Laboratory Proficiency Testing Market

The global laboratory proficiency testing market in terms of revenue was estimated to be worth $1.2 billion in 2023 and is poised to reach $1.6 billion by 2028, growing at a CAGR of 7.4% from 2023 to 2028.The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The proficiency testing market is projected to experience substantial expansion in the forecasted period due to its mandatory requirement for laboratories operating in various regulated industries like APIAC, CLIA, and CLSI. The market's growth is further bolstered by stringent safety and quality regulations governing food and pharmaceutical products, alongside a growing emphasis on water testing. However, the requirement of high capital investments for accurate and sensitive testing is expected to restrain the growth of this market during the forecast period.

In this report, the laboratory proficiency testing market is segmented based on industry, technology, and region.

Global Laboratory Proficiency Testing Market Trends

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Laboratory Proficiency Testing Market Dynamics

Driver: Stringent safety and quality regulations for food and pharmaceutical products

Growing complexities in the supply chain of food and pharmaceutical products, rising use of economic lack of adoption of proper hygiene, growing instances of adulteration, and sanitation practices during production, transportation, and storage, lack of awareness about allergens, growing instances of cross-contamination, and non-compliance with labeling laws have increased the incidence of contamination of final products, which in turn are responsible for large-scale outbreaks of foodborne illnesses in consumers. This has raised severe concerns among producers, regulatory authorities, end consumers, and other industry stakeholders.

To curb such violations, regulatory authorities across countries are focusing on framing and implementing strict safety and quality regulations. This has fueled the growth of the inspection, testing, and certification markets, with regulatory bodies such as the United States Department of Agriculture (USDA) and EFSA introducing guidelines for testing, inspection, and sampling services for the food industry to ensure the safety and quality of products. Thus, the increasing focus of regulatory organizations on product safety is driving the growth of the laboratory proficiency market.

Restraint: Requirement of high-capital investments for accurate and sensitive testing

The growing utilization of proficiency testing as a means for accreditation bodies to verify the credibility of laboratories engaged in accreditation initiatives is placing increased financial strain on the laboratories involved. The expenses tied to proficiency testing typically encompass the operational overhead costs of running a laboratory. These investments are necessary at different stages of proficiency testing programs, including program preparation, sample processing, sample handling, and shipment, as well as the interpretation and reporting phases. The need for thorough sample preparation necessitates laboratory analysts to employ sophisticated testing methodologies and advanced technologies. Advanced technologies, such as liquid chromatography (LC), high-performance liquid chromatography (HPLC), and spectrometry, are accurate, sensitive, and efficient. However, these technologies come with drawbacks, including prolonged sample preparation times and calibration challenges, contributing to the substantial investments needed for proficiency testing. Furthermore, many analytical methods are tailored to specific sample types, necessitating the adoption of more advanced techniques for substances like pharmaceuticals and opioids. This incorporation of advanced methods, however, escalates the overall testing expenses, thereby leading to increased capital outlays for laboratories.

Opportunity: Growth opportunities in emerging countries

Emerging economies such as China, India, and South Korea are expected to offer significant growth opportunities for players operating in the laboratory proficiency testing market. This can primarily be attributed to the presence of less stringent regulatory policies, low labor costs, and high growth in their respective pharmaceutical and food sectors.

These countries are attracting pharmaceutical companies not only because of the low-cost manufacturing advantage but also due to the high and growing incidence of chronic and infectious diseases, rising disposable income levels, improving access to healthcare services, and implementation of favorable government policies. The growing presence of global as well as local pharmaceutical and biopharmaceutical companies in these countries is, in turn, driving the demand for proficiency testing services.

Challenge: Logistical and data interpretation challenges

Participation in external PT programs, internal PT programs, and benchmarking or comparison studies (between laboratories using proficiency testing or reference materials) is needed for the validation and evaluation of test methods. However, certain logistical activities, such as shipping and handling of samples (availability of carriers or spills in traffic), need careful planning as they may potentially influence the end results. Also, the number of laboratories necessary to conduct a valid inter-laboratory comparison and the availability of a commercial PT program for a specific analyte of interest may also influence the overall results. These are some of the major challenges faced by laboratories while assessing their standards and gaining accreditation.

Laboratory Proficiency Testing Market Ecosystem Map

Based on industry, Clinical Diagnostics to account for the largest share of the laboratory proficiency testing industry during the forecast period.

Based on industry, the laboratory proficiency testing market is categorized into various segments, including clinical diagnostics, pharmaceuticals, microbiology, water analysis, environmental testing, food & animal feed, biologics, commercial beverages, cannabis/opioids, cosmetics, dietary supplements, and nutraceuticals. In the year 2022, the clinical diagnostics segment held the largest share of the market. This can be attributed to advancements in clinical diagnostic techniques, a rising demand for early and precise disease detection, increased government initiatives aimed at enhancing the quality and affordability of clinical diagnostic tests, and growing investments from both public and private sectors, including research funding and grants, aimed at developing innovative laboratory testing procedures.

Based on technology, the global laboratory proficiency testing market has been segmented into PCR, immunoassays, cell culture, spectrophotometry, chromatography , and other technologies. In 2022, the cell culture segment accounted for the largest share of the market. Growing awareness about the application of cell cultures in the production and testing of microbiology samples, biopharmaceuticals, and clinical diagnostic samples is supporting the growth of this market.

The APAC laboratory proficiency testing industry is projected to grow at the highest rate during the forecast period.

The laboratory proficiency testing market is anticipated to witness its highest growth rate in the Asia-Pacific (APAC) region during the forecast period. This can be attributed to the presence of emerging economies like China and India and the substantial expansion in outsourcing services in recent years. Additionally, Singapore is emerging as another promising market within the APAC region. Other than these APAC countries, Latin American countries also exhibit significant growth potential in the market. Most of this growth is driven by the significant growth in the healthcare industry. Technological advancements in clinical diagnostics, low-cost manufacturing advantage, microbiology, and pharmaceutical industries are contributing to the growth opportunities of the laboratory proficiency market in these regions.

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The prominent players in this market are LGC Limited (UK), American Proficiency Institute (US), College of American Pathologists (US), Bio-Rad Laboratories (US), Randox Laboratories (UK), Merck (Germany), Fapas (UK), Waters Corporation (US), Weqas (UK), AOAC INTERNATIONAL (US).

Scope of the Laboratory Proficiency Testing Industry:

This report categorizes the global laboratory proficiency testing market to forecast revenue and analyze trends in each of the following submarkets:

By Industry

• Clinical Diagnostics
  • Clinical Chemistry
  • Immunoassay/immunochemistry
  • Hematology
  • Molecular diagnostic
  • Cytology
  • Other Clinical Diagnostics
• Microbiology
  • Pathogen Testing
  • Sterility Testing
  • Endotoxin & Pyrogen Testing
  • Growth Promotion Testing
  • Other Microbial Testing
• Food & Animal Feed
  • Meat & Meat Products
  • Vegetables & Fruits
  • Dairy Products
  • Fish
  • Egss
  • Fat/oil
  • Other Food & Animal Feed
• Commercial Beverages
  • Non-Alcoholic Beverages
  • Alcoholic Beverages
• Environmental
• Pharmaceuticals
  • Branded/Innovator Drugs
  • Generic Drugs
  • Over-THE -Counter Drugs
  • Biosimilars
• Water
• Nutraceuticals
• Biologics
  • Monoclonal Antibodies
  • Vaccines
  • Blood
  • Tissue
• Cannabis/Opioids
  • Potency Testing
  • Terpene Profiling
  • Residual Solvents
  • Pesticide Screening
  • Heavy Metal Testing
  • Other Cannabis/Opioids Testing
• Dietary Supplements
• Cosmetics
  • Trace Elements
  • Other Cosmetic Testing

By Technology

• Cell Culture
• PCR
• Immunoassays
• Chromatography
• Spectrophotometry
• Others

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • ROE
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • RoPAC
• Latin America
• Middle East & Africa

Recent Developments of Laboratory Proficiency Testing Industry

• In July 2023, LGC Limited (US) acquired Kavo International (US) to strengthen its portfolio of quality measurement tools.
• In March 2023, the College of American Pathologists (US)launched a new proficiency testing program focused on the monkeypox (mpox) virus. By introducing the new mpox PT program, laboratories can enhance the quality assurance of their molecular testing process and contribute to the assurance of precise and dependent test outcomes, aiding in the detection of the mpox virus.
• In April 2022, Spex CertiPrep (US) acquired NSI Lab Solutions (US) to strengthen its product portfolio in the proficiency testing segment.
• In January 2022, Fera Science Ltd. - FAPAS (UK) formed a partnership with BioFront Technologies, which will act as the agent representing FAPAS proficiency testing services in the United States.
• In October 2021, Waters Corporation (US) entered into a partnership with Sartorius AG (Germany). The objective of this collaboration was to offer bioprocess experts direct access to top-notch mass spectrometry (MS) data, thereby enhancing the efficiency and precision of biopharmaceutical process development.
• Also in October 2021, Waters Corporation (US) partnered with the University of Delaware (US) to develop new analytical solutions for bioprocessing and biomanufacturing.

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