Market Insights
The prevalence of Irritable Bowel Syndrome is growing at a phenomenal rate worldwide. Annually, millions of individuals are believed to suffer from the disorder; however, very few patients undergo an appropriate diagnosis of the same. This drawback is majorly attributed to the unknown pathophysiology and robust risk factors for the condition.
Subject to the dominant symptoms, IBS is categorized into three types:
- Diarrhea-predominant IBS (IBS-D)
- Constipation –predominant IBS (IBS-C)
- Mixed IBS (IBS-M)
This report studies the drug market indicated for IBS-D. The global IBS-D drugs market is currently at a nascent stage. However, with the introduction of two patented drugs, thus totaling three, this market has opened avenues for further research and development, hence the market entry of potential treatment options and market players. The IBS-D drugs market is studied by drug type, prescription type, and geographic distribution.
Based on drug type, the drugs studied for this market are eluxadoline, rifaximin, alosetron, loperamide, diphenoxylate & atropine, and dicyclomine & hyoscyamine drugs markets. The market size and forecast for these drugs for 2014 to 2022 are provided along with their respective CAGRs from 2016 to 2022, considering 2015 as the base year.
Regarding prescription type, the global IBS-D drugs market is categorized into prescribed and OTC drugs. Furthermore, the prescribed drugs market is further sub-segmented into prescribed branded and generic drugs markets. Similar to market segmentation by drug type, the market size and CAGRs for the above segments are provided for 2014-2022 and 2016-2022, respectively.
North America, Europe, Asia Pacific, and the Rest of the world comprise the global IBS-D drugs market. These regional markets are further studied for major country-level markets.
The national/sub-regional markets studied for each respective region are:
North America
Europe
- The U.K.
- Germany
- Rest of Europe
Asia Pacific
- Japan
- China
- Rest of Asia Pacific
Rest of the World
- The Middle East and North Africa
- Latin America
The qualitative analysis of the IBS-D drugs market is studied based on parameters such as drivers, challenges and opportunities, attractive investment proposition, and fractal map analysis for competition assessment. The report concludes with a profiling of major market players engaged in manufacturing IBS-D drugs.
In the past, IBS-D patients had fewer drug options for treating the disorder. Alosetron, the previously approved drug, has been under restrictions after reporting severe safety issues. Lotronex (alosetron) acts by slowing stool movements. The drug was withdrawn from the market in 2000 after reportedly being linked to severe gut problems, including constipation and colitis. In the year 2002, the availability of Lotronex through a restricted marketing program.
The availability of very few IBS-D drugs in the market is related to a lack of understanding of the mechanism and cause of IBS. Diet alteration and stress reduction help in containing the disorder to some extent. Doctors also prescribe antidepressants to relieve symptoms such as abdominal discomfort and pain and antispasmodics.
In 2015, eluxadoline (Viberzi) and Xifaxan (rifaximin) were the two novel drugs approved for treating IBS-D. Viberzi is an opioid antagonist and is to be taken twice a day with food. The drug was FDA approved based on two clinical trials enrolling over 2400 subjects who were given a placebo or Viberzi. Viberzi reportedly worked better in easing abdominal pain and discomfort and improving stool consistency over 26 weeks.
Xifaxan is administered thrice a day for two weeks (14 days). Then, the drug is prescribed an additional dose on recurrence of symptoms. The FDA approved Xifaxan based on three clinical trials with approximately 1900 people. Patients who took Xifaxan more likely reported improvement in stool consistency and abdominal pain than those who were given a placebo. In the third study, over 600 patients whose symptoms returned were given a 14-day dose of Xifaxan or a placebo. The patients on the active drug reported considerable relief from abdominal pain and better stool consistency.
The most serious risk with Viberzi is the chance of muscle spasms near bile and pancreatic ducts. Thus, caution is raised for patients with a history of liver and bile problems. Common side effects of Viberzi include constipation, abdominal discomfort, and nausea. Nausea is also a common side effect of Xifaxan. The rise in the liver enzyme is another reported side effect of the drug; hence, caution is to be kept with doctors while prescribing Xifaxan to patients with a history of liver diseases.
Both these drugs are to be administered paired with certain recommended lifestyle changes. A few suggested lifestyle alterations include: limiting symptom-aggravating foods, controlling overeating and avoiding carbonated drinks, and so on. Viberzi is a narcotic. Thus, its schedule status is expected to be controlled in the future. Xifaxan, by Salix, is already available in the market for treating liver issues and has been in off-label use. The price of 60 tablets costs approximately USD 1800 and is expected to be covered under insurance for IBS-D treatment.
Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) drug market is often observed to be open with only one drug: Lotronex, enjoying Rx status; yet restricted. However, the situation is expected to change with the recent label expansion for Xifaxan (rifaximin) and approval for Viberzi (eluxadoline).
Viberzi assists in reducing bowel contractions, thus containing diarrhea. On the other hand, the antibiotic Xifaxan works by altering the gut flora, thus reducing diarrhea. The global prevalence of IBS ranges between 10% and 20%, at a median of 15%. In the U.S., more than 45 million individuals are estimated to be living with IBS.
Viberzi is prescribed twice a day with meals. The drug has been approved based on two clinical trials. Xifaxan is orally administered for 2 weeks, with possible extension if the need arises. The FDA approved Xifaxan based on three separate trials. Xifaxan had been reportedly used off-label for treating IBS-D. Label expansion of the drug is expected to be instrumental in reporting breakthrough sales in the market.
The global irritable bowel syndrome with diarrhea (IBS-D) market is cumulatively formed of four regional markets: North America, Europe, Asia Pacific, and the Rest of the World.
North America is the largest regional market for IBS-D drugs. The region houses a prime market for novel drugs. Greater healthcare awareness, higher prevalence of IBS in the U.S. population, and better status of self-reporting even in the early stages of disease development are some driving factors in the North American IBS-D drugs market. Moreover, other regional market drivers include better and evolved reimbursement policies, perpetual growth in the the senior population in palliative care, and others. The North America IBS-D drugs market comprises U.S. and Canada national markets. Between the two, the U.S. captures the dominant market share and is also the largest national market worldwide. The North American IBS-D drugs market was valued at USD 128.33 Mn in 2015.
On the other hand, Asia Pacific is the fastest growing pharmaceutical market worldwide. Rapidly developing healthcare infrastructure, improving per capita economic status of the general population, and rising awareness about chronic disease management are the major factors that facilitate the growth of the Asia Pacific IBS-D drugs market. Japan is the largest market for IBS-D drugs in the Asia Pacific region. Anticipated approval of Xifaxan in 2018 in Japan is the expected event in the market.
The global IBS-D drugs market is categorized into prescribed and over-the-counter drugs markets. The prescribed drugs market is further categorized into branded and generic drugs markets.
The OTC IBS-D drugs segment is estimated to decline during the forecast period. However, their demand in the Asia Pacific and the rest of the world’s developing markets is expected to remain steady during the forecast period.The prescribed branded drugs segment is expected to report the fastest growth rate during the forecast period. This growth is majorly facilitated by the anticipated trigger of the demand for eluxadoline and rifaximin drugs in the global market. In addition, 2016 and 2018 are expected to be milestones for the rifaximin market as approvals for the Xifaxan are scheduled in Europe and Japan, respectively.
The demand for generic OTC drugs is expected to remain steady in Asia and the rest of the world markets due to later approvals of the drugs mentioned above and lesser awareness in the population. Collaborative strategies for manufacturing and marketing branded drugs in emerging markets, however, will assist in augmenting the demand for these drugs in the Asia Pacific region.
Among these sub-segments, the prescribed branded drugs segment is expected to report the fastest market growth of over 19% from 2016 to 2022. Recent FDA approvals for eluxadoline and rifaximin and their anticipated commercialization in the worldwide markets are the prime contributing factors to the growth of this market.
