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Granulomatosis With Polyangiitis, also previously referred to as Wegener's granulomatosis is a rarer form of the autoimmune disease known as vasculitis. In this disorder, the smaller sized blood vessels of lungs, kidneys, nose, sinuses, and ears become inflamed, which leads to the damage to these organs and parts of the body. According to the National Institutes of Health (NIH), granulomatosis with polyangiitis affects an estimated 3 per 100,000 individuals’ in the U.S.
In October 2018, the Food and Drug Administration (FDA) approved the update of the label, to include the follow up treatment of adult patients with Genentech’s product offering of Rituxan (Rituximab) for the treatment of two rarer forms of vasculitis: Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), after their administration showed disease control. Rituxan, in combination with corticosteroids, is the only FDA approved therapy for this rare, life-threatening disease affecting the blood vessels.
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Due to the regulatory approval of the combination therapy of Rituxan (Rituximab) and the corticosteroids and the greater awareness of the disease in the developed and the developing markets positively driving the market growth considerably. The further advances of the R&D and the life-threatening nature of the disease is also contributing positively to the market growth.
The factor that is expected to inhibit the growth of the market is the associated side effects of the treatment options such as the medication toxicity and the adverse effects of corticosteroids. Regulatory and clinical hurdles might also impact the growth of the market due to delays in product approvals, which might limit the launches of new products.
Some of the major companies that are present in the global Granulomatosis with Polyangiitis Treatment market Genentech, Inc., GlaxoSmithKline plc., Sonoma Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Antares Pharma, Medac Pharma, Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Pfizer Inc.
By Drug Class
By Route of Administration
By Distribution Channel
· Hospital Pharmacies
· Retail Pharmacies
· North America (USA and Canada)
· Europe (UK, Germany, France, Italy, Spain, Scandinavia and Rest of Europe)
· Asia Pacific (Japan, China, India, Australia, Southeast Asia and Rest of Asia Pacific)
· Latin America (Brazil, Mexico and Rest of Latin America)
· Middle East & Africa (South Africa, GCC and Rest of Middle East & Africa)
At present, steroids account for the largest proportion of the market and this is not expected to change in the forecast period based on the regulatory scenario. This is because of the only regulatory approved treatment option is of corticosteroids combined with the Rituxan.
The global Granulomatosis with Polyangiitis Treatment market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America followed by Europe are the two largest markets for Granulomatosis with Polyangiitis Treatment at present and they are expected to account for a large proportion of the market in the forecast period as well. The first U.S. FDA approval for the treatment of Granulomatosis with Polyangiitis was Rituxan in combination with corticosteroids, which was approved by the FDA in the U.S. in 2011 and the further label update was approved in 2018. In the Asia Pacific region, Japan is expected to provide the largest market opportunity. This is because Japan and China has the comparatively highest prevalence of the disease and also the diagnostic capacities.
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