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抗生物質および新スーパードラッグの探求:技術・市場・競合企業・機会の分析と予測

Antibiotics And The Quest For New Super Drugs:Technologies, Markets, Competitors And Opportunities-2017-2022 Analysis And Forecasts

発行 Amadee & Company, Inc. 商品コード 301230
出版日 ページ情報 英文 299 pages
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抗生物質および新スーパードラッグの探求:技術・市場・競合企業・機会の分析と予測 Antibiotics And The Quest For New Super Drugs:Technologies, Markets, Competitors And Opportunities-2017-2022 Analysis And Forecasts
出版日: 2017年07月11日 ページ情報: 英文 299 pages
概要

当レポートでは、抗生物質市場の概要と抗菌剤耐性薬剤の動向と課題、新薬開発動向とともに、参入企業のプロファイルを織り交ぜお届けします。

エグゼクティブサマリー

イントロダクション

抗生物質の概要

  • 菌の分類
  • 病原菌の背景
  • 抗生物質の定義
  • スーパードラッグの探求
  • 土壌微生物
  • 抗生物質の分類
  • グラム陽性 vs. グラム陰性菌
  • 感受性、有効性、およびMIC
  • 殺菌性抗生物質
  • 効能および安全性、ほか

ESKAPE (腸球菌、黄色ブドウ球菌、クレブシエラ属、アシネトバクター・バウマンニ、緑膿菌、エンテロバクター属)

  • 最も一般的な感染症
  • 抗生物質耐性の予防
  • 抗生物質耐性菌と戦う国家的なアクションプラン
  • BARDA および NIAID 予算
  • 国家科学技術諮問会議 (韓国)
  • 英国の抗微生物薬耐性に関するレビュー
  • Margolis Center for Health Policy (米国)
  • GAIN Act (米国)
  • 21st Century Cures Act (米国)
  • MRSAの減少、ほか

抗生物質スーパードラッグの探求

  • ディスカバリープラットフォームの崩壊
  • 新しい抗生物質ディスカバリープロセス
  • 既存抗生物質の合理的な改善
  • 古い抗生物質の再発見
  • 古い医薬品を別の目的で再利用
  • 未試験の新しい化学物質の多様性を発見
  • ターゲットに基づいたアプローチ
  • 長期的に低い成功率
  • 新規抗菌薬へのフォーカスが確立
  • 新規抗菌薬クラスの不足、ほか

抗生物質市場

  • 抗生物質の生産規模 (金額ベース)
  • 生産規模:クラス別 (金額ベース)
  • キノロン類
  • セファロスポリン
  • マクロライド
  • ペニシリン
  • カルバペネム
  • テトラサイク
  • スルホンアミド
  • アミノグリコシド、ほか

企業プロファイル

  • Achaogen Inc
  • Actelion Ltd.
  • AstaZeneca plc
  • Atox Bio
  • Basilea Pharmaceutica AG
  • Cempra Inc
  • CrystalGenomics, Inc.
  • Cubist Pharmaceuticals, Inc.
  • Destiny Pharma Ltd.
  • Dong Wha Pharmaceuticals
  • Durata Therapeutics, Inc.
  • エーザイ
  • Furiex Pharmaceuticals, Inc.
  • GlaxoSmithKline, Plc.
  • Grupo Ferrer Internacional S.A.
  • Insmed Incorporated
  • KaloBios Pharmaceuticals, Inc.
  • Melinta Therapeutics, Inc.
  • Merck & Co., Inc.
  • MerLion Pharmaceuticals Pte Ltd
  • MicuRx Pharmaceuticals, Inc.
  • Nabriva Therapeutics AG
  • Osel Inc
  • Novartis AG
  • Otonomy, Inc.
  • 大塚製薬
  • Paratek Pharmaceuticals, Inc.
  • Pfizer Inc
  • Polyphor Ltd.
  • Rebiotix, Inc.
  • Roche Holding AG
  • Savara Pharmaceuticals
  • Sequella, Incorporated
  • Seres Therapeutics, Inc.
  • Summit, plc
  • TaiGen Biotechnology Co., Ltd.
  • Tetraphase Pharmaceuticals, Inc.
  • The Medicines Company
  • Theravance Biopharma Inc

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目次

Antibiotics are drugs used to treat infections that are caused by bacteria.

The introduction of antibiotics is recognized as one of the most transformative events in medicine.

Prior to the introduction of the first antibiotics in the 1930s and 1940s, bacterial infections were often fatal, and invasive surgery was accompanied by a high risk of infectious complications.

Today, antibiotics are used routinely to treat and prevent infection.

However, drug- and multi-drug-resistant bacterial strains pose a serious threat in the clinical setting as they directly contribute to an increase in morbidity and mortality, as compared to the underlying disease itself.

Due to antibiotic resistance, new antibiotic super drugs are desperately needed to fight infections like MRSA, CRE, ESBLs and C. difficile.

And that is beyond dealing with diseases like drug-resistant Gonorrhea, which affects an estimated 78 million people globally, or TB, which affects 10 million people worldwide, or even the 1 million+ people in the U.S. who get hospitalized with Pneumonia annually.

Or bioweapons like Anthrax.

Unfortunately, it is hard to discover new antibiotics.

Further compounding the problem, from approximately 20 traditional pharmaceutical companies investing in antibiotic research in the 1980s, there are now only five with significant active internal research programs.

As a result, most novel antibiotic development is now being conducted by small biotech companies.

Over the last few years there has been a growing realization among the various stakeholders (Industry players, governments, authorities and medical charities) that something needs to be done to address the issues impacting antibiotic R&D, and avoid the looming socio-economic burden of antimicrobial resistance.

Current antibiotics work now, for the most part.

But if an epidemic of one of the multi-drug-resistant strains rapidly spreading across the globe happens, it will be too late to start funding the discovery of new antibiotics.

The need to invest is now, so there are options when the inevitable next black death appears.

This report addresses these issues.

Specifically, it provides:

  • Antibiotics Overview.
  • Quest for Super Antibiotic Drugs.
  • Antibiotics Market.
  • Company Profiles.

In addition to 37 company profiles, the report contains 14 tables and 62 figures.

Table of Contents

EXECUTIVE SUMMARY

INTRODUCTION

  • Report Objectives
  • Methodology and Sources
  • Statistical Notes

ANTIBIOTICS OVERVIEW

  • Bacteria Taxonomy
  • Microbes in Context
  • Antibiotics Definition
  • Quest for Super Drugs
  • Soil Microbes
  • Antibiotic Categories
  • Gram-Positive vs. Gram-Negative Bacteria
  • Static vs. Cidal
  • Susceptibility, Potency and MIC
  • Bactericidal Antibiotics
  • Breakpoint
  • Efficacy and Safety
  • Mechanisms of Action
  • Antibiotic Resistance
  • Resistance Is Nothing New
  • Costs of Antibiotic Resistance
  • Treatment Guidelines
  • Antibiotic Overuse
  • ESKAPE
  • Most Common Infections
  • Antibiotic Resistance Prevention
  • National Action Plan for Combating Antibiotic Resistant Bacteria
  • BARDA and NIAID Budgets
  • Presidential Advisory Council
  • United Kingdom Review on Antimicrobial Resistance
  • Margolis Center for Health Policy
  • GAIN Act
  • 21st Century Cures Act
  • MRSA on the Decline
  • CRE Poses an Urgent Threat
  • Failure Rate High
  • Global Problem
  • U.S. Cases
  • Carbapenems Use Increasing
  • ESBLs Pose a Serious Threat
  • New Delhi Metallo-Beta-Lactamase
  • Clostridium difficile
  • Few New Antibiotics Being Produced
  • Low NPV
  • Cost of Trials
  • New Antibiotics Hard to Discover
  • iChip
  • Five Pharma Companies Left
  • Development Now Done by Startups
  • Numerous Studies on Situation
  • Disaster Planning
  • Path Forward
  • Alternative Is Unimaginable

QUEST FOR SUPER ANTIBIOTIC DRUGS

  • Discovery Platform Has Collapsed
  • New Antibiotic Discovery Process
  • Rationally Improve Existing Antibiotics
  • Rediscover Old Antibiotics
  • Repurpose Old Drugs
  • Discover Untested New Chemical Diversity
  • Community for Open Antimicrobial Drug Discovery
  • Target-Based Approaches
  • Long Time-Lower Success Rates
  • Focus for New Antibiotic Drugs Well Established
  • Dearth of New Antibiotic Drug Classes
  • R&D Development and Commercial Challenges
  • Modest Performance of New Antibiotics
  • Few Big Players Remain
  • New Key Initiatives
  • Growing Wave of Activity in Antibiotics
  • Activity Mostly Led by Biotechs
  • Renewed Enthusiasm
  • Antibiotics in Late Clinical Development
  • Obtaining Investments for New Antibiotics Is Difficult
  • Startups Believe They Can Find New Antibiotics
  • Antibiotics Approved in Recent Years
  • Stewardship
  • New Antibiotics That Have Received Marketing Authorization
  • Disappointing Sales Post-Launch
  • Generic Competition
  • Beta-lactamases, Cephalosporinase and Carbapenemase Inhibitors
  • New Cephalosporins
  • New Aminoglycosides
  • New Pleuromutilins
  • New Tetracyclines
  • New Macrolides
  • New Fluoroquinolones and DNA Gyrase Inhibitors
  • New Oxazolidinones
  • New Fatty Acid Biosynthesis Inhibitors
  • New Folate Biosynthesis Inhibitors
  • Defensin-Mimetic Peptides
  • Other Classes
  • Old Antibiotics with New Dosing
  • Ramoplanin
  • Fusidane
  • Fosfomycin
  • Early-Stage Molecules
  • Analogs of Existing Classes Still Difficult to Develop
  • New Oral Antibiotics for Outpatients Urgently Needed
  • New Oral Antibiotics for Children Urgently Needed
  • Government Incentives Needed
  • Options Market for Antibiotics
  • Antibiotics Prize

ANTIBIOTICS MARKET

  • Antibiotics Production Value
  • Production Value by Class
  • Quinolones
  • Cephalosporins
  • Marcolides
  • Penicillins
  • Carbapenems
  • Tetracyclines
  • Sulfonamides
  • Aminoglycosides
  • Other Antibiotics
  • Production by Region
  • Consumption Volume Data
  • Antibiotic Market Volume
  • Consumption by Country
  • Class Differences by Country
  • Inappropriate Use
  • Public Health Issues
  • Applications
  • Anti-MRSA Antibiotics
  • Cubicin
  • Zyvox
  • Teflaro
  • Tygacil
  • Vibativ
  • Dalvance
  • Other
  • Community Acquired Bacterial Pneumonia
  • Healthcare-Associated Infections Decreasing
  • Medicare Part D
  • Competitive Environment
  • Large Pharma Exits Antibiotics
  • Biotech Enters Antibiotics
  • Antibiotic Deal Making
  • Competitors
  • Market Shares
  • Antibiotic Supply Chains
  • India and China Antibiotic Supply Chains
  • Antibiotic Pollution Issues
  • Chinese Companies
  • North China Pharmaceutical Group
  • CSPC Pharmaceutical Group/Inner Mongolia Changsheng Pharmaceuticals
  • Sinopharm WeiQida
  • Shandong Lukang Pharmaceuticals
  • Harbin Pharmaceutical Group
  • Tonglian Group
  • United Laboratories
  • Indian Companies
  • Aurobindo
  • Mylan Laboratories Ltd.
  • Dr Reddy's
  • Hetero Drugs Ltd.
  • Orchid Pharmaceuticals

COMPANY PROFILES

  • Achaogen Inc
    • (Company Overview, CRE, Plazomicin, Trials, EPIC, CARE, Launch, QIDP Designation, BARDA, Pipeline, C-Scape, LpxC, P. aeruginosa, Antibacterial Monoclonal Antibodies, Other Monoclonal Antibody Programs, Intellectual Property, Competition, Financial)
  • Actelion Ltd.
    • (Company Overview)
  • AstaZeneca plc
    • (Company Overview, Small Molecule Unit)
  • Atox Bio
    • (Company Overview)
  • Basilea Pharmaceutica AG
    • (Company Overview, Ceftobiprole)
  • Cempra Inc
    • (Company Overview, Solithromycin, Applications, BARDA, Fusidic Acid, ABSSSI)
  • CrystalGenomics, Inc.
    • (Company Overview, CG400549)
  • Cubist Pharmaceuticals, Inc.
    • (Company Overview, Sivextro)
  • Destiny Pharma Ltd.
    • (Company Overview, Pipeline)
  • Dong Wha Pharmaceuticals
    • (Company Overview)
  • Durata Therapeutics, Inc.
    • (Company Overview)
  • Eisai Co., Ltd.
    • (Company Overview)
  • Furiex Pharmaceuticals, Inc.
    • (Company Overview)
  • GlaxoSmithKline, Plc.
    • (Company Overview, Gepotidacin)
  • Grupo Ferrer Internacional S.A.
    • (Company Overview, Ozenoxacin)
  • Insmed Incorporated
    • (Company Overview, ARIKAYCE, Approvals, Patent, INS1007)
  • KaloBios Pharmaceuticals, Inc.
    • (Company Overview, Technology, KB001-A)
  • Melinta Therapeutics, Inc.
    • (Company Overview, Baxdela)
  • Merck & Co., Inc.
    • (Company Overview, Cubicin, Primaxin, Zerbaxa, Sivextro, MK-7655A, Acute Care Position)
  • MerLion Pharmaceuticals Pte Ltd
    • (Company Overview, Finafloxacin, MRSA, Intraabdominal Infections, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Other Hospital and Critical Care Infections, Helicobacter pylori)
  • MicuRx Pharmaceuticals, Inc.
    • (Company Overview)
  • Nabriva Therapeutics AG
    • (Company Overview, Lefamulin, BC-7013)
  • Osel Inc
    • (Company Overview, LACTIN-V, CBM588)
  • Novartis AG
    • (Company Overview, Sandoz, Antibiotics)
  • Otonomy, Inc.
    • (Company Overview)
  • Otsuka Pharmaceutical Co. Ltd.
    • (Company Overview, Tuberculosis Effects More Than 10 Million, Delamanid, Bedaquiline)
  • Paratek Pharmaceuticals, Inc.
    • (Company Overview)
  • Pfizer Inc
    • (Company Overview, AstraZeneca Acquisition, Antibiotics, Tygacil)
  • Polyphor Ltd.
    • (Company Overview, Technology, Murepavadin, Roche Collaboration)
  • Rebiotix, Inc.
    • (Company Overview, RBX2660)
    • Roche Holding AG
    • (Company Overview, Antibiotics, OP0595)
  • Savara Pharmaceuticals
    • (Company Overview)
  • Sequella, Incorporated
    • (Company Overview, Available Markets)
  • Seres Therapeutics, Inc.
    • (Company Overview, SER-109)
  • Summit, plc
    • (Company Overview)
  • TaiGen Biotechnology Co., Ltd.
    • (Company Overview, Taigexyn®)
  • Tetraphase Pharmaceuticals, Inc.
    • (Company Overview, Eravacycline, TP-271, TP-6076, QIDP, Licensed from Harvard, BARDA)
  • The Medicines Company
    • (Company Overview, Infectious Disease Business, Meropenem-Vaborbactam, MINOCIN®, ORBACTIV®, R&D)
  • Theravance Biopharma Inc
    • (Company Overview, VIBATIV, Competition)

APPENDIX 1: ANTIBIOTIC CLASSES

  • Aminoglycosides
  • β-Lactams
  • β-Lactam Resistance
  • Penicillins
  • Carbapenems
  • Cephalosporins
  • Fluoroquinolones
  • Lipoglycopeptides
  • Lipopeptides
  • Oxazolidinones
  • Macrolides
  • Tetracyclines

APPENDIX 2: REGULATION

  • Food, Drug, and Cosmetic Act
  • Approval Process
  • Preclinical Studies
  • Clinical Trials
  • Marketing Approval
  • Foreign Clinical Trials
  • Approval Letter
  • Special FDA Expedited Review and Approval Programs
  • Breakthrough Therapy
  • Post-Approval Requirements
  • Section 505(b)(2)
  • Qualified Infectious Disease Product Exclusivity

TABLES

  • 1.) Microbes Vs. Humans by Factor
  • 2.) Characteristics of Antibiotics by Class
  • 3.) Antibiotics Currently in Clinical Development: March 2017
  • 4.) Global Antibiotics Market ($ Million): 2017-2022
  • 5.) Global Antibiotics Market by Class ($ Million): 2017-2022
  • 6.) Global Antibiotics Production in U.S., EU, Rest of World ($ Million): 2017-2022
  • 7.) MRSA Cases, I.V. MRSA Treatment Days, U.S. Market for Anti-MRSA Antibiotics by Drug and Producer ($ Million): 2017-2022
  • 8.) 10 Most Common Antibiotics Prescribed to Medicare Part D Beneficiaries (Million Claims, $ Million): 2013
  • 9.) 222 Companies Producing or Doing R&D on Antibiotics, Headquarters Country and Website: 2017
  • 10.) Antibiotics Production and Market Shares by Company ($ Million, %): 2016
  • 11.) Achaogen Inc Income Statement ($ Thousand): 2012-2016
  • 12.) AstraZeneca's Small Molecule Antibiotic Products
  • 13.) Merck Revenue by Segment and Products ($ Million): 2016
  • 14) Pfizer Anti-Infective U.S. and Non-U.S. Sales by Product ($ Million): 2013-2020
  • 15.) Classes of Antibiotics by Type and Generic, Brand, Target, MOA, Formulation, AE

FIGURES

  • 1.) Living Organism Taxonomy
  • 2.) Taxonomy of E. coli
  • 3.) Gram Staining and Cell Wall Composition
  • 4.) Bacteriostatic vs. Bactericidal Antibiotics
  • 5.) Time-Dependent vs. Concentration-Dependent Bactericidal Effects
  • 6.) Antibiotic Mechanisms of Action
  • 7.) Publications Citing Antibiotic Resistance (Number): 1987-2015
  • 8.) Antibiotic Mechanisms of Resistance
  • 9.) Costs of the Five Most Common Hospital-Acquired Infections (HAIs) in the U.S. ($ Billion)
  • 10.) Bacterial Infections by Pathogen Species, by CDC Threat Level (Urgent, Serious, Concerning), by Infections/Year (Number), by Drug-Resistant Infections (Number), by Lethal Infections (Number), by MDR Infections (Number), by G+/G-
  • 11.) Percentage of Staphylococcus Aureus Isolates That Are Methicillin Resistant (MRSA) by Country: 2011-2014
  • 12.) Percentage of Carbapenem-Resistant Klebsiella Pneumoniae by Country: 2011-2014
  • 13.) Percentage of Extended-Spectrum Beta-Lactamase Producing Escherichia Coli by Country: 2011-2014
  • 14.) Spread of New Delhi Metallo-Beta-Lactamase-1: First Detection
  • 15.) Different Approaches to Discover New Antibiotics
  • 16.). Examples of Rediscovered Antibiotics
  • 17.) Approved or Late-Stage Clinical Antibiotics That Do Not Obey Drug-Like Rules for Oral Availability
  • 18.) Approved or Late-Stage Clinical Antibiotics with Undesirable Chemical Functional Groups
  • 19.) The CO-ADD Screening Workflow
  • 20.) Target-Based Antibiotics
  • 21.) Typical Antibiotic Drug Development Pathway
  • 22.) Top Antibiotic Resistance Threats Categorized by Level of Concern
  • 23.) New Classes of Antibiotics Discovered by Decade (Number): 1890s-2010s
  • 24.) Generations of Approved Antibiotics
  • 25.) Antibiotic New Molecular Entity Drugs Launched Worldwide (Number): 1980-2015
  • 26.) Past and Forecast Performance of Six Recently Launched Antibiotic Drugs ($ Million): 2014-2022
  • 27.) M&A and Pharma R&D Departure for the Antibiotic Space (Deal Count Number): 1995-2015
  • 28.) Key Antibiotic Initiatives: 2010-2014
  • 29.) U.S. Antibiotic Initiatives and Their Value Chain Targets
  • 30.) European Antibiotic Initiatives and Their Value Chain Targets
  • 31.) Other Antibiotic Initiatives and Their Value Chain Targets
  • 32.) U.S. Venture Capital Raised for Infectious Disease Companies by Novel R&D and Drug Improvement R&D ($ Million, Number of Companies Funded): 2007-2016
  • 33.) Biotech M&A Deals by Therapeutic Area (%): 2013-2015
  • 34.) Developers of Clinical Stage Antibiotics by Type (%): 2016
  • 35.) Venture Capital Antibiotic Startup Investments: 2016
  • 36.) Big Pharma Renewed Interest in Antibiotics: 2016
  • 37.) Product Launches: New Antibiotics vs. Other Brands ($ Million): Two years Post-Launch
  • 38.) Global Antibiotic Consumption by Class (Standard Units): 2000-2010
  • 39.). Antibiotics Consumption Per Person and Growth Rate of Antibiotic Drug Consumption (Standard Units): 2000-2010
  • 40.) Antibiotics Consumption by Class in the U.S., France, Germany, China, India, UK (Standard Units): 2000-2010
  • 41.) Peak Month for Antibiotic Consumption and Correlation Between Consumption and Its 12 Month Harmonic: 2000-2010
  • 42.) U. S. Hospital Discharges for Pneumonia (Number): 1993-2011
  • 43.) Macrolide Market Opportunity: 2017
  • 44.) CABP Antibiotic Retail RXs by Class, Number and Brand: 2016
  • 45.) Small Group Writes a Disproportionate Share of AZ and LEVO CABP Prescriptions
  • 46.) 80,000 Prescribers are Responsible for 60% of TRx Volume
  • 47.) Cumulative Sales of Selected IV Antibiotics Post Launch ($ Million
  • 48.) Global Antibiotic Supply Chain
  • 49.) China and India Antibiotic Supply Chain
  • 50.) Zhuhai United Laboratories, NCPC, Shandong Lukang, CPSC Zhongnuo, Harbin Pharmaceutical Supply Chains
  • 51.) Aurobindo Supply Chain
  • 52.) Orchid Pharmaceuticals and Mylan Supply Chains
  • 53.) Achaogen Product Offering
  • 54.) Plazomicin Trials
  • 55.) Achaogen Products Pipeline
  • 56.) Cempra Portfolio
  • 57.) Solithromycin Range of Indications
  • 58.) Binding of Lefamulin to the PTC
  • 59.) Nabriva Product Candidates and the Status of Development.
  • 60.) Otonomy Product and Product Candidate Pipeline
  • 61.) OTIVIDEX Commercial Opportunity in U.S.
  • 62.) OTIPRIO Commercial Opportunity in U.S.
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