REFERENCE CODE GDHC1113CFR PUBLICATION DATE M AY 2013

Transcription

1 REFERENCE CODE GDHC1113CFR PUBLICATION DATE M AY 2013 PSORIASIS -

2 Executive Summary Sales for Psoriasis in China We estimate the 2012 PsO drug sales to be $392.2m in China. By forecast end in 2022, sales will increase to over $446.7 at a Compound Annual Growth Rate (CAGR) of 1.3%, due to the absence of pipeline therapies and biosimilars. This growth will be driven by: Figure below presents the PsO drug sales in China during the forecast period. Sales for Psoriasis in the China by Drug Class, % 37% 2012 Total: $392.2m Providing healthcare to all Chinese citizens under the Five-Year Plan will increase drug uptake 49% Prescription of branded drugs in public hospitals increases drug revenue Despite these drivers, the major barriers to the growth of the PsO market in China will include: Anti-TNF Biosimilars Non-Steroidal 14% 37% 2022 Total: $446.7m Alternative PsO therapies: biosimilars and TCM take away from branded drug sales Lack of IP guidelines hinders innovative drug uptake Lack of efficient Chinese patient cohorts hinder anti-tnf therapy uptake 49% Source: GlobalData Anti-TNF Biosimilars Non-Steroidal 2

3 Executive Summary What do the Physicians Think? Drug resistance and patients becoming refractory to therapies in less than three years have become main issues of discussion in the PsO world. The resistance issue will be an issue in the fiveyear [time] frame. We need alternative, possible alternative choices. The larger the number of available drugs, the better. [EU] key opinion leader, January 2013 The upcoming launches of the IL-17 inhibitors have KOLs extremely excited, as they hope to be able to put them to use early in the treatment paradigm. However, we encountered some physician experts who felt that the current pipeline would not unseat the established anti-tnf drugs. The use of biosimilars has also been a hot topic among dermatologists and other physicians who prescribe biologics for the warranted indications. However, there is a misconception as to the pricing of these biologic generics; we discovered mixed feelings among physicians regarding their presence due to manufacturing or pricing. I think it s an opportunity. This market is highly price-sensitive...when they come to the market; they will completely grab the market of the anti- TNFs, provided the prices are 30 to 50%. It is very significant If it s 20%, then I m disappointed. [EU] key opinion leader, January 2013 I m most excited about the antagonist IL-17. I find these drugs very effective and quite safe. I think they will probably have a role in the future. [EU] key opinion leader, January 2013 I don t think [the] new biologics coming will have an impact on the use of TNF inhibitors. [US] key opinion leader, December

4 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Symptoms Disease Management Treatment Overview China Diagnosis Clinical Practice Competitive Assessment Overview Strategic Competitor Assessment Product Profiles Major Brands

5 Table of Contents Enbrel (etanercept) Remicade (infliximab) Taclonex (calcipotriene hydrate and betamethasone dipropionate) Methotrexate Sodium (numerous generic names) Minor Therapeutic Drug Classes Used in Psoriasis Non-Pharmacological Therapy Opportunity and Unmet Need Overview Unmet Needs Improved Drug Safety and Efficacy Profiles Biomarkers for Predicting Remission More Cost-Effective Therapies Through Oral Formulation and Biosimilars Education and Treatment of Psychological Factors Accompanying Psoriasis An Effective Biologic/Systemic Topical Therapy More Effective Treatment for Mild Psoriasis, Specifically UV Therapies Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis Opportunities Unmet Needs Gap Analysis Predictive Tools for Diagnosis and Treatment Target Specificity Topical Biologic/Systemic Therapeutic Options Helping Patients with Psychological Issues Associated with Psoriasis Pipeline Assessment

6 Table of Contents 7.1 Overview Promising Drugs in Clinical Development Phase II Pipeline Products Phase I Pipeline Products Biosimilars Pipeline Products Market Outlook China Forecast Key Events Drivers and Barriers Appendix Bibliography Abbreviations Methodology Forecasting Methodology Diagnosed Psoriasis Patients Percent Drug-Treated Patients Drugs Included in Each Therapeutic Class General Pricing Assumptions Individual Drug Assumptions Generic Erosion Physicians and Specialists Included in this Study Primary Research Prescriber Survey

7 Table of Contents 9.7 About the Authors Analysts Global Head of Healthcare About GlobalData Disclaimer

8 Table of Contents 1.1 List of Tables Table 1: Immune Cells Involved in Lesions Table 2: Symptoms of Psoriasis Table 3: Minimal Investigative Measures Required Before Prescribing Biologics for Psoriasis Table 4: Treatment Guidelines for Psoriasis Table 5: Top Three Biologics Prescribed for Moderate to Severe Psoriasis by Market, Table 6: Leading Treatments for Psoriasis, Table 7: Product Profile Enbrel Table 8: Enbrel SWOT Analysis, Table 9: Product Profile Remicade Table 10: Efficacy Results of RESTORE1 Trial of Remicade vs. MTX at Week Table 11: Safety Results (AEs) of RESTORE1 Trial of Remicade vs. MTX at Week Table 12: Remicade SWOT Analysis, Table 13: Product Profile Taclonex Table 14: Taclonex SWOT Analysis, Table 15: Product Profile Methotrexate Table 16: Methotrexate SWOT Analysis, Table 17: Summary of Minor Therapeutic Drug Classes for Psoriasis, Table 18: Overall Unmet Needs in Psoriasis Current Level of Attainment Table 19: Clinical Unmet Needs in Psoriasis Gap Analysis, Table 20: Psoriasis Phase Pipeline, Table 21: Comparison of Therapeutic Classes in Development for Psoriasis, Table 22: Phase II Psoriasis Pipeline, Table 23: Phase I Psoriasis Pipeline,

9 Table of Contents Table 24: Biosimilars Pipeline, Table 25: Sales Forecasts ($) for Psoriasis in China, Table 26: Key Events Impacting Sales for Psoriasis in China Table 27: Psoriasis Market in China Drivers and Barriers, Table 28: Physicians Surveyed, By Country

10 Table of Contents 1.2 List of Figures Figure 1: Psoriatic Plaque on Elbow of Patient Figure 2: The Three Layers of the Skin and Associated Structures Figure 3: Healthy Skin Versus Psoriatic Skin Figure 4: BB-UVB Therapy Guidelines, According to the AAD Figure 5: NB-UVB Therapy Guidelines, According to the AAD Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in Psoriasis, Figure 7: Estimated Sales of Biosimilars vs. Their Branded Counterparts in Psoriasis, Figure 8: Sales for Psoriasis in China by Drug Class,

11 Introduction 2 Introduction 2.1 Catalyst The psoriasis market is currently very dynamic, with novel therapies awaiting approval, such as: Novartis interleukin-17 (IL-17) inhibitor, secukinumab Merck s interleukin-23 (IL-23) inhibitor, MK-3222 Celgene s phosphodiesterase-4 (PDE-4) inhibitor, apremilast These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, if their safety and efficacy profiles are proven once they enter the market. The impending patent cliff will allow for the emergence of biosimilars to all the marketed brands. Patent expiries begin in 2014 for the current market leaders, such as: Johnson & Johnson s Remicade (infliximab) AbbVie s (Abbott s pharmaceutical division) Humira (adalimumab) The drivers for market growth will also include affordable treatments throughout the world, as well as the push for long-term drug efficacy. India and China will also contribute to market growth as their populations obtain increasing access to Psoriasis (PsO) pharmacotherapy, but we expect slow growth, particularly in India. The challenges will be the crowded marketplace, comprising a highlydiversified field of therapies, with individual drugs struggling to distinguish themselves Amgen s Enbrel (etanercept) Johnson & Johnson s Stelara (ustekinumab) The drivers for market growth will also include affordable treatments throughout the world, as well as the push for long-term drug efficacy. India and China will also contribute to market growth as their populations obtain increasing access to PsO pharmacotherapy, but we expect slow growth, particularly in India. The challenges will be the crowded marketplace, comprising a highlydiversified field of therapies, with individual drugs struggling to distinguish themselves. 2.2 Related Reports GlobalData (2013). Psoriasis US Drug Forecast and Market Analysis to 2022, GDHC1106CFR. GlobalData (2013). Psoriasis France Drug Forecast and Market Analysis to 2022, GDHC1107CFR. 11

12 Introduction GlobalData (2013). Psoriasis Germany Drug Forecast and Market Analysis to 2022, GDHC1108CFR. GlobalData (2013). Psoriasis Italy Drug Forecast and Market Analysis to 2022, GDHC1109CFR. GlobalData (2013). Psoriasis Spain Drug Forecast and Market Analysis to 2022, GDHC1110CFR. GlobalData (2013). Psoriasis United Kingdom Drug Forecast and Market Analysis to 2022, GDHC1111CFR. GlobalData (2013). Psoriasis Japan Drug Forecast and Market Analysis to 2022, GDHC1112CFR. GlobalData (2013). Psoriasis India Drug Forecast and Market Analysis to 2022, GDHC1114CFR. GlobalData (2013). Enbrel (Psoriasis) Forecast and Market Analysis to 2022, GDHC1177DFR. GlobalData (2013). Humira (Psoriasis) Forecast and Market Analysis to 2022, GDHC1178DFR. GlobalData (2013). Remicade (Psoriasis) Forecast and Market Analysis to 2022, GDHC1179DFR. GlobalData (2013). Stelara (Psoriasis) Forecast and Market Analysis to 2022, GDHC1180DFR. GlobalData (2013). Brodalumab (Psoriasis) Forecast and Market Analysis to 2022, GDHC1170DFR. GlobalData (2013). Secukinumab (Psoriasis) Forecast and Market Analysis to 2022, GDHC1171DFR. GlobalData (2013). Ixekizumab (Psoriasis) Forecast and Market Analysis to 2022, GDHC1172DFR. 12

13 Introduction GlobalData (2013). MK-3222 (Psoriasis) Forecast and Market Analysis to 2022, GDHC1173DFR. GlobalData (2013). Xeljanz (Psoriasis) Forecast and Market Analysis to 2022, GDHC1174DFR. GlobalData (2013). Apremilast (Psoriasis) Forecast and Market Analysis to 2022, GDHC1175DFR. GlobalData (2013). Alzumab (Psoriasis) Forecast and Market Analysis to 2022, GDHC1176DFR. GlobalData (2013). Psoriasis Current and Future Players, GDHC1015FPR. 13

14 Appendix 9.8 About GlobalData GlobalData is a leading global provider of business intelligence in the healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India, and Singapore. 9.9 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of the publisher, GlobalData. 94