The term “immunoglobulin” refers to the breakdown of blood plasma that contains antibody. IVIg is a blood product which is administered intravenously. It contains polyvalent IgG antibodies which are extracted from the plasma of more than thousand of blood donors. Individuals who are unable to produce adequate amount of antibodies, such as patients with common variable immunodeficiency, Wiskott Aldrich Syndrome, X-linked agammaglobulinemia and other forms of hypogammaglobulinemia, get benefit from IVIg to maintain the appropriate level of antibodies in the body.
The global market of IVIg is categorized based on plasma protein and by therapeutic area. The plasma protein segment is further sub-segmented in polyvalent IVIg, albumin, Factor VIII, hyperimmunes (IM&IV) and Factor IX. Polyvalent IVIg sub-segment holds the largest market share in global IVIg market. Moreover, the therapeutic area segment includes immune deficiencies, autoimmune diseases and acute infections. The immune deficiency sub-segment comprises major diseases, such as, hypogammaglobulinemia (primary immune deficiencies), X-linked agammaglobulinemia and acquired compromised immunity conditions (secondary immune deficiencies), featuring low antibody levels. The autoimmune disease sub-segment includes immune thrombocytopenia (ITP) and Inflammatory diseases.
In terms of geography, North America is the largest market for IVIg followed by Europe and Asia. In North America, the U.S. represents the largest market for IVIg. In Europe, Germany, France and the U.K. covers the major share of IVIg market. Asia represents the fastest growing market for IVIg, due to increasing aging population. Elderly people are more susceptible to antibody deficiency diseases.
Globally, IVIG market is witnessing a strong growth due to increasing number of patients with bleeding disorders, rising geriatric population and increasing number of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) patients. Moreover, increasing investment in healthcare sector is also supporting in growth of IVIg market. In addition, increasing number of patients suffering with autoimmune diseases and other pathological conditions are also supporting growth of IVIg products in the market.
However, stringent regulations hamper the growth of the IVIg market. Several government associations have imposed strict guidelines for appropriate usage of IVIg products. For instance, Canadian Blood Services and National Advisory Committee on Blood and Blood Products of Canada provide practice guidelines on the usage of IVIg products in hematological diseases.
In addition, high treatment cost also impedes growth of IVIg market. Some patients cannot afford IVIg products, due to high cost of their treatment. IVIg products are very expensive as the materials required to produce them cost more and the manufacturing process requires a significant amount of blood samples from donors. The collection of large amount of blood samples is a very complex and tedious process. Furthermore, high risks of side-effects associated with IVIg treatment also restrain growth of the IVIg market. Some of the major side-effects of IVIg treatment are headache, migraine, dizziness, fever, nausea, vomiting, fast heart rate, itching, high blood pressure, cough and abdominal pains. These side-effects inhibit the acceptance of IVIg products by many patients.
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Some of the key players operating in IVIg market are Baxter International Inc., Beijing Tiantan Biological Products Co., Ltd., Biotest AG, China Biologic Products, Inc., CSL Limited, Guizhou Taibang Biological Products Co., Ltd., Shanghai RAAS Blood Products Co., Ltd., Octapharma AG, Grifols, S.A, Hualan Biological Engineering Inc., OMRIX Biopharmaceuticals Ltd. and Kedrion S.p.A.