Pipeline Insight: Breakthrough Pain

Fast-acting players will capture majority market share

Publication Date	November 2006
Publisher	Datamonitor
Product Type	Report
Pages	140
ISBN Number	not applicable
Product Code	DAT04541

Buy this product or for assistance call +44 20 7060 7474

PDF £6,855.00$11403 | €7672

FAX Order above formats by FAX

Summary

Introduction

In spite of generic Actiq competition, Cephalon's reign of the breakthrough pain market will be secured in the short-term with sales of its follow-on brand Fentora. From 2008, however, a number of fast-acting analgesics will enter the arena and battle for market share; this and other growth drivers will see the market more than double from 2005 to reach an estimated $2.5 billion in 2016.

Scope

Discussion and quantification of the patient potential and market size of breakthrough pain in both malignant and non-malignant diseases
Assessment of the unmet clinical needs in breakthrough pain as validated by interviewed international opinion leaders
Detailed overview and assessment of key drugs in Phase II and above clinical development, including Fentora, Rapinyl, and BEMA Fentanyl
Ten-year sales forecasts to 2016 for key pipeline products

Highlights

Relatively high unmet clinical need, additional patient groups, the launch of new products, and no further key patent expiries within the next ten years will see the breakthrough pain market more than double from 2005 to reach $2.5 billion in 2016.

As well as for oral transmucosal fentanyl products, opportunities also exist for non-oral analgesics. Intranasal and inhaled technology may provide convenient and fast acting analgesia and are potentially suitable for self-administration in the lucrative outpatient setting.

A key growth strategy will be to gain initial approval for cancer breakthrough pain and then drive sales in additional indications through off-label use or regulatory approval. Key non-malignant applications for fast acting analgesics include breakthrough pain in post-operative pain, chronic low back, and osteoarthritic pain.

Reasons to Purchase

Explore the strategies that have made Cephalon the market leading company in breakthrough pain
Examine the potential for intranasal and inhaled analgesics and what other factors companies are using to differentiate their products
Analyze the competitive environment at the time of product launch and identify lucrative gaps in the market

Content

Chapter 1 Executive Summary
- Scope of the analysis
- Datamonitor insight into the breakthrough pain market
- Summary
Chapter 2 Patient Potential
- Definition of breakthrough pain
- Epidemiology of breakthrough pain
- Breakthrough cancer pain
- Breakthrough pain is more prevalent in advanced cancer stages
- Patients have between four to seven episodes per day
- Breakthrough pain is a common cause of hospital admissions
- Breakthrough pain in non-malignant diseases
- Breakthrough pain also occurs in neuropathic, musculoskeletal, visceral and postoperative pain syndromes
- Market sizing assumptions and caveats
- Unmet need in breakthrough pain
- Need for an analgesic that acts rapidly, predictably, and just for the duration of a breakthrough pain episode
- Need for quick, simple, and safe drug administration
- Need for improved convenience, cost, and safety of patient-controlled analgesia
- Need to reduce the abuse and overdosing potential of opioids
- Need to minimize opioid-related adverse events
- Need for standardized diagnosis and assessment tools for breakthrough pain
Chapter 3 R&d Approach
- Classification of pipeline products
- Majority of pipeline products are reformulations of existing opioids
- Oral transmucosal opioids
- Oral inhaled opioids
- Intranasal opioids
- Subcutaneous opioids
- Transdermal opioids
- Clinical trial design in breakthrough pain
- Actiq clinical trials set the standard
- Actiq pivotal trial overview
- Clinical trial endpoints in breakthrough 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 4 Breakthrough Pain Pipeline Analysis
- Pipeline overview
- The success of Actiq and established efficacy make fentanyl a popular target
- Key companies involved in the breakthrough pain pipeline
- Cephalon: leading the way in breakthrough pain
- Strong CNS focus is good for market growth
- Follow-on drug strategy can offset generic incursion
- Drug delivery expertise provides positive long term outlook
- Leverage oncology resource to reach out to key treatment decision makers
- Strategies for success
- Broaden customer base with key additional indications
- Back pain
- Postoperative pain
- Neuropathic pain
- Osteoarthritis
- Refractory migraine
Chapter 5 Late-Stage Drug Analysis & Forecasts
- Overview
- Late stage pipeline summary
- Definition of current comparator therapy
- Comparison of key compounds
- Comparative forecasts
- Fentora
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Rapinyl
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- BEMA Fentanyl
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Intranasal morphine gluconate, nastech
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Rylomine (intranasal morphine)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- PMI-150 (intranasal ketamine)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Fentanyl Taifun (oral inhaled fentanyl)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- AeroLEF (oral inhaled fentanyl)
- Profile
- Drug overview
- Clinical trial data
- Patient potential
- Marketing factors
- Satisfaction of unmet needs
- Forecasts to 2016
- Datamonitor drug assessment summary
- Other drugs
- Titragesia (transdermal fentanyl patch)
- Pain pen (subcutaneous hydromorphone injection)
- TPM-01 (transdermal morphine cream)
- AD-923 (sublingual fentanyl)
- nasalfent (intranasal fentanyl)
Bibliography
- Journal articles and conference abstracts
- Websites
Appendix A
- Contributing experts
- Sales forecasts
- Competitive positioning analysis of pipeline breakthrough pain drugs
- Methodology
- Datamonitor forecast methodology and assumptions
- Product forecasts
- Estimation of launch dates
- Patient expiry and generic assumptions
- Definition of a standard unit
Appendix B
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- About the CNS analysis team
- Disclaimer
List of Tables
- Table 1: Prevalence of breakthrough pain across the seven major markets, 2006
- Table 2: Estimation of the breakthrough pain market across the seven major markets, 2005
- Table 3: Characteristics of immediate-release opioids useful for breakthrough pain
- Table 4: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain
- Table 5: Characteristics of patients enrolled in the Farrar et al. (1998) Actiq trial
- Table 6: Number of R&D projects in each class split by mode of delivery, 2006
- Table 7: Clinical R&D pipeline for breakthrough pain drugs, 2006
- Table 8: Cephalon's inline and pipeline pain product range, 2006
- Table 9: Key products in late-stage R&D pipeline for breakthrough pain, 2006
- Table 10: Primary opioid-related adverse events for 130 patients initially enrolled in the trial of Actiq for cancer-related breakthrough pain
- Table 11: Pharmacokinetic parameters in adult subjects receiving the various doses of Actiq
- Table 12: Fentora product claims on www.fentora.com
- Table 13: Key approval and launch dates impacting Fentora's revenue forecast, 2006-2016
- Table 14: Key approval and launch dates impacting Rapinyl's revenue forecast, 2006-2016
- Table 15: BEMA technology product claims taken from BioDelivery Sciences's website
- Table 16: Key approval and launch dates impacting BEMA Fentanyl revenue forecast, 2006-2016
- Table 17: Key approval and launch dates impacting intranasal morphine gluconate revenue forecast, 2006-2016
- Table 18: Key approval and launch dates impacting Rylomine revenue forecast, 2006-2016
- Table 19: Key approval and launch dates impacting PMI-150 revenue forecast, 2006-2016
- Table 20: Key approval and launch dates impacting Fentanyl Taifun revenue forecast, 2006-2016
- Table 21: Key approval and launch dates impacting AeroLEF revenue forecast, 2006-2016
- Table 22: Datamonitor's forecast sales of pipeline breakthrough pain drugs and the total breakthrough pain market across the seven major markets ($m), 2006-2016
- Table 23: Summary of commercial and research/clinical attractiveness of late-stage drugs for breakthrough pain
- Table 24: Estimation of launch dates by phase of development
- Table 25: Estimated generic discounts by country, 2006*
- Table 26: Estimates of brand erosion by following patent expiry by country
List of Figures
- Figure 1: Datamonitor's breakthrough pain forecast market across the seven major markets, 2006-2016
- Figure 2: Datamonitor breakthrough pain drug assessment summary, 2006-2016
- Figure 3: The different types of breakthrough pain
- Figure 4: The current versus ideal approach to breakthrough pain treatment
- Figure 5: Onset of action versus duration of action of opioid formulations
- Figure 6: Actiq study design
- Figure 7: Breakthrough pain drug pipeline by development phase and formulation, 2006
- Figure 8: Breakdown of the breakthrough pain pipeline by formulation, 2006
- Figure 9: Breakdown of the pipeline by molecule, 2006
- Figure 10: Difference in pain intensity between Actiq and placebo (ITT analysis)
- Figure 11: Pain relief of Actiq versus placebo (ITT analysis)
- Figure 12: Datamonitor's comparative forecast of sales for key products across the seven major markets ($m), 2006-2016
- Figure 13: Pain intensity difference of Fentora versus placebo over time
- Figure 14: Comparison of pain intensity difference scores of Actiq versus Fentora
- Figure 15: Datamonitor's forecast of sales for Fentora across the seven major markets ($m), 2006-2016
- Figure 16: Datamonitor's competitive positioning analysis for Fentora, 2006-2016
- Figure 17: Datamonitor's forecast of sales for Rapinyl across the seven major markets ($m), 2006-2016
- Figure 18: Datamonitor's competitive positioning analysis for Rapinyl, 2006-2016
- Figure 19: Datamonitor's forecast of sales for BEMA Fentanyl across the seven major markets ($m), 2006-2016
- Figure 20: Datamonitor's competitive positioning analysis for BEMA Fentanyl, 2006-2016
- Figure 21: Datamonitor's forecast of sales for Intranasal morphine gluconate across the seven major markets ($m), 2006-2016
- Figure 22: Datamonitor's competitive positioning analysis for Intranasal morphine gluconate, 2006-2016
- Figure 23: Datamonitor's forecast of sales for Rylomine across the seven major markets ($m), 2006-2016
- Figure 24: Datamonitor's competitive positioning analysis for Rylomine, 2006-2016
- Figure 25: PMI-150 study design
- Figure 26: Datamonitor's forecast of sales for PMI-150 across the seven major markets ($m), 2006-2016
- Figure 27: Datamonitor's competitive positioning analysis for PMI-150, 2006-2016
- Figure 28: Datamonitor's forecast of sales for Fentanyl Taifun across the seven major markets ($m), 2006-2016
- Figure 29: Datamonitor's competitive positioning analysis for Fentanyl Taifun, 2006-2016
- Figure 30: Datamonitor's forecast of sales for AeroLEF across the seven major markets ($m), 2006-2016
- Figure 31: Datamonitor's competitive positioning analysis for AeroLEF, 2006-2016