REFERENCE CODE GDHC1114CFR PUBLICATION DATE M AY 2013

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1 REFERENCE CODE GDHC1114CFR PUBLICATION DATE M AY 2013 PSORIASIS - Psoriasis - India Drug Forecast and Market Analysis to

2 Executive Summary Sales for Psoriasis in India 2012 We estimate the 2012 PsO drug sales to be $7.3m in India. By forecast end in, sales will increase to over $42.4m at a Compound Annual Growth Rate (CAGR) of 19.2%, due to the absence of pipeline therapies and biosimilars. This growth will be driven by: Figure below presents the PsO drug sales in India during the forecast period. Sales for Psoriasis in the India by Drug Class, Total: $7.33m Providing healthcare to all Indian citizens may increase drug uptake India s first home-grown brand will provide a new therapy and increase drug sales 100% Non-Steroidal Despite these drivers, the major barriers to the growth of the PsO market in India will include: 20% Total: $42.4m Alternative PsO therapies: biosimilars and Indian homeopathic medicine take away from branded drug sales Lack of IP guidelines hinders innovative drug uptake Downward pricing pressure limits drug sales growth Source: GlobalData Cytokine Inhibitor 80% Non-Steroidal Psoriasis - India Drug Forecast and Market Analysis to 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 2012 Psoriasis - India Drug Forecast and Market Analysis to 3

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 India Diagnosis Clinical Practice Competitive Assessment Overview Strategic Competitor Assessment Product Profiles Major Brands Psoriasis - India Drug Forecast and Market Analysis to 4

5 Table of Contents 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 Overview Promising Drugs in Clinical Development Psoriasis - India Drug Forecast and Market Analysis to 5

6 Table of Contents Alzumab (itolizumab) Phase II Pipeline Products Phase I Pipeline Products Biosimilars Pipeline Products Market Outlook India 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 Pricing of Pipeline agents Physicians and Specialists Included in this Study Primary Research Prescriber Survey Psoriasis - India Drug Forecast and Market Analysis to 6

7 Table of Contents 9.7 About the Authors Analysts Global Head of Healthcare About GlobalData Disclaimer Psoriasis - India Drug Forecast and Market Analysis to 7

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 Taclonex Table 8: Taclonex SWOT Analysis, Table 9: Product Profile Methotrexate Table 10: Methotrexate SWOT Analysis, Table 11: Summary of Minor Therapeutic Drug Classes for Psoriasis, Table 12: Overall Unmet Needs in Psoriasis Current Level of Attainment Table 13: Clinical Unmet Needs in Psoriasis Gap Analysis, Table 14: Psoriasis Phase Pipeline, Table 15: Comparison of Therapeutic Classes in Development for Psoriasis, Table 16: Product Profile Alzumab Table 17: Alzumab SWOT Analysis, Table 18: Global Sales Forecasts ($) for Alzumab, Table 19: Phase II Psoriasis Pipeline, Table 20: Phase I Psoriasis Pipeline, Table 21: Biosimilars Pipeline, Table 22: Sales Forecasts ($) for Psoriasis in India, Table 23: Key Events Impacting Sales for Psoriasis in India Psoriasis - India Drug Forecast and Market Analysis to 8

9 Table of Contents Table 24: Psoriasis Market in India Drivers and Barriers, Table 25: Physicians Surveyed, By Country Psoriasis - India Drug Forecast and Market Analysis to 9

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 India by Drug Class, Psoriasis - India Drug Forecast and Market Analysis to 10

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 highly-diversified 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. Psoriasis - India Drug Forecast and Market Analysis to 11

12 Introduction 2.2 Related Reports GlobalData (2013). Psoriasis US Drug Forecast and Market Analysis to, GDHC1106CFR. GlobalData (2013). Psoriasis France Drug Forecast and Market Analysis to, GDHC1107CFR. GlobalData (2013). Psoriasis Germany Drug Forecast and Market Analysis to, GDHC1108CFR. GlobalData (2013). Psoriasis Italy Drug Forecast and Market Analysis to, GDHC1109CFR. GlobalData (2013). Psoriasis Spain Drug Forecast and Market Analysis to, GDHC1110CFR. GlobalData (2013). Psoriasis United Kingdom Drug Forecast and Market Analysis to, GDHC1111CFR. GlobalData (2013). Psoriasis Japan Drug Forecast and Market Analysis to, GDHC1112CFR. GlobalData (2013). Psoriasis China Drug Forecast and Market Analysis to, GDHC1113CFR. GlobalData (2013). Psoriasis India Drug Forecast and Market Analysis to, GDHC1114CFR. GlobalData (2013). Enbrel (Psoriasis) Forecast and Market Analysis to, GDHC1177DFR. GlobalData (2013). Humira (Psoriasis) Forecast and Market Analysis to, GDHC1178DFR. GlobalData (2013). Remicade (Psoriasis) Forecast and Market Analysis to, GDHC1179DFR. Psoriasis - India Drug Forecast and Market Analysis to 12

13 Introduction GlobalData (2013). Stelara (Psoriasis) Forecast and Market Analysis to, GDHC1180DFR. GlobalData (2013). Brodalumab (Psoriasis) Forecast and Market Analysis to, GDHC1170DFR. GlobalData (2013). Secukinumab (Psoriasis) Forecast and Market Analysis to, GDHC1171DFR. GlobalData (2013). Ixekizumab (Psoriasis) Forecast and Market Analysis to, GDHC1172DFR. GlobalData (2013). MK-3222 (Psoriasis) Forecast and Market Analysis to, GDHC1173DFR. GlobalData (2013). Xeljanz (Psoriasis) Forecast and Market Analysis to, GDHC1174DFR. GlobalData (2013). Apremilast (Psoriasis) Forecast and Market Analysis to, GDHC1175DFR. GlobalData (2013). Alzumab (Psoriasis) Forecast and Market Analysis to, GDHC1176DFR. GlobalData (2013). Psoriasis Current and Future Players. GDHC1015FPR. Psoriasis - India Drug Forecast and Market Analysis to 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. Psoriasis - India Drug Forecast and Market Analysis to 89

REFERENCE CODE GDHC1174DFR PUBLICATION DATE M AY 2013

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