Osteoporosis Therapeutics in Asia-Pacific Markets to 2022-Growth Driven by Rising Prevalence, Growing Awareness and Expected Launch of Anabolic Therapies

Osteoporosis Therapeutics in Asia-Pacific Markets to 2022-Growth Driven by Rising Prevalence, Growing Awareness and Expected Launch of Anabolic Therapies


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Executive Summary

Osteoporosis Therapeutics in Asia-Pacific Markets to 2022-Growth Driven by Rising Prevalence, Growing Awareness and Expected Launch of Anabolic Therapies

Summary

Osteoporosis, the most common metabolic bone disease, is characterized by low bone mass, microarchitectural deterioration of bone tissue, and a consequent increase in fracture risk. Osteoporosis is generally known as an asymptomatic disease, as there are no visible signs until a fracture occur. In most of the cases, fracture is the clinical outcome associated with osteoporosis, and it has a complex pathogenesis that involves trauma to the bone and increased skeletal fragility. Osteoporosis is a major global public health problem, associated with significant morbidity, mortality, and socioeconomic burden. An aging global population will result in an increased number of people living with the condition, thereby acting as a driver for revenue growth.

The osteoporosis market is undergoing a gradual transition from a focus on antiresorptive therapies to anabolic drug treatment. The market is set to be driven by recently launched products, and the approval of drugs that will supplement current market leaders and offer greater therapeutic options. The marketed products landscape comprises a wide range of treatment options, including bisphosphonates, SERMs, RANKL inhibitors, a dual-action non-bisphosphonate (strontium ranelate), calcitonins and PTH analogues. Nevertheless, significant unmet need remains for products that can improve bone formation, as well as effective antiresorptive therapies that offer increased compliance with few side effects.

Scope

The osteoporosis Asia-Pacific market will be valued at USD 7.7 billion in 2022, growing from USD 4.5 billion in 2015 at a CAGR of 7.8%.

Bisphosphonates and SERMs dominate the osteoporosis market. However, unmet needs exist in terms of safety and efficacy. Will the drugs under development fulfill the unmet needs of the osteoporosis market?

How will immunotherapies such as Prolia contribute to growth?

What effect will the patent expirations of currently branded therapies have on market value?

The pipeline contains a range of molecule types and molecular targets, including those that are well established in osteoporosis, and novel, first-in-class therapies.

Which molecular targets appear most frequently in the pipeline?

Is there strong potential for the pipeline to address unmet needs within the osteoporosis market?

Will the pipeline address unmet needs related to limited anabolic therapies for osteoporosis patients?

The market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value, due to the emergence of novel therapies.

How will the annual cost of therapy and market size vary between the five Asia-Pacific markets?

How could changes in risk factors such as aging population, calcium and vitamin D deficiency influence the market?

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

What are the barriers that limit the uptake of premium-priced therapeutics in the assessed countries?

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

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.

Visualize the composition of the osteoporosis 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 current market.

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

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



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1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 8

1.2 List of Figures 8

2 Introduction 10

2.1 Disease Introduction 11

2.2 Epidemiology 11

2.3 Symptoms 12

2.4 Etiology and Pathophysiology 14

2.4.1 Pathophysiology 14

2.5 Diagnosis 15

2.6 Disease Stages 17

2.7 Prognosis 20

2.8 Treatment Options 21

2.8.1 Treatment Algorithm 21

2.8.2 Pharmacological Treatments 22

2.8.3 Non-Pharmacological Treatments 24

2.8.4 Exercise 24

2.8.5 Dietary Interventions 24

3 Marketed Products 26

3.1 Overview 26

3.2 Bisphosphonates 26

3.2.1 Risedronate-Warner Chilcott 26

3.2.2 Alendronate-Merck & Co 28

3.2.3 Boniva (ibandronate)-Roche 29

3.2.4 Zoledronic Acid-Novartis 30

3.2.5 Recalbon/Bonoteo (minodronate)-Ono and Astellas Pharma 31

3.2.6 Etidronate-Procter & Gamble and Sumitomo Pharmaceuticals 32

3.3 Dual-Acting Non-Bisphosphonates 33

3.3.1 Strontium Ranelate-Servier 33

3.4 Selective Estrogen Receptor Modulators 34

3.4.1 Evista (raloxifene)-Eli Lilly 34

3.4.2 Viviant (bazedoxifene)-Ligand and Pfizer 35

3.5 Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Inhibitor 36

3.5.1 Prolia (denosumab)-Amgen 36

3.6 Calcitonins 37

3.6.1 Calcitonin-salmon 37

3.7 Parathyroid Hormone 38

3.7.1 Forteo (teriparatide)-Eli Lilly 38

3.8 Comparative Efficacy and Safety of Marketed Products 39

4 Pipeline Analysis 42

4.1 Overview 42

4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 43

4.3 Pipeline by Molecular Target 45

4.4 Promising Pipeline Candidates 48

4.4.1 Romosozumab (AMG-785)-Amgen 48

4.4.2 Abaloparatide-SC (BA-058-SC)-Radius Health 51

4.4.3 Odanacatib (MK-0822 )-Merck & Co 54

4.4.4 Uni-PTH-Uni-Bio Science 56

4.5 Comparative Efficacy and Safety of Pipeline Products 58

4.6 Product Competitiveness Framework 59

5 Clinical Trial Analysis 61

5.1 Failure Rate 61

5.1.1 Overall Failure Rate 61

5.1.2 Failure Rate by Phase and Molecule Type 63

5.1.3 Failure Rate by Phase and Molecular Target 63

5.2 Clinical Trial Duration 64

5.2.1 Clinical Trial Duration by Molecule Type 64

5.2.2 Clinical Trial Duration by Molecular Target 66

5.3 Clinical Trial Size 67

5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 67

5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 69

5.4 Competitive Clinical Trials Metrics Analysis 71

6 Multi-Scenario Forecast 73

6.1 Geographical Markets 73

6.2 Asia-Pacific Market 74

6.3 India 75

6.3.1 Treatment Usage Patterns 75

6.3.2 Annual Cost of Therapy 77

6.3.3 Market Size 78

6.4 China 79

6.4.1 Treatment Usage Patterns 79

6.4.2 Annual Cost of Therapy 80

6.4.3 Market Size 81

6.5 Australia 82

6.5.1 Treatment Usage Patterns 82

6.5.2 Annual Cost of Therapy 83

6.5.3 Market Size 85

6.6 South Korea 86

6.6.1 Treatment Usage Patterns 86

6.6.2 Annual Cost of Therapy 87

6.6.3 Market Size 88

6.7 Japan 89

6.7.1 Treatment Usage Patterns 89

6.7.2 Annual Cost of Therapy 89

6.7.3 Market Size 90

7 Drivers and Barriers 92

7.1 Drivers 92

7.1.1 Rising Prevalence 92

7.1.2 Increasing Health Insurance Coverage for Aged Population 92

7.1.3 Increasing Public and Policymaker Awareness 92

7.1.4 Promising Late-Stage Pipeline Products can Change the Treatment Paradigm 93

7.2 Barriers 93

7.2.1 Impending Patent Cliffs and Generic Erosion 93

7.2.2 Low Diagnosis and Treatment Rates 93

7.2.3 Non-Availability or Lack of Benefits for Combination Anabolic and Antiresorptive Therapies 93

7.2.4 Competition from Traditional Medicines 94

8 Deals and Strategic Consolidations 95

8.1 Licensing Deals 95

8.1.1 Deals by Region and Value 95

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 96

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 96

8.1.4 Key Licensing Deals 99

8.2 Co-Development Deals 101

8.2.1 Deals by Region and Value 101

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 102

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 103

8.2.4 Key Co-Development Deals 104

9 Appendix 106

9.1 All Pipeline Drugs by Stage of Development 106

9.1.1 Discovery 106

9.1.2 Preclinical 108

9.1.3 Investigational New Drug/ Clinical Trial Authorization-Filed 110

9.1.4 Phase I 110

9.1.5 Phase II 111

9.1.6 Phase III 111

9.1.7 Pre-registration 111

9.2 Market Forecasts to 2021 112

9.2.1 Asia-Pacific 112

9.2.2 India 112

9.2.3 China 113

9.2.4 Australia 113

9.2.5 South Korea 114

9.2.6 Japan 114

9.3 Bibliography 115

9.4 Abbreviations 126

9.5 Research Methodology 127

9.5.1 Secondary Research 128

9.5.2 Marketed Product Profiles 128

9.5.3 Late-Stage Pipeline Candidates 128

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 129

9.5.5 Product Competitiveness Framework 129

9.5.6 Pipeline Analysis 129

9.5.7 Forecasting Model 130

9.5.8 Deals Data Analysis 131

9.6 Contact Us 131

9.7 Disclaimer 131

1.2 List of Figures

Figure 1: Osteoporosis Therapeutics Market, Treatment Algorithm of Osteoporosis 22

Figure 2: Osteoporosis Therapeutics Market, Comparative Efficacy and Safety Heat Map for Marketed Products for the Treatment of Osteoporosis 40

Figure 3: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Marketed Products for the Treatment of Osteoporosis in Men 40

Figure 4: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Marketed Products for the Treatment of Glucocorticoid-Induced Osteoporosis 41

Figure 5: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Marketed Products for the Prevention of Osteoporosis in Postmenopausal Women 41

Figure 6: Pipeline for Osteoporosis Therapeutics, Global, 2016 44

Figure 7: Pipeline for Osteoporosis Therapeutics by Molecular Target, Global, 2016 47

Figure 8: Pipeline for Osteoporosis Therapeutics by Molecular Target and Stage of Development, Global, 2016 48

Figure 9: Osteoporosis Therapeutics Market, Asia-Pacific, Romosozumab Market Forecast (USD m), 2018-2022 51

Figure 10: Osteoporosis Therapeutics Market, Asia-Pacific, Abaloparatide Market Forecast (USD m), 2018-2022 54

Figure 11: Osteoporosis Therapeutics Market, Asia-Pacific, Odanacatib Market Forecast (USD m), 2018-2022 56

Figure 12: Osteoporosis Therapeutics Market, Asia-Pacific, Uni-PTH Market Forecast (USD m), 2020-2021 58

Figure 13: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Pipeline Products 59

Figure 14: Osteoporosis Therapeutics Market, Global, Competitor Matrix for Marketed and Pipeline Products, 2016 60

Figure 15: Osteoporosis Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2015 62

Figure 16: Osteoporosis Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2015 63

Figure 17: Osteoporosis Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2015 64

Figure 18: Osteoporosis Therapeutics, Global, Clinical Trial Duration by Molecule Type, 2006-2015 65

Figure 19: Osteoporosis Therapeutics, Global, Clinical Trial Duration by Molecular Target, 2006-2015 66

Figure 20: Osteoporosis Therapeutics, Global, Clinical Trial Size per Product by Molecule Type, 2006-2015 68

Figure 21: Osteoporosis Therapeutics, Global, Clinical Trial Size per Product by Molecular Target, 2006-2015 69

Figure 22: Osteoporosis Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type, 2006-2015 70

Figure 23: Osteoporosis Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target, 2006-2015 71

Figure 24: Osteoporosis Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 72

Figure 25: Osteoporosis Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 72

Figure 26: Osteoporosis Therapeutics Market, Asia-Pacific, Treatment Patterns (million) and Market Size (USD bn), 2015-2022 74

Figure 27: Osteoporosis Therapeutics Market, India, Treatment Patterns (million), 2015-2022 76

Figure 28: Osteoporosis Therapeutics Market, India, Annual Cost of Therapy (USD ), 2015-2022 77

Figure 29: Osteoporosis Therapeutics Market, India, Market Size (USD m), 2015-2022 78

Figure 30: Osteoporosis Therapeutics Market, China, Treatment Patterns (million), 2015-2022 79

Figure 31: Osteoporosis Therapeutics Market, China, Annual Cost of Therapy (USD ), 2015-2022 80

Figure 32: Osteoporosis Therapeutics Market, China, Market Size (USD m), 2015-2022 81

Figure 33: Osteoporosis Therapeutics Market, Australia, Treatment Patterns (000), 2015-2022 82

Figure 34: Osteoporosis Therapeutics Market, Australia, Annual Cost of Therapy (USD ), 2015-2022 84

Figure 35: Osteoporosis Therapeutics Market, Australia, Market Size (USD m), 2015-2022 85

Figure 36: Osteoporosis Therapeutics Market, South Korea, Treatment Patterns (000), 2015-2022 86

Figure 37: Osteoporosis Therapeutics Market, South Korea, Annual Cost of Therapy (USD ), 2015-2022 87

Figure 38: Osteoporosis Therapeutics Market, South Korea, Market Size (USD m), 2015-2022 88

Figure 39: Osteoporosis Therapeutics Market, Japan, Treatment Patterns (million), 2015-2022 89

Figure 40: Osteoporosis Therapeutics Market, Japan, Annual Cost of Therapy (USD ), 2015-2022 90

Figure 41: Osteoporosis Therapeutics Market, Japan, Market Size (USD m), 2015-2022 91

Figure 42: Osteoporosis Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2015 95

Figure 43: Osteoporosis Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2015 96

Figure 44: Osteoporosis Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2015 97

Figure 45: Osteoporosis Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2015 98

Figure 46: Osteoporosis Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value (USD ), 2006-2015 99

Figure 47: Osteoporosis Therapeutics Market, Global, Co-development Deals by Region, 2006-2015 101

Figure 48: Osteoporosis Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2015 102

Figure 49: Osteoporosis Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2015 103

Figure 50: Osteoporosis Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2015 103

1.1 List of Tables

Table 1: Osteoporosis Therapeutics Market, Classical Case of Osteoporosis with Respect to Age 13

Table 2: Osteoporosis Therapeutics Market, Common Types of Fracture in Osteoporosis 13

Table 3: Osteoporosis Therapeutics Market, Diagnosis Tests for Osteoporosis 16

Table 4: Osteoporosis Therapeutics Market, T-Score Ranges for Determination of BMD 16

Table 5: Osteoporosis Therapeutics Market, Clinical Stage Characteristics 17

Table 6: Osteoporosis Therapeutics Market, Clinical Types of Osteoporosis 17

Table 7: Osteoporosis Therapeutics Market, Characteristics of Type 1 and 2 Primary Osteoporosis 19

Table 8: Osteoporosis Therapeutics Market, Causes of Secondary Osteoporosis 20

Table 9: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Discovery, 2016 106

Table 10: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 108

Table 11: Osteoporosis Therapeutics Market, Global, All Pipeline Products, IND/CTA-Filed, 2016 110

Table 12: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Phase I, 2016 110

Table 13: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Phase II, 2016 111

Table 14: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Phase III, 2016 111

Table 15: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2016 111

Table 16: Osteoporosis Therapeutics Market, Asia-Pacific, Market Forecast, 2015-2022 112

Table 17: Osteoporosis Therapeutics Market, India, Market Forecast, 2015-2022 112

Table 18: Osteoporosis Therapeutics Market, China, Market Forecast, 2015-2022 113

Table 19: Osteoporosis Therapeutics Market, Australia, Market Forecast, 2015-2022 113

Table 20: Osteoporosis Therapeutics Market, South Korea, Market Forecast, 2015-2022 114

Table 21: Osteoporosis Therapeutics Market, Japan, Market Forecast, 2015-2022 114

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