Commercial and Pipeline Insight: Opioids - Short acting and anti-abuse technologies set to fragment and grow the market

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the CNS pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Scope of the analysis
  • Contributing experts
  • Datamonitor insight into the opioid market
  • Related reports
• CHAPTER 2 MARKET OVERVIEW AND POTENTIAL
  • Market overview and pain definition
    • Definition of opioid market
  • Market potential
    • Epidemiology of pain
      • Incidence
      • The burden of pain on every day life
      • Commonly-reported pain conditions
    • Definition of pain
      • Nociceptive pain
      • Neuropathic pain
      • Types of pain treated with opioids
    • Diagnosis of pain
    • Treatment of pain
      • Acute pain and cancer pain
      • Chronic non-cancer pain
    • Unmet need in pain treatment
      • Need to reduce the abuse and overdosing potential of opioids
      • Need to minimize opioid-related adverse events
      • Improved short-acting opioids
  • Current market value and future market forecasts
    • Current market dynamics
      • OxyContin dominates the opioid market
      • The US generated more revenue from opioid therapies than the EU and Japan combined
    • The opioid market is set to grow throughout the forecast period
      • Short-acting opioids-large growth driver
      • Anti-abuse reformulations take share from OxyContin
      • Generics are ever present
• CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
  • Marketed brands overview
  • Short-acting opioid brands
    • Actiq (fentanyl oral transmucosal)
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Clinical trial data
    • Fentora
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Patient potential
      • Marketing factors
      • Clinical trial data
  • Long-acting opioid brand
    • OxyContin (oxycodone HCl controlled-release)
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Clinical trial data
    • Kadian (morphine sulfate XR)
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Clinical trial data
    • Avinza (morphine sulfate XR)
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Clinical trial data
    • Duragesic (fentanyl transdermal patch)
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Clinical trial data
    • Opana
      • Drug overview
      • Forecasts to 2017
      • SWOT analysis
      • Clinical trial data
• CHAPTER 4 FORECAST ANALYSIS
  • Key events
    • New product launches
      • Key drug launch assumptions
    • Product launches in Japan
    • Patent expiries
  • Data definitions, limitations and assumptions
    • Standard units
    • Japanese market data
    • Derivation of sales forecasts and pricing trends
  • Forecast methodology
• CHAPTER 5 STRATEGIES FOR SUCCESS
  • Broaden customer base with key additional indications
    • Back pain
    • Postoperative pain
    • Neuropathic pain
    • Osteoarthritis
    • Refractory migraine
  • Opportunities for specialized niche companies to enter the market
  • Delivery reformulation
  • Anti-abuse technologies
• CHAPTER 6 PIPELINE OVERVIEW-R&D DYNAMICS AND APPROACH
  • Pipeline overview
  • Classification of pipeline products
    • Majority of pipeline products are reformulations of existing opioids
    • Short-acting opioids
      • Oral transmucosal opioids
      • Intranasal opioids
      • Oral inhaled opioids
    • Long-acting opioids
      • Oral opioids
      • Subcutaneous opioids
      • Transdermal opioids
  • Clinical trial design
    • Actiq clinical trials set the standard
    • Actiq pivotal trial overview
  • Clinical trial endpoints in pain
    • Primary endpoints: the brief pain inventory is often used to assess pain in cancer patients
    • Secondary endpoints: economic and quality-of-life measures are important
• CHAPTER 7 SHORT-ACTING OPIOID DRUG ANALYSIS & FORECASTS
  • Late-stage short-acting pipeline overview
  • Fentanyl based formulations
    • Rapinyl (sublingual)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
    • BEMA fentanyl (buccal)
      • Drug overview
      • Forecasts to 2017
      • Marketing factors
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
    • Instanyl (intranasal)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
    • Nasalfent (intranasal)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical data
    • AD-923 (sublingual spray)
      • Drug overview
      • Ongoing clinical trial program
      • Forecasts to 2017
    • HFT-290 (transdermal)
  • Morphine-based formulations
    • Rylomine (intranasal)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
  • Buprenorphine based formulations
    • V1003 (intranasal)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Clinical trial data
    • BEMA LA (buccal)
      • Drug overview
      • Clinical trial data
  • Drugs on hold
    • Taifun (inhaled)
      • Drug overview
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
    • AeroLEF (inhaled)
      • Drug overview
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
• CHAPTER 8 LONG-ACTING OPIOID DRUG ANALYSIS & FORECASTS
  • Late-stage long-acting pipeline overview
  • Oxycodone based formulations
    • Remoxy (oxycodone)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
    • Oxytrex (oxycodone and naltrexone)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Ongoing clinical trial program
    • ELI-216 (naltrexone hydrochloride, oxycodone)
      • Drug overview
      • Marketing potential
      • Patient potential
      • Ongoing clinical trial program
    • Acurox/OxyADF (oxycodone) tablet
      • Drug overview
      • Clinical trial data
  • Morphine-based formulations
    • Embeda (morphine sulfate, naltrexone hydrochloride)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Satisfaction of unmet needs
      • Clinical trial data
    • Morphine-6-glucuronide (M6G)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Clinical trial data
    • Egalet morphine (morphine)
    • EpiCept MP/DP (morphine, lidocaine)
      • Drug overview
  • Tramadol-based formulations
    • Tapentadol
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Clinical trial data
    • Tramadol ER
      • Drug overview
      • Forecasts to 2017
      • Clinical trial data
    • NS-315 (tramadol hydrochloride)
      • Drug overview
    • BVF-146 (tramadol in combination with NSAID)
  • Other
    • Ionsys (transdermal delivery system)
      • Drug overview
      • Forecasts to 2017
      • Marketing potential
      • Patient potential
      • Clinical trial data
    • Sufentanil patch
      • Drug overview
      • Forecasts to 2017
      • Clinical trial data
    • Vicodin CR
      • Drug overview
      • Forecasts to 2017
    • Hydromorphone nasal spray
      • Drug overview
      • Clinical trial data
    • Q8003IR (morphine and oxycodone)
      • Drug overview
      • Clinical trial data
    • ADL-5859
      • Drug overview
      • Clinical trial data
    • Nalbuphine ER
      • Drug overview
      • Clinical trial data
    • NRP-290
      • Drug overview
      • Clinical trial data
    • MGX-001
      • Drug overview
  • Suspended drugs
    • Titragesia (fentanyl)
• CHAPTER 9 EARLY-STAGE PROJECTS
  • Key Phase I and earlier opioids in development
    • Phase I overview
    • TPM-01/ Morphine
    • CR665
      • Clinical trial data
• BIBLIOGRAPHY
  • Journal papers
  • Websites
  • DM reports
• APPENDIX
  • Report methodology
    • Contributing experts
  • About Datamonitor
    • About Datamonitor Healthcare
    • About the CNS team
    • Disclaimer
  • List of Tables
    • Table 1: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain
    • Table 2: Characteristics of immediate-release opioids useful for breakthrough pain
    • Table 3: Side effects experienced in OxyContin clinical trials
    • Table 4: Forecast launch dates in the US and 5EU
    • Table 5: Forecast launch dates in Japan
    • Table 6: Pivotal patent expiries for key marketed drugs in the US and 5EU
    • Table 7: Key pipeline opioids in late-stage development , 2008
    • Table 8: Characteristics of patients enrolled in the Farrar Actiq trial
    • Table 9: Key short-acting opioids in late-stage development, 2008
    • Table 10: Key long-acting opioids in late stage development, 2008
    • Table 11: Opioids in Phase development, 2008
    • Table 12: Datamonitor drug assessment parameters
  • List of Figures
    • Figure 1: Historical (2006) and forecast (2007-17) sales revenue for key marketed and pipeline opioids across the 7MM
    • Figure 2: Key unmet needs in the opioid market
    • Figure 3: The current versus ideal approach to breakthrough pain treatment
    • Figure 4: Onset of action versus duration of action of opioid formulations
    • Figure 5: Opioid sales revenue trend, 7MM, 2004-E2007
    • Figure 6: Estimated sales revenue generated by opioids per molecule, 2007
    • Figure 7: Opioid sales by revenue, by region and country, 2006-17
    • Figure 8: Opioid total market value in the US, Japan and 5EU split by molecule, 2006-17
    • Figure 9: Opioid total market value in the US, Japan and 5EU, 2006-17
    • Figure 10: Short-acting opioids sales revenue ($m), 7MM, 2006-17
    • Figure 11: Sales revenue ($m) of key long-acting opioids, 2006-17
    • Figure 12: Historical sales revenue (2006-07) and forecast sales revenue (2008-17) for key opioids across the 7MM
    • Figure 13: Actiq sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 14: Actiq SWOT analysis
    • Figure 15: Fentora sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 16: Drug assessment summary for Fentora, 2008
    • Figure 17: Fentora SWOT analysis
    • Figure 18: OxyContin sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 19: Drug assessment summary for OxyContin, 2008
    • Figure 20: OxyContin SWOT analysis
    • Figure 21: Kadian sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 22: Kadian SWOT analysis
    • Figure 23: Avinza sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 24: Avinza SWOT analysis
    • Figure 25: Duragesic sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 26: Duragesic SWOT analysis
    • Figure 27: Opana franchise sales revenue ($m) across the 7MM, 2006-07 estimates, 2008-17 forecasts
    • Figure 28: Opana ER SWOT analysis
    • Figure 29: Impact of each key event on the opioid market across the seven major markets, 2007-12
    • Figure 30: Cephalon' s breakthrough pain franchise, 2004-07
    • Figure 31: Cephalon' s franchise as a percentage of Q1 2004 Standard Units
    • Figure 32: Drugs in development by class, 2008+
    • Figure 33: Actiq study design
    • Figure 34: Historical (2006), estimated (2007) and forecast (2008-17) sales revenue for key short-acting pipeline opioids across the 7MM
    • Figure 35: Drug assessment summary overview of key pipeline short-acting opioids, 2008
    • Figure 36: Sales forecast for Rapinyl to 2017 in the 7MM
    • Figure 37: Drug assessment summary for Rapinyl, 2008
    • Figure 38: Sales forecast for BEMA Fentanyl to 2017 in the 7MM
    • Figure 39: Drug assessment summary for BEMA Fentanyl, 2008
    • Figure 40: Sales forecast for Instanyl to 2017 in the 7MM
    • Figure 41: Drug assessment summary for Instanyl, 2008
    • Figure 42: Sales forecast for Nasalfent to 2017 in the 7MM
    • Figure 43: Drug assessment summary for Nasalfent, 2008
    • Figure 44: Sales forecast for sublingual spray to 2017 in the 7MM
    • Figure 45: Drug assessment summary for sublingual spray, 2008
    • Figure 46: Sales forecast for Rylomine to 2017 in the 7MM
    • Figure 47: Drug assessment summary for Rylomine, 2008
    • Figure 48: Sales forecast for V1003 to 2017 in the 7MM
    • Figure 49: Drug assessment summary for V1003, 2008
    • Figure 50: Key long-acting opioid late-stage pipeline overview, 2008
    • Figure 51: Drug assessment summary overview of key pipeline long-acting opioids, 2008
    • Figure 52: Sales forecast for Remoxy to 2017 in the 7MM
    • Figure 53: Drug assessment summary for Remoxy, 2008
    • Figure 54: Sales forecast for Oxytrex to 2017 in the 7MM
    • Figure 55: Drug assessment summary for Oxytrex, 2008
    • Figure 56: Sales forecast for Embeda to 2017 in the 7MM
    • Figure 57: Drug assessment summary for Embeda, 2008
    • Figure 58: Sales forecast M6G to 2017 in the 7MM
    • Figure 59: Drug assessment summary for M6G, 2008
    • Figure 60: Sales forecast for Tapentadol to 2017 in the 7MM
    • Figure 61: Drug assessment summary for Tapentadol, 2008
    • Figure 62: Sales forecast for Ionsys to 2017 in the 7MM
    • Figure 63: Sales forecast for the Sufentanil patch to 2017 in the 7MM
    • Figure 64: Sales forecast for Vicodin CR to 2017 in the 7MM
    • Figure 65: Drug assessment summary for Vicodin CR, 2008