Biologic Lyophilization Patents: Leaders, Trends & White Space 2026
- A long tail, not a monopoly. the ranked leader holds 201 records but the top 5 combined are just 7.5% of all 10,484 records in scope.
- Filing peaked in 2017 at 660 records and the 2021→2024 complete-year window shows a 41% decline, from 516 to 304 filings.
- A61K dominates at 90.0% of records while drying-specific F26B claims sit at just 8.1%, marking a narrower but more contested band of prior art.
Filing growth compares 2021 (516 records) with 2024 (304) — 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 10,484 records in scope (CR5), not by the ranked leaders only.
What this landscape covers
This landscape maps 10,484 published records filed between 2015 and mid-2026 that combine lyophilization or freeze-drying process terms with cryoprotectant, buffer, glass transition and solid-content formulation language, restricted to IPC classes covering drying equipment, pharmaceutical preparations and microorganism handling. It captures the intersection of two disciplines: the physical process of freeze-drying and the formulation science of keeping a biologic stable through it.
Because publication trails filing by roughly 18 months, the most recent one to two years in any trend chart will always look thinner than they eventually turn out to be. Treat 2024 as the last complete comparison year and read 2025 onward as still filling in.
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Filing trends and technology composition
Two views of the same 10,484-record corpus: how filing volume has moved year over year, and which IPC subclasses the records cluster in.
Filing trend: a 2017 peak followed by a real decline
Filings hit their peak so far in 2017 at 660 records. Using only complete years, 2021 to 2024 fell 41%, from 516 to 304 records. That is a genuine slowdown in formal filing activity, not an artefact of publication lag, though the 2025-2026 figures will rise somewhat as later applications publish.
IPC composition: concentrated in medicinal preparations, thinner in drying-specific claims
A61K (medicinal preparations) touches 90.0% of the 10,484 records, with A61P (therapeutic activity) at 34.5% and C12N (microorganisms and genetic engineering) at 19.5%. F26B (drying, the process-engineering class) sits at just 8.1%, and food-adjacent A23L and agrochemical A01N classes each sit near 4.2% — smaller pools worth checking for transferable claim language.
Shares are the percentage of the 10,484 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Biologic Lyophilization Formulation Development with Eureka
This page is one run against one query. Ask Eureka your own question about biologic lyophilization formulation development and every answer comes back with the patent numbers behind it.
Try EurekaRepresentative and most-cited records
US11446250B2 — Lyophilization of RNA
The present invention is directed to the field of RNA formulation, in particular to lyophilization of RNA. The invention provides a method for lyophilization of RNA, a lyophilized composition obtainable by that method, a pharmaceutical composition, a vaccine, and a kit or kit of parts, together with the use of a lyoprotectant for lyophilizing RNA and first and second medical uses of the resulting compositions.Filed by CureVac Manufacturing GmbH, granted 2022-09-20 — one of the few records in this corpus that ties lyophilization method claims directly to RNA rather than protein biologics.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US5336616A | Method for processing and preserving collagen-based tissues for transplantation | 978 |
| 2 | WO1998058668A2 | Vaccines containing bordetella pertussis antigen | 829 |
| 3 | US4818542A | Porous microspheres for drug delivery and methods for making same | 754 |
| 4 | US5302401A | Method to reduce particle size growth during lyophilization | 631 |
| 5 | US6037323A | Apolipoprotein A-I agonists and their use to treat dyslipidemic disorders | 433 |
| 6 | US6004925A | Apolipoprotein A-I agonists and their use to treat dyslipidemic disorders | 400 |
| 7 | US6933326B1 | Particulate acellular tissue matrix | 356 |
| 8 | US20040049150A1 | Vaccines | 343 |
| 9 | US7820788B2 | Compositions and methods of delivery of pharmacological agents | 337 |
| 10 | WO2017218704A1 | Stabilized formulations of lipid nanoparticles | 320 |
Citation counts accumulate over time inside this searched corpus, so older records are structurally favoured. Read them as markers of foundational influence, not current commercial relevance.
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Three patterns stand out once volume, concentration and technology class are read together.
No single owner controls the field
The ranked leader holds 201 records, and the top 5 combined account for only 7.5% of all 10,484 records in scope. The top 10 combined reach 11.8%. That is a wide, fragmented ownership base rather than a blocking cluster — freedom-to-operate work needs to check many mid-sized filers, not just the obvious names.
Filing volume is genuinely cooling
From a 2017 peak of 660 records, complete-year filings fell from 516 in 2021 to 304 in 2024, a 41% drop. Several of the largest historical filers show negative year-over-year momentum in the latest tracked year as well, suggesting the wave of core formulation patenting has passed its most active phase.
Process claims are the thinner layer
90.0% of records sit in A61K medicinal-preparation language, but only 8.1% carry F26B drying-process claims. Most of the corpus is formulation-side (excipients, cryoprotectants, buffers) rather than equipment- or process-parameter claims, which is where more specific technical differentiation may still be claimable.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to biologic lyophilization formulation development, with the prior art for and against each one.
Who holds ground, and where the gaps sit
The ranked leaders span large-molecule originators, contract formulation specialists and equipment makers, but ownership thins quickly outside the top tier.
A single filer well ahead of the field
The top-ranked assignee holds 201 records, roughly double the fifth-place filer's 113 and more than double tenth place at 86. That gap at the very top does not translate into field-wide control given the 7.5% top-5 share of all records.
A broad, fragmented ownership base
The ranking returns 100 companies, and by tenth place the count has already dropped to 86 records. Below that, ownership spreads across pharma originators, CDMOs, academic institutions and drying-equipment makers, none holding a dominant share.
Collaboration is limited and specific
Only 10 co-assignee pairs appear in the corpus. The strongest pairing links a large infusion-therapy company with a university partner, followed by an internal pairing between related corporate entities, and a smaller pairing between two vaccine-focused units — collaboration here looks more like corporate restructuring and sponsored research than open industry alliance.
| Assignee | Recent year | YoY |
|---|---|---|
| Amgen Inc. | 1 | -80% |
| Takeda Pharmaceutical Company Limited | 1 | -83% |
| IMA Life North America Inc. | 1 | -67% |
| Chr. Hansen A/S | 1 | -67% |
| Chugai Pharmaceutical Co., Ltd. | 1 | 0% |
| Shire Human Genetic Therapies, Inc. | 0 | — |
| GlaxoSmithKline Biologicals SA | 0 | -100% |
| Abraxis BioScience, LLC | 0 | — |
Where to take this analysis
The landscape numbers point to specific next steps depending on whether the goal is freedom-to-operate, white-space filing, or competitive tracking.
Run a freedom-to-operate check against the long tail
With 100 ranked assignees and no single owner above single digits of the total, an FTO review needs to cover mid-tier filers, not just the top names.
Explore assignee coverage in EurekaMap claim language inside the thinner F26B class
At 8.1% of records, drying-process claims are far less crowded than formulation claims, and are worth a closer read before drafting new process-parameter claims.
Search F26B claim language in EurekaTrack momentum among the largest historical filers
Several top filers show declining year-over-year activity in the latest tracked year, which may signal a shift toward licensing or maturity rather than continued core filing.
Set up assignee alerts in EurekaCommon questions on biologic lyophilization patents
The ranked list returns 100 companies, with the top-ranked assignee holding 201 records, well ahead of the fifth-place filer at 113 and tenth place at 86. Despite that gap at the top, the top 5 combined account for only 7.5% of all 10,484 records in scope, so no single company controls the field. Effective competitive tracking needs to look beyond the top few names into the broader ranked list, which includes large biologic originators, contract formulation specialists and drying-equipment manufacturers.
No, not over the most recent complete comparison window. Filing peaked in 2017 at 660 records, and using only complete years, activity fell 41% from 516 records in 2021 to 304 in 2024. Figures for 2025 and 2026 will rise somewhat as publication catches up, since publication typically lags filing by around 18 months, but the underlying complete-year trend is a genuine decline rather than a lull.
Medicinal-preparation claims under A61K appear in 90.0% of the 10,484 records, making it by far the largest class. Therapeutic-activity claims (A61P) sit at 34.5% and microorganism/genetic-engineering claims (C12N) at 19.5%. Drying-process claims under F26B, the more equipment- and parameter-focused class, appear in only 8.1% of records, indicating that most patenting activity concerns formulation ingredients and conditions rather than the physical drying process itself.
US11446250B2, titled Lyophilization of RNA, is held by CureVac Manufacturing GmbH and was granted on 2022-09-20. It covers a method for lyophilizing RNA, the resulting lyophilized composition, related pharmaceutical compositions, vaccines and kits, and the use of a lyoprotectant specifically for RNA lyophilization. It is notable in this corpus for tying formulation and process claims directly to RNA rather than the protein biologics that dominate most of the field.
The thinner IPC classes point to it directly: F26B drying-process claims sit at just 8.1% of records against A61K's 90.0%, suggesting equipment and process-parameter claims are less crowded than ingredient and formulation claims. RNA-specific lyoprotectant systems, solid-content optimisation for high-concentration biologics, and buffer-pH stabilisation for combination products are narrower branches with comparatively less density. Co-assignee collaboration is also limited to just 10 pairs, meaning most white-space opportunities have not yet been claimed jointly across institutions.
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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.