Industry Facts

• Plasma protein therapies, which include plasma-derived therapies and their recombinant analogs, are used to treat  serious, chronic, often genetic diseases and disorders such as primary immunodeficiency diseases, hemophilia and other bleeding disorders and alpha-1 antitrypsin deficiency, also known as hereditary emphysema.  All of these are orphan diseases. In the U.S., orphan diseases are those considered to have a prevalence of fewer than 200,000 affected individuals. All together, fewer than 80,000 individuals in the U.S. are diagnosed with these conditions.
• Rho(D) immunoglobulin (IG), made from human plasma,  is given to pregnant women who are Rh-negative and carrying an Rh-positive baby to prevent the body from treating the baby as a foreign invader and from being attacked by the body’s own immune system. This condition is known as hemolytic disease of the newborn. 
• Plasma protein therapies also are used to treat individuals who are in shock; have sustained severe burns; are fighting certain cancers including leukemia; and those who have had a bone marrow transplant. Plasma protein therapies are used during cardiopulmonary bypass surgery and to treat pediatric HIV as well.
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a form of nerve disease that is treated with a plasma protein therapy.
• Plasma is used to produce vaccines for individuals who have been exposed to rabies, tetanus and anthrax.

• There are 335 U.S. Food and Drug Administration licensed and International Quality Plasma Program (IQPP)-certified source plasma donation centers in the United States.
• There are 27 IQPP-certified source plasma donation centers located in Europe (Germany and Austria) that are licensed by the appropriate national authority.
• One government licensed and IQPP-certified source plasma collection center is located in Canada.
• There are a total of 363 licensed and industry certified source plasma donation centers in the U.S., Europe and Canada.
• In 2007, there were 15 million source plasma donations made in the United States at federally licensed and industry certified source plasma collection centers.
• In 2007, there were 1.1 million source plasma donations made in industry certified plasma donation centers that are licensed by the appropriate national authority in Europe.
• Source plasma donated by committed, healthy donors in the United States is used to produce life-saving therapies used in the U.S. and the European Union.
• Source plasma donated by committed, healthy donors in the European Union is used in life-saving therapies used only in Europe. 
• In the U.S. in 2007, approximately 14.6 million liters of plasma were available for use in producing life-saving therapies. This figure includes source plasma collection in licensed and industry certified centers via plasmapheresis, as well as plasma recovered from whole blood donations.
• 20 million liters of plasma are used worldwide every year to manufacture plasma protein therapies for patients with blood clotting disorders, immune deficiencies or autoimmune or neurological disorders.
• Plasmapheresis is the process in which whole blood is removed from a donor and separated into its component parts, including white and red blood cells, platelets and plasma, by a specialized piece of medical equipment. The plasma is retained, while the other blood components are returned to the donor’s body. All materials that come into contact with a donor and his or her blood are sterile and single use. 

PPTA Member Companies Producing Plasma Protein Therapies

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