Grifols, S.A. (Grifols) is a global specialty plasma therapeutics company.
The company is developing, manufacturing, and distributing a broad range of biological medicines based on plasma derived proteins. Plasma derivatives are proteins found in human plasma, which once isolated and purified, have therapeutic value. These protein-based therapies extend and enhance the lives of individuals who suffer from chronic and acute, often life-threatening, conditions, including primary and secondary imm...
Grifols, S.A. (Grifols) is a global specialty plasma therapeutics company.
The company is developing, manufacturing, and distributing a broad range of biological medicines based on plasma derived proteins. Plasma derivatives are proteins found in human plasma, which once isolated and purified, have therapeutic value. These protein-based therapies extend and enhance the lives of individuals who suffer from chronic and acute, often life-threatening, conditions, including primary and secondary immunological deficiencies, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), A1PI deficiency and related emphysema, immune-mediated ITP, Guillain Barre syndrome, Kawasaki disease, allogeneic bone marrow transplants, hemophilia A and B, von Willebrand disease, traumatic or hemorrhagic shock and severe burns. In addition, the company has built a diagnostic business that focuses on researching, developing, manufacturing, and marketing in vitro diagnostics products for use in clinical and blood bank laboratories. The company also specializes in providing infusion solutions, nutrition products, and medical devices for use in hospitals and clinics.
The company's products and services are used by healthcare providers in over 100 countries to diagnose and treat patients with hemophilia, immune deficiencies, infectious diseases, and a range of other medical conditions. The company has a direct presence, through the operation of commercial subsidiaries, in over 30 countries.
The company is a producer in the industry in terms of total sales globally. It has a top three market position in various segments of the plasma derivatives industry, including A1PI, IG and albumin, as well as in terms of plasma collection centers and fractionation capacity.
The company is a vertically integrated global producer of plasma derivatives. The company's activities include sourcing raw materials, manufacturing various plasma derivative products, and selling and distributing final products to healthcare providers. The company has expanded its plasma collection network and manufacturing capacity through a combination of organic growth and acquisitions. As of December 31, 2024, the company had had more than 400 operating plasma collection centers located across the United States, Germany, Austria, Hungary, Canada and Egypt (through its joint venture with Egypt’s National Services Projects Organization, or ‘NSPO’).
The company also researches, develops, manufactures, and markets in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in clinical and blood bank laboratories and hospital products.
On February 3, 2025, the company completed the acquisition of 28 plasma collection centers in the United States from ImmunoTek GH, LLC (ImmunoTek). This acquisition was initiated on July 29, 2021, when the company entered into an agreement with ImmunoTek, which was amended in 2023 and 2024, to arrange for the construction, licensing, and commissioning of the 28 centers. Pursuant to this agreement, the company formed a joint operation company named Biotek America LLC (ITK JV), through which it initially held a 75% interest in each of the 28 plasma collection centers, while ImmunoTek held the remaining 25%.
In 2024, the company acquired 14 plasma collection centers and effective as of February 3, 2025, it completed the acquisition of the remaining 14 centers.
On June 18, 2024, the company closed the sale of a 20% equity stake in Chinese company Shanghai RAAS Blood Products Co Ltd.
The company organizes its business into five business units: Plasma Procurement, Biopharma, Diagnostic, Bio Supplies, and Others.
Plasma Procurement: The Plasma Procurement business unit includes all activities relating to plasma collection, including the evaluation and screening of plasma donors and the operation of its plasma collection centers. The company reports no revenue from the Plasma Procurement business unit because all plasma collected in its facilities is sold to Grifols companies in the Biopharma business unit.
Biopharma (formerly Bioscience): The Biopharma business unit includes activities relating to the manufacture of plasma derivatives for therapeutic use, including the reception, analysis, quarantine, classification, fractionation and purification of plasma and the sale and distribution of end products. The main plasma products the company manufactures are IG, Factor VIII, Alpha 1 (A1PI) and albumin. The company also manufactures intramuscular (hyperimmune) immunoglobulins, ATIII, Factor IX and plasma thromboplastin component (PTC).
Diagnostic: The Diagnostic business unit focuses on researching, developing, manufacturing, and marketing in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in clinical and blood bank laboratories, covering the entire value chain from donation to transfusion. The company concentrates its Diagnostic business in transfusion medicine (immunology and immunohematology) and specialty diagnostics, such as hemostasis. The Diagnostic business unit’s main customers are blood donation centers, clinical analysis laboratories, and hospital immunohematology services. The Nucleic Acid Testing (NAT) Donor Screening Unit is engaged in the research, development, manufacturing, and commercialization of assays and instruments based on NAT technology for transfusion and transplantation screening. NAT technology makes it possible to detect the presence of infectious agents in blood and plasma donations, contributing to greater transfusion safety.
Bio Supplies: Net revenue from Bio Supplies primarily consists of revenue related to biological products for non-therapeutic use and plasma sales to third parties.
Other Activities and Operations: In addition to its four business units, the company has other smaller operations, activities, and business lines (Others), which revenue primarily originates from the provision of manufacturing services to third parties, third-party plasma sales, and research activities. Others also includes the company's Healthcare Solutions (formerly its Hospital Division). This business unit includes, in addition, pharmaceutical products manufactured by the group and intended for hospital pharmacies, as well as the marketing of products that complement its own products.
Geographic Markets
The company is a leading plasma derivatives producer globally. The company is the world’s largest producer of A1PI, which is used for the treatment of A1PI deficiency-related emphysema.
The company operates in over 100 countries through distributors and subsidiaries in over 30 countries. For the year ended December 31, 2024, the United States and Canada accounted for 56.7% of the company's total net revenue, the European Union accounted for 21.4% of its total net revenues (27.4% of which was generated in Spain), and the rest of the world accounted for 22.0% of its total net revenue.
Certain sales regions, particularly in emerging markets, have experienced continuous growth, driven by enhanced socioeconomic conditions, including a general increase in the testing of patients for immunodeficiencies, autoimmune diseases, and low levels of alpha-1 protein, all conditions treatable by the company's products. More informed patients are demanding better quality medical care, and there is increasing government healthcare spending on plasma derivative products. These emerging markets are expected to experience significant growth. The company's presence and experience in Latin America, in countries, such as Mexico, Colombia, Argentina, Chile, and Brazil, where it has been marketing and selling products for over 20 years, have positioned it to benefit from this additional growth in both its Biopharma and Diagnostic business units. In the Asia-Pacific region, the company has established a presence through its subsidiaries and representative offices in Malaysia, China, Thailand, Singapore, Australia, Japan, India, Hong Kong, Taiwan, and Indonesia. The company has also opened a Middle Eastern representative office in Dubai and Saudi Arabia.
Distribution Process
With each batch of plasma derivatives, the company delivers electronic information regarding the origin, characteristics, and controls of each of the units of plasma that it uses in the preparation of the batch to its customers. This feature, called the PediGri On Line system, allows healthcare users of the company's products and regulatory authorities to have immediate and easy access to this information, providing tangible proof of the full traceability of its products.
The company has its own sales and distribution networks covering substantially all of its markets, staffed with highly trained personnel. A majority of the company’s sales in 2024 were made through its own distribution network, which is experienced in the proper handling of the company’s products.
Biopharma Products and Services
Collected plasma, whether source or recovered, is fractionated into different component proteins. The company fractionates and purifies a broad range of plasma derivative products that improve patient care. The company's Biopharma business unit also sells a non-plasma derivative medicinal product, Tavlesse (fostamatinib), in Europe.
Intravenous immunoglobulin (IVIG)
Gamunex-C IVIG, a ready-to-use liquid IVIG product, is one of the leading products in the IVIG segment. The company is one of the market leaders in the production and marketing of immunoglobulin, with 24.3% market share in volume in the United States for the twelve-month period ended November 30, 2024, according to PPTA.
Subcutaneous Immunoglobulin (SCIG)
Xembify, the company's 20% SCIG, was first launched in the United States in 2019, with the indication for the treatment of primary immunodeficiencies. In 2024, the FDA approved a label expansion that allows patients who are IG treatment-naive to start SCIG therapy with Xembify without having to first go through IVIG therapy, making Xembify the first 20% SCIG product in the United States with such an indication. Xembify is also approved for use in both primary and secondary immunodeficiencies in Canada and several countries in the European Union. The company launched Xembify in ten countries in 2023 and 2024, including Spain and Australia in 2023, followed by Norway, Sweden, France, Czech Republic, Slovakia, Iceland, Finland, and the United Kingdom in 2024.
Human Rabies Immunoglobulin (HRIG)
HyperRAB is the world’s leading HRIG indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies who have not been previously vaccinated with rabies vaccine. HyperRAB, a 300 IU/ml formulation of which is available in the United States, is the only HRIG provided as a higher-potency formulation, potentially requiring fewer injections in administration of each dose.
Alpha-1-Antitrypsin Augmentation Therapy (AAT)
On December 31, 2024, the company AAT products had 58 licenses in 27 countries worldwide, 19 of which are located in North America and Europe. The company's main brand for AAT products is Prolastin, a chronic augmentation and maintenance therapy to treat emphysema related to severe hereditary A1PI deficiency. The company sells the freeze-dried powder formulation of Prolastin primarily in North and South America and Europe. In 2024, the company launched new 4- and 5-gram vial sizes for this formulation of Prolastin in several countries in Europe, including Germany, Denmark, France, Austria, Spain, Portugal, and Italy. In addition, the company's ready-to-use liquid formulation of AAT (Prolastin-C Liquid) is FDA-approved and sold in the United States, and the company is conducting a worldwide clinical trial to meet post-approval regulatory commitments and obtain regulatory approval for Prolastin-C Liquid in Europe.
Hemophilia A
Between Koate-DVI, Fanhdi and Alphanate, all products to control bleeding in hemophilia A patients, the company had an estimated 14.3% market share based on volume globally in the pdFVIII hemophilia A market in 2023 (excluding Von Willebrand disease use).
Albumin
The company has several albumin-based products, primarily under its Albutein brand. The company's albumin products meet U.S., European, and Chinese requirements, making them attractive to biotechnology companies, genetic labs, as well as hospitals and physicians. In 2021 and 2022, the company launched and began to market in the United States Albutein 25% and 5% FlexBag, a flexible container designed to add convenience, ease of use, and durability. In 2024, sales of Albutein 25% and 5% FlexBag in the United States represented 39.0% of the total Albutein brand sales. The company expects to launch Albutein FlexBag in China and selected European countries.
Chronic Immune Thrombocytopenia (ITP)
Tavlesse, the first oral therapy commercialized by Grifols Biopharma, is a novel SYK-inhibitor in-licensed from Rigel Pharmaceuticals for commercialization in Europe and additional markets in the Middle East and North Africa. Tavlesse is indicated to treat chronic immune thrombocytopenia in adult patients who are refractory to other treatments. In 2024, the company launched Tavlesse in Slovakia and the United Arab Emirates and also sell the product in Czech Republic, Norway, Denmark, The Netherlands, Germany, Spain, Italy, France, and the United Kingdom. The company is planning to expand its Tavlesse sales into Saudi Arabia.
Other Products
The company produces antithrombin products (e.g., AT, ATIII, and pdAT), such as Anbinex and Thrombate III, which are used in the prevention and treatment of thromboembolic complications in patients with antithrombin deficiency; and AlphaNine, Profilnine and Factor IX Grifols, which are used in the prevention and control of bleeding in patients with hemophilia B.
The company commercializes intramuscular (hyperimmune) immunoglobulins, which are used for the prevention and treatment of tetanus, prevention and treatment of hepatitis B, and Rh factor complications during birth. Niuliva and Igantibe are used after liver transplants to prevent hepatitis B reinfection of the graft.
The company also manufactures Vistaseal/Veraseal, a biological fibrin sealant composed of fibrinogen and human thrombin used in surgical operations to expedite the healing process. This product is commercialized in the United States and Canada, in some European countries (i.e. Germany, the United Kingdom, Switzerland, Estonia, Latvia, Lithuania, Austria, Ireland, the Netherlands, France, and Italy), as well as in South Korea, Taiwan, Singapore, Puerto Rico, Israel and Australia by Johnson & Johnson MedTech (a Johnson & Johnson company). In 2024, VistaSeal received approval to treat surgical bleeding in pediatric patients with its fibrin sealant solution in the United States, Canada and Australia.
As of December 31, 2024, the company had 1,101 Biopharma product licenses registered in 90 countries throughout Europe, the United States, Latin America, Asia, and the rest of the world. As of December 31, 2024, the company's most significant government-issued licenses for Biopharma products were:
Gamunex/Gamunex-C/Flebogamma DIF. The company has 223 licenses for the marketing and sale of one or more IVIG products;
Xembify. The company has 35 licenses for the marketing and sale of this product;
Prolastin/Prolastin-C/ Prolastin-C Liquid/Prolasplan/Prolastina/Pulmolast/Lynspand. Alpha 1-Proteinase Inhibitor (Human). The company has 64 licenses for the marketing and sale of one or more of these A1PI products;
Fanhdi/Alphanate/Koate- DVI Factor VIII. The company has 220 licenses for the marketing and sale of one or more of these Factor VIII products;
Albutein/Human Albumin Grifols/Plasbumin. The company has 283 licenses for the marketing and sale of one or more of these albumin products in their various concentrations;
VistaSeal/VeraSeal. The company has 29 licenses for the marketing and sale of this product; and
Tavlesse. The company has EMA authorization for Tavlesse in the European Union and national authorization in the United Kingdom. Tavlesse is currently sold in Czech Republic, Norway, Denmark, The Netherlands, Germany, Spain, Italy, France, the United Kingdom, the United Arab Emirates and Slovakia.
In addition to the sale of the products described above, the company has entered into a series of arrangements with many Spanish transfusion organizations to fractionate recovered plasma (plasma separated from blood obtained from a blood donation) from such organizations and manufacture plasma derivatives under its own brand name for use by hospitals. The company charges the transfusion centers for the fractionation and manufacturing service. The company also provides virus photo-inactivation of transfusion plasma to hospitals and clinics in Spain. The plasma is inactivated at the company's manufacturing facilities and then sent back to the clinic or hospital at which it was collected, where it is used for transfusions.
The Diagnostic Business Unit
The Diagnostic business unit, which accounted for 8.9% of total net revenue in 2024, focuses on researching, developing, manufacturing and marketing in vitro diagnostics products, including analytical instruments, reagents, software and associated products for use in diagnostic clinical and blood bank laboratories.
The main areas of specialization of this business unit are transfusion medicine and clinical and specialty diagnostics.
In addition, the company has increased its sales of automated immunohematology systems and reagents to hospital transfusion services and blood centers in several key global markets. The company also continues to grow its portfolio of clinical and diagnostic products in select areas, including autoimmunity, and has agreements to extend the number of antigens it manufactures for use in clinical and blood bank diagnostic tests. The company's principal diagnostic products are:
Procleix Panther systems/Procleix Panther with Automation Ready Technology (ART). Automated NAT blood screening systems, assays and software is Used to detect infectious viruses and parasites in donated blood and plasma, including: HIV (Types 1 & 2); Hepatitis A, Hepatitis B, Hepatitis C and Hepatitis E; parvovirus B19; Plasmodium, Babesia and Arbovirus like, Chikungunya, West Nile Virus, Dengue, Zika.
Wadiana/Erytra /Erytra Eflexis analyzers. Automated immunohematology analyzers that use gel agglutination technology to enable automatic processing of DG Gel system, including DG Gel cards, reagent red blood cells, antisera and associated software. Manual and semiautomated equipment are also part of the DG Gel system is Used for routine pre-transfusion compatibility testing, including blood typing, unexpected antibody screening and identification, extended phenotype and cross-match tests, among others.
BLOODchip ID/ IDCoreXT/ IDHPAXT/ IDRHDXT / IDCORECONTRO / BIDSXT. A multiplex blood group genotyping family of products based on Luminex technology, including kits for the main allelic variants of red blood cells, human platelet antigens, a positive control for ID COREXT, and an accompanying software is used to help determine blood groups in individuals who may not be able to be typed with traditional blood grouping methods due to recent transfusions, autoantibodies, or other limitations.
Antigens. Critical component of certain infectious disease tests is used in the manufacture of clinical diagnostic and blood donor screening immunoassays.
Promonitor. Highly specific immunoassays for quantification of serum drug levels and anti-drug antibodies of various biological drugs are used to measure quantity of drug and antibodies for a number of biological drugs, commonly used in the treatment of various inflammatory diseases.
AlphaID. Genetic test for patients for alpha-1 deficiency. This is a free cheek swab to screen for alpha-1, the most common genetic form of Chronic Obstructive Pulmonary Disease (COPD).
The company manufactures most of its gel cards and red blood cells and assembles its immunohematology analyzers at its Parets facility in Spain. The company also manufactures gel cards in Australia and red blood cells in Switzerland. The company manufactured at its Emeryville facility in the United States, while oligos and other critical components of the transcription-mediated amplified NAT kits for blood and plasma infectious diseases screening are manufactured at its San Diego facility in the United States. The company also expects to start manufacturing gel cards in its San Diego facilities in 2025 and red blood cells either in late 2025 or early 2026 depending on approvals from regulatory authorities.
In several countries, the company distributes BLOODchip blood group genotyping tests manufactured by its subsidiary Progenika Biopharma, S.A. (Progenika). This product line includes ID CORE XT, which determines 37 antigens of red blood cell groups, ID RHD XT, a molecular diagnostic kit that detects the most relevant RhD variations, HPA-1, and the ID HPAXT kit to determine 12 Human Platelet Antigen (HPA) systems. BIDSXT is the software tool that allows for the analysis, interpretation, and database management to transmit the results to the Laboratory Information System (LIS).
The production, marketing and sale of many of the company’s Diagnostic business unit products are subject to the prior registration of such products with the relevant authorities of the applicable jurisdictions. As of December 31, 2024, the company had 3,643 diagnostic product licenses registered in over 50 countries in Europe, the United States, Canada, Latin America, the Asia-Pacific, the Middle East and Africa.
The company’s Diagnostic business unit includes a complete line of products and systems to perform blood donor screening molecular tests aimed at detecting the pathogenic agents of transfusion-related infectious diseases, such as HIV (Types 1 & 2), Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis E, parvovirus B19, Plasmodium, Babesia and Arboviruses, such as Chikungunya, West Nile Virus, Dengue and Zika.
Recent Efforts in Transfusion Medicine
As part of its strategy of geographic expansion, the company continues to consider requests to include NAT screening for blood and plasma donations in countries as they develop their health systems. From 2020 to 2024, the company entered several new countries, such as Guatemala, Paraguay, and the Czech Republic. In recent years, the company has focused on obtaining FDA and other regulatory approvals to expand its portfolio.
Product Description
Procleix Quality Controls, intended for use as an external assayed quality control material to monitor the performance of several assays performed on the Procleix Panther system.
Procleix Plasmodium Assay, for use on the Procleix Panther System, in Brazil.
Through the company’s U.S. subsidiaries Biomat USA and Interstate Blood Bank Inc., it has entered into an agreement with Creative Testing Solutions (CTS), a nonprofit blood donor testing laboratory organization in the United States. Pursuant to this agreement, as of April 1, 2022, CTS began to operate for a period of ten years (renewable for up to another ten years) the company’s three testing laboratories located in Memphis, Tennessee and San Marcos and Austin, Texas, to perform donor screening for blood and plasma collections. Grifols Laboratory Solutions will continue to provide specialty testing, including in-process and final product testing, as well as diagnostic solutions for clinical issues related to Molecular and Serological Immunohematology. The facility in Austin, Texas, provides testing, consultation and integrated solutions to optimize patient care for specialists in Hematology, Oncology, Perinatology, Obstetrics, Pharmacy, Transplantation and Transfusion Medicine.
The company operates a product line of high-quality antigens, which are critical components of clinical diagnostic and blood screening immunoassay tests sold worldwide, produced through a joint business with Quidel Ortho. As part of this joint business, the company has a contract with Abbott Laboratories for the supply of high-quality antigens used in the manufacture of immunoassay diagnostics. The company also has a longstanding agreement with OraSure Technologies that has been in place since 2005 (valid until 2026), whereby it supplies antigens to OraSure Technologies’ line of antibody tests. The table below summarizes the company's recent efforts to obtain more licenses and increase the market for its immunohematology products:
Immunohematology Product Description and Main Applications
Blood Typing Manager, designed to aid in the interfacing and managing of data among immunohematology instruments, blood establishment computer software and laboratory information systems as part of the DG Gel System.
Grifols sCD38, designed to counteract daratumumb-mediated pan-reactivity without significantly diluting the patients’ plasma and enables subsequent screening and identification of irregular antibodies in DG Gel system and tube techniques, and crossmatch in DG Gel system. Daratumumab is a CD38-directed monoclonal antibody for treating multiple myeloma. However, during treatment the drug binds to the CD38 protein on red blood cells and can alter the results of critical blood pre-transfusion tests. This can delay lifesaving transfusions for these patients.
DG Gel 8 Direct Coombs card, used for the evaluation of the direct antiglobulin test of two different human blood samples. This product is designed to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. The card is intended to be used with the DG Gel System.
The DG Gel DC Scan Plus, intended to be used in gel technique for the evaluation of the direct antiglobulin test. This test permits the differentiation of red blood cells sensitized in vivo by IgG, IgA and IgM type immunoglobulins and/or with the complement C3b, C3d and C4b fractions in human blood samples. The DG Gel DC Scan Plus card is intended for the investigation of clinical situations where the presence of hemolysis has been established, or is suspected, to distinguish immune from nonimmune hemolytic anemia. The card can be used manually or with automated instruments of the DG Gel System.
Sero-Cyte Pool Dia 0.8%, designed for routine testing for the screening of irregular antibodies, including the antigen Dia, in donors. This reagent complements the existing reagent red blood cells and allows the company to reinforce its presence in markets, such as Brazil, where the identification of the antigen Dia is required by local regulations.
DG Reader NET, a single card processing platform operating with the same consumables and reagents as its fully automated systems. This product is designed to be used on the company’s DG Gel systems.
Below are the main recent developments in respect of products of the company’s Diagnostic business unit:
The company obtained registrations in the Chinese market for DG Reader Net, its semi-automated blood bank system to process DG gel cards and Erytra Eflexis, its flagship fully automated blood typing platform;
The company obtained CE mark for the Procleix ArboPlex Assay 4-in-1 NAT for arbovirus screening. This assay is an in vitro nucleic acid test that detects four types of arboviruses spread through mosquito vectors: chikungunya, dengue, West Nile and Zika viruses. Arboviruses are a growing threat, with changes in climate and increasing global connectivity making the geographic spread more prevalent. This is the first CE mark under the IVDR for an acid nucleic test specifically designed for screening arboviruses;
The company obtained CE mark in 2022, and is working to obtain approval in the United States, for the Procleix Plasmodium Assay, an assay to detect ribonucleic acid (RNA) from Plasmodium species (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens that cause Malaria disease. The assay is designed to be used for routine screening by blood banks on the Procleix Panther system, where the company estimates that it is currently the market leader and continue its efforts to offer innovative solutions to blood banks.
Clinical and Specialty Diagnostics
The company retains the first FDA-approved biological molecular test that uses the DNA of the patient for the diagnostic. This genetic test to detect alpha-1 antitrypsin deficiency (the A1AT Genotyping Test) can be conducted on DNA extracted from blood as well as a drop of blood collected on paper (a Dry Blood Spot) or human saliva samples collected as buccal swabs. This test was developed by Progenika. In 2022, A1AT Genotyping Test was also CE-marked. Although highly complex, the test has been designed so any molecular biology laboratory can process it with minimal human intervention.
AlphaID, the company’s cheek swab that greatly simplifies the sample collection process, allows physicians and healthcare providers to obtain a sufficient oral sample for alpha-1 screening avoiding the need to order lab results. The test has been available in the U.S. since 2019. The company’s subsidiary Progenika has developed a free service named AlphaID At Home Genetic Health Risk Service, offering, directly to homes, a diagnostic solution to potential patients of alpha-1 antitrypsin deficiency.
Through the company’s subsidiary Progenika, it manufactures a genetic diagnosis test for Familial Hypercholesterolemia (FH) using next generation sequencing technology (NGS). The Diagnostic business unit continues its efforts to broaden the Promonitor line, used to monitor biologic drugs as sales continue in Chile, select European Union countries, Australia and in the U.S. The Promonitor product line includes an ELISA (enzyme-linked immunoabsorbent assay) device line also developed by Progenika to monitor patients being treated with biological medicines for rheumatoid arthritis and other chronic inflammatory diseases. The company maintains CE marking of two additional tests in the Promonitor family that enable treatment with the biological product golimumab, and several tests to permit the use of a single dilution to measure quantity of drug and antibodies for a few biological drugs, commonly used in the treatment of various inflammatory diseases, such as rheumatoid arthritis and ulcerative colitis. Progenika also co-developed with DIESSE Diagnostica Senese the Chorus Promonitor, an adaptation of the Promonitor ELISA kits to DIESSE’s Chorus Analyzer. This adaptation to monotest and ready-to-use devices is meant to address customer and market needs for improved automation. The Chorus Promonitor facilitates an improved testing workflow, resulting in earlier feedback for the clinician.
Pursuant to an exclusive agreement with AESKU Diagnostics GmbH & Co. (AESKU), the company distributes autoimmunity diagnostic products in Chile, Portugal, Spain, and Mexico.
The Bio Supplies Business Unit
The Bio Supplies Business Unit provides human biological materials for the biotechnology industry intended for research, clinical trials and manufacturing of pharmaceutical and diagnostic products. Most materials and products come from the company’s collection centers with vertical integration manufacturing processes (in-house production).
Products in the company’s Bio Supplies business unit cover a broad spectrum of applications where the need for human-based biological material cannot be replaced by other types of products, such as:
Cell Therapy: providing human-based cell culture supplements, plasma proteins, and leukocyte apheresis (white blood cell concentrate obtained through apheresis and used in the development of new cell therapies).
Pharma Manufacturing: human-based plasma proteins to be used as excipients (i.e. inactive substances that serve as vehicles or mediums for a drug or other active substances in the manufacturing of therapeutic drugs). Human plasma and intermediates used to manufacture plasma derived medicines.
Diagnostic Manufacturing: human blood cells, proteins, plasma and serum for the manufacturing of quality controls and calibrators used in in vitro diagnostics tests.
Life Science Research: Human blood derived products and biospecimens used in life science basic research or by in vitro diagnostic companies to develop and validate their analytical assays.
The company’s Bio Supplies business unit also performs plasma sales to third parties.
Other Activities and Operations (Others)
Others represents operations and activities, including the provision of manufacturing services to third parties and third-party plasma sales, and pharmaceutical products manufactured by the Grifols Group intended for hospital pharmacies.
The Healthcare Solutions business line provides services and manufactures products used by hospitals, blood banks, plasma collection centers and other healthcare systems. These products include parenteral solutions, robotics and software, as well as third parties’ products that the company markets to supplement the products that it manufactures.
Biopharma Initiatives
The company has a number of research and development projects in its Biopharma business unit underway, 15 of which are in the clinical development phase.
Xembify – Secondary immunodeficiency in CLL. The primary objective of this clinical trial is to obtain an indication for Xembify in secondary immunodeficiency as result of chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and Non-Hodking Lymphoma (NHL). CLL is the most common leukemia in older adults in Western countries, with an average age at diagnosed of 72. The disease is characterized by an accumulation of monoclonal, mature, CD5+ B cells in the peripheral blood, bone marrow, and secondary lymphoid organs. The Phase 3 clinical trial is currently enrolling patients in the United States and in European countries to support the FDA submission in the United States.
Alpha-1 Proteinase Inhibitor – Emphysema due to congenital deficiency. SPARTA (Study of Prolastin-C Randomized Therapy with Alpha-1 augmentation; NCT01983241), the company’s phase 4 (the U.S.) / phase 3 (E.U.) clinical trial designed to determine if alpha-1- antitrypsin deficiency (AATD) (alpha-1) patients with emphysema have a slower progression of lung tissue loss when treated weekly with two separate dose regimens of intravenous (IV) Grifols Prolastin-C Alpha-1, is an underdiagnosed genetic disorder that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, which can occur when a patient has low levels of AAT, a protective protein that safeguards the lungs. The currently approved dosage is 60 mg/kg in weekly IV infusions.
The company is also conducting a Phase I/II study (NCT04722887) evaluating Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% (Alpha-1 15%), a subcutaneous (SC) AAT treatment being compared to Liquid Alpha1-Proteinase Inhibitor (Human) IV.
Fibrin Sealant: The company begins clinical trials into the safety and efficacy of the use of fibrin sealant as a supportive treatment for the improvement of hemostasis in vascular, organ and soft-tissue surgery in 2008. In 2014, the company completed a clinical trial in the European Union for the use of fibrin sealant in vascular surgery. Three additional clinical trials were performed: (i) a Phase III clinical trial in the United States for the use of fibrin sealant in solid organ surgery; (ii) a Phase III clinical trial in the United States for the use of fibrin sealant in soft-tissue surgery; and (iii) a Phase III clinical trial for the use of fibrin sealant in vascular surgery in the United States. All of the U.S. clinical trials for fibrin sealant were completed in 2015. A distribution agreement was made with a third party, requiring an additional regulatory supplement. Vistaseal was launched in the U.S. during 2019 and Veraseal was launched in the E.U. in 2020. Additionally, a Phase IV study to evaluate safety and efficacy of fibrin sealant as an adjunct to haemostasis during surgery in pediatric subjects was completed in 2022 to support the FDA and EMA regulatory licenses.
Immunoglobulin. In 2023, the company entered into a global collaboration and licensing agreement with Selagine, a pioneering developer of eye disease treatments, to explore the potential of an immunoglobulin eye drop to treat dry eye disease (DED), a pathology that affects more than 100 million people worldwide in 2023. In a pilot Phase I/II clinical trial, subjects treated with eye drops based on Grifols Flebogamma DIF twice daily for eight weeks, secured a significant reduction in the signs and symptoms of DED, and with no difference in tolerability or adverse events. Several different sources of inflammation, including proteins (cytokines or chemokines), cells (neutrophils, T-cells and dendritic cells) and pathogenic antibodies, are present on the ocular surface in DED and contribute to its signs and symptoms which may benefit from application of immunoglobulin. The company is in pre-clinical development in the use of Flebogamma DIF 5% in the treatment of DED and expects to move to a Phase II clinical trial in 2025.
Fibrinogen: The AdFIrst study is a prospective, active-controlled, multicenter Phase III study investigating the efficacy and safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency (AFD), which typically occurs during surgical procedures when there is insufficient fibrinogen to arrest bleeding. Patients who have high blood loss during planned spinal and abdominal surgery are randomized 1:1 to treatment with BT524 or FFP/Cryoprecipitate. To evaluate efficacy, further blood loss is compared between the two treatment options. The AdFirst Study met its primary endpoint in February 2024, demonstrating that the fibrinogen concentrate BT524 is as effective in treating AFD as the current standard of care for this condition. The concentrate reduces intraoperative blood loss in patients with AFD undergoing planned major spinal or abdominal surgery.
Trimodulin. Study 996: This multinational Phase III clinical trial plans to enroll approximately 590 adult hospitalized patients with severe sCAP (Community Acquired Pneumonia) requiring invasive mechanical ventilation. The ESCAPE trial will be conducted worldwide and patients are treated either with trimodulin or with a placebo as add-on therapy to standard of care.
The clinical concept of this prospective, double-blind, placebo-controlled, Phase III trial was developed based on promising results from the previous Phase II clinical trial (CIGMA) with 160 sCAP patients requiring invasive mechanical ventilation. The trial is being conducted in up to 20 countries, including the United States, and recruitment of patients is ongoing.
Other Initiatives
Through its subsidiary Araclon Biotech, S.L. (Araclon), the company is dedicated to finding solutions that promote new diagnostic and therapeutic approaches to Alzheimer’s disease, to be applied in the early stages of the disease. Araclon is working on the validation of an early diagnostic test and the development of a vaccine (ABvac40) to combat Alzheimer’s disease in the asymptomatic stage. The vaccine has passed the animal experimentation stage, and Phase 1 and Phase 2 clinical trials have been completed.
Through its subsidiary Alkahest, the company focuses on identifying proteins that change with age and also with the onset of diseases that have a biological impact. To date, Alkahest has identified over 10,000 separate proteins using advanced molecular analysis techniques at the cellular level, some of which it entered the company's discovery and development pipeline as new targets to treat diseases of aging. In 2024, Alkahest pivoted to early discovery efforts, advancing Chronos PD, a target proteomic platform that can detect diseases before they manifest phenotypically. Chronos PD is starting with Parkinson’s Disease, with plans to move to other disease areas.
The company's subsidiary, GigaGen Inc. (GigaGen), is developing a novel class of therapeutics, recombinant polyclonal antibodies, to address unmet needs in infectious disease. In 2024, GigaGen dosed its first patient in a Phase 1 clinical trial to assess the safety and tolerability of GIGA-2339, the company’s first recombinant polyclonal antibody candidate for treating hepatitis B virus (HBV) infection, following its FDA clearance as an investigational new drug (IND). GIGA-2339 includes more than 1,000 recombinant human antibodies targeting HBV to mimic the body’s natural immune response, with the potential to eliminate the virus and activate the immune system. There is presently no cure for HBV, which affects more than 296 million people globally and causes over 800,000 deaths every year. Additionally, in May 2024, GigaGen announced the first patient dosing in a Phase 1 clinical trial evaluating the safety and tolerability of its anti-CTLA-4 monoclonal antibody, GIGA-564, for the treatment of metastatic or locally advanced solid tumors in collaboration with the U.S. National Cancer Institute.
In 2024, the company initiated a strategic partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to evaluate the nonclinical efficacy of ocular surface immunoglobulin (OSIG) eye drops for the treatment of sulfur mustard-induced ocular injury.
During 2024, the company discontinued the Grifols Pyrenees Research Center, SL, which it held under a joint venture with the Government of Andorra, as well as the AlbaJuna Therapeutics S.L initiative and the Trimodulin study 1,001 due to the termination of the applicable agreements and following a strategic realignment of R&D resources toward higher-priority programs.
Marketing and Distribution
The company sells Biopharma, Diagnostic and Healthcare Solutions products to hospitals and clinics, GPOs, governments and other distributors in over 100 countries.
In the United States, the sales model is complex, with many intermediaries, requiring the company to execute multi-faceted arrangements for the distribution of its products. Sales of finished goods are distributed through various channels such as distributors, wholesalers, specialty pharmacies, home health care companies, clinics, hospitals, government entities and directly to physician offices. Payers and purchasers also control access to products, requiring separate negotiations with payers and GPOs. GPOs are entities that act as purchasing intermediaries for their members, which are primarily hospitals. GPOs negotiate the price and volume of supplies, equipment and pharmaceutical products, including plasma derivatives, used by their members.
The company markets its products to healthcare providers and other decision-makers, such as those in hospitals, through focused sales presentations. Although price and volume are negotiated through contractual agreements with intermediaries, demand for its products is generated through promotional efforts by Grifols’ sales representatives. In the case of GPOs, the actual sales are made to the authorized distributor(s) of each GPO at the contract price, and the distributor then sells the products to the members of that GPO. The company promotes its products directly to the GPO’s members. For safety and post-sale service reasons, the distributor is required to provide the company with the specifics of the ultimate delivery to the client.
The sales, marketing and distribution process is different in Europe, where the bulk of sales are generally made directly to hospitals. The company has developed long-standing relationships with major hospitals in most of its European markets. Due to the nature of the company’s customer base and the prevalence of repeat sales in the industry, it markets the company’s products through focused sales presentations rather than by advertising campaigns.
Sales to Eastern Europe, the Middle East and some Asian countries are made mostly by third parties outside of its sales network. The company’s sales in Latin America are made mainly by its sales network.
Sales Representatives
The company requires its sales representatives to be able to highlight the technical differences between its products and those of its competitors. This skill necessitates a high degree of training, as the salesperson must be able to interact and discuss product differences with doctors, pharmacists, and other medical staff. Sales representatives call on office-based healthcare providers and hospital-based healthcare providers, departmental heads, purchasing agents, senior hospital directors, lab directors, and pharmacy managers. The company compensates its sales representatives with a fixed salary and a bonus component based on sales. The company divided its sales efforts are divided along the lines of its main product categories. Its sales personnel are primarily located in Europe and the United States, but the company also has sales personnel in Latin America and Asia-Pacific.
In the company's Biopharma business unit, it utilizes mixed sales units comprises both marketing and sales personnel. In some countries, the company has product line-specific sales units for immunology and neurology, pulmonary, intensive care, and coagulation factors.
Advertising
The company participates in medical conferences, conventions and fairs and occasionally publish advertisements in medical journals and trade magazines. This promotional activity is also supported by online activities.
Distribution
The company's distribution network is experienced in the proper handling of its products and allows it to know where its products are located, enabling the company to act quickly in the event of a suspected problem or product recall.
The company's distribution network personnel are located in Europe, Latin America, the United States, and the Asia-Pacific, handling the distribution of its biological medicine, diagnostic, and other medical products, as well as goods manufactured by other premier healthcare companies that complement its own products.
During 2024, the company distributed the majority of its products through its own distribution network. In some cases, particularly in the field of Diagnostics, the company distributes products through marketing partners and third-party distributors. The company has a direct presence in more than 30 countries and carefully selects distributors in the countries where it does not have a direct presence. The company has a responsive, effective logistics organization that is able to punctually meet the needs of hospital centers and other customers throughout the world.
Patents, Trademarks and Licenses
Patents and Trademarks
As of December 31, 2024, the company owned 2,759 patents and patent applications in various countries throughout the world, of which 688 are in the final application process. In some countries, these patents grant a 20-year protection period. Approximately 1,216 of these patents are set to expire in the next ten years. In terms of recent expirations, the patent for the Grifols Sterile Filling system expired in January 2024, and the patent for the process of removing viruses in Fibrinogen solutions expired in March 2024.
As of December 31, 2024, the company also owned 3,601 trademarks and trademark applications in various countries throughout the world, of which 130 are in the final application process. In addition, the company co-owns certain patents and patent applications with third parties, including patent rights co-owned with Novartis following the Novartis Acquisition.
Patents for Plasma Derivative Products
As of December 31, 2024, the company owned 2,175 patents and patent applications related to plasma derivatives, including 986 in Europe, 311 in the United States and Canada, and 878 in the rest of the world.
Patents for Diagnostic Products and Healthcare Solutions
As of December 31, 2024, the company owned 552 patents and patent applications related to its Diagnostic products and Healthcare Solutions business line, including 319 in Europe, 93 in the United States and Canada, and 140 in the rest of the world.
Licenses from Third Parties
The company licenses certain intellectual property rights from third parties, including Singulex and Hologic. Singulex granted the company an exclusive worldwide license under certain intellectual property rights for the use and sale of specific products and services for blood donor and plasma screening. Pursuant to an intellectual property license with Hologic, the company obtained a fully paid-up license to certain of Hologic’s intellectual property for use in the NAT Donor Screening Unit.
Licenses from Government Authorities
The company has 1,101 Biopharma product licenses registered in 90 countries, which include the licenses it holds from the FDA for the sale in the United States of IG, A1PI, albumin, Factor VIII, Factor IX, ATIII, and PTC. The production, marketing, and sale of many of the company's Diagnostic business unit products are subject to the prior registration of such products with the relevant authorities of the applicable jurisdictions. The company has 3,643 diagnostic product licenses registered in a total of 81 countries in Europe, the United States, Canada, Latin America, Oceania, and Asia.
Regulatory
Drugs that are also biological products, such as the company’s plasma derivative products IG, A1PI, Factor VIII and albumin, and also certain in vitro diagnostic products associated with testing blood and blood components, must also satisfy the requirements of the PHS Act (Public Health Service Act) and its implementing regulations. In order for a biological drug product, or for these in vitro diagnostic tests, to be legally marketed in the United States, the product must have a BLA (Biologics License Applications) approved by the FDA.
After regulatory approval of a product is obtained, the company is required to comply with a number of post-approval requirements. For example, as a condition of approval of a Biologics License Applications (BLA), the FDA may require post-marketing testing and surveillance to monitor the product’s safety or efficacy.
The Federal Drug Quality and Security Act of 2013 regulates pharmaceutical supply chain requirements and pre-empts certain state laws. Title II of this act, known as the Drug Supply Chain Security Act (DSCSA) establishes a national electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, including certain of the company’s products.
Since the company supplies products and services that are reimbursed by the U.S. federal healthcare programs, such as Medicare and Medicaid, its activities are also subject to regulation by CMS (U.S. Centers for Medicare & Medicaid Services) and enforcement by the OIG (the U.S. Office of the Inspector General).
The company is also subject to certain United States and foreign laws and regulations concerning the conduct of its foreign operations, including the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, German anti-corruption laws, and other anti-bribery laws and laws pertaining to the accuracy of the company’s internal books and records, which have been the focus of increasing enforcement activity globally in recent years.
Research and Development
The company’s research and development spending was €382.0 million in 2024.
History
Grifols, S.A. was founded in 1909. The company was incorporated with limited liability under Spanish law in 1987.
