Biologic Lyophilization Patents: Leaders, Trends & White Space 2026
- 10.9% concentration at the top. The five leading assignees hold 749 of 6,865 records in scope — a real lead, but not a lock on the field.
- Filings cooled after a 2018 peak. Activity ran from 395 records in 2018 down to 147 by 2024, a 47% drop across 2021–2024 alone.
- Drying-specific claims are a minority. Only 18.7% of records sit in F26B (Drying) directly — most protection is anchored in formulation (A61K) instead of process hardware.
Filing growth compares 2021 (279 records) with 2024 (147) — 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 6,865 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
Biologic lyophilization primary drying sits at the intersection of process engineering and formulation science: controlling chamber pressure, shelf temperature, sublimation rate and product temperature to hit a drying endpoint without collapsing the cake. The dataset behind this page pulls 6,865 published records filed against that vocabulary, spanning IPC classes for drying equipment, medicinal preparations, and microorganism handling.
Filing runs from 2015 through the current data cut-off, with publication understood to lag actual filing by roughly 18 months — so the last one to two years in any trend understate real activity. The picture that emerges is a field anchored by a handful of large biopharma and equipment filers, with a long tail of single- or few-filing entrants working narrower formulation or hardware angles.
Filing trend and technology composition
Two views of the same 6,865-record dataset: how filing volume has moved year over year, and how records distribute across IPC subclasses (a record can carry more than one class, so shares add to more than 100%).
Filing trend: a 2018 peak, then a real pullback
Filings rose from 365 in 2017 to a peak of 395 in 2018, then declined; the clearest complete-year comparison in the data shows 279 records in 2021 falling to 147 in 2024, a 47% drop. The final years in the chart (2025–2026) are still filling in as publications catch up with filing dates, so they should not be read as a continued collapse.
Technology composition: formulation dominates, drying hardware is a minority
A61K (medicinal preparations) touches 83.8% of the 6,865 records in scope, with A61P (therapeutic activity) at 31.9%. F26B (drying, the hardware side of the process) accounts for 18.7%, and C07K (peptides & proteins) and C12N (microorganisms & genetic engineering) sit at 14.9% and 13.0% respectively — evidence that most protection in this field is written around what is being dried and delivered, not the drying equipment itself.
Shares are the percentage of the 6,865 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Biologic Lyophilization Primary Drying with Eureka
This page is one run against one query. Ask Eureka your own question about biologic lyophilization primary drying and every answer comes back with the patent numbers behind it.
Try EurekaA representative primary-drying control patent
Method and system for controlling a freeze drying process (US8800162B2)
The patent describes monitoring and controlling a freeze drying process by isolating the drying chamber, sensing pressure and shelf temperature during primary drying, and calculating product-related values from those readings to manage the drying phase.Filed by Syntegon Telstar Technologies, S.L.U.; granted 2014-08-12.
| # | 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 | US20030113316A1 | Stable lyophilized pharmaceutical formulation of IgG antibodies | 309 |
| 7 | WO2000027363A1 | Aerosols comprising nanoparticle drugs | 286 |
| 8 | US20030035843A1 | Method for processing and preserving collagen-based tissues for transplantation | 270 |
| 9 | US6811767B1 | Liquid droplet aerosols of nanoparticulate drugs | 256 |
| 10 | US6284282B1 | Method of spray freeze drying proteins for pharmaceutical administration | 251 |
Citation counts favour older filings simply by virtue of being searchable longer; 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.
Put your own technology through the same analysis
Eureka on the web
When you want the answer in the next five minutes.
The agent works the prompt against patents and technical literature, citing every source.
Run your analysis now →MCP server & REST API
When it has to run inside your own pipeline.
Patent search, landscape analysis and assignee resolution as MCP tools. Drop them into any agent framework, or call REST directly.
Browse MCP servers →What the concentration and trend numbers mean for filing strategy
The dataset supports a few concrete conclusions about where claim space is dense and where the field is heading.
Leadership is real but not dominant
The leading assignee holds 192 records and the fifth-placed holds 128, together with the rest of the top five totalling 749 of 6,865 records — 10.9% of the field. That leaves the large majority of filings spread across a long tail, which is typical of a field defined more by shared formulation science than by a small set of controlling process patents.
Volume has pulled back from its 2018 peak
Filings peaked at 395 in 2018 and the last complete-year comparison shows a drop from 279 in 2021 to 147 in 2024. That is a genuine pullback in documented activity, though the most recent one to two years in any such chart are always understated because publication lags filing by about 18 months.
Hardware claims are the minority path
Most records carry medicinal-preparation classification (A61K, 83.8%) rather than drying-equipment classification (F26B, 18.7%). A filer building a case around shelf design or chamber control alone is working a narrower, less crowded slice of the field than one filing on formulation stability during drying.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to biologic lyophilization primary drying, with the prior art for and against each one.
Assignee landscape and recent momentum
The ranked leaders span large biopharma manufacturers and specialist freeze-drying equipment suppliers. Momentum in the most recent tracked year is down across several of the largest historical filers, consistent with the broader post-2018 pullback in the field.
A single filer sits ahead of the pack
The top-ranked assignee holds 192 records against a fifth-place count of 128 and a tenth-place count of 83 — a clear gradient rather than a cliff, suggesting several firms are filing at comparable, sustained volume rather than one company running away with the field.
Large legacy filers have gone quiet in the latest tracked year
Several of the historically largest assignees show zero filings in the latest year, with year-over-year drops of -80% to -100% among the biggest names. Given the 18-month publication lag, this likely overstates the actual slowdown, but it is consistent with the broader multi-year decline the trend data shows.
Co-filing is concentrated in a small number of pairings
Only ten co-assignee pairs appear in the dataset, and the strongest pair shares 50 records — evidence of a tight equipment-and-manufacturer relationship rather than a broad web of cross-licensing or joint development across the field.
| Assignee | Recent year | YoY |
|---|---|---|
| Takeda Pharmaceutical Company Limited | 1 | -80% |
| Amgen Inc. | 0 | -100% |
| Merck Sharp & Dohme Corp. | 0 | — |
| Otsuka Pharmaceutical Co., Ltd. | 0 | -100% |
| Pfizer Inc. | 0 | — |
| Wyeth LLC | 0 | — |
| Baxter International Inc. | 0 | — |
| Shire Human Genetic Therapies, Inc. | 0 | — |
Where to take this analysis
The dataset points to specific follow-up work depending on whether the goal is freedom-to-operate, licensing, or new filing strategy.
Map claim scope on the leading assignees
With concentration at only 10.9% among the top five, a freedom-to-operate review should look past the leader to the full ranked set rather than assuming one company controls the field.
Explore assignee claims in EurekaTest white space in drying-hardware claims
F26B accounts for just 18.7% of records against 83.8% for A61K — sensing and endpoint-control claims written around hardware, not formulation, face a thinner prior art field.
Run a white space search in EurekaWatch for the 2025–2026 publication catch-up
Because publication lags filing by roughly 18 months, the apparent decline through 2024 should be re-checked once the most recent two years finish publishing.
Track filing trends in EurekaCommon questions on this landscape
The leading assignee in this dataset holds 192 of the 6,865 records in scope, with the fifth-ranked assignee at 128 and the tenth at 83. Together the top five account for 749 records, or 10.9% of the field, which shows leadership without dominance. The rest of the ranked 100 assignees and a long tail of smaller filers hold the majority of the remaining records, so a competitive review should not stop at the single leader.
Filing peaked at 395 records in 2018 and the clearest complete-year comparison shows a decline from 279 records in 2021 to 147 in 2024, a 47% drop. Because publication typically lags actual filing by about 18 months, the 2025 and 2026 figures in any chart are still incomplete and should not be read as proof the decline is continuing. The safest reading is that documented activity cooled meaningfully after 2018 through the last fully reported year.
US8800162B2, assigned to Syntegon Telstar Technologies, describes monitoring and controlling a freeze-drying process by isolating the drying chamber and sensing pressure and shelf temperature during primary drying, then calculating product-related values from those readings. It is a process-control patent tied to specific chamber-isolation and pressure-sensing steps rather than a broad claim over freeze-drying as a concept. Anyone building an automated primary-drying endpoint system should review its specific method steps rather than assume it blocks all pressure-based endpoint detection.
The technology composition data shows drying-specific hardware claims (F26B, 18.7% of records) are far less dense than formulation-side claims (A61K, 83.8%), pointing to more open space in sensing, endpoint prediction and chamber-control hardware than in stabilizer or excipient formulation. Real-time sublimation rate sensing, collapse-temperature prediction and non-invasive product temperature mapping stand out as narrower, less crowded branches within that hardware side. A targeted novelty search on those specific sub-areas is more productive than a broad search across the whole field.
Several of the historically largest filers in this dataset show zero or near-zero filings in the most recent tracked year, with year-over-year drops as steep as -100% among some of the biggest historical names. That pattern likely overstates the real slowdown because of the roughly 18-month lag between filing and publication. The safer signal is the multi-year trend — a decline from a 2018 peak through 2024 — rather than any single most-recent year of momentum data.
Research Biologic Lyophilization Primary Drying in depth with Eureka
Go past this page: query the whole biologic lyophilization primary drying corpus yourself, in your own scope.
Every answer comes back with patent numbers you can open.
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.