Single-Use Bioreactor Sterilization Patents: Leaders & Trends 2026
- Concentrated at the top. The five leading assignees together hold 140 of 222 records in scope (63.1%), and the top ten account for 200 (90.1%) — a field with little room for a new entrant to out-file the incumbents head-on.
- Filing has plateaued, not declined. Filings ran 4 in 2021 and 4 in 2024 — flat over that span (0% growth) — with a peak of 64 records in 2023; 2025-2026 figures are still filling in as publication lags filing by about 18 months.
- Claim density sits on sterilization mechanics, not biology. C07K (peptides/proteins) appears in 37.8% of the 222 records and B01D (separation/filtration) in 19.4%, showing sterilization claims are frequently bundled with downstream purification and filtration hardware.
Filing growth compares 2021 (4 records) with 2024 (4) — 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 222 records in scope (CR5), not by the ranked leaders only.
What this patent set covers
This landscape covers patents and published applications combining single-use or disposable bioreactor hardware — bags, bioreactor bags and mixing systems — with sterilization-adjacent process claims: steam cycles, thermal mapping, sterile filtration, condensate removal, biological indicators and sterile hold. The scope is drawn from IPC classes covering bioreactors and enzyme apparatus (C12M) and captures 222 records published between 2015 and mid-2026.
Because the search combines hardware terms with sterilization-process terms, the set skews toward filings that treat sterility assurance as a design feature of the disposable vessel itself, rather than as a separate downstream unit operation. That framing matters for freedom-to-operate work: a claim on the bag material alone will rarely intersect with a claim on the sterile-hold cycle, but many records in this set claim both together.
Filing trend and technology composition
Two views of the same 222-record set: activity over time, and where claims cluster across IPC subclasses. Both use the full record count as denominator, so class shares add up to more than 100% because a single record can carry several IPC codes.
Filing activity, 2017-2026
Filings rose from 13 in 2017 to a peak of 64 in 2023, then held flat between 2021 and 2024 (4 to 4, 0% change) before the most recent two years understate true activity due to publication lag — treat 2025 and 2026 as incomplete, not as a downturn.
Technology composition by IPC subclass
C12M (bioreactors and enzyme apparatus) is present in all 222 records by construction of the search. Beyond that, C07K (peptides and proteins) at 37.8% and B01D (separation processes including filtration) at 19.4% are the two largest secondary clusters, followed by C12P (fermentation) at 18.5%, C12N (microorganisms and genetic engineering) at 15.3%, and B01F (mixing and stirring) at 11.7%. A61M and F04B are minor clusters at 2.7% and 2.3% respectively.
Shares are the percentage of the 222 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Single-Use Bioreactor Sterilization with Eureka
This page is one run against one query. Ask Eureka your own question about single-use bioreactor sterilization and every answer comes back with the patent numbers behind it.
Try EurekaRepresentative filing and most-cited records
Single-use bioreactor and head plate, and a process for manufacturing same
A single-use bioreactor, suitable in particular for use in a parallel bioreactor system for applications in cell culture and/or microbiology, a head plate for such a single-use bioreactor and a process for manufacturing the single-use bioreactor and the head plate. The single-use bioreactor comprises a head plate, a dimensionally stable container and a mixer, the head plate and the container enclosing a reaction chamber, and the mixer having a mixer shaft and a stirring member, said mixer shaft being mounted rotatably about a rotational axis in a bearing and the stirring member being fastened torsionally rigidly to the mixer shaft. The mixer and the bearing are arranged entirely within the reaction chamber.Filed by Eppendorf SE, published 2015-05-14 — one of the earlier hardware-plus-mixer configurations in this set.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | US20170349874A1 | Single Use Bioreactor | 135 |
| 2 | US20150133636A1 | Purification of Biological Molecules | 97 |
| 3 | US20180010082A1 | Bioreactor With Higher Agitation Rates | 79 |
| 4 | US7377686B2 | Disposable mixing system | 65 |
| 5 | US20130196375A1 | Biopharmaceutical process apparatuses assembled into a column | 51 |
| 6 | WO2017207822A1 | Single use bioreactor | 46 |
| 7 | US20050063250A1 | Disposable mixing system | 37 |
| 8 | US20090075362A1 | Disposable Bioreactor Comprising a Sensor Arrangement | 30 |
| 9 | US20110229927A1 | Sample port of a cell culture system | 27 |
| 10 | WO2019212921A1 | Scalable clarification process for recombinant AAV production | 26 |
Citation counts favour older filings that have had more time to accumulate references within the searched corpus — read them as a signal of influence on subsequent filers, not as a ranking of current commercial relevance.
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Three read-outs from the same 222-record set: how concentrated the field is, how the technology splits between hardware and process, and where the citation record points.
Five assignees hold most of the ground
The five leading assignees combine for 140 of the 222 records in scope, and the top ten push that to 200 records (90.1%). A new entrant is not filing into open ground at the hardware-plus-sterilization intersection; it is filing around dense, already-claimed positions held by a small number of incumbents.
Sterilization claims rarely stand alone
Nearly four in ten records pair bioreactor sterilization claims with peptide/protein processing claims (C07K), and almost one in five (19.4%) also claim separation or filtration hardware (B01D). Isolated sterile-hold or steam-cycle claims without a downstream process tie are the minority pattern here.
A plateau, not a retreat
Annual filings held flat from 4 in 2021 to 4 in 2024, after peaking at 64 in 2023. The apparent drop in 2025-2026 numbers reflects the roughly 18-month lag between filing and publication, not a genuine slowdown in filing activity.
Older hardware filings anchor the citation graph
The most-cited record in this set, on single-use bioreactor configuration, has drawn 135 citations — well ahead of the next-ranked records. That reflects age and foundational scope more than current relevance; newer filings have not had comparable time to accumulate citations.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to single-use bioreactor sterilization, with the prior art for and against each one.
Who is filing, and where the gaps sit
The ranking covers 52 companies across the full 222-record set — not a top-50 or top-100 cut, the complete list the data endpoint returns for this scope. A handful of names dominate, and momentum in the most recent complete year is flat across nearly all of them.
A single leader well ahead of the field
The top-ranked assignee holds 54 records, more than three times the fifth-placed assignee's 15. That gap is the clearest signal in the ranking: this is not a crowded pack of near-equal filers but one incumbent with a durable lead, followed by a steep drop to the rest of the top ten.
A sharp drop-off after the top ten
By the tenth-ranked assignee, record counts have fallen to 7 — down from 54 at the top. The top ten together still cover 90.1% of all 222 records, leaving a long tail of the remaining 42 ranked companies filing in single digits.
Co-filing is rare and narrow
Only six co-assignee pairs appear across the set, and the strongest pairing accounts for 19 shared records — a joint filing relationship far denser than any other pair identified. Outside that one relationship, co-assignment activity is thin, suggesting most incumbents file independently rather than through joint ventures.
| Assignee | Recent year | YoY |
|---|---|---|
| Regeneron Pharmaceuticals Inc | 0 | -100% |
| Just-Evotec Biologics Inc | 0 | — |
| EMD Millipore Corp | 0 | — |
| Merck Sharp & Dohme Corp | 0 | — |
| GeoSynFuels LLC | 0 | — |
| Lonza AG | 0 | — |
| Amgen Inc | 0 | -100% |
| Stobbe GmbH | 0 | -100% |
Using this landscape
The dataset points to where claim space is dense and where it thins out. What a team does with that depends on whether the goal is freedom-to-operate, a licensing target, or a first-filing strategy.
Map claims against the top-ten incumbents
With 90.1% of records held by ten assignees, any new filing in this space should be checked directly against those portfolios before drafting, not against the field generally.
Explore assignee portfolios in EurekaTest white-space claims for real gaps
Under-claimed branches such as condensate removal in flexible geometries or multi-bag sterile-hold validation warrant a focused prior-art pull before a first claim is drafted.
Run a white-space search in EurekaTrack the 2025-2026 filings as they publish
Because publication lags filing by about 18 months, the most recent two years in this set will keep filling in — worth re-checking on a quarterly cadence rather than treating the current figures as final.
Set up monitoring in EurekaCommon questions on single-use bioreactor sterilization patents
The ranked list covers 52 assignees across 222 records, and it is heavily front-loaded: the leading assignee holds 54 records, more than three times the count at fifth place (15). The top five assignees together account for 63.1% of all 222 records in scope, and the top ten reach 90.1%. That concentration means due diligence on this space should focus on a small number of incumbent portfolios rather than a broad field of near-equal competitors.
Filings were flat between 2021 and 2024, holding at 4 records in each of those years for 0% change, after peaking at 64 records in 2023. The 2025 and 2026 figures look lower, but that is a publication-lag artifact: patent applications typically publish around 18 months after filing, so the most recent two years are still filling in and should not be read as a real decline.
Sterilization claims in this set are frequently bundled with downstream biological processing. C07K (peptides and proteins) appears in 37.8% of the 222 records, B01D (separation and filtration processes) in 19.4%, and C12P (fermentation and enzymatic synthesis) in 18.5%. Because a single record can carry multiple IPC classes, these shares sum to more than 100%, but the pattern is clear: pure sterilization-only claims are less common than claims that tie sterilization to purification, filtration, or fermentation hardware.
Comparatively thin direct coverage appears around condensate removal in flexible bag geometries, biological indicator placement tied to thermal mapping, and sterile-hold cycle validation across multi-bag trains. Positive-displacement pump integration (overlapping F04B) and body-fluid device crossover applications (overlapping A61M) are minor clusters at 2.3% and 2.7% of records respectively, suggesting less-crowded ground there too. Any white-space claim should still be checked against the top-ten incumbents' portfolios before drafting, since dominant players sometimes hold defensive filings outside their core claim clusters.
Very narrow. Only six co-assignee pairs were identified across the full 222-record set, and one relationship accounts for 19 shared records while the next-strongest pairs show only 2 shared records each. This indicates most filers in single-use bioreactor sterilization file independently rather than through joint development or co-ownership arrangements, with one notable exception.
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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.