U.S. Molecular Diagnostics Market Latest Innovations And Challenges By 2030

U.S. Molecular Diagnostics Market Summary

The U.S. molecular diagnostics market size was valued at USD 5.83 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 4.82% between 2023 and 2030. The rising prevalence of infectious diseases, coupled with technological advancements in molecular diagnostic testing, is a key factor driving this growth. In addition, favorable reimbursement frameworks and increasing government initiatives, including funding programs for diagnostic research and development, are supporting broader adoption. These supportive measures are enabling improved accessibility and affordability of molecular diagnostic technologies, which are essential in strengthening early detection and precise disease management.

The growing incidences of infections across the country are further fueling demand for cost-effective and highly efficient diagnostic methods. For instance, according to a study published by the Journal of Clinical Virology in March 2023, enterovirus infection incidents rose by 21.7% compared to the previous year. Enterovirus predominantly impacts children under 5 years of age, with approximately 41% of affected toddlers requiring supplemental oxygen. Additionally, the National Library of Medicine reported in May 2021 that nearly 40% of the U.S. population is affected annually by H. pylori infection, demonstrating the significant need for advanced diagnostic tools to manage infectious diseases effectively.

Key Market Trends & Insights

• The respiratory disease segment dominated the U.S. molecular diagnostics market in 2022, accounting for a share of 40.79%. This dominance is primarily due to the high prevalence of respiratory infections, including human parainfluenza viruses (HPIVs), multidrug-resistant tuberculosis (MDR-TB), and group A streptococcal infections. Moreover, increased awareness among patients and healthcare providers regarding the availability of advanced diagnostic solutions has contributed to higher adoption rates for respiratory disease testing, reinforcing this segment’s leadership position.
• The hospital core laboratory segment held the largest market share of 38.43% in 2022 and is expected to expand at the fastest CAGR during the forecast period. The rising number of hospital admissions for infections such as methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus (SA), and enterovirus is driving the demand for accurate and rapid testing within hospital laboratory settings. This growing reliance on hospital-based diagnostic testing reflects the urgent need for timely results to support critical treatment decisions.
• Reference laboratories are also anticipated to register significant growth over the coming years. This expansion is supported by favorable government initiatives, funding programs, and reimbursement policies aimed at enhancing access to advanced diagnostic services. Such measures are enabling reference labs to increase their testing capacity and expand service offerings to meet the rising demand.

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Market Size & Forecast

• 2022 Market Size: USD 5.83 billion
• 2030 Projected Market Size: USD 8.46 billion
• CAGR (2023- 2030): 4.82%

Key Companies & Market Share Insights

Leading companies operating in the market are employing strategies such as acquisitions, partnerships, collaborations, product launches, and expansions to strengthen their presence and enhance product penetration. For example, in January 2023, QIAGEN N.V. entered a strategic partnership with Helix to develop hereditary disease companion diagnostics. This collaboration is expected to improve access to genomic testing for both providers and patients, expanding QIAGEN’s reach in precision medicine. Similarly, in May 2021, F. Hoffmann-La Roche Ltd acquired GenMark Diagnostics for USD 1.8 billion. The acquisition aimed to enhance Roche’s syndromic testing portfolio by leveraging GenMark’s advanced expertise in molecular diagnostics, thus broadening the company’s offerings in the infectious disease space.

Key Players

• Abbott
• Siemens Healthcare GmbH
• QIAGEN
• 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.

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Conclusion

The U.S. molecular diagnostics market is set to witness steady growth over the coming years, driven by rising infection rates, technological innovations, and favorable policy support. The dominance of respiratory diagnostics, coupled with the growing role of hospital laboratories and reference labs, highlights the increasing importance of timely and accurate disease detection. Strategic collaborations and acquisitions by leading players such as QIAGEN and Roche are reshaping the competitive landscape and accelerating product innovation. With growing government support and expanding adoption across healthcare settings, molecular diagnostics will play an essential role in advancing precision medicine and improving healthcare outcomes nationwide.