Home
»
Market Trend Reports
»
Global & India Laboratory Proficiency Testing Market Trend Analysis & Future Outlook

Global And India Laboratory Proficiency Testing Market Trend Report

Global And India Laboratory Proficiency Testing Market Trend Analysis And Future Outlook

Published: Dec, 2025
Report ID: GVR-MT-100529
Format: PDF/Excel databook

No. of Pages/Datapoints: 50
Report Coverage: 2024 - 2030

Report Overview

Proficiency Testing (PT) in clinical diagnostics is an external evaluation process in which a clinical laboratory’s testing performance is assessed by comparing its results against those of peer laboratories, reference values, or established criteria using standardized test samples. It is conducted under the framework of External Quality Assessment (EQA) and is essential for ensuring the accuracy, reliability, and comparability of laboratory test results.

Diagnostic Area	Key PT Coverage Areas	Purpose of PT in This Area
Clinical Biochemistry	• Electrolytes (Na⁺, K⁺, Cl⁻, Ca²⁺, Mg²⁺) • Organ function markers (LFT, KFT) • Lipid profile • Glucose metabolism markers • Endocrine biomarkers	Ensures analytical precision and comparability of automated chemistry analyzers across laboratories.
Hematology	• Complete blood counts (CBC) • Differential counts (DLC) • Reticulocyte counts • Peripheral smear morphology • Hemoglobin variants • Coagulation assays (PT, aPTT, INR)	Maintains consistency in analyzer-based results and manual interpretation for diagnostic reliability.
Immunology & Serology	• Autoimmune markers (ANA, ENA profile) • Viral serology (HIV, HBV, HCV) • Bacterial serology • Allergy markers (IgE) • Hormones (TSH, T3/T4, β-hCG)	Ensures accuracy of immunoassays and antibody/antigen detection across platforms.
Microbiology	• Organism identification (bacteria, fungi) • Antimicrobial susceptibility testing (AST) • Gram staining and microscopy • Culture growth and interpretation • Mycology • Parasitology	Supports high-quality pathogen detection and reliable antimicrobial therapy decision-making.
Histopathology & Cytopathology	• Stained and unstained tissue slides • Virtual slide interpretation • Morphological diagnosis • Immunohistochemistry (IHC) scoring • Cytology (pap smears, FNAC)	Ensures pathologist competency and consistency in tissue-based and cytological assessments.
Molecular Diagnostics	• Qualitative PCR • Quantitative PCR / viral load • NGS mutation panels • Gene expression assays • DNA/RNA detection (HIV, HBV, MTB, SARS-CoV-2) • Molecular oncology • HLA DNA typing	Validates accuracy and sensitivity of high-complexity molecular assays.
Transplant Immunology & Flow Cytometry	• HLA typing (Class I & II) • HLA antibody detection • Flow cytometric immunophenotyping • Leukemia/lymphoma classification	Ensures precision in transplant compatibility testing and immunophenotypic analysis.
Clinical Pathology	• Urinalysis (chemical & microscopic) • Stool microscopy • Body fluid analysis • Semen evaluation	Ensures accuracy and reliability in routine pathology parameters.
Prenatal & Maternal Screening	• First-trimester markers (PAPP-A, Free β-hCG) • Second-trimester markers (AFP, Inhibin-A, uE3) • Down syndrome risk markers	Ensures reliability and consistency in fetal and maternal risk assessment screening programs.

India PT Market Structure

Market Layer	Key Entities / Examples	Role in PT Market
Demand Side (Laboratory Customers)	Private labs, Government hospitals, Standalone diagnostic centers, Corporate chains, Public health labs.	These are the primary buyers of PT programs. They participate in PT to meet ISO 15189, regulatory requirements, hospital audit expectations, and internal quality needs. Their demand drives PT frequency (monthly/quarterly/biannual). Small labs are price-sensitive, while larger chains seek high-volume PT, multi-module bundles, and specialized programs.
National Research & Government PT Providers	ICMR–NITVAR, ICMR–NIV, AIIMS (ISHTM), CMC Vellore.	These organizations offer domain-specific PT, e.g., HIV VL, CD4 count, virology, hematology morphology. They focus on public health relevance, not commercial expansion. Their programs often have very high credibility, low fees, and massive participation across India. They set quality baselines for infectious disease testing.
Large Diagnostic (Commercial PT Providers)	Dr Lal PathLabs, Metropolis, Neuberg.	These players provide broad-spectrum PT, covering routine clinical chemistry, hematology, microbiology, immunoassays, etc. They leverage their large laboratory ecosystems to produce commutable PT samples. Their strength is pan-India reach, strong logistics, and large participant volumes, making them influential in setting benchmarking norms.
Independent Specialist PT Providers	RML Pathology QAP, Aashvi PT LLP, Chimera EQAS, Global PT Provider, UNIQAS PT Division, FARE Labs, Fugen Biomed.	These providers form the core of India’s PT market. They offer diversified PT programs across clinical biochemistry, hematology, molecular diagnostics, maternal screening, environmental/food testing, oncology, HLA, and flow cytometry. They are known for technical specialization, material manufacturing capabilities, and NABL ISO 17043 accreditation. Some also hold ISO 17034, enabling production of Certified Reference Materials (CRMs).
Academic Hospitals & Centers of Excellence	Tata Memorial Hospital (MPQAP), CMC Vellore, AIIMS.	They produce expert-reviewed PT samples for morphology, IHC scoring, molecular oncology, and transplant immunology. Their main strength is clinical expertise, ensuring high-quality interpretive PT. These programs are widely respected because they reflect real-world diagnostic material used in complex disease diagnosis.
Accreditation & Recognition Ecosystem	NABL (ISO/IEC 17043), ILAC, APAC, ISO 17034 (RMs), CAP (indirect participation).	NABL grants PT accreditation in India, giving PT providers legal and professional legitimacy. ILAC and APAC ensure international acceptance of PT reports. ISO 17034 certifies reference material production, adding higher scientific credibility. CAP approval (where applicable) enhances international benchmarking. This ecosystem ensures PT providers operate at globally acceptable quality levels.
Material Sourcing & Production Layer	Global PT Provider, FARE Labs, Aashvi PT, RML QAP, Fugen Biomed.	These organizations create PT materials such as serum, plasma, whole blood, RMs, synthetic DNA/RNA, paraffin blocks, and virtual slides. They ensure homogeneity, stability, commutability, and safety. This is a high technical barrier domain that requires complex equipment, QA systems, and ISO compliance.
Logistics & Distribution Network	National courier services, cold-chain providers, regional logistics hubs.	PT materials require temperature control, safe packaging, timely transport, and tracking. Logistics performance directly impacts sample stability and PT accuracy. Providers with strong logistics ensure pan-India reach, even to remote laboratories.
Data Management, Software & Analytics	PT provider in-house software, third-party statistical tools, cloud-based systems.	These systems manage large datasets, automating z-scores, SDIs, qualitative scoring, and consensus evaluation. They allow labs to analyze performance trends, participate in root-cause analysis, and document corrective actions for accreditation audits.
Regulators & Policy Influencers	NABL, NQAS, state health departments, hospital quality boards.	They indirectly drive PT demand by mandating PT participation. State health departments and regulatory bodies enforce quality and compliance, making PT essential for government lab empanelment, insurance tie-ups, and hospital accreditation cycles.
Training, Education & Capacity Building Layer	RML QAP, AIIMS, CMC, Uniqas, Several private QC consultants.	This layer provides post-PT training, workshops, corrective-action support, and quality-improvement modules. They help labs understand errors, method biases, reagent impact, instrument calibration issues, and strengthen staff competence for ISO audits and inspections.
End-User Outcomes / Market Impact Layer	All clinical & public-health laboratories using PT programs.	High-performing PT participation results in accurate diagnostics, reduced laboratory errors, enhanced patient outcomes, regulatory approval, and trust among clinicians. This is the ultimate goal of the PT market - ensuring dependable results in clinical medicine and public health.

Accreditation Bodies in PT

Body	Scope	PT Relevance
National Accreditation Bodies
NABL (National Accreditation Board for Testing & Calibration Laboratories)	Primary accreditation body for labs and PT providers in India; recognizes ISO/IEC 17043:2010 for PT providers.	Most PT providers in India are NABL-accredited. NABL ensures PT programs are competent, reliable, and recognized internationally.
Quality Council of India (QCI)	Umbrella organization overseeing NABL and other accreditation programs.	Indirectly supports PT accreditation policy and implementation.
Internationally Recognized / Mutual Recognition Bodies
ILAC (International Laboratory Accreditation Cooperation)	Global body that sets mutual recognition arrangements for lab and PT accreditation.	NABL is an ILAC signatory, which means Indian PT results can be internationally recognized.
APAC (Asia Pacific Accreditation Cooperation)	Regional cooperation of accreditation bodies.	NABL’s membership ensures regional acceptance of PT results.
ANAB (ANSI National Accreditation Board)	USA / Global	Accredits PT providers according to ISO/IEC 17043; ILAC MRA recognized for international acceptance
UKAS (United Kingdom Accreditation Service)	UK / Global	Accredits PT providers under ISO/IEC 17043; ensures international recognition via ILAC MRA
DAkkS (Deutsche Akkreditierungsstelle)	Germany / EU / Global	Accredits PT providers under ISO/IEC 17043; recognized through ILAC MRA
COFRAC (Comité Français d’Accréditation)	France / EU / Global	Accredits PT providers under ISO/IEC 17043; ILAC MRA signatory ensures global recognition
JAB / JCSS (Japan Accreditation Board / Japan Calibration Service System)	Japan	Accredits PT providers according to ISO/IEC 17043; globally recognized through ILAC MRA
CMA (China Metrology Accreditation)	CMA (China Metrology Accreditation)	CMA (China Metrology Accreditation)
NATA (National Association of Testing Authorities)	Australia / Global	Accredits PT providers according to ISO/IEC 17043; ILAC MRA ensures international validity
SCC (Standards Council of Canada)	Canada / Global	Accredits PT providers under ISO/IEC 17043; ILAC MRA ensures results are globally recognized

Comparison of Proficiency Testing (PT) / EQA Providers in India

Company / Institution	Company Profile	PT / EQA Programs Offered	Pricing
ISHTM–AIIMS External Quality Assurance Programme (EQAP)	Established in 2003 by the Department of Hematology, AIIMS New Delhi, in collaboration with ISHBT. A nationally recognized hematology-focused PT/EQA provider with several hundred participating laboratories across India. NABL-accredited under ISO/IEC 17043:2023 (PC-1098).	Hematology PT including CBC parameters, Hb, HCT, MCV, MCH, MCHC, RBC, WBC, Platelets, Reticulocyte count, Peripheral smear (DLC, RBC morphology, diagnosis).	Annual participation fee: Private labs – 27.82; Government labs – 22.25
ICMR – National Institute of Translational Virology and AIDS Research (NITVAR)	Established in 1992 under ICMR (formerly NARI), Pune. National reference institute for HIV/AIDS diagnostics, surveillance, and research. Operates a dedicated NABL-accredited PT Provider Unit under ISO/IEC 17043.	HIV serology (ELISA, rapid tests, immunoblot), CD4/CD8 enumeration (flow cytometry), HIV-1 viral load (RT-PCR), HIV-1 total nucleic acid testing, and related infectious disease serology (HBsAg, HCV, RPR, TPHA).	HIV Serology EQAS: 167.69 (2 rounds) / 83.85 per round; CD4 EQA: 279.49 (2 rounds) / 139.74 per round
CHIMERA	NABL-accredited diagnostic organization specializing in molecular genetics and transplant immunology. Operates 24×7, supporting cadaveric transplants and complex immunology workflows. ISO 15189:2022 compliant with annual NABL audits.	Transplant immunology & genetics PT/EQA: HLA typing (SSO/SSP), CDC & Flow Crossmatch, DSA (SAB Class I & II), PRA (Class I & II), ABO antibody titers, STR profiling (autosomal & Y-STR), mtDNA analysis, immunophenotyping.	Transplant Immunology EQAS: 291.55/year; Immunophenotyping EQAS: 369.44/year
Tata Memorial Hospital (TMH) – PT Services (MPQAP)	Established in 1941, Mumbai. Premier national cancer care and research institution under Tata Memorial Centre. Developed MPQAP to address gaps in molecular oncology EQA in India using method-based PT.	Molecular pathology & cytogenetics PT: FISH (HER2, ALK, ROS1, EWSR1, 1p19q), PCR/RT-PCR (EGFR, EWS-FLI), gene sequencing (BRAF, IDH1/2, KIT, PDGFRA, RAS), clonality assays, NGS, ddPCR, nucleic acid QC.	Per-module pricing ranges from 44.67 to 279.20; Combo package: 893.46
Christian Medical College (CMC) Vellore – CMC-EQAS	One of India’s oldest and most reputed private medical institutions. NABL-accredited laboratories under ISO 15189. Operates its own NABL-accredited EQAS under ISO/IEC 17043, serving national and international labs.	Clinical biochemistry EQAS (Chemistry I & II), thyroid & cortisol, HbA1c, reproductive hormones, tumor markers, cardiac markers, urine chemistry, trace metals, prenatal screening markers.	Program-wise pricing ranges from 5.58 to 94.94, depending on module

Competitors Growth And Operational Strategies

This involves offering new or enhanced proficiency testing schemes to cover a wider range of analytes and technologies, especially those that are emerging or are subject to new regulations.

Control Lab (Quality Control for Laboratories LTDA):
- Strategy: Digital Transformation and Value-Added Reporting. Control Lab is penetrating the market by making its services more integrated and insightful through advanced digital tools, moving beyond a simple pass/fail report.
- In a recent innovation showcase, Controllab unveiled:
  - Multi-equipment Reports: Allowing participants to immediately compare results from different in-house instruments for the same test before external peer comparison.
  - Proficiency Testing Automation: A world-first initiative to connect the sample, laboratory software, and the Online System, ensuring agility in result submission.
  - Metricare Analytical BI Module: A data intelligence platform that automatically structures PT data for strategic comparisons across lab networks (e.g., used by Rede D'Or São Luiz). These innovations deepen the product's utility, making it indispensable for labs seeking continuous quality improvement.
- WLSH (Wisconsin State Laboratory of Hygiene) PT:
  - Strategy: Regulatory Alignment and New Program Development. As a state-affiliated provider, its penetration is strongly linked to meeting and anticipating regulatory changes, particularly the CLIA mandates in the US.
  - WLSH is actively updating its programs in response to the upcoming CLIA Proficiency Testing Revisions effective January 1, 2025. This includes developing new 5-sample programs for analytes like FSH, LH, PTH, and Progesterone, and adjusting reporting criteria. This proactive alignment ensures mandatory enrollment from labs that fall under CLIA regulations, driving market penetration by necessity.

Specialization and Niche Market Focus

Focusing on highly specialized or rapidly growing areas where competitor PT schemes may be less mature.

QCMD (Quality Control for Molecular Diagnostics):
- Strategy: High-Growth Niche Dominance. QCMD concentrates solely on External Quality Assessment (EQA) for Molecular Diagnostics, a high-growth segment (PCR & Molecular Methods are advancing at a 7.23% CAGR).
- QCMD's entire business model is a market penetration strategy within the molecular niche, offering EQA Schemes across various methodologies (commercial and in-house). This deep specialization makes them the default choice for labs performing complex molecular tests, such as those related to infectious disease and genetic testing, where standardized quality control is paramount.
LGC Axolabs (LGC Limited):
- Strategy: Integrated Quality Solution and Next-Gen Therapeutics. As part of the larger LGC Group, their penetration in the PT space is achieved through acquisitions and expansion into cutting-edge areas, linking PT with other quality services.
- While LGC Axolabs focuses on Nucleic Acid Therapeutics (NAT), the broader LGC Group's strategy is evident in its acquisition-led penetration, such as the acquisition of DiaMex in December 2024. DiaMex complements LGC's serology and molecular quality control portfolio, allowing LGC to offer a more comprehensive portfolio from a single supplier, thereby penetrating deeper into existing customer accounts across multiple testing disciplines. Furthermore, LGC's expansion in Nucleic Acid Therapeutics (NAT) capacity (e.g., new Berlin site operational in 2024) allows it to develop and offer specialized PT programs for this burgeoning field, a clear market penetration move into a next-generation segment.

Maintain Trust and Broad Discipline Coverage

Strategy: Maintain Trust and Broad Discipline Coverage. INSTAND, as a major German provider, leverages its long-standing reputation and accreditation to maintain and increase its market share, particularly in Central Europe, by offering a very broad and comprehensive catalog of PT programs.

INSTAND's strategy, like many large EQA providers, is often less about aggressive price-cutting and more about maintaining high-quality accreditation and data integrity, which are non-negotiable for lab compliance. While specific recent news on aggressive market penetration is less publicly available compared to product development news, its very existence and size demonstrate a successful long-term strategy of providing the necessary compliance services across a wide spectrum of laboratory disciplines to meet mandatory regulatory requirements. The stability and breadth of its offering are its key penetration tools.

Provider	Primary marketing strategies
CAP	Regulatory alignment (CLIA/ISO) + authority-driven adoption; deep programme breadth and strong digital tools (shipping calendar, e-reporting) encourage institutional retention.
API	Transparency & ease: public annual schedules, simple enrollment, LIS-friendly reporting; designed to reduce friction for mid-sized & community labs.
Bio-Rad EQAS	Cross-selling via Bio-Rad QC/reagent/instrument ecosystem + digital EQAS Online platform to strengthen long-term customer lock-in.
RCPAQAP	Digital portal (myQAP) + ANZ pathology leadership; product improvements and biomarker/pathology modules drive institutional adoption.
QCMD	Flexible participation (1/2/4 challenges) + niche molecular infectious specialism; pilot→full scheme model accelerates adoption.
INSTAND	Large-scale national reference credibility + high scheme volume; attractive for ministries of health and national tenders.
Controllab	Regional (LATAM) depth: local-language support + localized disease panels; alignment with national accreditation to boost trust.
RCPAQAP	Digital portal (myQAP) + ANZ pathology leadership; product improvements and biomarker/pathology modules drive institutional adoption.
RIQAS (Randox)	Broadest global reach + frequent cycles (monthly/bi-monthly); strong QC/EQA bundling for multi-site private networks.
LGC AXIO	Multi-sector PT (food/environment/clinical) + global sales infrastructure; strong fit for government tenders and multi-domain buyers.
WSLH PT	U.S. public-sector trust + transparent pricing/audit bundles; built for hospital networks and U.S. regulatory auditors.

Source: Grand View Research

Request a Free Sample

GET A FREE SAMPLE

This FREE sample includes market data points, ranging from trend analyses to market estimates & forecasts. See for yourself.

Or view our licence options:

NEED A CUSTOM REPORT?

We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as offer affordable discounts for start-ups & universities.