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What Is Driving Hologic's Strength in the US Diagnostics Market?
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Key Takeaways
Hologic's Diagnostics revenue rose in Q4 on stronger U.S. molecular testing and 4.4% organic growth.
Molecular Diagnostics led gains, fueled by Hologic's BV CV/TV and Panther Fusion assay momentum.
HOLX broadened its Diagnostics lineup with EU expansion for Genius and new Panther Fusion assays.
Hologic (HOLX - Free Report) offers a wide range of diagnostic products to help in the screening and diagnosis of human disease. Although the performance of the Diagnostics segment in recent quarters has been impacted by macroeconomic conditions, like reduced USAID funding for HIV testing in Africa and an operating environment in China, the underlying strength has always remained solid. With the U.S. Diagnostics market projected to expand at a CAGR of 9.12% through 2025-2030, Hologic is well-poised to continue capturing market share.
In the fourth quarter of fiscal 2025, Diagnostics revenues increased 1.5% in constant currency (CC), driven by higher core U.S. molecular diagnostics sales. Excluding COVID-19 and related revenues, organic diagnostics sales grew 4.4% at CC. The Molecular Diagnostics unit remained the main growth engine, supported by higher sales of the BV, CV/TV and Panther Fusion assays. Approved in 2019, the BV, CV/TV vaginitis assay continues to offer a solid runway for Hologic. More than 20 million U.S. women experience vaginitis each year, with less than 40% being tested, mainly with older manual testing methods.
Further, management has emphasized the role of the Panther Fusion sidecar in future Diagnostics growth. Post-pandemic trends reflected the strong customer preference for Panther’s workflow efficiency and labs looking to consolidate their testing into fewer platforms. Panther Fusion addresses this by using PCR technology to run more than 23 assays spanning several testing categories. Its open-access functionality gives labs the flexibility to run their lab-developed tests on the Fusion platform.
Among two recent major developments, the Genius Digital Diagnostics System achieved expanded CE marking in the European Union and is now approved to image and review both cell and tissue specimens. Hologic also secured FDA 510(k) clearance and CE Mark approval for the Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays. These approvals should further boost HOLX’s strength in the diagnostic market going forward.
Latest Update From Hologic's Peers: ABT and RHHBY
Abbott (ABT - Free Report) recently announced that its over-the-counter continuous glucose monitor and app, Lingo, is now available for Android devices. Already available for Apple iOS devices, this expansion gives millions more people access to real-time glucose data, empowering informed choices that help support better energy, sleep, focus and overall well-being. In addition, Abbott has tapped into the growing muscle health movement by rolling out two new Ensure Max protein shakes.
Roche Holdings (RHHBY - Free Report) secured CE Mark approval for its mass spectrometry reagent pack for antibiotic drug monitoring. This establishes the company’s in-vitro diagnostics (IVD) menu as the broadest available for any automated mass spectrometry platform, including already 39 of the most frequently tested targets. Additionally, Roche achieved CE Mark for its cobas BV/CV assay to accurately identify specific bacteria and yeast responsible for vaginitis.
HOLX Stock Performance, Valuation and Estimates
Year to date, Hologic shares have increased 3.8%, outperforming the industry’s 3.1% growth.
Image Source: Zacks Investment Research
Hologic is trading at a forward five-year price-to-sales (P/S) of 3.86X, lower than the industry average of 4.35X.
Image Source: Zacks Investment Research
See how analysts are projecting Hologic’s fiscal 2026 and 2027 earnings.
Image: Bigstock
What Is Driving Hologic's Strength in the US Diagnostics Market?
Key Takeaways
Hologic (HOLX - Free Report) offers a wide range of diagnostic products to help in the screening and diagnosis of human disease. Although the performance of the Diagnostics segment in recent quarters has been impacted by macroeconomic conditions, like reduced USAID funding for HIV testing in Africa and an operating environment in China, the underlying strength has always remained solid. With the U.S. Diagnostics market projected to expand at a CAGR of 9.12% through 2025-2030, Hologic is well-poised to continue capturing market share.
In the fourth quarter of fiscal 2025, Diagnostics revenues increased 1.5% in constant currency (CC), driven by higher core U.S. molecular diagnostics sales. Excluding COVID-19 and related revenues, organic diagnostics sales grew 4.4% at CC. The Molecular Diagnostics unit remained the main growth engine, supported by higher sales of the BV, CV/TV and Panther Fusion assays. Approved in 2019, the BV, CV/TV vaginitis assay continues to offer a solid runway for Hologic. More than 20 million U.S. women experience vaginitis each year, with less than 40% being tested, mainly with older manual testing methods.
Further, management has emphasized the role of the Panther Fusion sidecar in future Diagnostics growth. Post-pandemic trends reflected the strong customer preference for Panther’s workflow efficiency and labs looking to consolidate their testing into fewer platforms. Panther Fusion addresses this by using PCR technology to run more than 23 assays spanning several testing categories. Its open-access functionality gives labs the flexibility to run their lab-developed tests on the Fusion platform.
Among two recent major developments, the Genius Digital Diagnostics System achieved expanded CE marking in the European Union and is now approved to image and review both cell and tissue specimens. Hologic also secured FDA 510(k) clearance and CE Mark approval for the Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays. These approvals should further boost HOLX’s strength in the diagnostic market going forward.
Latest Update From Hologic's Peers: ABT and RHHBY
Abbott (ABT - Free Report) recently announced that its over-the-counter continuous glucose monitor and app, Lingo, is now available for Android devices. Already available for Apple iOS devices, this expansion gives millions more people access to real-time glucose data, empowering informed choices that help support better energy, sleep, focus and overall well-being. In addition, Abbott has tapped into the growing muscle health movement by rolling out two new Ensure Max protein shakes.
Roche Holdings (RHHBY - Free Report) secured CE Mark approval for its mass spectrometry reagent pack for antibiotic drug monitoring. This establishes the company’s in-vitro diagnostics (IVD) menu as the broadest available for any automated mass spectrometry platform, including already 39 of the most frequently tested targets. Additionally, Roche achieved CE Mark for its cobas BV/CV assay to accurately identify specific bacteria and yeast responsible for vaginitis.
HOLX Stock Performance, Valuation and Estimates
Year to date, Hologic shares have increased 3.8%, outperforming the industry’s 3.1% growth.
Image Source: Zacks Investment Research
Hologic is trading at a forward five-year price-to-sales (P/S) of 3.86X, lower than the industry average of 4.35X.
Image Source: Zacks Investment Research
See how analysts are projecting Hologic’s fiscal 2026 and 2027 earnings.
Image Source: Zacks Investment Research
HOLX stock currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.