Market Overview
- The Global Chronic Immune Thrombocytopenia Market is expected to grow at a CAGR of 0.54% during the forecasting period (2019-2026).
- Chronic Immune Thrombocytopenia (chronic ITP) is an autoimmune disorder in which patients produce antiplatelet autoantibodies and specialized white blood cells that destroy their blood platelets and, in some cases, damage their megakaryocytes, causing a decrease in platelet production.
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Market Dynamics
- Growing demand for therapeutics for the treatment of rare blood related disorders, and increasing number of products approved by the Food and Drug Administration are some of the major factors driving the growth of the chronic immune thrombocytopenia (ITP) market globally. According to National Organization of Rare Disorders (NORD), the incidence of ITP among adults in the USA is estimated to be 3.3 per 100,000 adults/year. The prevalence is 9.5 cases per 100,000. The incidence of ITP increases with age and is more common over the age of 60. Among adults (age 30-60) diagnosed with chronic ITP, there are 2.6 cases among women for every case involving a male.
- Several pharmaceutical companies conducting research in rare diseases arena have received approvals from the FDA recently which is boosting the growth of the chronic immune thrombocytopenia market. For instance, in June 2019, the FDA approved Avatrombopag (Doptelet, Dova Pharmaceuticals) for the treatment of adults with chronic immune thrombocytopenia. In April 2018, the FDA approved Tavaliss, an oral spleen tyrosine kinase (SYK) inhibitor which acts by impeding platelet destruction. In December 2018, FDA approved Nplate (Romiplostim) for the treatment of pediatric patients with chronic immune thrombocytopenia (ITP). In August 2018, Lusutrombopag received FDA approval to treat thrombocytopenia adults with chronic liver disease.
- In addition, increasing drugs in pipeline offers growth opportunities in the chronic immune thrombocytopenia (ITP) market. Argenx’s Efgartigimod is currently (August 2019) tested in Phase 2 clinical trials in immune thrombocytopenia (ITP). Rigel Pharmaceuticals, Inc. manufactures drugs for treatment of rare diseases, immune, hematologic disorders, and cancer. Phase 1 study of R835 and Phase 3 study with fostamatinib in autoimmune hemolytic anemia are major pipelines of the company.
- However, despite the increasing use of Thrombopoietin Receptor Agonist (TPO-RA), many patients remain refractory to available treatments. Current research is focused on combining therapies to address multiple mechanisms of disease simultaneously which may result into which may result into improved response rates and less toxicity.
Market Segmentation
- On the basis of drug class, the global chronic immune thrombocytopenia market is segmented into Immunoglobulin, Thrombopoetin (TPO) Receptor Agonist, Steroids, Platlet Stimulating Agents, and others. Among these, Steroids holds significant market share in 2018 and estimated to grow at a CAGR of 5.74% during the forecast period. There are two main types of steroids: corticosteroids and anabolic-androgenic steroids (or anabolics for short). Corticosteroid drugs, like prednisone, are the standard initial treatment for patients with immune thrombocytopenia ITP. They prevent the destruction of platelets by macrophages within the spleen and liver thereby increasing platelet levels. Corticosteroids are usually prescribed as a short-term treatment (3–4 weeks) because long-term use leads to significant side effects that outweigh the benefits of reducing the risk of serious bleeding.
- Chronic ITP is cured either when the platelet count falls below 30,000, or when there is bleeding. A steroid (such as prednisone) is the first treatment; if steroids do not keep the platelet count above 50,000, then it is treated with intravenous gamma globulin. If these treatments are not effective and the platelet count remains dangerously low or there is bleeding, other options such as removal of the spleen (splenectomy), treatment with rituximab (Rituxan), Romiplostim (Nplate) or Eltrombopag (Promacta, Revolade) are preferred. If these initial treatments aren't effective, tranfusions, fostamatinib (Tavalisse), danazol (Danocrine) or immune-suppressing medications (such as azathioprine (Imuran), cyclophosphamide (Cytoxan, Neosar), or vincristine (Oncovin and others)) may be recommended. Combinations of these treatments may be effective when individual treatments are not.
Geographical Analysis
- North America holds the dominant market share for Chronic Immune Thrombocytopenia in 2018, and it is expected to maintain the growth over the forecast period, owing to the rising prevalence of immune thrombocytopenia, availability of treatment options and existence of effective reimbursement policies. According to the National Organization for Rare Disorders (NORD), the prevalence of immune thrombocytopenia among adults in the US is estimated to be 3.3 per 100,000 adults/year. In the United States, an estimated 30,000 new cases of ITP are diagnosed each year. Approximately 70% of adults with ITP are women, and 70 percent of these women are under the age of 40 when diagnosed.
- The Europe Chronic ITP market is also growing at a significant CAGR during the forecast period, due to increasing cases of chronic ITP coupled with rising research activities for the treatment of chronic ITP. The European Medicines Agency (EMEA) has recognized chronic immune thrombocytopenia (ITP) as an orphan disease, with nearly 50,000 adult patients with chronic ITP in the European Union.
Competitive Landscape
- The Chronic ITP market is concentrated by few major players holding significant share in the market. Some of the major players in the chronic immune thrombocytopenia market are: Novartis AG, Dova Pharmaceuticals, F.Hoffmann-La Roche Ltd., CSL Limited, Amgen Inc., Kyowa Hakko Kirin Co., Ltd., Shionogi Inc., Rigel Pharmaceuticals, Inc., Jiangsu Hengrui Pharmaceutical Co., Ltd., and Shire and Ligand Pharmaceuticals, Inc.
- The players are engaged in development of more effective chronic ITP drugs to remain competitive in the global market. The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the Chronic Immune Thrombocytopenia market globally. For instance,
- In June 2019, the FDA approved Avatrombopag (Doptelet, Dova Pharmaceuticals) for the treatment of adults with chronic immune thrombocytopenia.
- In December 2018, FDA approved Nplate (Romiplostim) for the treatment of pediatric patients with chronic immune thrombocytopenia (ITP).
- In August 2018, Lusutrombopag received FDA approval to treat thrombocytopenia adults with chronic liver disease.
- In April 2018, the FDA approved Tavaliss, an oral spleen tyrosine kinase (SYK) inhibitor which acts by impeding platelet destruction.
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