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THERAPY ANALYSIS

Psoriasis Therapeutics in Asia-Pacific Markets to 2021: Advent of Novel Biologics and

Expanding Treatment Pool to Drive Growth

Report Code: GBIHC360MR Published: May 2015

© GBI Research. This is a licensed product and is not to be photocopied

GBIHC360MR / Published May 2015

GBI Research Report Guidance

Chapter two provides an overview of psoriasis in terms of symptoms, etiology, pathophysiology, diagnosis, classification, epidemiology, and treatment options and management.

Chapter three provides detailed profiling and a comparative heatmap analysis in terms of the safety and efficacy of currently marketed psoriasis products.

Chapter four presents a detailed pipeline analysis for psoriasis and analysis of the distribution of molecule types across the psoriasis developmental pipeline. In addition, it contains detailed analyses of clinical trial failure rates, clinical trial durations by phase, and clinical trial sizes by participant numbers.

Chapter five provides market forecasts for four APAC countries: China, India, Japan, and Australia. The multiple-scenario forecasts take into account a range of factors that are likely to vary and provide a clear perspective of the potential degree of variance in market size.

Chapter six covers the major deals that have taken place in the global psoriasis market in recent years. Coverage includes co-development deals and licensing agreements, segmented according to geography and total value. A concomitant analysis of the licensing deal values for products by molecule type and molecular target is also provided.



Executive Summary

Changes to Treatment Pattern and an Increase in the Prevalence Population will be the Key Market Drivers

The current psoriasis therapeutics market is impeded by a low treatment population. Almost half of all patients with mild psoriasis, one quarter of patients with moderate psoriasis, and almost XX% of patients with severe psoriasis receive no treatment for their condition. For those who are treated, undertreatment is not uncommon (Armstrong et al., 2013). Across the Asia-Pacific (APAC) market (for the purposes of this report, this refers to Australia, China, India and Japan only), systemic treatments are widely considered to be appropriate for patients with moderate-to-severe psoriasis. However, the majority of these patients receive treatment with topical agents only, which are typically less expensive and less effective than systemic drugs.

The treatment population is projected to rise substantially by 2021. This will be driven by a marginal increase in the prevalence population of psoriasis, as well as an increase in the diagnosis rate, resulting from heightened disease awareness and improved diagnostic methods. Additionally, psoriasis is increasingly being recognized as a serious systemic disease with associated quality-of-life impairment and disability, rather than a cutaneous disease, which denotes a merely cosmetic affliction. As perceptions of the disease continue to change, healthcare professionals will increasingly consider treatment non-optional. In particular, the use of expensive systemic drugs will increase, accelerating market growth.

The treatment landscape of psoriasis is dense and complex, with treatment options prescribed based on the severity of the indication. More than XX% psoriasis patients fall under the category of mild or moderate, whose first line of treatment is topical drugs or phototherapy, or a combination of both. For severe patients, non-steroidal drugs such as methotrexate, cyclosporine, and acitretin are practiced as the first line. However, toxicity concerns mean that they cannot be prescribed for long durations.

Biologics such as Tumor Necrosis Factor (TNF) inhibitors (adalimumab, etanercept, infliximab) and Interleukin (IL) inhibitors (ustekinumab) are prescribed mostly as second-line therapy when none of the above options have provided the desired results. However, during the forecast period biologics are likely gain a significant patient share due to healthcare plans in APAC countries and awareness regarding their effectiveness. Among the recently launched biologics, Cosentyx (secukinumab), a novel IL-17 inhibitor from Novartis, has shown better efficacy than etanercept. Biocon India has launched Alzumab, which is a first-in-class novel molecule that targets the Cluster of Differentiation (CD)-6 protein and anticipated to be a leading biologic in India by the end of the forecast period. Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab) are expected to lose their patents during the forecast period, but will be very well compensated for by biosimilars, which are approved in the APAC market. The value of the market for psoriasis in the APAC markets is expected to increase from $XXm in 2014 to $XX billion in 2021, at a Compound Annual Growth Rate (CAGR) of XX%. Among the four APAC markets, China has the highest market share of XX%, followed by Australia with XX% and India with XX%.

The current psoriasis therapeutics market is impeded by a low treatment population. However, the treatment population is projected to rise substantially by 2021.



Psoriasis Market, Asia-Pacific, Market Size ($m), 2014–2021

2014 2015 2016 2017 2018 2019 2020 2021

Mar

ket s

ize

($m

)

Low variance Mid variance High variance Projected

Source: GBI Research, Proprietary Pipeline Products Database; GBI Research, Proprietary Marketed Products Database

Strong Pipeline Containing a Diverse Set of Products

The pipeline for psoriasis contains XX products, distributed relatively unevenly between the different stages of development, although Preclinical, Phase I and Phase II have similar shares. Only four molecules are currently in the pre-registration phase and seeking approval during the forecast period. The pipeline molecules apremilast, ixekizumab, brodalumab, tofacitinib and tildrakizumab are expected to be approved during the forecast period. The XX active pipeline molecules consist of:

Discovery phase: XX%, or XX molecules

Investigational New Drug (IND)/Clinical Trial Approval (CTA)-filed phase: XX%, or XX molecules

Preclinical phase: XX%, or XX molecules

Phase I: XX%, or XX molecules

Phase II: XX%, or XX molecules

Phase III: XX%, or XX molecules

Pre-registration: XX%, or XX molecules

Undisclosed: XX%, or XX molecules


GBIHC360MR / Published May 2015 Page 6

1 Table of Contents

1 Table of Contents .............................................................................................................................................6 1.1 List of Tables .........................................................................................................................................8 1.2 List of Figures ........................................................................................................................................8

2 Introduction ...................................................................................................................................................... 10 2.1 Symptoms ............................................................................................................................................. 11

2.1.1 Skin Manifestations .................................................................................................................... 11 2.1.2 Psychological Impact ................................................................................................................. 11

2.2 Etiology, Co-morbidities and Risk Factors ...................................................................................... 11 2.2.1 Genetics ....................................................................................................................................... 11 2.2.2 Psoriatic Arthritis ......................................................................................................................... 11 2.2.3 Mental Health Disorders ........................................................................................................... 11 2.2.4 Metabolic Syndrome, Smoking, Diet and Alcohol Consumption ..................................... 12 2.2.5 Infections ..................................................................................................................................... 12 2.2.6 Köebner Phenomenon ............................................................................................................. 12 2.2.7 Other Immune-Mediated Diseases ........................................................................................ 13

2.3 Pathophysiology ................................................................................................................................. 13 2.4 Diagnosis ............................................................................................................................................. 13 2.5 Epidemiology ...................................................................................................................................... 14 2.6 Treatment and Management ........................................................................................................... 16

2.6.1 Pharmacological Therapies ..................................................................................................... 17 2.6.2 Non-pharmacological Therapies ............................................................................................ 17 2.6.3 Combination and Rotational Therapies ................................................................................. 18 2.6.4 Quality of Life Assessments .................................................................................................... 18 2.6.5 Summary ..................................................................................................................................... 19

3 Marketed Products ........................................................................................................................................ 20 3.1 Overview ............................................................................................................................................. 20 3.2 Methotrexate-Based Products ........................................................................................................ 20 3.3 Sandimmune/Neoral (cyclosporine/modified cyclosporin) – Novartis ..................................... 21 3.4 Humira (adalimumab) – AbbVie ..................................................................................................... 22 3.5 Enbrel (etanercept) – Amgen .......................................................................................................... 24 3.6 Remicade (infliximab) – Janssen Biotech ..................................................................................... 26 3.7 Stelara (ustekinumab) – Janssen Biotech .................................................................................... 27 3.8 Comparative Efficacy and Safety ................................................................................................... 29

4 Psoriasis Market to 2021 – Pipeline Products ........................................................................................... 31 4.1 Overview .............................................................................................................................................. 31 4.2 Overall Pipeline................................................................................................................................... 31 4.3 Pipeline Analysis by Molecule Type .............................................................................................. 33 4.4 Pipeline Analysis by Molecular Target .......................................................................................... 34 4.5 Clinical Trials ...................................................................................................................................... 36

4.5.1 Overall Failure Rate .................................................................................................................. 36 4.5.2 Failure Rate by Molecule Type ...............................................................................................37 4.5.3 Failure Rate by Molecular Target .......................................................................................... 38 4.5.4 Patient Enrollment and Clinical Trial Size ............................................................................ 39 4.5.5 Duration ...................................................................................................................................... 40 4.5.6 Summary of Psoriasis Clinical Trials ....................................................................................... 41

4.6 Promising Drug Candidates in the Pipeline ................................................................................. 42 4.6.1 LY2439821 (ixekizumab) – Eli Lilly ........................................................................................ 42 4.6.2 Xeljanz (tofacitinib) – Pfizer .................................................................................................... 43 4.6.3 Brodalumab – Amgen .............................................................................................................. 44

5 Market Forecast to 2021 .............................................................................................................................. 46



5.1 Geographical Markets ...................................................................................................................... 46 5.1.1 Asia-Pacific Market Overview................................................................................................. 46 5.1.2 China ........................................................................................................................................... 48 5.1.3 India ............................................................................................................................................. 49 5.1.4 Japan............................................................................................................................................ 51 5.1.5 Australia ...................................................................................................................................... 52

5.2 Drivers and Barriers .......................................................................................................................... 54 5.2.1 Drivers ......................................................................................................................................... 54 5.2.2 Barriers ....................................................................................................................................... 54

6 Deals and Strategic Consolidations ........................................................................................................... 56 6.1 Major Co-development Deals ......................................................................................................... 56

6.1.1 AbbVie Enters into Co-development Agreement with Biotest for Tregalizumab ........ 60 6.1.2 Lycera Enters into Research Agreement with Merck ........................................................ 60 6.1.3 LEO Pharma Enters into Research Agreement with 4SC Discovery for Inflammatory

Skin Diseases ............................................................................................................................. 61 6.1.4 Amgen Enters into Co-Development Agreement with AstraZeneca for Five Human

Monoclonal Antibodies Including Brodalumab .................................................................... 61 6.2 Major Licensing Deals ...................................................................................................................... 62

6.2.1 Leo Pharma Enters into Licensing Agreement with Virobay for Psoriasis Drug .......... 65 6.2.2 Foamix Enters into Licensing Agreement with Dr. Reddy's Laboratories...................... 65 6.2.3 Cipher Pharmaceuticals Enters into Licensing Agreement with IBSA Institut

Biochimique for Betesil Patch ................................................................................................ 65 6.2.4 Phenex Pharmaceuticals Enters into Licensing Agreement with Janssen Biotech for

Retinoid-Acid Receptor-Related Orphan Receptor Gamma t Program.......................... 66 7 Appendix ......................................................................................................................................................... 67

7.1 All Pipeline Drugs by Phase ............................................................................................................ 67 7.1.1 Discovery.................................................................................................................................... 67 7.1.2 Preclinical ................................................................................................................................... 68 7.1.3 IND/CTA-Filed ........................................................................................................................... 69 7.1.4 Phase I ........................................................................................................................................ 70 7.1.5 Phase II ........................................................................................................................................ 71 7.1.6 Phase III ...................................................................................................................................... 72 7.1.7 Pre-registration...........................................................................................................................73

7.2 Market Forecasts to 2021 .................................................................................................................73 7.2.1 Global ...........................................................................................................................................73 7.2.2 China ............................................................................................................................................73 7.2.3 India ..............................................................................................................................................74 7.2.4 Japan............................................................................................................................................74 7.2.5 Australia .......................................................................................................................................74

7.3 Market Definitions ..............................................................................................................................74 7.4 Abbreviations ..................................................................................................................................... 75 7.5 References ......................................................................................................................................... 76 7.6 Research Methodology .................................................................................................................... 80

7.6.1 Coverage .................................................................................................................................... 80 7.6.2 Secondary Research ................................................................................................................. 81 7.6.3 Primary Research ....................................................................................................................... 81 7.6.4 Therapeutic Landscape ............................................................................................................ 81 7.6.5 Geographical Landscape ........................................................................................................ 83 7.6.6 Pipeline Analysis ....................................................................................................................... 84

7.7 Expert Panel Validation .................................................................................................................... 84 7.8 Contact Us .......................................................................................................................................... 84 7.9 Disclaimer ........................................................................................................................................... 84



1.1 List of Tables

Table 1: Psoriasis Market, Global, Types of Psoriasis, 2015 ..............................................................10 Table 2: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Discovery, 2014 .................67 Table 3: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 .....68 Table 4: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 .....69 Table 5: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 .....70 Table 6: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 .....71 Table 7: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 .....72 Table 8: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014 .....73 Table 9: Psoriasis Market, Asia-Pacific, Forecast Data, 2014–2021...................................................73 Table 10: Psoriasis Market, China, Forecast Data, 2014–2021 ............................................................73 Table 11: Psoriasis Market, India, Forecast Data, 2014–2021 .............................................................74 Table 12: Psoriasis Market, Japan, Forecast Data, 2014–2021 ...........................................................74 Table 13: Psoriasis Market, Australia, Forecast Data, 2014–2021 .......................................................74

1.2 List of Figures

Figure 1: Psoriasis Market, Global, Composite Treatment Algorithm, 2015 .......................................16 Figure 2: Psoriasis Market, Global, Humira (adalimumab), Annual Sales ($bn), 2007–2014 ..............24 Figure 3: Psoriasis Market, Global, Enbrel (etanercept), Annual Sales ($bn), 2007–2014 .................25 Figure 4: Psoriasis Market, Global, Remicade (infliximab), Annual Sales ($bn), 2007–2014 ..............27 Figure 5: Psoriasis Market, Global, Stelara (ustekinumab), Annual Sales ($bn), 2010–2014 ..............28 Figure 6: Psoriasis Market, Global, Comparative Safety and Efficacy of Marketed Products Heatmap

(1/2), 2015 ..............................................................................................................................29 Figure 7: Psoriasis Market, Global, Comparative Safety and Efficacy of Marketed Products Heatmap

(2/2), 2015 .............................................................................................................................30 Figure 8: Psoriasis Market, Global, Pipeline by Stage of Development, Program Type and Route of

Administration, 2015 .............................................................................................................32 Figure 9: Psoriasis Market, Global, Pipeline by Molecule Type and Stage of Development, 2015 ...33 Figure 10: Psoriasis Market, Global, Pipeline by Molecular Target (1/2), 2015 .....................................34 Figure 11: Psoriasis Market, Global, Pipeline by Molecular Target (2/2), 2015 ....................................35 Figure 12: Psoriasis Market, Global, Pipeline by Molecular Target, Molecule Type and Stage of

Development, 2015 ...............................................................................................................36 Figure 13: Psoriasis Market, Global, Clinical Trial Failure Rate (%), 2015 ..............................................37 Figure 14: Psoriasis Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2015................38 Figure 15: Psoriasis Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2015 ............39 Figure 16: Psoriasis Market, Global, Clinical Trial Size, 2015 ................................................................40 Figure 17: Psoriasis Market, Global, Clinical Trial Duration (months), 2015 ..........................................41 Figure 18: Psoriasis Market, Asia-Pacific, Treatment Use Patterns and Market Size ($m), 2014–2021

...............................................................................................................................................47 Figure 19: Psoriasis Market, China, Treatment Use Patterns, Annual Cost of Therapy ($) and Market

Size ($m), 2014–2021 ............................................................................................................49 Figure 20: Psoriasis Diabetes Market, India, Treatment Use Patterns, Annual Cost of Therapy ($), and

Market Size ($m), 2014–2021 ...............................................................................................50 Figure 21: Psoriasis Market, Japan, Treatment Use Patterns, Annual Cost of Therapy ($), Market Size

($m), 2014–2021....................................................................................................................52 Figure 22: Psoriasis Market, Australia, Treatment Use Patterns, Annual Cost of Therapy ($), Market

Size ($m), 2014–2021 ............................................................................................................53 Figure 23: Psoriasis Market, Global, Co-development Deals by Geography, Deals by Value, 2006–

2014 .......................................................................................................................................57 Figure 24: Psoriasis Market, Global, Co-development Deals by Year, Deals by Phase and Molecule

Type, 2006–2014 .................................................................................................................58 Figure 25: Psoriasis Market, Global, Co-development Deals by Molecule Type and Deal Value, Deals

by Molecular Target and Deal Value, 2006–2014 ...............................................................59 Figure 26: Psoriasis Market, Global, Co-development Deals by Geography, 2006–2014 ..................60



Figure 27: Psoriasis Market, Global, Licensing Deals by Geography and Value, 2006–2014 .............62 Figure 28: Psoriasis Market, Global, Licensing Deals by Year, Licensing Deals by Phase and

Molecule Type, 2006–2014 .................................................................................................63 Figure 29: Psoriasis Market, Global, Licensing Deals by Year and by Phase, 2006–2014 ..................64 Figure 30: Psoriasis Market, Global, Licensing Deals by Geography, 2006–2014 ..............................65 Figure 31: GBI Research Market Forecasting Model (Example)............................................................83



2 Introduction

Psoriasis is a chronic, autoimmune, relapsing, inflammatory disease triggered by deregulated Thymus-derived cells (T cells), resulting in inflammation and benign hyperplasia of keratinocytes within the skin (Cai et al., 2012). Manifestations of affected skin are red, thickened plaques with an overlying silver-white scale, which significantly impairs the patient’s physical and mental wellbeing (Krueger and Bowcock, 2005). The primary cause of psoriasis is unknown, as are the mechanisms that lead to immune cells directing inflammatory responses towards the skin. The extent and severity of the disease varies greatly between patients and often varies within individuals over the course of time. While some patients experience little change in their symptoms over their lifetime, others experience periods of remission or improvement in between flare periods (Peters et al., 2000).

The severity of psoriasis is usually defined by the percentage of the patient’s Body Surface Area (BSA) affected, where XX% is equal to surface area of hand. Psoriasis is generally considered mild if 0–XX% BSA is affected, moderate if XX% BSA is affected, and severe if greater than XX% BSA is affected. However, when determining the severity of the disease, physicians may also take other factors into account, such as the emotional impact on the patient or the location of the lesions on the body. Although a patient’s symptoms may fluctuate with time, approximately XX% of patients have mild psoriasis, compared to XX% with moderate psoriasis and XX% with severe psoriasis (National Psoriasis Foundation, 2009). There are also several types of psoriasis, with plaque psoriasis being the most common form, occurring in XX% of psoriatic patients.

Table 1: Psoriasis Market, Global, Types of Psoriasis, 2015

Type of Psoriasis Symptoms and characteristics Patient distribution (%)

Source: Brown and Korman, 2008; Duweb et al., 2003; Langley et al., 2005; NPF, 2011; Psoriasis Association, 2011; WHO, 2013



2.6 Treatment and Management

While there is no cure for psoriasis, numerous and varied treatment options are available, which can help to improve symptoms and quality of life for patients. The typical treatment algorithm for psoriasis is represented in Figure 1. This shows that there are two different types of drugs used: topical drugs, which are applied to the skin, and systemic drugs, which are taken orally, by injection or by intravenous infusion and have an effect on the entire body. Systemic drugs include non-biologic (conventional) drugs manufactured by chemical synthesis and biologic drugs produced in living cell cultures. Patients may also receive phototherapy, a non-pharmacological treatment, which involves exposing the skin to ultraviolet light. These treatment options and their associated side effects are discussed in more details in sections 3.6.1 and 3.6.2.

Figure 1: Psoriasis Market, Global, Composite Treatment Algorithm, 2015

Patients with psoriasis

Third line of therapy: Biologic drugs

TNF-alpha inhibitors e.g. Enbrel (etanercept), Humira (adalimumab), Remicade (inf liximab)

Interleukin inhibitors e.g. Stelara (ustekinumab)

First line of therapy: Topical drugs

Corticosteroids e.g. Diprolene (betamethasone dipropionate)

Vitamin D analogues e.g. Dovonex(calcipotriene)

Vitamin A analogues e.g. Tazorac (tazarotene)Calcineurin inhibitors e.g. Tacrolimus,

Pimecrolimus Anthralin/dithranolCalcitriol

Keratolytics e.g. Salicylic acid Emollients

Tars

Second line of therapy: Phototherapy

Broadband UVB (full spectrum)Narrowband UVB (small part of spectrum)

UVA and psolaren (PUVA)

Non-biologic (conventional) systemic drugsImmunosuppressive agents e.g. Methotrexate,

cyclosporineVitamin A analogues e.g. Soriatane (acitretin)

Fumaric acid esters e.g. Fumaderm (dimethyl fumarate and ethyl fumarate)

Mild to moderate psoriasis

Moderate to severe psoriasis

Inadequate response to

therapy

Inadequate response to

therapy

Third line of therapy: Biologic drugs

TNF-alpha inhibitors e.g. Enbrel (etanercept), Humira (adalimumab), Remicade (inf liximab)

Interleukin inhibitors e.g. Stelara (ustekinumab)

mild-to-moderate psoriasis

moderate-to-severe psoriasis

Source: Chaudhari et al., 2008a; Chaudhari et al., 2008b; NPF, 2012; Prodanovic and Korman, 2008; Shah and Weinberg, 2008



3 Marketed Products

3.1 Overview

As previously discussed, topical and systemic agents comprise an extensive psoriasis drugs market. Topical drugs are usually the first-line therapies for patients with mild-to-moderate psoriasis, while systemic drugs are usually reserved for more severe forms of psoriasis, or psoriasis that is unresponsive to topical agents. Big pharma corporations such as Pfizer, Abbott Laboratories, Amgen, LEO Pharma and Janssen Biotech (Johnson & Johnson) are important players in the marketed products landscape, having developed lucrative drugs that account for a sizeable proportion of global market sales. However, small and generic pharma companies are also numerous. The dosage regimens, molecular targets, side effects and costs of these drugs vary considerably, but they are all administered with the common objective of attaining skin clearance. It is possible for patients to experience complete skin clearance with antipsoriatic drugs, although often only partial skin clearance can be achieved. As psoriasis is an incurable disease, symptoms usually return after patients discontinue drug use, and this is often necessary as the toxicity of some antipsoriatic drugs renders them unsuitable for long-term use. Even if long-term use is permitted, patients may eventually become drug-resistant over the course of time. For these reasons rotational and combination therapies are very common strategies in the treatment of psoriasis.

3.2 Methotrexate-Based Products

Methotrexate is an immunosuppressant, small molecule drug that was first discovered in the 1940s as a treatment for acute leukemia by scientists working at Harvard Medical School. Since then, the drug has been used in the treatment of various conditions including inflammatory diseases such as psoriasis, psoriatic arthritis, rheumatoid arthritis and Crohn’s disease; various cancers and leukemia; medical abortion; and ectopic pregnancy. Studies as early as the 1950s implicated the therapeutic potential of methotrexate in psoriasis. However, it was not until the 1970s that the drug received FDA approval. Since then, methotrexate has been used extensively in the treatment of psoriasis and is usually a first-line systemic therapy for patients with moderate-to-severe psoriasis. Numerous generic versions of methotrexate are available across the major markets, as the drug is no longer patent protected. Patients usually receive an initial dose of XX per week, which is administered orally, intramuscularly or intravenously. Depending on tolerability, the dosage may be increased gradually to achieve optimal efficacy. However, to minimize toxicity, the dosage should not exceed XXmg per week (Leung and Lau, 2009; Naldi and Griffiths, 2005).



4 Psoriasis Market to 2021 – Pipeline Products

4.1 Overview

Treatment algorithms and prescription habits in psoriasis have altered significantly in recent years, as a result of the emergence of biologics as a new class of therapy. An abundance of literature exploring the potential for biologics to change the treatment of psoriasis has also been produced in the past decade, demonstrating a renewed scientific interest in the psoriasis therapeutics market. Major pharmaceutical corporations have also capitalized on this new era of innovation; Janssen Biotech, Amgen, AbbVie (formerly Abbott Laboratories), Eli Lilly and Novartis have all invested in the development of biologic agents.

However, in spite of the developments in recent years, there remains a significant unmet need in terms of administration route, adverse effects and drug efficacy. Although psoriasis treatments can be administered in a variety of ways, many are inconvenient for patients. Topical agents often have offensive odors, are messy and time consuming to apply, and can lead to stains on the skin, hair and clothing. Systemic therapies, such as biologic drugs, are often administered via intravenous infusion or subcutaneous injection, which is likely to cause inconvenience and a level of discomfort. More seriously, some patients may also experience injection- or infusion-site reactions.

4.2 Overall Pipeline

The current developmental pipeline for psoriasis therapeutics is strong and has potential drug candidates across various phases of clinical development that are expected to provide comparable safety and efficacy profiles. The market is highly competitive and diversified, with a high level of generic penetration. As such, the barrier for novel products in terms of performance in the clinical setting is relatively high. The current pipeline indicates that this high level of competition will be sustained and possibly even intensified in the coming years.

Psoriasis pipeline appears exhaustive with promising drug class in late stage of development.



Figure 8: Psoriasis Market, Global, Pipeline by Stage of Development, Program Type and Route of Administration, 2015

DiscoveryIND/CTA-

filed

Preclinical

Phase I

Phase II

Phase III

Pre-registration

Undisclosed

A) Pipeline by stage of development

NovelGeneric

Repositioned

Biosimilar

B) Pipeline by program type

Oral

Topical

SubcutaneousIntravenous

Combination

Other

Undisclosed

C) Pipeline by RoA

Dis

cove

ry

IND

/CTA

-file

d

Pha

se II

Pha

se II

I

Pha

se I

Pre

-regi

stra

tion

Pre

clin

ical

Und

iscl

osed

Num

ber o

f m

olec

ules

D) Pipeline by program type and stage of development

Biosimilar Generic Repositioned Novel

Source: GBI Research, Proprietary Pipeline Products Database

CTA: Clinical Trial Application; IND: Investigational New Drug



5 Market Forecast to 2021

5.1 Geographical Markets

5.1.1 Asia-Pacific Market Overview

5.1.1.1 Treatment Use Patterns

Nearly XX million people worldwide, or XX% of the world population, are currently suffering from psoriasis, one of the most prevalent autoimmune disorders. It is more prevalent in Caucasians than African-Americans or Asians. In the APAC region, which includes China, India, Japan, and Australia, psoriasis is most prevalent in Australia. One of the main reasons behind this could be its geographical location, as it is more distant from equator. Figure 18 displays the overall treatment use patterns and market size forecasts for psoriasis therapeutics in the four countries of the APAC region. The parameters, which are incidence, prevalence, diagnosis rate and treatment patterns, are not uniform across these countries. The overall prevalence population reported across the four countries was approximately XX million in 2014, and is expected to grow to nearly XX million by the end of the forecast period, at a CAGR of XX%. Although Australia has the highest prevalence rate of approximately XX%, India and China together hold the majority of the psoriasis population in the APAC region (XX%) with India having the highest number of psoriasis patients.

5.1.1.2 Market Size

The following figure shows that the APAC psoriasis drugs market is projected to experience substantial growth during the forecast period. The market was estimated to be worth $XXm in 2014 and is projected to increase at a CAGR of XX% to $XX billion in 2021. The peak market size projection in a high-variance scenario is $XX billion, with a CAGR of XX%. Even in the low-market scenario, a substantial CAGR of XX% is projected. In this scenario, the market size will reach $XX billion by 2021.



Figure 18: Psoriasis Market, Asia-Pacific, Treatment Use Patterns and Market Size ($m), 2014–2021

2014 2015 2016 2017 2018 2019 2020 2021

Pop

ulat

ion

(mill

ion)

A) Treatment use patterns

Prevalence population Treatment population

2014 2015 2016 2017 2018 2019 2020 2021

Mar

ket s

ize

($m

)

B) Market size

Low variance Mid variance High variance Projected

Source: GBI Research, Proprietary Pipeline Products Database; GBI Research, Proprietary Marketed Products Database



6 Deals and Strategic Consolidations

The benefits of co-development and licensing deals to pharmaceutical companies include the distribution of risks for continued drug development, capital investment, and access to clinical, regulatory and commercial expertise, all of which are conducive to innovative drug development. Trends in co-development and licensing deals can provide insight into the commercial interest in drug development within an indication.

6.1 Major Co-development Deals

Co-development deals concerning psoriasis products that occurred during the 2006–2014 period are represented in Figure 23. The arrows represent directionality, based on company headquarters locations, and the number of deals is represented by the thickness of the lines and the size of the nodes for each region. The majority of co-development deals involving products for the treatment of psoriasis were situated in North America (XX%, XX deals), and the remainder largely in Europe (XX%, XX deals) or the APAC region (XX%, XX deals). The majority of deals were associated with the West, involving EU nations such as the UK, Germany, Denmark, Switzerland, and the US and Canada in North America.



Figure 23: Psoriasis Market, Global, Co-development Deals by Geography, Deals by Value, 2006–2014

North America

Europe

Asia-Pacific

Undisclosed

A) Co-development deals by region

<$50 million

$50-<100 million

$100-<200 million

>$200 million

Undisclosed

B) Co-development deals by value

Dis

cove

ry

Prec

linic

al

Pha

se I

Pha

se II

Phas

e III

Und

iscl

osed

Num

ber o

f dea

lsTo

tal d

iscl

osed

dea

l val

ue ($

m)

C) Co-development deals by phase and valueDeal value ($m) Upfront payment ($m)

Source: GBI Research, Proprietary Deals Database



7 Appendix

7.1 All Pipeline Drugs by Phase

7.1.1 Discovery

Table 2: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Discovery, 2014

Product name Company Molecule type Mechanism of action




7.1.2 Preclinical

Table 3: Psoriasis Market, Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2014

Product name Company Molecule type Target




7.1.3 IND/CTA-Filed






7.1.4 Phase I






7.1.5 Phase II






7.1.6 Phase III






7.1.7 Pre-registration




7.2 Market Forecasts to 2021

7.2.1 Global

Table 9: Psoriasis Market, Asia-Pacific, Forecast Data, 2014–2021

Year 2014 2015 2016 2017 2018 2019 2020 2021 CAGR (%)

Prevalence population (‘000)

Treatment population ('000)

Minimum market size ($m)

Projected market size ($m)

Maximum market size ($m)

Source: GBI Research, Proprietary Database

7.2.2 China

Table 10: Psoriasis Market, China, Forecast Data, 2014–2021

Year 2014 2015 2016 2017 2018 2019 2020 2021 CAGR (%)









7.2.3 India

Table 11: Psoriasis Market, India, Forecast Data, 2014–2021

Year 2014 2015 2016 2017 2018 2019 2020 2021 CAGR (%)







7.2.4 Japan

Table 12: Psoriasis Market, Japan, Forecast Data, 2014–2021

Year 2014 2015 2016 2017 2018 2019 2020 2021 CAGR (%)







7.2.5 Australia

Table 13: Psoriasis Market, Australia, Forecast Data, 2014–2021

Year 2014 2015 2016 2017 2018 2019 2020 2021 CAGR (%)







7.3 Market Definitions

Market coverage: The market coverage is the psoriasis in the Asia-Pacific region, comprising China, India, Japan, and Australia.

The prevalence population is the estimated number of people at any given point of time who are affected by psoriasis.

The prescription rate is the percentage of the prevalence population that has been prescribed any drug therapy for psoriasis.

The prescription population is the number of people taking any drug for psoriasis.



7.4 Abbreviations

µg: microgram

ACoT: Annual Cost of Therapy

APAC: Asia-Pacific

BSA: Body Surface Area

CAGR: Compound Annual Growth rate

CD: Cluster of Differentiation

CDC: Centers for Disease Control and Prevention

CTA: Clinical Trial Application

DLQI: Dermatology Life Quality Index

EGF: Epidermal Growth Factor

EMA: European Medicines Agency

FAE: Fumaric Acid Ester

g: grams

GM-CSF: Granulocyte Macrophage Colony-Stimulating Factors

GPCR: G Protein Coupled Receptor

GR: Glucocorticoid Receptor

HLA: Human Leukocyte Antigen

IFPA: International Federation of Psoriasis Associations

IL: Interleukin

IND: Investigational New Drug

JAK: Janus Kinase

kg: kilogram

mAb: monoclonal Antibody

mg: milligrams

ml: milliliter

NAPSI: Nail Psoriasis Severity Index

NHI: National Health Insurance

PASI: Psoriasis Area and Severity Index

PBS: Pharmaceutical Benefit Scheme

PDE4: Phosphodiesterase 4

PGA: Physician Global Assessment

RORt: Retinoid Acid Receptor Related Orphan Receptor Gamma t

T cell: Thymus-derived cell

TH: T Helper

TNF: Tumor Necrosis Factor

VAP-1: Vascular Adhesion Protein-1

VDR: Vitamin D Receptor



Shah SK and Weinberg JM (2008). Traditional systemic therapy II: retinoids and others (hydroxyurea, thiopurine antimetabolites, mycophenlic acid, sulfasalazine). In: Weinberg JM, ed. Treatment of Psoriasis (Milestones in Drug Therapy). Birkhäuser, Basel.

SIGN (2010). Diagnosis and management of psoriasis and psoriatic arthritis in adults: A national clinical guideline. Scottish Intercollegiate Guidelines Network. Accessed from: http://www.sign.ac.uk/pdf/sign121.pdf

Singh AK and Narsipur SS (2011). Cyclosporine: A Commentary on Brand versus Generic Formulation Exchange. Journal of Transplantation; 2011: 1–6

Stern RS et al. (2004). Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. Journal of Investigative Dermatology Symposium Proceedings; 9: 136–139

Takahashi H et al. (2011). Analysis of psoriasis patients registered with the Japanese Society for Psoriasis Research from 2002–2008. Journal of Dermatology; 38: 1125–1129

Traub M and Marshall K (2007). Psoriasis – pathophysiology, conventional, and alternative approaches to treatment. Alternative Medicine Review; 12: 319–330

Vorhees AV et al. (2009). The Psoriasis and Psoriatic Arthritis Pocket Guide: Treatment Algorithms and Management Options. National Psoriasis Foundation. Available from: http://www.psoriasis.org/document.doc?id=354 [Accessed on January 22, 2015]

Weinstein GD and Menter A (2003). An Overview of Psoriasis. In: Weinstein GD and Gottlieb AB, ed. Therapy of Moderate–to–Severe Psoriasis. Marcel dekker, Inc., New York

Yang H et al. (2012). Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double–blind, placebo–controlled multicenter trial. Chinese Medical Journal; 125: 1845–1851

Yuqi TT (2005). Review of a Treatment for Psoriasis Using Herose, a Botanical Formula. The Journal of Dermatology; 32: 940–945

Zhernakova A et al. (2009). Detecting shared pathogenesis from the shared genetics of immune–related diseases. Nature Reviews Genetics; 10: 43–55

7.6 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with advanced statistical expertise and marketing, market research and consulting backgrounds in the pharmaceutical industry.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised.

7.6.1 Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: market capitalization; revenues; and media attention, innovation and market potential.

An exhaustive search of 56 member exchanges is conducted and companies are prioritized on the basis of their market capitalization.

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage.



Companies that are making the news, or that are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the pharmaceutical industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional input from GBI Research’s expert panel (see below).

7.6.2 Secondary Research

The research process begins with extensive secondary research using internal and external sources in order to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings

Industry trade journals, scientific journals and other technical literature

Internal and external proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market

7.6.3 Primary Research

GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

Provides first-hand information on the market size, market trends, growth trends, competitive landscape and future outlook

Validates and strengthens secondary research findings

Further develops the analysis team’s expertise and market understanding

Primary research involves e-mail and telephone interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants that typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers

Hospital stores, laboratories, pharmacies, distributors and paramedics

Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets

Key opinion leaders: physicians and surgeons specializing in relevant therapeutic areas

7.6.4 Therapeutic Landscape

Revenues for each indication, geography-wise, are arrived at by utilizing the GBI Research market forecasting model. The global revenue for each indication is the sum value of revenues of all seven regions.

The annual cost of therapy for each indication is arrived at by considering the cost of the drugs, dosage of the drugs and the duration of the therapy.

The generic share of the market for each indication is obtained by calculating the prescription share for generic drugs and the respective cost of treatment.



The treatment use pattern, which includes quantitative data on the diseased population, treatment-seeking population, diagnosed population and treated population for an indication, is arrived at by referring to various sources as mentioned below.

GBI Research uses the epidemiology-based treatment flow model to forecast market size for therapeutic indications.

7.6.4.1 Epidemiology-Based Forecasting

The forecasting model used at GBI Research makes use of epidemiology data gathered from research publications and primary interviews with physicians to represent the treatment flow patterns for individual diseases and therapies. The market for any disease segment is directly proportional to the volume of units sold and the price per unit.

Sales = Volume of Units sold X Price per Unit

The volume of units sold is calculated on the average dosing regimen for that disease, duration of treatment and number of patients who are prescribed drug treatment (prescription population). Prescription population is calculated as the percentage of population diagnosed with a disease (diagnosis population). Diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (treatment-seeking population). Prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition.

Data on the treatment seeking rate, diagnosis rate and prescription rate, if unavailable from research publications, are gathered from interviews with physicians and are used to estimate the patient volumes for the disease under consideration. Therapy uptake and compliance data are fitted in the forecasting model to account for patient switching and compliance behavior.

To account for differences in patient affordability of drugs across various geographies, macroeconomic data, such as inflation and GDP, and healthcare indicators such as healthcare spending, insurance coverage and average income per individual are used.

Annual cost of therapy is calculated using product purchase frequency and the average price of the therapy. Product purchase frequency is calculated from the dosage data available for the therapies, and drug prices are gathered from public sources. The sources for the drug prices are MIMS India, MIMS China and ZenRx.

The epidemiology-based forecasting model uses a bottom-up methodology and makes use of estimations in the absence of data from research publications. Such estimations may result in a final market value that is different from the actual value. To correct this gap the forecasting model uses triangulation with the help of base year sales data (from company annual reports, internal and external databases) and sales estimations.

Analogous Forecasting Methodology

Analogous forecasting methodology is used to account for the introduction of new products, patent expiries of branded products and the subsequent introduction of generics. Historical data for new product launches and generics penetration are used to arrive at robust forecasts. The increase or decrease of prevalence rates, the treatment seeking rate, the diagnosis rate and the prescription rate are fitted into the forecasting model to estimate market growth rate.

The proprietary model enables GBI Research to account for the impact of individual drivers and restraints in the growth of the market. The year of impact and the extent of impact are quantified in the forecasting model to provide close-to-accurate data sets.

Diseased Population

The diseased population for any indication is the prevalence. The prevalence population for this report is taken from articles published in various journals, including the National Psoriasis Foundation and Journal of Investigative Dermatology.

Prescription Population

Psoriasis has multiple treatment options depending on the stage of the disease and the effectiveness of previous treatment such as topical therapy and phototherapy. The prescription



population is defined as the number of patients who are prescribed drug therapy non steroidal drugs as well as biologics. This is calculated as a percentage of the diagnosis population. Prescription population proportion is taken from articles published in journals such as the World Health Report and the National Psoriasis Foundation.

7.6.4.2 Market Size by Geography

The treatment use pattern and annual cost of therapy in each country has been factored in while deriving the individual country market size.

Forecasting Model for Therapeutic Areas

Figure 31: GBI Research Market Forecasting Model (Example)

Source: GBI Research

The above figure represents a typical forecasting model followed in GBI Research. As discussed previously, the model is built on the treatment flow patterns. The model starts with the general population, then diseased population as a percentage of the general population and then follows the treatment seeking population as a percentage of the diseased population and diagnosed population as a percentage of the treatment seeking population. Finally, the total volume of units sold is calculated by multiplying the treated population by the average dosage per year per patient.

7.6.5 Geographical Landscape

GBI Research analyzes four Asia-Pacific geographies: China, India, Japan, and Australia. The total market size for each country is provided which is the sum value of the market sizes of all the indications for that particular country. The maximum and minimum estimated market sizes are then



provided by adjusting all variables expected to impact on the market during the forecast period in order to provide the best and worst-case scenarios.

Articles from research journals and agency publications such as the National Psoriasis Foundation and ClinicalTrials.gov are the source of data for the estimation of market size and making forecasts.

7.6.6 Pipeline Analysis

This section provides a list of molecules at various stages in the pipeline for various indications. The list is sourced from internal databases and validated for the accuracy of phase and mechanism of action at ClinicalTrials.gov and company websites. The section also includes a list of promising molecules, which is narrowed down based on the results of the clinical trials at various stages and the novelty of the mechanism of action. A heatmap, sourced from relevant clinical trials, is provided in order to compare these products to one another in addition to currently marketed products. The latest press releases issued by the company and news reports are also a source of information for the status of the molecules in the pipeline. This list of pipeline molecules, in conjunction with a list of ongoing and completed clinical trials, is analyzed in this section, and a full breakdown of pipeline molecules and clinical trials by phase, molecule type and molecular target is provided.

7.7 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, and international sales managers from pharmaceutical companies, academics from research universities and key opinion leaders from hospitals.

Historical data and forecasts are relayed to GBI Research’s expert panel and are adjusted in accordance with their feedback.

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, GBI Research.

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