OpportunityAnalyzer: Osteoarthritis – Opportunity Analysis and Forecasts to 2026

  • Pages: 227
  • Published: September 2017
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  • Report Code: GDHC073POA
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Osteoarthritis (OA) is the most common joint disease affecting over 27 million people in the US alone in 2005. It is a major cause of disability and pain amongst elderly in the western world, second only to cardiovascular disease. OA is a slowly progressive joint disease characterized by degradation of the articular cartilage coating the bone proximities of synovial joints as well as cell stress and extra cellular matric degradation, which leads to maladaptive repair responses resulting in loss of function and culminating in illness. OA is a disease of the whole organ, adversely affecting the subchondral bone, tendons, ligaments and synovium. Damage to these structures causes irritation and pain, which intensifies with disease progression and can significantly decrease individuals’ quality of life. The sites mainly affected by OA are the weight bearing bones such as knees and hips, as well as hands.

GlobalData estimates the 2016 sales for the OA market at approximately $1.6 billion across the 7MM, encompassing the US, the five major European Union countries (5EU: France, Germany, Italy, Spain, and UK) and Japan. Over the course of the 10-year forecast period, the OA market will grow at a Compound Annual Growth Rate (CAGR) of 8.1% across the 7MM. Each of the 7MM are anticipated to grow significantly, recording CAGRs of 9.2%, 4.8% and 6.1% across the US, 5EU and Japan, respectively. At the end of 2026, the US will account for 75% of sales across the 7MM, while the 5EU and Japan will account for around 15% and 10% of sales, respectively. The higher sales numbers for the US can be attributed to large OA population, which will continue to grow to over 274 million by 2026, as well as higher anticipated high annual cost of therapy (ACOT) of biologic analgesics including Pfizer’s tanezumab and Regeneron’s fasinumab as well as DMOADs including TissueGene’s Invossa and Samumed’s SM04690, in the US market.

Scope

Overview of OA, including epidemiology (separation between symptomatic and radiographic patients), etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

Topline OA market revenue from 2016–2026. ACOT and major pipeline product sales in this forecast period are included.

Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting OA therapeutics sales in the 7MM.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

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.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the global OA therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the OA therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Companies mentioned

Ampio Pharmaceuticals

Cara Therapeutics

Cellular Biomedicine Group

Centrexion Therapeutics

Eli Lilly

Flexion Therapeutics

Healthcare Life Sciences

Kolon Life Sciences

Mitsubishi Tanabe Pharma

Mundipharma

Ono Pharmaceutical ...

Ampio Pharmaceuticals

Cara Therapeutics

Cellular Biomedicine Group

Centrexion Therapeutics

Eli Lilly

Flexion Therapeutics

Healthcare Life Sciences

Kolon Life Sciences

Mitsubishi Tanabe Pharma

Mundipharma

Ono Pharmaceutical

Pfizer

Regeneron Pharmaceuticals

Samumed

Seikagaku Corp

Techfields Pharma

Teva Pharmaceutical

TissueGene

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Osteoarthritis: Executive Summary

2.1 OA Market ...

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Osteoarthritis: Executive Summary

2.1 OA Market Expected to Experience Strong Growth from 2016–2026

2.2 Drug Development Focused on Analgesics with Novel MOAs and DMOADs

2.3 Clinical Unmet Need Will Remain Largely Unfulfilled

2.4 The OA Market Provides an Abundance of Opportunities for the Development of Novel Analgesics and DMOADs

2.5 Anti-NGFs Are Likely to Become the Most Attractive New Treatment Option

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Symptoms

4.3 Prognosis and Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for OA (2016–2026)

5.5.1 Total Prevalent Cases (Radiographic) of Hand OA

5.5.2 Total Prevalent Cases (Symptomatic) of Hand OA

5.5.3 Diagnosed Prevalent Cases (Symptomatic) of Hand OA

5.5.4 Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA

5.5.5 Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA

5.5.6 Diagnosed Prevalent Cases (Symptomatic) of Hand OA, by Severity

5.5.7 Total Prevalent Cases (Radiographic) of Knee OA

5.5.8 Total Prevalent Cases (Symptomatic) of Knee OA

5.5.9 Diagnosed Prevalent Cases (Symptomatic) of Knee OA

5.5.10 Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA

5.5.11 Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA

5.5.12 Diagnosed Prevalent Cases (Symptomatic) of Knee OA, by Severity

5.5.13 Total Prevalent Cases (Radiographic) of Hip OA

5.5.14 Total Prevalent Cases (Symptomatic) of Hip OA

5.5.15 Diagnosed Prevalent Cases (Symptomatic) of Hip OA

5.5.16 Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA

5.5.17 Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA

5.5.18 Diagnosed Prevalent Cases (Symptomatic) of Hip OA, by Severity

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

6.2 Diagnosis and Treatment

6.2.1 Diagnosis

6.2.2 Treatment Guidelines and Leading Prescribed Drugs

6.3 Product Profiles – Major Therapies

6.3.1 Oral NSAIDs (numerous branded and generic products)

6.3.2 Topical Therapies (numerous branded and generic products)

6.3.3 Opioids (numerous branded and generic products)

6.3.4 Antidepressants (numerous branded and generic products)

6.3.5 Intra-articular Corticosteroid Injections (numerous branded and generic products)

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Development of Disease-Modifying OA Drugs to Halt the Progress of OA

7.2.1 Unmet Need

7.2.2 Gap Analysis

7.2.3 Opportunity

7.3 Analgesics with Improved Efficacy and Safety Profiles

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Therapies to Treat OA in Patients with Comorbid Conditions

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

7.5 Improved Patient Adherence to Non-pharmacological Treatments

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

7.6 Increased Awareness of OA as a Serious Disease that Requires Medical Intervention

7.6.1 Unmet Need

7.6.2 Gap Analysis

7.6.3 Opportunity

7.7 Earlier Detection of OA to Facilitate Treatment

7.7.1 Unmet Need

7.7.2 Gap Analysis

7.7.3 Opportunity

8 Research & Development Strategies

8.1 Overview

8.1.1 Development of Analgesics with Novel MOA to Improve Tolerability and Efficacy

8.1.2 Development of DMOADs to Differentiate from Competition

8.1.3 Strategic Partnerships

8.2 Current Clinical Trial Design

8.2.1 Limitations of Patient-Reported Outcomes

8.2.2 Lack of Appropriate Subpopulations for Targeted Therapies

8.2.3 Lack of Consensus on DMOAD Trial Design

8.3 Future Clinical Trial Design

8.3.1 Sensitive Measurement Tools for Evaluating Joint Morphology

8.3.2 Biomarkers to Facilitate Development of DMOADs

8.3.3 Need for Consideration of Joint Tissues Other than Articular Cartilage

8.3.4 Trials on the Management of Multiple Joint Pain

9 Pipeline Assessment

9.1 Overview

9.2 Promising Analgesics in Clinical Development

9.2.1 Tanezumab

9.2.2 Fasinumab

9.2.3 Zilretta (FX006)

9.2.4 Ampion

9.2.5 CR845 (difelikefalin)

9.2.6 CNTX-4975

9.2.7 SI-613

9.2.8 X-0002 (ibuprofenamine)

9.3 Promising DMOADs in Clinical Development

9.3.1 SM04690

9.3.2 Invossa (tonogenchoncel-L)

9.3.3 ReJoin

9.4 Other Drugs in Development

9.4.1 Additional Therapies in Late-Stage Clinical Development

9.4.2 Drugs in Early-Stage Clinical Development

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.1.1 Clinical Benchmark of Key Pipeline Novel Analgesics

10.1.2 Clinical Benchmark of Key Pipeline DMOADs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.2.1 Commercial Benchmark of Key Pipeline Novel Analgesics

10.2.2 Commercial Benchmark of Key Pipeline DMOADs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Assumptions and Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.5 Primary Research – Payers Interviewed for This Report

11.6 Primary Research – Prescriber Survey

11.7 About the Authors

11.7.1 Analysts

11.7.2 Therapy Area Directors

11.7.3 Epidemiologist

11.7.4 Managing Epidemiologists

11.7.5 Global Director of Therapy Analysis and Epidemiology

11.7.6 Global Head and EVP of Healthcare Operations and Strategy

11.8 About GlobalData

11.9 Contact Us

11.10 Disclaimer

List of tables

Table 1: Osteoarthritis: Key Metrics in Seven Major Pharmaceutical Markets

Table 2: Genes Associated with Joint Development and OA

Table 3: Etiology of OA

Table ...

Table 1: Osteoarthritis: Key Metrics in Seven Major Pharmaceutical Markets

Table 2: Genes Associated with Joint Development and OA

Table 3: Etiology of OA

Table 4: Risk Factors and Comorbidities for OA

Table 5: Severity Scoring System for Classifying the Hand, Knee, and Hip OA Using the KL Grading Scale

Table 6: 7MM, Total Prevalent Cases (Radiographic) of Hand OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 7: 7MM, Total Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 8: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 9: 7MM, Total Prevalent Cases (Radiographic) of Knee OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 10: 7MM, Total Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 11: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 12: 7MM, Total Prevalent Cases (Radiographic) of Hip OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 13: 7MM, Total Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 14: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ≥18 Years, N, Selected Years 2016–2026

Table 15: Kellgren-Lawrence (KL) Grading Scale

Table 16: Treatment Recommendations for OA

Table 17: Overview of Leading NSAIDs Prescribed for OA Treatment

Table 18: Studies Evaluating the Efficacy of NSAIDs in OA

Table 19: NSAIDs SWOT Analysis, 2017

Table 20: Overview of Leading Topical Treatments for OA

Table 21: Studies Evaluating the Efficacy of Topical Treatments in OA

Table 22: Topical Treatments SWOT Analysis, 2017

Table 23: Overview of Leading Opioids for OA Treatment

Table 24: Studies Evaluating the Efficacy of Opioids in OA

Table 25: Opioids SWOT Analysis, 2017

Table 26: Overview of Leading Antidepressants for OA Treatment

Table 27: Studies Evaluating the Efficacy of Antidepressants in OA

Table 28: Antidepressants SWOT Analysis, 2017

Table 29: Overview of Leading IA Corticosteroid Injections for OA Treatment, 2017

Table 30: Studies Evaluating the Efficacy of IA Injections in OA

Table 31: IA Corticosteroid Injections SWOT Analysis, 2017

Table 32: Clinical Trial Design of Key Pipeline Drugs for OA, 2017

Table 33: Product Profile – Tanezumab

Table 34: Phase III Trials Evaluating the Efficacy of Tanezumab in Treatment of Knee or Hip OA

Table 35: Tanezumab SWOT Analysis, 2017

Table 36: Product Profile – Fasinumab

Table 37: Results from Phase I/II Trial Evaluating the Efficacy of Fasinumab in Treatment of Knee or Hip OA

Table 38: Results from Phase II/III Trial Evaluating the Efficacy of Fasinumab in Treatment of Knee or Hip OA

Table 39: Results from Phase I/II Trial Evaluating the Safety of Fasinumab in Treatment of Knee or Hip OA

Table 40: Fasinumab SWOT Analysis, 2017

Table 41: Product Profile – Zilretta

Table 42: Open-Label Study Evaluating the Safety of Repeat Administration of Zilretta in Treatment of Knee OA

Table 43: Zilretta SWOT Analysis, 2017

Table 44: Product Profile – Ampion

Table 45: Clinical Trials Evaluating the Efficacy of Ampion for Treatment of Knee OA

Table 46: Ampion SWOT Analysis, 2017

Table 47: Product Profile – CR845

Table 48: Phase IIb Trial Evaluating the Efficacy of CR845 for Treatment of Hip or Knee OA

Table 49: CR845 SWOT Analysis, 2017

Table 50: Product Profile – CNTX-4975

Table 51: CNTX-4975 SWOT Analysis, 2017

Table 52: Product Profile – SI-613

Table 53: SI-613 SWOT Analysis, 2017

Table 54: Product Profile – X-0002

Table 55: Phase III Trial Evaluating the Efficacy of X-0002 in Treatment of Knee OA

Table 56: X-0002 SWOT Analysis, 2017

Table 57: Product Profile – SM04690

Table 58: Phase II and Phase III Trials Evaluating the Efficacy of SM04690 in Treatment of Knee OA

Table 59: SM04690 SWOT Analysis, 2017

Table 60: Product Profile – Invossa

Table 61: Invossa SWOT Analysis, 2017

Table 62: Product Profile – ReJoin

Table 63: ReJoin SWOT Analysis, 2017

Table 64: Drugs in Phase III Development for OA, 2017

Table 65: Drugs in Phase I and Phase II Development for OA, 2017

Table 66: Clinical Benchmark of Key Pipeline Analgesics for OA

Table 67: Clinical Benchmark of Key Pipeline Analgesics for OA (continued)

Table 68: Clinical Benchmark of Key Pipeline DMOADs for OA

Table 69: Commercial Benchmark of Key Pipeline Analgesics for OA

Table 70: Commercial Benchmark of Key Pipeline Analgesics for OA (continued)

Table 71: Commercial Benchmark of Key Pipeline DMOADs for OA

Table 72: Top-Line Sales Forecasts ($m) for OA, 2016–2026

Table 73: Key Events Impacting Sales for OA, 2016–2026

Table 74: OA Market: 7MM – Drivers and Barriers, 2016–2026

Table 75: Key Historical and Projected Launch Dates for OA

Table 76: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of figures

Figure 1: Sales for OA by Region, 2016–2026

Figure 2: Competitive Assessment of Late-Stage Pipeline Analgesics in OA

Figure 3: Competitive Assessment of Late-Stage ...

Figure 1: Sales for OA by Region, 2016–2026

Figure 2: Competitive Assessment of Late-Stage Pipeline Analgesics in OA

Figure 3: Competitive Assessment of Late-Stage Pipeline DMOADs in OA

Figure 4: Schematic View of the Main Structures of a Healthy Joint and a Joint Affected by OA

Figure 5: 7MM, Age-Standardized Diagnosed Prevalence (Symptomatic) (%), Hand OA, Men and Women, Ages ≥18 Years, 2016

Figure 6: 7MM, Age-Standardized Diagnosed Prevalence (Symptomatic) (%), Knee OA, Men and Women, Ages ≥18 Years, 2016

Figure 7: 7MM, Age-Standardized Diagnosed Prevalence (Symptomatic) (%), Hip OA, Men and Women, Ages ≥18 Years, 2016

Figure 8: 7MM, Sources Used to Forecast Total Prevalent Cases (Radiographic), Hand OA

Figure 9: 7MM, Sources Used to Forecast Total Prevalent Cases (Symptomatic), Hand OA

Figure 10: 7MM, Sources Used to Forecast Total Prevalent Cases (Radiographic), Knee OA

Figure 11: 7MM, Sources Used to Forecast Total Prevalent Cases (Symptomatic), Knee OA

Figure 12: 7MM, Sources Used to Forecast Total Prevalent Cases (Radiographic), Hip OA

Figure 13: 7MM, Sources Used to Forecast Total Prevalent Cases (Symptomatic), Hip OA

Figure 14: 7MM, Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ≥18 Years, N, 2016

Figure 15: 7MM, Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hand OA, Both Sexes, Ages ≥18 Years, N, 2016

Figure 16: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hand OA by Severity, Both Sexes, Ages ≥18 Years, N, 2016

Figure 17: 7MM, Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ≥18 Years, N, 2016

Figure 18: 7MM, Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Knee OA, Both Sexes, Ages ≥18 Years, N, 2016

Figure 19: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Knee OA by Severity, Both Sexes, Ages ≥18 Years, N, 2016

Figure 20: 7MM, Age-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ≥18 Years, N, 2016

Figure 21: 7MM, Sex-Specific Diagnosed Prevalent Cases (Symptomatic) of Hip OA, Both Sexes, Ages ≥18 Years, N, 2016

Figure 22: 7MM, Diagnosed Prevalent Cases (Symptomatic) of Hip OA by Severity, Both Sexes, Ages ≥18 Years, N, 2016

Figure 23: Stepped-Care Approach for the Treatment of OA

Figure 24: Unmet needs and Opportunities in OA 2016

Figure 25: Key Phase IIb and Phase III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for OA in the 7MM During the Forecast Period

Figure 26: A Bulls Eye Figure of Key Phase IIb and Phase III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for OA in the 7MM During the Forecast Period

Figure 27: Competitive Assessment of Late-Stage Pipeline Analgesics in OA

Figure 28: Competitive Assessment of Late-Stage Pipeline DMOADs in OA

Figure 29: Sales for OA by Region, 2016–2026

Figure 30: US Sales for OA, 2016–2026

Figure 31: 5EU Sales for OA, 2016–2026

Figure 32: Japan Sales for OA, 2016–2026

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