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市場調查報告書

類風濕性關節炎市場上進步

Advances in the Rheumatoid Arthritis Market

出版商 Espicom Business Intelligence 商品編碼 293851
出版日期 內容資訊 英文 85 Pages
商品交期: 最快1-2個工作天內
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類風濕性關節炎市場上進步 Advances in the Rheumatoid Arthritis Market
出版日期: 2014年01月20日 內容資訊: 英文 85 Pages
簡介

類風濕性關節炎,目前是沒有治療方法的慢性疾病。根據WHO,全球2013年約2350萬個成人罹患類風濕性關節炎。再根據PhRMA,2013年約29萬4000人的18歲以下兒童罹患兒童風濕以及其他的風濕疾病。2012年的全球免疫疾病治療藥銷售額約366億美元,其中3分之2是風濕相關疾病管理相關(245億美元)。到2018年免疫疾病治療藥市場預計超過385億美元。

本報告提供類風濕性關節炎(RA)市場上近幾年的開發趨勢之相關詳細分析、American College of Rheumatology (ACR) 及 European League against Rheumatism (EULAR) 的指南對產品的普及的影響,及全球RA市場上生技仿製藥的潛在影響等議論,為您概述為以下內容。

第1章 類風濕性關節炎為何重要,為何是現在?

緩解疾病抗風濕藥(SDMARDs):市場預測

類風濕性關節炎的管理上新策略

新藥

方法1:標的SDMARDs

藥物類型1:口服激化酵素抑制劑

關注的藥物

Baricitinib (Eli Lilly/Incyte) VX-509 (Vertex)

等候核准

ASP015K (Janssen/Astellas Pharma) INCB039110 (Incyte) GLPG0634 (AbbVie/Galapagos)

Long Shot

IPI-145 (Infinity Pharmaceuticals)

方法1:標的SDMARDs

藥物類型2:非激酶劑

等候核准

Apremilast (Celgene) CCX354 (ChemoCentry/GSK)

Long Shot

LX2931 (Lexicon Pharmaceuticals) PLX5622 (Plexxikon/ 第一三共)

SDMARD開發的結論:預測

方法2:生物劑

藥物類型2:非白細胞介素抑制劑

關注的藥物

Sirukumab (Janssen/GlaxoSmithKline) Sarilumab (Sanofi/Regeneron) Secukinumab (Novartis)

等候核准

Clazakizumab (BMS/Alder Pharmaceuticals)

Long Shot

ALX-0061(AbbVie/Ablynx) Guselkumab (Janssen Biotech/MorphoSys) Ixekizumab (Eli Lilly) Olokizumab (Eli Lilly)

方法2:生物劑

藥物類型2:非白細胞介素策略

等候核准

Mavrilimumab (MedImmune) MOR103 (GlaxoSmithKline/MorphoSys) Tregalizumab (AbbVie/Biotest GA)

Long Shot

AMP-110 (Amplimmune) BIIB 023 (Biogen Idec) Dekavil (Pfizer/Philogen SpA) Otelixizumab (GlaxoSmithKline/Tolerx) PRTX-100 (Protalex) TNF-Kinoid (Neovacs)

BDMARD開發的結論:預測

附錄1

調查手法

簡稱

參考資料

章節附註

圖表清單

目錄
Product Code: RF219

Rheumatoid arthritis (RA) is a chronic disorder for which there is currently no cure. It affects around 23.5 million adults in the world (WHO, 2013) and approximately 294,000 children under the age of 18 are affected by pediatric arthritis and other rheumatologic conditions (PhRMA, 2013).

In 2012, immunology drugs generated global sales of around US$36.6bn of which two thirds were associated with the management rheumatology related conditions (US$24.5bn), the remainder of sales were split evenly between the treatment of dermatological and gastroenterology related conditions. Revenues growth has been driven by improvements in diagnosis and early, more aggressive treatment of RA, the approval of new disease modifying anti rheumatic drugs (DMARDs), new formulations/devices and line extensions. By 2018, we forecast the immunology market will be worth over US$38.5bn as leading players focus on growing their RA franchises in the emerging markets, launch innovative targeted synthetic DMARDs and biologic DMARDs to address unmet clinical needs and biosimilars emerge in the European market to carve out US$3bn share of revenues.

The market is on the cusp of change as the first orally active biologic Xeljanz (tofacitimib) from Pfizer/Takeda entered the US market at the end of 2012; several new synthetic and biological DMARDs are in late stage clinical development and Europe approved the first biosimilar generic infliximab (Remicade) from Celltrion/Egis and Hospira in September 2013. Generic entanercept (Enbrel) is not far behind from Baxter/Cogerus and several manufacturers have begun to make copycat versions of Humira which goes off patent in the US in 2016.

This report examines in more detail the recent developments that have occurred in the RA market, including the expansion of approved products for new indications, formulations and new market launches and analyses the progression of pipeline products. It assesses how the new American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) guidelines will impact product uptake and discusses the potential impact of biosimilars on the global RA market.

Table of Contents

SCOPE OF THE REPORT

CATALYST

About the Author

SECTION 1: WHY IS RHEUMATOID ATHRITIS IMPORTANT, WHY NOW?

  • Introduction - where are we now?
    • Around a half of patients stop responding to DMARDs within 5 years
    • 2012 ACR guidelines recommend more aggressive, early treatment of RA
    • 2013 EULAR guidelines include the use of Pfizer new oral agent Xeljanz
  • What synthetic DMARDs lead the field in the treatment of rheumatoid arthritis?
  • MTX is the preferred sDMARD for first line therapy in early and active disease
  • Pfizer's Xeljanz is the first targeted sDMARD to reach the market
    • Will Pfizer's Xeljanz be able to compete in psoriasis?
    • Will Pfizer's Xeljanz be able to compete on price?
  • Eisai/Toyama's Careram a new DMARD for the Japanese market
  • How do bDMARDs compare with one another?
    • Humira, Enbrel and Remicade are the most prescribed bDMARDs across the globe
  • Comparative effectiveness studies with bDMARDs are limited
    • Head to head study Orencia comparable to Humira
    • Head to head study show Actemra superior to Humira
  • New formulations and devices help drive patient compliance and product acceptance
    • Oral agents may cause a new shift in RA treatment paradigms
    • Subcutaneous formulations remain the mainstay for biological DMARDs
    • New Infusion formulations add value
  • New indications stimulate sales growth in bDMARDs
    • Humira's new indications will add roughly US$1.5bn in incremental global sales
    • Janssen to seek several new line extension for Simponi and Stelara before 2017
    • Cimzia sales growth stimulated by new indications and new markets
  • Companies turn to Japan and the emerging markets to grow DMARD sales
    • AbbVie set sights on BRIC economies to drive Humira franchise forward
    • Amgen expanding capabilities in Japan to commercialize its product pipeline
    • BMS partnered with Simcere to maximize Orencia penetration in the emerging markers
  • Pricing and reimbursement
    • US reimbursement of DMARDS mainly through private insurance programs
    • In Europe DMARDs reimbursed based on clinical and economic data and price referencing
    • Reimbursement of Japanese drugs set Chuikyo
    • Patient's face high out-of-pockets expenses in the emerging economies
    • Chinese government has accelerated and expanded patient access to DMARDs
    • Russian Federation has expand access to innovative biologics
    • High out of pocket expenses curb bDMARD use India
  • What impact will biosimilars have on the treatment of RA?
  • Biosimilar etanercept
    • Biosimilar etanercept available in China and India
    • Etanercept biosimilars are under clinical development in Europe and the US
  • Biosimilar adalimumab
  • Biosimilar infliximab
    • The first infliximab biosimilar now approved in Europe
    • Several infliximab biosimilars are under development for the developed markets
  • Biosimilar rituximab
    • Rituximab biosimilars available in India since 2007
    • Several Rituximab biosimilars under development in the emerging economies

ANTI-RHEUMATOID ARTHRITIS DISEASE MODIFYING DRUGS - MARKET FORECASTS

NEW STRATEGIES IN THE MANAGEMENT OF RHEUMATOID ARTHRITIS

  • New regulatory guidance to fuel RA development

NEW DRUGS ON THE BLOCK

APPROACH 1: TARGETED SDMARDS

DRUG TYPE 1: ORAL KINASE INHIBITORS

ONES TO WATCH

  • Baricitinib (Eli Lilly/Incyte)
  • VX-509 (Vertex)

WAITING IN THE WINGS

  • ASP015K (Janssen/Astellas Pharma)
  • INCB039110 (Incyte)
  • GLPG0634 (AbbVie/Galapagos)

LONG SHOTS

  • IPI-145 (Infinity Pharmaceuticals)

APPROACH 1: TARGETED SDMARDS DRUG TYPE 2: NON-KINASE AGENTS

WAITING IN THE WINGS

  • Apremilast (Celgene)
  • CCX354 (ChemoCentry/GSK)

LONG SHOTS

  • LX2931 (Lexicon Pharmaceuticals)
  • PLX5622 (Plexxikon/ Daiichi Sankyo Company)

CONCLUSIONS ON SDMARD DEVELOPMENTS - FORECASTS

APPROACH 2: BIOLOGICAL AGENTS

DRUG TYPE 2: ANTI-INTERLEUKIN INHIBITORS

ONES TO WATCH

  • Sirukumab (Janssen/GlaxoSmithKline)
  • Sarilumab (Sanofi/Regeneron)
  • Secukinumab (Novartis)

WAITING IN THE WINGS

  • Clazakizumab (BMS/Alder Pharmaceuticals)

LONG SHOTS

  • ALX-0061(AbbVie/Ablynx)
  • Guselkumab (Janssen Biotech/MorphoSys)
  • Ixekizumab (Eli Lilly)
  • Olokizumab (Eli Lilly)

APPROACH 2: BIOLOGICAL AGENTS

DRUG TYPE 2: NON ANTI-INTERLEUKIN STRATEGIES

WAITING IN THE WINGS

  • Mavrilimumab (MedImmune)
  • MOR103 (GlaxoSmithKline/MorphoSys)
  • Tregalizumab (AbbVie/Biotest GA)

LONG SHOTS

  • AMP-110 (Amplimmune)
  • BIIB 023 (Biogen Idec)
  • Dekavil (Pfizer/Philogen SpA)
  • Otelixizumab (GlaxoSmithKline/Tolerx)
  • PRTX-100 (Protalex)
  • TNF-Kinoid (Neovacs)

CONCLUSIONS ON BDMARD DEVELOPMENTS - FORECASTS

APPENDIX 1

  • Clinical endpoints to assess disease activity and response to treatment

METHODOLOGY

  • Primary research
  • Secondary research

ACRONYMS

REFERENCES

ENDNOTES

List of Tables

  • Table 1: Leading oral synthetic DMARDs
  • Table 3: Leading bDMARDs SC formulations
  • Table 4: Leading bDMARDs IV formulations
  • Table 5: Line extensions of leading DMARDs
  • Table 6: Enbrel regional sales 2012
  • Table 7: Etanercept biosimilars under development
  • Table 9: Adalimumab biosimilars under development
  • Table 10: Remicade regional sales 2012
  • Table 11: Infliximab biosimilars under development
  • Table 12: Rituxan sales 2012
  • Table 13: Rituximab biosimilars under development
  • Table 14: Synthetic and biological DMARDs, biosimilar sales forecasts, 2011-2018 (US$mn)
  • Table 15: Recent small molecule agents discontinued in clinical trials in RA
  • Table 16: Recent biological agents discontinued in clinical trials in RA
  • Table 17: Oral kinase inhibitors in clinical development
  • Table 18: Phase II baricitinib data in RA patients at week 12
  • Table 19: Phase II baricitinib data in RA patients at week 24
  • Table 20: Phase II INCB039110 data in RA patients at week 12
  • Table 21: Phase II INCB039110 data in RA patients at week 12
  • Table 22: Non-kinase inhibitors in clinical development
  • Table 23: Phase II PoC data in RA patients at week 12
  • Table 24Developmental sDMARD kinase inhibitor forecasts
  • Table 25: Anti-interleukin agents in clinical development
  • Table 26: Phase II sarilumab clinical data in RA patients
  • Table 27: Phase II Secukinumab clinical data in RA patients
  • Table 28: Phase II Secukinumab clinical data in RA patients
  • Table 29: Phase III secukinumab clinical data in psoriasis patients
  • Table 31: Phase II Ixekizumab clinical data in plaque psoriasis patients at week 12
  • Table 33: Phase II Mavrilimumab data in RA patients at week 12
  • Developmental bDMARD anti-interleukin forecasts

List of Charts

  • Figure 1: Main pharmacological strategies for rheumatoid arthritis
  • Figure 2: Classification of DMARDs for the management of RA
  • Figure 3: ACR Guidelines for the Management of Early RA
  • Figure 4: Guidelines for the Management of Established RA
  • Figure 5: EULAR Guidelines for the Management of RA - Phase I
  • Figure 6: EULAR Guidelines for the Management of RA - Phase II
  • Figure 8: Overall clinical benefits events associated with the treatment of RA with conventional sDMARDs
  • Figure 9: Overall adverse events associated with the treatment of RA with conventional sDMARDs
  • Figure 10: Overall clinical benefit events associated with the treatment of RA with bDMARDs
  • Figure 11: Overall adverse events associated with the treatment of RA with bDMARDs
  • Figure 12: Humira, Enbrel and Remicade are the most prescribed bDMARD in the US
  • Figure 13: Humira, Enbrel and Remicade are the most prescribed bDMARD in the ex US markets
  • Figure 14: Roche's Actemra gains market share in biologic monotherapy based on ADACTA data
  • Figure 15: Two thirds of immunology drug sales treat rheumatology related conditions, 2012
  • Figure 16: Cimzia sales momentum driven by new indications
  • Figure 17: Emerging markets to deliver strong pharma growth
  • Figure 18: Drug access and pricing across the globe
  • Figure 19: Drug financing for emerging economies
  • Figure 20: Patent expiration of leading bDMARDs
  • Figure 21: Clinical development of rheumatoid arthritis drugs, 2013
  • Figure 22: INCB039110 response rates over 12 weeks
  • Figure 23: Novel targets for the development of new rheumatoid arthritis drugs
  • Figure 24: Clinical efficacy of sirukumab SC in patients with RA
  • Figure 25: Sarilumab's on-going clinical trial program
  • Figure 26: Percentage of patients achieving ACR and EULAR responses at week 4
  • Figure 27: Percentage of patients achieving DAS28, mean changes from baseline
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