IBS Treatment Test: Linaclotide Drug segment to flourish as demand and success rates of the drugs support growth

Published On: March 2018

Market Overview:

The Americas IBS treatment market for drug type is expected to grow at a CAGR of 9.3% during the forecast period 2017-2023. Factors such as a huge demand for treatment, increasing research & development funding in the region and considerable success rates are helping the market grow at a healthy pace.

In the Americas IBS Treatment market, Linaclotide (brand name LINZESS) held a major market share of 31.3% in 2016. In the U.S. more than 585,000 total LINZESS prescriptions were filled in the fourth quarter of 2015. Roughly 30% increase was reported to be associated to the fourth quarter of 2014, as per IMS Health.

Furthermore Linaclotide was formerly approved by the FDA for the treatment of adults with CIC as a 145 mcg capsule to be taken once per day. In addition, it is approved for the treatment of adults with irritable bowel syndrome (IBS) with constipation (IBS-C) as a 290 mcg capsule to be consumed once per day. Since FDA approval in December of 2012, more than 1 million patients have filled a prescription for linaclotide, according to IMS Health.

Furthermore, another drug, Eluxadoline, could become the first treatment for both male and female diarrhea-pre-dominant IBS-D patients in the U.S. Without proposing restrictions, this drug will be the first product indicated for IBS-D. It will consequently be free from any direct competition in the market.

Technologically advanced products in the pipeline

The Food and Drug Administration (FDA), and other government authorities are establishing a new standard for IBS Treatment test accuracy. The FDA standard is majorly driven by technological advances, improved meter accuracy, reports of hospital and outpatient deaths, research studies, and consumer complaints about product. Due to increasing incidence rate of diabetes, competition among blood glucose monitor manufacturers is also rising. Existing and new marketers are continuously coming up with innovative products to meet the proposed FDA guidelines. In recent years, various new glucose monitoring devices have been approved by FDA and the European regulatory bodies such as DexCom G4 Platinum, Medtronic Diabetes Guardian Real-Time, Abbott Freestyle Libre, GMate Smart Blood Glucose Monitoring System by Philosys, Artificial pancreas system, and many others. Thus, development of new devices may emerge as the new revenue pockets for the growth of this market.

Where is the market heading?

IBS (Irritable Bowel Syndrome) is a global issue, with 5%-15% of the total population experiencing symptoms that would satisfy the definition of IBS. In a systematic review on the global prevalence of this disorder, in 2015 Lovell and Ford documented a collective prevalence of 11% with all regions of the world anguishing from this disorder at parallel rates. Given its prevalence, the regularity of symptoms and their associated debility for many patients and the fact that IBS typically occurs in adults aged younger than 50— an important period for furthering education, embarking on careers, and/or raising families, the socioeconomic impact of IBS is considerable. These unforeseen costs are usually compounded by the direct costs associated to additional medical tests and the use of several medical and nonmedical medications that may have limited impact.

Moreover, irritable bowel syndrome affects 10%-15% of the U.S. population to some degree. This condition is characterized by stomach pain and distress with altered bowel habits in the absence of any other mechanical, inflammatory or biochemical clarification for these symptoms. Irritable bowel syndrome is expected to affect women more than men and is most common in patients ranging from 30 to 50 years of age. Indications are improved equally by diets, complemented with fiber or hydrolyzed guar gum, but more patients prefer hydrolyzed guar gum.

Yet another treatment– antispasmodic agents, may be used as desirable, but anticholinergic and other side effects limit their use in some patients. Furthermore, Loperamide is a choice for the treatment of discreetly severe diarrhea. Antidepressants have also been shown to dismiss pain and may be effective in low doses. Trials using a drug named Alosetron showed a clinically substantial, although modest gain over placebo, but it is specified only for women with severe diarrhea-predominant symptoms or in those where conventional treatment has failed. Tegaserod drug has an advantage over placebo in constipation-predominant irritable bowel syndrome.

Who has the ability to hinder the market growth?

Strict FDA regulations and unsatisfactory effectiveness of the treatment are some of the major restrains hindering the growth of the Americas IBS treatment Market

IBS Drugs to overpower therapies for treatment!!

IBS is the discomfort of belly or pain in the bowel, it is a chronic functional bowel disease having symptoms such as abdominal pain, bloating, and diarrhea or constipation. Change in lifestyle, increase in infection or inflammation in the intestines, abnormalities in the digestive system are the few causes which leads to irritable bowel syndrome. Functional gastrointestinal (GI) and motility disorders are the most common GI disorders. According to a report published by the International Foundation for Functional Gastrointestinal Disorders, in 2016, the prevalence rate of these disorders was more than one in every four individuals in the United States.

Many types of IBS drugs are available in the market. However, many of them have side effects in particular situation, such as Viberzi which is an approved drug for IBS-D is banned by FDA for patients without gallbladders after getting the review report, which suggested that it may cause death in such cases and thus, this increases the number of opportunities for the manufacturers to develop new drugs. Companies are continuously involved in research and development to develop effective treatment. For instance, in 2016, Synthetic Biologics, Inc. announced the completion of the end of phase II meeting with FDA for SYN-010 which is expected to be used for the IBS treatment. Thus, development of new drugs can pose tons of opportunities for the growth of the market.

Many developments have taken place for IBS-C in past, such as Amitiza in 2008, linaclotide (Linzess) in 2012. A study is going on plecanatide for the treatment of IBS-C, currently, it is not prescribed to the individuals having IBS-C despite the commitment of many researchers, although the FDA has approved this drug for the treatment of IBS.

In case of IBS-D, there are different medications used for the treatment of pain associated with this disorder, such as Viberzi, although an advisory has been issued by the FDA to discontinue the use of Viberzi for patients without a gallbladder. Still, it is one of the most effective treatments used for patients with IBS-D. The market players involve themselves more in research and development to introduce therapies for pain relief. As the currently available treatment targets the pain’s sensory mechanisms in the brain as opposed to the pain arising within the gastrointestinal tract.

In recent year’s strategic movement by major players such as: involving more in acquisitions and collaborations for developing product portfolios and strengthening science and technology across the American region. Apart from that, major players and parent companies are involved in business expansion by making subsidiaries, which are used as market penetration strategies and to reduce competition.

The market for IBS is growing on a steady pace, due to, increasing innovations, leading brands are also conscious about the scientific advancements of the drugs and more effective medicines are available easily in the Americas region.