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Recombinant Plasma Protein Patents: Who Leads, White Space 2026

Recombinant Plasma Protein Patents: Who Leads, White Space 2026
https://www.patsnap.com/resources/blog/rd-blog/recombinant-alternatives-to-plasma-proteins-patent-landscape/ · Patsnap · data cut-off 2026-07-31 · downloaded from the live page
Patent Landscape · Biologics Manufacturing
Recombinant Alternatives to Plasma Proteins: Patents Mapped Through 2026
  • 70.0% of all 397 records sit with just five assignees — this field is concentrated at the top, not fragmented.
  • A61K and C07K dominate at 71.0% and 58.7% of records respectively, showing formulation and protein-engineering claims crowd the same ground.
  • Filing rose 10% from 2021 to 2024 (10 to 11 records) — modest but real growth once the reporting lag is accounted for.
Get a prior-art report on your approach
397
Published Records
70%
Top-5 Share of All Records
+10%
Filing Growth 2021→2024
US
Leading Jurisdiction

Filing growth compares 2021 (10 records) with 2024 (11) — 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 397 records in scope (CR5), not by the ranked leaders only.

Published byPatsnap Research··7 min readSourced from Patsnap Eureka
Field Overview

What this landscape covers

Recombinant alternatives to plasma proteins replace donor-derived coagulation factors and other plasma fractions with cell-line-manufactured equivalents. The patent activity in this dataset spans 397 records filed or published between 2015 and mid-2026, covering claims on cell line development, post-translational modification, half-life extension, manufacturing cost reduction, and strategies for displacing plasma-derived products in the market. The search string ties recombinant coagulation factor or plasma protein subject matter directly to these translational and commercial concerns, rather than to recombinant protein production generally.

The technology sits at the intersection of protein engineering and formulation science: most records carry claims in medicinal preparations (A61K) and peptide/protein chemistry (C07K), with a substantial minority reaching into microbial and genetic engineering (C12N) for the underlying cell line work. Filing offices skew toward the United States, Europe, and Australia, with WIPO PCT filings indicating that assignees actively pursue multi-jurisdiction protection for their lead candidates.

Filing activity and technology composition, 2015–2026
  1. 1EAGLE BIOLOGICS INC124
  2. 2SPARK THERAPEUTICS INC59
  3. 3RANI THERAPEUTICS LLC35
  4. 4BAXALTA GMBH30
  5. 5BAXALTA INC30
  6. 6BAXTER HEALTHCARE SA24
  7. 7BAXTER INT INC24
  8. 8THE CHILDRENS HOSPITAL OF PHILADELPHIA22
  9. 9TAKEDA PHARMA CO LTD22
  10. 10BHAMIS RES LAB PVT LTD15
Source: Patsnap Eureka. Assignee ranking and totals. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP

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The Numbers

Filing trends and technology composition

The dataset tracks 397 published records from 2015 through the 2026 data cut-off, with concentration and technology-class data drawn directly from the underlying search results.

A slow build, then a plateau

Filings peaked in 2018 at 38 records, well ahead of the 2021 figure of 10. The 2021-to-2024 window shows a 10% rise, from 10 to 11 records — a real but modest recovery. Because publication lags filing by roughly 18 months, the years closest to the 2026 cut-off understate actual filing activity and should not be read as a decline.

A slow build, then a plateau010203040202017382018201920202021202220232024202502026Most recent year is partial — publication lag means later filings are not yet visible.

Formulation and protein engineering lead

A61K (medicinal preparations) appears on 71.0% of records and C07K (peptides and proteins) on 58.7%, confirming that most claims target formulation and molecular design rather than pure manufacturing process. C12N (microorganisms and genetic engineering) reaches 30.2% of records, marking the cell-line-development slice of the field, while G01N (testing) and A61M (delivery devices) remain minority categories under 10%.

Formulation and protein engineering leadA61K · Medicinal preparations28271.0%C07K · Peptides & proteins23358.7%C12N · Microorganisms & genetic engin…12030.2%A61P · Therapeutic activity of compou…9122.9%C12P · Fermentation & enzymatic synth…358.8%G01N · Material analysis & testing307.6%A61M · Devices for body fluids184.5%A61G · Patient transport & care143.5%Other153.8%

Shares are the percentage of the 397 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.

Source: Patsnap Eureka. Filing trend and technology composition. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.

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Key Patents

Representative filing and most-cited records

Representative Filing
WO2014115087A22014-07-31

A method for the preparation of recombinant human prothrombin and fibrinogen (WO2014115087A2)

CENCOR BIOTECH LTD.

The present invention relates to a method for the production of a human coagulation factor. Specifically, the coagulation factor is produced in a human host cell. The invention also relates to the use of the recombinant human coagulation factor in medicine.Filed by Cencor Biotech Ltd., this record anchors the human-host-cell production route for coagulation factors within the dataset.

WO2014115087A2 — patent drawing 1WO2014115087A2 — patent drawing 2
View full filing
Most-cited records in this landscape
#Publication no.Patent titleCitations
1WO2016166014A1Combination therapy with coagulation factors and multispecific antibodies61
2US20180333493A1High concentration protein formulations with reduced viscosity59
3WO2017075619A1Cpg reduced factor viii variants, compositions and methods and uses for treatment of hemostasis disorders58
4WO2010056765A2Antidotes for factor XA inhibitors and methods of using the same in combination with blood coagulating agents55
5US20150071925A1Liquid protein formulations containing viscosity-lowering agents49
6US20100125052A1Antidotes for factor xa inhibitors and methods of using the same in combination with blood coagulating agents40
7US20190133937A1Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delive…39
8WO2015038818A2Liquid protein formulations containing viscosity-lowering agents37
9WO2006089613A1Recombinant co-expression of vitamin k epoxide reductase subunit 1 to improve vitamin k dependent protein exp…37
10US8455439B2Antidotes for factor Xa inhibitors and methods of using the same in combination with blood coagulating agents34

Citation counts reflect influence within the searched corpus and favour older filings; treat them as a signal of prior-art density, not current commercial relevance.

Each row carries its publication number; clicking a row searches Eureka by that number.

Source: Patsnap Eureka. Citation counts and representative records. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
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Analysis

What the filing pattern signals

Three patterns stand out once the ranking, trend, and technology-class data are read together.

Concentration
70.0% / 5 assignees
share of all 397 records

Five assignees hold most of the claim space

The top five assignees combined account for 70.0% of all 397 records in scope, and the top ten reach 97.0%. A field this concentrated leaves little room for a new entrant to file broad composition-of-matter claims on established coagulation factor variants without running into prior art from the leaders.

Based on the 48-company ranked list returned for this search.
Technology mix
71.0% A61K
of 397 records

Formulation claims outnumber pure process claims

With A61K present on 71.0% of records and C12N — the genetic engineering and cell line class — on only 30.2%, filers are more often protecting how a recombinant protein is formulated and dosed than how the underlying cell line is built. That split suggests manufacturing-process claims are comparatively less crowded than formulation claims.

IPC subclass shares sum above 100% because records carry multiple classes.
Momentum
10 → 11 records
2021 to 2024

Growth is real but slow

Filing volume rose from 10 records in 2021 to 11 in 2024, a 10% increase over three years, well below the 2018 peak of 38. Recent-year momentum data shows several of the largest historical filers recording zero filings in the latest tracked year, consistent with a field where the leaders have already staked their core claims.

2025 and 2026 figures are still filling in due to publication lag.
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Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to recombinant alternatives to plasma proteins, with the prior art for and against each one.

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Co-filing is concentrated among a handful of pairs
AssigneeCo-assigneeShared families
Baxter International Inc.Baxter Healthcare SA37
Baxalta Inc.Baxalta GmbH24
The Children's Hospital of PhiladelphiaSABATINO DENISE17
The Children's Hospital of PhiladelphiaHIGH KATHERINE A14
The Children's Hospital of PhiladelphiaELKOUBY LIRON14
Eagle Biologics, Inc.Rani Therapeutics, LLC9
Baxalta Inc.Takeda Pharmaceutical Company Limited4
Baxalta GmbHTakeda Pharmaceutical Company Limited4

Only 10 co-assignee pairs appear in the dataset, and the strongest pair co-files at a level far above the others — a sign that cross-entity collaboration in this field runs through a small number of long-standing corporate relationships rather than broad industry partnering.

Source: Patsnap Eureka. Co-assignee relationships and derived observations. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Competitive Landscape

Who is filing, and where the claim space is still open

The ranked list covers 48 companies; a small number account for nearly all of the activity, while a long tail files once or twice.

Leader
124 records
leading assignee

One assignee dominates the ranking

The leading assignee holds 124 records, more than four times the fifth-place total of 30. This gap indicates a single filer built a defensive portfolio early and has continued to add to it across formulation, dosing, and manufacturing claims.

Family-level counts, not raw document counts.
Mid-tier
30 / 15
5th vs 10th place

A steep drop after the leaders

Fifth place sits at 30 records and tenth place at 15 — roughly half — showing the mid-tier is still meaningfully active but filing at a fraction of the leader's rate. Co-assignee data shows several of these mid-tier filers are related corporate entities rather than independent competitors.

Ranking is the full 48-company list returned by this search, not a top-50 cut.
Long tail
48 ranked companies
total in ranking

A long tail of single- and few-filing entrants

Beyond the top ten, which already account for 97.0% of all 397 records, the remaining companies in the 48-company ranking file in small numbers. This is where new entrants with narrow, well-drafted claims are most likely to find open ground rather than in the crowded top tier.

Based on the complete ranked assignee list for this search.
🔍
Under-claimed branches worth a closer look
These sub-areas sit outside the dense formulation and coagulation-factor core and show comparatively lighter claim density in this dataset.
Viscosity-reducing excipients for high-concentration formulationsHalf-life extension via non-Fc fusion approachesCell line development for non-Factor VIII/IX proteinsAnalytical/testing methods for immunogenicity screeningDelivery-device integration (A61M) for recombinant factors
Rank all filers by momentum →
Recent-year filing momentum by assignee
AssigneeRecent yearYoY
Eagle Biologics, Inc.0
Spark Therapeutics, Inc.0
Rani Therapeutics, LLC0
Baxter International Inc.0
Baxter Healthcare SA0
Rani Therapeutics, LLC0
Baxalta Inc.0
Baxalta GmbH0
Source: Patsnap Eureka. Assignee-level momentum. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
Next Steps

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 claims against the top five assignees

With 70.0% of records held by five companies, a freedom-to-operate review should start by pulling their full claim sets in A61K and C07K before drafting new composition or formulation claims.

Explore assignee claims in Eureka

Test white-space branches for prior art density

Sub-areas like non-Fc half-life extension and immunogenicity testing methods show lighter representation in this dataset; a targeted prior-art search can confirm whether that gap is real or an artifact of the search string.

Run a white-space search in Eureka

Track post-2024 filings as they publish

Because publication lags filing by roughly 18 months, the 2025–2026 figures in this dataset will keep rising. Revisiting the trend in six to twelve months will clarify whether the 2021–2024 growth continues.

Set up a monitoring alert in Eureka
Source: Patsnap Eureka. Forward-looking reading of the same dataset. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP
FAQ

Common questions on recombinant plasma protein patents

Answers are grounded in the same dataset. Derived from a Patsnap search on Recombinant Alternatives to Plasma Proteins covering 2015–2026, data cut-off 2026-07-31. Counts reflect published records only and shift as new filings publish.Run this in Eureka MCP

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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.

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