The U.S. molecular diagnostics market size was estimated at USD 6.1 billion in 2022 and is expected to surpass around USD 9.78 billion by 2032 and poised to grow at a compound annual growth rate (CAGR) of 4.83% during the forecast period 2023 to 2032.
The U.S. molecular diagnostics market is a dynamic and rapidly evolving sector within the broader healthcare industry. Molecular diagnostics involves the detection and analysis of genetic material (DNA and RNA), proteins, and other biomarkers to diagnose diseases, assess treatment options, and monitor patient health. This market has witnessed significant growth in recent years, driven by technological advancements, the increasing demand for personalized medicine, and the pivotal role of molecular testing in the diagnosis and management of various medical conditions.
The growth of the U.S. Molecular Diagnostics market is propelled by several key factors. Firstly, advancements in genomic technology, such as next-generation sequencing and PCR techniques, have enabled more precise and sensitive testing methods. Secondly, the concept of precision medicine, tailoring treatments based on genetic profiles, has gained prominence, boosting the demand for molecular diagnostics. Thirdly, the role of molecular tests in infectious disease management, exemplified during the COVID-19 pandemic, underscores their significance in public health. Additionally, molecular diagnostics have revolutionized cancer care by facilitating personalized treatment decisions. Lastly, increasing consumer interest in health and wellness, along with direct-to-consumer genetic testing, contributes to market expansion as individuals seek insights into their genetic predispositions and health risks. These factors collectively drive the growth and innovation within the U.S. molecular diagnostics market.
U.S. Molecular Diagnostics Market Report Scope
|Market Size in 2023||USD 6.39 Billion|
|Market Size by 2032||USD 9.78 Billion|
|Growth Rate From 2023 to 2032||CAGR of 4.83%|
|Forecast Period||2023 to 2032|
|Segments Covered||Disease, end-use|
|Market Analysis (Terms Used)||Value (US$ Million/Billion) or (Volume/Units)|
|Report Coverage||Revenue forecast, company ranking, competitive landscape, growth factors, and trends|
|Key Companies Profiled||Abbott; Siemens Healthcare GmbH; QIAGEN; F. Hoffmann-La Roche Ltd; Quest Diagnostics Incorporated; Danaher; Thermo Fisher Scientific, Inc.; Hologic Inc.; BD; Charles River Laboratories; Bio-Rad Laboratories, Inc.; Illumina, Inc.; Agilent Technologies, Inc.|
U.S. Molecular Diagnostics Market Dynamics
The growing adoption of precision medicine, which tailors treatments to individual genetic profiles, fuels the demand for molecular diagnostics, as it offers personalized healthcare solutions.
Molecular diagnostics have transformed cancer care by identifying specific genetic and protein biomarkers, enabling oncologists to select targeted therapies and monitor treatment responses, leading to improved outcomes for cancer patients.
Stringent regulatory requirements and the lengthy approval process for new molecular diagnostic tests can impede market growth. Navigating the regulatory landscape and obtaining necessary approvals can be time-consuming and costly for diagnostic developers.
Inconsistent reimbursement policies for molecular diagnostic tests in the U.S. healthcare system can hinder their widespread use. Many tests may not be adequately reimbursed, leading to financial challenges for laboratories and healthcare providers.
The trend towards personalized medicine is a significant opportunity. Molecular diagnostics can play a crucial role in tailoring treatments to individual genetic profiles, offering better therapeutic outcomes and reduced adverse effects.
Liquid biopsy tests, which analyze blood or other bodily fluids for cancer biomarkers, offer a non-invasive approach for cancer diagnosis and monitoring. The expansion of liquid biopsy applications is a promising opportunity.
Stringent regulatory requirements by agencies such as the FDA can result in lengthy approval processes for new molecular diagnostic tests. Navigating these regulatory hurdles can be time-consuming and costly for companies, delaying market entry.
Inconsistent and evolving reimbursement policies for molecular diagnostics can pose challenges for diagnostic laboratories and healthcare providers. Many tests may not receive adequate reimbursement, impacting their financial viability.
The respiratory disease segment led the market with a share of 40.83% in 2022. The growth is attributed to the increasing prevalence of respiratory infections such as HPIVs, MDR-TB, and group A streptococcal, among others, coupled with the increasing awareness regarding the availability of diagnostics tests for diagnosing and treatment of infections. According to a study conducted by the CDC, there has been a significant increase in the number of parainfluenza infections till December 2022. This is further contributing to the growing number of hospitalizations caused by HPIVs.
The healthcare-associated infections segment is expected to witness the fastest growth from 2023 to 2032. The growth is attributed to the increasing incidences of HAI and technological advancements in diagnostic techniques are driving the growth. According to a study published by the National Library of Medicine in December 2022, around 4% of the total hospitalizations are affected by HAI in the U.S. every year. Furthermore, rising government support in the form of initiatives to reduce the incidence of infections during hospitalizations is anticipated to fuel the 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 incidences of infection during hospitalization and improve overall patient safety.
The hospital core laboratory contributed the largest share of 38.49% of the market for U.S. molecular diagnostics in 2022 and is anticipated to grow at the fastest CAGR over the forecast period. The segment growth is attributed to the increasing prevalence of infections, such as MRSA, Staphylococcus aureus (SA), and enterovirus. According to a study published by NCBI in May 2022, the prevalence of SA carriage was found to be 30.2% among individuals aged between 18 years and 64 years, 20.7% among children, and 16.7% among people aged more than 65 years.
Reference labs is expected to expand at the fastest CAGR during the forecast period. Increasing government support through initiatives and reimbursement policies is anticipated to drive market growth over the forecast period. For instance, in March 2023, the U.S. government launched the AHRQ Safety Program for MRSA Prevention. The program is anticipated to boost the demand for molecular diagnostic techniques by creating awareness regarding multidrug-resistant organisms and MRSA transmission.
Some of the prominent players in the U.S. Molecular Diagnostics Market include:
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2020 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Molecular Diagnostics market.