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Published by: Datamonitor
Published: Mar. 26, 2008 - 233 Pages
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
AbstractIntroduction
The opioid market is currently valued at $7.7 billion and is set to increase over the next 10 years at a CAGR of 2.4%. Despite this market being exclusively comprised of old genericized molecules, novel formulations and delivery methods have stimulated growth over the last 5 years. This growth is set to continue as current market players instigate lifecycle management strategies to retain value.
Scope
Sales volume and value forecasts to 2017 of marketed brands, generics, and key late-stage pipeline drugs. Analysis of patient potential, unmet needs and clinical trial design in the opioid market. Overview of key marketed brands, late- and early-stage pipeline drugs. Identification of future market events that are expected to affect opioid revenues.
Highlights
Short-acting opioids represent good in-licensing opportunities for companies with large sales and marketing resources. This market is expected to triple in value over the next 10 years, driven by Cephalon's Fentora for use in breakthrough pain, and supported by other new short-acting fentanyl formulations. The long-acting opioid market was valued at over $3 billion in 2007, and is due to grow until the patent expiry of market leader OxyContin in 2011. After a short lived decline, market growth will be stimulated by the launch of anti-abuse formulations, a technical development anticipated to create a $1 billion market. The topical market represents an opportunity for companies to enter a comparatively underserved market. Although Johnson and Johnson's market leading Duragesic (fentanyl patch) has faced generic opposition since 2005, sales remain relatively strong due to brand strength and the lack of branded competition.
Reasons to Purchase
Benchmark key late-stage pipeline opioids against current market leading brands. Assess region-specific (US, Japan, 5EU) sales forecasts of key late-stage pipeline drugs and marketed brands. Understand unmet needs and opportunities in the opioid market based on key opinion leader comments.
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