U.S. Molecular Diagnostics Market (By Disease: Healthcare-associated Infections, Respiratory; By End-use: Hospital Core Laboratory, Decentralized Test Sites) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. molecular diagnostics market size was estimated at around USD 6.14 billion in 2023 and it is projected to hit around USD 9.87 billion by 2033, growing at a CAGR of 4.85% from 2024 to 2033.

Key Pointers

• By Disease, the respiratory disease segment led the market with a share of 42% in 2023.
• By End-use, the hospital core laboratory segment contributed the largest market share of 40% in 2023.

U.S. Molecular Diagnostics Market Overview

The U.S. molecular diagnostics market represents a dynamic and rapidly evolving sector within the broader field of healthcare. Molecular diagnostics involves the analysis of genetic material at the molecular level to gain insights into various aspects of health and disease. In the United States, this market has experienced substantial growth, driven by technological advancements, a rising incidence of chronic diseases, and a shift towards personalized medicine.

U.S. Molecular Diagnostics Market Growth Factors

The growth of the U.S. molecular diagnostics market is driven by an advancement of technology, with the integration of cutting-edge tools such as polymerase chain reaction (PCR) and next-generation sequencing (NGS), enhancing the precision and efficiency of diagnostic procedures. A surge in the incidence of chronic diseases, including cancer and genetic disorders, further fuels market expansion as molecular diagnostics plays a pivotal role in early detection and personalized treatment strategies. Collaborations and partnerships within the industry contribute to the development of innovative diagnostic solutions, fostering a climate of shared expertise and resources. Additionally, regulatory support and evolving standards ensure the safety and efficacy of diagnostic technologies, providing a conducive environment for market growth. The trajectory is further buoyed by the transformative shift toward personalized medicine, where treatment plans are tailored to an individual's genetic makeup, reflecting a holistic approach to healthcare.

Report Scope of the U.S. Molecular Diagnostics Market

U.S. Molecular Diagnostics Market Dynamics

Drivers

• Increasing Incidence of Chronic Diseases: A notable driver is the rising prevalence of chronic diseases such as cancer, cardiovascular disorders, and genetic abnormalities. Molecular diagnostics, with its ability to detect and analyze diseases at the genetic level, plays a pivotal role in early diagnosis and management, meeting the growing demand for effective diagnostic methods.
• Shift Towards Personalized Medicine: The market experiences significant impetus from the paradigm shift towards personalized medicine. Molecular diagnostics facilitates tailored treatment approaches based on individual genetic profiles, aligning with the broader trend in healthcare towards more targeted and patient-centric interventions.

Restraints

• Reimbursement Issues: One notable restraint is the complex landscape of reimbursement for molecular diagnostics. The absence of standardized reimbursement policies can create barriers to widespread adoption, limiting the accessibility of these advanced diagnostic procedures.
• Integration with Traditional Diagnostic Methods: While molecular diagnostics offer advanced capabilities, seamless integration with traditional diagnostic methods remains a challenge. Harmonizing molecular diagnostics with established testing processes is essential for a smooth transition and widespread acceptance within the broader healthcare system.

Opportunities

• Precision Oncology: The increasing understanding of the genetic basis of cancer opens doors for precision oncology applications within molecular diagnostics. Targeted therapies based on individual genetic profiles present a significant opportunity for advancing cancer treatment and improving patient outcomes.
• Expansion of Genetic Screening Programs: The expansion of genetic screening programs, both prenatally and postnatally, offers substantial growth prospects. Molecular diagnostics can play a crucial role in identifying genetic disorders early in life, allowing for timely intervention and personalized treatment plans.

Disease Insights

The respiratory disease segment dominated the market with a share of 42% in 2023. 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 2023. This is further contributing to the growing number of hospitalizations caused by HPIVs.

The healthcare-associated infections segment is anticipated to witness the fastest growth from 2024 to 2033. 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 2023, 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 2023, 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 held the largest share of 40% in 2023 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 2023, 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 are also expected to register a considerable 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.

U.S. Molecular Diagnostics Market Key Companies 

• 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 Report Segmentations:

By Disease

• Healthcare-associated Infections (HAI)
  • Methicillin-resistant Staphylococcus Aureus
  • Staphylococcus Aureus
  • Enterovirus
  • Clostridioides Difficile
  • Van A
  • Sepsis Panel
• Respiratory
  • Flu
  • Respiratory Syncytial Virus
  • Paraflu
  • Multidrug-resistant Tuberculosis
  • Mycobacterium Avium-intracellulare
  • Group A Streptococcal
  • Adenovirus
  • Human Metapneumovirus
  • Rhinoviruses
  • Middle East Respiratory Syndrome Coronavirus
  • Tuberculosis
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • Human Bocavirus-Infection
  • Bordetella
  • Mycoplasma Pneumonia
  • Respiratory Panels
• Gastrointestinal (GI)
  • Norovirus
  • Helicobacter Pylori
  • Shiga Toxin
  • GI Parasite Panel
  • GI Bacterial Panel
  • GI Viral Panel
  • GI Panels
• Women’s Health/STI
  • Chlamydia trachomatis (CT)/Neisseria Gonorrhoeae (NG)
  • Trichomonas Vaginalis
  • Mycoplasma Genitalium
  • Human Papillomavirus
  • Bacterial Vaginosis
  • Gonorrhoea Colloquially
  • Mycoplasma Genitalium Resistance
  • Herpes Simplex Virus
  • Group B Streptococcus
• Immunocompromised
  • Cytomegalovirus
  • Epstein-barr Virus
  • Varicella-zoster Virus
  • BK virus
• Virology
  • Human Immunodeficiency Viruses
  • Hepatitis C Virus
  • Hepatitis B Virus
  • Hepatitis E Virus
  • Other Targets
  • Babesia
  • Zika
  • West Nile Virus
  • Chikungunya Virus/dengue Virus
  • Enhancer of Zeste Homolog 2
  • PIK3CA
  • Malaria
  • Monkeypox Virus
• Other Panels
  • Meningitis Panel
  • Lyme Panel
  • UTI Panel
• Oncology
  • Microsatellite Instability
  • B-raf
  • Epidermal Growth Factor Receptor
  • Kirsten RAT SARCOMA VIRUS
  • Others

By End-use

• Hospital Core Laboratory
• Hospital Alternative Sites
• Decentralized Test Sites
• Reference Lab