Synagis (Pediatric RSV)

Transcription

1 Synagis (Pediatric RSV) Forecast and Market Analysis to 2022 GDHC1135DFR / Published April 2013

2 Executive Summary Table below provides a summary of the key metrics in the pediatric RSV prophylactics market in the US, the single market covered in this report. Pediatric RSV Prophylactics Market: Key Metrics in the US 2012 Epidemiology At-risk population 157,935 Treated population 82, Market Sales US Pipeline Assessment $577.9m Number of prophylactics in Phase I II 2 Number of first-in-class prophylactics Key events ( ) Synagis (palivizumab) composition patent expiry Synagis formulation patent expiry 2022 Market Sales US Source: GlobalData 2 (vaccines) Level of Impact None $612.9m Sales Growth of Prophylactic Products for Pediatric RSV in the US Remains Low Between 2012 and 2022 GlobalData s patient-based estimate of the US market size for prophylactic products used for pediatric RSV, which is based on the patient segments that are typically provided prophylactic treatment, as per the American Academy of Pediatrics (AAP) guidelines, was $578m in GlobalData estimates that by 2022 the market will reach $612.8m, growing at a Compound Annual Growth Rate (CAGR) of 0.6%. The size of the pediatric RSV market during the forecast period is expected to be impacted by two salient events: the loss of AstraZeneca s composition and formulation patents for Synagis (palivizumab) in 2015 and 2023, respectively. While GlobalData expects AstraZeneca to protect its formulation patent fiercely, clinical trials by generic manufacturers seeking to launch biosimilars within this market in 2016 draw focus upon the potential strength of AstraZeneca s formulation patent. In addition to these critical events, the growth of the pediatric RSV prophylactics market during the forecast period from will be driven by: Lack of a prophylactic vaccine to prevent RSV infection in both healthy and at-risk children Increased diagnostic testing for conditions affecting lung function in children to increase the number of eligible patients receiving treatment Increased awareness of RSV infections in areas of high incidence, such as Florida Page 2 GDHC1135DFR / Published APR 2013

3 Executive Summary Barriers to the growth of the pediatric RSV prophylactics market include: Low utilization and compliance rates associated with the administration of Synagis in eligible patients High cost of Synagis, which leads to payer pushback and limited reimbursement Figure below provides an analysis of the company portfolio gap in pediatric RSV prophylactics during the forecast period. Company Portfolio Gap Analysis in Pediatric RSV Prophylactics, Seasonal nature of the infection, which is rampant for approximately five months of the year General mistrust of vaccines by the public Manufacturers Focus on Development of Vaccines for Active Immunization Over Products for Passive Immunization AstraZeneca, through its acquisition of MedImmune, has remained the clear market leader in the pediatric RSV prophylactics market. MedImmune developed and currently markets the present gold standard, Synagis, in the US. Due to the restrictive patient segments that are eligible for treatment, AstraZeneca has maintained its stronghold on the market, while newer companies have been focused on targeting other at-risk populations for prophylactic treatment. The high cost associated with RSV prevention is a strong driver to motivate the production of new early-clinical-phase treatments, as indicated by the development of vaccines by Novavax and AstraZeneca. While AstraZeneca is likely to maintain its current patient share with Synagis, GlobalData forecasts that newer players, like Novavax, will likely gain market share among the underserved patient segments beyond the present forecast period. Strength of Marketed Products Low High Source: GlobalData Current Players Low Strength of Pipeline Current and Future Players Future Players High Page 3 GDHC1135DFR / Published APR 2013

4 Executive Summary The Pediatric RSV Prophylactics Market is Poised to Face Similar Unmet Needs for the Next Decade The current status of the pediatric RSV prophylactics market is based on the utilization of a single product: AstraZeneca s Synagis. While the prospect of biosimilar entry within the US is a point of contention, GlobalData acknowledges that significant unmet needs continue to exist within this market as a result of there being a sole prophylactic option. GlobalData s primary research with key opinion leaders (KOLs) indicated that primary clinical unmet needs exist regarding the lack of a prophylactic vaccines against RSV in both healthy and at-risk children, the increased bioavailability of monoclonal antibodies (mabs) and the need for a cheaper prophylactic option. In addition, environmental factors reflect a need for increased availability of the therapy for all eligible patient groups, which stems from reported uneven reimbursement for at-risk groups, based on the existing treatment guidelines. Due to the early development stage of the existing pipeline drugs, these unmet needs are unlikely to change during the forecast period. However, the eventual launches of prophylactic vaccines from Novavax and AstraZeneca will help increase the market size of this indication by targeting newer patient segments. New Entrants Set to Gain Inroads by Targeting New Patient Segments Due to the high cost of AstraZeneca s biologic, Synagis, treatment guidelines have focused on preventing the severity of RSV infection in high-risk patients, such as premature neonates. However, with the launch of prophylactic vaccines by newer manufacturing companies like Novavax, new patient segments are likely to receive appropriate preventative treatment. Novavax, with its Phase II F-protein vaccine, is currently testing the vaccine in women of childbearing age to achieve protection of the target population through maternal immunization. Prevention of neonatal infections through maternal immunization is a new market segment within the pediatric RSV prophylactics market and one that is unlikely to usurp the role of existing mabs that are administered to premature neonates. As the majority of maternal antibodies to RSV are conferred later during the gestational period, these patients are unlikely to benefit from vaccines that utilize this route of administration. Page 4 GDHC1135DFR / Published APR 2013

5 Executive Summary Vaccines Pave the Way for Newer Target Segments within the Pediatric RSV Prophylactics Market Given the current standing of the Synagis patent and the scant product pipeline associated with RSV, vaccines are likely to become the wave of the future beyond the current forecast period. These vaccines, developed by both Novavax and AstraZeneca, are currently seeking approval for use in maternal and infant immunization, respectively. These new prophylactic options will confer immunization in those currently not protected under the existing AAP treatment guidelines that is, children not at high risk and possibly children older than two years. With the approval of these vaccines, the landscape of pediatric RSV prophylactics market is expected to grow dramatically, since they are indicated specifically for women of childbearing age and will be incorporated into routine immunization schedules for children. GlobalData forecasts a surge in the market size for eligible patients, while the existing treatment populations will not be affected. Figure below provides a competitive assessment of the early-stage pipeline agents in pediatric RSV prophylactics during the forecast period. Competitive Assessment of Early-Stage Pipeline Agents in Pediatric RSV Prophylactics, Commercial Attributes High Low Low Clinical Attributes High Note: Bubble size represents approximate peak year sales of pipeline drug Source: GlobalData AstraZeneca s MEDI-559 Novavax s F-Protein Vaccine Page 5 GDHC1135DFR / Published APR 2013

6 Executive Summary What Do the Physicians Think? GlobalData s primary research with KOLs revealed that physicians are generally satisfied with Synagis, but recognize the need for more prophylactic interventions. These would mainly include vaccines for both active and maternal immunization. They also recognize the challenges associated with the development of novel mabs, especially because of Synagis strong safety and efficacy profile. Finally, the KOLs expressed concerns about the AAP guidelines and the discrepancies between the FDA label of Synagis and the 2009 policy statement issued by the AAP s Committee on Infectious Diseases (COID). There is a really high water mark to achieve to really get into this field, and when people see what happens with palivizumab, a drug that is going to be very hard for them to emulate or even to surpass in terms of their efficacy I think the real aim needs to be towards working on a monoclonal that has more lasting power. US Key Opinion Leader, March 2013 I would love to see some sort of maternal immunization study being done. But the problem with maternal immunization, again, is that it doesn t protect the preterm kids, because maternal antibodies are transferred in the late stage. US Key Opinion Leader, March 2013 If you looked at it from the perspective of what [the] AAP is doing, and the Committee on Infectious Diseases, the so-called COID, it s largely focused on balancing [the] books on the backs of our babies, as opposed to achieving a reasonable or meaningful way of prophylaxis. US Key Opinion Leader, March 2013 US Key Opinion Leader, March 2013 I think MedImmune [AstraZeneca] has done a pretty good job in pricing it [Synagis] at the limit of cost effectiveness, so that it s right at the borderline. US Key Opinion Leader, March 2013 Page 6 GDHC1135DFR / Published APR 2013

7 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 Pathophysiology Prognosis Quality of Life Symptoms Disease Management Treatment Overview Diagnosis Clinical Practice Competitive Assessment Overview Synagis (palivizumab) Overview Efficacy Safety SWOT Analysis Forecast Appendix Bibliography Page 7 GDHC1135DFR / Published APR 2013

8 Table of Contents 7.2 Abbreviations Methodology Forecasting Methodology Number of eligible patients for prophylaxis Utilization rates of Synagis Patient share and generic erosion Weight of high risk infants Cost per day Number of prophylaxis days per year Annual cost of therapy Patient compliance Total sales Drugs Included in Each Therapeutic Class Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Physicians and Specialists Included in this Study About the Authors Authors Epidemiologist Global Head of Healthcare About GlobalData Contact Us Disclaimer Page 8 GDHC1135DFR / Published APR 2013

9 Table of Contents 1.1 List of Tables Table 1: Symptoms of RSV infection Table 2: Treatment Guidelines for Pediatric RSV Prevention Table 3: Most Prescribed Prophylactics for Pediatric RSV in the US, Table 4: Leading Prophylactic Treatments for Pediatric RSV, Table 5: Product Profile Synagis Table 6: Synagis SWOT Analysis, Table 7: US Sales Forecasts ($m) for Synagis, Table 8: Key Launch Date Table 9: Key Patent Expiries List of Figures Figure 1: Schematic Representation of the RSV Virion Page 9 GDHC1135DFR / Published APR 2013

10 Introduction 2 Introduction 2.1 Catalyst The pediatric respiratory syncytial virus (RSV) prophylactic market has remained relatively stagnant over the past decade following the 1998 launch of AstraZeneca s (MedImmune) Synagis (palivizumab). However, since then, the high cost of Synagis has rendered it as an expensive resource, which has resulted in its strict use only in severely high-risk patients. The expected 2015 composition patent expiry on Synagis in the US will potentially draw entry from biosimilar manufacturers, who will attempt to steal patient share away from Synagis. These manufacturers will be held at bay with Synagis formulation patent, which is likely to end up in litigation. The new guidelines released in 2012 by the National Perinatal Association (NPA) regarding RSV prophylaxis in children deviate slightly from the existing 2009 guidelines of the American Academy of Pediatrics (AAP), which will result in more physicians adopting methods that are better aligned with the needs of their clinical practice. The development of more diagnostic methods that are designed to identify patients with serious genetic disorders that can affect their lung function will increase the pediatric RSV prophylactics market size considerably within the US. The advancement of Novavax's F-protein vaccine based on positive top-line Phase II study results reaffirms the movement from passive to active prophylaxis of RSV. These results indicated that the adjuvanted vaccine elicited a significant immune response after immunization. 2.2 Related Reports GlobalData (2013). PharmaFocus: Vaccine Adjuvants in Infectious Disease, March, 2013, GDHC001PFR. GlobalData (2013). Pediatric Respiratory Syncytial Virus (RSV) Prophylactics Current and Future Players, April, 2013, GDHC1010FPR. Page 10 GDHC1135DFR / Published APR 2013

11 Appendix 7.7 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. 7.9 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. Page 49 GDHC1135DFR / Published APR 2013