Celiac Disease Drugs MarketOutlook: A sea of opportunity beckons
However, stringent regulatoryframeworks for drug approval is a major restraint for growth of the global CeliacDisease Drugs Market. Regional segmentation by Coherent Market Insightscomprises North America, Europe, Asia Pacific, Latin America, Middle East, andAfrica. 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% peopleare undiagnosed and untreated. Around 3 million people were suffering fromdiabetes type1, out of which 6% (180,000) also had celiac disease; around610,000 unexplained infertility cases were reported, out of which 6% alsosuffered from celiac disease. The prevalence of celiac disease in the U.S. inhealthy people is 1 in 133 and is estimated at 1 in 56 in people with relatedsymptoms. People with first degree and second degree relatives suffering fromceliac disease are 1 in 22 and 1 in 39, respectively. This creates highlylucrative growth opportunities for players in the global celiac disease drugsmarket, post clinical trials approval. Asia Pacific is likely to show highgrowth rates in the years post drug approval in the global celiac disease drugsindustry, with China and India being the highest revenue contributors.
Celiac disease is an autoimmunedisorder that mainly affects the small intestine. It is mainly observed inindividual who are hereditarily inclined towards gluten. Celiac diseasesymptoms include gastrointestinal malfunction such as diarrhea, abdominaldistention, loss of appetite, and among kids failure to grow normally and alsosometimes loss of lymphocytes.
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Coeliac disease is triggered by abodily reaction to gluten, generally found in wheat and in other grains such asbarley and rye. As the mechanism of action is still shrouded in an air ofuncertainty, many pharmaceutical companies are conducting clinical trials todevelop specific products to treat celiac disease. The success of the celiacdrug innovation would be a big milestone for any pharmaceutical company inceliac disease drugs market.
100% gluten-free diet is the onlyexisting treatment for celiac disease
According to National Foundationfor Celiac Awareness (NFCA), celiac disease affects both men and women of allage groups and races. It is estimated that around 83% of all local Americanswho have celiac disease are untreated or misdiagnosed with other boweldisorders. People with untreated celiac disease incur additional averagemedical costs of US$ 3,964 as compared to healthy individuals. Of all thepeople diagnosed with celiac disease, 5-22% have an immediate family member whowas diagnosed with celiac disease. There are no specific drugs to treat celiacdiseases. The total number of individuals diagnosed in the U.K. with celiacdisease has increased fourfold between 1990 and 2011, from 5.2 per 100,000 to19.1 per 100,000. This inadvertently creates a highly conducive environment forgrowth of the celiac disease drugs market, once such a drug is commercializedin the market.
Celiac Disease Drugs MarketScenario: Bowel biopsy the only available method to confirm celiac disease
The celiac disease drugs arestill undergoing clinical trials. It is challenging to identify celiac diseasein the primary stages, as the symptoms are deceptively similar to those ofother bowel disorders. Various subtle and selective blood tests such asanti-tissue transglutaminase antibodies are used to screen the disease. If thetest results are positive, then the individual is asked to undergo a smallbowel biopsy to confirm the disease, as there is no specific or definedtreatment. Extensive R&D activities currently underway are expected to paveway for more effective and advanced diagnostic options and innovative drugs, inturn positioning the global celiac disease drugs market on high growthtrajectory.
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Major players in the GlobalMarket
Key players operating the marketinclude Alvine Pharmaceuticals, Inc., Alba Therapeutics Corporation, ImmusanT,and the Institute for Protein Design. All the above mentioned companies havetheir celiac disease drugs in clinical trial phase I and II.
Key Developments in the GlobalMarket
Key players in the market arefocused on approval and launch of novel drugs intended for the treatment ofceliac disease. For instance, in August 2019, ActoBio Therapeutics, Inc., awholly owned subsidiary of Intrexon Corporation, announced that the U.S. Foodand Drug Administration (FDA) granted an Investigational New Drug (IND) applicationfor AG017, an orally-delivered drug for the treatment of celiac disease.
Moreover, in August 2019,Innovate Biopharmaceuticals, Inc., a clinical stage biotechnology company basedin the U.S., announced first patient enrollment in its Phase III clinicaltrial, CeD LA 3001 for Larazotide acetate, a drug candidate for the treatmentof celiac disease.
Major institutes and universitiesare focused on R&D activities related to celiac disease. For instance, inAugust 2019, researchers from the Massachusetts General Hospital and The Walterand Eliza Hall Institute, Australia, found that gluten-specific CD4+ T cellsare rapidly reactivated by antigen -exposure likely causing celiacdisease-associated gastrointestinal symptoms. The development is expected to offerdiagnostic blood test for celiac disease.
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