Glycated Hemoglobin Assay Patents: Who Leads, Where the Gaps Are 2026
- 58.4% concentration at the top. The five leading assignees hold 90 of the 154 records in scope, so most of the core boronate-affinity and immunoassay claim space is already staked out by a small group.
- Filing has cooled from its 2020 peak. Publications ran 6 in 2021 down to 4 in 2024, a 33% decline over that span, though 2025-2026 counts are still filling in due to publication lag.
- G01N dominates, G16H is thin. 48.7% of records sit in material analysis and testing (G01N), while only 9.1% touch healthcare informatics (G16H) — software-side HbA1c interpretation is comparatively open.
Filing growth compares 2021 (6 records) with 2024 (4) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field. Top-5 share is the combined record count of the five largest assignees divided by all 154 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
Glycated hemoglobin (HbA1c) assays measure the fraction of hemoglobin bound to glucose, giving a rolling average of blood glucose exposure used to diagnose and monitor diabetes. The patent activity mapped here spans boronate affinity chemistry, variant hemoglobin interference correction, standardization programs that tie assay output to reference methods, and point-of-care formats that move testing out of central labs. It also covers sample stability claims, since HbA1c reagents and specimens must tolerate storage and transport without drifting from the reference value.
The 154 records in scope run from 2015 through the 2026 cut-off, with the most recent one to two years understated because publication typically lags filing by roughly 18 months. Reading the trend, the composition and the assignee concentration together shows not just who has filed the most, but which technical sub-areas remain comparatively open.
Filing trend and technology composition
Two views of the same 154-record set: publication activity by year, and the IPC subclasses those records carry.
Filing trend: a 2020 peak, then a decline
Publications rose from 9 in 2017 to a peak of 14 in 2020, then eased to 6 in 2021 and 4 in 2024 — a 33% decline over that three-year window. Counts for 2025 and 2026 will continue to rise as filings from those years publish, so the recent-year figures should not be read as the trend's final word.
Technology composition by IPC subclass
G01N (material analysis and testing) appears on 48.7% of the 154 records, confirming that most activity is assay-mechanism work rather than therapeutic or informatics claims. A61K and A61P together suggest a meaningful share of records also carry pharmaceutical or therapeutic-activity claims, likely from combination diagnostic-treatment filings, while G16H (healthcare informatics) sits at just 9.1% and G06F at 3.2% — the software and data-interpretation layer around HbA1c results is comparatively lightly claimed.
Shares are the percentage of the 154 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Glycated Hemoglobin Assays with Eureka
This page is one run against one query. Ask Eureka your own question about glycated hemoglobin assays and every answer comes back with the patent numbers behind it.
Try EurekaMost-cited records in this dataset
US6316265B1 — Determination of % glycated hemoglobin
A glycated hemoglobin assay utilizes a simple procedure for the determination of standardized %GHb in whole blood samples correlated to the Diabetes Control and Complications Trial (DCCT). A lysed whole blood sample is incubated with a solid phase coupled to boronic acid or a similar boronate compound, then a labeled antibody to human hemoglobin is added; the resulting signal is directly proportional to the %GHb in the sample.Filed by Abbott Laboratories, published 2001-11-13 — one of the earlier boronate-affinity immunoassay constructions in this space.


| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US6632399B1 | Devices and methods for using centripetal acceleration to drive fluid movement in a microfluidics system for … | 272 |
| 2 | US20040089616A1 | Devices and methods for using centripetal acceleration to drive fluid movement in a microfluidics system for … | 113 |
| 3 | US20110143364A1 | Centrifugal micro-fluidic structure for measuring glycated hemoglobin, centrifugal micro-fluidic device for m… | 77 |
| 4 | WO2013162035A1 | Modified amadoriase capable of acting on fructosyl hexapeptide | 68 |
| 5 | US20100145174A1 | System And Method For Providing A Personalized Tool For Estimating Glycated Hemoglobin | 56 |
| 6 | WO2015060429A1 | HEMOGLOBIN A1c MEASUREMENT METHOD AND MEASUREMENT KIT | 55 |
| 7 | US6162645A | Determination of % glycated hemoglobin | 54 |
| 8 | US20180030516A1 | Microbiome Diagnostics | 31 |
| 9 | WO1998040750A1 | Determination of % glycated hemoglobin | 31 |
| 10 | US6316265B1 | Determination of % glycated hemoglobin | 22 |
Citation counts are drawn from within this searched corpus and skew toward older filings; treat them as a signal of influence rather than current relevance.
Each row carries its publication number; clicking a row searches Eureka by that number.
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Browse MCP servers →What the numbers mean for a filing decision
Three patterns worth acting on before drafting new claims in this space.
Core assay chemistry is crowded at the top
The five leading assignees account for 90 of the 154 records in scope, and the top ten extend that to 76.0% (117 records). New boronate-affinity or standard immunoassay claims are likely to run into dense prior art from this group.
Filing has pulled back from its peak
Publications dropped from a 2020 peak of 14 to 6 in 2021 and 4 in 2024 — a 33% decline across that span. That does not necessarily mean interest has cooled; standardization-heavy fields often see filing bursts around reference-method changes rather than steady output.
The data-interpretation layer is thin
Only 14 records carry a G16H healthcare-informatics classification and just 5 carry G06F. Given how much HbA1c decision-support and continuous-monitoring correlation work is happening clinically, algorithmic interpretation of assay output looks under-claimed relative to the assay mechanisms themselves.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to glycated hemoglobin assays, with the prior art for and against each one.
Who is filing, and where the gaps sit
The ranking covers 42 assignees; the field is led by a single company at 47 records, with fifth place at 6 and tenth place at 5 — a steep drop-off after the leader rather than a gradual taper.
One filer well ahead of the rest
The top assignee holds 47 of the 154 records, far more than the 6 held by fifth place. That gap suggests the leader has built a broad portfolio across multiple assay formats rather than a single claim family.
A tight mid-field, then a long tail
Positions five through ten cluster closely together at 5-6 records each, pointing to several companies maintaining active but modest portfolios rather than one clear second leader.
Co-filing is rare and concentrated
Only 7 co-assignee pairs appear across the dataset, with the strongest pair filing together 6 times. Most portfolios here were built independently rather than through joint development.
| Assignee | Recent year | YoY |
|---|---|---|
| Sanofi-Aventis Deutschland GmbH | 0 | — |
| Abbott Laboratories | 0 | — |
| Kikkoman Corporation | 0 | — |
| Beckman Coulter, Inc. | 0 | — |
| Samsung Electronics Co., Ltd. | 0 | — |
| BARDY GUST H | 0 | — |
| ALFERNESS CELEVATORON A | 0 | — |
| Roche Diagnostics Operations, Inc. | 0 | — |
Where to take this
The dataset points to concrete next steps depending on whether the goal is freedom-to-operate or new filing strategy.
Check freedom-to-operate against the leader's portfolio
With one assignee holding 47 of 154 records, any new boronate-affinity or immunoassay filing should be checked against that portfolio specifically, not just the field broadly.
Explore assignee portfolios in EurekaScope claims around the informatics gap
G16H and G06F classifications are thin relative to G01N assay-mechanism claims, suggesting room for algorithmic interpretation and decision-support claims tied to HbA1c output.
Run a white-space search in EurekaWatch for standardization-driven filing bursts
The 2020 peak suggests filing activity clusters around reference-method or standardization events rather than flowing steadily, worth tracking for timing new applications.
Track filing trends in EurekaCommon questions on HbA1c assay patents
A single assignee leads this dataset with 47 of the 154 records in scope, well ahead of the field. The next several positions cluster closely together, with fifth place at 6 records and tenth place at 5, before a long tail of companies with one or two filings each. Overall, the top five assignees combined hold 58.4% of all 154 records, so most core assay-chemistry claim space sits with a small group rather than being spread evenly across the 42 ranked companies.
US6316265B1, assigned to Abbott Laboratories and published in 2001, claims a procedure for determining standardized percent glycated hemoglobin using a solid phase coupled to boronic acid, followed by a labeled antibody to human hemoglobin whose signal is proportional to %GHb. It is a foundational boronate-affinity plus immunoassay combination correlated to the DCCT reference standard. Anyone building a similar solid-phase boronate capture step paired with antibody-based signal generation needs to check their specific reagent chemistry and workflow against this claim rather than assume the general concept is free to use, since the patent is old enough that its core term may have expired but related family members or continuations could still be active.
Filing peaked in 2020 at 14 published records, then declined to 6 in 2021 and 4 in 2024, a 33% drop over that three-year span. However, 2025 and 2026 figures are still incomplete because publication typically lags actual filing by around 18 months, so the most recent years understate real activity. The honest read is that the field has cooled from its 2020 high point through the last fully-observable year, 2024, without yet knowing whether that decline continues.
Relative to the 48.7% of records carrying G01N material-analysis claims, healthcare informatics (G16H, 9.1%) and digital data processing (G06F, 3.2%) are thinly claimed. That suggests algorithmic interpretation of HbA1c readings, glucose-correlation software, and point-of-care variant-interference flagging are less crowded than the core assay chemistry itself. A first claim in this space would likely center on a computational method for correcting or flagging variant hemoglobin interference from raw assay signal, rather than another boronate-affinity or immunoassay construction.
It is concentrated at the top and long-tailed below it: the top five assignees hold 58.4% of all 154 records, and the top ten extend that to 76.0%. Only 42 companies appear in the ranking at all, meaning a large share of the remaining records are held by a long tail of single- or few-filing entrants. Co-filing is also uncommon, with only 7 co-assignee pairs identified across the whole dataset, so most portfolios were built independently rather than through joint ventures.
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Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
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Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company’s registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.