Immunoglobulins are critical part of the immune response, which specifically recognize and bind to particular antigens such as bacteria or viruses aiding in their inhibition. Immunoglobulins also called as antibodies are the glycoprotein molecules produced by plasma cells i.e. white blood cells. The antibody immune response is highly complex and very specific. The various immunoglobulin classes and subclasses (isotypes) differ in their biological features, structure, target specificity and distribution. Hence, the assessment of the immunoglobulin isotype can provide useful insight into complex humoral immune response.
There are different classes of immunoglobulin such as IgG, IgA, and IgM, which are used for the treatment of various immunological and neurological diseases. These immunoglobulins can be administered intravenously and subcutaneously.
Immunoglobulin are used in treatment of autoimmune diseases such as multiple sclerosis, Primary Humoral Immunodeficiency (PIDD), Immune Thrombocytopenia Purpura (ITP), and autoimmune haemolytic anemia. Furthermore, immunoglobulin have applications in various other field such as hematology, neurology, immunology, dermatology, ophthalmology, nephrology and rheumatology, which is driving growth of the immunoglobulin market.
Immunoglobulin Market Dynamics
Furthermore, increasing application of immunoglobulin is gaining significant traction among pharmaceutical and Biopharmaceuticals Company for the research and development of immunoglobulin. Moreover, increasing number of intravenous product approvals and clinical trials for new clinical applications is anticipated to provide potential growth opportunities to the industry. For instance, in May 2018, ADMA Biologics, Inc. announced that the company had received U.S. patent for treating respiratory infection. The patent consist of usage of polyclonal immunoglobulin preparation for treatment of respiratory infection, where the issued patent extends to January 2035.
Furthermore, Kedrioin Biopharma and Kamada Ltd. together in May 2018, launched two human-derived protein therapeutics companies announced that KEDRAB [Rabies Immune Globulin (Human)] has been launched in the U.S. as it has received U.S. Food and Drug Administration approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal and concurrent with the rabies vaccine. Such advancement and launches in field of immunoglobulin are expected to foster growth of the immunoglobulin market in near future.
Increasing incidences of Primary Immunodeficiency Disease (PID) worldwide is also a major factor driving growth of the immunoglobulin market. As per Center for Disease Control and Prevention (CDC), in 2012, the incidence rate of hypogammaglobulinemia across the globe was around 2 per 100,000 populations annually and is expected to increase in near future. Furthermore, increasing number of geriatric population, which is more prone to develop disease due to low antibody immune response of body is propelling the demand for immunoglobulin. However, high cost of treatment, long-term side-effects, stringent regulatory framework, and emergence of alternative therapies such recombinant products are expected to restrain growth of the immunoglobulin market.
Immunoglobulin Market - Regional Insights
Geographically, global Immunoglobulin market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America accounted for the largest share in the immunoglobulin market, followed by Europe in 2016. This is attributed to increasing number of the U.S. Food and Drug Administration approval for immunoglobulin. For instance, in 2016, Shire plc. announced the launch of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] the first and only Subcutaneous 20% treatment option without proline available in the U.S. to treat adult and pediatric patients (two years of age and older) with primary immunodeficiency (PI).
Furthermore, several pharmaceutical and biotechnological companies from Asia Pacific are focusing on expanding in their products overall the globe. For instance, the South Korea’s Green Cross in November 2017, stated that the company expects to launch its immunodeficiency drugs in U.S. market in 2018, as company is been working with US FDA to prepare additional production-related data on its drug IVIG-SN, human normal immunoglobulin G for intravenous administration
Immunoglobulin Market - Competitive Analysis
The major players operating in the market include Baxter international Inc., CSL Ltd., Grifols S.A, Octapharma AG, Kedrion Biopharma Inc., LFB group, Biotest AG, China Biologics Products, Inc., BDI Pharma Inc., and Bayer Healthcare. Other players in the immunoglobulin market include Hualan Biological Engineering Inc., Omrix Biopharmaceuticals Ltd., Behring GmbH, Shanghai RAAS Blood Products Co., Ltd., Option Care Enterprises, Inc., ADMA Biologics, Inc., and BioScrip, Inc.
Immunoglobulin manufactures are involved in research and development to develop new immunoglobulin drug. For instance, GigaGen received US$ 3 million grant from the National Institutes of Health in January 2018, to develop novel antibody therapies to advance its next-generation plasma therapy for patients with immune deficiencies
Evolve Biologics, a division of Therapure Biopharma Inc. in May 2018, announced the start of phase III clinical trial of PlasmaCap IG (Intravenous Immunoglobulin or “IVIG”). The PlasmaCap IG is an investigational IVIG replacement therapy being studied in both adult and pediatric patients with Primary Immune Deficiency Diseases (PIDD). More such ongoing clinical trials are supporting growth of the immunoglobulin market.
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