United States IVD Market to Reach US$ 65.01 Billion by 2033, Driven by Early Diagnosis Demand and Technological Advancements

According to the latest report by Renub Research, the United States In Vitro Diagnostics (IVD) Market is projected to grow from US$ 42.71 Billion in 2024 to US$ 65.01 Billion by 2033, expanding at a CAGR of 4.78% during the forecast period.

renubresearch

Jul 3, 2025 - 15:30

According to the latest report by Renub Research, the United States In Vitro Diagnostics (IVD) Market is projected to grow from US$ 42.71 Billion in 2024 to US$ 65.01 Billion by 2033, expanding at a CAGR of 4.78% during the forecast period. This sustained growth is fueled by the increasing prevalence of chronic and infectious diseases, rising demand for early disease detection, technological advancements in diagnostic tools, and a shift toward personalized medicine.

📊 Request Free Sample Report:
👉 https://www.renub.com/request-sample-page.php?gturl=united-states-in-vitro-diagnostics-market-p.php

IVD Market Grows with Shift Toward Preventive and Personalized Healthcare

In Vitro Diagnostics (IVD) play a pivotal role in the healthcare ecosystem by facilitating early and accurate disease detection, monitoring, and treatment decision-making. With the growing focus on preventive care, IVD is becoming more critical for chronic disease management, particularly in conditions such as diabetes, cancer, cardiovascular disease, and infectious diseases.

The shift toward personalized medicine, which tailors treatment based on an individual's genetic makeup and disease profile, is further propelling the adoption of molecular diagnostics, genetic testing, and companion diagnostics.

Rising Chronic Disease Burden Bolsters Market Demand

The growing burden of non-communicable diseases (NCDs) in the United States has significantly increased the demand for reliable and efficient diagnostic solutions. According to the CDC, 6 in 10 adults in the U.S. live with at least one chronic disease. These conditions require regular screening and diagnostic monitoring, for which IVD tools are indispensable.

Additionally, increasing awareness about routine health checkups, especially post-COVID-19, has encouraged both healthcare providers and individuals to adopt advanced diagnostic testing for risk assessment and disease prevention.

Technological Advancements Revolutionizing IVD Testing

Rapid innovation is reshaping the IVD market with the introduction of next-generation diagnostics that are faster, more accurate, and often portable. Key technologies driving this transformation include:

Real-time PCR and Digital PCR
Next-generation Sequencing (NGS)
CRISPR-based diagnostic tools
Point-of-Care (POC) testing devices
AI-integrated diagnostic platforms

These innovations have made it possible to deliver quicker diagnoses, decentralized testing, and greater patient engagement, particularly in outpatient settings and home healthcare.

COVID-19 Accelerated Acceptance of IVD Testing

The COVID-19 pandemic dramatically accelerated the adoption of IVD tools, especially in RT-PCR, antigen, and antibody testing. It reinforced the importance of early detection, widespread screening, and testing infrastructure in managing public health emergencies.

Post-pandemic, the infrastructure and public acceptance built around self-testing kits, home diagnostics, and POC devices have continued to benefit the IVD market in the U.S., expanding applications beyond infectious diseases to include chronic and genetic conditions.

Market Segmentation: United States In Vitro Diagnostics Market

By Technology:

Immunoassay
Clinical Chemistry
Molecular Diagnostics
Hematology
Microbiology
Coagulation and Hemostasis
Others

By Application:

Infectious Diseases
Diabetes
Cancer (Oncology)
Cardiology
Nephrology
Autoimmune Diseases
Others

By End-User:

Hospitals
Diagnostic Laboratories
Academic and Medical Institutions
Homecare
Others

📘 Explore complete segmentation and forecasts by requesting your sample:
👉 https://www.renub.com/request-sample-page.php?gturl=united-states-in-vitro-diagnostics-market-p.php

Hospital and Laboratory Testing Remains Dominant, Home Testing on the Rise

Hospitals and diagnostic laboratories are the primary users of IVD products, driven by high patient footfall, availability of specialized staff, and integrated testing facilities. However, home-based testing is gaining immense traction due to the rise of self-monitoring devices for diabetes, fertility, infectious diseases, and genetic testing.

Home testing kits supported by telehealth services and digital health platforms offer consumers greater control over their health, convenience, and cost savings. This trend is expected to grow substantially over the next decade.

Key Companies in the U.S. IVD Market

The U.S. IVD industry is highly competitive, with global and domestic players continuously investing in product development, regulatory approvals, partnerships, and technological innovation. Major companies operating in the market include:

Roche Diagnostics
Abbott Laboratories
Thermo Fisher Scientific Inc.
Bio-Rad Laboratories Inc.
Danaher Corporation (Beckman Coulter)
Siemens Healthineers
Becton Dickinson and Company (BD)
Hologic, Inc.
QuidelOrtho Corporation
Quest Diagnostics
BioMérieux SA

These players are focused on expanding their U.S. market presence through mergers, acquisitions, and launches of high-performance testing platforms for hospitals and decentralized settings.

Challenges Hindering Growth

Despite robust expansion, the U.S. IVD market faces several challenges:

Regulatory complexities and long approval timelines by FDA
High cost of advanced diagnostic tests
Data privacy concerns in genetic testing and digital diagnostics
Limited awareness and accessibility in rural populations

Addressing these challenges will require policy improvements, price transparency, and public-private collaboration to democratize access to advanced diagnostics.

Opportunities Ahead: AI, Genomics, and Companion Diagnostics

The future of the U.S. IVD market lies in AI-powered predictive diagnostics, precision medicine, and next-generation sequencing technologies. The emergence of companion diagnostics, particularly in oncology, will enable clinicians to match patients with tailored therapies, improving outcomes and reducing trial-and-error prescriptions.

Also, the integration of machine learning algorithms, real-time data analytics, and cloud-based platforms will support early disease risk identification, enabling timely intervention and better population health management.

Outlook: A Tech-Driven, Patient-Centric IVD Ecosystem

As the U.S. healthcare system moves toward value-based care, IVD will play a central role in delivering actionable insights, lowering healthcare costs, and enhancing patient satisfaction. By 2033, the market is expected to evolve into a digitally connected, patient-centric ecosystem, where diagnostics are personalized, accessible, and outcome-driven.

The ongoing collaboration between biotech firms, technology developers, and healthcare providers will be critical in shaping the next era of diagnostics and disease prevention.

New Publish Report:

About the Company

Renub Research is a Market Research and Consulting Company with more than 15 years of experience, especially in international Business-to-Business Research, Surveys, and Consulting. We provide a wide range of business research solutions that help companies make better business decisions. We partner with clients across all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

Our wide clientele includes key players in Healthcare, Travel & Tourism, Food & Beverages, Power & Energy, Information Technology, Telecom & Internet, Chemicals, Logistics & Automotive, Consumer Goods & Retail, Building & Construction, and Agriculture. Our core team comprises experienced professionals with graduate, postgraduate, and Ph.D. qualifications in Finance, Marketing, Human Resources, Bio-Technology, Medicine, Information Technology, Environmental Science, and more.

Media Contact

Company Name: Renub Research
Contact Person: Rajat Gupta, Marketing Manager
Phone No: +91-120-421-9822 (IND) | +1-478-202-3244 (USA)
Email: rajat@renub.com

🔗 Full Report: https://www.renub.com/united-states-in-vitro-diagnostics-market-p.php
📄 Sample Request: https://www.renub.com/request-sample-page.php?gturl=united-states-in-vitro-diagnostics-market-p.php