Laboratory Proficiency Testing Market - By Industry (Clinical Diagnostics, Microbiology, Pharmaceuticals), By Technology (Cell Culture, PCR, Immunoassays), By End-use (Hospitals, CROs, Diagnostic Laboratories) & Forecast, 2023 – 2032

Laboratory Proficiency Testing Market Size

Laboratory Proficiency Testing Market size was valued at around USD 1.2 billion in 2022 and it is estimated to reach over USD 2.2 billion in 2032. Increasing adoption of stringent laboratory guidelines and mandatory quality protocols, rising instances of different outbreaks in past couple of years and increase in overall research spending among other factors are anticipated to prove beneficial for industry growth.
 

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For instance, as per the data reported by U.S. Dept. of Health and Human Services, the Medicare Part B Spending on lab tests in the country witnessed a surge of 17% in 2021 revenue compared to 2020 data. This increase was primarily attributed to genetic and chemistry tests as well as COVID-19 tests. Moreover, growing trend towards legalization of medical cannabis that in turn leading to increase in number of cannabis testing laboratories coupled with surging demand for research in pharmaceutical industry is expected to fuel the market growth. Hence, all the afore-mentioned pointers are projected to support the laboratory proficiency testing market growth over the forecast period.
 

Proficiency testing is the evaluation of research facilities to check and verify the performance of analytical laboratories. It is a mandatory requirement for all the laboratories based on pre-established criteria to ensure that a facility's processes are accurate, safe and in line to other laboratory groups.
 

The accreditation or regulatory bodies look after and monitor the operational excellence of research laboratories operating in different categories. Thus, research facilities face an additional financial thrust of fulfilling the mandatory quality protocols to maintain their credibility ratings as outlined by such associations. Academic as well as small scale laboratories find it difficult to implement and continuously attain such high budget requirements that involves adoption of advanced techniques such as spectrometry, chromatography, etc. Hence, high capital investments in conjunction with lack of trained professionals for proper facility operation is anticipated to hamper the market growth in the coming years.
 

COVID-19 Impact

The recent outbreak of COVID-19 pandemic had a positive impact on the laboratory proficiency testing market revenue in 2020. To curb the spread of virus several restrictions including nation-wide lockdowns were imposed across different countries globally. This resulted in increased focus on diagnostic laboratories for precise and safe outcome of numerous diagnostic tests. The SARS-CoV-2 infection test volume recorded manifold surge throughout the initial period, resulting in overall industry growth. The laboratories were going through different quality assessment programs for several categories such as serologic, molecular and antigen testing. Hence, owing to the need for accurate testing results and maintaining the facility's credibility, the industry recorded a positive impact during the pandemic.
 

Laboratory Proficiency Testing Market Trends

Quality and standard of the outcome is considered paramount and an indispensable prerequisite for all the research facilities including diagnostic laboratories, pharma, and biotech labs, etc. Adoption of advanced technologies and application of novel approaches such as healthcare laboratory informatics for reliable and accurate results improve the testing facility's credibility. Additionally, testing facilities around the world are focusing on going through a rigid mechanism of proficiency testing which in turn would aid in improving the overall efficiency of the centre. Such proficiency testing programs would verify and evaluate the reliability of a laboratory's testing capabilities and other issues including competency of the testing professional, instruments determining scientifically flawed results, reduction in operational cost, etc.
 

Numerous countries around the world are signatories of international associations for accreditation bodies such as International Laboratory Accreditation Cooperation (ILAC), The Asia Pacific Laboratory Accreditation Cooperation (APLAC), etc. Thus, standards and guidelines stated by such firms allows the laboratories to achieve high quality operational excellence as proficiency testing is considered as a prerequisite for such organizations, thereby supporting the market growth over the analysis period.
 

Laboratory Proficiency Testing Market Analysis

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Based on industry, the market is categorized into clinical diagnostics, microbiology, pharmaceuticals, biologics, and others. The clinical diagnostics segment accounted for largest revenue share in 2022 and is predicted to reach around USD 723 million in 2032. The high revenue share is primarily attributed to increasing trend towards early disease diagnosis, growing need for development of complex diagnostic tests, among others. Further, use of proficiency testing in clinical diagnostics makes quality management a key pointer, thereby, allowing test reproducibility and improving the efficiency as well as accuracy of tests.
 

Based on technology, the laboratory proficiency testing market is segmented into polymerase chain reaction, cell culture, spectrometry, chromatography, immunoassays, and others. The cell culture segment accounted for major revenue share and was valued at around USD 355 million in 2022. Increasing use of cell culture in pharmaceutical industry owing to numerous benefits including vaccines and cell culture-based products will fuel the segmental growth. Additionally, adoption of cell culture-based products such as monoclonal antibodies, further boosted the adoption of cell culture tests to maximize the output from microbial strain cultures.
 

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Based on end-use, the laboratory proficiency testing market is bifurcated into hospitals, diagnostic laboratories, contract research organizations, academic research, and pharmaceutical & biotechnology companies. The pharmaceutical & biotechnology companies segment held the significant revenue share in 2022 and is anticipated to witness a CAGR of 6.4% throughout the forecast period. Pharmaceutical companies play a critical role in research, development, and manufacturing, particularly in areas such as vaccines and blood and tissue-related research. These organizations must adhere to stringent sterility and quality standards for both raw materials and finished products. To ensure accurate results and laboratory efficiency, proficiency testing services are employed in these firms. These services enable monitoring and modification of flawed processes, leading to improved overall functioning and product quality in line with regulatory guidelines.
 

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North America held a dominant market share in the global laboratory proficiency testing market and is expected to witness at 5.5% CAGR through 2032. This high market growth is owing to several factors such as increasing regulatory compliance, technological advancements, and industrial collaboration among others. Additionally, presence of key market players, an increase in the number of chronic diseases, and rising awareness regarding several clinical benefits offered by laboratory proficiency testing is expected to boost the market growth. Regulatory agencies, such as the FDA and Health Canada, have implemented stringent quality standards and regulations for laboratories. Moreover, laboratories in North America are adopting proficiency testing to ensure compliance with these regulations and demonstrate their commitment to quality. Therefore, technological advancements, government support & initiatives and aforementioned factors are expected to augment the regional growth in the near future.
 

Laboratory Proficiency Testing Market Share

Few of the leading players operating in the laboratory proficiency testing market include:

• Bio-Rad Laboratories Inc
• Randox Laboratories Ltd
• Absolute Standards Inc
• LGC Limited
• Fera Science Limited 
• American Proficiency Institute
   

The market is competitive in nature, with leading players, regional and local companies, along with start-ups further consolidating the industry competition. The leading market players are involved in strategic developments including collaborations, research and development, mergers, and acquisitions, to improve their market positioning and revenue generating capabilities.
 

Laboratory Proficiency Testing Industry News:

• In October 2021, Waters Corporation announced a strategic partnership with University of Delaware to develop technology for analytical characterization of manufacturing processes for biologics and novel modalities. This collaborative partnership to advance novel solutions to biopharmaceutical process development and manufacturing. This strategic move helped the company to increase their operational capabilities and enhance their business revenue.
   
• In October 2020, The Central Testing Laboratory of the Abu Dhabi Quality announced a strategic partnership with Conformity Council, to implement laboratory proficiency testing program to verify the competency of medical laboratories carrying out COVID-19 tests. This strategic initiative helped the company to enhance their R&D capabilities and increase their market presence.
   

Laboratory proficiency testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD million from 2018 to 2032, for the following segments:

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By Industry

• Clinical Diagnostics
• Clinical Chemistry
• Immunochemistry
• Hematology
• Molecular Diagnostics
• Others 
• Microbiology
• Pathogen Testing
• Sterility Testing
• Endotoxin & Pyrogen Testing
• Others
• Pharmaceuticals
• Biologics
• Others

By Technology

• Cell Culture
• Spectrometry
• Polymerase Chain Reaction
• Chromatography
• Immunoassays
• Others

By End-use

• Hospitals
• Diagnostic Laboratories
• Academic Research
• Contract Research Organizations
• Pharmaceutical & Biotechnology Companies

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Sweden
  • The Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Indonesia
  • Philippines
  • Vietnam
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Columbia
  • Peru
  • Chile
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Turkey
  • Israel
  • Iran