REFERENCE CODE GDHC209CFR PUBLICAT ION DATE J ANU ARY 2014 CROHN S DISEASE 5EU DRUG FORECAST AND MARKET ANALYSIS TO 2022

Size: px
Start display at page:

Download "REFERENCE CODE GDHC209CFR PUBLICAT ION DATE J ANU ARY 2014 CROHN S DISEASE 5EU DRUG FORECAST AND MARKET ANALYSIS TO 2022"

Transcription

1 REFERENCE CODE GDHC209CFR PUBLICAT ION DATE J ANU ARY 2014 CROHN S DISEASE 5EU DRUG FORECAST AND MARKET ANALYSIS TO 2022

2 Executive Summary The below mentioned table presents the key metrics for Crohn s disease (CD) in the 5 major EU markets: Crohn s Disease: Key Metrics in the 5EU Markets 2012 Market Sales France Germany Italy Spain UK Total Key Events ( ) Approval and launch of Takeda s Entyvio: 2014 J&J s Remicade patent expiry: 2015 Infliximab biosimilars launch: 2015 Approval and launch of J&J s Stelara: 2015 AbbVie s Humira patent expiry: 2018 Adalimumab biosimilars launch: 2018 Approval and launch of ChemoCentryx s vercirnon: Market Sales France Germany Italy Spain UK Total Source: GlobalData $95.6m $79.7m $52.5m $68.2m $100.8m $396.8m Type of Impact $119.5m $84.0m $58.0m $79.8m $116.3m $457.6m Sales for CD in the 5 Major EU markets in : The 5 Major EU CD market was worth approximately $396.8 million in 2012, with an estimated increase in total sales to $457.6 million in Major growth drivers in the 5EU CD market over the forecast period include: High number of CD sufferers Introduction of new biologics during the early forecast period Germany s comfort and experience with biosimilars will pave the way for the rapid uptake of anti-tnf biosimilars Continued uptake of TNF inhibitors Italian Medicines Agency s ongoing initiatives to promote biosimilar use Continued uptake of TNF inhibitors, like Humira particularly in Spain. Conversely, major barriers to the growth of the CD market in the 5EU include: Physicians not subscribing to the EMA s view of indication extrapolation for anti-tnf biosimilars Cost-containment measures to reduce medical care costs and ensure the future financial stability of the Statutory Health Insurance (SHI) may hinder the uptake of high-priced therapies. 2

3 Executive Summary Declining patient population pool over the coming decade Securing the NICE s recommendation is critical for drug uptake particularly in the UK market. Below mentioned figure illustrates the sales for CD in 5EU by region during the 10-year forecast period. CD: Sales of CD by Countries, % Total: $396.8m 24% 17% 20% France Germany Italy Spain 13% UK What Do Physicians Think? Following the approval of Hospira/Celltrion s Inflectra, a biosimilar of the market-leading biologic, Remicade, in September 2013 for the multiple autoimmune indications for which Remicade is approved, some KOLs highlighted that they would await data from a CD- or an IBDspecific trial before prescribing Inflectra for their CD or UC patients. This, in turn, could limit the initial uptake of Inflectra. I am not interested in [using] Inflectra in [my] IBD [patients] unless it is tested in IBD[-specific] clinical trials. [EU] key opinion leader KOLs stressed that predicting the course of CD remains the most challenging aspect of managing their CD patients. 25% 26% 2022 Total: $457.6m I think the most challenging aspect is to, first of all, risk-stratify as to what patients are going to do badly in the long run, and trying to tailor an France effective therapy for them. 18% 13% 18% Germany Italy Spain UK [Outside-US] key opinion leader Having biomarkers included in their diagnostic tools is important to gastroenterologists, as it could allow them to effectively predict the course of CD Source: GlobalData in a given patient and allow them to offer a personalized treatment approach. 3

4 Executive Summary I think we need a more biomarker-based approach.i think we are falsely diagnosing early disease. With Crohn s, two days of endoscopic techniques and two days of radiological assessments are precise enough to allow you to see the morphological damage, but in pre-stage patients at risk of developing the disease, we do have difficulties in properly assessing the disease. [EU] key opinion leader KOLs stressed their desire for new drug therapies to treat the anti-tnf refractory patient segment. We are learning that the anti-tnf therapies have a limited lifespan.we are going to run into a problem where we have a lot of people losing response to anti-tnf therapy early on in their disease course, and then they don t have an option later on. [US] key opinion leader KOLs validated that emerging therapies with novel MOAs will form the basis of their treatment paradigm. In the future, what we will do is either switching of anti-tnf therapies, or we will switch to alternative mechanisms, and we will soon have [the] alpha4beta7, vedolizumab. [EU] key opinion leader According to KOLs, anti-il-6 therapies, which are currently in early clinical development, hold promise. There are so many companies out there with anti- IL-6 agents that I feel there could be a new paradigm coming up, which could add to the value of innovation not just to the molecule, but also to the way we use it. [EU] key opinion leader All these drugs [anti-tnfs] have a finite natural history, as we rapidly move from one drug to another, and five years down the road, someone with a history of Crohn s is going to be with no treatment options. [US] key opinion leader 4

5 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 Prognosis Quality of Life Disease Management Treatment Overview France Diagnosis Clinical Practice Germany Diagnosis Clinical Practice Italy Diagnosis Clinical Practice Spain

6 Table of Contents Diagnosis Clinical Practice UK Diagnosis Clinical Practice Competitive Assessment Overview Strategic Competitor Assessment Product Profiles Major Brands Remicade (infliximab) Humira (adalimumab) Cimzia (certolizumab pegol) Tysabri (natalizumab) Other Marketed Products Biosimilars Introduction Hospira s Inflectra Versus J&J s Remicade in Key Autoimmune Diseases Biosimilars in the Immunology Community By the Numbers: Biosimilars in Development The Impact of Biosimilars Will be Felt Through out the Pharmaceutical Industry Opportunity and Unmet Need Overview Physicians Desire Biomarkers That Will Allow a Personalized Treatment Approach More Therapies for Anti-TNF-Refractory Patients Unmet Needs Gap Analysis Targeted Therapies Predictive Tools for Early Diagnosis and Treatment

7 Table of Contents 7 Pipeline Assessment Overview Promising Drugs in Clinical Development Entyvio (vedolizumab) Stelara (ustekinumab) Vercirnon (formerly GSK ) Other Late-Stage Pipeline Products Cx RHB-104 (clarithromycin + clofazimine + rifabutin) Market Outlook Global Markets Drivers and Barriers Global Issues EU France Forecast Key Events Drivers and Barriers Germany Forecast Key Events Drivers and Barriers Italy Forecast Key Events Drivers and Barriers Spain Forecast

8 Table of Contents Key Events Drivers and Barriers UK Forecast Key Events Drivers and Barriers Appendix Bibliography Abbreviations Methodology Forecasting Methodology Diagnosed CD Patients Percent Drug-Treated Patients Drugs Included in Each Therapeutic Class Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Generic Erosion Pricing of Pipeline agents Physicians and Specialists Included in This Study Primary Research Prescriber Survey About the Authors Author/Reviewer Global Head of Healthcare About GlobalData Disclaimer

9 Table of Contents 1.1 List of Tables Table 1: Symptoms of CD Table 2: Treatment Guidelines for CD Table 3: Most Commonly Prescribed Drugs for CD in the Global Markets by Disease Severity, Table 4: Leading Branded Drugs Used to Treat CD Table 5: Product Profile Remicade Table 6: Remicade SWOT Analysis, Table 7: Product Profile Humira Table 8: Humira SWOT Analysis, Table 9: Product Profile Cimzia Table 10: Cimzia SWOT Analysis, Table 11: Product Profile Tysabri Table 12: Tysabri SWOT Analysis, Table 13: Summary of the Minor Therapeutic Classes in CD, Table 14: Biosimilars Pipeline, Table 15: Overall Unmet Needs in CD Current Level of Attainment Table 16: Clinical Unmet Needs in CD Gap Analysis, Table 17: Promising Drugs in Clinical Development for CD Pipeline Phase, Table 18: Comparison of Therapeutic Classes in Development for CD, Table 19: Product Profile Entyvio Table 20: Efficacy of Entyvio in GEMINI II Studies of CD Table 21: Entyvio SWOT Analysis, Table 22: Product Profile Stelara

10 Table of Contents Table 23: Comparison of Stelara s Phase IIb CERTIFI trial Efficacy Data Versus Tysabri s Phase III Efficacy Data in Anti-TNF Refractory CD Patients Table 24: Stelara SWOT Analysis, Table 25: Product Profile Vercirnon Table 26: Vercirnon SWOT Analysis, Table 27: Product Profile Cx Table 28: Cx601 SWOT Analysis, Table 29: Product Profile RHB Table 30: RHB-104 SWOT Analysis, Table 31: Global CD Market Drivers and Barriers, Table 32: Sales Forecasts ($) for CD in France, Table 33: Key Events Impacting Sales for CD in France, Table 34: CD Market in France Drivers and Barriers, Table 35: Sales Forecasts ($) for CD in Germany, Table 36: Key Events Impacting Sales for CD in Germany, Table 37: CD Market in Germany Drivers and Barriers, Table 38: Sales Forecasts ($) for CD in Italy, Table 39: Key Events Impacting Sales for CD in Italy, Table 40: CD Market in Italy Drivers and Barriers, Table 41: Sales Forecasts ($) for CD in Spain, Table 42: Key Events Impacting Sales for CD in Spain, Table 43: CD Market in Spain Drivers and Barriers, Table 44: Sales Forecasts ($) for CD in the UK, Table 45: Key Events Impacting Sales for CD in the UK, Table 46: CD Market in the UK Drivers and Barriers,

11 Table of Contents Table 47: Key Launch Dates Table 48: Key Patent Expiries Table 49: Physicians Surveyed, By Country List of Figures Figure 1: Mucosa of the Bowel in a Healthy Individual (Left) and a Patient With CD (Right) Figure 2: Potential Biologic Drug Targets for CD Figure 3: Patient Care Path for CD Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in CD, Figure 5: Sales for CD in France by Drug Class, Figure 6: Sales for CD in Germany by Drug Class, Figure 7: Sales for CD in Italy by Drug Class, Figure 8: Sales for CD in Spain by Drug Class, Figure 9: Sales for CD in the UK by Drug Class,

12 Introduction 2 Introduction 2.1 Catalyst The Crohn s disease (CD) market is currently very dynamic, with novel biologic therapies on the horizon, such as: Takeda s alpha4beta7 inhibitor, Entyvio (vedolizumab) Johnson & Johnson s (J&J s) interleukin (IL)-12/23 inhibitor, Stelara (ustekinumab) These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, as they aim to tap into the lucrative portion of the CD therapeutics market. If their promising safety and efficacy profiles translate to clinical practice once they enter the market, their launch will be to the detriment of the existing market leaders, Remicade (infliximab) and Humira (adalimumab). The loss of patent protection of the anti-tnf marketed brands will allow for the emergence of biosimilars, such as Hospira s Inflectra (infliximab) a Remicade biosimilar. Patent expiries begin in 2015 for the current market leaders: J&J s Remicade AbbVie s Humira Focusing on country dynamics, Canada and the emerging markets of China and India will also play a key role in driving growth in the long term, with each market forecast to post positive Compound Annual Growth Rates (CAGRs) from 2012 to 2022, primarily due to the anticipated strong uptake of Remicade over the forecast period. Exciting times lay ahead for the CD marketplace, as the market events noted above are due to occur against the backdrop of a steadily rising global CD prevalent population. With the clinical unmet need for better diagnostic tools and treatment options for the anti-tnf-refractory population, CD represents an attractive autoimmune disease for drug developers. This, in turn should fuel commercial interest in this subtype of IBD. 12

13 Introduction 2.2 Related Reports GlobalData (2013). PharmaPoint: Psoriasis Global Drug Forecast and Market Analysis to 2022, May 2013, GDHC48PIDR GlobalData (2013). PharmaPoint: Rheumatoid Arthritis Global Drug Forecast and Market Analysis Event-Driven Update, July 2013, GDHC60PIDR GlobalData (2014). PharmaPoint: Crohn s Disease Global Drug Forecast and Market Analysis to 2022, January 2014, GDHC77PIDR GlobalData (2014). Crohn s Disease US Drug Forecast and Market Analysis to 2022, January 2014, GDHC208CFR GlobalData (2014). Crohn s Disease Japan Drug Forecast and Market Analysis to 2022, January 2014, GDHC210CFR GlobalData (2014). Crohn s Disease Canada Drug Forecast and Market Analysis to 2022, January 2014, GDHC211CFR GlobalData (2014). Crohn s Disease China Drug Forecast and Market Analysis to 2022, January 2014, GDHC212CFR GlobalData (2014). Crohn s Disease India Drug Forecast and Market Analysis to 2022, January 2014, GDHC213CFR GlobalData (2014). Cimzia (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC323DFR GlobalData (2014). Entyvio (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC324DFR GlobalData (2014). Humira (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC325DFR GlobalData (2014). Prochymal (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC326DFR GlobalData (2014). Remicade (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC327DFR 13

14 Introduction GlobalData (2014). Stelara (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC328DFR GlobalData (2014). Tysabri (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC329DFR GlobalData (2014). Vercirnon (Crohn s Disease) Forecast and Market Analysis to 2022, January 2014, GDHC330DFR GlobalData (2014). Crohn s Disease Current and Future Players, January 2014, GDHC1027FPR 2.3 Upcoming Related Reports GlobalData (2014). PharmaPoint: Ulcerative Colitis Global Drug Forecast and Market Analysis to

15 Appendix 10.8 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, San Francisco, Boston, London, India, Korea, Japan, Singapore, and Australia 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. 167