Press Release

Increasing Concentration of Abuse-Resistant Branded Generics Alter Competitive Dynamics in the Flat Opioids Market

January 11th, 2013

Global Information Inc. would like to present a new market research report, "Opioids Market to 2018 - Increasing Concentration of Abuse-Resistant Branded Generics Alter Competitive Dynamics in this Flat Market" by GBI Research.

Strong Diversification of Opioid Products across Pain Markets

The current opioids market is characterized by a very broad and highly diversified product portfolio. Patients experiencing moderate to severe pain caused by a range of underlying physiological conditions are treated almost exclusively with opioid analgesics. As a result, the therapeutic landscape across most pain markets for patient populations experiencing considerable levels of pain, with the exception of indications such as migraines, are heavily dominated by opioids. As a therapeutic drug class, opioids have virtually no competition from molecules with non-opioid receptor targets, although the current environment within this therapeutic class is highly competitive. Currently, 352 opioid-based products are approved for a range of painful conditions across the seven major developed markets considered in this report, including the US, Germany, the UK, France, Italy, Spain, and Japan. These products are based on 16 different opioid compounds and are differentiated according to a range of characteristics, including dosage, route of administration, and pharmacokinetic features, as well as increasingly on the basis of tamper-resistant formulation technologies.

Continual Trend towards Abuse-Resistant Formulations

Due to growing concerns among regulatory authorities and physicians regarding increasing opioid abuse, particularly in the US, there has been a seismic shift towards developing abuse-resistant formulations of Extended-Release (ER) opioid analgesics. Since the 2009 US launch of Embeda (morphine sulfate and naltrexone hydrochloride), the first opioid product designed to be abuse-resistant, a whole range of novel products and reformulations of existing products have been brought to the market. Although abuse-resistant formulations do not confer any clinical benefits, they have nevertheless become an essential feature in the current market environment in order for products to remain competitive in the future. Due to growing regulatory requirements for opioid compounds, virtually every opioid-based, ER product that has been launched over the last three years has had to fulfill post-marketing study requirements in order to determine how effective these formulations are in deterring abuse. As these studies are designed to run for three years, there is currently little evidence available, and the evidence that has been obtained so far is inconclusive. However, the post-marketing data for Embeda have suggested that its safety profile is comparable to the standard ER morphine formulation, but may confer some degree of abuse resistance. While additional post-marketing data will be needed before a judgment about the effects of abuse-resistant formulation technologies can be made, the post-marketing data for Embeda can be considered as a positive beginning in the effort to curb opioid abuse. It is also important to note that the currently marketed products use different abuse-resistant formulation technologies, so the combined total effect of this novel generation of products on opioid abuse is currently unclear. However, identifiable trends are likely to become apparent over the next two years as more data from post-marketing studies become available.

Weak Developmental Pipeline

The current developmental pipeline of opioid products for the management of a range of painful conditions is very small compared to the total revenue and patient pool for the existing products. This is indicative of a very low level of innovation and a high level of market saturation. GBI Research has identified a total of 54 monotherapies and combination opioid-based therapies that are currently being tested for the treatment of acute and chronic pain, as well as for osteoarthritic, neuropathic, and post-operative pain. Three monotherapies and nine combination therapies are currently in the discovery or preclinical stages of development, respectively, while Investigational New Drug (IND) applications have been submitted for two developmental programs. Across the clinical stages of drug development, 12, 11, and 13 monotherapies or combination therapies are currently in Phase I, II, and III, respectively. Another three products have been filed for regulatory approval.

The opioids pipeline contains virtually no novel compounds in the later stages of development, which is indicative of a high level of competition and market saturation. The current late-stage products are differentiated on the basis of small and incremental changes in formulation, delivery, and speed of onset of analgesia, and also very frequently on the basis of the tamper-resistance of strong opioid compounds. Notably, no weak opioids are currently in development, which is strongly indicative of a perceived lack of incentives to develop products for patient populations suffering from moderate pain levels.

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Product Code : 200292