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Report Overview

2024

Base Year

2018-2024

Historical Year

2025-2034

Forecast Year

North America In-vitro Diagnostics Market Outlook

The North America in-vitro diagnostics market is expected to grow at a CAGR of 4.7% during the period 2025-2034.

north-america-in-vitro-diagnostics-market

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In-vitro diagnostics can help identify early warning signs and individual risk factors, generating new openings for prevention and early intervention. Generally, in-vitro diagnostics (IVD) tests are considered medical gadgets. These may include reagents, techniques, instruments, or a combination thereof employed in-vitro for the investigation of samples such as blood, urine or tissue to obtain a diagnosis from assays in a controlled environment outside a living organism. Several leading companies offer in-vitro diagnostic (IVD) solutions that deliver rapid, sensitive results while minimizing cost and complexity. Modern in-vitro diagnostics (IVDs) enable better diagnosis for prevention and management of infectious and chronic diseases. These factors are expected to drive market growth

Market Likely to be Driven by Demand for Quality Medical Care and Advanced Solutions by Leading Companies

A majority of in-vitro diagnostics market is concentrated in developed nations, key being USA, Europe and Japan; the in-vitro diagnostics market, overall, is led by major players including Roche Diagnostics, Abbott Diagnostics, Siemens, Johnson & Johnson Medical Devices and Diagnostics, Beckman Coulter and BioMerieux. Roche Diagnostics is a key player in in-vitro diagnostics and tissue-based cancer diagnostics. In 2020, 23 billion tests were carried out across the world using the company’s diagnostics products. Companies like Roche are engaged in understanding how diseases differ at the molecular level, and developing novel tests and drugs that prevent, diagnose and treat such illnesses. Diagnosis is an important and complex activity; accurate diagnosis is vital to ensure correct treatment. Roche Diagnostics Canada offers a distinct and wide product portfolio, with advanced solutions to physicians, hospitals, laboratories, patients, and researchers, in the domains of immunology, clinical chemistry, molecular biology, point-of-care, pathology and life science.

North America In-vitro Diagnostics Market Growth

The domain of point-of-care (POC) diagnostics offers the likelihood of providing rapid diagnostic results in non-laboratory environments. With increasingly connected consumer electronic devices, patients and consumers are progressively changing their interaction with POC medical technologies in conjunction with mobile devices; consumers are looking to manage and take control of their own health. POC diagnostic and monitoring devices are likely to increase in popularity in various environments, including home, hospital, clinic, and in developed as well as developing nations. Point of care (POC) diagnostics comprises a significant portion of the total in-vitro diagnostics market in the USA, with the US dominating the general POC market; rising popularity of POC diagnostics is expected to stimulate the growth of the North America in-vitro diagnostics market.

Expansion of Capabilities by Major Companies Likely to Stimulate the Market

Major companies are looking to broaden their offerings and come together to enhance capabilities. For example, in 2023, Medix Biochemica acquired all shares of Bioresrouce Technology to widen its base matrix abilities and further reinforce its local presence in the United States market. Through the partnership, Medix Biochemica would provide its customers an extensive offering of raw materials for IVD quality control products. The organisation and operations of BRT would form a significant portion of Medix Biochemica’s IVD Biomaterials Business Unit, which also comprised manufacturing of native antigens, enzymes, proteins and biologicals in St. Louis, Missouri. Such developments are likely to boost the North America in-vitro diagnostics market.

In 2023, ALine, Inc. and Nectar Product Development announced a strategic partnership to advance point-of-care IVD medical products. The partnership sought to get the microfluidic consumable design to interface robustly with the instrument while fulfilling all instrument design and performance requirements.

north-america-in-vitro-diagnostics-market-by-segmentation

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North America In-vitro Diagnostics Market Segmentation

By product and service, the market is segmented into:

  • Reagents and Kits
  • Instruments
  • Software and Services

By technology, the market is divided into:

  • Immunoassay/Immunochemistry
  • Clinical Chemistry
  • Molecular Diagnostics
  • Microbiology
  • Haematology
  • Blood Glucose Self-Monitoring
  • Coagulation and Haemostasis
  • Urinalysis
  • Others

By application, the market is divided into:

  • Infectious Diseases
  • Diabetes
  • Oncology
  • Cardiology
  • Autoimmune Diseases
  • Nephrology
  • Others

By country, the market is classified into:

  • United States
  • Canada

north-america-in-vitro-diagnostics-market-by-region

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Key Industry Players in the North America In-vitro Diagnostics Market

The report presents a detailed analysis of the following key players in the North America in-vitro diagnostics market, looking into their capacity, and latest developments like capacity expansions, plant turnarounds, and mergers and acquisitions:

  • Becton, Dickinson and Company
  • Beckman Coulter, Inc.
  • Bio-Rad Laboratories, Inc. 
  • Surmodics IVD, Inc.
  • Illumina, Inc.
  • Others

The EMR report gives an in-depth insight into the industry by providing a SWOT analysis as well as an analysis of Porter’s Five Forces model.

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2018-2024
Forecast Period 2025-2034
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product and Service
  • Technology
  • Application
  • Region
Breakup by Product and Service
  • Reagents and Kits
  • Instruments
  • Software and Services
Breakup by Technology
  • Immunoassay/Immunochemistry
  • Clinical Chemistry
  • Molecular Diagnostics
  • Microbiology
  • Haematology
  • Blood Glucose Self-Monitoring
  • Coagulation and Haemostasis
  • Urinalysis
  • Others
Breakup by Application
  • Infectious Diseases
  • Diabetes
  • Oncology
  • Cardiology
  • Autoimmune Diseases
  • Nephrology
  • Others
Breakup by Region
  • United States
  • Canada
Market Dynamics
  • SWOT Analysis
  • Porter's Five Forces Analysis
  • Key Indicators for Demand
  • Key Indicators for Price
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Company Overview
    • Product Portfolio
    • Demographic Reach and Achievements
    • Certifications
Companies Covered
  • Becton, Dickinson and Company
  • Beckman Coulter, Inc.
  • Bio-Rad Laboratories, Inc. 
  • Surmodics IVD, Inc.
  • Illumina, Inc.
  • Others
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Key Questions Answered in the Report

The market is projected to grow at a CAGR of 4.7% between 2025 and 2034.

The major drivers of the North America in-vitro diagnostics market include the technological advancements, rising levels of income, rising standards of living, newly insured patients, and modernised healthcare facilities.

The rising popularity of point of care diagnostics and growing demand for quality medical care are the key industry trends propelling the market's growth.

The major countries in the industry are United States and Canada.

The various products and services in the market are reagents and kits, instruments, software and services.

Based on technology, the market is segmented into immunoassay/immunochemistry, clinical chemistry, molecular diagnostics, microbiology, haematology, blood glucose self-monitoring, coagulation and haemostasis, and urinalysis, among others.

The major applications of the market are infectious diseases, diabetes, cardiology, oncology, autoimmune diseases, and nephrology, among others.

The major players in the industry are Becton, Dickinson and Company, Beckman Coulter, Inc., Bio-Rad Laboratories, Inc., Surmodics IVD, Inc., and Illumina, Inc., among others.

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