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PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis - Global Drug Forecast and Market Analysis to 2025

Published: Jan-2017 | Format: PDF | GlobalData | Number of pages: 407 | Code: MRS - 120245

PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis - Global Drug Forecast and Market Analysis to 2025

Summary

Systemic lupus erythematosus (SLE) is a systemic inflammatory autoimmune disease that can affect any organ or tissue and is the prototypic autoimmune disease. As a multisystem disorder, SLE is heterogeneous in nature-no two cases of lupus are alike-and can affect multiple major organ systems in the body, one of its most severe manifestations includes renal (kidney) involvement, known as lupus nephritis (LN). The etiology of SLE and LN remains incompletely understood, but genetic and environmental factors have been shown to play pivotal roles in the development of the disease.

To date, the cornerstone of lupus therapy still relies on generic steroids and unspecific immunosuppressive agents; both of which are associated with severe adverse events (SAEs) and contribute significantly to the morbidity and mortality in lupus. The much anticipated approval of Benlysta (belimumab) in 2011 had only a small impact on the treatment paradigm, and off-label Rituxan/MabThera (rituximab) remains the market leader in terms of sales. R&D efforts in lupus are high, however late-stage clinical failure remains a major barrier to market entry. The anticipated release of six new pipeline agents for SLE and LN will have the potential to revolutionize the lupus treatment. GlobalData expects the global SLE and LN market-which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan)-to expand during the next decade at an astonishing CAGR of 10.6%, reaching total sales of $3.2 billion by 2025.

Highlights

Key Questions Answered

- Based on interviews with key opinion leaders (KOLs), GlobalData has identified key unmet needs in the SLE and LN marketplace.
- What will be the effect of recent and upcoming biologics on the SLE and LN treatment landscape?
- How will the upcoming first-in-class and me-too pipeline agents be received in the different markets?
- What research and development (R&D) strategies will companies leverage to compete in the future SLE and LN marketplace?
- Which patient population(s) are most likely to be targeted by newly introduced pipeline agents?

Key Findings

- GlobalData has calculated that the global SLE and LN market generated about $1.2 billion in sales in 2015. This global market is expected to grow by an astonishingly strong compound annual growth rate (CAGR) of 10.6% from 2015-2025, reaching annual sales of $3.2 billion by the end of the forecast period. The majority of this growth will occur in the US, driven by an increased diagnosed disease prevalence of SLE and LN and the launch of three new first-in-class pipeline drugs (anifrolumab, Orencia [abatacept], and Lupuzor) and three improved therapeutic options (atacicept, blisibimod, and voclosporin). The SLE and LN market in the US is expected to grow at a CAGR of 10.4%, reaching sales of $2.8 billion by 2025. GlobalData estimates that sales in the 5EU to grow at a CAGR of 14.1% during the next 10 years, reaching $312.4m by 2025, while Japan will experience the lowest growth with a CAGR of 9.8%.
- KOLs interviewed by GlobalData repeatedly identified the need for efficacious drugs as the most important clinical unmet need, with reducing lupus morbidity and mortality and the development of sensitive and reliable biomarkers for diagnosis and disease management as key areas of need as well.
- GlobalData anticipates that opportunities will center on the development of safer and more efficacious drugs to treat the various disease manifestations in lupus.

Scope

- Overview of SLE and LN, including epidemiology, etiology, pathophysiology, as well current routine SLE and LN recommendations of all 7MM covered.
- Top-line SLE and LN market revenue from 2015-2025. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the SLE and LN market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the global SLE and LN marketplace. 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 SLE and LN market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the SLE and LN 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.
1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
1.2 List of Figures 22
2 Introduction 24
2.1 Catalyst 24
2.2 Related Reports 25
2.3 Upcoming Related Reports 25
3 Disease Overview 26
3.1 Etiology and Pathophysiology 26
3.1.1 Etiology 26
3.1.2 Pathophysiology 27
3.2 Symptoms 29
3.3 Prognosis 31
3.4 Quality of Life 32
4 Epidemiology 33
4.1 Disease Background 33
4.2 Risk Factors and Comorbidities 35
4.3 Global Trends 37
4.3.1 SLE and LN Prevalence 37
4.3.2 LN Classification 41
4.4 Forecast Methodology 41
4.4.1 Sources Used 42
4.4.2 Forecast Assumptions and Methods 47
4.4.3 Sources Not Used 59
4.5 Epidemiological Forecast for SLE and LN (2015-2025) 61
4.5.1 Diagnosed Prevalent Cases of SLE 61
4.5.2 Age-Specific Diagnosed Prevalent Cases of SLE 63
4.5.3 Sex-Specific Diagnosed Prevalent Cases of SLE 65
4.5.4 Age-Standardized Diagnosed Prevalence of SLE 67
4.5.5 Diagnosed Prevalent Cases of SLE Segmented by Severity 68
4.5.6 Diagnosed Prevalent Cases of LN 70
4.5.7 Diagnosed Prevalent Cases of LN Segmented by Class 72
4.6 Discussion 76
4.6.1 Epidemiological Forecast Insight 76
4.6.2 Limitations of the Analysis 77
4.6.3 Strengths of the Analysis 79
5 Disease Management 80
5.1 Diagnosis Overview 80
5.1.1 SLE Diagnosis 80
5.1.2 LN Diagnosis 83
5.2 Treatment Overview 85
5.2.1 Treatment Guidelines and Leading Prescribed Drugs 87
5.3 US 90
5.3.1 Diagnosis 91
5.3.2 Clinical Practice 92
5.4 France 94
5.4.1 Diagnosis 95
5.4.2 Clinical Practice 95
5.5 Germany 97
5.5.1 Diagnosis 98
5.5.2 Clinical Practice 98
5.6 Italy 100
5.6.1 Diagnosis 101
5.6.2 Clinical Practice 101
5.7 Spain 103
5.7.1 Diagnosis 104
5.7.2 Clinical Practice 104
5.8 UK 106
5.8.1 Diagnosis 107
5.8.2 Clinical Practice 107
5.9 Japan 109
5.9.1 Diagnosis 110
5.9.2 Clinical Practice 110
6 Competitive Assessment 112
6.1 Overview 112
6.2 Strategic Competitor Assessment 113
6.3 Product Profiles - Major Brands, Small Molecules 114
6.3.1 Antimalarials (numerous brand names) 114
6.3.2 Steroids (numerous brand names) 122
6.3.3 Methotrexate (numerous brand names) 129
6.3.4 Mycophenolate Mofetil (numerous brand names) 136
6.3.5 Cyclophosphamide (numerous brand names) 145
6.3.6 Azathioprine (numerous brand names) 151
6.3.7 Calcineurin Inhibitors (numerous brand names) 158
6.4 Product Profiles - Major Brands, Biologics 167
6.4.1 Benlysta (belimumab) 167
6.4.2 Rituxan (rituximab) 177
6.5 Minor Therapeutic Classes 185
7 Unmet Needs Assessment and Opportunity Analysis 186
7.1 Overview 186
7.2 Drugs with Superior Efficacy and Safety Profiles, Particularly for LN 188
7.2.1 Unmet Need 188
7.2.2 Gap Analysis 192
7.2.3 Opportunity 195
7.3 Refined Clinical Trial Design Tailored to Heterogeneous Lupus Patient Populations 197
7.3.1 Unmet Need 197
7.3.2 Gap Analysis 198
7.3.3 Opportunity 200
7.4 Reduced Morbidity and Mortality in Lupus Patients 203
7.4.1 Unmet Need 203
7.4.2 Gap Analysis 204
7.4.3 Opportunity 205
7.5 Improved Physician Education 207
7.5.1 Unmet Need 207
7.5.2 Gap Analysis 208
7.5.3 Opportunity 210
7.6 Sensitive and Reliable Biomarkers for Diagnosis and Disease Management 211
7.6.1 Unmet Need 211
7.6.2 Gap Analysis 212
7.6.3 Opportunity 213
7.7 Increased Compliance Rates for SOC SLE and LN Therapies 213
7.7.1 Unmet Need 213
7.7.2 Gap Analysis 214
7.7.3 Opportunity 215
8 Pipeline Assessment 216
8.1 Overview 216
8.2 Clinical Trial Mapping 216
8.2.1 Clinical Trials by Therapy Type 216
8.3 Promising Drugs in Late-Stage Clinical Development 217
8.3.1 Blisibimod 221
8.3.2 Atacicept 231
8.3.3 Orencia (abatacept) 239
8.3.4 Anifrolumab 247
8.3.5 Lupuzor (IPP-201101, P-140) 255
8.3.6 Voclosporin 261
8.4 Promising Drugs in Early-Stage Clinical Development 270
8.4.1 Overview 270
8.5 Other Drugs in Clinical Development 278
8.6 Biosimilars 280
8.6.1 Overview 280
8.6.2 Hospira’s Inflectra Versus J&J’s Remicade in Key Autoimmune Diseases 281
8.6.3 Biosimilars in the Immunology Community 281
8.6.4 By the Numbers: Biosimilars in Development for Potential Off-Label Use in SLE and LN 281
8.6.5 The Impact of Biosimilars Will Be Felt Throughout the Pharmaceutical Industry 284
8.6.6 Uptake of Biosimilars for SLE and LN Is Expected to Vary by Country/Region 285
8.6.7 Biosimilars Forecast for SLE and LN 285
9 Current and Future Players 287
9.1 Overview 287
9.2 Trends in Corporate Strategy 291
9.3 Company Profiles 292
9.3.1 GlaxoSmithKline 292
9.3.2 Roche 294
9.3.3 Bristol-Myers Squibb 296
9.3.4 AstraZeneca 298
9.3.5 Merck KGaA 300
9.3.6 Anthera Pharmaceuticals 302
9.3.7 Aurinia Pharmaceuticals 303
9.3.8 ImmuPharma 305
9.3.9 Pfizer 306
10 Market Outlook 307
10.1 Global Markets 307
10.1.1 Forecast 307
10.1.2 Drivers and Barriers - Global Issues 316
10.2 US 317
10.2.1 Forecast 317
10.2.2 Key Events 321
10.2.3 Drivers and Barriers 322
10.3 5EU 322
10.3.1 Forecast 322
10.3.2 Key Events 329
10.3.3 Drivers and Barriers 330
10.4 Japan 330
10.4.1 Forecast 330
10.4.2 Key Events 335
10.4.3 Drivers and Barriers 336
11 Appendix 337
11.1 Bibliography 337
11.2 Abbreviations 371
11.3 Methodology 376
11.4 Forecasting Methodology 376
11.4.1 Diagnosed SLE and LN Patients 376
11.4.2 Drugs Included in Each Therapeutic Class 377
11.4.3 Percent Drug-Treated Patients 378
11.4.4 Launch and Patent Expiry Dates 379
11.4.5 General Pricing Assumptions 381
11.4.6 Individual Drug Assumptions 382
11.4.7 Generic Erosion 394
11.4.8 Pricing of Pipeline Agents 395
11.5 Primary Research - KOLs Interviewed for this Report 397
11.6 Primary Research - Prescriber Survey 401
11.7 About the Authors 402
11.7.1 Analyst 402
11.7.2 Therapy Area Directors 402
11.7.3 Epidemiologists 403
11.7.4 Global Director of Therapy Analysis and Epidemiology 405
11.8 About GlobalData 406
11.9 Disclaimer 406

                        
            

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