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自己免疫疾患:市場機会の評価、市場動向、パイプライン製品の分析 (2019年下半期)

Autoimmune Diseases - Opportunity Assessments, Market Dynamics and Pipeline Analytics, H2 2019

出版日: | 発行: GervanoRA Data Services LLP | ページ情報: 英文 313 Pages | 納期: 即納可能 即納可能とは

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自己免疫疾患:市場機会の評価、市場動向、パイプライン製品の分析 (2019年下半期)
出版日: 2020年02月19日
発行: GervanoRA Data Services LLP
ページ情報: 英文 313 Pages
納期: 即納可能 即納可能とは
  • 全表示
  • 概要
  • 図表
  • 目次
概要

現在、自己免疫疾患向けパイプライン医薬品のうち、合計1494種類の製品が治験段階の途上にあります。そのうち、第III相の製品が205種類、第II相の製品が379種類、第I相の製品が227種類あることが分かりました。また、この分野でも2010年以降、合計291件もの資本取引が実施されています。

当レポートでは、世界の自己免疫疾患向け医薬品 (治療薬) の市場について分析し、疾患の概要や疫学的動向の見通し、アンメットニーズと市場機会、主な資本取引の傾向 (M&A、事業協力など)、パイプライン製品の分析と治験の進行状況、現在・将来の競争環境、主要企業のSWOT分析、新規企業のプロファイルと市場機会、といった情報を取りまとめてお届けいたします。

第1章 イントロダクション

第2章 エグゼクティブサマリー

第3章 自己免疫疾患の概要

  • 疾患の定義と症状
  • 病因とリスク要因
  • 診断
  • 治療アルゴリズムとガイドライン

第4章 市場のダイナミクス:自己免疫疾患

  • 資本取引 (企業合併・買収 (M&A)、事業協力 (コラボレーション))
    • 取引分析:取引の種類別
    • 取引分析:年間頻度別
    • 取引分析:企業別
  • 特許分析(失効/ジェネリック化)
    • パイプライン医薬品の特許分析

第5章 自己免疫疾患のパイプライン医薬品分析

  • 関節リウマチ (RA):パイプライン医薬品分析
    • 開発段階別
    • 地域別
    • 投与経路別
    • 薬剤クラス別
    • 作用機序別
    • 分子の種類別
    • 企業の種類別
  • 1型糖尿病 (T1D):パイプライン医薬品分析
  • クローン病 (CD):パイプライン医薬品分析
  • 自己免疫性肝炎 (AIH):パイプライン医薬品分析
  • 他の自己免疫疾患:パイプライン医薬品分析
    • 感覚器官に影響を及ぼす自己免疫疾患
    • 生殖系に影響を及ぼす自己免疫疾患
    • 内分泌系に影響を及ぼす自己免疫疾患
    • 神経系に影響を及ぼす自己免疫疾患
    • 筋骨格系に影響を及ぼす自己免疫疾患
    • 血液循環系に影響を及ぼす自己免疫疾患
    • 尿路系に影響を及ぼす自己免疫疾患
    • 消化管系に影響を及ぼす自己免疫疾患
    • 複数の組織・臓器に影響を及ぼす自己免疫疾患
    • リンパ系・呼吸器系に影響を及ぼす自己免疫疾患
    • パイプライン分子:大学・研究機関別 - ライセンスの市場機会

第6章 治験段階のパイプライン医薬品の概略と、開発のマイルストーン

  • 関節リウマチ (RA)
    • 登録前段階のパイプライン分子
      • フィルゴチニブ (Gilead Sciences Inc / Galapagos NV)
    • 第III相のパイプライン分子
      • ピクリデノソン (CF101) (Can-Fite BioPharma / Cipher Pharmaceuticals / Gebro Pharma)
      • オチリマブ (GSK3196165)(GlaxoSmithKline Plc / MorphoSys AG)
      • オロキズマブ (R Pharm)
      • SM03 (SinoMab BioScience)
      • TS-152 (オゾラリズマブ) (大正製薬ホールディングス/Ablynx)
    • 第II相のパイプライン分子
      • ABBV-3373 (Abbvie Inc)
      • ABBV-599 (Abbvie Inc)
      • ABX464 (Abivax)
      • BTK阻害剤 (Bristol-Myers Squibb Co)
      • ラベキシモド (Cyxone AB)
    • 第I相のパイプライン分子
      • ABBV-154 (Abbvie Inc)
      • ATI-450 (Aclaris Therapeutics Inc)
      • エファベリューキンアルファ (AMG 592) (Amgen Inc)
      • ART-I02 (Arthrogen BV)
      • MEDI5117 (AstraZeneca Plc)
  • 1型糖尿病 (T1D)
    • 登録前段階のパイプライン分子
      • Farxiga (ダパグリフロジン) (AstraZeneca Plc / Bristol-Myers Squibb)
      • エンパグリフロジン (BI10773) (Boehringer Ingelheim International GmbH / Eli Lilly and Co)
    • 第III相のパイプライン分子
      • ダシグルカゴン (Zealand Pharma AS)
      • ドニスレセル (BB-11807) (CellTrans Inc)
      • テプリズマブ (PRV-031) (Provention Bio Inc)
      • インスリンアスパルト/インスリンアスパルト30 (Sihuan Pharmaceutical Holdings Group Ltd)
    • 第II相のパイプライン分子
      • AG019 (ActoBio Therapeutics Inc)
      • Dance 501 (501-ヒトインスリン) (Aerami Therapeutics)
      • CLBS03 (Caladrius Biosciences)
      • 経口HDVインスリン技術 (Diasome Pharmaceuticals Inc)
      • テメリマブ (GeNeuro SA)
    • 第I相のパイプライン分子
      • AT247 (Arecor Ltd)
      • Aux-101 (Auxulin Pharmaceuticals Inc)
      • イモトープ (ImCyse SA)
      • INS-068 (Jiangsu Hengrui Medicine Co Ltd)
      • AB101 (Rezolute Inc)
  • クローン病 (CD)
    • 登録前段階のパイプライン分子
      • Entyvio (武田薬品工業)
    • 第III相のパイプライン分子
      • オザニモド (RPC-1063) (Bristol-Myers-Squibb Co)
      • フィルゴチニブ (Galapagos NV / Gilead Sciences)
      • エトロリズマブ (Genentech Inc / Roche)
      • RHB-104 (RedHill Biopharma Ltd)
      • エトラシモド (Arena Pharmaceuticals Inc)
    • 第II相のパイプライン分子
      • E6011 (EA Pharma Co Ltd)
      • Remestemcel-L (Prochymal) (Mesoblast Ltd / Osiris Therapeutics)
      • MT-1303 (田辺三菱製薬)
      • PTG-200 (Protagonist Therapeutics Inc / Janssen Biotech Inc)
      • PRV-6527 (Provention Bio Inc / Janssen Pharmaceutica NV)
    • 第I相のパイプライン分子
      • Thetanix (4D Pharma Plc)
      • ACT-101 (Alpha Cancer Technologies Inc)
      • ETX-201 (ETX Pharma Inc)
      • HAV anti-MAP Vaccine (HAV Vaccines Ltd)
      • IMU-838 (Immunic Inc)
  • 自己免疫性肝炎 (AIH)
    • 第II相のパイプライン分子
      • イアナルマブ (VAY736) (MorphoSys AG / Novartis)
      • ST-AH-01 (Stero Biotechs)
      • ブデノファルク (Calliditas Therapeutics / Dr. Falk Pharma)
      • JKB-122 (TaiwanJ Pharmaceuticals / Newsoara Biopharma)
    • 第I相のパイプライン分子
      • TregCel (TRACT Therapeutics Inc)
      • JKB-122 (TaiwanJ Pharmaceuticals)
      • 合成着床前因子 (sPIF) (BioIncept LLC)

第7章 推定される承認スケジュール

  • 分析手法
    • 関節リウマチ (RA) 分子の推定承認スケジュール (米国国内/国外)
    • 1型糖尿病 (T1D) 分子の推定承認スケジュール (米国国内/国外)
    • クローン病 (CD) 分子の推定承認スケジュール (米国国内/国外)
    • 自己免疫性肝炎 (AIH) 分子の推定承認スケジュール (米国国内/国外)

第8章 市場機会の評価:企業間の相互比較

  • 外部への依存
  • パイプライン製品のポートフォリオ
  • 市場参入の見通し
  • 特許と排他性
  • 市場動向と提携活動
  • 規制上の特別扱いの獲得状況
  • 企業の発展
  • 新興企業の市場シェア (見通し)

第9章 現在および将来の競合情勢

  • 既存会社
    • 主要企業のプロファイルとSWOT分析
      • ELY LILY AND COMPANY
      • PFIZER PHARMACEUTICALS
      • NOVARTIS AG
  • 新興企業
    • 主な新興企業のプロファイル
      • PROVENTION BIO, INC
      • CAN-FITE BIOPHARMA LTD.
      • CALLIDITAS THERAPEUTICS AB
      • SOLIGENIX, INC
      • INNOVATE BIOPHARMACEUTICALS, INC
      • CYXONE AB
      • OSE IMMUNOTHERAPEUTICS SA
      • SUZHOU CONNECT BIOPHARMACEUTICALS, LTD
      • ABIVAX SA
      • PROTAGONIST THERAPEUTICS, INC
図表

LIST OF TABLES

  • TABLE 01: REPORT HIGHLIGHTS IN NUMERICALS
  • TABLE 02: TOP 5 AUTOIMMUNE DISEASE DEALS WITH RESPECT TO DEAL AMOUNT (2018-2019)
  • TABLE 03: LIST OF AUTOIMMUNE DISEASES WITH AFFECTED ORGANS
  • TABLE 04 LIST OF DIFFERENT IN-VITRO DIAGNOSTIC TESTS USED TO DIAGNOSE AUTOIMMUNE DISEASES
  • TABLE 05: LATEST DRUG APPROVALS FOR AUTOIMMUNE DISEASES FROM FDA AND EMA
  • TABLE 06: MAJOR MERGERS AND ACQUISITION DEALS IN AUTOIMMUNE DISEASE AREA
  • TABLE 07: MAJOR COLLABORATION DEALS IN AUTOIMMUNE DISEASE AREA
  • TABLE 08: MAJOR LICENSING DEALS IN AUTOIMMUNE DISEASE AREA
  • TABLE 09: MAJOR FINANCING DEALS IN AUTOIMMUNE DISEASE AREA
  • TABLE 10: MAJOR TERMINATION DEALS IN AUTOIMMUNE DISEASE AREA
  • TABLE 11: US ISSUED PATENTS OF INN-202 WITH RESPECT TO AUTOIMMUNE DISEASE TREATMENTS
  • TABLE 12: PATENTS OF CYXONE WITH RESPECT TO AUTOIMMUNE DISEASE TREATMENTS
  • TABLE 13: PATENTS OF CONNECT BIOPHARMACEUTICALS WITH RESPECT TO AUTOIMMUNE DISEASE TREATMENTS
  • TABLE 14: PATENTS OF ABIVAX WITH RESPECT TO AUTOIMMUNE DISEASE TREATMENTS
  • TABLE 15: RA PIPELINE DRUGS BY STAGE OF DEVELOPMENT
  • TABLE 16: RHEUMATOID ARTHRITIS DRUG CANDIDATES UNDER PRE-REGISTRATION
  • TABLE 17: RHEUMATOID ARTHRITIS PHASE 3 DRUG CANDIDATES
  • TABLE 18: RHEUMATOID ARTHRITIS PHASE 2 DRUG CANDIDATES
  • TABLE 19: RHEUMATOID ARTHRITIS PHASE 1 DRUG CANDIDATES
  • TABLE 20: RHEUMATOID ARTHRITIS PRECLINICAL DRUG CANDIDATES
  • TABLE 21: RHEUMATOID ARTHRITIS PRECLINICAL DRUG CANDIDATES
  • TABLE 22: RHEUMATOID ARTHRITIS INACTIVE AND DISCONTINUED PIPELINE DRUG CANDIDATES
  • TABLE 23: CLINICAL STAGE RHEUMATOID ARTHRITIS PIPELINE DRUGS WITH INJECTABLE AS ROA
  • TABLE 24: CLINICAL STAGE RHEUMATOID ARTHRITIS PIPELINE DRUGS WITH ORAL ROA
  • TABLE 25: CLINICAL STAGE RHEUMATOID ARTHRITIS PIPELINE DRUGS ANALYSIS BY MAJOR DRUG CLASSES
  • TABLE 26: RA PIPELINE DRUGS ANALYTICS BY COMPANY TYPE
  • TABLE 27: T1D PIPELINE DRUGS BY STAGE OF DEVELOPMENT
  • TABLE 28: REGISTRATION STAGE PIPELINE MOLECULES OF T1D
  • TABLE 29: PHASE 3 PIPELINE MOLECULES OF T1D
  • TABLE 30: PHASE 2 PIPELINE MOLECULES OF T1D
  • TABLE 31: PHASE 1 PIPELINE MOLECULES OF T1D
  • TABLE 32: PRECLINICAL PIPELINE MOLECULES OF T1D
  • TABLE 33: EARLY R&D PIPELINE MOLECULES OF T1D
  • TABLE 34: T1D INACTIVE AND DISCONTINUED PIPELINE MOLECULES
  • TABLE 35: T1D PIPELINE DRUG ANALYTICS BY COMPANY TYPE
  • TABLE 36: NORTH AMERICAN CLINICAL STAGE COMPANIES
  • TABLE 37: CROHN'S DISEASE PIPELINE ANALYSIS BY STAGE OF DEVELOPMENT
  • TABLE 38: CROHN'S DISEASE PHASE 3 MOLECULES
  • TABLE 39: CROHN'S DISEASE PHASE 2 MOLECULES
  • TABLE 40: CROHN'S DISEASE PHASE 1 MOLECULES
  • TABLE 41: CROHN'S DISEASE PRECLINICAL MOLECULES
  • TABLE 42: CROHN'S DISEASE R&D MOLECULES
  • TABLE 43: CROHN'S DISEASE INACTIVE AND DISCONTINUED MOLECULES
  • TABLE 44: US CLINICAL STAGE COMPANIES
  • TABLE 45: EU CLINICAL STAGE COMPANIES
  • TABLE 46: CANADIAN CLINICAL STAGE COMPANIES
  • TABLE 47: CHINESE CLINICAL STAGE COMPANIES
  • TABLE 48: AUTOIMMUNE HEPATITIS PIPELINE DRUGS BY STAGE OF DEVELOPMENT
  • TABLE 49: PHASE 2 PIPELINE DRUG CANDIDATES IN AUTOIMUNE HEPATITIS DRUG PIPELINE
  • TABLE 50: PHASE 1 PIPELINE DRUG CANDIDATES IN AUTOIMMUNE HEPATITIS DRUG PIPELINE
  • TABLE 51: PRECLINICAL DRUG CANDIDATES IN AUTOIMMUNE HEPATITIS DRUG PIPELINE
  • TABLE 52: DRUG CLASSES SCENARIO OF THE AUTOIMMUNE HEPATITIS PIPELINE DRUG CANDIDATES
  • TABLE 53: AUTOIMMUNE HEPATITIS PIPELINE DRUGS ANALYTICS BY COMPANY TYPE
  • TABLE 54: TOTAL PIPELINE MOLECULES WITH RESPECT TO AUTOIMMUNE DISEASE GROUPS BASED ON AFFECTING ORGAN
  • TABLE 55: TOTAL PIPELINE MOLECULES FOR THE TREATMENT OF AUTOIMMUNE DISEASES AFFECTING SENSORY ORGANS
  • TABLE 56: PIPELINE MOLECULES FOR ENDOMETRIOSIS
  • TABLE 57: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING ENDOCRINE SYSTEM/GLANDS
  • TABLE 58: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING ENDOCRINE SYSTEM/GLANDS
  • TABLE 59: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING MUSCULOSKELETAL SYSTEM
  • TABLE 60: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING BLOOD/HEART AND CIRCULATORY SYSTEM
  • TABLE 61: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING URINARY SYSTEM
  • TABLE 62: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING GASTROINTESTINAL SYSTEM
  • TABLE 63: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING MULTIPLE TISSUES AND ORGANS
  • TABLE 64: PIPELINE MOLECULES FOR AUTOIMMINE DISEASES AFFECTING LYMPHATIC AND RESPIRATORY SYSTEMS
  • TABLE 65: AVAILABLE TECHNOLOGIES FOR LICENCING - CONFIRMED THROUGH PRIMARY
  • TABLE 66: AVAILABLE TECHNOLOGIES FOR LICENCING - THROUGH SECONDARY SEARCH
  • TABLE 67: ESTIMATED APPROVAL TIMELINES US & EX-US OF RA PIPELINE MOLECULES (REGISTRATION AND PHASE 3)
  • TABLE 68: ESTIMATED APPROVAL TIMELINES US & EX-US OF T1D PIPELINE MOLECULES (REGISTRATION AND PHASE 3)
  • TABLE 69: ESTIMATED APPROVAL TIMELINES US & EX-US OF CD PIPELINE MOLECULES (REGISTRATION AND PHASE 3)
  • TABLE 70: ESTIMATED APPROVAL TIMELINE OF ALL KEY PIPELINE DRUGS FOR AUTOIMMUNE HEPATITIS
  • TABLE 71: COMPANIES WITH REGULATORY ALLOWANCES
  • TABLE 72: ELI LILLY'S TOP PRODUCTS WITH RESPECT TO SALES IN THE FIRST NINE MONTHS OF 2019
  • TABLE 73: ELI LILLY'S COMPOUNDS UNDER DEVELOPMENT WITH RESPECT TO DIABETES
  • TABLE 74: ELI LILLY'S COMPOUNDS UNDER DEVELOPMENT WITH RESPECT TO IMMUNOLOGY
  • TABLE 75: ELI LILLY'S COMPOUNDS UNDER DEVELOPMENT WITH RESPECT TO NEURODEGENERATION
  • TABLE 76: ELI LILLY'S COMPOUNDS UNDER DEVELOPMENT WITH RESPECT TO ONCOLOGY
  • TABLE 77: ELI LILLY'S COMPOUNDS UNDER DEVELOPMENT WITH RESPECT TO PAIN
  • TABLE 78: RESEARCH AND DEVELOPMENT ACTIVITIES OF ELI LILLY
  • TABLE 79: RECENT DEVELOPMENTS OF ELI LILLY
  • TABLE 80: PFIZER TOP 5 PRODUCTS UNDER MAJOR PRODUCTS IN BIOPHARMA SEGEMENT
  • TABLE 81: PFIZER TOP 5 PRODUCTS UNDER MAJOR PRODUCTS IN UPJOHN SEGMENT
  • TABLE 82: CLINICAL PROGRAMS UNDER INFLAMMATION AND IMMUNOLOGY AREA
  • TABLE 83: CLINICAL PROGRAMS UNDER INTERNAL MEDICINES
  • TABLE 84: CLINICAL PROGRAMS UNDER ONCOLOGY THERAPY AREA
  • TABLE 85: CLINICAL PROGRAMS UNDER RARE DISEASES
  • TABLE 86: CLINICAL PROGRAMS UNDER VACCINES
  • TABLE 87: RESEARCH AND DEVELOPMENT ACTIVITIES OF PFIZER
  • TABLE 88: RECENT DEVELOPMENTS MADE BY PFIZER
  • TABLE 89: NOVARTIS'S SALES IN MILLION $ OF TOP 10 PRODUCTS IN 9 MONTHS IN 2019
  • TABLE 90: NOVARTIS'S IN REGISTRATION MOLECULES
  • TABLE 91: NOVARTIS'S PHASE 3 MOLECULES
  • TABLE 92: NOVARTIS'S RESEARCH AND DEVELOPMENT ACTIVITIES
  • TABLE 93: NOVARTIS'S RECENT DEVELOPMENTS
  • TABLE 94: NOVARTIS'S ANTICIPATED MILESTONES
  • TABLE 95: PIPELINE ASSETS OF PROVENTION BIO
  • TABLE 96: RESEARCH AND DEVELOPMENT ACTIVITIES OF PROVENTION BIO
  • TABLE 97: RECENT DEVELOPMENTS OF PROVENTION BIO
  • TABLE 98: PRESENTATIONS AND EVENTS OF PROVENTION BIO
  • TABLE 99: PIPELINE ASSETS OF CAN-FITE
  • TABLE 100: RESEARCH AND DEVELOPMENT ACTIVITIES OF CAN-FITE
  • TABLE 101: RECENT DEVELOPMENTS OF CAN-FITE
  • TABLE 102: PRESENTATIONS AND EVENTS OF CAN-FITE
  • TABLE 103: PUBLICATIONS OF CAN-FITE
  • TABLE 104: PIPELINE ASSETS OF CALLIDITAS
  • TABLE 105: RESEARCH AND DEVELOPMENT ACTIVITIES OF CALLIDITAS
  • TABLE 106: RECENT DEVELOPMENTS OF CALLIDITAS
  • TABLE 107: PRESENTATION AND EVENTS OF CALLIDITAS
  • TABLE 108: PIPELINE ASSETS OF SOLIGENIX WITH RESPECT TO SPECIALIZED BIOTHERAPEUTICS SEGMENT
  • TABLE 109: PIPELINE ASSETS OF SOLIGENIX WITH RESPECT TO PUBLIC HEALTH SOLUTIONS SEGMENT
  • TABLE 110: RESEARCH AND DEVELOPMENT ACTIVITIES OF SOLIGENIX
  • TABLE 111: RECENT DEVELOPMENTS OF SOLIGENIX
  • TABLE 112: PRESENTATIONS AND EVENTS OF SOLIGENIX
  • TABLE 113: INNOVATE BIOPHARMACEUTICALS PIPELINE ASSETS
  • TABLE 114: US ISSUED PATENTS OF INN-202
  • TABLE 115: INN-108 PATENT LICENSE WITH SEACHAID PHARMACEUTICALS, INC.
  • TABLE 116: RESEARCH AND DEVELOPMENT ACTIVITIES OF INNOVATE BIOPHARMACEUTICALS
  • TABLE 117: RECENT DEVELOPMENTS OF INNOVATE PHARMACEUTICALS
  • TABLE 118: COLLABORATIONS OF INNOVATE BIOPHARMACEUTICALS
  • TABLE 119: PRESENTATIONS AND EVENTS OF INNOVATE BIOPHARMACEUTICALS
  • TABLE 120: PIPELINE ASSETS OF CYXONE
  • TABLE 121: PATENTS OF CYXONE
  • TABLE 122: RESEARCH AND DEVELOPMENT ACTIVITIES OF CYXONE
  • TABLE 123: RECENT DEVELOPMENTS OF CYXONE
  • TABLE 124: PIPELINE ASSETS OF OSE IMMUNOTHERAPEUTICS WITH RESPECT TO IMMUNO-ONCOLOGY
  • TABLE 125: PIPELINE ASSETS OF OSE IMMUNOTHERAPEUTICS WITH RESPECT TO AUTOIMMUNE DISEASES
  • TABLE 126: PATENTS OF OSE IMMUNOTHERAPEUTICS
  • TABLE 127: RESEARCH AND DEVELOPMENT ACTIVITIES OF OSE IMMUNOTHERAPEUTICS
  • TABLE 128: RECENT DEVELOPMENTS OF OSE IMMUNOTHERAPEUTICS
  • TABLE 129: PRESENTATIONS AND EVENTS OF OSE IMMUNOTHERAPEUTICS
  • TABLE 130: PIPELINE ASSETS OF CONNECT BIOPHARMACEUTICALS
  • TABLE 131: PATENTS OF CONNECT BIOPHARMACEUTICALS
  • TABLE 132: RESEARCH AND DEVELOPMENT ACTIVITIES OF CONNECT BIOPHARMACEUTICALS
  • TABLE 133: RECENT DEVELOPMENTS OF CONNECT BIOPHARMACEUTICALS
  • TABLE 134: PRESENTATIONS AND EVENTS OF CONNECT BIOPHARMACEUTICALS
  • TABLE 135: PIPELINE ASSETS OF ABIVAX
  • TABLE 136: PATENTS OF ABIVAX
  • TABLE 137: RESEARCH AND DEVELOPMENT ACTIVITIES OF ABIVAX
  • TABLE 138: RECENT DEVELOPMENTS OF ABIVAX
  • TABLE 139: PRESENTATIONS AND EVENTS OF ABIVAX
  • TABLE 140: PIPELINE ASSETS OF PROTAGONIST
  • TABLE 141: RESEARCH AND DEVELOPMENT ACTIVITIES OF PROTAGONIST
  • TABLE 142: RECENT DEVELOPMENTS OF PROTAGONIST
  • TABLE 143: PRESENTATIONS AND EVENTS OF PROTAGONIST
  • TABLE 144: PUBLICATIONS OF PROTAGONIST

LIST OF FIGURES

  • FIGURE 01: KEY EVENTS IN THE COMPETITIVE SPACE
  • FIGURE 02: BASIC MECHANISM OF AUTOIMMUNITY
  • FIGURE 03: AUTOIMMUNE DISEASE DEALS SCENARIO
  • FIGURE 04: AUTOIMMUNE DISEASE DEALS ANALYTICS BY ANNUAL FREQUENCY
  • FIGURE 05: AUTOIMMUNE DISEASES DEALS SCENARIO IN 2019
  • FIGURE 06: RHEUMATOID ARTHRITIS PIPELINE VS STAGES OF DEVELOPMENT
  • FIGURE 07: RHEUMATOID ARTHRITIS DRUG PIPELINE SPLIT BY GEOGRAPHY
  • FIGURE 08: RHEUMATOID ARTHRITIS DRUG PIPELINE ANALYTICS BY ROA
  • FIGURE 09: RA DRUG PIPELINE ANALYTICS BY MOLECULE TYPE
  • FIGURE 10: GEOGRAPHICAL CATEGORIZATION OF CLINICAL STAGE COMPANIES WORKING ON RA
  • FIGURE 11: T1D PIPELINE DRUGS BY STAGE OF DEVELOPMENT
  • FIGURE 12: T1D PIPELINE DRUG ANALYTICS BY GEOGRAPHY
  • FIGURE 13: T1D PIPELINE DRUG ANALYTICS BY ROUTE OF ADMINISTRATION
  • FIGURE 14: T1D PIPELINE DRUG ANALYTICS BY MOLECULE TYPE
  • FIGURE 15: GEOGRAPHY VS CLINICAL STAGE COMPANIES WORKING ON T1D
  • FIGURE 16: CROHN'S DISEASE PIPELINE ANALYSIS BY STAGE OF DEVELOPMENT
  • FIGURE 17: CROHN'S DISEASE PIPELINE ANALYSIS BY GEOGRAPHY
  • FIGURE 18: CROHN'S DISEASE PIPELINE ANALYSIS BY ROUTE OF ADMINISTRATION
  • FIGURE 19: CROHN'S DISEASE PIPELINE ANALYSIS BY MOLECULE TYPE
  • FIGURE 20: CROHN'S DISEASE PIPELINE ANALYSIS BY COMPANY TYPE
  • FIGURE 21: AUTOIMMUNE HEPATITIS PIPELINE DRUGS BY STAGES OF DEVELOPMENT
  • FIGURE 22: AIH DRUG PIPELINE ANALYTICS BY MOLECULE TYPE
  • FIGURE 23: GEOGRAPHICAL CATEGORIZATION OF COMPANIES WORKING ON AIH
  • FIGURE 24: PIPELINE MOLECULES OF AUTOIMMUNE DISEASES AFFECTING SENSORY ORGANS
  • FIGURE 25: PIPELINE MOLECULES OF AUTOIMMUNE DISEASES AFFECTING NERVOUS SYSTEM
  • FIGURE 26: PIPELINE MOLECULES OF MAJOR AUTOIMMUNE DISEASES AFFECTING MUSCULOSKELETAL SYSTEM
  • FIGURE 27: PIPELINE MOLECULES OF MAJOR AUTOIMMUNE DISEASES AFFECTING BLOOD/HEART AND CIRCULATORY SYSTEM
  • FIGURE 28: PIPELINE MOLECULES OF MAJOR AUTOIMMUNE DISEASES AFFECTING URINARY SYSTEM
  • FIGURE 29: PIPELINE MOLECULES OF MAJOR AUTOIMMUNE DISEASES AFFECTING GASTROINTESTINAL SYSTEM
  • FIGURE 30: PIPELINE MOLECULES OF MAJOR AUTOIMMUNE DISEASES AFFECTING MULTIPLE TISSUES AND ORGANS
  • FIGURE 31: RESEARCH AND DEVELOPMENT EXPENSES OF TOP 5 COMPANIES IN $M
  • FIGURE 32: PIPELINE PORTFOLIO WITH (NUMBER OF MOLECULES)
  • FIGURE 33: EXPECTED MARKET ENTRY WITH RESPECT TO DRUG CANDIDATES TREATING AUTOIMMUNE DISEASES
  • FIGURE 34: TIME LINE OF PATENT EXPIRIES WITH RESPECT TO AUTOIMMUNE DISEASE TREATMENTS
  • FIGURE 35: RANKING TOP 5 EMERGING COMPANIES BASED ON THEIR PARTNERING ACTIVITIES
  • FIGURE 36: R&D EXPENSES AS WELL AS NET PRODUCT REVENUES FOR YEARS 2016, 2017 AND 2018 MADE BY ELI LILLY
  • FIGURE 37: R&D EXPENSES AS WELL AS NET PRODUCT REVENUES FOR THE FIRST NINE MONTHS OF 2018 AND 2019 MADE BY ELI LILLY
  • FIGURE 38: FINANCIAL INFORMATION OF PFIZER FOR 2016, 2017 AND 2018
  • FIGURE 39: REVENUE BREAKDOWN BETWEEN PFIZER'S SEGMENTS FOR THE FIRST NINE MONTHS ENDED IN 2019
  • FIGURE 40: NOVARTIS'S REVENUES EARNED IN MILLION $ FOR 2016, 2017 AND 2018
  • FIGURE 41: NOVARTIS'S BREAKDOWN OF REVENUES EARNED IN THE YEAR END OF 2018
  • FIGURE 42: RESEARCH AND DEVELOPMENT EXPENSES OF PROVENTION BIO FOR FINANCIAL YEARS OF 2017 AND 2018 IN $K
  • FIGURE 43: R&D EXPENSES INCURRED BY CAN-FITE FOR FINANCIAL YEARS OF 2014, 2015, 2016, 2017 AND 2018 IN $K
  • FIGURE 44: RESEARCH AND DEVELOPMENT EXPENSES INCURRED BY CALLIDITAS FOR FINANCIAL YEARS OF 2017 AND 2018 IN $M
  • FIGURE 45: RESEARCH AND DEVELOPMENT EXPENSES INCURRED BY SOLIGENIX FOR FINANCIAL YEARS OF 2017 AND 2018 IN $K
  • FIGURE 46: RESEARCH AND DEVELOPMENT EXPENSES OF SOLIGENIX FOR FIRST NINE MONTHS OF 2018 AND 2019 IN $K
  • FIGURE 47: R&D EXPENSES OF INNOVATE BIOPHARMACEUTICALS IN $M FOR THE NINE MONTHS ENDED OF 2018 AND 2019
  • FIGURE 48: TOTAL OPERATING AND R&D COSTS INCURRED BY ABIVAX DURING FIRST HALVES OF 2018 AND 2019 RESPECTIVELY IN $M
  • FIGURE 49: R&D EXPENSES OF PROTAGONIST FOR THE FINANCIAL YEARS OF 2014, 2015, 2016, 2017 AND 2018 IN $K
  • FIGURE 50: R&D EXPENSES AND REVENUES EARNED BY PROTAGONIST FOR THE FIRST NINE MONTHS OF 2018 AND 2019 IN $K
目次
Product Code: GERPH913

GervanoRA has assessed and analyzed the Autoimmune Diseases drugs pipeline by conducting a thorough secondary research and search of internal propriatory databases and has identified a number of pipeline molecules anticipated to enter the therapeutic market to serve the increasing disease population with unmet needs. We have classified the Autoimmune Diseases drugs pipeline into segments based on the molecules' Highest Stage of Development, Drug Class, Mechanism of Action, Route of Administration, Target and Company type. GervanoRA analysis predicts the Autoimmune Diseases drugs market size to increase in the near future with an increasing number of pipeline molecules entering clinical stages of development. Our comprehensive analysis on the Autoimmune Diseases drugs pipeline identified 1494 drug candidates undergoing different stages of development- from Early R&D to Pre-registration stage developing by around 1172 global companies actively. Among these, 205 drug candidates are in the Phase 3 stage of development, 379 candidates are in Phase 2 stage, 227 drug candidates are in Phase 1 stage of development and remaining molecules are in non-clinical stage of development. The drug pipeline consists of more number of preclinical drug candidates and followed by early stages of discovery. Along with these pipeline candicates, there are around 15 drug candidates in their pre-registration stage of development for different indications and geographies. GervanoRA has also analyzed that there are drug candidates who have been inactive or were discontinued due to various reasons from further developments. Below table shows total pipeline molecules for the treatment of autoimmune diseases gouped based on affected organ or body system.

An in-depth analysis based on the route of administration (ROA) of the therapeutic candidates sees that the major portion has been occupied by the oral and injectable candidates. The oral candidates occupying more than 50 percent in the drug pipeline are followed by injectable drug candidates making up a share of 41 percent. Inhalation and Topical drug candidates constitute a minor portion from the drug pipeline. Our analysis on geography has seen that, majority of the drug candidates targeting Autoimmune Diseases are anticipated to be filed for regulatory approvals in the US, followed by Europe. GervanoRA has performed pipeline analysis of Autoimmune Diseases molecules based on the target i.e. the type of Autoimmune Diseases receptor targeted. Autoimmune Disease area has witnessed a total of 291 major deals since 2010 to till the date. A year-by-year deals analytics have been provided highlighting the most active players in the competitive partnering landscape. An abrupt increase had been observed in the number of deals, increasing from 51 deals in the year 2018 to 94 deals in the year 2019. To add further, the year 2019 has marked some of the major deals in the healthcare industry, mainly the mergers and acquisition deals between Bristol-Myers Squibb Company and Celgene Corporation, and, Takeda Pharmaceutical Company Limited and Shire plc worth a total deal amount of $74 billion and $62 billion, respectively. As per the GervanoRA's analytics, a total of 43 mergers and acquisitions deals have occurred in the autoimmune disease area from the year 2015-2020 and 95 collaboration deals have taken place from the year 2010 till date. The Autoimmune Disease therapeutic area has witnessed a total of 65 major licensing deals from the year 2010 till date, from which 47 major licensing deals have occurred from the year 2017 till January 2020. There were a total of seventeen licensing deals in the year 2019, twelve in the year 2018 and fourteen in the year 2017. A total of 78 financing deals have occurred from the year 2010 till date, from which around 60 financing deals have been reported to take place in between 2017 and 2019.

As per GervanoRA analytics, Takeda Pharmaceutical's Entyvio IV will achieve China regulatory approvals in 2020 and Europe regulatory approval of Entyvio SC in 2021 for the treatment of Crohn's Diseases. Along with this molecule, Filgotinib of Gilead Sciences Inc/Galapagos NV, and PF-06410293 (Humira Biosimilar) of Pfizer may also get regulatory approvals in 2020. PF-06410293 (Humira Biosimilar) will get approval in Europe and Filgotinib in US for the treatment of Rheumatoid Arthritis. As per GervanoRA's estimated drug approval timelines, AbbVie's Risankizumab (Skyrizi) and Bristol-Myers Squibb's Ozanimod (RPC-1063) may achive regulatory approvals by 2022 in the US and by 2023 in Europe and Japan for the treatment of Crohn's Diseases. Along with these, there are other six pipeline molecules can compete to get US regulatory approvals in the year 2023 for the treatment of Crohn's Diseases. Dapagliflozin, Empagliflozin/BI10773, Ultra-Rapid Lispro/LY900014 and SAR341402 (Insulin Aspart) of AstraZeneca/Bristol-Myers Squibb, Boehringer Ingelheim International GmbH/Eli Lilly and Company, Eli Lilly and Company and Sanofi respectively are in pre-registration phase of development and may realize their regulatory approvals either end of 2020 or in 2021 for the treatment of Type 1 diabetes. Piclidenoson (CF101), Otilimab (Previously GSK3196165), Olokizumab, SM03 and TS-152 (Ozoralizumab) of Can-Fite BioPharma Ltd/Cipher Pharmaceuticals Inc/Gebro Pharma, GlaxoSmithKline Plc/MorphoSys AG, R Pharm, SinoMab BioScience and Taisho Pharmaceutical Holdings Inc/Ablynx are currently in Phase 3 stage of development with promising results and may get regulatory approvals in near future for the treatment of Rheumatoid Arthritis.

TABLE OF CONTENTS

1. INTRODUCTION

  • 1.1. REPORT DESCRIPTION
  • 1.2. METHODOLOGY
  • 1.3. UPCOMING AND OTHER AVAILABLE PIPELINE ANALYSIS REPORTS
  • 1.4. ABOUT US: GERVANORA DATA SERVICES

2. EXECUTIVE SUMMARY

  • 2.1. REPORT SUMMARY
  • 2.2 KEY EVENTS IN THE COMPETITIVE SPACE OF AUTOIMMUNE DISEASES
  • 2.3. REPORT MAJOR FINDINGS
    • 2.3.1. DRIVERS
    • 2.3.2. RESTRAINTS
    • 2.3.3. OPPORTUNITIES

3. AUTOIMMUNE DISEASES OVERVIEW

  • 3.1. DISEASES DEFINITION AND SYMPTOMS
  • 3.2. CAUSES AND RISK FACTORS
  • 3.3. DIAGNOSIS
  • 3.4. TREATMENT ALGORYTHM AND GUIDELINES

4. MARKET DYNAMICS OF AUTOIMMUNE DISEASES

  • 4.1. DEALS (MERGERS/ ACQUISITIONS/ COLLABORATIONS)
    • 4.1.1 DEALS ANALYTICS BY DEAL TYPE
      • 4.1.1.1. MERGERS AND ACQUISITIONS
      • 4.1.1.2. COLLABORATION AGREEMENTS
      • 4.1.1.3. LICENSING AGREEMENTS
      • 4.1.1.4. FINANCING DEALS
      • 4.1.1.5. TERMINATION AGREEMENTS AND SETTLEMENTS
    • 4.1.2 DEALS ANALYTICS BY ANNUAL FREQUENCY
    • 4.1.3 DEALS ANALYTICS BY ACTIVE PLAYER
  • 4.2. PATENT ANALYSIS (EXPIRES AND GENERICIZATION)
    • 4.2.1. PATENT ANALYTICS OF PIPELINE DRUGS

5. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES

  • 5.1. PIPELINE DRUGS ANALYTICS OF RHEUMATOID ARTHRITIS (RA)
    • 5.1.1 PIPELINE DRUGS ANALYTICS BY STAGE OF DEVELOPMENT
      • 5.1.1.1. PHASE 3 PIPELINE MOLECULES
      • 5.1.1.2. PHASE 2 PIPELINE MOLECULES
      • 5.1.1.3. PHASE 1 PIPELINE MOLECULES
      • 5.1.1.4. PRECLINICAL PIPELINE MOLECULES
      • 5.1.1.5. EARLY R&D PIPELINE MOLECULES
      • 5.1.1.6. INACTIVE AND DISCONTINUED PIPELINE MOLECULES
    • 5.1.2. PIPELINE DRUGS ANALYTICS BY GEOGRAPHY
      • 5.1.2.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.1.3. PIPELINE DRUGS ANALYTICS BY ROUTE OF ADMINISTRATION
      • 5.1.3.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.1.4. PIPELINE DRUGS ANALYTICS BY DRUG CLASS
      • 5.1.4.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.1.5. PIPELINE DRUGS ANALYTICS BY MECHANISM OF ACTION
      • 5.1.5.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.1.6. PIPELINE DRUGS ANALYTICS BY MOLECULE TYPE
    • 5.1.7. PIPELINE DRUGS ANALYTICS BY COMPANY TYPE
  • 5.2. PIPELINE DRUGS ANALYTICS OF TYPE 1 DIABETES (T1D)
    • 5.2.1 PIPELINE DRUGS ANALYTICS BY STAGE OF DEVELOPMENT
      • 5.2.1.1. PHASE 3 PIPELINE MOLECULES
      • 5.2.1.2. PHASE 2 PIPELINE MOLECULES
      • 5.2.1.3. PHASE 1 PIPELINE MOLECULES
      • 5.2.1.4. PRECLINICAL PIPELINE MOLECULES
      • 5.2.1.5. EARLY R&D PIPELINE MOLECULES
      • 5.2.1.6. INACTIVE AND DISCONTINUED PIPELINE MOLECULES
    • 5.2.2. PIPELINE DRUGS ANALYTICS BY GEOGRAPHY
      • 5.2.2.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.2.3. PIPELINE DRUGS ANALYTICS BY ROUTE OF ADMINISTRATION
      • 5.2.3.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.2.4. PIPELINE DRUGS ANALYTICS BY DRUG CLASS
      • 5.2.4.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.2.5. PIPELINE DRUGS ANALYTICS BY MECHANISM OF ACTION
      • 5.2.5.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.2.6. PIPELINE DRUGS ANALYTICS BY MOLECULE TYPE
    • 5.2.7. PIPELINE DRUGS ANALYTICS BY TARGET
    • 5.2.8. PIPELINE DRUGS ANALYTICS BY COMPANY TYPE
  • 5.3. PIPELINE DRUGS ANALYTICS OF CROHN'S DISEASE (CD)
    • 5.3.1 PIPELINE DRUGS ANALYTICS BY STAGE OF DEVELOPMENT
      • 5.3.1.1. PHASE 3 PIPELINE MOLECULES
      • 5.3.1.2. PHASE 2 PIPELINE MOLECULES
      • 5.3.1.3. PHASE 1 PIPELINE MOLECULES
      • 5.3.1.4. PRECLINICAL PIPELINE MOLECULES
      • 5.3.1.5. EARLY R&D PIPELINE MOLECULES
      • 5.3.1.6. INACTIVE AND DISCONTINUED PIPELINE MOLECULES
    • 5.3.2. PIPELINE DRUGS ANALYTICS BY GEOGRAPHY
      • 5.3.2.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.3.3. PIPELINE DRUGS ANALYTICS BY ROUTE OF ADMINISTRATION
      • 5.3.3.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.3.4. PIPELINE DRUGS ANALYTICS BY DRUG CLASS
      • 5.3.4.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.3.5. PIPELINE DRUGS ANALYTICS BY MECHANISM OF ACTION
      • 5.3.5.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.3.6. PIPELINE DRUGS ANALYTICS BY MOLECULE TYPE
    • 5.3.7. PIPELINE DRUGS ANALYTICS BY TARGET
    • 5.3.8. PIPELINE DRUGS ANALYTICS BY COMPANY TYPE
  • 5.4. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE HEPATITIS (AIH)
    • 5.4.1 PIPELINE DRUGS ANALYTICS BY STAGE OF DEVELOPMENT
      • 5.4.1.1. PHASE 2 PIPELINE MOLECULES
      • 5.4.1.2. PHASE 1 PIPELINE MOLECULES
      • 5.4.1.3. PRECLINICAL PIPELINE MOLECULES
      • 5.4.1.4. EARLY R&D PIPELINE MOLECULES
    • 5.4.2. PIPELINE DRUGS ANALYTICS BY GEOGRAPHY
      • 5.4.2.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.4.3. PIPELINE DRUGS ANALYTICS BY ROUTE OF ADMINISTRATION
      • 5.4.3.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.4.4. PIPELINE DRUGS ANALYTICS BY DRUG CLASS
      • 5.4.4.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.4.5. PIPELINE DRUGS ANALYTICS BY MECHANISM OF ACTION
      • 5.4.5.1. UNMET NEEDS AND OPPORTUNITIES
    • 5.4.6. PIPELINE DRUGS ANALYTICS BY MOLECULE TYPE
    • 5.4.7. PIPELINE DRUGS ANALYTICS BY TARGET
    • 5.4.8. PIPELINE DRUGS ANALYTICS BY COMPANY TYPE
  • 5.5. PIPELINE DRUGS ANALYTICS OF OTHER AUTOIMMUNE DISEASES
    • 5.5.1. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING SENSORY ORGANS
    • 5.5.2. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING REPRODUCTIVE SYSTEM
    • 5.5.3. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING ENDOCRINE SYSTEM
    • 5.5.4. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING NERVOUS SYSTEM
    • 5.5.5. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING MUSCULOSKELETAL SYSTEM
    • 5.5.6. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING BLOOD & CIRCULATORY SYSTEM
    • 5.5.7. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING URINARY SYSTEM
    • 5.5.8. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING GASTROINTESTINAL SYSTEM
    • 5.5.9. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING MULTIPLE TISSUES AND ORGANS
    • 5.5.10. PIPELINE DRUGS ANALYTICS OF AUTOIMMUNE DISEASES AFFECTING LYMPHATIC AND RESPIRATORY SYSTEM
    • 5.5.11. PIPELINE MOLECULES BY UNIVERSITIES AND INSTITUTES - LICENSING OPPORTUNITIES

6. CLINICAL STAGE PIPELINE DRUGS DESCRIPTIONS AND DEVELOPMENT MILESTONES

  • 6.1. CLINICAL STAGE PIPELINE DRUGS DESCRIPTIONS AND DEVELOPMENT MILESTONES OF RA
    • 6.1.1. PRE-REGISTRATION PIPELINE MOLECULES

Filgotinib - (Gilead Sciences Inc/Galapagos NV)

    • 6.1.2. PHASE 3 PIPELINE MOLECULES

Piclidenoson (CF101) - (Can-Fite BioPharma/Cipher Pharmaceuticals/Gebro Pharma)

Otilimab (GSK3196165) - (GlaxoSmithKline Plc/MorphoSys AG)

Olokizumab - (R Pharm)

SM03 - (SinoMab BioScience)

TS-152 (Ozoralizumab) - (Taisho Pharmaceutical Holdings Inc/Ablynx)

    • 6.1.3. PHASE 2 PIPELINE MOLECULES

ABBV-3373 - (Abbvie Inc)

ABBV-599 - (Abbvie Inc)

ABX464 - (Abivax)

BTK Inhibitor - (Bristol-Myers Squibb Co)

Rabeximod - (Cyxone AB)

    • 6.1.4. PHASE 1 PIPELINE MOLECULES

ABBV-154 - (Abbvie Inc)

ATI-450 - (Aclaris Therapeutics Inc)

Efaveleukin Alfa (AMG 592) - (Amgen Inc)

ART-I02 - (Arthrogen BV)

MEDI5117 - (AstraZeneca Plc)

  • 6.2. CLINICAL STAGE PIPELINE DRUGS DESCRIPTIONS AND DEVELOPMENT MILESTONES OF T1D
    • 6.2.1. PRE-REGISTRATION MOLECULES

Farxiga (Dapagliflozin) - (AstraZeneca Plc/Bristol-Myers Squibb)

Empagliflozin (BI10773) - (Boehringer Ingelheim International GmbH/Eli Lilly and Co)

    • 6.2.2. PHASE 3 PIPELINE MOLECULES

Dasiglucagon - (Zealand Pharma AS)

Donislecel (BB-11807) - (CellTrans Inc)

Teplizumab (PRV-031) - (Provention Bio Inc)

Insulin Aspart and Insulin Aspart 30 - (Sihuan Pharmaceutical Holdings Group Ltd)

    • 6.2.3. PHASE 2 PIPELINE MOLECULES

AG019 - (ActoBio Therapeutics Inc)

Dance 501 (501-Human Insulin) - (Aerami Therapeutics)

CLBS03 - (Caladrius Biosciences)

Oral HDV Insulin Technology - (Diasome Pharmaceuticals Inc)

Temelimab - (GeNeuro SA)

    • 6.2.4. PHASE 1 PIPELINE MOLECULES

AT247 - (Arecor Ltd)

Aux-101 - (Auxulin Pharmaceuticals Inc)

Imotopes - (ImCyse SA)

INS-068 - (Jiangsu Hengrui Medicine Co Ltd)

AB101 - (Rezolute Inc)

  • 6.3. CLINICAL STAGE PIPELINE DRUGS DESCRIPTIONS AND DEVELOPMENT MILESTONES OF CD
    • 6.3.1. PRE-REGISTRATION MOLECULES

Entyvio - (Takeda Pharmaceutical Co Ltd)

    • 6.3.1. PHASE 3 PIPELINE MOLECULES

Ozanimod (RPC-1063) - (Bristol-Myers-Squibb Co)

Filgotinib - (Galapagos NV/Gilead Sciences)

Etrolizumab - (Genentech Inc/Roche)

RHB-104 - (RedHill Biopharma Ltd)

Etrasimod - (Arena Pharmaceuticals Inc)

    • 6.3.2. PHASE 2 PIPELINE MOLECULES

E6011 - (EA Pharma Co Ltd)

Remestemcel-L (Prochymal) - (Mesoblast Ltd/Osiris Therapeutics)

MT-1303 - (Mitsubishi Tanabe Pharma Corp)

PTG-200 - (Protagonist Therapeutics Inc/Janssen Biotech Inc)

PRV-6527 - (Provention Bio Inc/Janssen Pharmaceutica NV)

    • 6.3.3. PHASE 1 PIPELINE MOLECULES

Thetanix - (4D Pharma Plc)

ACT-101 - (Alpha Cancer Technologies Inc)

ETX-201 - (ETX Pharma Inc)

HAV anti-MAP Vaccine - (HAV Vaccines Ltd)

IMU-838 - (Immunic Inc)

  • 6.4. CLINICAL STAGE PIPELINE DRUGS DESCRIPTIONS AND DEVELOPMENT MILESTONES OF AIH
    • 6.4.2. PHASE 2 PIPELINE MOLECULES

Ianalumab (VAY736) - (MorphoSys AG/Novartis)

ST-AH-01 - (Stero Biotechs)

Budenofalk - (Calliditas Therapeutics/Dr. Falk Pharma)

JKB-122 - (TaiwanJ Pharmaceuticals/ Newsoara Biopharma)

    • 6.4.3. PHASE 1 PIPELINE MOLECULES

TregCel - (TRACT Therapeutics Inc)

JKB-122 - (TaiwanJ Pharmaceuticals)

Synthetic PreImplantation Factor (sPIF) - (BioIncept LLC)

7. ESTIMATED APPROVAL TIMELINES

  • 7.1. METHODOLOGY
    • 7.1.1. ESTIMATED APPROVAL TIMELINES (US & EX-US) OF RA MOLECULES
    • 7.1.2. ESTIMATED APPROVAL TIMELINES (US & EX-US) OF T1D MOLECULES
    • 7.1.3. ESTIMATED APPROVAL TIMELINES (US & EX-US) OF CD MOLECULES
    • 7.1.4. ESTIMATED APPROVAL TIMELINES (US & EX-US) OF HID MOLECULES

8. OPPORTUNITY ASSESSMENTS THROUGH COMPETITIVE BENCH-MARKING

  • 8.1. EXTERNAL DEPENDENCIES
  • 8.2. PIPELINE PORTFOLIO
  • 8.3. EXPECTED MARKET ENTRIES
  • 8.4. PATENTS AND EXCLUSIVITY
  • 8.5. MARKET DYNAMICS WITH PARTNERING ACTIVITIES
  • 8.6. ACHIEVEMENTS OF SPECIAL REGULATORY ALLOWANCES
  • 8.7. COMPANY DEVELOPMENTS
  • 8.8. EXPECTED MARKET SHARES BY EMERGING COMPANIES

9. CURRENT AND FUTURE COMPETITIVE LANDSCAPE

  • 9.1. ESTABLISHED COMPANIES
    • 9.1.1. KEY COMPANY PROFILES AND SWOT ANALYSIS
      • 9.1.1.1. ELY LILY AND COMPANY
      • 9.1.1.2. PFIZER PHARMACEUTICALS
      • 9.1.1.3. NOVARTIS AG
  • 9.2. EMERGING COMPANIES
    • 9.2.1. KEY EMERGING COMPANY PROFILES
      • 9.2.1.1. PROVENTION BIO, INC
      • 9.2.1.2. CAN-FITE BIOPHARMA LTD.
      • 9.2.1.3. CALLIDITAS THERAPEUTICS AB
      • 9.2.1.4. SOLIGENIX, INC
      • 9.2.1.5. INNOVATE BIOPHARMACEUTICALS, INC
      • 9.2.1.6. CYXONE AB
      • 9.2.1.7. OSE IMMUNOTHERAPEUTICS SA
      • 9.2.1.8. SUZHOU CONNECT BIOPHARMACEUTICALS, LTD
      • 9.2.1.9. ABIVAX SA
      • 9.2.1.10. PROTAGONIST THERAPEUTICS, INC
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