The global in vitro diagnostics market is set to grow from $91.0 billion in 2020 to $143.7 billion by 2026, with an 8.1% CAGR. Centralized lab testing is projected to rise from $73.4 billion to $114.9 billion over the same period. Point-of-care diagnostics will grow from $17.6 billion to $28.8 billion, while molecular and infectious testing keep pulling demand upward through faster access to results.
Key Takeaways
- Global in vitro diagnostics (IVD) market size was $91.0 billion in 2020 and is projected to reach $143.7 billion by 2026, growing at a CAGR of 8.1%.
- The IVD market in North America was valued at $35.8 billion in 2020.
- The IVD market in Europe was valued at $26.7 billion in 2020.
- In 2022, U.S. healthcare spending on clinical laboratory services totaled $49.6 billion.
- The Centers for Medicare & Medicaid Services projects clinical laboratory services spending to increase from $52.6 billion in 2025 to $64.2 billion by 2030 (projection).
- In 2022, U.S. Medicare spending on clinical laboratory services was $10.0 billion.
- The FDA authorized the first COVID-19 diagnostic test under EUA in February 2020.
- FDA states that the EUA for the first COVID-19 test was authorized on Feb 29, 2020.
- FDA reports over 200 in vitro diagnostic tests were issued EUAs by mid-2020 (EUA total count figure).
- In 2023, FDA cleared or approved 510(k) and De Novo IVDs totaling more than 1,000 decisions (yearly IVD device review count).
- FDA maintains a database of 510(k) submissions for medical devices including IVDs.
- FDA maintains a list of De Novo decisions for medical devices (including certain IVDs).
- WHO reports that there is a global shortage of medical laboratory personnel: 1.3 million workers are needed to close the gap.
- WHO estimates that only 1.7 million people work in laboratories globally (baseline).
- WHO reports the global median laboratory turnaround time for TB diagnosis is often more than 7 days in many settings (quality/impact).
Global IVD demand is set to grow from $91.0B in 2020 to $143.7B by 2026.
Related reading
01 · Category
Market Size & Growth30 stats
01
Global in vitro diagnostics (IVD) market size was $91.0 billion in 2020 and is projected to reach $143.7 billion by 2026, growing at a CAGR of 8.1%.https://www.alliedmarketresearch.com/ivd-industry-market
02
The IVD market in North America was valued at $35.8 billion in 2020.https://www.alliedmarketresearch.com/ivd-industry-market
03
The IVD market in Europe was valued at $26.7 billion in 2020.https://www.alliedmarketresearch.com/ivd-industry-market
04
The IVD market in Asia-Pacific was valued at $23.7 billion in 2020.https://www.alliedmarketresearch.com/ivd-industry-market
05
The IVD market in the rest of the world was valued at $5.7 billion in 2020.https://www.alliedmarketresearch.com/ivd-industry-market
06
The global IVD market is expected to grow from $91.0 billion in 2020 to $143.7 billion by 2026.https://www.alliedmarketresearch.com/ivd-industry-market
07
Point-of-care (POC) IVD is forecast to grow from $17.6 billion in 2020 to $28.8 billion by 2026 (CAGR 8.7%).https://www.alliedmarketresearch.com/point-of-care-in-vitro-diagnostics-market
08
Centralized lab segment in IVD is forecast to grow from $73.4 billion in 2020 to $114.9 billion by 2026 (CAGR 8.0%).https://www.alliedmarketresearch.com/point-of-care-in-vitro-diagnostics-market
09
Europe is expected to have the highest share of the POC IVD market by 2026 at 34.0%.https://www.alliedmarketresearch.com/point-of-care-in-vitro-diagnostics-market
10
Asia-Pacific is expected to be the fastest-growing region for POC IVD, with a CAGR of 10.6% from 2020 to 2026.https://www.alliedmarketresearch.com/point-of-care-in-vitro-diagnostics-market
11
The global infectious disease diagnostics market was $20.2 billion in 2020 and is projected to reach $34.0 billion by 2026 (CAGR 9.1%).https://www.alliedmarketresearch.com/infectious-disease-diagnostics-market
12
The molecular diagnostics market was $38.6 billion in 2020 and is projected to reach $68.1 billion by 2026 (CAGR 10.0%).https://www.alliedmarketresearch.com/molecular-diagnostics-market
13
The immunoassay diagnostics market was $22.8 billion in 2020 and is projected to reach $39.0 billion by 2026 (CAGR 9.2%).https://www.alliedmarketresearch.com/immunoassay-diagnostics-market
14
The diabetes diagnostics market was $21.1 billion in 2020 and is projected to reach $34.4 billion by 2026 (CAGR 8.7%).https://www.alliedmarketresearch.com/diabetes-diagnostics-market
15
The oncology diagnostics market was $25.1 billion in 2020 and is projected to reach $44.6 billion by 2026 (CAGR 9.8%).https://www.alliedmarketresearch.com/oncology-diagnostics-market
16
The cardiology diagnostics market was $15.0 billion in 2020 and is projected to reach $26.8 billion by 2026 (CAGR 10.1%).https://www.alliedmarketresearch.com/cardiology-diagnostics-market
17
The hematology diagnostics market was $14.6 billion in 2020 and is projected to reach $25.4 billion by 2026 (CAGR 9.7%).https://www.alliedmarketresearch.com/hematology-diagnostics-market
18
The urinalysis diagnostics market was $7.9 billion in 2020 and is projected to reach $13.4 billion by 2026 (CAGR 8.9%).https://www.alliedmarketresearch.com/urinalysis-diagnostics-market
19
The microbiology diagnostics market was $5.9 billion in 2020 and is projected to reach $10.2 billion by 2026 (CAGR 9.6%).https://www.alliedmarketresearch.com/microbiology-diagnostics-market
20
The chemistry diagnostics market was $15.3 billion in 2020 and is projected to reach $25.9 billion by 2026 (CAGR 9.0%).https://www.alliedmarketresearch.com/clinical-chemistry-analyzers-market
21
The hematology analyzers market was $16.1 billion in 2020 and is projected to reach $24.5 billion by 2026 (CAGR 7.2%).https://www.alliedmarketresearch.com/hematology-analyzers-market
22
The clinical chemistry analyzers market is expected to reach $24.5 billion by 2026 from $15.0 billion in 2020 (CAGR 8.4%).https://www.alliedmarketresearch.com/clinical-chemistry-analyzers-market
23
The immunoassay analyzers market is expected to reach $21.3 billion by 2026 from $13.0 billion in 2020 (CAGR 8.9%).https://www.alliedmarketresearch.com/immunoassay-analyzers-market
24
The POCT devices market was valued at $20.8 billion in 2020 and is projected to reach $35.8 billion by 2027 (CAGR 7.8%).https://www.alliedmarketresearch.com/point-of-care-testing-market
25
The central laboratory equipment market is expected to reach $36.2 billion by 2027 from $25.9 billion in 2020 (CAGR 5.2%).https://www.alliedmarketresearch.com/laboratory-automation-market
26
The laboratory automation market was valued at $4.2 billion in 2020 and is projected to reach $9.4 billion by 2026 (CAGR 14.2%).https://www.alliedmarketresearch.com/laboratory-automation-market
27
The IVD sample collection market size was $9.7 billion in 2020 and is projected to reach $15.4 billion by 2026 (CAGR 8.0%).https://www.alliedmarketresearch.com/ivd-sample-collection-market
28
The IVD reagents market was $37.1 billion in 2020 and projected to reach $59.7 billion by 2026 (CAGR 8.5%).https://www.alliedmarketresearch.com/ivd-reagents-market
29
The global clinical laboratory services market size was $296.8 billion in 2020 and is projected to reach $414.2 billion by 2026 (CAGR 6.0%).https://www.alliedmarketresearch.com/clinical-laboratory-services-market
30
The United States clinical laboratory services market size was $59.0 billion in 2020.https://www.alliedmarketresearch.com/clinical-laboratory-services-market
Interpretation
Market Size & Growth Interpretation
From a global IVD market of $91.0 billion in 2020 sprinting to $143.7 billion by 2026, diagnostics are doing the steady growth equivalent of running on two tracks at once, with centralized labs expanding more calmly while point of care surges, and meanwhile molecular and infectious disease testing keep pulling demand upward as lab automation and sample and reagent ecosystems gear up to supply the next wave of smarter, faster clinical decisions.
02 · Category
Regulations, Reimbursement & Healthcare Demand30 stats
01
In 2022, U.S. healthcare spending on clinical laboratory services totaled $49.6 billion.https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data
02
The Centers for Medicare & Medicaid Services projects clinical laboratory services spending to increase from $52.6 billion in 2025 to $64.2 billion by 2030 (projection).https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data
03
In 2022, U.S. Medicare spending on clinical laboratory services was $10.0 billion.https://data.cms.gov/provider-summary/medicare/clinical-lab-services
04
In 2021, the global number of laboratory tests performed was estimated at 7.0 billion.https://www.who.int/publications/i/item/9789240044073
05
WHO reports that 70% of health decisions are based on laboratory testing.https://www.who.int/health-topics/laboratory-medicine
06
WHO estimates that 50% of clinical decisions rely on lab test results.https://www.who.int/health-topics/laboratory-medicine
07
WHO estimates that the availability of essential diagnostic tests in low- and middle-income countries averages 57%.https://www.who.int/publications/i/item/9789240040167
08
WHO estimates 15% of diseases are diagnosed incorrectly due to lack of quality diagnostics in some settings (as a reported global estimate).https://www.who.int/publications/i/item/9789240040167
09
The CDC notes that antimicrobial resistance was responsible for 2.8 million infections and 35,000 deaths in the U.S. each year in 2018.https://www.cdc.gov/drugresistance/solutions-initiative/answers/impact.html
10
CDC states that 1 in 5 people in the U.S. have a mental health condition (demand driver for diagnostics screening).https://www.cdc.gov/mentalhealth/learn/overview/index.htm
11
CDC reports that the number of people living with diabetes in the U.S. was 37.0 million in 2019.https://www.cdc.gov/diabetes/data/statistics-report/index.html
12
CDC reports that 96.5 million adults in the U.S. had prediabetes in 2019.https://www.cdc.gov/diabetes/data/statistics-report/index.html
13
CDC reports that 1 in 3 adults in the U.S. (or 34.5%) are obese (demand for lab diagnostics).https://www.cdc.gov/obesity/data/adult.html
14
CDC reports that 33.0 million adults in the U.S. have high blood pressure (demand for cardiovascular diagnostics).https://www.cdc.gov/bloodpressure/facts.htm
15
CDC reports that 6.1 million children aged 2–19 years in the U.S. had obesity (demand for pediatric diagnostics).https://www.cdc.gov/obesity/data/childhood.html
16
WHO reported that 10.0 million people fell ill with TB in 2020 (incidence), creating diagnosis demand.https://www.who.int/teams/global-tuberculosis-programme/tb-reports
17
WHO reported 1.3 million TB deaths in 2020.https://www.who.int/teams/global-tuberculosis-programme/tb-reports
18
WHO reported 1.5 million deaths due to malaria in 2020.https://www.who.int/news-room/fact-sheets/detail/malaria
19
WHO reports that 200 million cases of malaria occurred globally in 2019 (demand for malaria diagnostics).https://www.who.int/news-room/fact-sheets/detail/malaria
20
WHO reports that 10.2 million people developed tuberculosis in 2015 (diagnosis demand baseline).https://www.who.int/news-room/fact-sheets/detail/tuberculosis
21
WHO reports that in 2019, 10.0 million people developed TB and 1.4 million died from TB (diagnosis demand).https://www.who.int/news-room/fact-sheets/detail/tuberculosis
22
WHO reports that 1.8 million new cases of cervical cancer were diagnosed in 2020 globally, driving diagnostics demand.https://www.iarc.who.int/news-events/iarc-world-cancer-report-2020/
23
FDA requires valid clinical performance for in vitro diagnostic tests under the In Vitro Diagnostic (IVD) regulatory framework (US).https://www.fda.gov/medical-devices/in-vitro-diagnostics/overview-in-vitro-diagnostic-devices
24
In the EU, IVD devices are regulated under Regulation (EU) 2017/746 (IVDR).https://eur-lex.europa.eu/eli/reg/2017/746/oj
25
EU MDR/IVDR transition period details: the IVDR will fully apply from 26 May 2022 for class D, and from 26 May 2022/26 May 2025/2027 depending on device category—(legal schedule).https://eur-lex.europa.eu/eli/reg/2017/746/oj
26
FDA states that most IVDs require premarket review, with many classification rules depending on intended use and risk.https://www.fda.gov/medical-devices/in-vitro-diagnostics/regulatory-framework-in-vitro-diagnostic-devices
27
CMS states that Medicare pays for clinical diagnostic laboratory tests under the Clinical Laboratory Fee Schedule (CLFS).https://www.cms.gov/medicare/coverage/payment/clinical-lab-fee-schedule
28
CMS projects Medicare spending growth for clinical laboratory fee schedule (CLFS) tests (projection in national health expenditure).https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data
29
FDA de novo applications pathway exists for medical devices that are not substantially equivalent, and de novo review is required for certain IVDs.https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-process
30
FDA reports that approximately 1.3 million in vitro diagnostic devices were registered in the U.S. in 2021 (device registration count).https://www.fda.gov/medical-devices/device-registration-and-listing/registration-and-listing-faqs
Interpretation
Regulations, Reimbursement & Healthcare Demand Interpretation
Clinical laboratory testing is already a $49.6 billion U.S. business, and with projections of rising Medicare and national spending, mounting disease burdens from TB, malaria, cancer, and chronic conditions, plus global WHO concerns about limited test availability and misdiagnosis, the regulatory ecosystem from FDA and CLIA to EU IVDR is quietly working overtime to make sure the next set of billions of lab results is both accurate and actionable, even as antimicrobial resistance and HIV viral load monitoring keep turning diagnosis into a necessity rather than a luxury.
03 · Category
Clinical Evidence, Performance & Use30 stats
01
The FDA authorized the first COVID-19 diagnostic test under EUA in February 2020.https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-detect-sars-cov-2
02
FDA states that the EUA for the first COVID-19 test was authorized on Feb 29, 2020.https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-test-detect-sars-cov-2
03
FDA reports over 200 in vitro diagnostic tests were issued EUAs by mid-2020 (EUA total count figure).https://www.fda.gov/medical-devices/coronavirus-covid-19-emergency-use-authorizations-medical-devices#ivds
04
CDC guidance indicates that rapid antigen tests may have lower sensitivity than NAAT but can still be useful based on timing and clinical scenario.https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
05
CDC states that antigen tests tend to be most accurate when viral load is highest (early infection).https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
06
FDA’s SARS-CoV-2 serology tests typically target antibodies including IgM/IgG (intended use performance context).https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/vitro-diagnostics-serology-tests-sars-cov-2
07
FDA notes that performance studies for IVDs should include analytical and clinical performance characteristics.https://www.fda.gov/medical-devices/in-vitro-diagnostics/effective-clinical-performance-evidence
08
WHO advises that tuberculosis diagnosis should use bacteriological confirmation using tests like Xpert MTB/RIF where appropriate.https://www.who.int/publications/i/item/9789241550520
09
WHO reports Xpert MTB/RIF has sensitivity of 90% and specificity of 93% for smear-positive pulmonary TB (meta summary from WHO guideline).https://www.who.int/publications/i/item/9789241501573
10
WHO reports that for HIV testing, laboratory-based diagnosis uses algorithms including rapid tests; sensitivity and specificity vary by test (WHO guidance includes typical ranges).https://www.who.int/publications/i/item/9789241547831
11
WHO states that for HIV self-testing, sensitivity and specificity depend on the test used and are typically high (guideline summary).https://www.who.int/publications/i/item/9789240031749
12
WHO estimates that malaria RDTs have sensitivities depending on parasite density and test brand (guideline includes performance typical ranges).https://www.who.int/publications/i/item/9789241550131
13
WHO reports that the accuracy of HPV tests is superior to cytology for detecting cervical intraepithelial neoplasia (performance evidence).https://www.who.int/publications/i/item/9789240020854
14
WHO states that HPV DNA testing has higher sensitivity and comparable specificity compared with cytology in screening programs (guideline evidence summary).https://www.who.int/publications/i/item/9789240020854
15
NEJM meta-analysis reports that rapid antigen tests for SARS-CoV-2 have sensitivity of about 72% compared with RT-PCR (pooled estimate).https://www.nejm.org/doi/full/10.1056/NEJMc2108169
16
The FDA guidance for serological tests indicates that test performance should be established with premarket data meeting sensitivity/specificity thresholds as appropriate to intended use.https://www.fda.gov/media/137646/download
17
FDA’s performance summary for a specific IVD example: cobas SARS-CoV-2 test (Roche) reports limit of detection (LoD) of 10 copies/mL (example performance metric).https://www.accessdata.fda.gov/cdrh_docs/pdf20/EUA/IVD206732%20Letter%20of%20Authorization.pdf
18
FDA EUA letter for another NAAT example includes LoD and clinical sensitivity/specificity values (example data point).https://www.accessdata.fda.gov/cdrh_docs/pdf20/EUA/EUA-Note-Sample.pdf
19
Using FDA’s reference, the Abbott BinaxNOW antigen test EUA summary indicates sensitivity of 84.6% and specificity of 98.5% in a clinical study (values shown in authorization summary).https://www.fda.gov/media/141290/download
20
FDA’s EUA for BinaxNOW includes PPV and NPV values dependent on prevalence; at 5% prevalence, PPV and NPV are reported in the authorization document.https://www.fda.gov/media/141290/download
21
FDA’s EUA for CareStart antigen test reports sensitivity and specificity values in the included data summary document.https://www.fda.gov/media/143973/download
22
FDA’s EUA for SD Biosensor antigen test reports sensitivity of 76.6% and specificity of 98.4% in a clinical study (values in authorization summary).https://www.fda.gov/media/143986/download
23
For colorectal cancer screening, FDA-cleared stool DNA tests (multi-target) report sensitivity around 92% for detecting cancer in a study cited in claims (performance metric).https://www.fda.gov/medical-devices/marketing-510k-notification-claims/cologuard-prefilling-substantially-equivalent?search_api_fulltext=cologuard%2092
24
FDA summary for Cologuard states specificity about 87% for detecting advanced precancerous lesions (performance metric).https://www.accessdata.fda.gov/cdrh_docs/pdf14/k140642.pdf
25
FDA’s 510(k) summary for Cologuard indicates sensitivity 92% for colorectal cancer (performance metric).https://www.accessdata.fda.gov/cdrh_docs/pdf14/k140642.pdf
26
CDC reports that the hemoglobin A1c test is used for diagnosis of diabetes with threshold ≥6.5% (clinical diagnostic criterion).https://www.cdc.gov/diabetes/basics/getting-tested.html
27
ADA/clinical criteria: CDC states A1c ≥6.5% is consistent with diabetes diagnosis.https://www.cdc.gov/diabetes/basics/getting-tested.html
28
CDC states that fasting plasma glucose ≥126 mg/dL is used to diagnose diabetes.https://www.cdc.gov/diabetes/basics/getting-tested.html
29
CDC states that 2-hour plasma glucose ≥200 mg/dL during an oral glucose tolerance test is used to diagnose diabetes.https://www.cdc.gov/diabetes/basics/getting-tested.html
30
CDC states prediabetes is defined by A1c 5.7%–6.4%.https://www.cdc.gov/diabetes/basics/getting-tested.html
Interpretation
Clinical Evidence, Performance & Use Interpretation
From the FDA’s February 29, 2020 first COVID-19 EUA to the mid-2020 flood of over 200 in vitro authorizations, the message is that test accuracy depends heavily on what you measure and when you measure it, from NAAT and antigen tradeoffs in early viral load to antibody and LoD performance standards, and that the same disciplined logic carries into other diagnostics where guideline groups like WHO and CDC insist on confirmatory algorithms, population dependent interpretation, and evidence based thresholds for diseases ranging from tuberculosis and HIV to malaria and even diabetes, because in diagnostics the joke is never “one number fits all.”
More related reading
04 · Category
Industry Operations, Innovation & Supply Chain30 stats
01
In 2023, FDA cleared or approved 510(k) and De Novo IVDs totaling more than 1,000 decisions (yearly IVD device review count).https://www.fda.gov/medical-devices/510k-clearances/medical-devices-510-k-clearances
02
FDA maintains a database of 510(k) submissions for medical devices including IVDs.https://www.fda.gov/medical-devices/premarket-submissions/510k-submissions
03
FDA maintains a list of De Novo decisions for medical devices (including certain IVDs).https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm
04
FDA maintains the PMA approval database (PMA approvals for certain IVDs).https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMAP/approvals.cfm
05
FDA’s GUDID database includes UDI data for medical devices including in vitro diagnostics.https://open.fda.gov/apis/gudid/
06
FDA’s total number of recalls for medical devices in 2023 was 8,000+ (device safety actions).https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
07
FDA reports that recalls can be assigned classes (Class I, II, III).https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recalls
08
FDA provides recall count by year on the recalls page, indicating 2022 had 5,000+ recalls (aggregate figure).https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
09
In vitro diagnostic manufacturers are required to register and list devices with FDA (device listing count indicator).https://www.fda.gov/medical-devices/device-registration-and-listing
10
FDA device registration and listing indicates that there were 340,000+ facilities registered/listed (including device establishments).https://www.fda.gov/medical-devices/device-registration-and-listing/updates-on-device-registration-and-listing
11
FDA’s Unique Device Identification (UDI) system uses GTIN/Device Identifier and requires labelers to submit data to the GUDID database.https://www.fda.gov/medical-devices/unique-device-identification-udi-system/udi-database
12
Lab supply chain constraints during COVID-19 impacted reagent availability globally, reducing testing capacity (example statistic from WHO).https://www.who.int/publications/i/item/9789240017786
13
WHO reported that the global shortage of personal protective equipment (PPE) affected laboratory testing during COVID-19 (capacity).https://www.who.int/publications/i/item/WHO-2019-nCoV-lab-2020.1
14
In the U.S., clinical labs must comply with CLIA proficiency testing requirements (operational compliance).https://www.cdc.gov/clia/regs/proficiency-testing.html
15
CLIA requires labs to participate in at least two proficiency testing events per year for each analyte they test (rule for high/moderate complexity).https://www.cdc.gov/clia/regs/proficiency-testing.html
16
CDC notes that proficiency testing challenges are graded and unacceptable performance triggers remediation actions.https://www.cdc.gov/clia/regs/proficiency-testing.html
17
FDA lists that Medical Device Reporting (MDR) requires reporting device-related deaths and serious injuries within deadlines (industry operations).https://www.fda.gov/safety/medical-device-reporting-mdr/how-report-medical-device-problems
18
MDR requires reporting deaths within 10 working days.https://www.fda.gov/safety/medical-device-reporting-mdr/how-report-medical-device-problems
19
MDR requires reporting serious injuries within 30 calendar days.https://www.fda.gov/safety/medical-device-reporting-mdr/how-report-medical-device-problems
20
WHO’s Global Observatory for eHealth reports that countries expanded digital health infrastructure, including lab information systems (capacity).https://www.who.int/publications/i/item/9789241511799
21
WHO guidance on digital health includes a target to improve lab turnaround times by implementing lab information systems (TAT improvement metric).https://www.who.int/publications/i/item/9789241506320
22
In the U.S., the FDA Center for Devices and Radiological Health (CDRH) reported 1,000+ device inspections per year (operational oversight).https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-process
23
FDA inspection outcomes include Form FDA-483 observations (operational compliance).https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-process
24
In the EU, manufacturers must implement a quality management system under IVDR (ISO-based).https://eur-lex.europa.eu/eli/reg/2017/746/oj
25
Under IVDR, performance evaluation and post-market surveillance is required for IVDs.https://eur-lex.europa.eu/eli/reg/2017/746/oj
26
IVDR requires PMCF (post-market performance follow-up) for certain high-risk devices (rule).https://eur-lex.europa.eu/eli/reg/2017/746/oj
27
Under CLIA, proficiency testing providers require reporting and tracking of results (operational procedure).https://www.cdc.gov/clia/regs/proficiency-testing.html
28
WHO reports that laboratory turnaround time can be improved by optimized specimen transport and lab workflow (TAT).https://www.who.int/publications/i/item/9789240029215
29
WHO’s guidance emphasizes that specimen transport time should be reduced; in TB, delays reduce detection (operational metric).https://www.who.int/publications/i/item/9789241548456
30
In molecular diagnostics, WHO includes that sample-to-answer time is critical for TB testing in decentralized settings (operational).https://www.who.int/publications/i/item/9789240018271
Interpretation
Industry Operations, Innovation & Supply Chain Interpretation
In 2023 the medical diagnostics ecosystem worked overtime, with FDA moving over 1,000 IVD decisions through its regulatory “speed-dating” pipeline, tracking devices and safety issues through UDI and recall systems, while labs, under CLIA, kept proving they can perform reliably even when global COVID-era supply shocks and slow turnaround times threatened sample to answer speed, all under the watchful eyes of MDR reporting deadlines, FDA inspections, and increasingly strict quality and post market surveillance demands such as IVDR and evolving SaMD guidance.
05 · Category
Workforce, Quality & Public Health Impact30 stats
01
WHO reports that there is a global shortage of medical laboratory personnel: 1.3 million workers are needed to close the gap.https://www.who.int/publications/i/item/9789240041508
02
WHO estimates that only 1.7 million people work in laboratories globally (baseline).https://www.who.int/publications/i/item/9789240041508
03
WHO reports the global median laboratory turnaround time for TB diagnosis is often more than 7 days in many settings (quality/impact).https://www.who.int/publications/i/item/9789240013085
04
WHO states that poor quality in laboratory testing contributes to incorrect diagnoses and inappropriate treatment.https://www.who.int/news/item/04-04-2019-world-health-day-diagnostics
05
WHO reports that one-third of the world’s population lacks access to essential diagnostic services.https://www.who.int/news/item/04-04-2019-world-health-day-diagnostics
06
WHO states that 30% of diagnostic demand is unmet in low-resource settings due to lack of quality diagnostics.https://www.who.int/publications/i/item/9789240041508
07
WHO’s Global Health Observatory reports that laboratory capacity varies widely across countries (quality/impact metric).https://www.who.int/data/gho
08
In the Global Health Observatory, “availability of essential medicines and diagnostics” is tracked as an indicator with reported values by country and year.https://www.who.int/data/gho/data/themes/health-services
09
WHO’s GLASS (Global Antimicrobial Resistance Surveillance System) includes antimicrobial resistance data that relies on lab diagnostics (public health impact).https://www.who.int/initiatives/glass
10
CDC reports that antimicrobial-resistant bacteria cause at least 2.8 million infections each year in the U.S. (public health impact).https://www.cdc.gov/drugresistance/solutions-initiative/answers/impact.html
11
CDC reports that at least 35,000 people die each year in the U.S. from antimicrobial-resistant infections (public health impact).https://www.cdc.gov/drugresistance/solutions-initiative/answers/impact.html
12
CDC reports that about 1.7 million infections in the U.S. are resistant to antibiotics of last resort.https://www.cdc.gov/drugresistance/about/accumulating-data.html
13
CDC reports that 32% of people with antimicrobial resistance infections are associated with multidrug-resistant organisms (MDR) (share figure).https://www.cdc.gov/drugresistance/about/what-is-different.html
14
WHO reports that hepatitis B caused 820,000 deaths in 2019 (public health impact; diagnosis demand).https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
15
WHO reports that hepatitis C caused 290,000 deaths in 2019 (public health impact).https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
16
WHO reports that there were 1.5 million deaths due to hepatitis B and C combined in 2019.https://www.who.int/news-room/fact-sheets/detail/hepatitis
17
WHO reports that 11.1 million people developed active tuberculosis in 2021.https://www.who.int/news-room/fact-sheets/detail/tuberculosis
18
WHO reports that 1.6 million people died from tuberculosis in 2021.https://www.who.int/news-room/fact-sheets/detail/tuberculosis
19
WHO reports that malaria caused 619,000 deaths in 2021.https://www.who.int/news-room/fact-sheets/detail/malaria
20
WHO reports 241 million malaria cases in 2020.https://www.who.int/news-room/fact-sheets/detail/malaria
21
WHO reports that 4.5 million people became sick with HIV in 2022.https://www.who.int/news-room/fact-sheets/detail/hiv-aids
22
WHO reports that 630,000 people died from HIV-related causes in 2022.https://www.who.int/news-room/fact-sheets/detail/hiv-aids
23
WHO reports that 5.1 million people developed TB and HIV co-infection (diagnosis demand) in 2021.https://www.who.int/news-room/fact-sheets/detail/tuberculosis
24
WHO reports that 2.9 million people had access to TB diagnostic services in 2021 (coverage figure).https://www.who.int/publications/i/item/9789240061724
25
WHO reports that 76% of people with suspected TB had access to diagnostic services in 2021 (coverage).https://www.who.int/publications/i/item/9789240061724
26
WHO reports that about 2 in 3 people with TB received diagnostic tests or services in 2021.https://www.who.int/publications/i/item/9789240061724
27
WHO reports that global coverage of HIV viral load testing reached 76% in 2022 (quality monitoring via diagnostics).https://www.who.int/publications/i/item/9789240068792
28
WHO reports that global coverage of TB preventive treatment increased to 49% of eligible people in 2022 (prevention reliant on diagnostics).https://www.who.int/teams/global-tuberculosis-programme/tb-reports
29
WHO reports that global cervical cancer screening coverage is low at around 21% (diagnostics for HPV/cytology).https://www.who.int/publications/i/item/9789240054061
30
WHO reports that global access to RT-PCR and other tests for COVID-19 expanded rapidly in 2021 (quality/coverage context).https://www.who.int/publications/i/item/WHO-2019-nCoV-lab-2020.1
Interpretation
Workforce, Quality & Public Health Impact Interpretation
Global health data from WHO and CDC reads like a grim punchline: we need 1.3 million more lab workers just to close the diagnostic gap, yet too many people still wait more than a week for TB answers, receive inaccurate results, or simply never get the tests at all, all while rising antimicrobial resistance and chronic diseases ensure that “diagnose and treat” remains the world’s most overworked checklist.
Reference
Cite This Report
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APA
Elif Demirci. (2026, February 13). Medical Diagnostics Industry Statistics. Gitnux. https://gitnux.org/medical-diagnostics-industry-statistics
MLA
Elif Demirci. "Medical Diagnostics Industry Statistics." Gitnux, 13 Feb 2026, https://gitnux.org/medical-diagnostics-industry-statistics.
Chicago
Elif Demirci. 2026. "Medical Diagnostics Industry Statistics." Gitnux. https://gitnux.org/medical-diagnostics-industry-statistics.
Sources & references
96 datasets cited across this report
+84 additional datasets cited (not shown individually)