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Glycated Hemoglobin Assay Patents: Who Leads, Where the Gaps Are 2026

Glycated Hemoglobin Assay Patents: Who Leads, Where the Gaps Are 2026
https://www.patsnap.com/resources/blog/rd-blog/glycated-hemoglobin-assays-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Clinical Chemistry
Glycated Hemoglobin Assay Patents: Filing Concentration and Open Claim Space
  • 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.
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154
Published Records
58%
Top-5 Share of All Records
-33%
Filing Growth 2021→2024
US
Leading Jurisdiction

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.

Published byPatsnap Research··7 min readSourced from Patsnap Eureka
Overview

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 activity and technology composition, 2015-2026
  1. 1SANOFI AVENTIS DEUT GMBH47
  2. 2ABBOTT LAB INC19
  3. 3KIKKOMAN CORP10
  4. 4BECKMAN COULTER INC8
  5. 5ALFERNESS CELEVATORON A6
  6. 6SAMSUNG ELECTRONICS CO LTD6
  7. 7BARDY GUST H6
  8. 8CONNOLLY JIM5
  9. 9ROCHE DIAGNOSTICS OPERATIONS INC5
  10. 10ROCHE DIAGNOSTICS GMBH5
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
The Data

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.

Filing trend: a 2020 peak, then a decline048111592017201820191420202021202220232024202502026Most recent year is partial — publication lag means later filings are not yet visible.

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.

Technology composition by IPC subclassG01N · Material analysis & testing7548.7%A61K · Medicinal preparations4931.8%A61P · Therapeutic activity of compou…4126.6%A61B · Diagnosis & surgery2013.0%C12Q · Measuring & testing involving …159.7%G16H · Healthcare informatics149.1%C12N · Microorganisms & genetic engin…138.4%G06F · Electric digital data processi…53.2%Other2113.6%

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%.

Source: Patsnap Eureka. Filing trend and technology composition. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.

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.

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Key Patents

Most-cited records in this dataset

Representative filing
US6316265B12001-11-13

US6316265B1 — Determination of % glycated hemoglobin

ABBOTT LABORATORIES

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.

US6316265B1 — patent drawing 1US6316265B1 — patent drawing 2
View full record
Highest-citation records, 2015-2026
#Publication no.Patent titleCitations
1US6632399B1Devices and methods for using centripetal acceleration to drive fluid movement in a microfluidics system for …272
2US20040089616A1Devices and methods for using centripetal acceleration to drive fluid movement in a microfluidics system for …113
3US20110143364A1Centrifugal micro-fluidic structure for measuring glycated hemoglobin, centrifugal micro-fluidic device for m…77
4WO2013162035A1Modified amadoriase capable of acting on fructosyl hexapeptide68
5US20100145174A1System And Method For Providing A Personalized Tool For Estimating Glycated Hemoglobin56
6WO2015060429A1HEMOGLOBIN A1c MEASUREMENT METHOD AND MEASUREMENT KIT55
7US6162645ADetermination of % glycated hemoglobin54
8US20180030516A1Microbiome Diagnostics31
9WO1998040750A1Determination of % glycated hemoglobin31
10US6316265B1Determination of % glycated hemoglobin22

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.

Source: Patsnap Eureka. Citation counts and representative records. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
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Insights

What the numbers mean for a filing decision

Three patterns worth acting on before drafting new claims in this space.

Concentration
58.4% / 90 of 154
held by the top 5 assignees

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.

Ranking covers 42 assignees total
Trend
14 in 2020, 4 in 2024
peak year vs. most recent complete year

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.

2025-2026 figures still incomplete due to publication lag
Composition
9.1% G16H, 3.2% G06F
share of 154 records touching informatics classes

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.

Compare to 48.7% for G01N assay mechanisms
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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.

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Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Players

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.

Leader
47 records
leading assignee

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.

Based on the 42-company ranking
Mid-field
6 at 5th, 5 at 10th
records at the fifth and tenth ranked positions

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.

Top 10 combined hold 76.0% of all 154 records
Collaboration
7 co-assignee pairs
joint-filing relationships found

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.

Strongest pair: 6 shared filings
🔍
Under-claimed sub-areas worth checking before filing
Branches with comparatively light IPC coverage relative to the core assay mechanism claims
Algorithmic HbA1c-to-glucose correlation softwareVariant hemoglobin interference flagging at point of careSample-stability formulations for room-temperature transportCross-platform standardization calibration methods
Rank all filers by momentum →
Recent-year filing momentum by assignee
AssigneeRecent yearYoY
Sanofi-Aventis Deutschland GmbH0
Abbott Laboratories0
Kikkoman Corporation0
Beckman Coulter, Inc.0
Samsung Electronics Co., Ltd.0
BARDY GUST H0
ALFERNESS CELEVATORON A0
Roche Diagnostics Operations, Inc.0
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
What's Next

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 Eureka

Scope 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 Eureka

Watch 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 Eureka
Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
FAQ

Common questions on HbA1c assay patents

Answers are grounded in the same dataset. Derived from a Patsnap search on Glycated Hemoglobin Assays covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP

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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.

Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.

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.

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