Rapid Growth in the Opioid-Induced Constipation Market is Expected from 2012 to 2017, Reveals New Report

Publisher estimates the 2012 sales for opioid-induced constipation (OIC) to be approximately $144.42m across the six major pharmaceutical markets covered in this forecast: the US, France, Germany, Italy, Spain, and the UK. The EU contributed the majority of these sales, with the region generating an estimated $75.4m. In particular, Germany was the largest market, with an estimated $41.5m in sales in 2012. By the end of the forecast period, OIC sales will grow to approximately $1.98 billion, at a compound annual growth rate (CAGR) of 68.9% over the five-year period. The majority of sales will come from the US, which will represent more than 90% of the market (based on 6MM) in 2017.

Major drivers to the growth of the OIC market over the forecast period will include:

• The introduction of several highly targeted, oral, peripherally acting mu-opioid receptor antagonist (PAMORA) therapies, which are easily administrated with convenient dosing: AstraZeneca’s naloxegol, Cubist’s bevenopran and Salix’s oral Relistor.
• The launch of Amitiza across the EU and the approval of Linzess across the 6MM for OIC, which will increase physician and patient awareness of non-laxative prescription options to treat constipation.
• The growing number of OIC sufferers due to the overall population growth and continued use of opioids in the treatment of chronic non-cancer pain.

Major barriers to the growth of the OIC market will include:

• The high price of PAMORAs compared with standard laxative therapy, which may prevent their reimbursement by local health authorities and health insurance companies.
• Patient awareness of OIC. This includes the underlying difference between OIC and functional constipation, and awareness of non-laxative OIC prescription therapies. A further barrier to treating OIC is patients’ reluctance to report constipation symptoms to physicians.
• Physician awareness of OIC and the resulting impact on pain management and QOL, including follow-up questions and treatment for refractory patients with non-laxative prescription drugs, which represent a barrier for OIC treatment.

Aligned R&D Strategies Are Imperative for Attaining Access to a Lucrative and Underserved OIC Market

OIC remains a hugely untapped market with little competition in the pharmaceutical arena, with the first pharmacological treatment only becoming licensed in 2008. As of September 2013, there are currently only two EU- and FDA-approved treatments available. The OIC market has a commercially attractive patient population size (more than half a million patients in the US and 5EU), as well as the scope for companies to seek accelerated approval, enabling a potentially faster and more cost-effective R&D program. As this is a new and rapidly forming market that has yet to be fully established, aligned R&D strategies are indispensable for admittance into a previously unpenetrated market.

Demonstrating High Efficacy while Proving No Reduction of Analgesia or Major Cardiovascular Adverse Effects is Essential

According to key opinion leaders (KOLs) interviewed by Publisher, the key attribute for companies wanting to establish themselves in the OIC therapeutic arena is to utilize understanding of the disease mechanism to generate safe therapies with a low side-effect profile. This will include designing clinical trial safety endpoints that adequately satisfy approval bodies.

Future R&D strategies need to develop therapies using the fundamental understanding of OIC by investing in research, which in turn will be imperative for discovering a long-term efficacious drug with a lack of undesirable side effects.

Corporate Strategies Include Label Expansion of Approved Constipation Drugs into OIC

Other corporate trends include expanding the label indication for functional constipation drugs into OIC to maximize sales from this lucrative market. The decision by the FDA in April 2013 to approve Amitiza for a third indication has led companies currently developing constipation drugs to consider commencing clinical trials in patients with OIC. Ironwood has expressed interest in pursuing a label expansion into OIC for its constipation drug Linzess, and it is likely that other companies will follow suit.

Extensive Marketing of OIC Prescriptions Drugs is Required to Convert Patients from OTC Laxatives

A common strategy being undertaken by companies in the OIC space is to enter partnerships and acquisitions in a bid for companies to broaden their pipeline portfolio. Examples include the acquisitions of Adolor Corporation by Cubist Pharmaceuticals and the licensing of naloxegol to AstraZeneca by Nektar.

With the vast majority of novel therapeutic agents for OIC being developed by small to medium-sized pharmaceutical and biotechnology companies, Publisher anticipates that licensing activity and the formation of new partnerships with companies possessing strong GI sales experience will be key in competing in a soon-to-be-congested market populated by many me-too drugs.

Besides the advent of efficacious drugs, improving diagnosis and increasing the awareness of new treatments is a key unmet need essential in increasing the drug-treatment rate for OIC. The current OIC therapeutic market is dominated by inexpensive, widely available laxatives. Despite a lack of strong evidence and poor clinical efficacy, they are currently broadly accepted as the mainstay of constipation relief. The success of prescription OIC therapies compared with that of OTC laxatives will depend on extensive marketing. Such marketing must serve to increase both patient and physician awareness of the non-laxative prescription options when treating constipation, in particular for OIC.

A Highly Efficacious, Approved Therapy is the Most Pressing Need in OIC

The level of unmet need for OIC, both environmentally and clinically, is high. Key opinion leaders (KOLs) interviewed by Publisher highlight that there is an unprecedented need for an efficacious drug for OIC treatment. Such a drug must be targeted to the cause of OIC and can only be identified following future advancements based on further critical understanding of the etiology and pathophysiology of the disease.

Oral PAMORAs Set to Change the OIC Treatment Landscape

The new class of oral PAMORAs being developed is highly targeted, and KOLs interviewed by Publisher are eagerly anticipating this class of drug. There are currently five drugs in this class in late-stage clinical development, and all represent targeted, efficacious potential treatments for OIC. However, potential regulatory hurdles remain due to doubts over major adverse cardiovascular events (MACEs) associated with PAMORAs. The FDA is currently convening a body of experts to assess the drug class and provide guidance regarding the necessary clinical trials to sufficiently demonstrate safety. If approvals go ahead, the currently underserved OIC market is set to become very congested and competitive. Demonstrating superior efficacy, competitive pricing and good marketing will be crucial in gaining market share.

Over the next five years, the OIC market is expected to see significant changes. With the approval of three PAMORAs, there will be a shift in the way that drugs for OIC are prescribed. Although laxatives are likely to remain the first-line therapy, the advent of novel targeted oral therapies, alongside improved and timely diagnosis and improved physician awareness, will increase the number of patients receiving non-laxative prescription treatments.

Publisher assessed promising pipeline candidates both clinically and commercially, based on the opinions generated from interviews with KOLs. Salix’s oral Relistor emerged as the drug with the greatest future interest. This is mainly due to the substantial efficacy offered by this class of drug (PAMORA); its current commercial positioning in the OIC market, as the subcutaneous formulation is approved globally and is marketed by an industry-leading GI specialist; and its convenient as-needed oral dosage. Two competing PAMORAs, AstraZeneca’s naloxegol and Cubist’s bevenopran, also have very similar clinical and commercial attributes, placing them in direct competition in this soon-to-be congested market. Other players will include Theravance’s TD-1211, Shionogi’s naldemedine, and S.L.A. Pharmaceuticals’ Nalcol, all of which will require licensing partners for successful approval and/or launch.

Already marketed constipation therapies, namely Sucampo’s Amitiza and Ironwood’s Linzess, are expected to have an easier route to approval; however, their indirect MOA reduces their efficacy as assessed by the current measures of OIC relief. Therefore, cost-effectiveness will be difficult to prove and may result in challenges in terms of reimbursement.

Spanning over 160 pages, “OpportunityAnalyzer: Opioid-Induced Constipation - Opportunity Analysis And Forecasts To 2017 - Event-Driven Update” report covering the Disease Overview, Potential Patient Population, Current Treatment Options, Unmet Needs Assessment and Opportunity Analysis, R&D Strategies, Pipeline Assessment, Pipeline Valuation Analysis, Appendix.

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