United States Molecular Diagnostics Industry Analysis
The market for molecular diagnostics in the United States was valued at US$ 7.98 billion in 2023. It is projected to grow to US$ 14.01 billion by 2032, with a compound annual growth rate (CAGR) of 6.46% from 2024 to 2032.
Molecular diagnostics is a crucial field that involves the identification of genetic variations to assist in the detection, diagnosis, classification, prognosis, and monitoring of therapy responses. It employs techniques to examine biological markers in the genome and proteome, and investigates how cells express genes as proteins. This application of molecular biology to medical testing is widely used for identifying biological markers in the genome and proteome. For instance, it can be used to detect bacterial genes using PCR-based techniques and to measure the expression of bacterial infection-specific proteins using enzyme-linked immunosorbent assay (ELISA) and proteomics.
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Driving Factor in the US Molecular Diagnostics Market
Early detection and diagnosis: Molecular diagnostics play a critical role in detecting, diagnosing, and monitoring conditions like cancer and infectious diseases at an early stage. This modern approach has replaced traditional diagnostic methods. According to the American Cancer Society's 'Cancer Facts & Figures 2022', it is estimated that there will be a significant number of new cancer cases and deaths in the United States in 2023. The report also indicates that the high prevalence of cancer in the region is expected to fuel the growth of the oncology molecular diagnostics market, primarily due to the increasing use of molecular diagnostics for cancer diagnosis.
Importance of patient-centric healthcare services: The increasing demand for patient-centered healthcare services and the adoption of advanced testing products at point-of-care facilities such as clinics, retail pharmacies, and physician offices are expected to significantly drive market growth in the coming years. Market players are continuously innovating to develop new point-of-care testing products to capitalize on market opportunities. For example, in February 2023, Huwel Lifesciences introduced a portable RT-PCR instrument designed to test various viruses. The company stated that the test can provide results in approximately 30 minutes and is capable of analyzing respiratory and other infections using blood and gastrointestinal samples. Such proactive initiatives are anticipated to play a crucial role in propelling the market forward in the foreseeable future.
USA government funding to improve the creation of new test kits: The increasing support from government funding aimed at advancing the creation of innovative test kits is expected to propel the market forward. For example, in September 2022, Redbud Medicine secured a substantial USD 10 million in Series A funding. Government funding also assists local and state laboratories in expanding their capabilities to meet the growing demand. Similarly, in June 2023, Accelerate Diagnostics, Inc. obtained USD 24 million to expedite the development of the Wave platform and new rapid testing solutions. Given the diverse nature of contagious diseases and the growing resistance of causative agents, molecular diagnostic test menus for infectious diseases need to be dynamic and comprehensive rather than static and superficial. Healthcare-associated infections in the United States are projected to increase due to the rising number of cases and advancements in diagnostic technology. Approximately 4% of hospitalizations in the U.S. are affected by healthcare-associated infections each year. The government is providing support through initiatives such as the Hospital-Acquired Condition Reduction Program to reduce infections during hospitalizations and improve patient safety.
United States Molecular Diagnostics Company 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 – United States Molecular Diagnostics Market is divided into 6 Viewpoints
- Chips and Microarrays
- In Situ Hybridization
- Sequencing
- Mass Spectrometry (MS)
- PCR
- Other Technologies
Application – United States Molecular Diagnostics Market is divided into 6 Viewpoints
- Pharmacogenomics
- Infectious Disease
- Genetic Disease Screening
- Oncology
- Blood Screening
- Microbiology
- Human Leukocyte Antigen Typing
Product – United States Molecular Diagnostics Market is divided into 3 Viewpoints
- Instruments
- Reagents
- Other Products
End User – United States Molecular Diagnostics Market is divided into 3 Viewpoints
- Hospitals
- Laboratories
- Other End Users
Company Insights:
- Overviews
- Recent Developments & Strategies
- Product Portfolio & Product Launch in Last 1 Year
- Revenue
Companies Covered:
- F Hoffmann-la Roche Ltd
- Illumina Ltd
- Hologic Corporation
- Agilent Technologies Inc.
- Qiagen NV
- Myriad Genetics
- Abbott Laboratories
- Danaher Corporation
- Becton, Dickinson and Company
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