Kedrion Biopharma
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.
- Company typePrivate
- Founded2001
- HeadquartersFort Lee, United States
- Headcount5,001–10,000
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Kedrion Biopharma firmographics
Firmographics- 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
Kedrion Biopharma industry classification
Industry- 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
Where Kedrion Biopharma is headquartered
LocationHeadquarters
- HQ city
- Fort Lee
- HQ country
- United States
- HQ region
- North America
Offices9 records
Markets served
Kedrion Biopharma business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Infrastructure, Supply Chain, Technology or R&D, Marketing or Sales
Revenue model
- Plasma-derived therapeutics sales: Sale of plasma-derived therapies including immunoglobulins, albumin, and coagulation factors for treatment of rare and ultra-rare diseases
- Specialty pharmaceutical distribution: Distribution of 38 therapeutic products across over 100 countries through direct sales and distribution partnerships
- 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
- 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
Kedrion Biopharma product offering
Product offeringCore 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
Companies that use Kedrion Biopharma
Customer profileNamed customers8 records
Segments7 records
Ideal customer profiles3 records
Kedrion Biopharma technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Kedrion Biopharma partnerships and signals
Strategic signalPartnerships
18 partnerships are on record, tiered minor and core.
- InstaLILYminorCo-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.
- AvevoRxcoreSelected 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 InfusioncoreSelected 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)coreMulti-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 AGcoreLong-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)corePermira 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.
- SanofiminorCorporate partner in 'Bleeding.org LIVE!' and 'Educate to Elevate' bleeding disorders awareness campaigns.
- GenentechminorCorporate partner in bleeding disorders awareness campaigns including 'Bleeding.org LIVE!' and 'Educate to Elevate'.
- PfizerminorCorporate partner in 'Bleeding.org LIVE!' celebrity-driven national event for the bleeding disorders community.
- PPTA (Plasma Protein Therapeutics Association)coreKedrion 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 AGcoreCommercial and distribution partner in Switzerland since January 1, 2026. Handles marketing, sales and distribution of plasma derivatives in Switzerland.
- NextPharma LogisticsminorHandles product orders in Switzerland on behalf of Medvisis from location in Schaffhausen.
- Plasminogen Deficiency FoundationcorePatient advocacy organization collaborating on Plasminogen Deficiency Awareness Day events and promotion of earlier diagnosis of PLGD-1.
- National Organization for Rare Disorders (NORD)coreOperates 46 Rare Disease Centers of Excellence across the United States. Collaborating on rare disease awareness and education initiatives.
- GBS | CIDP Foundation InternationalcorePatient advocacy organization for Guillain-Barré Syndrome and CIDP. Kedrion supports dialogue, education, and awareness around these rare immune-mediated conditions.
- Italian National Health ServicecoreKedrion 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 AssociationscorePartnership with AVIS, FIDAS, FRATRES, and Croce Rossa Italiana for plasma collection through Italian Blood Transfusion Centers. Donations are voluntary, anonymous, and unremunerated.
- European ParliamentminorOngoing 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
Kedrion Biopharma competitors and assessment
Company assessmentEmerging 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
Kedrion Biopharma social profiles
Digital presenceKedrion Biopharma financial estimates
Financial estimateRevenue estimate
Valuation estimate
Kedrion Biopharma leadership team
Management profileNumber of profiles
Profiles9 records
Kedrion Biopharma subsidiaries and ownership
Company hierarchySubsidiaries8 records
Kedrion Biopharma funding detail
Funding detailFunding overview
Funding rounds2 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Kedrion Biopharma M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Kedrion Biopharma
What does Kedrion Biopharma do?
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.
Is Kedrion Biopharma a public or private company?
Kedrion Biopharma is a private company. It is classified as private equity controlled and is currently operating.
When was Kedrion Biopharma founded?
Kedrion Biopharma was founded in 2001. It employs 5,001 to 10,000 people.
Where is Kedrion Biopharma based?
Kedrion Biopharma is headquartered in Fort Lee, United States, in the North America region.
How does Kedrion Biopharma make money?
Four revenue lines are on record. Plasma-derived therapeutics sales are the primary driver. The others are specialty pharmaceutical distribution, contract manufacturing and technology transfer and italian National Health System partnership.
Who are Kedrion Biopharma's main competitors?
Emerging players on record are Emergent BioSolutions and ADMA Biologics. Direct peers are CSL Behring, Grifols, Octapharma, Takeda Pharmaceutical Company (Plasma-Derived Therapies / Baxalta legacy) and Biotest AG. Regional players are Sanquin Plasma Products and GC Biopharma (Green Cross). Pfizer (Rare Disease / Hemophilia franchise) is listed as a broad incumbent.
Does Kedrion Biopharma have an API?
No public API is recorded for Kedrion Biopharma.
What industry is Kedrion Biopharma in?
Kedrion Biopharma's product category is Plasma-derived Biopharmaceuticals. Its primary akta.pro industry code is HLAIAHAI, Plasma Fractionation & Purification Manufacturing, with a secondary code of HLAIAHAH, Plasma Collection & Donor Services (Plasmapheresis Centers). Its NAICS code is 325414 and its SIC code is 2834.