Whipple’s disease is a rare bacterial infection caused by bacteria called Tropheryma whipplei (T. whipplei) that primarily affects the small intestine. Bacterial infection can cause thickening of tissues in the small intestine and internal sores. Bacterial infection could affect many different organs of the body such as gastrointestinal system, central nervous system, joints, heart, lungs, and eyes, and interfere with the body's ability to metabolize fats. Whipple’s disease can be fatal, if left untreated.
Global incidence of the Whipple’s disease is 1 in 1 million people. Most of the reported cases are from North America and Europe. The disease is most common in Caucasian men, with a mean age of 50 years. The disease rarely affects women. The symptoms of the disease appears to be most common in farmers, as the bacteria are found in soil and sewage waste water. Very few cases of the disease have been reported to date due to genetic factors from the same family and inter-human transmission cases.
High rate of growth of the Whipple’s disease market can be attributed to the entry of novel, highly priced therapies and high unmet needs. More highly-priced therapies are expected during the forecast period. Kalydeco for cystic fibrosis and exon-skipping therapies for duchenne muscular dystrophy are the new therapies introduced in the market. Competitive activity is increasing as larger companies realize the rewards of investing in orphan therapeutics. High unmet needs and low competition in several regions is expected to attract more companies to the market in the near future. The clinical studies for the molecules receiving the funding from the U.S. government for the rare disease lead to increase in development of molecules. The global Whipple’s disease market can be segmented based on type of diagnosis, type of treatment, and end-user.
In terms of type of treatment, the global Whipple’s disease market can be divided into medications, supplements, and others. The medications segment can be classified into ceftriaxone (Rocephin), meropenem (Merrem I.V.), penicillin G (Pfizerpen), streptomycin (Streptomycin), doxycycline (Vibramycin), trimethoprim with sulfamethoxazole (Septra, Bactrim), and hydroxychloroquine (Plaquenil), and others. The supplements segment can be categorized into vitamin supplements, iron supplements, mineral supplements, and others.
In terms of type of diagnosis, the global Whipple’s disease market can be segmented into non-specific diagnosis, specific diagnosis, and indirect diagnosis. Non-specific diagnosis includes physical exam, blood tests, endoscopy, histologic study by specific staining, and electron microscopy. Specific diagnosis includes immune-histochemical diagnosis, molecular diagnosis, and culture. Indirect diagnosis includes indirect immunofluorescence and enzyme-linked immunosorbent assay.
Geographically, the Whipple’s disease market is segmented in five major regions, which are North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for major share of the Whipple’s disease market. According to Research Office Legislative Council Secretariat report there are over 30 million people suffering from rare diseases in the U.S. The strong focus on research and development, the government aids to promote R&D, such as research grants, tax credits and fee waivers contribute to the growth of the market. As a result, over 4,171 drugs have been designated orphan drug status in the U.S. as of June 2017. In addition, favorable reimbursement offered by the government and private payers for the treatment of rare diseases contributes to the market growth in the region.
Europe was the trailing second region in terms of revenues in orphan drugs market. According to Research Office Legislative Council Secretariat report 2015, over 30 million peoples were suffering from rare diseases in the European Union. The incentives offered to promote the manufacturing of orphan drugs in the region, such as 10-year period of marketing exclusivity, research grants and reduced fees for marketing authorization applications aid in the growth of the market. Over 1,805 drugs have been granted orphan drug status in the European Union and over 128 drugs were granted marketing authority during 2000 to 2016.
Geographically, the global Whipple’s disease market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Players operating in the global market are F. Hoffmann-La Roche Ltd., Pfizer, Inc., Bristol-Myers Squibb Company, and Sun Pharmaceutical Industries Limited.
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