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

Content

• 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