Uveitis Therapeutics in Asia-Pacific Markets to 2023 – Increasing Prevalence, Continued Uptake of Biologics and Novel Pipeline Drugs to Drive the Market

Uveitis refers to inflammation of the uvea, the middle vascular coat of the eye, comprising the iris, ciliary body, and choroid. It may also involve other adjacent tissues of the eye. Uveitis occurs at any age, but it most commonly affects individuals between 20 and 59 years of age. However, this trend is changing; the percentage of elderly uveitis patients has been increasing in recent years. Uveitis represents a major cause of ocular morbidity worldwide and often results in complications such as cataracts, glaucoma, ocular hypertension, macular issues, and retinal detachment.

It is a leading cause of blindness in both developed and developing countries and is the fifth most common cause of vision loss in the developed world. The uveitis market is characterized by a small selection of marketed drug options, consisting of corticosteroid therapies, immunosuppressive therapies and biologics. Historically, corticosteroid therapies have made up the bulk of the uveitis market.

Currently only one targeted therapy is available in the Asia-Pacific uveitis market, which is AbbVie’s Humira (adalimumab). The late-stage uveitis pipeline is composed of Santen’s Opsiria and Clearside Biomedical’s CLS-TA, which are expected to be highly lucrative and address some of the unmet needs.

These new drugs will expand the options available to treat uveitis patients and contribute to overall market growth by offering novel treatment mechanisms, including new drug delivery routes and novel, non-corticosteroid drug molecules.

Scope

– The Asia-Pacific uveitis market will be valued at $405.5m in 2023, growing from $179m in 2016, at a compound annual growth rate of 12.4%.

– What are the key factors driving the Asia-Pacific uveitis treatment market?

– How will targeted therapies such as Humira contribute to growth?

– Do branded therapies show continuous growth, and are they facing competition from generics?

– How will branded therapies be affected by upcoming pipeline therapies?

– Corticosteroid therapies dominate the uveitis market, but unmet needs exist in terms of safety and efficacy. Will the drugs under development fulfill the unmet needs?

– What are the common targets and mechanisms of action of pipeline therapies?

– What are the commercial prospects for the most promising late-stage products?

– Various drivers and barriers will influence the market over the forecast period.

– What are the barriers that will limit the uptake of premium-priced therapies in the assessed countries?

– Which factors are most likely to drive the market in these countries?

– What licensing and co-development deals have occurred within this therapy area since 2006?

Reasons to buy

- Understand the current clinical and commercial landscape through a comprehensive analysis of disease symptoms, diagnostic methods, etiology, pathophysiology, epidemiology, prognosis and treatment.

- Visualize the composition of the uveitis market in terms of dominant therapies, with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.

- Analyze the uveitis pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.

- Understand the potential of late-stage therapies, with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.

- Predict uveitis market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.

- Identify commercial opportunities in the uveitis deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 9

2.1 Disease Introduction 9

2.2 Epidemiology 10

2.3 Symptoms 11

2.4 Etiology and Pathophysiology 11

2.4.1 Autoimmune uveitis 12

2.4.2 Non-autoimmune uveitis 12

2.5 Diagnosis 14

2.6 Prognosis 15

2.7 Treatment Options 16

2.7.1 Corticosteroids 17

2.7.2 Immunosuppressive Agents 18

2.7.3 Biologics 18

2.7.4 Adjuvant Therapy 19

3 Marketed Products 20

3.1 Overview 20

3.1.1 Humira (adalimumab) - AbbVie 21

3.1.2 Retisert (fluocinolone acetonide) - Bausch & Lomb 22

3.1.3 Ozurdex (dexamethasone) - Allergan 23

3.1.4 Neoral (Cyclosporine) - Novartis 25

3.1.5 Mycept (Mycophenolate mofetil) - Panacea Biotec 26

3.1.6 Medrol (Methylprednisolone) - Pfizer 27

3.1.7 Betamethasone - Merck & Co. 28

3.1.8 Pred Forte (Prednisolone) - Allergan 28

3.2 Comparative Efficacy and Safety of Marketed Products 29

4 Pipeline Analysis 32

4.1 Overview 32

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 33

4.3 Pipeline by Molecular Target 34

4.4 Promising Pipeline Candidates 36

4.4.1 DE-109/ Opsiria (Sirolimus) - Santen 36

4.4.2 CLS-TA (triamcinolone acetonide) - Clearside BioMedical 37

4.5 Heatmap for Pipeline Products 38

4.6 Product Competitiveness Framework 40

5 Clinical Trial Analysis 42

5.1 Failure Rate 42

5.1.1 Overall Failure Rate 42

5.1.2 Failure Rate by Phase and Molecule Type 43

5.1.3 Failure Rate by Phase and Molecular Target 44

5.2 Clinical Trial Size 45

5.2.1 Patient Enrollment per Product by Molecule Type and Stage of Development 45

5.2.2 Patient Enrollment per Product by Molecular Target and Stage of Development 46

5.2.3 Patient Enrollment per Trial by Molecule Type and Stage of Development 47

5.2.4 Patient Enrollment per Trial by Molecular Target and Stage of Development 48

5.3 Clinical Trial Duration 49

5.3.1 Trial Duration by Molecule Type and Stage of Development 49

5.3.2 Trial Duration by Molecular Target and Stage of Development 50

5.4 Summary of Clinical Trial Metrics 51

6 Multi-scenario Forecast 53

6.1 Geographical Markets 53

6.2 Asia-Pacific Market 53

6.2.1 Treatment Usage Patterns 53

6.2.2 Market Size 54

6.3 India 55

6.3.1 Treatment Usage Patterns 55

6.3.2 Annual Cost of Therapy 56

6.3.3 Market Size 57

6.4 China 58

6.4.1 Treatment Usage Patterns 58

6.4.2 Annual Cost of Therapy 59

6.4.3 Market Size 60

6.5 Australia 61

6.5.1 Treatment Usage Patterns 61

6.5.2 Annual Cost of Therapy 62

6.5.3 Market Size 63

6.6 South Korea 64

6.6.1 Treatment Usage Patterns 64

6.6.2 Annual Cost of Therapy 65

6.6.3 Market Size 66

6.7 Japan 67

6.7.1 Treatment Usage Patterns 67

6.7.2 Annual Cost of Therapy 68

6.7.3 Market Size 69

7 Drivers and Barriers 71

7.1 Drivers 71

7.1.1 Increasing Usage of Biologics 71

7.1.2 Promising Late-Stage Pipeline Products Can Change Treatment Paradigm 71

7.1.3 Increasing Elderly Population and Incidence of Uveitis 71

7.2 Barriers 71

7.2.1 Uveitis - An Under-Researched Disease 71

7.2.2 Low Diagnosis and Treatment Rates 72

7.2.3 Steep Prices of Therapeutics to Slow Down Market Growth 72

8 Deals and Strategic Consolidations 73

8.1 Licensing Deals 73

8.1.1 Deals by Region and Value 73

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 73

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 73

8.1.4 Key Licensing Deals 76

8.2 Co-development Deals 77

8.2.1 Deals by region, value, year, stage of development, molecule type and molecular target 77

8.2.2 Key Co-development Deals 77

9 Appendix 78

9.1 All Pipeline Drugs by Stage of Development 78

9.1.1 Discovery 78

9.1.2 Preclinical 78

9.1.3 IND/CTA-filed 79

9.1.4 Phase I 79

9.1.5 Phase II 80

9.1.6 Phase III 80

9.1.7 Pre-registration 80

9.2 Market Forecasts to 2023 81

9.2.1 Asia-Pacific 81

9.2.2 India 81

9.2.3 China 81

9.2.4 Australia 82

9.2.5 South Korea 82

9.2.6 Japan 83

9.3 Bibliography 83

9.4 Abbreviations 87

9.5 Research Methodology 88

9.5.1 Secondary Research 88

9.5.2 Marketed Product Profiles 88

9.5.3 Late-Stage Pipeline Candidates 88

9.5.4 Comparative Efficacy and Safety Heatmap for Marketed and Pipeline Products 88

9.5.5 Product Competitiveness Framework 89

9.5.6 Pipeline Analysis 89

9.5.7 Forecasting Model 90

9.5.8 Deals Data Analysis 91

9.6 Contact Us 91

9.7 Disclaimer 91

List of Tables

1.1 List of Tables

Table 1: Uveitis Therapeutics Market, APAC, Anatomic Classification of Uveitis 9

Table 2: Uveitis Therapeutics Market, APAC, Definition of Onset, Duration and Course of Uveitis 10

Table 3: Uveitis Therapeutics, APAC, Diseases Most Frequently Associated with Uveitis 13

Table 4: Uveitis Therapeutics, APAC, Investigations for Systemic Conditions Causing Uveitis 15

Table 5: Uveitis Therapeutics Market, APAC, Prognosis for Uveitis Patients 16

Table 6: Uveitis Therapeutics Market, Global, Licensing Deals with Disclosed Deal Value, 2006-2017 77

Table 7: Uveitis Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 78

Table 8: Uveitis Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017 78

Table 9: Uveitis Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2017 79

Table 10: Uveitis, Global, All Pipeline Products, Phase I, 2017 79

Table 11: Uveitis Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 80

Table 12: Uveitis Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 80

Table 13: Uveitis Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2017 80

Table 14: Uveitis Therapeutics Market, Asia-Pacific, Market Forecast, 2016-2023 81

Table 15: Uveitis Therapeutics Market, India, Market Forecast, 2016-2023 81

Table 16: Uveitis Therapeutics Market, China, Market Forecast, 2016-2023 81

Table 17: Uveitis Therapeutics Market, Australia, Market Forecast, 2016-2023 82

Table 18: Uveitis Therapeutics Market, South Korea, Market Forecast, 2016-2023 82

Table 19: Uveitis Therapeutics Market, Japan, Market Forecast, 2016-2023 83

List of Figures

1.2 List of Figures

Figure 1: Uveitis Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for the Treatment of Uveitis 31

Figure 2: Uveitis Therapeutics Market, Global, Pipeline, 2017 34

Figure 3: Uveitis Therapeutics Market, Global, Pipeline by Molecular Target, 2017 35

Figure 4: Uveitis Therapeutics Market, APAC, DE-109/Opsiria Market ($m), 2019-2023 37

Figure 5: Uveitis Market, Comparative Efficacy and Safety Heatmap for Pipeline Products 39

Figure 6: Uveitis Therapeutics Market, Competitor Matrix for Uveitis Marketed and Pipeline Products, 2017 40

Figure 7: Uveitis Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 43

Figure 8: Uveitis Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2016 44

Figure 9: Uveitis Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2016 45

Figure 10: Uveitis Therapeutics, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2016 46

Figure 11: Uveitis Therapeutics, Global, Clinical Trial Size per Product by Molecular Target (participants), 2006-2016 47

Figure 12: Uveitis Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type (participants), 2006-2016 48

Figure 13: Uveitis Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target (participants), 2006-2016 49

Figure 14: Uveitis Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2016 50

Figure 15: Uveitis Therapeutics, Global, Clinical Trial Duration by Molecular Target (months), 2006-2016 51

Figure 16: Uveitis Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 52

Figure 17: Uveitis Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 52

Figure 18: Uveitis Therapeutics Market, APAC, Treatment Patterns (‘000), 2016-2023 54

Figure 19: Uveitis Therapeutics Market, APAC, Market Size ($m), 2016-2023 55

Figure 20: Uveitis Therapeutics Market, India, Treatment Patterns (‘000), 2016-2023 56

Figure 21: Uveitis Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 57

Figure 22: Uveitis Therapeutics Market, India, Market Size ($m), 2016-2023 58

Figure 23: Uveitis Therapeutics Market, China, Treatment Patterns (‘000), 2016-2023 59

Figure 24: Uveitis Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 60

Figure 25: Uveitis Therapeutics Market, China, Market Size ($m), 2016-2023 61

Figure 26: Uveitis Therapeutics Market, Australia, Treatment Patterns (‘000), 2016-2023 62

Figure 27: Uveitis Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 63

Figure 28: Uveitis Therapeutics Market, Australia, Market Size ($m), 2016-2023 64

Figure 29: Uveitis Therapeutics Market, South Korea, Treatment Patterns (‘000), 2016-2023 65

Figure 30: Uveitis Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 66

Figure 31: Uveitis Therapeutics Market, South Korea, Market Size ($m), 2016-2023 67

Figure 32: Uveitis Therapeutics Market, Japan, Treatment Patterns (‘000), 2016-2023 68

Figure 33: Uveitis Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 69

Figure 34: Uveitis Therapeutics Market, Japan, Market Size ($m), 2016-2023 70

Figure 35: Uveitis Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 73

Figure 36: Uveitis Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 74

Figure 37: Uveitis Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2017 75

Figure 38: Uveitis Therapeutics, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006-2017 76

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