Kedrion Biopharma

What Kedrion Biopharma does

Kedrion Biopharma is a privately held Italian-headquartered biopharmaceutical company founded in 2001 that manufactures plasma-derived therapeutics, including immunoglobulins (IVIG), albumin, hyperimmune products, and coagulation factors. The company is the world's fifth-largest player in plasma-derived products, operating seven FDA/EMA-grade production facilities across Italy, the United States, Canada, Hungary, and the United Kingdom, alongside 68 KEDPLASMA collection centers in the US and 8 UNICAplasma centers in Czech Republic. Kedrion distributes 38 therapeutic products across more than 100 countries, with a strategic focus on rare and ultra-rare diseases including Primary Immunodeficiency, hemophilia and bleeding disorders, Plasminogen Deficiency Type 1, GBS/CIDP, and Rh sensitization.

The company's vertically integrated model combines proprietary plasma fractionation technology with a dedicated Biological Safety Centre (BioSC) for viral and prion clearance studies, and includes an FDA-approved Bolognana facility producing RYPLAZIM — the first and only approved treatment for PLGD-1. Revenue streams span sales of branded plasma-derived therapies (including QIVIGY and YIMMUGO for primary immunodeficiency, and COAGADEX for Factor X Deficiency), contract manufacturing and technology transfer services for other companies and governments, and a structural partnership with the Italian National Health Service for national plasma self-sufficiency. Distribution is hybrid: direct sales to hospitals and infusion centers in major markets, channel partnerships with specialty pharmacies (AvevoRx, AOM Infusion), and major US wholesalers (CuraScript SD, Cencora, Cardinal Health, McKesson, BioCare) plus Premier GPO access.

Ownership sits with Kedrion Holding S.p.A., backed by Permira Funds and the Marcucci family following the 2022 merger with UK-based BPL (Bio Products Laboratory), which created the current combined entity under CEO Ugo Di Francesco (appointed January 2023) and Chairman Paolo Marcucci. Recent strategic moves include a €150 million Bolognana X3 Expansion Program to triple capacity to 3.3 million liters per year, multiple FDA and EMA Orphan Drug Designations across 2025-2026, and a deepening US commercial presence through specialty pharmacy and GPO relationships.

Name

Kedrion Biopharma

Legal name

Kedrion S.p.A. with sole Shareholder

Website

https://kedrion.com

Company type

Private

Founded year

2001

Operating status

Operating

Headcount range

5,001–10,000 employees

Short description

Kedrion Biopharma is a privately held Italian biopharmaceutical company and the world's fifth-largest plasma-derived therapeutics manufacturer, producing immunoglobulins, albumin, and coagulation factors for rare and ultra-rare diseases across 100+ countries from vertically integrated facilities and plasma collection centers.

Ownership category

akta.pro rank

Product category

Plasma-derived Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Plasma Fractionation & Purification Manufacturing (HLAIAHAI)

akta.pro secondary industries

Plasma Collection & Donor Services (Plasmapheresis Centers) (HLAIAHAH), Plasma-Derived Therapy Fill-Finish & Packaging (HLAIAHAJ), Plasma-Derived Coagulation Factors (Hemophilia Therapies) (HLAIAHAB), Hyperimmune (Specific) Immunoglobulins (e.g., Anti-D, Tetanus, Rabies, Hep B) (HLAIAHAE)

Keywords

• Plasma-derived therapeutics
• Plasma fractionation
• Immunoglobulin therapies
• Rare disease treatments
• Specialty biopharmaceuticals

Headquarters

HQ city

Fort Lee

HQ country

United States

HQ region

North America

Offices9 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Plasma-derived therapeutics sales: Sale of plasma-derived therapies including immunoglobulins, albumin, and coagulation factors for treatment of rare and ultra-rare diseases
2. Specialty pharmaceutical distribution: Distribution of 38 therapeutic products across over 100 countries through direct sales and distribution partnerships
3. Contract manufacturing and technology transfer: Services including plasma fractionation for other companies and countries, technology transfer for establishing domestic plasma processing capacity, and toll manufacturing
4. Italian National Health System partnership: Partnership with Italian National Health Service for plasma collection and processing to achieve self-sufficiency in plasma-derived products

Go-to-market motion2 records

Distribution channels7 records

Marketing channels6 records

Core offering

Kedrion Biopharma manufactures and globally distributes plasma-derived therapeutic products — including immunoglobulins, coagulation factors, albumin, and hyperimmune immunoglobulins — for the treatment of rare and ultra-rare diseases such as hemophilia, Primary Immunodeficiency, Plasminogen Deficiency Type 1, GBS/CIDP, and Rh sensitization. It operates a vertically integrated value chain combining owned plasma collection (76 centers in the U.S. and Czech Republic), plasma fractionation at seven production facilities across Italy, the U.S., Canada, Hungary, and the U.K., and distribution into more than 100 countries, supplemented by contract manufacturing and technology transfer services for national health systems.

Differentiator

Problem solved

Functional benefit

Products and services

• RYPLAZIM (plasminogen, intravenous) Plasma-derived treatment for Plasminogen Deficiency Type 1 (PLGD-1), the first and only FDA-approved therapy for this ultra-rare condition; produced at Kedrion's Bolognana facility.
• QIVIGY (Immune Globulin Intravenous, 10%) 10% intravenous immunoglobulin therapy for treatment of Primary Humoral Immunodeficiency in adults; Kedrion's first fully proprietary IVIG product, launched in the U.S. through a nationwide network of major distributors, GPOs, and specialty pharmacies.
• YIMMUGO (Immune Globulin Intravenous, 10%) 10% liquid intravenous immunoglobulin therapy for primary immunodeficiency developed by Biotest AG and distributed in the U.S. by Kedrion under a long-term exclusive distribution agreement.
• COAGADEX (coagulation Factor X) Plasma-derived coagulation Factor X therapy for treatment of Factor X deficiency; in 2025 received FDA Orphan Drug Designation and entered clinical trials for acquired Factor X Deficiency (aFXD).
• Anti-D Immunoglobulin Plasma-derived Anti-D Immunoglobulin produced at Kedrion's Melville, New York facility; used for prevention of Rh sensitization, with more than 200 people employed in production.
• Hyperimmune Immunoglobulins and Virus-Inactivated Products Specialty plasma-derived products including hyperimmune immunoglobulins and virus-inactivated therapies produced at the Sant'Antimo (Naples) facility; 29 therapeutic specialties distributed in approximately 60 countries from this site.
• Contract Manufacturing and Technology Transfer Services Plasma fractionation services for third parties and national health systems, technology transfer programs for establishing domestic plasma processing capacity, and toll manufacturing — including the partnership with the Italian National Health Service to return derivative products from collected plasma.
• Plasma-derived Therapeutic Portfolio (38 products) Broader portfolio of 38 plasma-derived therapeutic specialties distributed across more than 100 countries, including albumins, coagulation factors, standard immunoglobulins, and hyperimmune immunoglobulins for rare and ultra-rare diseases.

Quantifiable outcome

• 10% revenue growth in 2024
• +1 more outcomes

Named customers8 records

Segments7 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

18 partnerships are on record, tiered minor and core.

• InstaLILYminorStrategic or Co-development Partner · 2 June 2026Co-hosting the Rare Connections: Healthcare AI Innovation Summit on June 3, 2026 in New York as part of NY Tech Week, bringing together senior executives and industry innovators from pharma, investment, and research sectors.
• AvevoRxcoreChannel Partner/ Reseller/ Distributor · 30 March 2026Selected as network specialty pharmacy for nationwide launch of Kedrion's QIVIGY IVIG therapy. AvevoRx positioned among select group of specialty pharmacies participating in the QIVIGY launch.
• AOM InfusioncoreChannel Partner/ Reseller/ Distributor · 13 March 2026Selected as limited distribution specialty pharmacy for QIVIGY and YIMMUGO, expanding AOM's portfolio of immune therapy products. Recognized for clinical excellence and included in Kedrion's limited distribution network.
• National Bleeding Disorders Foundation (NBDF)coreGTM or Marketing Partner · 26 February 2026Multi-year awareness campaign 'Educate to Elevate' featuring celebrity advocates to improve diagnosis and healthcare access for individuals with bleeding disorders. Campaign addresses underdiagnosis, particularly in women and girls.
• Biotest AGcoreChannel Partner/ Reseller/ Distributor · 11 October 2024Long-term exclusive distribution agreement for YIMMUGO in the U.S. following FDA approval. Developed by Biotest AG and licensed to Kedrion for U.S. distribution. YIMMUGO is a 10% liquid immune globulin intravenous product.
• BPL (Bio Products Laboratory)coreStrategic or Co-development Partner · 1 September 2022Permira Funds and the Marcucci family completed the acquisition and merger of Kedrion and BPL in 2022, creating a leading global plasma derivatives company. Ugo Di Francesco appointed as CEO effective January 2023 to lead the combined business.
• SanofiminorGTM or Marketing PartnerCorporate partner in 'Bleeding.org LIVE!' and 'Educate to Elevate' bleeding disorders awareness campaigns.
• GenentechminorGTM or Marketing PartnerCorporate partner in bleeding disorders awareness campaigns including 'Bleeding.org LIVE!' and 'Educate to Elevate'.
• PfizerminorGTM or Marketing PartnerCorporate partner in 'Bleeding.org LIVE!' celebrity-driven national event for the bleeding disorders community.
• PPTA (Plasma Protein Therapeutics Association)coreStrategic or Co-development PartnerKedrion collaborates with PPTA for ongoing dialogue with European institutions. PPTA represents the plasma protein therapeutics industry and advocates for regulatory frameworks supporting the sector. Kedrion's Ferdinando Borgese serves as Chairman of PPTA EU Board of Directors.
• Medvisis Switzerland AGcoreChannel Partner/ Reseller/ DistributorCommercial and distribution partner in Switzerland since January 1, 2026. Handles marketing, sales and distribution of plasma derivatives in Switzerland.
• NextPharma LogisticsminorChannel Partner/ Reseller/ DistributorHandles product orders in Switzerland on behalf of Medvisis from location in Schaffhausen.
• Plasminogen Deficiency FoundationcoreGTM or Marketing PartnerPatient advocacy organization collaborating on Plasminogen Deficiency Awareness Day events and promotion of earlier diagnosis of PLGD-1.
• National Organization for Rare Disorders (NORD)coreGTM or Marketing PartnerOperates 46 Rare Disease Centers of Excellence across the United States. Collaborating on rare disease awareness and education initiatives.
• GBS | CIDP Foundation InternationalcoreGTM or Marketing PartnerPatient advocacy organization for Guillain-Barré Syndrome and CIDP. Kedrion supports dialogue, education, and awareness around these rare immune-mediated conditions.
• Italian National Health ServicecoreStrategic or Co-development PartnerKedrion partners with Italian National Health Service at all levels of operation in establishing self-sufficiency in plasma-derived therapies. Provides plasma fractionation services and returns derivative products.
• Italian Donor AssociationscoreStrategic or Co-development PartnerPartnership with AVIS, FIDAS, FRATRES, and Croce Rossa Italiana for plasma collection through Italian Blood Transfusion Centers. Donations are voluntary, anonymous, and unremunerated.
• European ParliamentminorOthersOngoing dialogue with European institutions on regulatory landscape including Biotech Act, pharmaceutical sector legislation, and plasma-derived medicines industry regulations.

Scale indicators12 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• Emergent BioSolutions: U.S.-based biopharmaceutical company with a plasma-derived and specialty products business, including VIGIV and related specialty therapeutics, competing in adjacent niches to Kedrion's rare-disease portfolio.
• ADMA Biologics: U.S.-based vertically integrated plasma fractionator focused on immunoglobulins (Bivigam, Asceniv) and hyperimmune products, smaller than the top four but an emerging U.S. competitor in the same IVIG category as QIVIGY.

Direct peers

• CSL Behring: Plasma-derived therapeutics arm of CSL Limited and the world's largest plasma fractionator. Direct competitor in immunoglobulins (Privigen), albumin, and coagulation factors; Kedrion is benchmarked against CSL Behring on capacity, GPO contracts, and IVIG share.
• Grifols: Spanish multinational and one of the top global plasma fractionators with a fully integrated donor-center-to-fractionation network, competing head-to-head with Kedrion in IVIG, alpha-1 antitrypsin, and coagulation factor franchises.
• Octapharma: Private Swiss plasma fractionator producing immunoglobulins (Octagam, Octanate), coagulation factors, and albumin. Comparable in product mix and self-supply strategy; one of the four players that Kedrion cites as outranking it globally.
• Takeda Pharmaceutical Company (Plasma-Derived Therapies / Baxalta legacy): Operates the inherited from Baxalta plasma-derived therapies franchise (e.g., Hyqvia, Gammagard), competing with Kedrion in IVIG and rare bleeding disorder therapies globally.
• Biotest AG: German plasma fractionator and Kedrion's YIMMUGO in-licensor; develops and manufactures IVIG (Intratect), coagulation factors, and hyperimmune products, directly overlapping with Kedrion's product portfolio.

Regional players

• Sanquin Plasma Products: Dutch blood-bank-affiliated plasma fractionator producing immunoglobulins, coagulation factors, and albumin for European and select export markets; comparable to Kedrion's national self-sufficiency model, though primarily Dutch-focused.
• GC Biopharma (Green Cross): Korean biopharmaceutical company with a plasma-derived therapeutics franchise (immunoglobulins, albumin, vaccines). Comparable to Kedrion in vertical integration and product breadth but with primary geographic focus on Asia.

Broad incumbents

• Pfizer (Rare Disease / Hemophilia franchise): Global big-pharma with a significant hemophilia and rare bleeding disorder franchise (e.g., BeneFIX, ReFacto), overlapping with Kedrion's coagulation factor portfolio as a broad incumbent with deeper commercial reach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

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

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries8 records

Funding overview

Funding rounds2 records

Investors2 records

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

M&A1 record

Investments

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

Frequently asked questions about Kedrion Biopharma