Diagnostic tests provide essential information to guide clinical decision-making, allowing healthcare professionals to accurately diagnose conditions, determine appropriate treatments, and assess the effectiveness of interventions. Rapid advancements in diagnostic technologies enhance early detection, contributing to better prognosis and improved patient outcomes. Diagnostic tests also play a pivotal role in preventive medicine, helping identify risk factors and enabling timely intervention to prevent the onset or progression of diseases. These tests are integral to public health initiatives, aiding in disease surveillance and control, especially in the context of infectious diseases and pandemics
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Data Bridge Market Research analyses the North America Diagnostic Tests Market, which was USD 1,57,104.45 million in 2022, and is expected to reach USD 3,24,714.32 million by 2030, at a CAGR of 9.5% during the forecast period 2023 to 2030. Significant investments in research and development in North America drive innovation in diagnostic technologies, spurring the creation of advanced and highly accurate tests.
Key Findings of the Study
Rise in a strong regulatory environment is expected to drive the market's growth rate
The North American diagnostic tests market benefits from a growing regulatory environment, spearheaded by organizations such as the FDA. This stringent regulatory framework ensures the safety and efficacy of diagnostic tests, instilling confidence among industry stakeholders. The assurance of compliance with high standards facilitates a smoother introduction of new products to the market. The FDA's oversight provides a sense of stability, encouraging innovation and investment in research and development within the sector. As a result, companies operating in the North American market are more inclined to pursue and bring forward advanced diagnostic technologies, contributing to the overall growth and dynamism of the industry.
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2023 to 2030
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Base Year
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2022
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Historic Years
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2021 (Customizable to 2015-2020)
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Quantitative Units
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Revenue in USD Million, Volumes in Units, Pricing in USD
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Segments Covered
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Type (Glucose Test, Infectious Diseases Test, Cytology Test, CBC Test, Blood Culture Test, Syphilis Test, Urea Test, C-Reactive Protein Test, Antigen Test, HBA1C Test, Pregnancy Test, Lipid Profile Test, Electrolytes Test, Liver Function Test, Stool Helicobacter Pylori Test, Calcium Test, Crossmatch Test, Thyroid Function Test, Stool Microscopy Test, Urine Microscopy Test, Unit Packed RBCS Test, ESR Test and Others Test), Solutions (Services and Products), Technology (Immunoassay-Based, PCR-Based, Next Gene Sequencing, Spectroscopy-Based, Chromatography-Based, Microfluidics, Substrate Technology and Others), Mode of Testing (Prescription-Based Testing and OTC Testing), Approach (Molecular Diagnostic Instrument, In-Vitro Diagnostic Instrument and Point Of Care Testing Instrument), Sample Type (Urine, Saliva, Blood, Hair, Sweat and Others), Application (Cardiology, Oncology, Neurology, Orthopedics, Gastroenterology, Gynecology, Odontology and Others), Testing Type (Biochemistry, Haematology, Microbiology, Histopathology and Others), Age (Pediatric, Adult and Geriatric), End User (Hospitals, Diagnostic Center, Research Labs and Institutes, Research Institute, Homecare, Blood Banks, Specialty Clinics, Ambulatory Surgical Centers and Others), Distribution Channel (Direct Tenders, Retail Sales and Online Sales)
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Countries Covered
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U.S., Canada, and Mexico in North America
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Market Players Covered
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F-Hoffman La-Roche Ltd. (Switzerland), ABBOTT (U.S.), Danaher (U.S.), B.D. (U.S.), Thermo Fisher Scientific Inc. (U.S.), ACON Laboratories Inc. (U.S.), Hemosure, Inc. (U.S.), MicroGen Diagnostics (U.S.), QIAGEN (Germany), Grifols, S.A (Spain), BODITECH MED INC. (South Korea), Chembio Diagnostic Systems, Inc. (U.S.), Nanoentek (South Korea), DiaSorin S.p.A. (Italy), Bio-Rad Laboratories, Inc. (U.S.), BIOMEDOMICS INC (U.S.), EKF Diagnostics Holdings plc (U.K.), Siemens Healthcare GmbH (Germany), PerkinElmer Inc. (U.S.), BIOMÉRIEUX (France), ARKRAY USA, Inc. (U.S.), Biohit Oyj (Finland), Germaine Laboratories, Inc. (U.S.), Quidel Corporation (U.S.), Illumina, Inc. (U.S.), Lamdagen Corporation (U.S.), LifeSign LLC. (U.S.), Medixbiochemica (Finland), Nova Biomedical (U.S.), Ortho Clinical Diagnostics (U.S.), Sannuo Biosensing Co., Ltd. (U.S.), STRECK (U.S.), Sysmex Corporation (Japan), among others
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
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Segment Analysis:
The North America diagnostic tests market is segmented on the basis of type, solution, technology, mode of testing, approach, sample type, application, testing type, age, end-user, and distribution channel.
- On the basis of type, the North America diagnostic tests market is segmented into glucose test, infectious diseases test, cytology test, CBC test, blood culture test, syphilis test, urea test, c-reactive protein test, antigen test, hba1c test, pregnancy test, lipid profile test, electrolytes test, liver function test, stool helicobacter pylori test, calcium test, crossmatch test, thyroid function test, stool microscopy test, urine microscopy test, unit packed RBCS test, ESR test and others test
- On the basis of solution, the North America diagnostic tests market is segmented into services and products
- On the basis of technology, the North America diagnostic tests market is segmented into immunoassay-based, PCR-based, next gene sequencing, spectroscopy-based, chromatography-based, microfluidics, substrate technology, and others
- On the basis of mode of testing, the North America diagnostic tests market is segmented into prescription-based testing and OTC testing
- On the basis of approach, the North America diagnostic tests market is segmented into molecular diagnostic instrument, in-vitro diagnostic instrument and point of care testing instrument
- On the basis of sample type, the North America diagnostic tests market is segmented into urine, saliva, blood, hair, sweat, and others
- On the basis of application, the North America diagnostic tests market is segmented into cardiology, oncology, neurology, orthopedics, gastroenterology, gynecology, odontology, and others
- On the basis of testing type, the North America diagnostic tests market is segmented into biochemistry, haematology, microbiology, histopathology, and others
- On the basis of age, the North America diagnostic tests market is segmented into paediatric, adult and geriatric
- On the basis of end-user, the North America diagnostic tests market is segmented into hospitals, diagnostic center, research labs and institutes, research institute, homecare, blood banks, specialty clinics, ambulatory surgical centers, and others
- On the basis of distribution channel, the North America diagnostic tests market is segmented into direct tenders, retail sales, and online sales
Major Players
Data Bridge Market Research recognizes the following companies as the major North America diagnostic tests market players in North America diagnostic tests market are F-Hoffman La-Roche Ltd. (Switzerland), ABBOTT (U.S.), Danaher (U.S.), B.D. (U.S.), Thermo Fisher Scientific Inc. (U.S.), ACON Laboratories Inc. (U.S.), Hemosure, Inc. (U.S.).
Market Developments
- In 2021, Roche made a significant stride in healthcare technology with the introduction of the Cobas Pulse System in select nations that accepted the CE Mark. This innovative point-of-care solution, part of Roche Diagnostics' latest generation, marked a notable advancement in expert blood glucose management. The system, designed to be networked, showcased Roche's commitment to providing cutting-edge solutions in the field of diagnostics
- In 2021, Ortho Clinical Diagnostics unveiled a groundbreaking tool for blood transfusion compatibility known as the Immediate Spin Crossmatch (ISXM). This tool was integrated into the company's Ortho Vision and Ortho Vision Max Analyzers. The introduction of ISXM served as a pivotal development in the field, enabling the rapid and accurate identification of recipient and donor incompatibility in blood transfusions. This showcased Ortho Clinical Diagnostics' dedication to advancing diagnostic capabilities and ensuring the safety and efficacy of blood transfusion procedures
- In 2020 witnessed Siemens Healthcare GmbH's official announcement of the RAPIDPoint 500e Blood Gas Analyzer. This marked a significant expansion of Siemens' product portfolio and had broader implications, particularly in the context of global efforts to combat the COVID-19 pandemic. The RAPIDPoint 500e played a crucial role in analyzing blood gases, thereby contributing to the comprehensive management of COVID-19 cases. This release not only showcased Siemens' commitment to technological innovation but also positioned the company as a key player in addressing healthcare challenges
- In 2020, Siemens Healthcare GmbH entered into a notable ten-year collaboration with the Marienhaus Hospital Group. This strategic partnership had far-reaching implications for Siemens, particularly in the field of diagnostics. The collaboration was anticipated to bring long-term benefits to Siemens Healthcare GmbH, enhancing its position in the diagnostics sector. Beyond diagnostics, this agreement was expected to have positive effects on the company's financial standing, demonstrating Siemens' proactive approach to fostering partnerships that contribute to its overall growth and success
Regional Analysis
Geographically, the countries covered in the North America diagnostic tests market report are U.S., Canada and Mexico in North America.
As per Data Bridge Market Research analysis:
U.S. is the dominant region in North America diagnostic tests market during the forecast period 2023-2030
The U.S. dominates the North American diagnostic tests market due to a combination of factors. Extensive investments in research and development, a forefront position in technological advancements, a strong regulatory framework led by the FDA, and a large and diverse healthcare market contribute to the country's leadership. Collaboration between academia and industry, a growing emphasis on personalized medicine, and the presence of major pharmaceutical and biotechnology companies further bolster the U.S.'s influence in the market.
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