OpportunityAnalyzer: Osteoarthritis – Opportunity Analysis and Forecasts to 2024

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Osteoarthritis (OA) is a slowly progressive joint disease that is typically seen in middle-aged to elderly people. The disease is caused by the breakdown of the joint cartilage due to mechanical stress or biochemical alterations, which causes the bone underneath to fail. OA can occur together with other types of arthritis, such as gout or rheumatoid arthritis (RA). OA tends to affect commonly used joints such as the hands and spine as well as the weight-bearing joints such as the hips and knees. The causes of OA are not fully understood. However, genetic factors, and damage to the joints, either through repeated excessive loading and stress of a joint over time (for example, the knee joint in an obese person) or by injury (such as a break or dislocation of a finger joint) increases the risk of developing OA. There is no single test to diagnose OA. Several methods are used to diagnose OA and to rule out other problems: medical history, physical exam, X-rays, blood tests, or joint fluid analysis. The structural changes that occur with old age may not be accompanied by symptoms, which makes the estimation of the prevalence of OA difficult.

Scope

Overview of OA, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized OA therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the OA therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

Analysis of the current and future market competition in the global OA therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global and Historical Trends

4.3.1Total Prevalence of OA – 7MM

4.3.2Diagnosed Prevalence of OA – 7MM

4.3.3US

4.3.45EU

4.3.5Japan

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast for OA (2014–2024)

4.5.1Total Prevalent Cases

4.5.2Diagnosed Prevalent Cases

4.5.3Severity of Knee OA Based on KL Grades

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Current Treatment Options

5.1Overview

5.2Product Profiles – Major Therapies

5.2.1NSAIDs (Numerous Branded and Generic Products)

5.2.2Topical Therapies (Numerous Branded and Generic Products)

5.2.3Opioids (Numerous Branded and Generic Products)

5.2.4Antidepressants (Numerous Branded and Generic Products)

5.2.5Intra-Articular Corticosteroid Injections (Numerous Branded and Generic Products)

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.2Analgesic Drugs that Adequately Address Pain

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Disease-Modifying Drugs

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Drugs with Improved Tolerability for Use in the Elderly Patient Population

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Improved Implementation of Guidelines on Non-pharmaceutical Treatments

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Early Detection and Intervention

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

7Research and Development Strategies

7.1Overview

7.2Development of Pharmacological Treatments with Novel MOAs

7.3Development of Disease-Modifying OA Drugs

7.4Strategic Partnerships

7.5Current Clinical Trial Design

7.5.1Limitations of Patient-Reported Outcomes

7.5.2Lack of Useful Subpopulations for Targeted Therapies

7.5.3Lack of Consensus on DMOAD Trial Design

7.6Future Clinical Trial Design

7.6.1Sensitive Measurement Tools for Evaluating Joint Morphology

7.6.2Developing and Qualifying Biomarkers to Enable DMOADs Development

7.6.3Future Trials Need to Take into Consideration Joint Tissues Other Than Articular Cartilage

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Ampion

8.2.2NKTR-181

8.2.3FX006 (Zilretta)

8.2.4Anti-NGF

8.2.5Invossa

8.2.6Sprifermin

8.3Innovative Early-Stage Approaches

8.3.1Targeting Innovative Pain Signaling Pathways

8.3.2Pro-inflammatory Cytokine Modulation

8.3.3Growth Factor Therapy

8.3.4Subchondral Bone Remodeling

9Pipeline Valuation Analysis

9.1Clinical Benchmarking of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top-Line 10-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed OA Patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4Launch and Patent Expiry Dates

10.4.5General Pricing Assumptions

10.4.6Individual Drug Assumptions

10.4.7Generic Erosion

10.4.8Pricing of Pipeline Agents

10.5Physicians and Specialists Included in this Study

10.6Primary Research—Prescriber Survey

10.7About the Authors

10.7.1Author

10.7.2Epidemiologist

10.8About GlobalData

10.9Contact Us

10.10Disclaimer

Table

Table 1: Etiology of OA

Table 2: Genes Associated with OA and Joint Development

Table 3: Signs and Symptoms of OA

Table 4: Hand, Knee, and Hip OA Severity Scoring System Using the Kellgren-Lawrence Scale

Table 5: Risk Factors and Comorbidities for OA

Table 6: Global Estimates for the Diagnosed Prevalence of OA

Table 7: 7MM, Sources of Epidemiological Data Used for the Forecast for Hand OA Total Prevalent Cases

Table 8: 7MM, Sources of Epidemiological Data Used for the Forecast of Knee OA Total Prevalent Cases

Table 9: 7MM, Sources of Epidemiological Data Used for the Forecast of Hip OA Total Prevalent Cases

Table 10: 7MM, Sources of Epidemiological Data Used for the Forecast of Hand OA Diagnosed Prevalent Cases

Table 11: 7MM, Sources of Epidemiological Data Used for the Forecast of Knee OA Diagnosed Prevalent Cases

Table 12: 7MM, Sources of Epidemiological Data Used for the Forecast of Hip OA Diagnosed Prevalent Cases

Table 13: 7MM, Sources of Epidemiological Data Used for the Severity* of Knee OA Based on KL Grade

Table 14: 7MM, Total Prevalent Cases of Hand OA, Both Sexes, Ages =20 Years, N, 2014–2024

Table 15: 7MM, Age-Specific Total Prevalent Cases of Hand OA, Both Sexes, N (Row %), 2014

Table 16: 7MM, Sex-Specific Total Prevalent Cases of Hand OA, Ages =20 Years, N (Row %), 2014

Table 17: 7MM, Total Prevalent Cases of Knee OA, Both Sexes, Ages =20 Years, N, 2014–2024

Table 18: 7MM, Age-Specific Total Prevalent Cases of Knee OA, Both Sexes, N (Row %), 2014

Table 19: 7MM, Sex-Specific Total Prevalent Cases of Knee OA, Ages =20 Years, N (Row %), 2014

Table 20: 7MM, Total Prevalent Cases of Hip OA, Both Sexes, Ages =20 Years, N, 2014–2024

Table 21: 7MM, Age-Specific Total Prevalent Cases of Hip OA, Both Sexes, N (Row %), 2014

Table 22: 7MM, Sex-Specific Total Prevalent Cases of Hip OA, Ages =20 Years, N (Row %), 2014

Table 23: 7MM, Diagnosed Prevalent Cases of Hand OA, Both Sexes, Ages =20 Years, N, 2014–2024

Table 24: 7MM, Age-Specific Diagnosed Prevalent Cases of Hand OA, Both Sexes, N (Row %), 2014

Table 25: 7MM, Sex-Specific Diagnosed Prevalent Cases of Hand OA, Ages =20 Years, N (Row %), 2014

Table 26: 7MM, Diagnosed Prevalent Cases of Knee OA, Both Sexes, Ages =20 Years, N, 2014–2024

Table 27: 7MM, Age-Specific Diagnosed Prevalent Cases of Knee OA, Both Sexes, N (Row %), 2014

Table 28: 7MM, Sex-Specific Diagnosed Prevalent Cases of Knee OA, Ages =20 Years, N (Row %), 2014

Table 29: 7MM, Diagnosed Prevalent Cases of Hip OA, Both Sexes, Ages =20 Years, N, 2014–2024

Table 30: 7MM, Age-Specific Diagnosed Prevalent Cases of Hip OA, Both Sexes, N (Row %), 2014

Table 31: 7MM, Sex-Specific Diagnosed Prevalent Cases of Hip OA, Ages =20 Years, N (Row %), 2014

Table 32: 7MM, Total and Diagnosed Prevalent Cases of Knee OA by Severity Based on KL Grades, Both Sexes, Ages =20 Years, N, 2014

Table 33: Overview of Leading NSAIDs for OA Treatment

Table 34: Efficacy of NSAIDs in OA Studies

Table 35: SWOT Analysis – NSAIDs, 2015

Table 36: Overview of the Leading Topical Therapies for OA, 2015

Table 37: Efficacy of Topical Therapies in OA

Table 38: SWOT Analysis – Topical Treatments, 2015

Table 39: Overview of the Leading Opioids for OA Treatment

Table 40: Studies Evaluating the Efficacy of Opioids in OA

Table 41: SWOT Analysis – Opioids, 2015

Table 42: Overview of the Leading Antidepressants for OA Treatment, 2015

Table 43: Overview of the Leading IA Corticosteroid Injectables for OA Treatment, 2015

Table 44: Efficacy of IA Corticosteroid Injectables in OA Studies

Table 45: SWOT Analysis – IA Steroid Injections in OA

Table 46: Unmet Needs in OA

Table 47: Clinical Trial Design of Key Pipeline Drugs for OA, 2015

Table 48: OA – Promising Drugs in Clinical Development, 2015

Table 49: Product Profile – Ampion

Table 50: Phase III (SPRING): Efficacy of Ampion in Patients with Knee OA at Week 12

Table 51: Phase III (SPRING Extension): Efficacy of Ampion in Patients with Moderate-to-Severe Knee OA at Week 12

Table 52: Ampion SWOT Analysis

Table 53: Product Profile – NKTR-181

Table 54: NKTR-181 SWOT Analysis, 2015

Table 55: Product Profile – FX006

Table 56: Phase IIb: Efficacy of FX006 in Patients with Moderate-to-Severe Knee OA at Week 12

Table 57: FX006 SWOT Analysis, 2015

Table 58: Product Profile – Tanezumab

Table 59: Phase III: Efficacy of Tanezumab in Patients with Knee or Hip OA

Table 60: Phase III: Efficacy of Tanezumab in Patients with Knee or Hip OA in Multiple Studies

Table 61: Tanezumab SWOT Analysis

Table 62: Product Profile – Fasinumab

Table 63: Phase II Efficacy of Fasinumab in Patients with Hip or Knee OA

Table 64: Fasinumab SWOT Analysis, 2015

Table 65: Product Profile – Invossa

Table 66: Phase IIb: Efficacy of Invossa in Patients with Knee OA

Table 67: Invossa SWOT Analysis, 2015

Table 68: Product Profile – Sprifermin

Table 69: Phase IIb: Efficacy of Sprifermin in Patients with Knee OA (at 12 Months)

Table 70: Sprifermin SWOT Analysis, 2015

Table 71: Early-Stage Pipeline Products for OA as of July 2015

Table 72: Clinical Benchmarking for OA

Table 73: Clinical Benchmarking for OA

Table 74: Top-Line Sales Forecast ($m) for OA, 2014–2024

Table 75: Key Events that Will Impact Sales for OA, 2014–2024

Table 76: Global OA Market – Drivers and Barriers, 2014–2024

Table 77: Key Launch Dates

Table 78: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

Figures

Figure 1: Schematic View of the Main Structures of a Healthy Joint and a Joint Affected by OA

Figure 2: 7MM, Total Prevalent Cases of Hand OA, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 3: 7MM, Total Prevalent Cases of Hand OA by Age Group, Both Sexes, N, 2014

Figure 4: 7MM, Total Prevalent Cases of Hand OA by Sex, Ages =20 Years, N, 2014

Figure 5: 7MM, Total Prevalent Cases of Knee OA, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 6: 7MM, Total Prevalent Cases of Knee OA by Age Group, Both Sexes, N, 2014

Figure 7: 7MM, Total Prevalent Cases of Knee OA by Sex, Ages =20 Years, N, 2014

Figure 8: 7MM, Total Prevalent Cases of Hip OA, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 9: 7MM, Total Prevalent Cases of Hip OA by Age Group, Both Sexes, N, 2014

Figure 10: 7MM, Total Prevalent Cases of Hip OA by Sex, Ages =20 Years, N, 2014

Figure 11: 7MM, Diagnosed Prevalent Cases of Hand OA, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 12: 7MM, Diagnosed Prevalent Cases of Hand OA by Age Group, Both Sexes, N, 2014

Figure 13: 7MM, Diagnosed Prevalent Cases of Hand OA by Sex, Ages =20 Years, N, 2014

Figure 14: 7MM, Diagnosed Prevalent Cases of Knee OA, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 15: 7MM, Diagnosed Prevalent Cases of Knee OA by Age Group, Both Sexes, N, 2014

Figure 16: 7MM, Diagnosed Prevalent Cases of Knee OA by Sex, Ages =20 Years, N, 2014

Figure 17: 7MM, Diagnosed Prevalent Cases of Hip OA, Both Sexes, Ages =20 Years, N, 2014–2024

Figure 18: 7MM, Diagnosed Prevalent Cases of Hip OA by Age Group, Both Sexes, N, 2014

Figure 19: 7MM, Diagnosed Prevalent Cases of Hip OA by Sex, Ages =20 Years, N, 2014

Figure 20: Stepped-Care Approach for the Treatment of OA, 2015

Figure 21: Competitive Assessment of OA Late-Stage Pipeline Agents, 2014–2024

Figure 22: Global Sales for OA by Region and Drug Class, 2014–2024

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