Biologic Lyophilization Patents: Top Companies & Trends 2026
- Leadership is thin at the top. the top 5 assignees combined hold only 10.7% of the 6,636 records in scope, and the top 10 just 17.7% — a long tail dominates this field.
- Filing has cooled from its 2018 peak. annual filings fell from 269 in 2021 to 126 in 2024, a 53% drop over three years, though 2025-2026 figures are still incomplete due to publication lag.
- Drying and formulation claims dominate. A61K medicinal preparations sit on 82.5% of records and F26B drying process claims on 19.4%, leaving process-control niches comparatively open.
Filing growth compares 2021 (269 records) with 2024 (126) — 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 6,636 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
Biologic lyophilization freezing control spans the equipment and process claims that govern how a biologic product is frozen, nucleated and dried inside a shelf-based freeze dryer. The search set combines lyophilization and freeze-drying terminology with freezing-rate, nucleation, annealing and shelf/product-temperature language, filtered to the F26B5/06, A61K9/19 and C12N1/04 classification codes that cover drying apparatus, biologic preparations and preserved microorganisms respectively.
That combination captures both the hardware side of freeze-drying — shelf temperature control, chamber pressure, cycle monitoring — and the formulation side, where excipients and cake structure are claimed alongside the freezing step itself. Records in scope run from 2015 through the mid-2026 data cut-off, with the most recent one to two years understated because publication trails filing by roughly 18 months.
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Filing trend and technology composition
The record set spans 6,636 published documents from 2015 to the 2026 data cut-off, drawn from receiving offices led by the United States, the EPO, WIPO's PCT route, Australia, Canada and Israel.
Filings rose to a 2018 peak, then eased
Annual filings climbed to 346 in 2017 and peaked at 411 in 2018. From 2021 to 2024 — the last year that can be treated as complete — filings fell from 269 to 126, a 53% decline; 2025 and 2026 counts will continue to fill in as later-filed applications publish.
Formulation claims outweigh drying-apparatus claims
A61K medicinal preparations appear on 82.5% of the 6,636 records, far ahead of A61P therapeutic-activity claims at 30.3% and F26B drying-apparatus claims at 19.4%. C07K peptide/protein claims (14.6%) and C12N microorganism claims (13.8%) trail, with heterocyclic compounds, agrochemical biocides and food applications each under 5% — signs that most patenting effort targets the biologic formulation rather than the freeze-dryer hardware itself.
Shares are the percentage of the 6,636 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Biologic Lyophilization Freezing Control with Eureka
This page is one run against one query. Ask Eureka your own question about biologic lyophilization freezing control and every answer comes back with the patent numbers behind it.
Try EurekaRepresentative and most-cited filings
US8800162B2 — Method and system for controlling a freeze drying process
Filed by Syntegon Telstar Technologies and granted in 2014, this patent claims a method for monitoring and controlling a freeze-drying process by isolating the drying chamber, sensing pressure and shelf temperature during primary drying, and calculating a product-related parameter from those readings to steer the cycle.Abstract trimmed for length; full claim set available in Eureka.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US5336616A | Method for processing and preserving collagen-based tissues for transplantation | 978 |
| 2 | US5302401A | Method to reduce particle size growth during lyophilization | 631 |
| 3 | US6933326B1 | Particulate acellular tissue matrix | 356 |
| 4 | WO2017218704A1 | Stabilized formulations of lipid nanoparticles | 320 |
| 5 | US20070116729A1 | Lyophilization process and products obtained thereby | 317 |
| 6 | WO2000027363A1 | Aerosols comprising nanoparticle drugs | 286 |
| 7 | US20030035843A1 | Method for processing and preserving collagen-based tissues for transplantation | 270 |
| 8 | US6811767B1 | Liquid droplet aerosols of nanoparticulate drugs | 256 |
| 9 | US6284282B1 | Method of spray freeze drying proteins for pharmaceutical administration | 251 |
| 10 | US5364756A | Method of cryopreserving a suspension of biological material | 251 |
Citation counts accumulate over time and favour older filings; treat them as a signal of influence on later work, not of current commercial 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 say about this field
Three patterns stand out once the filing trend, the assignee ranking and the technology split are read together.
No single company controls the field
The leader holds 180 records and fifth place holds 125, but the top 5 combined still account for only 10.7% of all 6,636 records in scope, and the top 10 only 17.7%. Freedom-to-operate work here means checking a long list of mid-size filers, not just the largest name.
Filing volume has come down from its peak
Filings ran from 269 in 2021 to 126 in 2024, a 53% decline over that span, following a 2018 peak of 411. Recent-year momentum tables also show several established filers, including Amgen, Otsuka and Ferring, at zero filings in the latest year — a pattern to confirm against 2025-2026 publication lag rather than read as exit.
Formulation claims outnumber apparatus claims four to one
A61K medicinal-preparation claims sit on 82.5% of records versus 19.4% for F26B drying apparatus and process claims. That gap suggests the freezing-control hardware and cycle-control logic itself is claimed far less densely than the biologic formulations dried inside it.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to biologic lyophilization freezing control, with the prior art for and against each one.
| Assignee | Co-assignee | Shared families |
|---|---|---|
| Baxter International Inc. | University of Connecticut | 47 |
| Baxter International Inc. | Baxter Healthcare Corporation | 45 |
| The Regents of the University of Colorado | Thera Vitae Switzerland GmbH | 28 |
| The Regents of the University of Colorado | Soligenix, Inc. | 10 |
| Merck Sharp & Dohme LLC | MERCK SHARP & DOHME LLC | 8 |
| Merck Sharp & Dohme LLC | BHAMBHANI AKHILESH | 7 |
| Wyeth LLC | The Regents of the University of Colorado | 6 |
| Wyeth LLC | WARNE NICHOLAS | 5 |
Only 10 co-assignee pairs appear in the dataset, and the strongest pairs are repeat partnerships between the same two organisations rather than a broad collaboration network — most patenting here is done by single assignees.
Who is filing, and where the field is still open
The assignee ranking covers 100 companies counted by record; the leader holds 180 records, tenth place holds 81, and the concentration figures above show that leadership is shallow rather than dominant.
A large-molecule specialist sets the pace
The top-ranked filer holds 180 records, well ahead of fifth place at 125, but even that lead translates into a small share of the total 6,636-record field. Its position reflects sustained filing across formulation and process claims rather than a single dominant patent family.
A dense mid-tier of pharma and equipment filers
Between fifth place (125 records) and tenth place (81 records) sits a cluster of pharmaceutical majors and freeze-drying equipment specialists, none of which individually shifts the concentration numbers much. This is the group worth watching for licensing or acquisition signals rather than the single leader.
Most of the field sits outside the ranked leaders
With the top 10 combined holding 17.7% of all 6,636 records, the remaining 82.3% is spread across universities, contract manufacturers and smaller biologics firms. That long tail is where freedom-to-operate searches typically turn up the most unexpected blocking claims.
| Assignee | Recent year | YoY |
|---|---|---|
| Amgen Inc. | 0 | -100% |
| Otsuka Pharmaceutical Co., Ltd. | 0 | -100% |
| Ferring B.V. | 0 | -100% |
| Pfizer Inc. | 0 | — |
| Merck Sharp & Dohme LLC | 0 | — |
| Shire Human Genetic Therapies, Inc. | 0 | — |
| Baxter International Inc. | 0 | — |
| Wyeth LLC | 0 | — |
Where to take this analysis
The figures above establish the shape of the field; the next step is usually narrower — checking a specific claim, a specific competitor, or a specific white-space branch against the full record set.
Check freedom-to-operate against the long tail
Because the top 10 assignees hold only 17.7% of records, a freedom-to-operate review has to cover the mid-tier and long-tail filers, not just the ranked leader.
Run a freedom-to-operate search in EurekaTrack momentum, not just headline volume
Several established filers show zero activity in the latest year; distinguishing real pullback from publication lag needs a claims-level, not just a count-level, view.
Monitor assignee activity in EurekaExplore the under-claimed process-control branches
Nucleation detection and annealing-step optimisation sit well below the formulation-claim density seen elsewhere in this dataset.
Explore white space in EurekaCommon questions about this landscape
The assignee ranking covers 100 companies, with the top-ranked filer holding 180 records and fifth place holding 125. However, the top 5 assignees combined account for only 10.7% of the 6,636 records in scope, so no single company controls the field. Practical competitive tracking should include the mid-tier filers ranked between fifth and tenth place, not just the single leader.
Filings rose through the late 2010s to a peak of 411 in 2018, then declined from 269 in 2021 to 126 in 2024, a 53% drop over that three-year span. Figures for 2025 and 2026 are still incomplete because publication typically lags filing by around 18 months, so the most recent years understate real activity. Treat the 2021-2024 decline, not the raw 2025-2026 numbers, as the reliable trend signal.
US8800162B2, assigned to Syntegon Telstar Technologies, claims a method for monitoring and controlling a freeze-drying process by isolating the drying chamber, collecting pressure and shelf-temperature readings during primary drying, and calculating a process parameter from those readings. It is a process-control patent focused on in-cycle measurement and calculation rather than on a specific biologic formulation. Anyone building automated shelf-temperature or chamber-pressure control logic for primary drying should review its claim scope directly.
A61K medicinal-preparation claims appear on 82.5% of the 6,636 records in scope, making formulation the most heavily claimed area by far. A61P therapeutic-activity claims (30.3%) and F26B drying-apparatus claims (19.4%) follow at meaningfully lower density. Because a single record can carry multiple IPC classes, these shares add up to more than 100% and should be read as overlap indicators, not as a breakdown of the whole field.
Relative to the dense A61K formulation cluster, sub-areas like real-time nucleation detection, controlled ice-nucleation induction, annealing-step optimisation for large-volume containers and shelf-temperature ramp algorithms show comparatively thin coverage in this dataset. These sit adjacent to the well-claimed formulation and drying-apparatus space rather than outside it entirely. A freedom-to-operate and whitespace review should confirm current claim scope in Eureka before treating any of these as fully open.
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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.