United States Molecular Diagnostics Market Report by Technology (Chips and Microarrays, In Situ Hybridization, Sequencing, Mass Spectrometry, PCR, and Other Technologies), Application, Product, End User, and Company Analysis 2024-2032

The United States Molecular Diagnostics Market was US$ 7.98 billion in 2023 and will reach US$ 14.01 billion by 2032, with a CAGR of 6.45% from 2024 to 2032.

Molecular diagnostics involves identifying genomic variants to aid in detecting, diagnosing, sub-classifying, prognosis, and monitoring therapy response. It utilizes techniques to analyze biological markers in the genome and proteome, examining how cells express genes as proteins. This field applies molecular biology to medical testing. It is widely used for identifying biological markers in the genome and proteome, such as detecting bacterial genes using PCR-based techniques and measuring expressed bacterial infection-specific proteins using enzyme-linked immunosorbent assay (ELISA) and proteomics.

Molecular diagnostics enable the early diagnosis of cancer, genetic disorders, and infectious diseases using PCR, sequencing, & genetic technologies. Furthermore, the region's high prevalence of infectious and chronic diseases, such as genetic diseases, STIs, and cancer, is projected to support market expansion. For instance, according to a report published by the CDC, congenital heart defects are the most prevalent congenital disability in the U.S., impacting around 1% of births annually.

Molecular diagnostics are crucial for the early detection, diagnosis, and monitoring of conditions such as cancer and infectious diseases. This has led to a shift from traditional diagnostic methods. The American Cancer Society's 'Cancer Facts & Figures 2022' reports the estimated number of new cancer cases and deaths due to cancer in the United States in 2023. It also suggests that the high incidence of cancer in the region is expected to drive the growth of the oncology molecular diagnostics market due to the increased adoption of molecular diagnostics for cancer diagnosis.

Increasing demand for patient-centric healthcare services and growing adoption of technologically advanced testing products at point-of-care facilities such as clinics, retail pharmacies, physician offices, and others are further projected to drive market expansion over the forecast period. Moreover, market players continuously develop novel POC testing products to capture market opportunities. For instance, in February 2023, Huwel Lifesciences developed a portable RT-PCR instrument to test different types of viruses. The company claimed that the test takes about 30 minutes and can be used to analyze respiratory and other infections using blood and gastrointestinal samples. Such initiatives are expected to drive the market in the years to come.

Additionally, growing government funding to enhance the development of novel test kits is anticipated to drive the market. For instance, in September 2022, Redbud Medicine raised USD 10 million in Series A funding. Federal funding also helps local and state laboratories increase their capacity and allows them to keep up with growing demand. Similarly, in June 2023, Accelerate Diagnostics, Inc. received USD 24 million to accelerate the development of the Wave platform and novel rapid testing. Molecular diagnostic test menus for infectious diseases cannot afford to be static or superficial due to the diverse nature of contagious diseases and the building resistance of causative agents.

Healthcare-associated infections are projected to increase more rapidly in the United States. This growth is linked to the rising number of HAI cases and advancements in diagnostic technology. According to a study released by the National Library of Medicine in December 2022, approximately 4% of hospitalizations in the U.S. are impacted by HAI each year. Furthermore, rising government support in the form of initiatives to reduce the incidence of infections during hospitalizations is anticipated to fuel growth over the forecast period. For instance, in 2022, the Centers for Medicare & Medicaid Services introduced the Hospital-Acquired Condition (HAC) Reduction Program to encourage hospitals to reduce infection during hospitalization and improve overall patient safety.

United States Molecular Diagnostics Industry Analysis

The leading market players in the United States Molecular Diagnostics market are F Hoffmann-la Roche Ltd, Illumina Ltd, Hologic Corporation, Agilent Technologies Inc., Qiagen NV, Myriad Genetics, Abbott Laboratories, Danaher Corporation, and Becton, Dickinson, and Company.

United States Molecular Diagnostics Company News

• In August 2023, QIAGEN received the U.S. FDA approval for the Therascreen PDGFRA RGQ PCR kit. This aids physicians in identifying patients with gastrointestinal stromal tumors (GIST).
• In January 2023, the U.S. FDA approved EUA for the VIASURE Monkeypox Virus Real-Time PCR Reagents developed by BD and CerTest Biotec to detect the Mpox virus.
• In March 2023, Lucira Health launched the first and only at-home COVID-19 and flu tests in the U.S. The U.S. FDA gave the COVID-19 & Flu Home Test the first and only Emergency Use Authorization (EUA) for OTC usage at home and other non-laboratory locations.
• January 2022, the United States Department of Health and Human Services announced that individuals with group health plans or covered by private health insurance who purchase at-home COVID-19 tests will get the benefits of cost coverage from the insurance or plan.

Technology - Market is divided into 6 Viewpoints

1. Chips and Microarrays

2. In Situ Hybridization

3. Sequencing

4. Mass Spectrometry (MS)

5. PCR

6. Other Technologies

Application - Market is divided into 6 Viewpoints

1. Pharmacogenomics

2. Infectious Disease

3. Genetic Disease Screening

4. Oncology

5. Blood Screening

6. Microbiology

7. Human Leukocyte Antigen Typing

Product - Market is divided into 3 Viewpoints

1. Instruments

2. Reagents

3. Other Products

End User - Market is divided into 3 Viewpoints

1. Hospitals

2. Laboratories

3. Other End Users

Company Insights:

• Overviews
• Recent Development
• Product Portfolio & Product Launch in Last 1 Year
• Revenue

Companies Covered:

1. F Hoffmann-la Roche Ltd

2. Illumina Ltd

3. Hologic Corporation

4. Agilent Technologies Inc.

5. Qiagen NV

6. Myriad Genetics

7. Abbott Laboratories

8. Danaher Corporation

9. Becton, Dickinson and Company