United States In-Vitro Diagnostics Market Report Forecast by Test Types, Products, Application, and Company Analysis 2025-2033

United States IVD market size is estimated to reach $ 65.01 billion by 2033. The IVD market is estimated to be at US$ 42.71 billion in 2024 and is likely to have a compound annual growth rate of 4.78% from 2024 to 2030. Such growth is propelled by enhanced diagnostic technology, rising demand for early disease detection, and chronic diseases.

United States In-Vitro Diagnostics Market Outlook

In-vitro diagnostics (IVD) refers to medical tests conducted on samples taken from the human body, like blood, urine, or tissue, to diagnose diseases, monitor health conditions, and guide treatment decisions. These tests are performed outside the body, in laboratories or diagnostic settings, using specialized instruments, reagents, and devices. IVD covers a wide range of products, such as test kits, diagnostic equipment, and laboratory reagents for detecting infections, cancer, diabetes, and cardiovascular diseases.

In the United States, IVD is important for improved patient outcomes through early disease detection and precise monitoring. These diagnostic tools play a crucial role in routine health checkups, chronic conditions management, and treatment protocols. The U.S. healthcare system extensively employs IVD for personalized medicine, where treatments can be modified according to individual genetic profiles and health conditions. The increasing incidence of chronic diseases, the progression of molecular diagnostics, and the increasing trend of point-of-care testing motivate the adoption of IVD technologies, contributing to better healthcare efficiency and quality care for patients across the nation.

Growth Driver in the United States In-Vitro Diagnostics Market

Technological Advancements in Diagnostics

Technological innovations are the growth drivers for the U.S. IVD market. With improvements in molecular diagnostics, next-generation sequencing, and automation, it is faster, more accurate, and less invasive than before. The advancement in technologies enables the early diagnosis of diseases such as cancer, genetic disorders, or infections and thus enhances the results in terms of patient outcome. Innovation in point-of-care testing and home diagnostic kits further increases accessibility and provides opportunities for patients to keep a check on their health outside the traditional healthcare setup. In July 2023, Siemens Healthineers launched a next-generation analyzer specifically designed for clinical chemistry and immunoassay testing. This versatile analyzer can be used in both standalone laboratories and satellite labs, improving the speed and precision of diagnostic tests.

Increasing Incidence of Chronic Diseases

The growing prevalence of chronic diseases, including diabetes, cardiovascular diseases, and cancer, is driving demand for IVD products in the United States. The demand for routine diagnostic testing and disease management has increased due to the increasing aging population and risk factors from lifestyle. According to America's Health Rankings senior report, more than 54 million senior citizens aged 65 and above live in the U.S., which constitutes 16.5% of the United States' population. This range is projected to exceed 85.7 million by 2050. Early detection and monitoring of chronic conditions with timely intervention and personalized treatment would involve IVD. Therefore, the increased demand for precise, reliable diagnostics is in itself a growth factor for the IVD market, an indispensable part of the U.S. healthcare system. For instance, the American Cancer Society estimated 1.96 million new instances of cancer in 2023 and 609,820 deaths from cancer.

Government Initiatives and Healthcare Reforms

Government initiatives, among them healthcare reforms and additional healthcare spending, play an important role in the growth of the IVD market within the United States. Expanding health care access due to the Affordable Care Act, has enhanced preventive health care services, particularly diagnostic testing. The public health care programs targeting early disease diagnosis and personalized medicine are responsible for in-vitro diagnostic technology uptake. Funding for more research and development in the medical sector also promotes innovation in diagnostics, which leads to more market growth in the U.S.

Challenges in the United States In-Vitro Diagnostics Market

Regulatory Obstacles and Compliance

One of the major challenges for the U.S. in-vitro diagnostics (IVD) market is the complicated regulatory environment. The FDA in the United States regulates IVD products strictly to ensure their safety and efficacy. However, long approval processes, extensive testing requirements, and compliance with international standards make it difficult for new products to reach the market in time. Manufacturers also have to meet the obligations of quality control, labeling, and post-market surveillance, which are expensive and time-consuming, thus creating a barrier for new entrants as well as established companies in the IVD sector.

High Cost of IVD Products

The high cost of advanced in-vitro diagnostics (IVD) products is a significant barrier in the U.S. market, especially for healthcare providers and patients in lower-income brackets. Though IVD technologies are accurate and timely in the detection of diseases, high expenses are involved in state-of-the-art equipment, reagents, and consumables. Health care systems require more money to implement the latest IVD solutions into routine care. It can restrict access to the latest diagnostics, especially in rural or underserved areas, thus hindering market growth.

United States PCR Market

Growth will be seen in the technology known as PCR (Polymerase Chain Reaction) in the in vitro diagnostics market, mainly because it's versatile, sensitive, and has a wide range of applications. PCR assays contribute in the diagnosis of infectious diseases, genetic disorders, and cancers, providing rapid and precise results. Advancements continue in real-time PCR and digital PCR, making PCR-based tests more potent for medical laboratories and healthcare settings. Improvements in these will create increased adoption of the technologies through PCR, hence generally propelling the growth of in vitro diagnostics market.

United States IVD Instruments Market

Instruments are expected to feature as the most significant market for products in the United States IVD market. This is as a result of their paramount position in conducting diagnostic examinations efficiently and accurately. The higher advanced automated units offer enlarged throughput, progressed workflow, and improved reliability, answering to the growing need for high-performance diagnostic solutions in medical labs and healthcare centers. With a focus on optimizing diagnostic methods and improving patient care outcomes, instruments remain a critical element in the increase and evolution of the IVD market in the United States.

United States In Vitro Diagnostics (IVD) Hematology Market

Hematology is expected to be one of the fastest-growing segments over the marketplace's forecast duration. This is because blood problems like anemia, leukemia, and hemophilia are becoming more common. There is an increasing need for accurate and timely tests to detect, diagnose, and treat these diseases. Moreover, technological innovations in hematology analyzers, which comprise improved automation and integration of superior parameters, also drive the adoption of hematology testing, making it a crucial growth segment in the United States IVD market.

Key Players

Roche Diagnostics, Danaher Corporation, Thermofisher Scientific Inc., Bio-Rad Laboratories, Inc., Biomerieux, Abbott Laboratories, and Sysmex Corporation are the major enterprises in the United States In-Vitro Diagnostics (IVD) Market.

In March 2023 - Atila Biosystems and Stilla Technologies agreed to sell co-labeled digital PCR equipment. Atila manufactures the kits and assays, which would be used on Naica systems, Stilla's lead PCR instrument.

In January 2023, QIAGEN launched the EZ2 Connect MDx platform for the improvement of its automation capabilities in sample processing. The advancement would be compatible with PCR, qPCR, and other downstream applications.

Test Types - Market breakup in 11 viewpoints:

1. ELISA & CLIA
2. PCR
3. Rapid Test
4. Fluorescence Immunoassays (FIA)
5. In Situ Hybridization
6. Transcription Mediated Amplification
7. Sequencing
8. Colorimetric Immunoassay
9. Radioimmunoassay (RIA)
10. Isothermal Nucleic Acid Amplification Technology
11. Others

Product - Market breakup in 3 viewpoints:

1. Reagents
2. Instruments
3. Services

Application - Market breakup in 7 viewpoints:

1. Immunochemistry
2. Clinical Chemistry
3. Hematology
4. Coagulation
5. Molecular Diagnostics
6. Microbiology
7. Others

All the Key players have been covered from 3 Viewpoints:

• Overview
• Recent Development
• Revenue Analysis

Company Analysis:

1. Roche Diagnostics
2. Danaher Corporation
3. Thermofisher Scientific Inc.
4. Bio-Rad Laboratories, Inc.
5. Biomerieux
6. Abbott Laboratories
7. Sysmex Corporation