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.
Key Takeaways:
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.
Growth Factors:
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
Report Attribute | Details |
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% |
Base Year | 2022 |
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
Drivers
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.
Restraints
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.
Opportunities
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.
Challenges
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.
Segments Insights:
Disease Insights
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.
End-use Insights
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.
By Disease
By End-use
Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Disease
1.1.2. End-use
1.1.3. Estimates and forecast timeline
1.2. Research Methodology
1.3. Information Procurement
1.3.1. Purchased database
1.3.2. Nova one advisors internal database
1.3.3. Secondary sources
1.3.4. Primary research
1.4. Information or Data Analysis
1.4.1. Data analysis models
1.5. Market Formulation & Validation
1.6. Model Details
1.6.1. Commodity flow analysis (Model 1)
1.6.1.1. Approach 1: Commodity flow approach
1.6.2. Volume price analysis (Model 2)
1.6.2.1. Approach 2: Volume price analysis
1.7. List of Secondary Sources
1.8. List of Primary Sources
1.9. Objectives
1.9.1. Objective 1
1.9.2. Objective 2
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Disease outlook
2.2.2. End-use outlook
2.3. Competitive Insights
Chapter 3. U.S. Molecular Diagnostics Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Penetration & Growth Prospect Mapping
3.3. Industry Value Chain Analysis
3.4. Market Dynamics
3.4.1. Market Driver Analysis
3.4.1.1. Increase in geriatric population
3.4.1.2. Introduction of technologically advanced products
3.4.1.3. Increase in demand for point-of-care testing
3.4.1.4. Growing prevalence of target diseases
3.4.1.5. Increasing external funding for R&D
3.4.2. Market Restraint Analysis
3.4.2.1. Presence of Ambiguous Regulatory Framework
3.4.2.2. High prices of molecular diagnostics tests
3.5. U.S. Molecular Diagnostics Market Analysis Tools
3.5.1. Industry Analysis - Porter’s
3.5.1.1. Supplier power
3.5.1.2. Buyer power
3.5.1.3. Substitution threat
3.5.1.4. Threat of new entrant
3.5.1.5. Competitive rivalry
3.5.2. PESTEL Analysis
3.5.2.1. Political landscape
3.5.2.2. Technological landscape
3.5.2.3. Economic Landscape
3.5.3. Major Deals & Strategic Alliances Analysis
3.5.4. Market Entry Strategies
Chapter 4. U.S. Molecular Diagnostics Market: Disease Estimates & Trend Analysis
4.1. Market Size & Forecasts and Trend Analyses, 2023 to 2032 for the following
4.1.1. Healthcare-Associated Infections
4.1.1.1. Methicillin-Resistant Staphylococcus aureus
4.1.1.1.1. Methicillin-Resistant Staphylococcus aureus Market Estimates and forecast 2020 to 2032
4.1.1.2. Staphylococcus aureus
4.1.1.2.1. Staphylococcus aureus Market Estimates and forecast 2020 to 2032
4.1.1.3. Enterovirus
4.1.1.3.1. Enterovirus market estimates and forecast 2020 to 2032
4.1.1.4. Clostridioides difficile
4.1.1.4.1. Clostridioides difficile market estimates and forecast 2020 to 2032
4.1.1.5. Van A
4.1.1.5.1. Van A market estimates and forecast 2020 to 2032
4.1.1.6. Sepsis Panel
4.1.1.6.1. Sepsis Panel market estimates and forecast 2020 to 2032
4.1.2. Respiratory
4.1.2.1. Flu
4.1.2.1.1. Flu market estimates and forecast 2020 to 2032
4.1.2.2. Respiratory Syncytial Virus
4.1.2.2.1. Respiratory Syncytial Virus market estimates and forecast 2020 to 2032
4.1.2.3. Paraflu
4.1.2.3.1. Paraflu market estimates and forecast 2020 to 2032
4.1.2.4. Multidrug-Resistant Tuberculosis
4.1.2.4.1. Multidrug-Resistant Tuberculosis market estimates and forecast 2020 to 2032
4.1.2.5. Mycobacterium Avium-Intracellular
4.1.2.5.1. Mycobacterium Avium-Intracellulare market estimates and forecast 2020 to 2032
4.1.2.6. Group A Streptococcal
4.1.2.6.1. Group A Streptococcal market estimates and forecast 2020 to 2032
4.1.2.7. Adenovirus
4.1.2.7.1. Adenovirus market estimates and forecast 2020 to 2032
4.1.2.8. Human Metapneumovirus
4.1.2.8.1. Human Metapneumovirus market estimates and forecast 2020 to 2032
4.1.2.9. Rhinoviruses
4.1.2.9.1. Rhinoviruses market estimates and forecast 2020 to 2032
4.1.2.10. Middle East Respiratory Syndrome Coronavirus
4.1.2.10.1. Middle East Respiratory Syndrome Coronavirus market estimates and forecast 2020 to 2032
4.1.2.11. Tuberculosis
4.1.2.11.1. Tuberculosis market estimates and forecast 2020 to 2032
4.1.2.12. Severe Acute Respiratory Syndrome Coronavirus 2
4.1.2.12.1. Severe Acute Respiratory Syndrome Coronavirus 2 market estimates and forecast 2020 to 2032
4.1.2.13. Human Bocavirus-Infection
4.1.2.13.1. Human Bocavirus-Infection market estimates and forecast 2020 to 2032
4.1.2.14. Bordetella
4.1.2.14.1. Bordetella market estimates and forecast 2020 to 2032
4.1.2.15. Mycoplasma Pneumonia
4.1.2.15.1. Mycoplasma Pneumonia market estimates and forecast 2020 to 2032
4.1.2.16. Respiratory Panels
4.1.2.16.1. Respiratory Panels market estimates and forecast 2020 to 2032
4.1.3. Gastrointestinal
4.1.3.1. Norovirus
4.1.3.1.1. Norovirus market estimates and forecast 2020 to 2032
4.1.3.2. Helicobacter pylori
4.1.3.2.1. Helicobacter pylori market estimates and forecast 2020 to 2032
4.1.3.3. Shiga toxin
4.1.3.3.1. Shiga toxin Market Estimates and forecast 2020 to 2032
4.1.3.4. GI Parasite Panel
4.1.3.4.1. GI Parasite Panel market estimates and forecast 2020 to 2032
4.1.3.5. GI Bacterial Panel
4.1.3.5.1. GI Bacterial Panel market estimates and forecast 2020 to 2032
4.1.3.6. GI Viral Panel
4.1.3.6.1. GI Viral Panel market estimates and forecast 2020 to 2032
4.1.3.7. GI Panels
4.1.3.7.1. GI Panels market estimates and forecast 2020 to 2032
4.1.4. Women’s Health/STI
4.1.4.1. Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG)
4.1.4.1.1. Chlamydia trachomatis (CT)/Neisseria gonorrhoeae (NG) market estimates and forecast 2020 to 2032
4.1.4.2. Trichomonas Vaginalis
4.1.4.2.1. Trichomonas Vaginalis market estimates and forecast 2020 to 2032
4.1.4.3. Mycoplasma Genitalium
4.1.4.3.1. Mycoplasma genitalium market estimates and forecast 2020 to 2032
4.1.4.4. Human Papillomavirus
4.1.4.4.1. Human Papillomavirus market estimates and forecast 2020 to 2032
4.1.4.5. Bacterial Vaginosis
4.1.4.5.1. Bacterial Vaginosis market estimates and forecast 2020 to 2032
4.1.4.6. Gonorrhoea Colloquially
4.1.4.6.1. Gonorrhoea Colloquially market estimates and forecast 2020 to 2032
4.1.4.7. Mycoplasma Genitalium Resistance
4.1.4.7.1. Mycoplasma Genitalium Resistance market estimates and forecast 2020 to 2032
4.1.4.8. Herpes Simplex Virus
4.1.4.8.1. Herpes Simplex Virus market estimates and forecast 2020 to 2032
4.1.4.9. Group B Streptococcus
4.1.4.9.1. Group B Streptococcus market estimates and forecast 2020 to 2032
4.1.5. Immunocompromised
4.1.5.1. Cytomegalovirus
4.1.5.1.1. Cytomegalovirus market estimates and forecast 2020 to 2032
4.1.5.2. Epstein-Barr virus
4.1.5.2.1. Epstein-Barr virus market estimates and forecast 2020 to 2032
4.1.5.3. Varicella-Zoster Virus
4.1.5.3.1. Varicella-Zoster Virus market estimates and forecast 2020 to 2032
4.1.5.4. BK virus
4.1.5.4.1. BK virus market estimates and forecast 2020 to 2032
4.1.6. Virology
4.1.6.1. Human immunodeficiency viruses
4.1.6.1.1. Human immunodeficiency viruses market estimates and forecast 2020 to 2032
4.1.6.2. Hepatitis C virus
4.1.6.2.1. Hepatitis C virus market estimates and forecast 2020 to 2032
4.1.6.3. Hepatitis B virus
4.1.6.3.1. Hepatitis B virus Market Estimates and forecast 2020 to 2032
4.1.6.4. Hepatitis E virus
4.1.6.4.1. Hepatitis E virus market estimates and forecast 2020 to 2032
4.1.7. Other Targets
4.1.7.1. Babesia
4.1.7.1.1. Babesia market estimates and forecast 2020 to 2032
4.1.7.2. Zika
4.1.7.2.1. Zika market estimates and forecast 2020 to 2032
4.1.7.3. West Nile Virus
4.1.7.3.1. West Nile Virus market estimates and forecast 2020 to 2032
4.1.7.4. Chikungunya virus/Dengue virus
4.1.7.4.1. Chikungunya virus/Dengue Virus Market Estimates and forecast 2020 to 2032
4.1.7.5. Enhancer of zeste homolog 2
4.1.7.5.1. Enhancer of zeste homolog 2 market estimates and forecast 2020 to 2032
4.1.7.6. PIK3CA
4.1.7.6.1. PIK3CA market estimates and forecast 2020 to 2032
4.1.7.7. Malaria
4.1.7.7.1. Malaria market estimates and forecast 2020 to 2032
4.1.7.8. Monkeypox Virus
4.1.7.8.1. Monkeypox Virus market estimates and forecast 2020 to 2032
4.1.8. Other Panels
4.1.8.1. Meningitis Panel
4.1.8.1.1. Meningitis Panel market estimates and forecast 2020 to 2032
4.1.8.2. Lyme Panel
4.1.8.2.1. Lyme Panel market estimates and forecast 2020 to 2032
4.1.8.3. UTI Panel
4.1.8.3.1. UTI Panel market estimates and forecast 2020 to 2032
4.1.9. Oncology
4.1.9.1. Microsatellite Instability
4.1.9.1.1. Microsatellite Instability market estimates and forecast 2020 to 2032
4.1.9.2. B-raf
4.1.9.2.1. B-raf market estimates and forecast 2020 to 2032
4.1.9.3. Epidermal Growth Factor Receptor
4.1.9.3.1. Epidermal Growth Factor Receptor market estimates and forecast 2020 to 2032
4.1.9.4. Kirsten Rat Sarcoma Virus
4.1.9.4.1. Kirsten Rat Sarcoma Virus market estimates and forecast 2020 to 2032
4.1.9.5. Others
4.1.9.5.1. Others Market Estimates and forecast 2020 to 2032
Chapter 5. U.S. Molecular Diagnostics Market: End-use Estimates & Trend Analysis
5.1. Market Size & Forecasts and Trend Analyses, 2023 to 2032 for the following
5.1.1. Hospital Core Laboratory
5.1.1.1. Hospital Core Laboratory market estimates and forecast 2020 to 2032
5.1.2. Hospital Alternative Sites
5.1.2.1. Hospital Alternative Sites market estimates and forecast 2020 to 2032
5.1.3. Decentralized Test Sites
5.1.3.1. Decentralized Test Site market estimates and forecast 2020 to 2032
5.1.4. Reference Lab
5.1.4.1. Reference Lab market Estimates and forecast 2020 to 2032
Chapter 6. Competitive Landscape
6.1. Recent Developments & Impact Analysis, By Key Market Participants
6.2. Company/Competition Categorization
6.3. Vendor Landscape
6.3.1. List of key distributors and channel partners
6.3.2. Key customers
6.3.3. Key Company Market Share Analysis, 2022
6.3.4. Abbott
6.3.4.1. Company overview
6.3.4.2. Financial performance
6.3.4.3. Product benchmarking
6.3.4.4. Strategic initiatives
6.3.5. Siemens Healthcare GmbH
6.3.5.1. Company overview
6.3.5.2. Financial performance
6.3.5.3. Product benchmarking
6.3.5.4. Strategic initiatives
6.3.6. QIAGEN
6.3.6.1. Company overview
6.3.6.2. Financial performance
6.3.6.3. Product benchmarking
6.3.6.4. Strategic initiatives
6.3.7. F. Hoffmann-La Roche Ltd
6.3.7.1. Company overview
6.3.7.2. Financial performance
6.3.7.3. Product benchmarking
6.3.7.4. Strategic initiatives
6.3.8. Quest Diagnostics Incorporated
6.3.8.1. Company overview
6.3.8.2. Financial performance
6.3.8.3. Product benchmarking
6.3.8.4. Strategic initiatives
6.3.9. Danaher
6.3.9.1. Company overview
6.3.9.2. Financial performance
6.3.9.3. Product benchmarking
6.3.9.4. Strategic initiatives
6.3.10. Thermo Fisher Scientific, Inc.
6.3.10.1. Company overview
6.3.10.2. Financial performance
6.3.10.3. Product benchmarking
6.3.10.4. Strategic initiatives
6.3.11. Hologic Inc.
6.3.11.1. Company overview
6.3.11.2. Financial performance
6.3.11.3. Product benchmarking
6.3.11.4. Strategic initiatives
6.3.12. BD
6.3.12.1. Company overview
6.3.12.2. Financial performance
6.3.12.3. Product benchmarking
6.3.12.4. Strategic initiatives
6.3.13. Charles River Laboratories
6.3.13.1. Company overview
6.3.13.2. Financial performance
6.3.13.3. Product benchmarking
6.3.13.4. Strategic initiatives
6.3.14. Bio-Rad Laboratories, Inc.
6.3.14.1. Company overview
6.3.14.2. Financial performance
6.3.14.3. Product benchmarking
6.3.14.4. Strategic initiatives
6.3.15. Illumina, Inc.
6.3.15.1. Company Overview
6.3.15.2. Financial performance
6.3.15.3. Product benchmarking
6.3.15.4. Strategic initiatives
6.3.16. Agilent Technologies, Inc.
6.3.16.1. Company Overview
6.3.16.2. Financial performance
6.3.16.3. Product benchmarking
6.3.16.4. Strategic initiatives