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EXECUTIVE SUMMARY Scope Datamonitor insight into the pain market Marketing strategy will be key in establishing high revenue products in the COX-II inhibitor market. Direct-to-consumer advertising and the successful management of the cardiovascular concerns associated with COX-II inhibitors will be important determinates to product uptake, while new indications will expand the patient potential of this market and will be key to Arcoxia achieving market leadership of second generation COX-II inhibitors by 2009 The opioid pipeline is dominated by new formulations of traditional opioid molecules specifically targeting niche markets. Though sales revenues for these opioid products will be low compared to COX-II inhibitors, return on investment will be high due to reduced research and marketing costs. The pending patent expiry of Neurontin will greatly impact the dynamics of the neuropathic pain market. However, the improved clinical profile of pregabalin, coupled with its uptake in additional markets, will keep Pfizer as the dominant company in this pain market for the foreseeable future. Key metrics TABLE OF CONTENTS PATIENT POTENTIAL Definition of pain Nociceptive pain Neuropathic pain Classification of pain types Postoperative pain Cancer pain Back pain HIV pain Neuropathies Arthritis Future trends in the incidence and prevalence of pain Postopertaive pain Cancer pain Back pain HIV pain Neuropathies Arthritic pain Diagnosis and treatment Diagnosis of pain type Diagnosis of pain severity Treatment of pain Unmet needs in pain Improved efficacay Adverse side effects Drug delivery formulations Other unmet needs R&D APPROACH Classification of pipeline products NSAIDs Opioids Class 3: Opioid combination therapies Other analgesics Definition of current ‘gold standard’ / comparator therapies NSAIDs Opioids Other analgesics Clinical trials endpoints in pain Pain scale ratings Pain questionnaire responses ACR values Quantitative sensory testing Critique of clinical trial design in pain PAIN PIPELINE OVERVIEW Pipeline overview Key drug delivery strategies in the pain market Product differentiation and improvement of unsuccessful compounds Protection from generic competition Return on investment and time to market Drug delivery formulations within the 2002 pain pipeline Key licensing strategies in the pain market Pipeline analysis by class Pipeline analysis by individual company Merck & Co Inc CeNeS GlaxoSmithKline Endo Pharmaceuticals Pfizer Pipeline analysis by licensing opportunity ML 3000 – EuroAlliance DepoMorphine- SkyePharma Devacade – Merck LATE STAGE DRUG ANALYSIS Comparative analysis of NSAIDs Comparative analysis of opioids Comparative analysis of novel compounds Late stage NSAID drug profiles Overview table for NSAID pipeline products Bextra (valdecoxib) Arcoxia (etoricoxib) ML 3000 Prexige (COX-189) Dynastat (parecoxib) NO-naproxen (HCT- 3012) Late stage opioid drug profiles Overview table for opioid pipeline products DepoMorphine (morphine) Numorphan TRx/ Oxymorphone Moraxen Avinza/Morphelan (morphine sulphate) AERx PMS (morphine) Oxycodone/Ibuprofen CEE 04-410 (Morphine 6-glucuronide) E-TRANS fentanyl (Transfenta) Late stage novel compounds Overview table for novel pipeline products Ziconotide Devacade (devazepide) Memantine Pregabalin Morphidex (dextromethorphan & morphine) CNS- 5161 INNOVATIVE EARLY STAGE PROJECTS Key drugs in early phase devolvement products NicOX- 701 (NO-paracetamol) Levetiracetam (Keppra) THE FUTURE DECODED Methodology Predicting initial market share Forecasting future growth Influencing factors Market drivers in pain Prospective drug launches in pain Forecast launches in pain from 2002 to 2009 Key R&D product forecasts Bextra Dynastat Arcoxia Prexige Avinza Moraxen DepoMorphine Numorphan AERx Morphidex Ziconotide Memantine Pregabalin Top 5 leading products by 2009 Alternative scenario APPENDIX Datamonitor's Central Nervous System Business Unit Introduction About the author Contributing experts Table of tables Table of figures Bibliography Epidemiology R & D Internet sites R&D research methodology Introduction Hypothesis formulation Hypothesis testing Data verification and quality control Quantification of data reliability