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Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2017 REFERENCE CODE GDHC004POA | PUBLICATION DATE SEPTEMBER 2013 OPIOID-INDUCED CONSTIPATION - OPPORTUNITY ANALYSIS AND FORECASTS TO 2017 OPIOID-INDUCED CONSTIPATION - OPPORTUNITY ANALYSIS AND FORECASTS TO 2017 Executive Summary The table below presents the key metrics for Rapid Growth in the Opioid-Induced opioid-induced constipation (OIC) in the six major Constipation Market is Expected from 2012 to pharmaceutical markets covered in this report (US, 2017 France, Germany, Italy, Spain, UK) during the GlobalData estimates the 2012 sales for opioid- forecast period from 2012–2017. induced constipation (OIC) to be approximately OIC: Key Metrics in Six Major Pharmaceutical $144.42m across the six major pharmaceutical Markets, 2012–2017 markets covered in this forecast: the US, France, 2012 Patient Population Potential Germany, Italy, Spain, and the UK. The EU Number of Cases of Opioid-Induced 5,878,257 contributed the majority of these sales, with the Constipation 2012 Market Sales region generating an estimated $75.4m. In US $69.0m particular, Germany was the largest market, with 5EU $75.4m an estimated $41.5m in sales in 2012. By the end Total $144.4m of the forecast period, OIC sales will grow to Key Events (2012–2017) Level of Impact approximately $1.98 billion, at a compound annual Launch of Amitiza in all EU markets in ↑↑ 2014 growth rate (CAGR) of 31.9% over the five-year Approval of naloxegol in the US in 2014; ↑↑ period. The majority of sales will come from the EU in 2015 Approval of bevenopran in the US in 2016; US, which will represent more than 90% of the ↑↑↑ EU in 2017 market (based on 6MM) in 2017. Approval of oral Relistor in the US in 2014; ↑↑↑ EU in 2015/2016 Major drivers to the growth of the OIC market over Approval of Linzess in the US in 2016; EU ↑↑ in 2017 the forecast period will include: 2017 Patient Population Potential The introduction of several highly targeted, Number of Chronic Opioid Users 15,921,077 Total Prescription Drug-Treated oral, peripherally acting mu-opioid receptor 1,810,755 Population (45%) antagonist (PAMORA) therapies, which are 2017 Market Sales easily administrated with convenient dosing: US $1.79bn AstraZeneca’s naloxegol, Cubist’s bevenopran 5EU $197.6m Total $1.99bn and Salix’s oral Relistor. Source: GlobalData. For the purposes of this report, the six major pharmaceutical markets = The launch of Amitiza across the EU and the US and 5EU (France, Germany, Italy, Spain, and UK) approval of Linzess across the 6MM for OIC, which will increase physician and patient awareness of non-laxative prescription options to treat constipation. Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2017 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. OPIOID-INDUCED CONSTIPATION - OPPORTUNITY ANALYSIS AND FORECASTS TO 2017 Executive Summary The growing number of OIC sufferers due to The figure below illustrates the OIC sales for the the overall population growth and continued six major markets during the forecast period. use of opioids in the treatment of chronic non- Sales for Opioid-Induced Constipation by Region, cancer pain. 2012 and 2017 Major barriers to the growth of the OIC market will 6% include: 8% 4% The high price of PAMORAs compared with standard laxative therapy, which may prevent 48% their reimbursement by local health authorities and health insurance companies. 29% 2012 Total: $144.42m Patient awareness of OIC. This includes the underlying difference between OIC and 5% functional constipation, and awareness of non- US France Germany Italy Spain UK 2% 2% laxative OIC prescription therapies. A further 1% 4% barrier to treating OIC is patients’ reluctance to 1% report constipation symptoms to physicians. Physician awareness of OIC and the resulting impact on pain management and QOL, 2017 including follow-up questions and treatment for Total: $1.98bn refractory patients with non-laxative prescription drugs, which represent a barrier 90% for OIC treatment. US France Germany Italy Spain UK Source: GlobalData. Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2017 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. OPIOID-INDUCED CONSTIPATION - OPPORTUNITY ANALYSIS AND FORECASTS TO 2017 Executive Summary Aligned R&D Strategies Are Imperative for discovering a long-term efficacious drug with a lack Attaining Access to a Lucrative and of undesirable side effects. Underserved OIC Market Corporate Strategies Include Label Expansion OIC remains a hugely untapped market with little of Approved Constipation Drugs into OIC competition in the pharmaceutical arena, with the Other corporate trends include expanding the label first pharmacological treatment only becoming indication for functional constipation drugs into OIC licensed in 2008. As of September 2013, there are to maximize sales from this lucrative market. The currently only two EU- and FDA-approved decision by the FDA in April 2013 to approve treatments available. The OIC market has a Amitiza for a third indication has led companies commercially attractive patient population size currently developing constipation drugs to consider (more than half a million patients in the US and commencing clinical trials in patients with OIC. 5EU), as well as the scope for companies to seek Ironwood has expressed interest in pursuing a accelerated approval, enabling a potentially faster label expansion into OIC for its constipation drug and more cost-effective R&D program. As this is a Linzess, and it is likely that other companies will new and rapidly forming market that has yet to be follow suit. fully established, aligned R&D strategies are Extensive Marketing of OIC Prescriptions indispensable for admittance into a previously Drugs is Required to Convert Patients from unpenetrated market. OTC Laxatives Demonstrating High Efficacy while Proving No Reduction of Analgesia or Major A common strategy being undertaken by Cardiovascular Adverse Effects is Essential companies in the OIC space is to enter partnerships and acquisitions in a bid for According to key opinion leaders (KOLs) companies to broaden their pipeline portfolio. interviewed by GlobalData, the key attribute for Examples include the acquisitions of Adolor companies wanting to establish themselves in the Corporation by Cubist Pharmaceuticals and the OIC therapeutic arena is to utilize understanding of licensing of naloxegol to AstraZeneca by Nektar. the disease mechanism to generate safe therapies With the vast majority of novel therapeutic agents with a low side-effect profile. This will include for OIC being developed by small to medium-sized designing clinical trial safety endpoints that pharmaceutical and biotechnology companies, adequately satisfy approval bodies. Future R&D GlobalData anticipates that licensing activity and strategies need to develop therapies using the the formation of new partnerships with companies fundamental understanding of OIC by investing in possessing strong GI sales experience will be key research, which in turn will be imperative for Opioid-Induced Constipation - Opportunity Analysis and Forecasts to 2017 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. OPIOID-INDUCED CONSTIPATION - OPPORTUNITY ANALYSIS AND FORECASTS TO 2017 Executive Summary in competing in a soon-to-be-congested market Oral PAMORAs Set to Change the OIC populated by many me-too drugs. Treatment Landscape Besides the advent of efficacious drugs, improving The new class of oral PAMORAs being developed diagnosis and increasing the awareness of new is highly targeted, and KOLs interviewed by treatments is a key unmet need essential in GlobalData are eagerly anticipating this class of increasing the drug-treatment rate for OIC. The drug. There are currently five drugs in this class in current OIC therapeutic market is dominated by late-stage clinical development, and all represent inexpensive, widely available laxatives. Despite a targeted, efficacious potential treatments for OIC. lack of strong evidence and poor clinical efficacy, However, potential regulatory hurdles remain due they are currently broadly accepted as the to doubts over major adverse cardiovascular mainstay of constipation relief. The success of events (MACE) associated with PAMORAs. The prescription OIC therapies compared with that of FDA is currently convening a body of experts to OTC laxatives will depend on extensive marketing. assess the drug class and provide guidance Such marketing must serve to increase both regarding the necessary clinical trials to sufficiently patient and physician awareness of the non- demonstrate safety. If approvals go ahead, the laxative prescription options when treating currently underserved OIC market is set to become constipation, in particular for OIC. very congested and competitive. Demonstrating A Highly Efficacious, Approved Therapy is the superior efficacy, competitive pricing and good Most Pressing Need in OIC marketing will be crucial in gaining market share. Over the next five years, the OIC market is The level of unmet need for OIC, both expected to see significant changes. With the environmentally and clinically, is high. Key opinion approval of three PAMORAs, there will be a shift in leaders (KOLs) interviewed by GlobalData highlight the way that drugs for OIC are prescribed. that there is an unprecedented need for an Although laxatives are
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