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Published by: Datamonitor
Published: Mar. 19, 2009 - 133 Pages
Table of 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 Grünenthal)
- 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
AbstractIntroduction
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
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