Kedrion USA

What Kedrion USA does

Kedrion Biopharma Inc. (commercialized as Kedrion USA) is the U.S. operating entity of the Italian-headquartered Kedrion S.p.A. group, the world's fifth-largest player in the plasma-derived biopharmaceutical sector. The company treats rare and ultra-rare diseases through a fully integrated model spanning plasma collection, fractionation, and finished-product delivery. In the United States it operates 68 plasma collection centers through its wholly owned subsidiary KEDPLASMA (with 8 additional centers in the Czech Republic via UNICAplasma) and runs a North American production facility in Melville, NY, with a second facility in Laval, Quebec. Group-wide, Kedrion operates 7 production facilities across 5 countries and distributes 38 plasma-derived products in over 100 countries.

The U.S. product portfolio spans four therapeutic categories: Standard Immunoglobulins (GAMMAKED, GAMMAPLEX, QIVIGY, YIMMUGO), Human Albumin products (ALBUKED, ALBUMINEX, KEDBUMIN), Coagulation Factors (COAGADEX, KOATE, RYPLAZIM), and Hyperimmune Immunoglobulins (KEDRAB, RHOGAM). QIVIGY represents Kedrion's first fully proprietary IVIG, developed over more than a decade and approved by the FDA in September 2025, with full U.S. commercial launch in March 2026. RYPLAZIM holds the position of the first and only FDA-approved therapy for Plasminogen Deficiency Type 1 (PLGD-1). Pricing for branded products ranges from approximately $48 per unit of 5% albumin to $2,495.85 per unit of RYPLAZIM, with high-value coagulation factors (COAGADEX) priced at $11.89/IU, reflecting standard rare-disease unit-based pricing rather than subscription models.

Kedrion monetizes primarily through one-time product sales to specialty pharmacies, infusion centers, hospitals, and other sites of care, with secondary revenue from contract fractionation services for foreign healthcare systems and technology-transfer engagements supporting national plasma self-sufficiency (notably with the Italian National Health Service). Go-to-market in the U.S. is enterprise field sales combined with a multi-channel limited-distribution model: exclusive specialty distributor CuraScript SD anchors YIMMUGO and supports QIVIGY alongside Cencora, Cardinal Health, McKesson Plasma and Biologics, and BioCare, with exclusive GPO access via Premier, Inc. and Premier Innovatix. End customers are highly fragmented (rare disease patients and prescribing providers), but channel concentration on a small set of specialty distributors and GPOs represents the principal commercial dependency.

Name

Kedrion USA

Legal name

Kedrion Biopharma Inc.

Website

https://kedrion.us

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Kedrion USA, the U.S. subsidiary of Italy's Kedrion S.p.A. and the world's fifth-largest plasma-derived biopharmaceutical company, collects plasma through 68 U.S. centers and sells 38 immunoglobulin, albumin, coagulation factor, and hyperimmune products to hospitals, infusion centers, and specialty pharmacies treating rare and ultra-rare diseases.

Ownership category

akta.pro rank

Headquarters

HQ city

Fort Lee

HQ country

United States

HQ region

North America

Offices8 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Technology or R&D, Operations, Personnel, Infrastructure, Marketing or Sales

Revenue model

1. Plasma-derived Product Sales: Sale of plasma-derived therapeutic products including immunoglobulins, coagulation factors, albumin, and hyperimmune IG products for treating rare and ultra-rare diseases
2. Contract Manufacturing: Fractionation and manufacturing services for other companies and countries, receiving locally collected plasma and returning derivative products
3. Technology Transfer: Expertise and technology transfer services to foreign healthcare systems for establishing self-sufficient plasma collection and fractionation capacity

Pricing tiers

Go-to-market motion2 records

Distribution channels7 records

Marketing channels5 records

Core offering

Kedrion USA manufactures and distributes plasma-derived therapeutic products used to treat rare and ultra-rare diseases. The portfolio spans Standard Immunoglobulins, Human Albumin, Coagulation Factors, and Hyperimmune Immunoglobulins, manufactured through an integrated global network that includes 68 US plasma collection centers, 8 Czech centers, and 7 production facilities across 5 countries. Beyond its own products, the company provides contract plasma fractionation and technology transfer services to foreign healthcare systems.

Product overview

Kedrion Biopharma is a plasma-derived biopharmaceutical company offering a diverse portfolio of plasma-derived therapies organized across four main therapeutic areas: Standard Immunoglobulins (GAMMAKED, GAMMAPLEX, QIVIGY, YIMMUGO), Human Albumin products (ALBUKED, ALBUMINEX, KEDBUMIN), Coagulation Factors (COAGADEX, KOÄTE, RYPLAZIM), and Hyperimmune IGs (KEDRAB, RHOGAM). The portfolio treats conditions including primary immunodeficiencies, coagulation disorders, hemophilia, and Rh sensitization. QIVIGY represents Kedrion's first fully proprietary IVIG product, while YIMMUGO is licensed from Biotest AG. Kedrion operates an integrated model with 68 plasma collection centers in the U.S., 8 in the Czech Republic, and 7 production facilities across 5 countries, distributing to over 100 countries worldwide.

Differentiator

Problem solved

Functional benefit

Brands

• KEDPLASMA: Plasma collection center brand operating in the United States
• UNICAplasma

Products and services

• GAMMAKED Human normal 10% intravenous immunoglobulin solution for treating primary immunodeficiencies and other immune-related conditions; manufactured by a third party and distributed by Kedrion in the U.S.
• GAMMAPLEX 5% and 10% intravenous immunoglobulin solution for treating primary immunodeficiencies and conditions requiring immune globulin replacement.
• QIVIGY FDA-approved 10% intravenous immunoglobulin (IVIG) for treatment of adults with primary humoral immunodeficiency; Kedrion's first fully proprietary IVIG developed and manufactured exclusively through its integrated global network.
• YIMMUGO Modern, highly purified 10% polyvalent human IgG for intravenous administration, indicated for treatment of primary immunodeficiency in patients aged 2 years and older; first approved product from Biotest's Next Level facility, licensed exclusively to Kedrion for U.S. commercialization.
• ALBUKED Human albumin solution used for clinical applications including volume replacement and hypoalbuminemia treatment.
• ALBUMINEX Human albumin product available in various concentrations for clinical use.
• KEDBUMIN Human albumin 25% solution for clinical applications.
• COAGADEX Human coagulation Factor X concentrate for treatment of hereditary Factor X deficiency; FDA-approved with Orphan Drug Designation for acquired Factor X Deficiency.
• KOATE Antihemophilic Factor VIII (AHF) concentrate for treatment of hemophilia A.
• RYPLAZIM Plasma-derived human plasminogen, the first and only FDA-approved treatment for Plasminogen Deficiency Type 1 (PLGD-1); addresses abnormal fibrin-rich lesions on mucosal surfaces that can lead to vision/hearing loss and other serious complications.
• KEDRAB Human rabies immunoglobulin for post-exposure prophylaxis following potential rabies exposure.
• RHOGAM Human Anti-D (Rho) immunoglobulin for prevention of Rh sensitization in Rh-negative women during pregnancy and after delivery.
• Contract Plasma Fractionation and Manufacturing Services Fractionation and manufacturing services for other companies and countries, receiving locally collected plasma and returning derivative plasma products.
• Plasma Industry Technology Transfer Services Expertise and technology transfer services to foreign healthcare systems for establishing self-sufficient plasma collection and fractionation capacity.

Named customers6 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature4 records

Partnerships

15 partnerships are on record, tiered core and minor.

• Biotest AG (Grifols group)coreOEM/ Whitelabel/ Licensing Partner · 13 June 2024Biotest AG granted Kedrion Biopharma exclusive rights to commercialize YIMMUGO in the United States. YIMMUGO is a modern, highly purified 10% intravenous immunoglobulin approved by FDA on June 13, 2024 for treatment of primary immunodeficiency. YIMMUGO is the first approved product from Biotest's new Next Level production facility.
• CuraScript SDcoreChannel Partner/ Reseller/ DistributorCuraScript SD serves as exclusive commercial distribution partner for YIMMUGO, ensuring streamlined access for patients and providers. CuraScript SD's demonstrated expertise in the Ig market and consistent reliability made them the ideal choice to serve specialty pharmacy members and other customers.
• Cencora, Inc.coreChannel Partner/ Reseller/ DistributorLeading specialty distributor included in Kedrion's nationwide distribution network for QIVIGY and other products, providing broad access across care settings nationwide.
• Cardinal Health, Inc.coreChannel Partner/ Reseller/ DistributorSpecialty distributor included in Kedrion's nationwide distribution network supporting commercial availability of QIVIGY and other plasma-derived therapies.
• McKesson Plasma and BiologicscoreChannel Partner/ Reseller/ DistributorSpecialty distributor included in Kedrion's nationwide distribution network for plasma-derived products.
• BioCare, Inc.coreChannel Partner/ Reseller/ DistributorSpecialty distributor included in Kedrion's nationwide distribution network for QIVIGY and other therapies.
• Premier, Inc.coreChannel Partner/ Reseller/ DistributorExclusive Group Purchasing Organization relationship providing access to acute care environments across the U.S., supporting streamlined onboarding and adoption.
• Premier InnovatixcoreChannel Partner/ Reseller/ DistributorExclusive GPO relationship across non-acute care environments, complementing Premier, Inc. for comprehensive care setting coverage.
• FFF EnterprisescoreChannel Partner/ Reseller/ DistributorExisting distribution partner for Ryplazim, the first and only FDA-approved therapy for PLGD-1 patients.
• The Alliance PharmacycoreChannel Partner/ Reseller/ DistributorExisting distribution partner for Ryplazim expanded network ensuring wider availability for PLGD-1 patients.
• CVS HealthcoreChannel Partner/ Reseller/ DistributorNew specialty pharmacy added to Ryplazim distribution network, increasing access points for patients.
• Soleo HealthcoreChannel Partner/ Reseller/ DistributorNew specialty pharmacy partner in expanded Ryplazim distribution network enhancing patient access.
• NufactorcoreChannel Partner/ Reseller/ DistributorSpecialty pharmacy partner in Ryplazim distribution network ensuring consistent supply for PLGD-1 patients.
• InstaLILYminorStrategic or Co-development PartnerCo-hosting the Rare Connections: Healthcare AI Innovation Summit as part of NY Tech Week, convening industry leaders to advance practical, responsible AI innovation in highly regulated industries.
• Italian National Health ServicecoreStrategic or Co-development PartnerKedrion serves as the major plasma fractionator for Italy with a full-cycle production capacity. The company provides partnership at all levels of operation in establishing self-sufficiency in plasma-derived therapies, receiving plasma from ~318 hospital-based Blood Transfusion Centers and converting it to medicinal products.

Scale indicators10 records

Recent moves6 records

Expansion highlights6 records

Market position

Strengths4 records

Weaknesses5 records

Competitive moat6 records

Customer concentration

• LinkedInit.linkedin.com/company/kedrion-biopharma

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kedrion USA