The anticipated size of the INR test meter market in 2022 was USD 1,268.3 million and is estimated to be USD 1,336.1 million in 2023. The rise in the prevalence of cardiovascular diseases and blood disorders across the globe is considered one of the primary drivers that will raise the growth of the INR test meter market.
Future Market Insights has mentioned in its reports that the INR test meter market will expand at a CAGR of 6.3% between 2023 and 2033, totaling around USD 2,453.3 million by 2033.
INR test meter is a battery-operated, portable device that is used to track a patient's response to warfarin. Meter contains a display screen that shows the results as well as a slot for meter-specific test strips. Test strip is introduced into the meter, and blood is drawn with a lancet (a medical pricking needle) and applied to the test strip.
Meter reads the test strip, counts the number of seconds it takes for the blood to clot, and calculates the result using a standardized formula called the International Normalized Ratio (INR). Providers and patients use the INR to evaluate if the warfarin dose is proper. The USA Food and Drug Administration regulates INR test meters and test strips as medical devices.
| Attributes | Details |
|---|---|
| Projected Forecast Value (2022) | USD 1,268.3 million |
| Projected Forecast Value (2023) | USD 1,336.1 million |
| Projected Forecast Value (2033) | USD 2,453.3 million |
| Growth rate | 6.3% CAGR |
| Forecast period | 2023 to 2033 |
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The global INR test meter market grew at a CAGR of 4.5% between 2017 and 2022. Growth forecasts remain optimistic, with the market predicted to exhibit a CAGR of 6.3% between 2023 and 2033.
Future Market Insights (FMI) projects that the INR test meter market contributed approximately 72.8% of the overall USD 1.66 billion of the global point-of-care coagulation testing devices market in 2021.
Standard test for patients on vitamin K antagonists (VKA), is the international normalized ratio (INR). It is also helpful in the evaluation of a patient's risk of bleeding or coagulation status.
As INR varies between patients, patients taking oral anticoagulants monitor their INR to adjust their VKA doses. Blood thinner warfarin is used to prevent and treat blood clots. Patient's warfarin dose is decided by their age, overall health, and genetic factors. Patient care includes regular INR monitoring and patient-centered INR education.
INR is derived from prothrombin time (PT). PT and INR are important parameters to keep track of a patient's coagulation status, particularly if they're using VKAs. Although the PT/INR is beneficial for monitoring the coagulation state. Activated partial thromboplastin time (aPTT), which assesses the intrinsic and common coagulation pathways, is frequently used in conjunction with PT/INR. Combination of PT/INR and aPTT values can confirm the diagnosis of a range of hematologic diseases.
Patients who benefit from PT tests are those who have thromboembolic complications requiring oral anticoagulation therapy (OAT), critical coagulopathy (such as SIC), haemorrhagic conditions, etc., triggered by hepatic or renal disorders, or diseased states such as dengue haemorrhagic fever, and others.
Patients with cardiovascular disorders (CVD), such as stroke, atrial fibrillation, transient ischemic attacks, myocardial infarction, valve prosthesis, pulmonary embolism, venous thrombosis, and others, are among the most common candidates for life-long oral therapy to prevent intravascular clot formation.
Application of PT/INR Testing in Smartphone Sensors
The application of PT/INR testing in smartphone sensors is expected to result in a cost-effective blood clot detection device. Custom electronics and hardware are not necessary for using smartphone hardware for medical purposes.
The use of such hardware reduces the development costs generally associated with obtaining regulatory approvals. The United States of America’s Food and Drug Administration (FDA) does not control smartphone hardware and only governs unique software features under its Mobile Medical Applications (MMA) and Software as a Medical Device (SaMD) regulations.
The FDA has approved or authorized commercially available MMAs that perform medical diagnostics using sensors such as microphones and cameras. INR testing on whole blood samples using a point-of-care testing (POCT) device at a thrombosis clinic is adequate and beneficial.
Due to the ease, shortened waiting time, and painless finger stick technique, it significantly improves the patient experience.
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Availability of Various Home PT/INR Testing Modules
Despite the availability of various home PT/INR testing modules, finding a cost-effective and accurate PT/INR test remains a challenge. In the United States of America, patients are only in the therapeutic range roughly 64% of the time.
Patients in developing nations such as Botswana, Uganda, and India fall into this category just 40% of the time due to less testing. Despite the potential benefits of home PT/INR testing, these devices are expensive, limiting their applicability in resource-constrained settings.
Especially in senior patients with various comorbidities, excessive waiting times can lead to greater patient dissatisfaction. After a thorough cost-benefit analysis, robust technology could be explored in order to deliver quick results while also ensuring patient convenience and satisfaction.
Such factors cumulatively hamper the market growth for INR test meters, and call for solutions to meet the requirements which hinder the overall sales and adoption of INR test meters across the globe.
Introduction of Coagulation Testing in the United States to Improve INR Test Meter Demand
The United States is expected to hold a market share of 32.1% and considerably dominates North America’s INR test meter market with a total share of about 35.6% in 2022 and is expected to continue to experience the same growth throughout the forecast period.
With the introduction of anticoagulants, the rising prevalence of blood clotting diseases, and the growing need for coagulation testing devices, North America is expected to be a prominent market for INT test meters. In North America, the United States is expected to be the largest market for coagulation testing, followed by Canada. This is anticipated to drive the demand for the INR test meter market in the United States, facilitating growth in North America through 2032.
Germany INR Test Meter Market to Benefit from Strong Presence of Key Manufacturers
Germany held a market share of nearly 3.6% in the Europe INR test meter market with a market share of 32.0%. Growth in the Germany INR test meter market is expected to witness strong growth with the presence of large medical device players, such as Merck KGaA, and SIEMENS Healthcare Diagnostics Products GmbH.
Key players in the market are focusing on new product launches and prototype products which have demonstrated the functioning of novel coagulation testing platforms and their functions. This is expected to push the demand for INR test meters in Germany.
Inflammation and Hysterical Viral Replication Promotes Hypercoagulability and Vascular Damage
The INR test meter market in China expanded at a CAGR of 10.1% share in the East Asia market, surpassing USD 67.1 million in 2021. Inflammation and hysterical viral replication promote hypercoagulability and vascular damage. Low platelet counts, increased D-dimer, and prolonged PT are linked to poor outcomes.
With the high prevalence of clotting and scattered intravascular coagulation in the country, India is expected to drive the demand for INR test meters and will likely expand at a CAGR of 8.4%, and hence functions as a major market development driver.
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INR Test Meter Devices to Account for Significant Share Through 2033
Devices are expected to present high growth at a CAGR rate of 6.8% throughout the forecast period, accounting for around 79.7% of the revenue. INR machines and devices can be appropriately utilized in various settings, including INR self-testing and home anticoagulation therapy.
Rapid approval processes for medical devices by regulatory bodies like the FDA, and the production of advanced systems, such as digitally integrated test meters via smartphones, have provided the market with several innovative opportunities to enhance sales growth throughout the forecasted years.
Demand for INR Test Meter in Hospitals to Surge at a Robust Pace between 2023 and 2033
Hospitals held the highest market share value of 32.4%, opines FMI. Hospital settings observe a higher adoption of the INR test meters, owing to the lower cost associated with bulk adoption of devices, greater utilization of disposable test strips, and higher patient footfall, especially in cases of trauma and emergency care.
Some of the prominent players in the global market are-
Some of the important developments of the key players in the market are:
| Report Attribute | Details |
|---|---|
| Growth Rate | CAGR of 6.3% from 2023 to 2033 |
| Market value in 2023 | USD 1,336.2 million |
| Market value in 2033 | USD 2,453.3 million |
| Base Year for Estimation | 2022 |
| Historical Data | 2017 to 2022 |
| Forecast Period | 2023 to 2033 |
| Quantitative Units | USD million for Value and CAGR from 2023 to 2033 |
| Report Coverage | Revenue Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis |
| Segments Covered |
By Product Type, By End-user, By Region |
| Regions Covered |
North America; Latin America; Western Europe; Eastern Europe; South Asia and Pacific; East Asia; Middle East & Africa |
| Key Countries Profiled | United States, Canada, Brazil, Mexico, Germany, United Kingdom, France, Spain, Italy, Poland, Russia, Czech Republic, Romania, India, Bangladesh, Australia, New Zealand, China, Japan, South Korea, GCC Countries, South Africa, Israel |
| Key Companies Profiled |
F. Hoffmann-La Roche Ltd; Lepu Medical Technology (Beijing) Co. Ltd.; ACON Laboratories, Inc.; CoaguSense Inc.; Abbott; Eurolyser Diagnostica GmbH; Horiba ABX SAS; Avalun SAS; Roche Diagnostics; Siemens Healthineers |
| Customization & Pricing | Available on Request |
The growth potential of the market is 6.3% through 2033
The United States holds high lucrativeness.
Application of PT/INR testing in smartphone sensors is the key opportunity.
Germany's INR test meter market gains from manufacturer presence.
Coagulation testing boosts demand in the United States.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2017 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Product 5.1. Device 5.2. Lancet 5.3. Test Strips 6. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Test Strips 6.1. Hospitals 6.2. Specialty Clinics 6.3. Ambulatory Surgical Centers 6.4. Home care settings 7. Global Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Region 7.1. North America 7.2. Latin America 7.3. Western Europe 7.4. Eastern Europe 7.5. South Asia and Pacific 7.6. East Asia 7.7. Middle East and Africa 8. North America Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 9. Latin America Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 10. Western Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 11. Eastern Europe Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 12. South Asia and Pacific Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 13. East Asia Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 14. Middle East and Africa Market Analysis 2017 to 2022 and Forecast 2023 to 2033, By Country 15. Key Countries Market Analysis 16. Market Structure Analysis 17. Competition Analysis 17.1. F. Hoffmann-La Roche Ltd 17.2. Lepu Medical Technology (Beijing) Co., Ltd. 17.3. ACON Laboratories, Inc. 17.4. CoaguSense Inc. 17.5. Abbott 17.6. Eurolyser Diagnostica GmbH 17.7. Horiba ABX SAS 17.8. Avalun SAS 17.9. Roche Diagnostics 17.10. Siemens Healthineers 18. Assumptions & Acronyms Used 19. Research Methodology
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INR Test Meter Market
