Osteoporosis Therapeutics in Asia-Pacific Markets to 2024 - Growth Driven by ongoing Transition from Anti-resorptive Agents to Anabolic Therapies, Rising Prevalence, and Growing Awareness

Osteoporosis Therapeutics in Asia-Pacific Markets to 2024 - Growth Driven by ongoing Transition from Anti-resorptive Agents to Anabolic Therapies, Rising Prevalence, and Growing Awareness


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Executive Summary

Osteoporosis Therapeutics in Asia-Pacific Markets to 2024-Growth Driven by ongoing Transition from Anti-resorptive Agents to Anabolic Therapies, Rising Prevalence, and Growing Awareness

Summary

Osteoporosis is a silent epidemic and as per the WHO declarations, it is a priority health issue. Osteoporosis is a disruption of bone architecture and decrease in bone mass, leading to a number of complications including increased chances of bone fractures and reduced bone strength. The most common sites of osteoporosis are the spine, hip and forearm, although it also affects other body parts.

The chronic nature of the disease, which requires ongoing treatment, relatively high annual cost of therapy (ACoT) of premium therapies, increasing prevalence and awareness about the disease among the patients over a period of time, and growing demand for mainly anabolic therapies, with only one anabolic therapy currently available in the market, have made osteoporosis treatment a highly lucrative market.

The osteoporosis therapeutic market has become very competitive due to the high number of new drug approvals, although the majority of them are incremental innovations of existing therapies. Competition is fierce, particularly among bisphosphonates and selective estrogen receptor modulators (SERMs), which are mostly used as first-line therapy and dominate the treatment market for osteoporosis patients.

Lack of effective and safe therapeutic options to treat osteoporosis was the major reason for development of currently marketed premium anabolic therapies. The competition among the premium therapies is expected to intensify during the forecast period due to expected launch of pipeline products. Additionally the expected launch of biosimilars will add fuel to the intense competition and make it tough for premium therapies to gain market share in the forecast period.

Patient compliance for osteoporosis therapies is a major unmet need, as the disease is asymptomatic until a fracture occurs and requires ongoing treatment. Drug delivery is crucial in the choice of medication.

Most medicines are administered orally, while others are administered intranasally or through injections. Medications with decreased dosing are often the preferred options. Therefore convenient and safe administration without significant compromise of therapy efficacy remains an unmet need.

Scope

- The current Asia-Pacific osteoporosis market contains novel products, including a humanized anti-sclerostin mAb, a synthetic peptide analog of human PTHrP, and a recombinant peptide and analogue of PTH.

- What are the competitive advantages of the novel drugs over current marketed drugs?

- 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?

- 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. There are over 136 active pipeline molecules, and most of the late-stage investigational drug candidates feature improved dosing regimens and administration routes in comparison to currently marketed products and combination therapies.

- Which classes of novel drugs are most prominent in the pipeline?

- What is the potential for pipeline products to address unmet needs in the osteoporosis market?

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

- Analysis of clinical trials since 2006 identified that the failure rates of osteoporosis molecules were highest in Phase III, with the overall attrition rate for osteoporosis standing at 83%.

- How do failure rates vary by stage of development, molecule type, and molecular target?

- How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?

- Over the 2017-2024 forecast period, the Asia-Pacific osteoporosis therapeutics market is expected to increase in value at a compound annual growth rate of 5.9%.

- Which markets make the most significant contribution to the current market size?

- What are the epidemiology trends in these markets?

- Will new market entrants lead to substantial changes in annual therapy costs?

- How will immunotherapies such as Prolia contribute to growth?

- How will different treatment usage patterns impact growth in the five assessed Asia-Pacific markets?

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

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

- A rising osteoporosis prevalence population and the uptake of newer therapies will lead to significant market growth over the forecast period, despite the launch of biosimilars.

- Will the launch of biosimilars or emerging pipeline molecules threaten the commercial success of existing drugs?

- 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?

- Licensing deals are the most common form of strategic alliance in the osteoporosis therapeutics market, with deal values ranging from under USD 10m to over USD 200m.

- How do deal frequency and value compare between target families and molecule types?

- What were the terms and conditions of key licensing deals?

Reasons to buy

- Understand the clinical context of osteoporosis by considering epidemiology, symptoms, etiology and pathophysiology, diagnosis, prognosis, treatment guidelines and options, and local and national registries.

- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.

- Identify key pipeline trends in terms of molecule type, administration route, molecular target, and novelty.

- Consider market opportunities and potential risks by examining trends in osteoporosis clinical trial size, duration, and failure rate by stage of development, molecule type, and molecular target.

- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in osteoporosis by examining clinical trial data and multi-scenario product forecast projections.

- Compare treatment usage patterns, annual therapy costs, and market growth projections for India, China, Australia, Japan and South Korea.

- Discover trends in licensing and co-development deals concerning osteoporosis products and identify the major strategic consolidations that have shaped the commercial landscape.



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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 10

2.2 Epidemiology 10

2.3 Symptoms 11

2.4 Etiology and Pathophysiology 13

2.4.1 Pathophysiology 14

2.5 Diagnosis 15

2.6 Disease Stages 17

2.7 Prognosis 19

2.8 Treatment Guidelines and Options 20

2.8.1 Treatment Guidelines 20

2.8.2 National and Local Registries 21

2.9 Treatment Options 22

2.9.1 Treatment Algorithm 22

2.9.2 Pharmacological Treatments 23

2.9.3 Non-Pharmacological Treatments 25

2.9.4 Exercise 25

2.9.5 Dietary Interventions 25

3 Marketed Products 27

3.1 Overview 27

3.2 Bisphosphonates 28

3.2.1 Risedronate-Warner Chilcott 28

3.2.2 Alendronate-Merck & Co. 29

3.2.3 Boniva (ibandronate)-Roche 30

3.2.4 Zoledronic Acid-Novartis 31

3.2.5 Recalbon/Bonoteo (minodronate)-Ono and Astellas Pharma 33

3.2.6 Etidronate-Procter & Gamble and Sumitomo Pharmaceuticals 33

3.3 Dual-Acting Non-Bisphosphonates 34

3.3.1 Strontium Ranelate-Servier 34

3.4 Selective Estrogen Receptor Modulators 35

3.4.1 Evista (raloxifene)-Eli Lilly 35

3.4.2 Viviant (bazedoxifene)-Ligand and Pfizer 36

3.5 Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Inhibitor 38

3.5.1 Prolia/Pralia (denosumab)-Amgen 38

3.6 Calcitonins 39

3.6.1 Calcitonin-salmon 39

3.7 Parathyroid Hormone 40

3.7.1 Forteo (teriparatide)-Eli Lilly 40

3.8 Vitamin D3 Derivative 42

3.8.1 Edirol (eldecalcitol)-Chugai 42

3.9 Comparative Efficacy and Safety of Marketed Products 42

4 Product Pipeline 46

4.1 Overview 46

4.2 Pipeline Distribution by Phase of Development, Molecule Type, Route of Administration and Novelty 47

4.3 Pipeline Distribution by Molecular Target 49

4.4 Promising Pipeline Candidates 52

4.4.1 Evenity (Romosozumab/AMG-785)-Amgen 52

4.4.2 Tymlos-Abaloparatide-SC-Radius Health 55

4.4.3 Uni-PTH-Uni-Bio Science 58

4.5 Comparative Efficacy and Safety of Pipeline Products 60

4.6 Product Competitiveness Framework 60

5 Clinical Trial Analysis 63

5.1 Failure Rate 63

5.1.1 Overall Failure Rate 63

5.1.2 Failure Rate by Phase and Molecule Type 65

5.1.3 Failure Rate by Phase and Molecular Target 65

5.2 Clinical Trial Duration 66

5.2.1 Clinical Trial Duration by Molecule Type 66

5.2.2 Clinical Trial Duration by Molecular Target 67

5.3 Clinical Trial Size 68

5.3.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 68

5.3.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 71

5.4 Summary of Clinical Trial Metrics 73

6 Multi-Scenario Forecast 74

6.1 Geographical Markets 74

6.2 Asia-Pacific Markets 75

6.3 India 76

6.3.1 Treatment Usage Patterns 76

6.3.2 Annual Cost of Therapy 77

6.3.3 Market Size 78

6.4 China 80

6.4.1 Treatment Usage Patterns 80

6.4.2 Annual Cost of Therapy 82

6.4.3 Market Size 83

6.5 Australia 85

6.5.1 Treatment Usage Patterns 85

6.5.2 Annual Cost of Therapy 85

6.5.3 Market Size 87

6.6 South Korea 89

6.6.1 Treatment Usage Patterns 89

6.6.2 Annual Cost of Therapy 90

6.6.3 Market Size 90

6.7 Japan 92

6.7.1 Treatment Usage Patterns 92

6.7.2 Annual Cost of Therapy 93

6.7.3 Market Size 94

7 Market Dynamics (Drivers and Barriers) of Osteoporosis Therapeutics Market 97

7.1 Drivers 97

7.1.1 Rising Prevalence 97

7.1.2 Increasing Health Insurance Coverage for Aged Population 97

7.1.3 Increasing Public and Policymaker Awareness 97

7.1.4 Promising Late-Stage Pipeline Products can Change the Treatment Paradigm 98

7.2 Barriers 98

7.2.1 Impending Patent Cliffs and Generic Erosion 98

7.2.2 Low Diagnosis and Treatment Rates 99

7.2.3 Non-Availability or Lack of Benefits for Combination Anabolic and Antiresorptive Therapies 99

7.2.4 Competition from Traditional Medicines 99

8 Deals and Strategic Consolidations 100

8.1 Licensing Deals 100

8.1.1 Deals by Region and Value 100

8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 101

8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 101

8.1.4 Key Licensing Deals 104

8.2 Co-development 106

8.2.1 Deals by Region and Value 106

8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 106

8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 107

8.2.4 Key Co-Development Deals 108

9 Appendix 110

9.1 All Pipeline Drugs by Stage of Development 110

9.1.1 Discovery 110

9.1.2 Preclinical 112

9.1.3 Phase I 115

9.1.4 Phase II 116

9.1.5 Phase III 116

9.1.6 Pre-registration 117

9.2 Summary of Multi-scenario Market Forecasts to 2024 117

9.2.1 Asia-Pacific 117

9.2.2 India 118

9.2.3 China 118

9.2.4 Australia 119

9.2.5 South Korea 119

9.2.6 Japan 120

9.3 Bibliography 120

9.4 Abbreviations 132

9.5 Research Methodology 134

9.5.1 Secondary Research 134

9.5.2 Marketed Product Profiles 135

9.5.3 Late-Stage Pipeline Candidates 135

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 135

9.5.5 Product Competitiveness Framework 135

9.5.6 Pipeline Analysis 136

9.5.7 Clinical Trials 136

9.5.8 Clinical trial Endpoint Analysis 136

9.5.9 Forecasting Model 137

9.5.10 Deals Data Analysis 138

9.6 Contact Us 138

9.7 Disclaimer 138

1.2 List of Figures

Figure 1: Osteoporosis Therapeutics Market, Indian Osteoporosis Treatment Guidelines, 2013 21

Figure 2: Osteoporosis Therapeutics Market, Treatment Algorithm of Osteoporosis 23

Figure 3: Osteoporosis Therapeutics Market, Comparative Efficacy and Safety Heat Map for Marketed Products for the Treatment of Osteoporosis, 2018 44

Figure 4: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Marketed Products for the Treatment of Osteoporosis in Men, 2018 44

Figure 5: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Marketed Products for the Treatment of Glucocorticoid-Induced Osteoporosis, 2018 45

Figure 6: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Marketed Products for the Prevention of Osteoporosis in Postmenopausal Women, 2018 45

Figure 7: Pipeline for Osteoporosis Therapeutics, Global, 2018 48

Figure 8: Pipeline for Osteoporosis Therapeutics by Molecular Target, Global, 2018 51

Figure 9: Pipeline for Osteoporosis Therapeutics by Molecular Target and Stage of Development, Global, 2018 52

Figure 10: Osteoporosis Therapeutics Market, Asia-Pacific, Romosozumab Market Forecast (USD m), 2018-2022 55

Figure 11: Osteoporosis Therapeutics Market, Asia-Pacific, Abaloparatide Market Forecast (USD m), 2018-2024 58

Figure 12: Osteoporosis Therapeutics Market, Asia-Pacific, Uni-PTH Market Forecast (USD m), 2019-2024 59

Figure 13: Osteoporosis Therapeutics Market, Comparative Efficacy Heat Map for Pipeline Products, 2018 60

Figure 14: Osteoporosis Therapeutics Market, Global, Competitor Matrix for Marketed and Pipeline Products, 2018 62

Figure 15: Osteoporosis Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2017 64

Figure 16: Osteoporosis Therapeutics, Global, Clinical Trial Failure Rates by Molecule Type (%), 2006-2017 65

Figure 17: Osteoporosis Therapeutics, Global, Clinical Trial Failure Rates by Molecular Target (%), 2006-2017 66

Figure 18: Osteoporosis Therapeutics, Global, Clinical Trial Duration by Molecule Type, 2006-2017 67

Figure 19: Osteoporosis Therapeutics, Global, Clinical Trial Duration by Molecular Target, 2006-2017 68

Figure 20: Osteoporosis Therapeutics, Global, Clinical Trial Size per Product by Molecule Type, 2006-2017 69

Figure 21: Osteoporosis Therapeutics, Global, Clinical Trial Size per Product by Molecular Target, 2006-2017 70

Figure 22: Osteoporosis Therapeutics, Global, Clinical Trial Size per Trial by Molecule Type, 2006-2017 71

Figure 23: Osteoporosis Therapeutics, Global, Clinical Trial Size per Trial by Molecular Target, 2006-2017 72

Figure 24: Osteoporosis Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 73

Figure 25: Osteoporosis Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 73

Figure 26: Osteoporosis Therapeutics Market, Asia-Pacific, Treatment Patterns (million) and Market Size (USD bn), 2017-2024 75

Figure 27: Osteoporosis Therapeutics Market, India, Treatment Patterns (million), 2017-2024 77

Figure 28: Osteoporosis Therapeutics Market, India, Annual Cost of Therapy (USD ), 2017-2024 78

Figure 29: Osteoporosis Therapeutics Market, India, Market Size (USD m), 2017-2024 79

Figure 30: Osteoporosis Therapeutics Market, China, Treatment Patterns (million), 2017-2024 81

Figure 31: Osteoporosis Therapeutics Market, China, Annual Cost of Therapy (USD ), 2017-2024 82

Figure 32: Osteoporosis Therapeutics Market, China, Market Size (USD m), 2017-2024 83

Figure 33: Osteoporosis Therapeutics Market, Australia, Treatment Patterns ('000), 2017-2024 85

Figure 34: Osteoporosis Therapeutics Market, Australia, Annual Cost of Therapy (USD ), 2017-2024 86

Figure 35: Osteoporosis Therapeutics Market, Australia, Market Size (USD m), 2017-2024 87

Figure 36: Osteoporosis Therapeutics Market, South Korea, Treatment Patterns ('000), 2017-2024 89

Figure 37: Osteoporosis Therapeutics Market, South Korea, Annual Cost of Therapy (USD ), 2017-2024 90

Figure 38: Osteoporosis Therapeutics Market, South Korea, Market Size (USD m), 2017-2024 91

Figure 39: Osteoporosis Therapeutics Market, Japan, Treatment Patterns (million), 2017-2024 93

Figure 40: Osteoporosis Therapeutics Market, Japan, Annual Cost of Therapy (USD ), 2017-2024 94

Figure 41: Osteoporosis Therapeutics Market, Japan, Market Size (USD m), 2017-2024 95

Figure 42: Osteoporosis Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2017 100

Figure 43: Osteoporosis Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 101

Figure 44: Osteoporosis Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 102

Figure 45: Osteoporosis Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006-2017 103

Figure 46: Osteoporosis Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value (USD ), 2006-2017 103

Figure 47: Osteoporosis Therapeutics Market, Global, Co-development Deals by Region, 2006-2017 106

Figure 48: Osteoporosis Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2017 106

Figure 49: Osteoporosis Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 107

Figure 50: Osteoporosis Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2006-2017 108

Figure 51: Osteoporosis Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006-2017 108

1.1 List of Tables

Table 1: Osteoporosis Therapeutics Market, Classical Case of Osteoporosis with Respect to Age 12

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 18

Table 8: Osteoporosis Therapeutics Market, Causes of Secondary Osteoporosis 19

Table 9: Osteoporosis Therapeutics Market, Global, Licensing Deals Valued over USD 10m, 2006-2017 105

Table 10: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Discovery, 2017 110

Table 11: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Preclinical, 2017 112

Table 12: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Phase I, 2017 115

Table 13: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Phase II, 2017 116

Table 14: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Phase III, 2017 116

Table 15: Osteoporosis Therapeutics Market, Global, All Pipeline Products, Pre-registration Phase, 2017 117

Table 16: Osteoporosis Therapeutics Market, Asia-Pacific, Market Forecast, 2017-2024 117

Table 17: Osteoporosis Therapeutics Market, India, Market Forecast, 2017-2024 118

Table 18: Osteoporosis Therapeutics Market, China, Market Forecast, 2017-2024 118

Table 19: Osteoporosis Therapeutics Market, Australia, Market Forecast, 2017-2024 119

Table 20: Osteoporosis Therapeutics Market, South Korea, Market Forecast, 2017-2024 119

Table 21: Osteoporosis Therapeutics Market, Japan, Market Forecast, 2017-2024 120

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