Biologic Lyophilization Patents: Top Companies & Filing Trends 2026
- Filing peaked in 2021 at 123 records then fell to 45 by 2024, a -63% swing over that three-year span — the clearest complete-year signal in the dataset.
- No single filer dominates the leader holds 134 records but the top 5 combined account for only 20.4% of all 1,754 records in scope, pointing to a fragmented field rather than a gated one.
- Drying hardware and formulation chemistry overlap heavily F26B drying classes appear in 37.2% of records alongside A61K medicinal-preparation claims in 67.6%, showing process and formulation are usually claimed together, not separately.
Filing growth compares 2021 (123 records) with 2024 (45) — 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 1,754 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
This dataset tracks patent filings at the intersection of biologic drug lyophilization and the process-control mechanisms that make continuous or semi-continuous freeze drying possible — controlled nucleation, moving-vial loading, sublimation-zone management and residence-time control. It spans 1,754 records published between 2015 and mid-2026, drawn from IPC classes covering drying equipment, pharmaceutical preparations and microorganism handling.
Because publication trails filing by roughly 18 months, the last one to two years in any trend understate real filing activity; the 2024 data point is the most recent year that can be read as complete.
Filing trend and technology composition
Two views of the same 1,754 records: how filing volume has moved year over year, and which IPC subclasses carry the claims.
Filing trend, 2017-2026
Filings rose to a peak of 123 in 2021, then declined to 45 by 2024 — a -63% move over that three-year window. Figures for 2025 and 2026 are still filling in as publications catch up to filing dates, so they should not be read as a continued decline.
IPC subclass composition
A61K (medicinal preparations) touches 67.6% of records and F26B (drying) touches 37.2%, confirming that most filings pair a drying-process claim with a formulation claim rather than filing either alone. Therapeutic-activity claims (A61P, 16.9%) and peptide/protein claims (C07K, 14.7%) sit well behind those two, with food-application filings under A23L a small but distinct 3.5% slice.
Shares are the percentage of the 1,754 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Biologic Lyophilization Continuous Lyophilization with Eureka
This page is one run against one query. Ask Eureka your own question about biologic lyophilization continuous lyophilization and every answer comes back with the patent numbers behind it.
Try EurekaMost-cited records in this corpus
Monitoring and control of freeze drying via in-process heat flow (US20150226617A1)
The filing describes measuring heat transfer at selected, position-representative vials using heat-flux sensors placed between the vials and the shelf or wall, to characterise and control the freezing and drying stages of a batch lyophilization run.Filed by Millrock Technology, Inc. — a specialist lyophilization equipment maker rather than a biologic sponsor, which is typical of the process-control layer of this field.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US6500463B1 | Encapsulation of sensitive components into a matrix to obtain discrete shelf-stable particles | 208 |
| 2 | US20080044481A1 | Microparticles for Oral Delivery | 170 |
| 3 | US6709669B1 | Fast-dispersing dosage forms containing fish gelatin | 161 |
| 4 | WO2003035030A1 | Kit for the preparation of a pharmaceutical composition | 154 |
| 5 | US20160271188A1 | Probiotic and prebiotic compositions, and methods of use thereof for treatment of gastrointestinal disorders | 152 |
| 6 | US6838076B2 | Pulmonary administration of chemically modified insulin | 152 |
| 7 | US20140288160A1 | Cleavable lipids | 148 |
| 8 | US20040082764A1 | Calicheamicin derivative-carrier conjugates | 141 |
| 9 | US20040247628A1 | Kit for the preparation of a pharmaceutical composition | 141 |
| 10 | WO2000061117A1 | Fast-dispersing dosage forms containing fish gelatin | 127 |
Citation counts favour older filings that have had more time to accumulate references within this searched corpus — read them as a signal of influence on the field, not as a ranking of current technical importance.
Each row carries its publication number; clicking a row searches Eureka by that number.
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Three patterns stand out once filing volume, assignee concentration and technology composition are read together.
The 2021 peak has cooled, not vanished
Filing volume fell -63% from its 2021 peak of 123 to 45 in 2024, the last year with a complete publication picture. That is a real pullback from peak, not evidence the field is closing — 2024 filings still outnumber every year before 2020 in this dataset.
Leadership is real but not a moat
The leading assignee holds 134 records and the top 5 combined account for 20.4% of all 1,754 records in scope. That leaves roughly four-fifths of filings spread across a long tail of equipment makers, biologic sponsors and contract manufacturers — no single entity has locked up the process-control layer.
Formulation and hardware claims travel together
Two-thirds of records touch medicinal-preparation claims (A61K) and over a third touch drying-equipment claims (F26B) — with substantial overlap between the two. Filers rarely claim a lyophilization process in isolation; they tie it to a specific formulation, which narrows the practical freedom to operate around any single grant.
Filing is concentrated in the US and Europe first
The United States (411) and the EPO (274) lead receiving offices, with WIPO/PCT (159), Australia (127), Canada (115) and Israel (114) following. That ordering reflects where biologic manufacturing capacity and regulatory review are concentrated, more than any technical constraint on the process itself.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to biologic lyophilization continuous lyophilization, with the prior art for and against each one.
Who is filing, and where the field is still open
The ranked leaders span equipment vendors, biologic sponsors and ingredient houses — a mix that reflects how many disciplines this technology touches.
One clear leader, no runaway gap
The top-ranked assignee holds 134 records, roughly three times the fifth-place count of 42. That gap is meaningful but not exclusionary: fifth through tenth place still hold double-digit counts each, so the leader's position rests on volume rather than a single blocking family.
A wide mid-field of equipment and pharma filers
Between the leader and the long tail sits a mid-field of lyophilization equipment specialists and biologic sponsors, together accounting for 29.5% of all records across the top 10. This is the group most likely to hold blocking process-control claims relevant to a new entrant's equipment design.
Equipment-and-research pairings are the main collaboration pattern
Only 10 co-assignee pairs appear in the dataset, the strongest linking a lyophilization equipment maker with a university research foundation. That is a thin collaboration layer for a field this technically cross-disciplinary, suggesting most process-control IP is still developed in-house rather than jointly.
| Assignee | Recent year | YoY |
|---|---|---|
| Sanofi Pasteur SA | 0 | — |
| Ferring BV | 0 | -100% |
| Millrock Technology, Inc. | 0 | — |
| Amgen Inc. | 0 | — |
| Windtree Therapeutics, Inc. | 0 | — |
| Praxair Technology, Inc. | 0 | — |
| R.P. Scherer Ltd. | 0 | — |
| Regeneron Pharmaceuticals, Inc. | 0 | -100% |
Where to take this analysis
The dataset points to a fragmented field with a cooling-from-peak filing rate and dense claim overlap between formulation and drying process. The next steps depend on whether the goal is freedom-to-operate or identifying a filing gap.
Map claim scope against the top assignees
Before designing new equipment or a new formulation-plus-process combination, check the granted claims held by the ranked leaders in this space, since the top 10 together already cover close to a third of all records.
Explore assignee claims in EurekaProbe the under-claimed sub-areas directly
Controlled nucleation triggering and moving-vial loading mechanisms show thinner density than the core drying and formulation classes — worth a targeted search before committing R&D time to either.
Run a white-space search in EurekaCommon questions about this landscape
The leading assignee in this dataset holds 134 records out of 1,754 in scope, with the next four ranked assignees each holding fewer than half that count. Together the top 5 assignees account for 20.4% of all records, and the top 10 account for 29.5%. That leaves the majority of filings spread across a long tail of equipment vendors, biologic sponsors and ingredient companies, so no single company controls the field outright.
Filing peaked in 2021 at 123 records and had fallen to 45 by 2024, a -63% decline over that three-year span, which is the most recent period that can be read as a complete year of publications. Filings for 2025 and 2026 look lower still in the raw counts, but that is expected: publication typically lags filing by around 18 months, so the newest years are always undercounted. The honest read is a pullback from a 2021 peak, not a field in terminal decline.
Medicinal preparation claims under A61K appear in 67.6% of the 1,754 records, and drying-process claims under F26B appear in 37.2% — the two classes overlap substantially, meaning most filers claim a specific formulation together with a specific drying process rather than either alone. Therapeutic-activity claims (A61P, 16.9%) and peptide/protein claims (C07K, 14.7%) trail behind. A smaller cluster of food-application filings sits under A23L at 3.5% of records, reflecting freeze-drying's use outside biologics.
The dataset shows thinner claim density around controlled ice-nucleation triggering, moving-vial continuous loading mechanisms and in-line sublimation endpoint sensing compared with the dense overlap in core formulation and drying classes. These are technically specific sub-areas rather than the broad A61K/F26B combination that most incumbents already claim. A freedom-to-operate search focused on these narrower mechanisms is more likely to surface open claim space than a search on lyophilization broadly.
The United States leads with 411 records, followed by the EPO at 274, WIPO/PCT filings at 159, Australia at 127, Canada at 115 and Israel at 114. This ordering tracks where biologic drug manufacturing and regulatory review capacity are concentrated rather than any jurisdiction-specific technical requirement. A company assessing freedom-to-operate should treat the US and European filings as the primary blocking risk and the PCT filings as an indicator of where applicants are still deciding on national phase entry.
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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.