https://www.patsnap.com/resources/blog/rd-blog/high-concentration-protein-formulation-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Biologics Formulation
High concentration protein formulation patents: who is filing, and where the field is still open
  • 31.1% concentration at the top. The five most active filers hold 642 of the 2,067 records in scope — a fifth-place company already sits at 93 records, so the lead does not belong to one player alone.
  • Filing has plateaued, not declined. 2021 to 2024 filings moved from 148 to 149, a flat +1% — the field is holding its filing rate at a mature plateau rather than accelerating or falling back.
  • Peptide chemistry outweighs delivery hardware. C07K peptide and protein claims sit in 49.9% of records, roughly ten times the 5.3% carrying A61M device claims — the contest is over molecule and excipient chemistry, not injection hardware.
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2,067
Published Records
31%
Top-5 Share of All Records
+1%
Filing Growth 2021→2024
US
Leading Jurisdiction

Filing growth compares 2021 (148 records) with 2024 (149) — 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 2,067 records in scope (CR5), not by the ranked leaders only.

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

What this landscape covers

High concentration protein formulation covers the chemistry and process work needed to get a biologic — typically a monoclonal antibody — into a liquid dose concentrated enough for subcutaneous injection without the solution becoming too viscous, self-associating, or turning opalescent on the shelf. The claims in this space run from viscosity-reducing excipients and self-association control through to the ultrafiltration steps used to concentrate the protein and the stability testing that qualifies the final formulation. It sits at the intersection of formulation chemistry and delivery: a viscosity problem solved with an excipient competes directly with one solved by a larger-bore needle or a different device.

The dataset in scope spans 2,067 published records filed between 2015 and mid-2026, drawn from a search string built around high concentration formulation, solution viscosity, protein-protein interaction and the specific excipient and stability terms that distinguish this niche from general biologics formulation art.

Filing activity and technology composition, 2015–2026
  1. 1REGENERON PHARMACEUTICALS INC150
  2. 2PROMETHEUS BIOSCIENCES INC138
  3. 3GENENTECH INC134
  4. 4EAGLE BIOLOGICS INC127
  5. 5CEDARS SINAI MEDICAL CENT93
  6. 6EVOLVED BY NATURE INC73
  7. 7OMEROS CORP73
  8. 8AMGEN INC71
  9. 9COMERA LIFE SCIENCES INC71
  10. 10ABBVIE BIOTECHNOLOGY LTD69
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on High Concentration Protein Formulation 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 2,067-record corpus: how filing activity has moved year over year, and which IPC subclasses carry the claims.

Filing trend, 2017–2026

Filings rose from 115 in 2017 to a peak of 166 in 2022, then settled to a plateau — 148 in 2021 against 149 in 2024, a flat +1% across that span. The final years in the chart, 2025 and 2026, are undercounted because publication typically lags filing by about 18 months; treat the recent taper as incomplete data, not a real slowdown.

Filing trend, 2017–2026050100150200115201720182019202020211662022202320242025112026Most recent year is partial — publication lag means later filings are not yet visible.

Technology composition by IPC subclass

A61K (medicinal preparations) touches 74.6% of records and C07K (peptides and proteins) touches 49.9%, confirming that the bulk of the art is formulation chemistry rather than hardware. A61P therapeutic-activity claims reach 24.1%, while device (A61M, 5.3%), sterilisation (A61L, 4.9%) and fermentation/synthesis (C12P, 4.8%) classes are present but comparatively thin. Records can carry more than one class, so these shares add to well over 100%.

Technology composition by IPC subclassA61K · Medicinal preparations1,54374.6%C07K · Peptides & proteins1,03249.9%A61P · Therapeutic activity of compou…49824.1%C12N · Microorganisms & genetic engin…1195.8%A61M · Devices for body fluids1105.3%A61L · Sterilising & disinfecting1014.9%C12P · Fermentation & enzymatic synth…1004.8%C08B · Polysaccharides & derivatives653.1%Other89143.1%

Shares are the percentage of the 2,067 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 High Concentration Protein Formulation covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.

Go deeper on High Concentration Protein Formulation with Eureka

This page is one run against one query. Ask Eureka your own question about high concentration protein formulation and every answer comes back with the patent numbers behind it.

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Key patents

A representative claim and the most-cited prior art

Representative filing
US20230279146A12023-09-07

US20230279146A1 — Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations

MERCK PATENT GMBH

The present invention relates to liquid compositions and formulations comprising a protein having a reduced viscosity and/or increased stability. Furthermore, the invention relates to methods for reducing the viscosity and/or increasing the stability of a protein solution.Filed by Merck Patent GmbH, published 2023-09-07.

US20230279146A1 — patent drawing 1US20230279146A1 — patent drawing 2
View full record
Most-cited records in this corpus
#Publication no.Patent titleCitations
1US3673143AOptically anisotropic spinning dopes of polycarbonamides430
2US3819587AWHOLLY AROMATIC CARBOCYCLIC POLYCARBONAMIDE FIBER HAVING ORIENTATION ANGLE OF LESS THAN ABOUT 45.degree.429
3EP0497525A2Pneumococcal polysaccharide conjugate vaccine409
4US3671542AOptically anisotropic aromatic polyamide dopes393
5EP0497524A2Polysaccharide antigens from streptococcus pneumoniae355
6US20090291062A1Protein formulations and methods of making same346
7US20100278822A1Stable high protein concentration formulations of human Anti-TNF-alpha-antibodies330
8WO1991018974A1HEMICELLULASE ACTIVE AT EXTREMES OF pH AND TEMPERATURE AND THE MEANS FOR THE PRODUCTION THEREOF255
9US5847112AProcess for making capsular polysaccharides from Streptococcus pneumoniae223
10US5623057APneumococcal polysaccharide conjugate vaccine222

High citation counts inside a searched corpus favour older, foundational filings — read them as markers of influence on the surrounding art, not as evidence of current commercial importance.

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 High Concentration Protein Formulation 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 say about the field

Three readings of the same dataset, each pointing at a different decision a formulation team needs to make.

Concentration
31.1% / 48.3%
share of all 2,067 records

The top ranks hold real share, but no single lock

The five most active filers together account for 31.1% of all records in scope, and the ranked ten reach 48.3%. That leaves more than half the corpus outside the leading ten filers — a long tail of single- and few-filing entrants still has room to establish position.

Based on the full assignee ranking of 100 companies
Momentum
148 → 149
filings, 2021 to 2024

A flat plateau, not a retreat

Filings moved from 148 in 2021 to 149 in 2024, a +1% change across three years. Several of the most active named filers show 0 filings and -100% year-on-year in the latest year, but that reads as the normal 18-month publication lag catching up with recent filings, not as an exit from the field.

2024 is the most recent year treated as complete
Composition
74.6% vs 5.3%
A61K share vs A61M share

Chemistry claims dwarf device claims

A61K medicinal-preparation claims cover 74.6% of records against 5.3% for A61M body-fluid-device claims. Excipient and formulation-composition work is where the claim density sits; device-side approaches to the same viscosity problem are comparatively open.

Class shares sum to more than 100% because records carry multiple IPC codes
Eureka AI Agent
Looking for what nobody has claimed yet?

Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to high concentration protein formulation, with the prior art for and against each one.

Find the white space →
Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on High Concentration Protein Formulation 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 crowded claims sit

The ranked leaders combine large pharmaceutical filers with smaller specialist entrants; a handful of strong co-filing pairs point to specific research collaborations rather than industry-wide alliances.

Leader
150 records
single top filer

One filer sits well ahead, but not by an order of magnitude

The leading assignee holds 150 records against 93 at fifth place and 69 at tenth — a real lead, but one that a mid-tier specialist filer could still close with a sustained filing programme.

Counted in patent families / records
Collaboration
89 shared records
strongest co-assignee pair

The strongest pairing is a dedicated research partnership

Of 10 identified co-assignee pairs, the strongest links two organisations across 89 shared records — far ahead of the next pairs at 14 and 9 — suggesting a specific long-running collaboration rather than a general industry norm of co-filing.

Out of 10 identified co-assignee pairs
Geography
US 370 / EPO 260
records by receiving office

Filing is concentrated in the US and Europe, with PCT as a strong secondary route

The United States (370) and the EPO (260) lead as receiving offices, with WIPO/PCT filings (205) close behind and Israel, Australia and Canada each carrying over 100 records — a filing footprint typical of biologics programmes chasing global regulatory approval.

Top receiving offices by record count
🔍
Under-claimed sub-areas worth a fresh claim search
These branches sit inside the same search space but carry comparatively few dedicated filings.
polysaccharide-based viscosity modifiersfermentation-derived stabilising excipientssterilisation-compatible high-concentration formatsdevice-integrated viscosity reductionultrafiltration process optimisation for high-titre concentration
Rank all filers by momentum →
Recent-year filing momentum by assignee
AssigneeRecent yearYoY
Regeneron Pharmaceuticals Inc0-100%
Prometheus Biosciences Inc0-100%
Genentech Inc0-100%
Eagle Biologics Inc0—
Cedars-Sinai Medical Center0-100%
Evolved by Nature Inc0—
Omeros Corp0-100%
Amgen Inc0-100%
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on High Concentration Protein Formulation 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 analysis

The landscape points to where claim density is heaviest and where it thins out. The next step is testing a specific formulation or excipient approach against that map.

Map a candidate excipient against the crowded classes

Run a targeted claim search inside A61K and C07K before committing to a viscosity-reduction approach, since these two classes carry the densest prior art in this corpus.

Explore excipient claims in Eureka

Check the under-claimed branches before filing

Polysaccharide-based modifiers, fermentation-derived excipients and device-integrated approaches show comparatively thin filing activity relative to the core chemistry classes — worth a freedom-to-operate check before assuming the space is open.

Search white space in Eureka

Watch the leading filers' next moves

With the top five holding 31.1% of records and momentum data showing recent-year lulls likely tied to publication lag, a watch list on the ranked leaders will surface their next wave of filings as it publishes.

Set up assignee tracking in Eureka
Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on High Concentration Protein Formulation 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 this landscape

Answers are grounded in the same dataset. Derived from a Patsnap search on High Concentration Protein Formulation 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

Research High Concentration Protein Formulation in depth with Eureka

Go past this page: query the whole high concentration protein formulation corpus yourself, in your own scope.
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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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