Celiac disease is an autoimmune disorder that mainly affects the small intestine. It is mainly observed in individual who are hereditarily inclined towards gluten. Celiac disease symptoms include gastrointestinal malfunction such as diarrhea, abdominal distention, loss of appetite, and among kids failure to grow normally and also sometimes loss of lymphocytes. Coeliac disease is triggered by a bodily reaction to gluten, generally found in wheat and in other grains such as barley and rye. As the mechanism of action is still shrouded in an air of uncertainty, many pharmaceutical companies are conducting clinical trials to develop specific products to treat celiac disease. The success of the celiac drug innovation would be a big milestone for any pharmaceutical company in celiac disease drugs market.
100% gluten-free diet is the only existing treatment for celiac disease
According to National Foundation for Celiac Awareness (NFCA), celiac disease affects both men and women of all age groups and races. It is estimated that around 83% of all local Americans who have celiac disease are untreated or misdiagnosed with other bowel disorders. People with untreated celiac disease incur additional average medical costs of US$ 3,964 as compared to healthy individuals. Of all the people diagnosed with celiac disease, 5-22% have an immediate family member who was diagnosed with celiac disease. There are no specific drugs to treat celiac diseases. The total number of individuals diagnosed in the U.K. with celiac disease has increased fourfold between 1990 and 2011, from 5.2 per 100,000 to 19.1 per 100,000. This inadvertently creates a highly conducive environment for growth of the celiac disease drugs market, once such a drug is commercialized in the market.
Celiac Disease Drugs Market Scenario: Bowel biopsy the only available method to confirm celiac disease
The celiac disease drugs are still undergoing clinical trials. It is challenging to identify celiac disease in the primary stages, as the symptoms are deceptively similar to those of other bowel disorders. Various subtle and selective blood tests such as anti-tissue transglutaminase antibodies are used to screen the disease. If the test results are positive, then the individual is asked to undergo a small bowel biopsy to confirm the disease, as there is no specific or defined treatment. Extensive R&D activities currently underway are expected to pave way for more effective and advanced diagnostic options and innovative drugs, in turn positioning the global celiac disease drugs market on high growth trajectory.
Celiac Disease Drugs Market Outlook: A sea of opportunity beckons
Regional segmentation by Coherent Market Insights comprises North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. According to the University of Chicago Medicine, Celiac Disease Center, approximately 1% of healthy average Americans are affected by celiac disease. In 2007, 3 million individuals were affected with Celiac Disease and 97% people are undiagnosed and untreated. Around 3 million people were suffering from diabetes type1, out of which 6% (180,000) also had celiac disease; around 610,000 unexplained infertility cases were reported, out of which 6% also suffered from celiac disease. The prevalence of celiac disease in the U.S. in healthy people is 1 in 133 and is estimated at 1 in 56 in people with related symptoms. People with first degree and second degree relatives suffering from celiac disease are 1 in 22 and 1 in 39, respectively. This creates highly lucrative growth opportunities for players in the global celiac disease drugs market, post clinical trials approval. Asia Pacific is likely to show high growth rates in the years post drug approval in the global celiac disease drugs industry, with China and India being the highest revenue contributors. However, stringent regulatory frameworks for drug approval is a major restraint for growth of the global market of celiac disease drugs.
Major players in the Global Market
Key players operating the market include Alvine Pharmaceuticals, Inc., Alba Therapeutics Corporation, ImmusanT, and the Institute for Protein Design. All the above mentioned companies have their celiac disease drugs in clinical trial phase I and II.
Key Developments in the Global Market
Key players in the market are focused on approval and launch of novel drugs intended for the treatment of celiac disease. For instance, in August 2019, ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation, announced that the U.S. Food and Drug Administration (FDA) granted an Investigational New Drug (IND) application for AG017, an orally-delivered drug for the treatment of celiac disease.
Moreover, in August 2019, Innovate Biopharmaceuticals, Inc., a clinical stage biotechnology company based in the U.S., announced first patient enrollment in its Phase III clinical trial, CeD LA 3001 for Larazotide acetate, a drug candidate for the treatment of celiac disease.
Major institutes and universities are focused on R&D activities related to celiac disease. For instance, in August 2019, researchers from the Massachusetts General Hospital and The Walter and Eliza Hall Institute, Australia, found that gluten-specific CD4+ T cells are rapidly reactivated by antigen -exposure likely causing celiac disease-associated gastrointestinal symptoms. The development is expected to offer diagnostic blood test for celiac disease.
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