U.S. Molecular Diagnostics Market To Grow At 8.84% CAGR Till 2033

U.S. Molecular Diagnostics Market To Grow At 8.84% CAGR Till 2033

The U.S. molecular diagnostics market size was exhibited at USD 6.11 billion in 2023 and is projected to hit around USD 9.81 billion by 2033, growing at a CAGR of 8.84% during the forecast period 2024 to 2033.

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U.S. Molecular Diagnostics Market Key Takeaways:

  • The respiratory disease segment dominated the market with a share of 41.79% in 2023.
  • The healthcare-associated infections segment is anticipated to witness the fastest growth from 2024 to 2033.
  • The hospital core laboratory held the largest share of 39.43% of the market for U.S. molecular diagnostics in 2023.
  • Reference labs are also expected to register a considerable CAGR during the forecast period.

The increasing prevalence of infections and technological advancements in molecular diagnostic tests drive the market. Furthermore, the presence of favorable reimbursement policies coupled with rising government support in the form of funding and initiatives for the development of diagnostics tests is anticipated to drive the U.S. molecular diagnostics growth over the forecast period.

The COVID-19 pandemic has positively impacted the market by encouraging players to develop novel and rapid diagnostic kits capable of detecting coronavirus. This has resulted in positive revenue growth for major market players operating in the infectious disease segment. For instance, Thermo Fisher Scientific reported 150% revenue growth owing to the rising demand for diagnostics offerings in April 2021. However, the rising adoption of vaccination in the region is anticipated to reduce the demand for COVID-19 testing over the forecast period.

Moreover, increasing incidences of infections in the country primarily drive the demand for cost-effective and efficient diagnostics techniques. According to a study published by the Journal of Clinical Virology in March 2023, enterovirus infection incidents increased by 21.7% compared to the previous year. Furthermore, enterovirus majorly affects the population with ages less than 5 years, of which around 41% of the infected toddlers require supplemental oxygen. In addition, according to the article published by the National Library of Medicine in May 2021, around 40 % of the U.S. population in the U.S. is affected by H. pylori infection every year.

The presence of government support in the form of approvals and funding is anticipated to fuel the market growth over the forecast period. For instance, in May 2023, Abbot received approval for its Alinity m STI Assay from the U.S. FDA. The test is capable of differentiating and detecting STIs. In addition, in 2020, ASPR’s Biomedical Advanced Research and Development Authority and NIH’s National Institute of Allergy and Infectious Diseases organized the Antimicrobial Resistance Diagnostic Challenge in which Visby Medical’s rapid PCR test won USD 19 million in federal funding.

High prices associated with molecular tests are one of the major factors impeding the market for U.S. molecular diagnostics. Furthermore, the scarcity of comparable tests is another reason for price hikes. The significant variations in prices for different applications of each molecular diagnostic product further compound this problem. However, the presence of favorable reimbursement policies in the country is anticipated to fuel the market demand. For instance, in January 2023, the U.S. 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 benefits of cost coverage from the insurance or plan.

U.S. Molecular Diagnostics Market By Disease Insights

The respiratory disease segment dominated the market with a share of 41.79% 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.

U.S. Molecular Diagnostics Market By End-use Insights

The hospital core laboratory held the largest share of 39.43% of the market for U.S. molecular diagnostics 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.

Some of the prominent players in the U.S. molecular diagnostics market include:

  • 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.

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 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. molecular diagnostics market

Disease

  • Healthcare-associated Infections (HAI)

  • Methicillin-resistant Staphylococcus Aureus
  • Staphylococcus Aureus
  • Enterovirus
  • Clostridioides Difficile
  • Van ASepsis 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 2Human Bocavirus-Infection
  • Bordetella
  • Mycoplasma Pneumonia
  • Respiratory Panels

  • Gastrointestinal (GI)

  • Norovirus
  • Helicobacter Pylori
  • Shiga Toxin
  • GI Parasite Panel
  • GI Bacterial Panel
  • GI Viral PanelGI 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 VirusGroup B Streptococcus

  • Immunocompromised

  • Cytomegalovirus
  • Epstein-barr Virus
  • Varicella-zoster Virus
  • BK virus

  • Virology

  • Human Immunodeficiency Viruses
  • Hepatitis C ViruHepatitis B VirusHepatitis E Virus

  • Other Targets

  • Babesia
  • Zika
  • West Nile Virus
  • Chikungunya Virus/dengue Virus
  • Enhancer of Zeste Homolog 2PIK3CAMalariaMonkeypox Virus

  • Other Panels

  • Meningitis Panel
  • Lyme Pane
  • lUTI Panel

  • Oncology

  • Microsatellite Instability
  • B-raf
  • Epidermal Growth Factor Receptor
  • Kirsten RAT SARCOMA VIRUS
  • Others

End-use

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

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