Updated 26 Oct 2026
China banned Illumina sequencer imports from 4 March 2025 but did not restrict reagents, consumables or maintenance. Illumina's Greater China consumables fell 16.74 percent while its instrument funnel closed entirely - a decaying annuity, not a shrinking market. In H1 2025 MGI and Berry Genomics took 59.3 percent of Chinese sequencer procurement value.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Medicare pays a new advanced diagnostic laboratory test at its own list price for roughly nine months, then at the median of actual claims. Shield launched at USD 1,495, Guardian360 at USD 5,000, Signatera at USD 3,500. And in the CY2025 fee schedule, one code moved 34.26 percent in ten days with no change to the product.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
10x Genomics sold 18.73 percent more consumable reactions for 2.79 percent more revenue: realised price per reaction fell 13.43 percent. Hold that decline and grow volume 12 percent and the library preparation market contracts 3.04 percent a year. The forecast rests entirely on that number narrowing toward 5 percent.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Four of the six largest tumour profiling participants lost money in 2025. The one that made USD 66.4 million sells two tests. Decipher grew 27 percent to USD 310.7 million on about 102,000 tests — roughly USD 3,046 each — while a broad menu turned USD 727 million into a 5.91 percent EBITDA margin. Coverage, not the panel, is the product.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
The colorectal screening determination effective 8 June 2026 requires either 90 percent sensitivity with 87 percent specificity, or 79 percent with 90 percent. Shield reports 83.1 and 89.6. Against the second route it is four-tenths of a point short — but the two specificity figures measure different denominators, and neither document available to a reader resolves which one applies.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
QIAcuity produced USD 89 million in 2025 against a USD 600 million digital PCR segment: 14.8 percent share. The 2028 target of USD 250 million, at 15 percent segment growth, requires 27.4 percent. A dollar target on a growing denominator is a share target in disguise, and the denominator is the part nobody states.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Guardant grew oncology revenue 26 percent on 34 percent more tests: realised revenue per test fell 6.04 percent. Veracyte fell 1.09 percent per test. Myriad's tumour profiling shrank while volume rose. In tumour profiling, growth is being bought with price, and the identity that reconciles volume to revenue is the most useful number in the category.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
QIAGEN sizes the 2025 qPCR market at about USD 2.7 billion. Roche's Molecular Lab alone reported USD 3,048 million in the same year. Both are honest and they cannot describe the same market: one measures open chemistry, the other measures closed cartridge systems. Adopting a supplier's addressable market as the size of a category understates the level and imports the wrong growth rate.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Consumables in this market have been deflated roughly 75 percent while forecast value growth runs at 20.50 percent - and that is not a contradiction, it is what happens when the unit of sale moves from the device to the experiment. The cost per usable data point decomposes into three inputs, and only one of them is broken.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
An FDA qualification licenses a use, not a product - and as of the end of 2024 no organ-on-chip model had completed the process. That single fact, not instrument performance, explains why a twenty-year-old technology still measures its market in hundreds of millions.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Transient transfection cannot be banked, licensed or scaled into commercial supply, which is why it will never become a manufacturing platform - and why its growth tracks the number of experiments started rather than plant capacity. The 2025 filings, and the multiples paid for transfection reagents, show where the value actually sits.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
ICH Q5A(R2) made next-generation sequencing an acceptable alternative to classical adventitious-agent testing. That created a sequencing market that is not driven by discovery funding but by the number of manufacturing batches started - and whose real product is a qualified bioinformatics pipeline, not an instrument.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
The FDA's laboratory-developed test rule was vacated, then replaced with something close to the status quo. That settled less than it appears. With the clinical laboratory fee schedule entering capped annual reductions in 2027 and the EU's IVDR dates now split by risk class, the growth rate of this market is a coverage forecast with a technology input.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Roche's diagnostics margin halved in 2025 while cost of sales rose five times faster than revenue. That is not a procurement failure - it is what happens to a business whose real product is a reagent sold through an installed base of instruments. A close read of the 2025 filings shows why placements are a cost and pull-through is the revenue.
Healthcare Molecular Diagnostics
Updated 26 Oct 2026
Illumina's 2025 revenue was flat at USD 4.34 billion. Read as a headline that looks like a market stalling; read underneath, it shows growth has migrated to the high-throughput instrument, the clinical customer and a published reimbursement code. The sequencer is no longer where the money is.
Healthcare Molecular Diagnostics