US In Vitro Diagnostics (IVD) Market Outlook 2028

US In Vitro Diagnostics (IVD) Market Overview

The US In Vitro Diagnostics (IVD) market is valued at USD 29.85 billion, driven by the rising prevalence of chronic diseases such as diabetes, cancer, and cardiovascular diseases, which have significantly increased the demand for diagnostic tools. Furthermore, advancements in molecular diagnostics, particularly in PCR and NGS technologies, have bolstered market growth. COVID-19 pandemic accelerated the adoption of IVD tools as testing became critical for healthcare systems, further strengthening market performance.

The US In Vitro Diagnostics market is predominantly driven by major healthcare hubs like New York, California, and Massachusetts. These regions offer advanced infrastructure, high R&D investment, and house leading biotechnology firms. The demand for diagnostic solutions is fueled by a high concentration of hospitals, research institutions, and the growing need for personalized medicine. Additionally, states like Texas are emerging as important players due to expanding healthcare services and government-backed research initiatives.

In 2023, the Centers for Medicare & Medicaid Services (CMS) launched an initiative to modernize the Clinical Laboratory Improvement Amendments (CLIA) regulations. This modernization aims to streamline the certification process for clinical laboratories, especially for advanced testing technologies such as molecular diagnostics. The initiative focuses on improving the adaptability of CLIA to new diagnostic technologies while maintaining the accuracy and reliability of laboratory testing services. This regulatory adjustment is expected to accelerate the approval and deployment of innovative IVD technologies, benefiting both laboratories and patients.

US In Vitro Diagnostics (IVD) Market Segmentation

By Technology: The US In Vitro Diagnostics market is segmented by technology into clinical chemistry, immunoassays, molecular diagnostics, microbiology, hematology, and coagulation. Among these, molecular diagnostics holds the largest market share in 2023 due to its widespread application in detecting infectious diseases and cancer. The growing demand for personalized medicine, coupled with advancements in NGS technology, has driven the adoption of molecular diagnostics. PCR tests have also seen increased utilization in infectious disease detection, particularly during the COVID-19 pandemic, contributing to the growth of this segment.

By Application: The US In Vitro Diagnostics market is segmented by application into oncology, infectious diseases, cardiology, endocrinology, and autoimmune diseases. Among these, infectious diseases hold the largest market share in 2023, driven by the need for rapid and accurate diagnostics for conditions like COVID-19, influenza, and HIV. The demand for reliable, point-of-care testing solutions has further propelled the growth of this segment. Additionally, oncology diagnostics have seen substantial growth due to rising cancer incidence rates and the increasing need for early-stage detection, with molecular diagnostics playing a critical role in identifying genetic markers and mutations.

US In Vitro Diagnostics (IVD) Market Competitive Landscape

The US IVD market is led by a mix of global and domestic companies, including Abbott Laboratories, Roche Diagnostics, and Thermo Fisher Scientific. These firms have extensive product portfolios covering multiple diagnostic areas, including clinical chemistry, molecular diagnostics, and immunoassays. The market is highly competitive, with frequent mergers and acquisitions aimed at expanding product offerings and technological capabilities. Many companies are investing heavily in the development of point-of-care testing devices and molecular diagnostics, driven by the need for rapid, accurate, and affordable testing solutions.

Company

Established

Headquarters

Product Portfolio

R&D Investment

Revenue (USD Bn)

Key Partnerships

Market Presence

Recent Developments

Abbott Laboratories

1888

Illinois, US

Roche Diagnostics

1896

Basel, Switzerland

Thermo Fisher Scientific

1956

Massachusetts, US

Siemens Healthineers

1847

Erlangen, Germany

Danaher Corporation

1969

Washington D.C., US

US In Vitro Diagnostics (IVD) Market Analysis

US In Vitro Diagnostics (IVD) Market Growth Drivers

Rise in Chronic Diseases (Diabetes, Cancer, Cardiovascular): The rise in chronic diseases such as diabetes, cancer, and cardiovascular conditions has significantly driven the demand for in vitro diagnostics (IVD) in the US. According to the CDC, approximately 34.2 million Americans suffer from diabetes, and cardiovascular diseases remain the leading cause of death, with over 697,000 fatalities in 2021. Cancer diagnoses have also increased, with the National Cancer Institute projecting more than 1.9 million new cancer cases in 2023. This surge in chronic illnesses has resulted in an increased demand for diagnostic solutions, particularly in early detection and disease management.

Aging Population (Geriatric Care): The aging population is a critical driver of IVD market growth in the US. This demographic is more prone to chronic illnesses like diabetes, hypertension, and Alzheimers disease, which require regular diagnostic testing. The rise in geriatric care demand has pushed for advancements in diagnostics to better cater to the aging population, enhancing the overall need for accurate and timely testing solutions in healthcare facilities.

Advancements in Molecular Diagnostics (PCR, NGS): Advancements in molecular diagnostics, particularly Polymerase Chain Reaction (PCR) and Next-Generation Sequencing (NGS), have transformed the IVD landscape in the US. PCR testing has become essential for infectious diseases such as COVID-19, with over 900 million COVID-19 PCR tests performed in the U.S. by the end of 2022. NGS technologies are increasingly utilized in genetic testing and personalized medicine, especially for cancer diagnostics. This technological evolution in molecular diagnostics enhances the precision and efficiency of detecting genetic mutations and pathogens, propelling market growth.

US In Vitro Diagnostics (IVD) Market Challenges

Regulatory Compliance (FDA, CLIA) Regulatory compliance remains a significant challenge in the US IVD market. The Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) mandate stringent regulatory frameworks for the development and distribution of diagnostic devices. The FDA has approved over 500 IVD tests since the beginning of 2023, but many manufacturers face delays due to compliance challenges in obtaining 510(k) clearances or Premarket Approvals (PMA). These regulations, although necessary for ensuring safety and accuracy, can slow the introduction of innovative diagnostic technologies.

High Costs of Diagnostics (Equipment, Reagents): The high costs associated with diagnostic equipment and reagents are a barrier to widespread adoption. For instance, a high-throughput PCR machine can cost between $50,000 and $150,000, while reagents for molecular tests may range from $20 to $50 per test, according to the American Clinical Laboratory Association. The rising costs of advanced diagnostic tools, particularly molecular diagnostics, limit accessibility, especially in smaller or rural healthcare settings. This cost burden is further compounded by the increasing price of raw materials and shipping.

US In Vitro Diagnostics (IVD) Market Future Outlook

Over the next five years, the US In Vitro Diagnostics market is expected to witness substantial growth driven by continuous advancements in molecular diagnostics, government support for healthcare innovations, and increasing consumer demand for personalized medicine. The rapid evolution of point-of-care testing and integration of artificial intelligence in diagnostics are projected to be key factors driving future market growth. Moreover, the rising prevalence of chronic and infectious diseases will continue to fuel the demand for more precise and rapid diagnostic tools across the country.

Market Opportunities
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Rise of At-Home Testing: At-home diagnostic testing has seen significant growth in the US, with over 40 million self-testing kits sold in 2023. The trend is driven by consumer preferences for privacy and convenience, with tests for conditions like COVID-19, diabetes, and pregnancy leading the market. Companies are rapidly expanding their at-home testing portfolios, including genetic and hormone tests, providing patients with easy access to health monitoring without the need for clinical visits. This trend is transforming healthcare by enabling proactive disease management.

Integration of Cloud-Based Diagnostic Solutions: The integration of cloud-based solutions in diagnostics is revolutionizing data storage and accessibility. These platforms enable real-time data sharing and remote diagnostics, facilitating faster decision-making and improved patient outcomes. Cloud-based diagnostic solutions are also enhancing the scalability of diagnostic services, particularly in decentralized or remote settings, where access to clinical infrastructure may be limited.
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