LABORATORY PROFICIENCY TESTING MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

The Laboratory Proficiency Testing Market size is expected to reach US$ 2.11 billion by 2030, from US$ 1.29 billion in 2023, at a CAGR of 7.3% during the forecast period. Laboratory proficiency testing involves the use of interlaboratory comparisons to determine the performance of individual laboratories for specific tests or measurements and monitoring laboratories' continuing performance. It is used to assess and enhance the quality of laboratory testing processes. The key advantages of proficiency testing include improving patient safety through robust quality control, meeting regulatory compliance standards, and gaining a competitive edge for laboratories.

The growth in the market is driven by factors such as the rising number of accredited laboratories and regulatory mandates for proficiency testing. The Laboratory Proficiency Testing Market is segmented by product & service, industry, and region. By product & service, the market is segmented into proficiency testing, reference material manufacturing, consultancy & advisory services, quality assurance services, and others, and By Industry the market is segmented into  Clinical Diagnostics, Pharmaceuticals, Biologics, Medical Devices, Food & Animal Feed, Commercial Beverages, Others. The proficiency testing segment accounted for the largest share of the Laboratory Proficiency Testing Market in 2022. The large share of this segment is attributed to the high use of proficiency testing services by laboratories to assess and monitor the quality of their testing processes.

Laboratory Proficiency Testing Market Regional Insights:

• North America is expected to be the largest market for Laboratory Proficiency Testing Market during the forecast period, accounting for over 40% of the market share in 2022. The growth of the market in North America is attributed to supportive government initiatives and a well-established healthcare system in the region.
• The Europe market is expected to be the second-largest market for Laboratory Proficiency Testing Market, accounting for over 30% of the market share in 2022. The growth of the market in is attributed to the presence of leading proficiency testing companies and stringent regulatory guidelines in the region.
• The Asia Pacific market is expected to be the fastest-growing market for Laboratory Proficiency Testing Market, with a CAGR of over 9% during the forecast period. The growth of the market in Asia Pacific is attributed to increasing investments in healthcare infrastructure and growth of the pharmaceutical and biotechnology industries in the region.

Figure 1. Global Laboratory Proficiency Testing Market Share (%), By Region, 2023

Laboratory Proficiency Testing Market Drivers:

• Growing adoption of proficiency testing services: The increasing adoption of proficiency testing services by laboratories is a major factor driving growth of the laboratory proficiency testing market. Proficiency testing enables laboratories to evaluate and monitor the quality and accuracy of their testing processes. More laboratories are utilizing these services to meet quality standards and regulatory requirements. The rising number of accredited laboratories and need to gain ISO certifications is further fueling the adoption of proficiency testing services. Many labs are also using these services to train staff, identify gaps, implement corrective measures, and improve patient safety. The growing reliance of healthcare providers on accurate test results provided by labs and rising focus on providing quality patient care are some of the key factors propelling the adoption of proficiency testing services.
• Increasing regulations and standards for laboratory accreditations: The imposition of stringent regulations and standards for laboratory accreditations and certifications is boosting the growth of the laboratory proficiency testing market. Government bodies and organizations such as CLIA, CAP, and ISO have mandated proficiency testing as an essential laboratory quality control measure. For instance, CLIA regulations in the US require proficiency testing for all regulated analytes. Additionally, many countries in Europe have adopted ISO 15189 standards which include requirements for quality control through proficiency testing. Such stringent regulatory policies are compelling laboratories to adopt proficiency testing regularly to maintain accreditation. This has led to increased demand for proficiency testing products and services.
• Outsourcing of clinical testing services to accredited laboratories: The growing trend of outsourcing clinical testing services to third-party accredited laboratories is propelling market growth. Many hospitals and physician offices lacking capabilities outsource services to certified independent labs that have expertise in conducting complex tests. As these accredited labs need to undertake proficiency testing regularly to maintain certifications, it is generating significant demand for proficiency testing services and boosting market expansion. Moreover, the rising burden of infectious diseases is compelling healthcare providers to outsource testing to labs with robust quality control through proficiency testing programs.
• Advancements in proficiency testing models and programs: Innovations in proficiency testing models and programs are expected to further accelerate market growth. Proficiency testing providers are utilizing advanced technologies to improve analysis and facilitate seamless data exchange between laboratories. Cloud-based online platforms are enabling easy discoverability and compliance tracking. Additionally, artificial intelligence-based solutions are being used to derive actionable insights from proficiency testing data. The development of highly sensitive PT samples and programs for emerging diseases and technologies such as next-generation sequencing will also boost adoption among laboratories. Such advancements are expanding the scope and utility of proficiency testing services for laboratories.

Laboratory Proficiency Testing Market Opportunities:

• Increasing adoption in emerging countries: The growing focus on improving healthcare quality and laboratory testing standards in emerging countries provides significant growth opportunities for laboratory proficiency testing market. Developing economies such as China, India, Brazil, and South Africa are undertaking initiatives to obtain international laboratory accreditations. This is expected to increase the adoption of quality control and proficiency testing practices to meet ISO and other certification requirements. Moreover, rising investments in healthcare infrastructure development and growth of clinical testing industry in these countries will further support market expansion. Players can capitalize on this demand by offering a diverse range of proficiency testing services tailored to meet the unique needs of laboratories in emerging markets.
• Integration with laboratory information systems: The integration of proficiency testing data management solutions with laboratory information systems provides an excellent opportunity for market players. Automated recording and exchange of proficiency testing data through LIS integration enhances workflow efficiency. It also enables easy and quick access to historical PT performance reports that laboratories can utilize for continuous quality improvement. Players in the market can focus on developing interoperable solutions that align with major LIS systems to increase adoption among laboratories. The launch of combined LIS and proficiency testing data management software can give players a competitive advantage.
• Growing demand for point-of-care testing quality control: The increasing use of point-of-care testing across hospitals, physician offices and homecare settings is creating lucrative opportunities. The rising adoption of POCT devices such as blood glucose meters, INR monitors, and rapid infectious disease tests drive the need for robust PT programs to ensure accuracy of test results. Collaborations between proficiency testing providers and POCT instrument manufacturers can help in the development of specially designed programs for quality control and assessment of POCT devices. Providers can also educate end-users about the importance of PT for POCT through training workshops.
• Partnerships with pharmaceutical and biotechnology companies: Partnerships with pharmaceutical and biotechnology companies provide growth opportunities for laboratory proficiency testing market. Biopharmaceutical firms utilize proficiency testing and external quality assessment for evaluating clinical trial lab sites, validating biomarkers, testing new assays, and monitoring network lab performance. Collaborations allow proficiency testing providers to design specialized programs as per the trial needs. Providers can also leverage the global presence of pharmaceutical companies to expand their geographic reach. Additionally, partnerships in precision medicine research help gain traction among genomic testing labs.

Laboratory Proficiency Testing Market Trends:

• Increasing focus on analytical and statistical analysis: There is an increasing focus on leveraging advanced analytics and statistical techniques for deriving actionable insights from proficiency testing data. Participants are employing statistical tools such as Z-scores, Youden plots, probabilistic and parametric analyses to obtain meaningful inferences from interlaboratory comparisons. This allows identification of performance issues or gaps that need resolution. It also helps determine training requirements and drive continuous quality improvement initiatives. Companies are offering software solutions encompassing analytical modules and decision support systems to aid in trend analysis based on historical proficiency testing data.
• Growing demand for multi-analyte proficiency testing: The demand for multi-analyte proficiency testing programs is growing rapidly. Multi-analyte panels allow simultaneous assessment of a laboratory's competency in testing for multiple analytes using the same clinical sample. This is more efficient and cost-effective compared to running individual PT schemes for each analyte separately. Laboratories are increasingly adopting it to monitor overall test performance, assess multiple instruments and operators, and reduce workload. Proficiency testing providers are expanding options for pre-designed multi-analyte panels covering commonly tested analytes. Custom multi-analyte offerings are also becoming popular.
• Rising adoption of online proficiency testing platforms: Web and cloud-based online proficiency testing platforms are gaining increasing adoption among laboratories due to benefits such as flexibility, ease-of-use, and data accessibility. Laboratories can participate conveniently on their own schedule. It also enables easy assignment and tracking of results as well as access to online reports. Providers are developing such platforms with new features like automated reminders, multi-site data management, and improved navigation. Online platforms also facilitate analysis, information sharing, and corrective action. The COVID-19 pandemic has further accelerated the transition to online proficiency testing solutions.
• Growing demand for interlaboratory comparison programs: There is a growing demand for interlaboratory comparison (ILC) programs as an alternative model for proficiency testing. ILC programs allow laboratories to compare testing performance informally without the risk of losing accreditation. They enable labs to identify potential issues, implement improvements, and validate new assays or instruments compared to peer groups prior to formal proficiency testing. Providers are collaborating with labs and accreditation agencies on the development of national and regional ILC programs focusing on emerging analytes and technologies not covered under existing PT schemes. This is gaining traction especially among research laboratories.

Laboratory Proficiency Testing Market Restraints:

• High costs of implementation and participation: The high costs associated with implementing and participating in proficiency testing programs restraint market growth. Accredited laboratories are required to undertake PT across diverse tests and analytes regularly, which entails very high costs. The expenses are much more pronounced for small to mid-sized laboratories with limited budgets. The costs include program enrollment fees, purchasing PT samples/kits, training, hiring dedicated personnel, implementing corrective actions, and maintaining documentation. Limited reimbursements for participation costs also restrain uptake among resource-constrained laboratories.
• Need for cold-chain logistics for some PT samples: The requirement of cold-chain logistics for the storage and transportation of some proficiency testing samples hinders growth. Samples such as microbiology cultures, coagulation specimens, and blood gas/electrolytes need maintenance under specific temperature conditions. Any temperature fluctuations can lead to alterations in samples and compromise test results. Logistical complexities in ensuring an uninterrupted cold chain increases costs for providers as well as labs. This can restrict participation especially when periodic testing is required using such temperature-sensitive samples.
• Challenges in global standardization and accreditation: Challenges in achieving global standardization and mutual recognition of laboratory accreditation procedures are key factors restricting the growth of the laboratory proficiency testing market. While ISO 15189 standards are internationally recognized, other accreditation programs such as CLIA are applicable to specific countries. Differences in pass/fail criteria, grading methods, and regulatory requirements across countries pose difficulties. This fragments the market and limits growth. Complexities around cross-border shipping of proficiency testing samples also hinder standardization. Lack of cooperation between accreditation agencies is further restricting harmonization.

Recent Developments:

New product launches:

• In January 2022, Randox Laboratories launched the Evidence Investigator cybersecurity software, an information governance tool enabling laboratories to control, secure, trace and report data. It helps ensure data integrity across networks.
• In June 2021, Merck launched the ViaCheck parathyroid hormone (PTH) controls for supporting quality control procedures for PTH assays. It helps ensure accuracy in PTH testing.
• In May 2020, LGC Maine Standards launched VALIDATE® UC1 and UC2 to verify the accuracy of urine drug testing assays. It helps laboratories meet guidelines and regulatory compliance.

Acquisition and partnerships:

• In April 2022, Sartorius acquired a major stake in Biosan Laboratories, a leading provider of calibrated glass capillaries for applications in chemistry and life sciences. This expands Sartorius' capabilities.
• In June 2020, QIAGEN partnered with Illumina to broaden global access to QIAGEN's QuantiFERON-TB test for detection of latent TB infection using Illumina's Next-Generation Sequencing technology.
• In January 2020, Meridian Bioscience acquired the business assets of Methapharm, a provider of quality control solutions for clinical diagnostic assays. This expands Meridian's quality control portfolio.

Figure 2. Global Laboratory Proficiency Testing Market Share (%), by Product & Service, 2023

Top companies in Laboratory Proficiency Testing Market:

• Bio-Rad Laboratories
• LGC Limited
• Merck KGaA
• Randox Laboratories
• Thermo Fisher Scientific
• Westgard QC
• Advanced Analytical Solutions, LLC
• AOAC International
• Bipea
• CAP
• Charmex
• Fera Science Limited (Fera)
• Finning UK & Ireland
• Helena Laboratories
• Hygiena
• International Education and Research Corporation (ERC)
• Maine Molecular Quality Controls, Inc. (MMQCI)
• Microbiologics, Inc.
• NSI Lab Solutions
• QACS Ltd.

Definition: Laboratory proficiency testing involves the use of interlaboratory comparisons to evaluate and ensure the accuracy of results from laboratories. It is a quality assurance program in which multiple laboratories measure the same samples and compare results. The goal is to monitor laboratories' continuing performance and identify issues that need improvement. Proficiency testing helps assess technical competence for specific tests and measurements and is mandated by certification and accreditation programs. It enables laboratories to enhance patient safety, meet regulatory compliance standards, and gain a competitive edge.

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