Global Irritable Bowel Syndrome with Diarrhea (IBS-D) Drugs Market By Drug Type (Eluxadoline, Alosetron, Rifaximin, Loperamide, Diphenoxylate + Atropine, Dicyclomine and Hyoscyamine, Pipeline Drug Analysis: Ibodutant, Ramosetron), Prescription (Prescribed and OTC Drugs, Prescribed Branded and Prescribed Generic Drugs) - Growth, Share, Opportunities, Competitive Analysis, and Forecast, 2016 - 2022

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 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 drugs 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 to three, this market has opened avenues for further research and development and hence market entry of potential treatment options and market players. For the purpose of this study, 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, elosetron, loperamide, diphenoxylate & atropine, and dicyclomine & hyoscyamine drugs markets. The market size and forecast for these drugs for the period 2014 to 2022 are provided along with their respective CAGRs during 2016-2022, considering 2015 as the base year.

In terms of prescription type, the global IBS-D drugs market is categorized into prescribed and OTC drugs. The prescribed drugs market is further sub-segmented into prescribed branded drugs and prescribed generic drugs markets. Similar to market segmentation by drug type, the market size and CAGRs for the above segments is provided for the period 2014-2022 and 2016-2022 respectively.

North America, Europe, Asia Pacific and Rest of the World cumulatively make 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
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • Rest of Asia Pacific
  • Rest of the World
    • 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 profiling of major market players engaged in manufacture of IBS-D drugs.

Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) drugs market is often observed to be open in nature 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).

Irritable Bowel Syndrome (IBS) Market

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 is approved on the basis of two clinical trials. Xifaxan is orally administered for a period of 2 weeks, with possible extension if the need arises. Xifaxan was approved by the FDA based on 3 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, namely North America, Europe, Asia Pacific and Rest of the World.

Irritable Bowel Syndrome (IBS) Market

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, better status of self reporting even in early stages of disease development are some of the driving factors in the North America IBS-D drugs market. Moreover, other drivers of this regional market include better and evolved reimbursement policies, perpetual growth in geriatric population in palliative care and others. The North America IBS-D drugs market comprises of U.S. and Canada national markets. Between the two, U.S. captures the dominant market share and is also the largest national market worldwide. The North America IBS-D drugs market was valued at USD 128.33 Mn in 2015.

On the other hand, Asia Pacific is the fastest growing pharmaceuticals 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 Asia Pacific IBS-D drugs market. Japan is the largest market for IBS-D drugs in Asia Pacific region. Anticipated approval of Xifaxan in 2018 in Japan is the major 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 prescribed drugs and generic prescribed drugs markets.

The OTC IBS-D drugs segment is estimated to decline during the forecast period. However, their demand in the developing markets of Asia Pacific and rest of the world are expected to remain steady during the forecast period.

Irritable Bowel Syndrome (IBS) Market

The prescribed branded drugs segment is expected to report the fastest growth rate during the forecast period. This growth is majorly facilitated with the anticipated trigger to the demand for eluxadoline and rifaximin drugs in the global market. 2016 and 2018 are expected to be milestones for rifaximin market as approvals for the Xifaxan is scheduled in Europe and Japan markets respectively.

The demand for generic OTC drugs is expected to remain steady in Asia Pacific and rest of the world markets, due to later approvals of the above mentioned drugs in these markets and lesser awareness in the population. Collaborative strategies for manufacturing and marketing of branded drugs in emerging markets however will assist in augmenting the demand for these drugs in Asia Pacific region.

Among these sub-segments, the prescribed branded drugs segment is expected to report the fastest market growth of over 19% during 2016-2022. 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.

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 of severe safety issues. Lotronex (alosetron) acts by slowing stool movements. The drug was withdrawn from the market in 2000 after it was reportedly linked to severe gut problems including constipation and colitis. In the year 2002, the availability of Lotronex through restricted marketing program.

Availability of very few IBS-D drugs in the market is related to 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 the treatment of IBS-D. Viberzi is an opioid antagonist and is to be taken twice a day with food. The drug was FDA approved on the basis of two clinical trials enrolling over 2400 subjects, who were given placebo or Viberzi. Viberzi reportedly worked better in easing abdominal pain and discomfort and improve stool consistency over 26 week period.

Xifaxan is administered orally thrice a day for 2 weeks (14 days). The drug is prescribed an additional dose on recurrence of symptoms. Xifaxan was approved by the FDA on the basis of 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 came back were given a 14-day dose of Xifaxan or placebo. The patients on active drug reported considerable relief from abdominal pain and better stool consistency.

The most serious risk with Viberzi is chances 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 also 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, control on overeating and avoiding carbonated drinks and so on. Viberzi is a narcotic, thus, it is expected that its schedule status will be controlled in the future. Xifaxan, by Salix, is already available in the market for treating liver issues and had 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.

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Published Date:  Mar 2016
Category:  Pharmaceuticals
Report ID:   57736
Report Format:   PDF
Pages:   120
Rating:    4.4 (65)
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