Upload
others
View
4
Download
0
Embed Size (px)
Citation preview
Humira (Psoriasis) - Forecast and Market Analysis to 2022 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
REFERENCE CODE GDHC1178DFR | PUBLICATION DATE MAY 2013
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Humira (Psoriasis) - Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Table below presents key metrics for Humira in the
seven of the nine major pharmaceutical markets.
Humira: Key Metrics in the Major Pharmaceutical Markets
2012 Market Sales
US $840.7m
5EU $602.7m
Japan $4.8m
Total 7MM $1.44bn
Total Global* $1.44bn
Key Events (2012–2022) Level of Impact
Humira(adalimumab) patent expiry in 2016 (US), 2018 (5EU) and 2017 (JP) ↓↓↓
2022 Market Sales
US $485.7m
5EU $481.6m
Japan $4.0m
Total 7MM $971.3m
Total Global* $971.3m
Source: GlobalData N/A: Not Applicable *For the purpose of this report, Global = US, France, Germany, Italy, Spain, UK, and Japan
Sales of Humira in the Global Psoriasis Market 2012–2022
We estimate the drug sales of Humira to be $1.44
billion across seven of the nine major markets
covered in this report which include: US, France,
Germany, Italy, Spain, UK, and Japan. By forecast
end in 2022, sales of Humira will decline due to
brand erosion and the entry of biosimilars. We
estimate the Humira market to decline at a
Compound Annual Growth Rate (CAGR) of
negative 3.92%. This decline will be driven by:
The launch of new PsO therapies into the
market by 2014, such as Celgene’s
phosphodiesterase-4 (PDE-4) inhibitor,
apremilast, and Amgen/AstraZeneca’s IL-17
inhibitor, brodalumab
The advent of adalimumab biosimilars in 2016
(US)
An increase in the uptake of IL-12/IL-23 first-in-
class brand Stelara over the coming decade
Despite these barriers, Humira will remain a top
anti-TNF and PsO therapy throughout the forecast
period despite declining sales come mid-forecast.
Also, patent expiry in the middle of the forecast
period beginning in 2016 (US) will allow for the
emergence of biosimilars in the major markets.
Humira (Psoriasis) - Forecast and Market Analysis to 2022 3 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Figure below presents the drug sales for Humira by
market during the forecast period.
Humira Sales for Psoriasis by Region, 2012–2022
58.1%
41.6%
0.3%
US
5EU
Japan
2012 Total: $1.44bn
50.0%49.6%
0.4%
US
5EU
Japan
2022 Total: $971.3m
Source: GlobalData
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 five-
year [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.
“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
Humira (Psoriasis) - Forecast and Market Analysis to 2022 4 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
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
Humira (Psoriasis) - Forecast and Market Analysis to 2022 5 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
1 Table of Contents
1 Table of Contents .......................................................................................................................... 5
1.1 List of Tables............................................................................................................................ 7
1.2 List of Figures .......................................................................................................................... 7
2 Introduction ................................................................................................................................... 8
2.1 Catalyst .................................................................................................................................... 8
2.2 Related Reports ....................................................................................................................... 9
2.3 Upcoming Related Reports .................................................................................................... 10
3 Disease Overview ....................................................................................................................... 11
3.1 Etiology and Pathophysiology ................................................................................................ 11
3.1.1 Etiology ........................................................................................................................... 11
3.1.2 Pathophysiology ............................................................................................................. 13
3.2 Symptoms .............................................................................................................................. 16
4 Disease Management.................................................................................................................. 17
4.1 Treatment Overview ............................................................................................................... 18
5 Competitive Assessment ............................................................................................................. 22
5.1 Overview ................................................................................................................................ 22
5.2 Strategic Competitor Assessment .......................................................................................... 23
6 Humira (adalimumab) .................................................................................................................. 24
6.1 Overview ................................................................................................................................ 24
6.2 Efficacy .................................................................................................................................. 25
6.3 Safety..................................................................................................................................... 26
Humira (Psoriasis) - Forecast and Market Analysis to 2022 6 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
6.4 SWOT Analysis ...................................................................................................................... 27
6.5 Forecast ................................................................................................................................. 29
7 Appendix ..................................................................................................................................... 30
7.1 Bibliography ........................................................................................................................... 30
7.2 Abbreviations ......................................................................................................................... 33
7.3 Methodology .......................................................................................................................... 35
7.4 Forecasting Methodology ....................................................................................................... 35
7.4.1 Diagnosed Psoriasis Patients ......................................................................................... 35
7.4.2 Percent Drug-Treated Patients ....................................................................................... 36
7.4.3 General Pricing Assumptions .......................................................................................... 36
7.4.4 Individual Drug Assumptions .......................................................................................... 37
7.4.5 Generic Erosion .............................................................................................................. 37
7.5 Physicians and Specialists Included in this Study................................................................... 38
7.6 Primary Research – Prescriber Survey .................................................................................. 39
7.7 About the Authors .................................................................................................................. 40
7.7.1 Analysts .......................................................................................................................... 40
7.7.2 Global Head of Healthcare .............................................................................................. 41
7.8 About GlobalData ................................................................................................................... 42
7.9 Disclaimer .............................................................................................................................. 42
Humira (Psoriasis) - Forecast and Market Analysis to 2022 7 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
1.1 List of Tables
Table 1: Immune Cells Involved in Lesions .................................................................................................... 13
Table 2: Symptoms of Psoriasis ..................................................................................................................... 16
Table 3: Minimal Investigative Measures Required Before Prescribing Biologics for Psoriasis ........................ 19
Table 4: Treatment Guidelines for Psoriasis ................................................................................................... 21
Table 5: Top Three Biologics Prescribed for Moderate to Severe Psoriasis by Market, 2012 .......................... 21
Table 6: Leading Treatments for Psoriasis, 2013 ........................................................................................... 23
Table 7: Product Profile – Humira .................................................................................................................. 25
Table 8: Humira SWOT Analysis, 2013 .......................................................................................................... 28
Table 9: Global Sales Forecasts ($) for Humira, 2012–2022 .......................................................................... 29
Table 10: Physicians Surveyed, By Country ................................................................................................... 39
1.2 List of Figures
Figure 1: Psoriatic Plaque on Elbow of Patient ............................................................................................... 12
Figure 2: The Three Layers of the Skin and Associated Structures ................................................................. 14
Figure 3: Healthy Skin Versus Psoriatic Skin .................................................................................................. 15
Humira (Psoriasis) - Forecast and Market Analysis to 2022 8 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
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)
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 highly-
diversified field of therapies, with individual drugs struggling to distinguish themselves.
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
Humira (Psoriasis) - Forecast and Market Analysis to 2022 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
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.
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 – China Drug Forecast and Market Analysis to 2022,
GDHC1113CFR.
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). Remicade (Psoriasis) – Forecast and Market Analysis to 2022,
GDHC1179DFR.
GlobalData (2013). Stelara (Psoriasis) – Forecast and Market Analysis to 2022,
GDHC1180DFR.
Humira (Psoriasis) - Forecast and Market Analysis to 2022 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
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.
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.
Humira (Psoriasis) - Forecast and Market Analysis to 2022 42 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
HUMIRA (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022
Appendix
7.8 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.
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.