United States In Vitro Diagnostics Market

United States In Vitro Diagnostics Market Size and Share:

The United States in vitro diagnostics market size was valued at USD 30.3 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 39.5 Billion by 2033, exhibiting a CAGR of 2.7% from 2025-2033. The market is growing, driven by the rising prevalence of chronic diseases, advancements in diagnostic technologies, and an increasing demand for personalized medicine.

The growing prevalence of chronic diseases and the rising demand for early and accurate diagnostic solutions are driving the expansion of the in vitro diagnostics market in the United States. The requirement for accurate diagnostic technologies that allow for instant identification and treatment has increased because of chronic disorders such as diabetes, cardiovascular diseases (CVDs), and cancer. These disorders tend to occur among older people, thus resulting in the demands on the geriatric population. Advanced tools for diagnosis are needed to improve patient treatment. Technological advancements in molecular diagnostics, including innovations like polymerase chain reaction (PCR) and next-generation sequencing (NGS), have enhanced the market's ability to deliver highly sensitive and specific results. For example, in April 2024, Tempus received FDA approval for its xT CDx, an NGS-based diagnostic that profiles 648 genes in solid tumors, enabling personalized cancer treatment by identifying genetic alterations and microsatellite instability. Furthermore, this progress has led to the integration of more efficient diagnostic platforms across hospitals, clinics, and laboratories nationwide, fueling overall market growth.

Additionally, raised demand for personalized medicine is a significant driver for the growth of the market, as individualized treatments demand highly specialized diagnostic equipment. The heightening awareness of precision medicine among patients and healthcare providers has further boosted in vitro diagnostics adoption. Government initiatives, including funding and policies aimed at improving healthcare infrastructure and encouraging innovation, have played a vital role in the industry's growth. For instance, in May 2024, the FDA finalized rules designating in vitro diagnostics (IVDs), including laboratory-developed tests (LDTs), as medical devices. A phased four-year policy mandates compliance with medical device reporting, quality systems, and premarket review requirements to ensure safety and effectiveness. Moreover, the advanced technologies like AI and ML are testing solutions which are becoming more accurate, speedier, and scalable. This leads to its application in urban and rural health care facilities, as diagnostic service demand continues to grow across the nation. These aspects reflect the gradual growth and change of the IVD market within the US.

United States In Vitro Diagnostics Market Trends:

Rising Adoption of Molecular Diagnostics

Molecular diagnostics is gaining traction due to its ability to detect diseases at the genetic level, offering unparalleled precision. The emergence of advanced technologies such as PCR and NGS has revolutionized the detection of cancer, genetic disorders, and infectious diseases. According to the research, The U.S. next-generation sequencing market reached USD 4.4 billion in 2024, with projections to grow to USD 20.9 billion by 2033, driven by increasing demand for personalized medicine, agricultural use, and technological advancements. Moreover, these tests provide earlier diagnosis and enable personalized treatment plans, which are increasingly demanded by patients and healthcare providers. The integration of automated platforms for molecular testing has reduced turnaround times, making these tools more accessible in clinical settings. As a result, molecular diagnostics is becoming a preferred method for disease detection, driven by its efficiency and reliability.

Growth of Point-of-Care Testing

Point-of-care testing (POCT) is changing the face of the IVD world as it brings diagnostic instruments closer to patients. This kind of equipment is portable and easy to use, allowing for instant results that help make quicker clinical decisions. The rising rate of chronic diseases, such as diabetes has driven the market for POCT devices like glucose monitors. Further, outbreaks of infectious diseases have necessitated decentralized testing solutions that have propelled the demand for POCT. Technological advances in miniaturization and connectivity have made these devices highly efficient which are offering integration with digital health systems for seamless data sharing. Moreover, the healthcare is shifting towards patient-centric models, POCT adoption continues to rise, emphasizing its role in improving healthcare access and reducing costs.

Increased Focus on AI-Driven Diagnostics

Artificial intelligence (AI) is changing the IVD market as it offers accuracy and efficiency of diagnostics. AI facilitates the analysis of vast datasets with greater speed and efficiency compared to traditional methods, enabling the identification of patterns and anomalies that might otherwise go unnoticed. This is beneficial in pathology and radiology, where analysis is crucially precise. AI further supports in developing predictive models for the assessment of disease risk, allowing early intervention. It has been able to streamline workflow and minimize errors with the assistance of machine learning algorithms within diagnostic platforms. With healthcare going increasingly towards precision medicine, AI-driven diagnostics will form the backbone of innovations leading to revolutionary changes in the field.

United States In Vitro Diagnostics Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the United States in vitro diagnostics market, along with forecasts at the country and regional levels from 2025-2033. The market has been categorized based on test type, product, usability, application, and end user.

Analysis by Test Type:

• Clinical Chemistry
• Molecular Diagnostics
• Immunodiagnostics
• Hematology
• Others

Clinical chemistry tests measure biomarkers and metabolic substances in blood, urine, and tissues for the assessment of organ function, detection of disease, and monitoring of treatment. Improvements in automation and high-throughput platforms are enhancing test accuracy and efficiency.

Molecular diagnostics utilizes genetic material to detect diseases at the molecular level. PCR and NGS will prove key to growth because of their ability to allow for precise, early diagnoses in genetic, infectious, and oncological conditions.

These diagnostic tests detect specific antibodies, antigens, or other immune markers to diagnose infections, autoimmune diseases, and cancer. In these, biosensors are coming along with multiplex assays that enhance the sensitivity.

Tests under the umbrella of hematology include analysis of blood cell counts, morphology, and clotting profiles for diagnosis of anemia, leukemia, and other blood disorders. Innovation in automation and data analysis is improving diagnostic accuracy and streamlining laboratory workflows.

Others category includes several diagnostic methods such as microbiology, point-of-care tests, and toxicology. The technological advancement drives improvements in test accuracy, time efficiency, and user-friendliness and opens applications in emergency, outpatient, and remote settings.

Analysis by Product:

• Reagents and Kits
• Instruments

Reagents and diagnostic kits play an important role in testing of medical conditions, such as infectious diseases, cancer, and genetic disorders. Products in these areas are advancing with amplified sensitivity, multiplexing ability, and user-friendly formats to provide results faster and more accurately.

Diagnostic instruments, such as analyzers, PCR machines, and automated systems, are improving in terms of precision and throughput. They play a critical role in the efficient performance of tests, improving laboratory workflows and enabling faster, more reliable diagnoses in multiple medical disciplines.

Analysis by Usability:

• Disposable IVD Devices
• Reusable IVD Devices

Disposable in vitro diagnostic devices are single-use products used for point-of-care testing, designed to be convenient and risk-free from cross-contamination. These comprise test strips, sample collection kits, and reagent containers, all of which are cheap and, therefore, essential for quick diagnostics.

Reusable in vitro diagnostic devices, such as analyzers and instruments, are designed to be used multiple times after proper cleaning and calibration. They provide long-term value, cost efficiency, and high throughput for diagnostic laboratories with minimal waste and support precision in medical testing.

Analysis by Application:

• Infectious Disease
• Diabetes
• Cancer/Oncology
• Cardiology
• Autoimmune Disease
• Nephrology
• Others

In vitro tests for infectious diseases mainly focus on the detection of pathogens that include bacteria, viruses, and fungi. These include PCR, serology, and antigen detection so that rapid and accurate results can be achieved to promote timely treatment.

For diabetes treatment, IVD products include products such as blood glucose meters, A1c testing, and continuous monitoring systems, offering the capability for individualized treatment plans to monitor glycemic control in people with diabetes.

Cancer diagnostics involves assays like liquid biopsy, molecular profiling, and PCR for the identification of tumor markers, mutations, and genetic alterations. Such technologies help in earlier diagnosis and prognosis, assessment, and monitoring of therapy response.

In vitro diagnostic technologies in cardiology include biomarker assays for troponin, BNP, and lipid profiles. All these biomarkers help assess cardiovascular conditions, guide their management, and monitor how a disease evolves in patients.

Autoimmune disease specific IVD tests detect the presence of antibodies or markers associated with diseases such as rheumatoid arthritis and lupus. These diagnosis and monitoring of autoimmune diseases support the treatment of patients on an individual basis.

In vitro diagnostics in nephrology focus on the diagnosis of kidney diseases, including CKD and AKI. They help in monitoring the progression of the disease, damage at the early stages, and provide the basis for clinical decisions on treatment. Improvement in biomarkers and platforms for diagnostic applications enhances the precision and efficiency of detecting kidney diseases.

Other diagnostic segments include tests of other conditions, for instance allergies, gastrointestinal disorders, and neurological diseases. The tests above offer wide health solutions, which helps in monitoring and control cases of several infections.

Analysis by End User:

• Hospitals Laboratories
• Clinical Laboratories
• Point-of-care Testing Centers
• Academic Institutes
• Patients
• Others

Hospitals operate with comprehensive diagnostic laboratory services with high testing volumes with advanced equipment, for both in and outpatients with results critical to treatment.

Clinical laboratories specialize in different services that facilitate routine and specialty diagnostics to benefit health providers and patients in an efficient way with the utilization of up-to-date technologies for more precise and timely medical information.

Point-of-care (POC) testing centers provide near-patient testing. Such centers facilitate immediate results, helping in quicker clinical decisions and access to diagnostic services across different health care settings.

Academic institutions contribute to innovation in diagnostics by engaging in research and development with IVD technologies. They support clinical investigations and training programs, promoting innovations in methods and tools for diagnosis.

Patient use of home diagnostic tools is accelerating due to its convenient and regularly monitors chronic conditions. This development is facilitated by the utility of user-friendly technologies to enable the tracking and management of health.

Additionally, end-users are research organizations, public health agencies, and diagnostic companies that use IVD tools for epidemiological studies, quality control purposes to develop new diagnostic products and solutions.

Regional Analysis:

• Northeast
• Midwest
• South
• West

In vitro diagnostic companies tend to cluster in the Northeast region, which has dense populations and top medical institutions that drive demand. This region has leading growth in molecular diagnostics, oncology, and infectious disease testing.

The Midwest has a mix of urban and rural healthcare settings. It is an amplifying market for immunodiagnostics and clinical chemistry tests which is driven by both healthcare systems and diagnostic innovation across medical institutions.

The South has witnessed higher healthcare expenditure, especially in cardiology, diabetes, and infectious disease diagnostics. The developing medical infrastructure and large geriatric population is one of the major regions for IVD adoption.

The West, being the hub of large biotechnology and healthcare companies, leads diagnostics, especially in molecular diagnostics, oncology, and autoimmune diseases. The area features various patient groups and modern facilities research.

Competitive Landscape:

The United States in vitro diagnostics market features a competitive landscape dominated by major players. The key companies leverage technological advancements, extensive product portfolios, and strategic collaborations to maintain market leadership. Innovation in molecular diagnostics, point-of-care devices, and automation solutions enhances their competitive edge. Smaller firms and startups contribute by introducing niche products and specialized solutions. Intense competition drives continuous investment in research and development, regulatory compliance, and marketing strategies. Partnerships with healthcare providers and expansion into personalized medicine further define the competitive dynamics in this evolving market.

The report provides a comprehensive analysis of the competitive landscape in the United States in vitro diagnostics market with detailed profiles of all major companies, including:

• Abbott
• Thermo Fisher Scientific Inc
• Agilent
• Hologic, Inc.
• Bio-Rad Laboratories
• QuidelOrtho Corporation

Latest News and Developments:

• In October 2024, the World Health Organization authorized Abbott Laboratories' Alinity m MPXV assay for emergency use. This PCR-based diagnostic test detects mpox DNA from skin lesion swabs, enhancing testing capacity in outbreak-affected regions and marking a milestone under WHO’s Emergency Use Listing procedure.

United States In Vitro Diagnostics Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the United States in vitro diagnosticsmarket from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the United States in vitro diagnosticsmarket.
• Porter's Five Forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the United States in vitro diagnosticsindustry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.