Laboratory Proficiency Testing Market: Trends And Competitive Analysis

Report overview 

The increasing focus on water testing to identify micropollutants, contaminants, and microorganisms in freshwater and wastewater. Common microbial contaminants include Legionella, Legionella pneumophila, Salmonella, enterococci, E. coli, Pseudomonas aeruginosa, coliforms, and staphylococci. Proficiency testing is critical in water microbiology as it ensures laboratories can reliably detect and quantify such contaminants. Through blind sample distribution, proficiency testing programs evaluate a laboratory’s capability to perform accurate and consistent water quality analysis, thus safeguarding public health. 

Further expanding the market, proficiency testing is used in environmental science to determine groundwater age using tritium, helping map aquifer reserves and assess vulnerability to surface contamination. According to the International Atomic Energy Agency (IAEA), only about half of the 78 laboratories conducting tritium testing currently meet the necessary analytical standards. Initiatives like the IAEA’s 2020 training program aim to improve global testing capabilities. Moreover, new product launches continue to create market opportunities. For instance, in March 2022, BIPEA introduced a new Proficiency Testing Scheme (PT 35d) for microbiological water testing, enabling labs to measure yeast and mold levels in freshwater. 

The legalization and increasing acceptance of medical cannabis in many countries, including the U.S., has significantly amplified the demand for laboratory proficiency testing. This testing is essential to ensure the safety, potency, and regulatory compliance of cannabis products. With the expansion of the cannabis industry, laboratories must demonstrate accurate performance in areas such as potency determination, pesticide residue analysis, microbial contamination, and heavy metal detection. 

In 2024, the U.S. had a sharp spike in foodborne illness outbreaks, with nearly 1,400 reported cases-98% of which were linked to just 13 significant outbreaks involving Listeria, Salmonella, and E. coli. Notably, a Listeria outbreak from frozen supplemental shakes led to 12 deaths across 21 states. These alarming figures have intensified regulatory scrutiny and underscored the necessity for enhanced food testing and quick recall capabilities. 

Estimated Annual Number Of Foodborne Illnesses, Hospitalizations, And Deaths Caused By Seven Major Pathogens, U. S.

The major pathogens, excluding Toxoplasma gondii, caused an estimated 9.9 million domestically acquired foodborne illnesses.

53,300 hospitalizations

An estimated 53,300 hospitalizations resulted from domestically acquired foodborne illnesses caused by the seven pathogens.

931 deaths

An estimated 931 deaths resulted from domestically acquired foodborne illnesses caused by the seven pathogens. 

Recent market trends and advancements

Digitalization & Automation: Laboratories globally are undergoing digital transformation, and proficiency testing programs are no exception. Vendors are integrating cloud-based portals, automated result submission systems, and LIMS (Laboratory Information Management System) connectivity to reduce administrative burden and improve accuracy. 

Key Developments

Digital PT Portals: Many providers now offer platforms that manage the entire proficiency testing lifecycle from registration and sample shipment tracking to result submission and feedback. These portals are helping laboratories save time and reduce manual errors. 

Cloud Integration: Integration of PT systems with Laboratory Information Management Systems (LIMS) streamlines data flow and reduces duplication. Companies such as Bio-Rad and LGC Limited are providing APIs and middleware solutions for this purpose. 

AI/ML-Driven Tools: Real-time access to PT performance reports, benchmarking tools, and corrective action tracking is now becoming standard among leading vendors. This has also facilitated remote participation, especially during and after the COVID-19 pandemic. 

LIMS Integration: AI and Machine Learning: Artificial intelligence is being used to identify trends and anomalies in PT results, enabling real-time feedback, early warning alerts, and predictive analytics. 

The Challenges and Opportunities in the Market

Challenges: 

The study, "Evaluating proficiency testing implementation and identifying challenges that government comprehensive specialized hospital laboratories in northwest Ethiopia faced as they participated in the external quality assessment scheme," published in American Journal of Clinical Pathology (September 2024), assesses the implementation of proficiency testing (PT) in government hospital laboratories in northwest Ethiopia. Conducted as a cross-sectional study from 2020 to 2022, it analyzed 41 laboratory test parameters across three hospitals. The study found that only 59.3% of tests were implemented properly, and 54.3% of laboratories performed adequately. The participation rate was 68.7%, with 61.8% maintaining consistency over three years. 

The key challenges identified included insufficient reagents and supplies, equipment malfunctions, inadequate proficiency testing materials, lack of management support, budget constraints, and insufficient training. Personnel shortages and motivation issues further contributed to ineffective implementation. 

Challenges in proficiency testing implementation in government hospital laboratories

Source: Evaluating proficiency testing implementation and identifying challenges that government comprehensive specialized hospital laboratories in northwest Ethiopia faced as they participated in the external quality assessment scheme," published in American Journal of Clinical Pathology (September 2024) 

The study highlights the need for stronger managerial support, increased budget allocation, improved access to PT materials, and better training programs to enhance laboratory performance. Addressing these issues is essential for ensuring higher-quality diagnostics and regulatory compliance in hospital laboratories. 

Opportunities:

Remote and AI-Assisted Testing: As cloud platforms mature, PT programs can offer instant result validation, benchmarking, and suggested corrective actions.

Localized PT Schemes: There is high potential for growth through development of regional or country-specific PT offerings that meet unique regulatory and linguistic needs.

Sustainability Innovations: Vendors can differentiate through eco-friendly PT kits, including biodegradable packaging and digital-only workflows.

Collaborative Ecosystems: Partnerships with government agencies, academic institutions, and public health organizations can drive PT coverage and innovation, particularly in underserved markets. 

Opportunities by Industry

1.    Clinical Diagnostics

The clinical diagnostics market presents a prime opportunity for laboratory proficiency testing providers. Increasing demand for accurate & reliable diagnostic testing and stringent regulatory requirements is expected to create growth opportunities for proficiency testing services. By offering comprehensive proficiency testing programs, providers can help laboratories meet regulatory compliance and ensure the accuracy of diagnostic results. In addition, advancements in diagnostic technologies and the expansion of point-of-care testing open new avenues for proficiency testing providers to develop innovative testing methodologies and cater to emerging trends. Increasing focus on quality assurance and patient care is expected to propel the demand for laboratory proficiency testing in the clinical diagnostics sector. 

According to an article published in African Journal of Laboratory Medicine in January 2024, proficiency testing (PT) is a critical component of external quality assessment (EQA) programs, ensuring laboratory accuracy in diagnostic testing. PT programs distribute pre-characterized clinical specimens to participating laboratories, which analyze and report results. Comparisons with established reference values help identify performance gaps and areas for improvement. PT is a requirement for laboratory accreditation and regulatory compliance. In East Africa, the East African Regional External Quality Assessment Scheme (EA-REQAS) coordinates PT for various diagnostic tests, including microbiology, serology, and molecular diagnostics. PT also supports laboratory training, policy development, and post-marketing surveillance of diagnostic products. 

2.    Pharmaceuticals

Stringent regulatory requirements in pharmaceutical manufacturing and quality control necessitate proficiency testing to ensure compliance. This creates a demand for comprehensive proficiency testing programs that support pharmaceutical laboratories in meeting regulatory standards.

In addition, with the increasing focus on patient safety and product quality, the need for accurate & reliable testing in the pharmaceutical industry is expected to grow. Consequently, proficiency testing providers can capitalize on this by offering programs that assess and improve laboratory testing capabilities, ensuring accurate & consistent results. In addition, proficiency testing programs can assist in developing and validating analytical methods for pharmaceutical products, enabling laboratories to demonstrate the accuracy & reliability of their testing procedures. 

Moreover, the biologics industry presents opportunities for laboratory proficiency testing providers to ensure regulatory compliance, quality assurance, and accurate testing of biologic products. With the increasing demand for biologics globally, proficiency testing providers can expand their services and cater to the specific testing needs of biologic therapies. By offering comprehensive proficiency testing programs tailored to the complexities of biologics, providers can aid in maintaining high-quality standards, regulatory compliance, and the development of safe and effective biologic products. Moreover, the increasing involvement of pharmaceutical & biotechnology companies, research & academic institutes, Contract Research Organizations (CROs), and others in the development & manufacturing of novel therapeutic products are anticipated to increase the demand for proficiency testing to obtain external quality assurance. 

3.    Microbiology

Laboratory proficiency testing players are expected to witness ample opportunities in microbiology testing. They can develop specialized programs catering to specific industries, such as food and beverages, pharmaceuticals, and healthcare, addressing their unique microbiology testing requirements. By staying at the forefront of technological advancements in microbiology testing methods, these players can offer innovative solutions and ensure laboratories are proficient in the latest techniques. Expanding their services globally allows them to tap into the growing demand for standardized microbiology testing across different regions and comply with international regulations. By seizing these opportunities, laboratory proficiency testing players can strengthen their market position, expand their customer base, and contribute to the quality & reliability of microbiology testing practices. 

Rising food safety regulations and industry standards drive demand for proficiency testing (PT) in microbiology. Increased compliance needs, quality assurance focus, and laboratory accreditation requirements fuel market growth for PT providers in food microbiology. In January 2024, BIPEA has introduced a new proficiency testing scheme, 56A: Microbiology in Flours: Artificial Contamination, to improve flour safety standards. The test assesses laboratories' ability to detect Salmonella spp. and quantify E. coli (CFU/g) in flour samples using NF ISO 16649-2 and NF ISO 6579-1 standards. The first round is scheduled for June 2024, with a registration deadline of April 26, 2024. Participating labs will receive 50g flour samples and must submit results within four weeks of shipment. This initiative aims to standardize microbiological testing across the industry. 

The growing emphasis on food safety and regulatory compliance drives demand for standardized microbiological testing in flour and grain products. PT providers can expand their services by developing customized proficiency testing schemes for food microbiology labs. This also highlights a market need for quality assurance programs to help laboratories maintain compliance with ISO standards. As food safety regulations tighten, more industries may adopt PT programs, creating further growth opportunities in microbiological quality control. 

Innovations and Key Competitors in the Laboratory Proficiency Testing Market:

Key Competitors landscape analysis

Major players utilize inorganic growth strategies to expand their product & service offerings in different regions, which results in increased share and opening up of new revenue streams. This enables the companies to benefit from economies of scale, allowing them to provide competitive prices and top-notch client services. Moreover, by continuing to spend in R&D to enhance the effectiveness and dependability of diagnostic enzymes, these businesses seek to increase their competitiveness even more.

Table 1 Recent strategic initiatives by key companies

Company Profile

BIPEA 

Company Overview:

• Headquarters: Courtaboeuf, France

• Founded: 1987

• Ownership: Private

• Specialization: BIPEA is a leading European provider of proficiency testing and quality control programs, primarily serving clinical laboratories. It offers a wide range of PT schemes covering microbiology, hematology, clinical chemistry, immunology, and molecular diagnostics, helping labs maintain accreditation and compliance with regulatory standards.

• Global Presence: Strong presence in Europe, particularly France, with expanding reach across international markets through partnerships and customized PT solutions. It emphasizes tailored services for emerging markets and specialized sectors like food microbiology and water testing.

Service Benchmarking

Testing Services:
Purified Water for Pharmaceutical Applications, Residual Solvents in Excipients, Microbiology of Pharmaceutical Process Water                                  

Customized PT Programs:

It includes:

• Quality control for a group of laboratories

• Verification of methods

• Characterization of methods (ISO 5725)

• Statistical study of results

• Manufacture of internal reference materials

• Preparation of control samples

Other Testing Services