Laboratory Proficiency Testing Market Size, Share & Trends Analysis Report By Technology (Cell Culture, Spectrometry, Polymerase Chain Reaction, Chromatography, Immunoassays, Others), By Industry Type (Clinical Diagnostics, Microbiology, Pharmaceuticals, Biologics, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Laboratory Proficiency Testing Market Size

The global laboratory proficiency testing market size was valued at USD 1.32 billion in 2023 and is projected to grow from USD 1.43 billion in 2024 to USD 3.32 billion by 2032, exhibiting a CAGR of 7.2% during the forecast period (2024-2032). The growth in the laboratory proficiency testing market is driven by increasing regulatory demands for accuracy and quality assurance, alongside the adoption of advanced technologies and digital platforms to enhance testing efficiency and standardization.

Laboratory proficiency testing is a quality assurance procedure to assess the reliability and accuracy of a laboratory's analytical results. In this procedure, laboratories compare the results of samples with known values to the anticipated results. This testing guarantees that laboratories consistently generate reliable and precise results that comply with established standards. It is an essential instrument for the preservation of high laboratory performance standards and the improvement of the credibility of test results.

Laboratory Proficiency Testing Market Trends

Expansion of Proficiency Testing Programs

Proficiency testing programs increasingly cover various diagnostic fields and specialized tests. This expansion includes launching new and revised surveys to meet diverse diagnostic requirements, exemplified by the updated Molecular Microbiology (MOLE-STI) survey and enhanced cytopathology assessments. This trend improves diagnostic precision and provides advanced training opportunities across various medical specialties.

• For instance, The introduction of the Molecular Microbiology (MOLE-STI) survey, which includes tests for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, replaces an older survey and highlights the evolving needs in infectious disease diagnostics.

This trend indicates a broader approach to proficiency testing, addressing more specific and diverse diagnostic requirements and responding to the need for enhanced accuracy and training across various medical disciplines.

Adoption of Digital Platforms for Proficiency Testing

Adopting digital platforms for managing proficiency testing programs is a key market trend, gaining traction as laboratories seek more efficient and standardized processes. These platforms simplify the workflow, from test result submission to data analysis and reporting, enabling laboratories to participate in proficiency testing remotely. This transition improves the efficiency of testing processes and provides real-time feedback, allowing laboratories to promptly address any issues and maintain high standards of accuracy and quality.

• For instance, Bio-Rad Laboratories launched its Unity Real Time 2.0, a cloud-based platform to enhance the proficiency testing process. This platform offers automated data entry, real-time peer group comparisons, and advanced analytics, allowing laboratories to identify trends and outliers in their testing data quickly. By integrating these digital tools, laboratories can ensure better compliance with regulatory requirements and improve their overall testing performance, reflecting the growing importance of digital transformation in the laboratory proficiency testing market.

Laboratory Proficiency Testing Market Growth Factors 

Stringent Safety and Quality Regulations

Stringent safety and quality regulations imposed by regulatory authorities worldwide significantly drive growth in the laboratory proficiency testing market. These regulations are designed to prevent contamination and ensure the safety of food and pharmaceutical products, thereby protecting public health. As a result, there is a growing demand for proficiency testing services to ensure that laboratories comply with these rigorous standards.
For instance, the U.S. Department of Agriculture (USDA) and the European Food Safety Authority (EFSA) implemented comprehensive guidelines for testing and sampling services in the food industry. 

These guidelines require regular proficiency testing to verify that laboratories can consistently produce accurate and reliable results. The increasing enforcement of these regulations has significantly boosted the proficiency testing market, as laboratories are compelled to participate in proficiency testing programs to maintain their accreditation and meet regulatory requirements.

Increased Launch of Disease-Specific Proficiency Testing

The surge in introducing disease-specific testing initiatives to address the rising complexity and diversity of diseases that laboratories encounter is a crucial driver for market growth. Disease-specific proficiency testing ensures that diagnostic processes are precise and reliable, especially as new pathogens and conditions emerge.

• For instance, In March 2023, the College of American Pathologists (CAP) launched a specialized proficiency testing program for the monkeypox virus following the global outbreak. This program aims to enhance the accuracy and reliability of monkeypox diagnostics, reflecting the growing demand for targeted testing solutions.

This focus on disease-specific proficiency testing helps laboratories stay up-to-date with emerging health threats, supports regulatory compliance, and improves overall diagnostic accuracy. It also highlights the industry's proactive approach to addressing diagnostic needs and public health challenges.

Laboratory Proficiency Testing Market Restraining Factors

High Capital Investments Required for Accurate and Sensitive Testing

The growing reliance on proficiency testing by accreditation bodies to ensure laboratory credibility imposes substantial financial burdens on laboratories. The costs involved in proficiency testing are multi-faceted, encompassing program preparation, sample processing, handling, and reporting. These stages necessitate advanced technologies such as liquid chromatography-mass spectrometry (LC-MS/MS) systems. Although this equipment can detect and quantify many substances, it is a significant capital expenditure. The initial purchase cost, ongoing maintenance, and the need for highly skilled technicians to operate and calibrate the equipment contribute to the financial burden. Additionally, laboratories may require specialized data analysis and interpretation software, further increasing costs.

• For instance, the initial cost of a Liquid Chromatography-Mass Spectrometry (LC-MS/MS) system can range from USD 1,000,000 to USD 2,000,000, as reported by MSACL - Mass Spectrometry & Advances in the Clinical Lab.

Logistical Challenges in Proficiency Testing for Genetic Disorders 

Proficiency testing for genetic disorders faces significant logistical challenges due to the rarity of many conditions and the limited number of specialized laboratories performing these tests. 

• For instance, a study published in the National Center for Biotechnology Information shows that over 2,300 clinical genetic tests are available. Many rare disorders are tested only by a few labs, making comprehensive and representative proficiency surveys difficult. Additionally, the logistical complexity is further compounded by the need to distribute a wide variety of samples to adequately assess the full spectrum of genetic variants, which is challenging given the small scale and infrequency of testing.

Global Laboratory Proficiency Testing Market Opportunities

Emerging Economies to Offer Growth Opportunities 

Emerging economies such as China, India, and South Korea present the laboratory proficiency testing market with substantial development opportunities. These countries provide benefits such as rapid growth in the pharmaceutical and food sectors, minimal labor costs, and fewer stringent regulations. The increasing prevalence of chronic and infectious diseases increased disposable incomes, and the expansion of healthcare access drives the demand for proficiency testing.

Furthermore, market potential is further enhanced by investments in healthcare infrastructure and initiatives to obtain international laboratory accreditations. Companies can capitalize on these trends by offering customized proficiency testing services that are customized to the changing requirements of laboratories in these expanding markets. Additionally, the anticipated growth in demand is expected to be further fueled by the growing emphasis on enhancing healthcare quality and laboratory standards in these regions, which will open up new opportunities for market expansion.

Laboratory Proficiency Testing Market Regional Analysis

The global laboratory proficiency testing market analysis is conducted across North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates with a 42.6% Market Share

North America maintains its position as the leading laboratory proficiency testing market due to its advanced healthcare infrastructure, stringent regulatory requirements, and substantial investments in technology. The region's emphasis on high diagnostic accuracy and quality assurance standards drives the demand for comprehensive proficiency testing services. North American countries, particularly the United States, have well-established regulatory frameworks that mandate rigorous proficiency testing to ensure the reliability of diagnostic results.

• For instance, in April 2022, Spex CertiPrep, a prominent US-based provider of certified reference materials, acquired NSI Lab Solutions to expand its proficiency testing offerings. This acquisition enhanced Spex CertiPrep’s capabilities in providing a wide range of proficiency testing solutions across various industries, including clinical diagnostics and pharmaceuticals. Similarly, in July 2023, LGC Limited, another major player in the US market, acquired Kavo International, strengthening its portfolio of quality measurement tools and proficiency testing services. These acquisitions reflect North America's focus on enhancing proficiency testing capabilities and maintaining leadership in the global market.

Key trends shaping the North American laboratory proficiency testing market include:

• Increased adoption of digital platforms improves proficiency testing efficiency and real-time feedback.
• Strict environmental regulations boost the demand for laboratory and proficiency testing services.
• Companies are expanding their proficiency testing portfolios through strategic acquisitions to enhance service offerings.
• Proactive government initiatives and funding contribute to the growth of the proficiency testing market.

Rapid Growth in Asia-Pacific Regions

The Asia-Pacific region is expected to grow at the highest CAGR over the forecast period due to the rising prevalence of chronic and infectious diseases, which drives demand for accurate diagnostics. Additionally, increased awareness and adoption of international standards and certifications promote proficiency testing. Furthermore, due to low labor costs and high-quality products, the region is becoming a hub for international biopharmaceutical and pharmaceutical companies. This makes continuous laboratory testing of raw materials, finished products, and microbial cultures crucial for production and FDA approval, further fueling market expansion.

Laboratory Proficiency Testing Market Segmental Analysis

The global laboratory proficiency testing market is segmented into technology and industry types.

By Technology

The market is bifurcated into cell culture, spectrometry, polymerase chain reaction, chromatography, immunoassays, and others.

The cell culture segment is dominated by its vital role in optimizing microbial cultures and detecting contaminants.

In 2023, the cell culture segment dominated the laboratory proficiency testing market. This is driven by the increasing adoption of cell culture-based products, such as monoclonal antibodies, which has heightened the demand for cell culture tests to optimize microbial strain cultures. In this area, proficiency testing (PT) is crucial for evaluating laboratory performance and identifying contaminants, including impurities in cell cultures. Minerva Biolabs GmbH is a crucial provider of proficiency tests tailored specifically to assess common contaminants and evaluate a laboratory's sensitivity to yeast/fungi, bacteria, and mycoplasmas, reinforcing the importance of cell culture PT in ensuring high-quality biotechnological products.

However, the chromatography segment is anticipated to grow at the highest CAGR during the forecast period. The increasing need to ensure the efficacy of chromatography devices and the reliability of test results is driving demand for proficiency test materials in this segment. 

• For instance, Merck offers a comprehensive range of gas chromatography proficiency test materials at competitive prices, starting as low as USD 257. These proficiency test programs are vital for laboratories to validate their chromatography techniques, assess their performance, and improve the accuracy and consistency of their analytical results. The rising importance of chromatography in various applications, such as pharmaceutical analysis and environmental testing, is further fueling the rapid growth of this segment in the proficiency testing market.

By Industry Type

The market is bifurcated into clinical diagnostics, microbiology, pharmaceuticals, biologics, and others.

Clinical diagnostics lead due to its critical role in ensuring accurate and reliable patient care testing.

In 2023, clinical diagnostics lead the market due to their crucial role in enhancing drug delivery, primarily due to the high demand for accurate and reliable testing in healthcare. This segment's dominance is driven by the critical need for proficiency testing to ensure the quality of diagnostic tests used in patient care, such as blood tests, molecular diagnostics, and infectious disease screening.

• For instance, In 2024, LGC AXIO launched over 50 new proficiency testing samples, including those specifically designed for clinical diagnostics. However, the pharmaceuticals segment is expected to grow at the highest CAGR during the forecast period. This rapid growth is fueled by the increasing complexity of pharmaceutical testing, the need for precise analytical methods, and the rising regulatory scrutiny on drug safety and efficacy. Proficiency testing in this segment is crucial for ensuring the reliability of drug development and quality control tests.

Recent Development

• April 2024- Proficiency Testing Services launched a new proficiency testing program specifically designed for laboratories conducting COVID-19 variant testing. This move was in response to the ongoing need for accurate testing methods during the pandemic.
• March 2024- Eurofins acquired a smaller proficiency testing company specializing in environmental testing in Southeast Asia. This acquisition reflects the increasing demand for proficiency testing in developing regions, particularly in environmental sectors.

Analyst Opinion 

Per our analyst, the laboratory proficiency testing market is experiencing robust growth driven by advancements in testing technologies and increasing regulatory pressures. The demand for precise and reliable test results across various sectors, including healthcare, environmental, and food safety, is pushing laboratories to adopt more sophisticated proficiency testing programs. Emerging markets, particularly in Asia Pacific, are rapidly expanding due to rising investments in healthcare infrastructure and growing awareness of quality standards. Additionally, integrating AI and machine learning into testing processes enhances the accuracy and efficiency of proficiency testing, offering new opportunities for market revenue growth and innovation. These trends contribute significantly to the overall market revenue, positioning proficiency testing as critical in maintaining high standards and compliance across industries.