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  4. > A Product and Pipeline Analysis of the Opioid Therapeutics and Drug Delivery Market : Increasing Regulation Push for Tamper-resistant Drugs Driving New Generation of Opioids

This market insight provides data for the Global Opioid Therapeutics market. The analysis looks at opioid pharmaceutical pipeline drugs currently in the market and drugs that are in Phase III stage, which pose a potential threat to competitors. It also offers a competitive analysis of the drugs, and the forecast outcome and impact of each of these drugs. Opioid drugs in the current market have a space for tamper-resistant formulations. The opioids market is segmented into relapsing neuropathic pain, acute and post-operative pain, cancer-induced pain, and moderate to severe chronic pain.

Methodology and Scope

•This research service focuses on the global opioid therapeutics market with a focus on current Phase 3 candidates, detailed timelines, rational for pivotal program design, Phase 2 data review, and key opinion leader (KOL) commentary.
•A pipeline assessment is provided for all active candidates in development.
•The information contained in this research service was derived from published sources including the following: Disease organization websites; Frost & Sullivan publications, including annual research studies; Securities and Exchange Commission (SEC) filings and press releases; United States government public sources; and scientific journals.

Executive Summary

•The global opioids market stands at around $ x billion in 2013 and is set to grow to about $ x billion, with new drugs entering the market.
•The increasing global aging population, rising incidence of cancer, and increasing number of surgeries, especially in the developed regions, spur the usage of opioids.
•Moderate to severe chronic pain therapeutics market is the most mature one and the largest opioid market segment, holding nearly x % of the market share.
•Prevalence is highest for acute and post-operative pain affecting nearly x billion people globally, compared to other pain segments.
•With the patent expiry of oxycodone in 2014, there is a gap in the chronic pain market. The Food and Drug Administration (FDA), however, refuses to approve any generics due to safety concerns.
•Patent expiration of Oxycontin and bad press for Purdue Pharma will boost sales of the newly-approved Zohydro ER drug for chronic pain.
•Oxycodone remained the largest revenue contributor to the pain therapeutics market in 2013, with revenues worth $ x billion.
•With patent expiration of Lidoderm, sales of Butrans transdermal pain patches have almost tripled since 2011, with US sales of $ x million in 2013.
•There are 20+ orally-delivered, marketed products with the majority of prescriptions being for immediate-release generic opioids.
•The pain therapeutics pipeline is dominated by tamper-resistant formulations (TRFs), predominately because these new formulations are endorsed by the FDA, deter abuse, and enable previously genericized products to remain branded.
•Stricter regulations in the United States are one of the main reasons why many companies and manufacturers are shifting focus to European and Asian countries like China where regulations are far more lenient.
•Branded products—such as TRFs—that lack generic formulations continue to succeed in capturing significant market share.

Regulatory Overview

In January 2013, the FDA issued a draft of abuse-deterrence study requirements for inclusion in product labeling.
The increasing number of abuse and recent scrutinization of key companies like Purdue has reinforced FDA’s stand on only approving tamper-resistant formulations.
•There is potential for pain-reducing drugs without TRF technology to be removed from the market, thus creating significant market opportunity for new TRF therapies to remain branded.
•New labeling falls into x suggested tiers to describe abuse-deterrent properties including:
oFormulation with physicochemical barriers
oReduction/blockage of opioid effect when the product is manipulated
oMeaningful reduction in abuse
oDemonstrated reduced abuse in the community
•All safety categories will likely be required for all tiers, with Tier III requiring clinical abuse potential studies and Tier IV requiring post-marketing data.

Purdue Pharma
FDA’s lack of approval of generic oxycodone allows Purdue Pharma to develop a tamper-resistant formulation of Oxycodone which is currently in Phase 3 of development. The company will soon seek approval from the FDA.
•Oxycontin is Purdue’s oxycodone ER TRF, which holds an estimated % of total prescription share value or $ x billion in US sales.
•Purdue Pharma also competes in the transdermal patch market with Butrans, which generated 2013 US sales of $ x million.
•The sales of Butrans have increased significantly since the patent expiration of Lidoderm.

Endo
Endo strongly competes both in the oral and transdermal patch markets.
•Endo’s flagship product is a transdermal patch, Lidoderm, which generated $ billion in US sales. But sales have and will continue to decrease due to patent expiration of Lidoderm and generic competition.
•Opana ER’s US sales were $ million in 2012,which slipped to $ million in 2013.

Pfizer
By 2020, Pfizer is projected to be the new leader in the pain market with a diverse portfolio including orally-delivered, transdermal, and IV candidates. This heavily depends on the success of their pipeline products.
•Pfizer recently walked away and cut its losses from its long-term investment, Remoxy, which has encountered many hurdles and has been static in the filed stage since 2008.
•Embeda: Pfizer’s pain therapy with abuse-deterrant drug was withdrawn from the market in 2013 and recently approved by the FDA. This drug is in direct competition to the newly-released Zohydro ER to replace Oxycodone, whose patent expired recently.
In June 2011, Pfizer gained approval for the first immediate-release oxycodone designed to deter abuse—Oxecta. However, Oxecta’s 2013 sales were disappointing at $ x .
•Pfizer is also developing a 3-day bupivacain transdermal patch which is expected to compete with J&J’s Duragesic.

J&J
J&J competes strongly both in the transdermal patch space and orals.
•Nucynta’s immediate release and extended-release (ER) formulations had combined US sales of $ x million in 2013. J&J is currently conducting clinical trials to show the abuse-deterrence of Nucynta ER to provide a label update in 2015 or early 2016.
•Ultram ER US sales peaked in 2009 with $ x million. However, 2013 sales have declined to $ x million due to entry of generic competition.
•J&J’s transdermal patch generated 2012 US revenues of $ million, but sales have been decreasing due to generic competition.
•Clinical studies comparing Nucynta ER and Purdue’s OxyContin have confirmed the drug’s potent efficacy. Additional benefits have also been documented which will aid in the clinical argument for commercial use.
•J&J already markets this drug for acute pain and the FDA approval is significant for the company.

Table Of Contents

A Product and Pipeline Analysis of the Opioid Therapeutics and Drug Delivery Market : Increasing Regulation Push for Tamper-resistant Drugs Driving New Generation of Opioids
Methodology and Scope 3
Executive Summary 5
Introduction 13
US Opioid Therapeutics Market Overview 19
Competitive Landscape 30
Timeline Transparency 53
Late-stage Development—Product Dashboards 58
The Last Word 65
The Frost and Sullivan Story 68

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