. Testing aids that have to comply with interkational criteria have been increasing due to the globalization of food supply chains, thus increasing the demand for PT schemes concentrating on pathogens.
   
• In addition, the embrace of culture methods into molecular tools such as PCR and Next Generation Sequencing brings about new security challenges. PT ensures that advanced techniques are not misapplied so that appropriate measures are taken and reliable outcomes are achieved. It is obligatory for laboratories to validate grade of the workflows, reagents used, and performance meta-analysis. With increasing accuracy of molecular diagnostic techniques, PT becomes increasingly relevantnof being ASSured of DeSemina standards hence leading to segmental growth.
   

U.S. laboratory proficiency testing market was valued at USD 389.3 million and USD 421.2 million in 2021 and 2022, respectively. The market size reached USD 476.3 million in 2024, growing from USD 449.3 million in 2023 and is anticipated to grow at a CAGR of 4.9% between 2025 to 2034 period.
 

• The U.S  remains the leading participant in the global market, owing to its well-established regulatory environment and extensive diagnostic research infrastructure. In 2023, the CLIA-certified laboratories in the U.S. had surpassed 320,000, with nearly 36% of them enrolled in mandatory proficiency testing programs. The College of American Pathologists (CAP) saw a year-on-year 15% increase in laboratory participation from 2021 to 2023, with over 23000 laboratories enrolled in their proficiency testing programs.
   
• Federal pandemic readiness programs earmarked funds in 2022 to improve laboratory testing including proficiency testing for infectious diseases and advanced molecular diagnostics of USD 1.7 billion. The CDC’s Laboratory Response Network is aimed at public health laboratories with emerging pathogen detection and molecular diagnostics and broadened their proficiency testing requirements to public health laboratories and claims coverage of 95% by 2024.
   
• Other major U.S. based companies are leading the market trends by increasing compliance through the introduction of Artificial Intelligence (AI) and remote based proficiency testing systems. This, alongside the increased availability of point-of-care diagnostics and decentralized testing further supports growth in the country.
   

Europe laboratory proficiency testing market accounted for USD 333 million in 2024 and is anticipated to show lucrative growth over the forecast period.
 

• With a strong policy framework covering adoption of ISO/IEC 17025 and ISO 15189, Europe mandates proficiency testing for many laboratories. Enforcement bodies such as European Cooperation for Accreditation (EA) and national bodies ensure adherence to these policies. This sort of regulatory enforcement guarantees uniform engagement across industries in PT schemes. Certification and operational readiness hinges on compliance. Increased regulatory scrutiny continually enhances PT demand.
   
• Europe has a well-established healthcare infrastructure and a growing number of diagnostic laboratories, especially in countries like Germany, France, and the UK. With rising demand for precision diagnostics and compliance with EU IVD Regulation (IVDR), labs are increasingly required to verify test accuracy via PT. The aging population and growing chronic disease burden further boost clinical testing volume. This fuels recurring participation in PT programs.
   

UK laboratory proficiency testing market is projected to grow remarkably in the coming years.
 

• In the UK, the market is growing due to rising investments in healthcare infrastructure and laboratory services. The NHS and private laboratories prioritize participation in proficiency testing programs to maintain high standards of diagnostic accuracy and patient safety. ISO 15189 accreditation requirements further propel market adoption in the UK.
   
• Additionally, the UK's focus on advanced molecular diagnostics and biopharmaceutical research has driven demand for proficiency testing in specialized domains such as cell culture and genetics. Collaborations between academic institutions and commercial laboratories have also increased the scope of testing programs in the region.
   

The Asia Pacific laboratory proficiency testing market is anticipated to grow at the highest CAGR of 6.6% during the analysis timeframe.
 

• The Asia Pacific region is witnessing an increase of diagnostic laboratories due to elevation in investments of the healthcare sector, increasing burden of diseases, and urbanization. The clinical testing capabilities of China, India, and other Southeast Asian nations is growing at a quicker pace. Along with this expansion, there is increasing need for labs to participate in proficiency testing for national and international standards acceptance. Both public and private sectors are supporting this, significantly increasing demand in the PT market.
   
• Governments in this region are intensifying the PT frameworks aimed at improving laboratory standards as well as patient services. National accreditation bodies like NABL (India), CNAS (China), JAB (Japan) have mandatory requirements of PT participation for certification. There is an increase in laboratories seeking accreditation which positively influences PT enrollment. The move is also aimed at synchronizing with global agreements such as ISO standards which is intensifying this trend.
   

China holds a dominant position in the Asia Pacific laboratory proficiency testing market.
 

• China is now a focal point in the market for laboratory proficiency testing because of its widening healthcare system as well as new developments in the area of research and technology. Chinese laboratories are now competing for diagnostis on a global scale and so are adopting international standards, which include proficiency testing. Enhanced diagnostic requirements and improving healthcare services have increased the need for effective and accurate diagnostic tools in the country.
   
• Policies that promote the awarding of laboratory accreditations and high end methodologies of carrying out the tests are significant. In addition, the growth of the bio-pharmaceutical and biotechnological sectors in China has increased the demand for cell culture proficency testing programs, thereby consolidating the country’s market position.
   

The Brazil laboratory proficiency testing market is experiencing robust growth in Latin America market.
 

• Brazil has developed into one of the world’s leading exporters of agricultural and food products, which sell in global markets after undergoing stringent quality checks. Laboratories responsible for checking pesticide, contaminant, and pathogen residues require proficiency testing. Testing accuracy validation is also critical in pollution monitoring driven by industrial activity and ecological regulations. Legislative bodies supporting PT such as MAPA (Ministério da Agricultura) and IBAMA (Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis) increase adoption.
   
• With innovation and health policies, Brazil is now funding research institutions, public health laboratories, and university-affiliated testing centers. These centers often take part in proficiency testing to qualify for PT and gain credibility, obtain funding, and enhance their reputation. There is a growing emphasis on biosciences, clinical research, disease surveillance, and healthcare innovation in the country that promotes PT. With the development of new technologies and laboratory capabilities, the demand for PT to confirm consistent results escalates.
   

Saudi Arabia laboratory proficiency testing market is poised to witness substantial growth in Middle East and Africa market during the forecast period.
 

• Saudi Arabia's Vision 2030 plan strategically allocates funds for healthcare system diagnostics, clinical laboratories, and other health-related technologies. In line with the country's pivot towards value-driven healthcare, laboratory medicine is being upgraded to international standards. Proficiency testing is regarded as an indispensable measure in safeguarding laboratory accuracy and reliability. This transformation is creating a sustained demand for PT programs to support healthcare excellence and compliance with mandatory national standards.
   
• The Saudi government created the centers for disease control and public health centers as reference labs to enhance the surveillance of diseases of public health concern. To provide benchmark quality, these laboratories work under strict quality control measures. Accreditation through PT fosters uniformity within laboratory systems and strengthens the trust in the national diagnostic programs. This centralized approach to laboratory development is the primary reason for accelerated adoption of proficiency testing in all sectors.
   

Laboratory Proficiency Testing Market Share

The market is moderately consolidated, with the top key players accounting for approximately 33% of the total market share. The competitive landscape is driven by a mix of global accreditation bodies, specialized independent providers, and institutional organizations offering proficiency testing schemes across various sectors such as clinical diagnostics, pharmaceuticals, food safety, and environmental testing. Leading companies compete based on their scope of test offerings, geographic reach, regulatory accreditation (e.g., ISO/IEC 17043), and technological integration for online result reporting and data analytics. Strategic collaborations with healthcare institutions and increasing demand for quality assurance programs across emerging markets are also shaping the competitive dynamics, with players focusing on expanding program diversity and compliance with international standards.
 

Laboratory Proficiency Testing Market Companies

Prominent players operating in the laboratory proficiency testing industry include:

• Aashvi PT
• ABSOLUTE STANDARDS
• American Proficiency Institute
• AOAC INTERNATIONAL
• BIO-RAD
• COLLEGE of AMERICAN PATHOLOGISTS
• FAPAS
• FLUXANA
• LGC
• MERCK
• QACS LAB
• RANDOX
• Trilogy
• Waters
• WEQAS
   
• Bio-Rad offers one of the most extensive External Quality Assessment (EQA) programs globally, covering clinical chemistry, immunoassays, infectious diseases, molecular diagnostics, and more helping labs meet regulatory and accreditation requirements with ease.
   
• College of American Pathologists (CAP) proficiency testing programs are globally recognized and often required for CLIA certification in the U.S., offering unmatched peer group comparison and stringent performance monitoring.
   

Laboratory Proficiency Testing Industry News

• In October 2024, Bio-Rad Laboratories launched its External Quality Assurance Services Specialty Immunoassay program (laboratory proficiency testing service) covering 13 key analytes. The program consolidated multiple EQA needs into a single, cost-effective solution for clinical labs. This development strengthened Bio-Rad's position in the market by offering a comprehensive and cost-effective solution, thereby attracting a broader customer base and driving market adoption.
   
• In October 2024, LGM Pharma expanded its analytical testing services (ATS) by introducing endotoxin and rapid sterility testing capabilities at its Irvine, California facility. These enhancements aim to accelerate turnaround times, improve quality control, and reduce costs for drug developers, particularly benefiting those producing sterile and injectable products.
   

The laboratory proficiency testing market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments: