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Forecast Insight: Opioids - Saturation limits the commercial potential of individual brands

Healthcare

Publication Date March 2009
Publisher Datamonitor
Product Type Report
Pages 133
ISBN Number not applicable
Product Code DAT01746

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Summary

Introduction

The opioids market is set to grow from $9.6 billion in 2008 to $11.9 billion in 2018 across the seven major markets. However, the number and diversity of products in late-stage development will limit the commercial potential of individual brands simply due to saturation and price competition in each opioids market.

Scope

This report gives a strategic analysis of the likely impact that recent events will have on the future opioids market

  • Includes forecasts for the key brands, generics, and pipeline agents in the seven major markets to 2018
  • Provides a global opioids market snapshot, and analysis of growth trends in key markets outside of the seven major pharmaceutical markets
  • Conclusions are supported by key opinion leader comment

Highlights

Purdue/Mundipharma/Napp Pharmaceutical's OxyContin (oxycodone controlled-release) is forecast to regain the prescriptions lost to generics following re-establishment of market exclusivity in the US. Sales peak at around $3 billion in 2009 across the seven major markets.

King Pharmaceutical's anti-abuse opioid franchise looks set to reach blockbuster levels over the forecast period. With combined sales of Remoxy (oxycodone controlled-release), Embeda (morphine extended-release and naltrexone) and the immediate-release opioid Acurox (oxycodone and niacin) forecast to generate around $1 billion per annum by 2018.

Reinvigoration of the short- and rapid-acting opioids market following approval of Fentora for non-cancer pain in the US, and the entry of regional specialist companies in the 5EU, will expand the market beyond that achieved by Cephalon to date.

Reasons to Purchase

  • Quantify the current size of the global opioids market
  • Assess the impact of recent and anticipated events (patent expiries, new product launches, regulatory approval) on opioid brand sales
  • Understand the country-specific impact of key events in the opioids market during the forecast period 2009 to 2018

Contents

  • ABOUT DATAMONITOR HEALTHCARE
    • About the CNS pharmaceutical analysis team
  • CHAPTER 1 EXECUTIVE SUMMARY
    • Strategic scoping and focus
    • Datamonitor insight into the disease market
    • Related reports
  • CHAPTER 2 MARKET DEFINITION AND OVERVIEW
    • Market definition for this report
    • Countries and regions included in this report
    • Seven major market assessment
    • Market segmentation
    • Total market forecasts
    • Rest of the world snapshot
    • Global market value
    • Global market volume
    • Rest of the world breakdown
  • CHAPTER 3 BRAND DYNAMICS - LONG-ACTING OPIOIDS
    • Overview of competitive landscape
    • Seven major market forecasts - long-acting opioids
    • Key brands across the seven major pharmaceutical markets
    • Update on the key marketed brands
    • OxyContin (oxycodone controlled-release, Purdue, Mundipharma, Napp)
    • Background and current market position - market leading brand
    • Recent events - strong sales following re-establishment of market exclusivity
    • Datamonitor comments and forecasts - anti-abuse versions set to shrink market share
    • Duragesic (fentanyl patch, Johnson & Johnson)
    • Background and current market position - available across all seven major markets
    • Recent events- additional generic manufacturers enter the market
    • Datamonitor comments and forecasts - branded value holds in the five major European markets
    • Kadian (morphine extended-release, Actavis)
    • Background and current market position - leading morphine brand
    • Recent events - King sells rights to Actavis following Alpharma acquisition
    • Datamonitor comments and forecasts - King concentration on Avinza
    • Avinza (morphine extended-release, King Pharmaceuticals)
    • Background and current market position - marginal historical growth
    • Recent events - King retains Avinza after its acquisition of Alpharma
    • Datamonitor comments and forecasts - switching to Embeda is likely
    • Opana extended-release (oxymorphone extended-release, Endo)
    • Background and current market position - first oral availability of molecule
    • Recent events - new doses launched
    • Datamonitor comments and forecasts - no clear differentiation from current opioids
    • Update on key pipeline drugs - anti-abuse technologies
    • Drivers to anti-abuse technologies
    • Enhanced media attention on opioid abuse in the US
    • Cost premium could limit uptake
    • Label changes unlikely
    • Patent challenges
    • Remoxy (oxycodone, Pain Therapeutics and King Pharmaceuticals)
    • Background - gelatin abuse-deterrent capsule
    • Recent events - delay due to additional data request
    • Datamonitor comments and forecasts - launch expected in late 2009
    • ELI-216 (oxycodone and naltrexone, Elite Pharmaceuticals)
    • Background - oxycodone and sequestered naltrexone
    • Recent events - Phase III trial planned
    • Datamonitor comments and forecasts - Elite likely to need a partner
    • Embeda (morphine and naltrexone, King Pharmaceuticals)
    • Background -the only morphine abuse-deterrent formulation in development
    • Recent events - product under FDA review
    • Datamonitor comments and forecasts
    • Oxytrex (oxycodone and naltrexone, Pain Therapeutics)
    • Background - targeting tolerance and dependence
    • Recent events - development progress not published
    • Datamonitor comments and forecasts - a high-risk, high-gain product
    • Update on other key pipeline drugs
    • Targin (oxycodone hydrochloride and naloxone, Mundipharma)
    • Background - targets gastrointestinal side effects
    • Recent events - Targin submitted for approval in the EU
    • Datamonitor comments and forecasts - an interesting lifecycle management strategy
    • Sufentanil patch (sufentanil, Durect)
    • Background - seven days of relief in one patch
    • Recent events - Endo pulls out of marketing
    • Datamonitor comments and forecasts - commercial potential affected by Endo withdrawal
    • Vicodin CR (hydrocodone bitartrate and acetaminophen controlled-release, Abbott)
    • Background - reformulation lifecycle management strategy
    • Recent events - Complete Response letter from the FDA
    • Datamonitor comments and forecasts - no clear benefit over parent drug
    • Tapentadol ER (tapentadol, Johnson & Johnson and Grnenthal)
    • Background - super tramadol
    • Recent events - positive clinical data publication
    • Datamonitor comments and forecasts - commercial success dependent on the results of full clinical trial program
  • CHAPTER 4 BRAND DYNAMICS - SHORT- AND RAPID-ACTING OPIOIDS
    • Overview of competitive landscape
    • Breakthrough pain
    • Seven major market forecasts - Short- and rapid-acting opioids
    • US market growth
    • Five major European market growth
    • Japan - no products yet available
    • Leading brands across the seven major pharmaceutical markets
    • Current market dynamics - sales data reveal market slowdown in the US
    • Pre-launch of Fentora and Actiq generics in the US (Q3 2003-Q3 2006)
    • Market falls after launch of Fentora and Actiq generics in the US
    • Factors contributing to decline in market volume
    • Market assumptions
    • Regulatory approvals and off-label prescribing pattern
    • Key differentiating factors for pipeline drugs
    • Speed of action
    • Marketing capabilities
    • Overdose and misuse potential
    • Differentiation from currently marketed brands
    • Key marketed brands
    • Actiq (transmucosal fentanyl, Cephalon)
    • Background - first product on the market
    • Recent events - strong growth in Europe
    • Datamonitor comments and forecasts - launch in Japan
    • Fentora (buccal fentanyl, Cephalon)
    • Background - follow-on product
    • Recent events - European launch
    • Datamonitor comments and forecasts - approval for non-cancer pain key
    • Ionsys (fentanyl iontophoretic transdermal system, Johnson & Johnson)
    • Background - failed delivery technology
    • Recent events - launched then withdrawal
    • Datamonitor comments - no way back
    • Update on key pipeline drugs - dissolvable formulations
    • Onsolis (buccal disc fentanyl, Meda and BioDelivery sciences)
    • Background - dissolvable polymer disc
    • Recent events - FDA approval and launch nears
    • Datamonitor comments and forecasts - strong EU marketing partner
    • Abstral (formerly Rapinyl, sublingual dissolvable tablet fentanyl, ProStrakan and Orexo)
    • Background - dissolvable fentanyl tablet for sublingual administration
    • Recent events - Endo withdraws from US marketing
    • Datamonitor comments and forecasts - US market potential limited
    • Update on key pipeline drugs - spray formulations
    • Instanyl (intranasal fentanyl, Nycomed)
    • Background - unlikely to be developed for the US market
    • Recent events - still in pre-registration in Europe
    • Datamonitor comments and forecasts - no US development
    • NasalFent (intranasal fentanyl, Archimedes)
    • Background - most rapid onset of action
    • Recent events - additional clinical trial data
    • Datamonitor comments and forecasts - no marketing partner
    • Rylomine (intranasal morphine, Javelin)
    • Background - morphine based
    • Recent events - no news
    • Datamonitor comments and forecasts - differentiated product
    • AD-923 (sublingual spray fentanyl, Sosei)
    • Background - commercial partner dropped, development partner sought
    • Datamonitor comments and forecasts - launch ex-Japan not forecast
    • Fentanyl TAIFUN (inhaled fentanyl, Johnson & Johnson, Akela, and Teikoku Seiyaku)
    • Background - Big Pharma marketing partner
    • Datamonitor comments and forecasts
  • CHAPTER 5 BRAND DYNAMICS - CONVENTIONAL OPIOIDS
    • Overview of competitive landscape
    • Update on key pipeline drugs
    • Acurox (oxycodone and niacin, Acura Pharmaceuticals, King Pharmaceuticals)
    • Background - King Pharmaceuticals' immediate-release anti-abuse product
    • Recent events - submission to the FDA
    • Datamonitor comments and forecasts - cost premium limits uptake
    • Morphine-6-glucuronide (Morphine metabolite, Paion)
    • Background - metabolite of morphine
    • Recent events - Paion acquires CeNeS
    • Tapentadol IR
    • Background - dual mechanism of action
    • Recent events - US approval in 2008
    • Datamonitor comments and forecasts - launch imminent
  • BIBLIOGRAPHY
    • Journal papers
    • Websites
    • Datamonitor reports
  • APPENDIX A - MARKET ASSUMPTIONS
    • New product launches
    • Patent expiries
    • Data definitions, limitations and assumptions
    • Standard units
    • Japanese market data
    • Derivation of sales forecasts and pricing trends
    • Forecast methodology
  • APPENDIX B
    • Contributing experts
    • Conferences attended
    • Report methodology
    • About Datamonitor
    • About Datamonitor Healthcare
    • About the CNS analysis team
    • Disclaimer
  • List of Tables
    • Table 1: Sales forecasts for the opioids market, sub-markets and key brands in the seven major markets ($m), 2007-2018
    • Table 2: Updated key long-acting opioid brands by 2007 sales revenue across the seven major markets ($m)
    • Table 3: Key long-acting opioids in the late-stage R&D pipeline, 2009
    • Table 4: Tapentadol Phase III clinical trial program, 2009
    • Table 5: Short- and rapid-acting opioid brands by 2007 sales revenue across the seven major markets ($m), 2007-2018
    • Table 6: Key short- and rapid-acting opioids in the late-stage R&D pipeline, 2009
    • Table 7: Companies planning to market short- and rapid-acting opioid drugs, 2009
    • Table 8: Datamonitor's estimated launch dates for opioid products in the seven major markets, 2009-2018
    • Table 9: Key patent expiry dates for the approved opioid brands in the seven major markets, 2009-2018
  • List of Figures
    • Figure 1: Overlap in opioid subclasses
    • Figure 2: Total opioids market value ($ billion), 2007-2018
    • Figure 3: Global opioid market sales by region ($m), 2007
    • Figure 4: Change in global opioid market sales revenue by region, 2004-07
    • Figure 5: Global opioid market split by volume (IMS Standard Units), 2007
    • Figure 6: Global opioid market sales by volume (IMS Standard Units), 2004-07
    • Figure 7: Rest of world opioid sales by region ($m), 2007
    • Figure 8: Long-acting opioids sales in the seven major markets, 2005-2018
    • Figure 9: Sales by volume (IMS Standard Units) for oxycodone controlled-release (branded and generics) in the US, 2005-08
    • Figure 10: OxyContin sales revenue estimates ($m) in the US, 2007-08
    • Figure 11: OxyContin (oxycodone extended-release) sales ($m) across the seven major markets, 2007-2018
    • Figure 12: Duragesic (and other fentanyl patch brands) sales ($m) across the seven major markets, 2007-2018
    • Figure 13: Kadian (morphine extended-release) sales ($m) across the seven major markets, 2007-2018
    • Figure 14: Avinza (morphine controlled-release) sales ($m) in the US, 2007-2018
    • Figure 15: Opana ER (oxymorphone extended-release) sales ($m) in the US, 2007-2018
    • Figure 16: Misuse of oral opioid formulations
    • Figure 17: Demand for each technology by key stakeholders
    • Figure 18: Remoxy's abuse and misuse potential
    • Figure 19: Remoxy (oxycodone controlled-release gel cap) sales ($m) across the US, 2009-2018
    • Figure 20: ELI-216's abuse and misuse potential
    • Figure 21: ELI-216 (oxycodone controlled-release and naltrexone) sales ($m) across the US, 2011-2018
    • Figure 22: Embeda's abuse and misuse potential
    • Figure 23: Embeda (morphine controlled-release) sales ($m) in the US, 2009-2018
    • Figure 24: Oxytrex abuse and misuse potential
    • Figure 25: Oxytrex sales ($m) across the US, 2010-2018
    • Figure 26: Targin (morphine controlled-release and naloxone) sales ($m) in the 5EU, 2007-2018
    • Figure 27: Sufentanil patch sales ($m) in the US and 5EU, 2011-2018
    • Figure 28: Vicodin CR (hydrocodone and acetaminophen controlled-release) sales ($m) in the US, 2010-2018
    • Figure 29: Tapentadol ER sales ($m) across the US and 5EU, 2010-2018
    • Figure 30: Short- and rapid-acting opioids market across the seven major markets, 2007-2018
    • Figure 31: Short- and rapid-acting branded opioid sales ($m) across the seven major markets, 2007-2019
    • Figure 32: Short- and rapid-acting opioids market ($m) in the US, 2007-2018
    • Figure 33: Short- and rapid-acting branded opioid sales ($m) in the US, 2007-2018
    • Figure 34: Short- and rapid-acting opioids market ($m) in the five major European markets (5EU), 2007-2018
    • Figure 35: Short- and rapid-acting branded opioid sales ($m) across the five major European markets, 2007-2018
    • Figure 36: Short- and rapid-acting opioids market ($m) in Japan, 2010-2018
    • Figure 37: Short- and rapid-acting opioid brands sales ($m) in Japan, 2010-2018
    • Figure 38: Quarterly change in IMS Standard Units sold for Actiq, generic Actiq and Fentora in the US, Q3 2003-Q2 2008
    • Figure 39: Quarterly change in sales revenue for Actiq, generic Actiq and Fentora in the US, Q3 2003-Q2 2008
    • Figure 40: Quarterly price per IMS Standard Unit for Actiq, generic Actiq and Fentora in the US, Q3 2003-Q2 2008
    • Figure 41: Quarterly change in combined IMS Standard Units sold for Actiq, generic Actiq and Fentora in the US, Q3 2003-Q2 2008
    • Figure 42: Quarterly sales for Fentora in the US, and Actiq in the 5EU ($m), and non-DTC promotional spend ($m), Q1 2007-Q2 2008
    • Figure 43: Key differentiating factors for pipeline agents in the short- and rapid-acting opioids market, 2009
    • Figure 44: Time to significant analgesia (minutes)
    • Figure 45: Quarterly change in sales revenue for Actiq in the five major European markets, Q3 2003-Q2 2008
    • Figure 46: Actiq (transmucosal fentanyl) sales ($m) across the seven major markets, 2007-2018
    • Figure 47: Fentora (buccal fentanyl) sales ($m) across in the US and 5EU, 2007-2018
    • Figure 48: Image of Ionsys fentanyl patch system
    • Figure 49: Onsolis (buccal fentanyl) sales ($m) in the US and 5EU, 2009-2018
    • Figure 50: Abstral (sublingual fentanyl) sales ($m) across the seven major markets, 2009-2018
    • Figure 51: Instanyl (intranasal fentanyl) sales ($m) in the five major European markets, 2009-2018
    • Figure 52: NasalFent (intranasal fentanyl) sales ($m) across the US and 5EU, 2010-2018
    • Figure 53: Rylomine (intranasal morphine) sales ($m) across the US and 5EU, 2010-2018
    • Figure 54: AD-923 (sublingual spray fentanyl) sales ($m) in Japan, 2012-2018
    • Figure 55: Fentanyl TAIFUN (inhaled fentanyl) sales ($m) across the seven major markets, 2011-2018
    • Figure 56: Acurox's abuse and misuse potential
    • Figure 57: Acurox (oxycodone and niacin) sales ($m) in the US, 2009-2018
    • Figure 58: Tapentadol IR sales ($m) in the US and 5EU, 2009-2018