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市場調査レポート

世界の生物薬剤およびバイオシミラー市場

Biologics and Biosimilars World Markets

発行 TriMark Publications 商品コード 278631
出版日 ページ情報 英文 403 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=102.12円で換算しております。
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世界の生物薬剤およびバイオシミラー市場 Biologics and Biosimilars World Markets
出版日: 2013年08月01日 ページ情報: 英文 403 Pages
概要

当レポートでは、世界の生物薬剤およびバイオシミラー市場について調査し、医薬品産業の概要、ジェネリック医薬品市場の概要、生物製剤・バイオシミラー市場の動向、規制動向、課題、機会、主要企業、主要薬剤、パイプライン動向および今後の収益予測などを提供しており、概略下記の内容でお届けいたします。

第1章 概要

第2章 医薬品産業:概要

  • 世界の製薬・バイオテクノロジー企業によるR&D支出
  • FDAの新薬承認
  • 特許失効の影響
  • GDP成長の下落に対する医薬品成長の免疫
  • 先進市場における医薬品の最小年間成長率
  • 大手医薬品企業の営業利益率の低下
  • 世界の医薬品企業トップ10
  • 医薬品企業トップ10:売上収益別
  • 世界の処方薬・OTC売上:治療分野別
  • 抗がん剤売上のトップ企業
  • 糖尿病治療薬市場のトップ企業
  • リウマチ治療薬市場のトップ10企業
  • ワクチン企業トップ10と世界の売上
  • 抗ウィルス薬企業のトップ10
  • 世界の医薬品ブランドトップ50
  • M&A取引
  • 世界の医薬品市場
  • 米国、欧州および日本における地域別の処方薬売上
  • 世界の処方薬売上

第3章 ブランド医薬品:概要

  • ブランド薬の産みの苦しみと寿命
  • ブランド薬の主な特許失効
  • 世界のブランド薬市場
  • R&Dパイプラインの増加

第4章 ジェネリック医薬品:概要

  • ジェネリック医薬品の生物学的同等性
  • 世界のジェネリック医薬品市場
  • ジェネリック医薬品企業の営業利益率
  • ジェネリック医薬品のアウトソースメーカー
  • 国際市場におけるジェネリック医薬品の活用
  • 世界のジェネリック医薬品売上:企業別

第5章 生物製剤

  • 生物製剤の規制
  • 生物製剤の複雑さ
  • 世界のバイオ医薬品製造の集中
  • 世界市場で入手可能な生物製剤の数
  • 生物製剤のシェア:国/地域別
  • 生物製剤の成長率:地域別
  • 生物製剤の生産能力
  • 生物製剤市場:セグメント別
  • 生物製剤の特許失効
  • 生物製剤の主要企業
  • バイオ医薬品企業のアウトソーシング
  • 生物製剤トップ20:売上別
  • ベストセラー生物製剤:クラス別
  • 生物製剤:過去7年間の市場動向
  • 世界および米国におけるベストセラー生物製剤の売上
  • 米国のバイオテクノロジー情勢
  • 欧州における生物製剤
  • 血友病における生物製剤

第6章 バイオシミラー

  • 国によって異なる生物製剤の名前
  • EUにおける生物製剤の承認経路
  • 議論を引き起こす生物製剤問題
  • バイオシミラーの機会
  • バイオシミラー発売の課題
  • バイオシミラーの生産と市場アクセス
  • 国によるバイオシミラー選定
  • バイオシミラー参入の高い障害
  • 世界におけるバイオシミラー間の競合
  • バイオシミラー製品の定義と解説
  • FDAのバイオシミラー向けガイドライン
  • 市場成長促進因子
  • バイオシミラーの中心的な治療領域
  • バイオシミラー部門における競合情勢
  • 3地域におけるバイオシミラーの機会
  • バイオシミラーの経験
  • バイオシミラーの開発
  • バイオシミラー市場の主要企業
  • 2020年以前に特許失効を迎える生物製剤の数
  • モノクロナール抗体:バイオシミラー開発の主な重点領域
  • 世界のバイオシミラーリーダー企業
  • バイオシミラーをリードする市場
  • バイオシミラーの機会
  • バイオシミラーのパイプライン:クラス別
  • 世界のバイオシミラー市場
  • 米国におけるバイオシミラー規制
  • 米国のバイオシミラー市場
  • バイオシミラーパイプラインの地域分布
  • 米国における将来のバイオシミラー市場
  • 欧州・日本におけるバイオシミラー市場
  • 収益予測:バイオシミラーインシュリン
  • 収益予測:バイオシミラー HGH 217
  • 収益予測:バイオシミラーIFNアルファ
  • 収益予測:バイオシミラーIFNベータIa
  • 収益予測:バイオシミラーフィルグラスチム
  • 収益予測:バイオシミラーエポエチンアルファ
  • 欧州におけるバイオシミラーの普及
  • 中国におけるバイオシミラー
  • インドのバイオシミラー市場
  • バイオシミラー韓国におけるバイオシミラーパイプライン:Celtrion
  • バイオシミラー分野における契約
  • バイオシミラー産業における取引
  • 注目のバイオシミラートップ10

第7章 企業プロファイル(40社)

付録

図表

目次
Product Code: TMRBIOL13-0801

Abstract

Description

Biologics are complex molecules manufactured through cell culture recombinant DNA technology. Biologics additionally comprise recombinant insulin, growth hormone and monoclonal antibodies for treating conditions such as cancer and autoimmunity. Also known as follow-on biologics or subsequent entry biologics (SEBs), biosimilars are to biologics what generics are to branded drugs; they lower healthcare expenditures. This TriMark Publications report describes the emergence of biologics and biosimilars and their potential role in shaping the future of the global healthcare industry. The study analyzes the changing dynamics of the pharmaceutical market and provides insight into the regulatory pathways for branded pharmaceuticals and biologics, patent expirations, business strategies, clinical trials and drug applications. Key biologics and biosimilars are covered, including Humira (Adalimumab), Remicade (Infliximab), Lantus (Insulin Glargine), Levemir (Insulin Detemir), Privigen (Immune Globulin Intravenous), Aranesp (Darbepoetin Alfa), Enbrel (Etanercept), Herceptin (Trastuzumab) and Remicade (Infliximab). Moreover, this report examines companies that are actively developing and marketing biologics and biosimilars in the world. Detailed tables and charts with sales forecasts and marketshare data are also included.

Table of Contents

1. Overview

  • 1.1 Statement of This Report
  • 1.2 About This Report
  • 1.3 Scope of the Report
  • 1.4 Objectives
  • 1.5 Methodology
  • 1.6 Executive Summary

2. Pharmaceutical Industry: An Overview

  • 2.1 Global R&D Spending by Pharma and Biotech Companies
    • 2.1.1 Top 20 Companies in R&D Spending
    • 2.1.2 Top 20 Most Valuable Pharmaceutical R&D projects
    • 2.1.3 Most Valuable R&D Projects Ranked by Net Present Value
  • 2.2 FDA New Drug Approvals
    • 2.2.1 Top Ten NMEs
  • 2.3 Impact of Patent Expirations
  • 2.4 Immunity of Pharmaceutical Growth against Drop in GDP Growth
  • 2.5 Minimal Annual Growth Rates of Pharmaceuticals in Developed Markets
  • 2.6 Falling Operating Profit Rate for Big Pharma
  • 2.7 Top Ten Global Pharmaceutical Firms
  • 2.6 Top Ten Pharmaceuticals by Sales Revenue
  • 2.7 Worldwide Prescription and OTC Sales by Therapy Area in 2018
  • 2.8 Top Companies in Oncology Sales
    • 2.8.1 Top Five Oncology Products
  • 2.9 Top Companies in Anti-Diabetes Market
    • 2.9.1 Top Five Anti-Diabetes Products
  • 2.10 Top Ten Companies in Anti-Rheumatics Market
    • 2.10.1 Top Ten Anti-Rheumatics Products
  • 2.11 Top Ten Vaccine Companies and Global Sales
    • 2.11.1 Top Five Vaccine Products
  • 2.12 Top Ten Anti-Viral Companies
    • 2.12.1 Top Five Anti-Viral Products
  • 2.13 Top 50 Global Pharmaceutical Brands in 2018
  • 2.14 M&A Transactions in 2012
  • 2.15 Global Pharmaceutical Market
    • 2.15.1 Global Pharmaceutical Sales by Region
    • 2.15.2 North American Pharmaceutical Market
      • 2.15.2.1 U.S. Prescription Drug Sales by Company
      • 2.15.2.2 Top 50 Pharmaceutical Products in the U.S.
      • 2.15.2.3 Top 50 Products in the U.S. in 2018
    • 2.15.3 Pharmaceutical Market in Europe
      • 2.15.3.1 European Prescription Drug Sales by Company
    • 2.15.4 Pharmaceutical Market in Asia/Pacific
      • 2.15.4.1 Prescription Drug Sales in Japan by Company
    • 2.15.5 Pharmaceutical Market in Latin America
    • 2.15.6 Pharmaceutical Market in Africa
    • 2.15.7 Pharmaceutical Market in the Middle East
  • 2.16 Regional Prescription Drug Sales in the U.S., Europe and Japan
  • 2.17 Global Prescription Drug Sales

3. Brand Name Pharmaceuticals: A Brief Overview

  • 3.1 Birth Pangs and Life Span of Branded Drugs
  • 3.2 Major Patent Expiries of Branded Drugs
  • 3.3 Global Market for Branded Drugs
  • 3.4 Increasing R & D Pipeline
    • 3.4.1 The 2012 R & D Pipeline by Phase
    • 3.4.2 Top Companies by Pipeline Size
    • 3.4.3 Total Number of Companies with Active R&D
    • 3.4.4 Global Distribution of Companies Active in Pharma R&D
    • 3.4.5 Top Therapy Areas in R & D
    • 3.4.5.1 Top 25 Individual Diseases in the R & D Pipeline
    • 3.4.6 Top 20 Mechanism of Action in R & D Pipeline
    • 3.4.7 Top 25 Drug Protein Targets

4. Generic Drugs: A Brief Overview

  • 4.1 Bioequivalence of Generics
  • 4.2 Global Market for Generics
  • 4.3 Operating Profit Rate for Generic Companies
  • 4.4 Outsourced Manufacture of Generics
  • 4.5 Generic Utilization in International Markets
  • 4.6 Global Generic Sales by Company

5. Biologics

  • 5.1 Regulations for Biologics
  • 5.2 Complexity of Biologics
  • 5.3 Concentration of Global Biopharmaceutical Manufacturing
  • 5.4 Number of Biologics Available in the Global Market
  • 5.5 Share of Biologics by Country/Region
  • 5.6 Rate of Growth for Biologics by Region
    • 5.6.1 Growth Rates of APIs and Biologics Compared
  • 5.7 Manufacturing Capacity of Biologics
  • 5.8 Biologics Market by Segment
  • 5.9 Patent Expiry for Biologic Drugs
    • 5.9.1 India's Opportunity from Biologic Patent Expirations
  • 5.10 Major Players in Biologics
  • 5.11 Biopharm Outsourcing
  • 5.12 Top 20 Biologics by Sales
    • 5.12.1 Roche's Biologics Arsenal
    • 5.12.2 Johnson & Johnson's Biologics Arsenal
    • 5.12.3 Lonza in Biologics
  • 5.13 The Best Selling Biologics by Class
  • 5.14 Biologic Drugs: Market Trends in the Past Seven Years
    • 5.14.1 Global Market for Biologics
  • 5.15 Global and U.S. Sales of Blockbuster Biologics
    • 5.15.1 Global Market for Humira
      • 5.15.1.1 Humira (adalimumab) Pen's Market by Geography
      • 5.15.1.2 U.S. Sales of Humira
      • 5.15.1.3 The Leader among Biologics
    • 5.15.2 Global Market for Remicade
      • 5.15.2.1 Remicade's Market by Geography
      • 5.15.2.2 U.S. Sales of Remicade
    • 5.15.3 Global Market for Enbrel
      • 5.15.3.1 Enbrel's Market by Geography
      • 5.15.3.2 U.S. Sales of Enbrel
    • 5.15.4 Global Market for Symponi
    • 5.15.5 Global Market for Tysarbi
      • 5.15.5.1 U.S. Market for Tysarbi
    • 5.15.6 Global Market for Lantus
      • 5.15.6.1 Lantus' Market by Geography
      • 5.15.6.2 U.S. Market for Lantus
    • 5.15.7 Global Market for NovoRapid
      • 5.15.7.1 Market for Novolog/Novorapid by Geography
      • 5.15.7.2 U.S. Market for NovoRapid
    • 5.15.8 Global Market for Victoza
    • 5.15.9 Global Market for Levemir
      • 5.15.9.1 U.S. Market for Levemir
    • 5.15.10 Global Market for Humalog
      • 5.15.10.1 Market for Humalog by Geography
    • 5.15.11 Global Market for Neulasta
      • 5.15.11.1 Neulasta's Market by Geography
      • 5.15.11.2 U.S. Market for Neulasta
    • 5.15.12 Global Market for Privigen
    • 5.15.13 Global Market for Perjeta
    • 5.15.14 Global Market for Xgeva/Prolia
    • 5.15.15 Global Market for Soliris
      • 5.15.15.1 U.S. Market for Soliris
    • 5.15.16 Global Market for Botox
    • 5.15.17 Global Market for Lucentis
      • 5.15.17.1 U.S. Market for Lucentis
    • 5.15.18 Global Market for Eylea
    • 5.15.19 Global Market for Avastin
      • 5.15.19.1 U.S. Market for Avastin
    • 5.15.20 Global Market for Rituxan
      • 5.15.20.1 Rituxan's Market by Geography
      • 5.15.20.2 U.S. Market for Rituxan
    • 5.15.21 Global Market for Revlimid
    • 5.15.22 Global Market for Herceptin
      • 5.15.22.1 Herceptin's Market by Geography
      • 5.15.21.2 U.S. Market for Herceptin
    • 5.15.22 Global Market for Prenvar 13
      • 5.15.22.1 U.S. Market for Prenvar 13
    • 5.15.23 Global Market for Gardasil
    • 5.15.24 Global Market for Fluzone/Varigrip
    • 5.15.25 Global Market for Varivax
    • 5.15.26 Global Market for Stelara
      • 5.15.26.1 U.S. Market for Stelara
    • 5.15.27 Global Market for Actemra
    • 5.15.28 Global Market for Gammagard Liquid
  • 5.16 The U.S. Biotech Landscape
    • 5.16.1 Top U.S. Biotech Companies
      • 5.16.1.1 Amgen
      • 5.16.1.2 Gilead Sciences
      • 5.16.1.3 Biogen Idec, Inc.
      • 5.16.1.4 Celgene Corporation
      • 5.16.1.5 Genzyme (Sanofi)
      • 5.16.1.6 Life Technologies Corporation
      • 5.16.1.7 Cephalon, Inc/Teva Pharmaceutical Industries Ltd.
      • 5.16.1.8 Alexion Pharmaceuticals, Inc.
      • 5.16.1.9 Cubist Pharmaceuticals, Inc.
      • 5.16.1.10 United Therapeutics Corporation
    • 5.16.2 Overall Performance of the U.S. Biotech Companies
    • 5.16.3 R & D Spending by Biotech Companies in the U.S.
    • 5.16.4 U.S. Market for Biologic Drugs
    • 5.16.5 The Leading Biologic Drug Classes in Terms of U.S. Sales
      • 5.16.5.1 Top Selling Biologic Drugs in the U.S.
      • 5.16.5.2 U.S. Sales of Biologics by Manufacturer
    • 5.16.6 U.S. Sales of mAbs
    • 5.16.7 U.S. Sales of Recombinant Hormones
    • 5.16.8 U.S. Sales of Blood Cell Growth Factors
    • 5.16.9 U.S. Market for Cytokines
    • 5.16.10 U.S. Sales of Blood Factors
    • 5.16.11 U.S. Sales of Therapeutic Enzymes
    • 5.16.12 U.S. Sales of Recombinant Vaccines
    • 5.16.13 U.S. Sales of Recombinant Anticoagulants
    • 5.16.14 Costs of Commonly Used Biologicals in the U.S.
    • 5.16.15 Biologics Used for Treating Rheumatoid Arthritis
      • 5.16.15.1 Cost Comparison of Arthritis Biologics
  • 5.17 Biologics in Europe
    • 5.17.1 Uptake of Biologics in Europe by Drug Type
    • 5.17.2 European Market for mAbs
  • 5.18 Biologics in Hemophilia
    • 5.18.1 Marker Leaders in Hemophilia
    • 5.18.2 Hemophilia A
    • 5.18.3 Hemophilia B
    • 5.18.4 Inhibitors

6. Biosimilars

  • 6.1 Different Names in Different Countries for Biologics
  • 6.2 E.U. Approval Pathway for Biosimilars
  • 6.3 Contentious Issues in Biosimilars
  • 6.4 Biosimilars Opportunity
  • 6.5 Challenges in Biosimilar Introduction
  • 6.6 Production and Market Access of Biosimilars
  • 6.7 Country Selection for Biosimilars
  • 6.8 High Barriers to the Entry of Biosimilars
  • 6.9 Global Competition among Biosimilars
  • 6.10 Definitions and Interpretations of Biosimilar Products
    • 6.10.1 Regulatory Requirements
      • 6.10.1.1 World Health Organization (WHO)
      • 6.10.1.2 Key Principles and Basic Concept
    • 6.10.2 Reference Biotherapeutic Product
      • 6.10.2.1 Quality
      • 6.10.2.2 Non-Clinical and Clinical Studies
    • 6.10.3 E.U.
      • 6.10.3.1 Key Principles and Basic Concept
      • 6.10.3.2 Reference Biotherapeutic Product
      • 6.10.3.3 Quality 170
      • 6.10.3.4 Non-Clinical and Clinical Evaluation
      • 6.10.3.5 Product Class-Specific Guidelines
    • 6.10.4 U.S.
    • 6.10.5 Canada
    • 6.10.6 Japan
    • 6.10.7 Korea
  • 6.11 FDA Guidelines for Biosimilars
  • 6.12 Market Drivers
    • 6.12.1 Cost Pressures
  • 6.13 Core Therapy Areas for Biosimilars
  • 6.14 Competitive Landscape in Biosimilar Sector
  • 6.15 Opportunities for Biosimilars in Three Geographies
    • 6.15.1 Opportunities for Biosimilars in the U.S.
    • 6.15.2 European Opportunities for Biosimilars
    • 6.15.3 Opportunities for Biosimilars in Emerging Markets
  • 6.16 Biosimilar Experience
  • 6.17 Development of Biosimilars
    • 6.17.1 Current and Future Trends in Biosimilar Development
  • 6.18 Top Players in Biosimilars Market
    • 6.18.1 Other Key Players in Biosimilars Market
  • 6.19 Number of Biologics Patent Expiries Prior to 2020
    • 6.19.1 Biologics Patent Expiries by Region
  • 6.20 Monoclonal Antibodies: The Key Focus Area for Biosimilars Development
    • 6.20.1 Biosimilar mAbs in Pipeline
    • 6.20.2 Disease Indications for Biosimilar mAbs
  • 6.21 Global Leaders in Biosimilars
  • 6.22 Market Leading Biosimilars
  • 6.23 Biosimilar Opportunities: Only for the Heartiest Biotech Firms
  • 6.24 Biosimilars Pipeline by Class
  • 6.25 Global Biosimilars Market
    • 6.25.1 Estimated Value and Growth Rates for Biosimilars by Type
    • 6.25.2 Market Leading Biosimilars in 2015
  • 6.26 Regulations for Biosimilars in the U.S.
    • 6.26.1 BPCIA and Guidance
    • 6.26.2 Scientific Considerations
    • 6.26.3 Quality Considerations
    • 6.26.4 Biosimilar User Fee Act
    • 6.26.5 12-Year Exclusivity Period
    • 6.26.6 Biosimilars Competitive Landscape in the U.S.
    • 6.26.7 Manufacturing Capabilities
    • 6.26.8 Clinical Trial Experience
    • 6.26.9 Market Experience
    • 6.26.10 Likely Early Entrants
    • 6.26.11 Recombinant Protein Competition
    • 6.26.12 mAbs Competition
  • 6.27 U.S. Biosimilars Market
    • 6.27.1 HGH Biosimilars in the U.S. Market
    • 6.27.2 Cost Benefits from Biosimilars for U.S. Healthcare
    • 6.27.3 Development Pipeline and Market Evolution of Biosimilars in the U.S.
      • 6.27.3.1 Target Reference Products 203
      • 6.27.3.2 Launchable Dates for Biosimilars in the U.S.
      • 6.27.3.3 Number of Biosimilar Products in the Pipeline
  • 6.28 Geographic Distribution of Biosimilars Pipeline
    • 6.28.1 Developers of Biosimilars
  • 6.29 Future of U.S. Biosimilars Market
    • 6.29.1 Future Pricing Models
    • 6.29.2 Future Price Reduction and the Profit Margin
  • 6.30 Biosimilars Market in Europe and Japan
    • 6.30.1 The Instant Growth of Biosimilars in Europe
    • 6.30.2 Biosimilar mAbs on the Horizon in Europe
    • 6.30.3 Biosimilars Approved in the E.U
    • 6.30.4 Utilization of G-CSF in Europe
  • 6.31 Revenue Forecast for Biosimilar Insulins
  • 6.32 Revenue Forecast for Biosimilar HGH 217
  • 6.33 Revenue Forecast for Biosimilar IFN Alpha
  • 6.34 Revenue Forecast for Biosimilar IFN Beta Ia
  • 6.35 Revenue Forecast for Biosimilar Filgrastim
  • 6.36 Revenue Forecast for Biosimilar Epoetin Alpha
  • 6.37 Uptake of Biosimilars in Europe
  • 6.38 Biosimilars in China
    • 6.38.1 Biosimilars Sales in China
  • 6.39 Indian Market for Biosimilars
    • 6.39.1 Domestic Biosimilar Developers in India
  • 6.40 Biosimilar Pipeline of Celtrion in Korea
  • 6.41 Deals in Biosimilar Space
    • 6.41.1 Technologies
    • 6.41.2 Manufacturing Agreements
    • 6.41.3 Clinical Development
    • 6.41.4 Licensing Agreements
  • 6.42 Transactions in Biosimilars Industry
    • 6.42.1 Biosimilars Market: Opportunities and Challenges
    • 6.42.2 Recent Transactions in Biosimilars Industry
  • 6.43 Top Ten Biosimilar Drugs to Watch
    • 6.43.1 Aranesp (darbepoetin alfa)
    • 6.43.2 Enbrel (etanercept)
    • 6.43.3 Epogen/Procrit/Eprex/Erypo (epoetin alfa)
    • 6.43.4 Genotropin (somatropin)
    • 6.43.5 Herceptin (trastuzumab)
    • 6.43.6 Humira (adalimumab)
    • 6.43.7 Neulasta (pegfilgrastim)
    • 6.43.8 Neupogen (filgrastim)
    • 6.43.9 Remicade (infliximab)
    • 6.43.10 Rituxan/MabThera (rituximab)

7. Company Profiles

  • 7.1 3Bio, Inc.
    • 7.1.1 EPIAO
    • 7.1.2 TPIAO
    • 7.1.3 INTEFEN
    • 7.1.4 INLEUSIN
    • 7.1.5 IV Iron Sucrose
  • 7.2 Abbott Laboratories
  • 7.3 AbbVie, Inc.
    • 7.3.1 Products
  • 7.4 Actelion Ltd.
  • 7.5 Amgen, Inc.
    • 7.5.1 Neulasta (filgrastim)
    • 7.5.2 Enbrel (etanercept)
    • 7.5.3 Aranesp (darbepoetin alfa)
    • 7.5.4 Epogen (epoetin alfa)
    • 7.5.5 Sensipar/Mimpara (cinacalcet)
    • 7.5.6 Vectibix (panitumumab)
    • 7.5.7 Nplate (romiplostim)
    • 7.5.8 Prolia/Xgeva (denosumab)
  • 7.6 Amoytop Biotech Co., Ltd
    • 7.6.1 Molgramostim (rhGM-CSF)
    • 7.6.2 Filgrastim (rh G-CSF)
    • 7.6.3 Oprelvekin (rhIL-11)
  • 7.7 Anhui Anke Biotechnology (Group) Co., Ltd.
    • 7.7.1 Alteferon alpha 2b Injection
    • 7.7.2 Ansomone
    • 7.7.3 Anteferon alpha 2b Cream
    • 7.7.4 Anteferon alpha 2b Eyedrop
  • 7.8 Apotex, Inc.
  • 7.9 Astellas Pharma, Inc.
  • 7.10 AstraZeneca
    • 7.10.1 AstraZeneca's R&D Portfolio
    • 7.10.2 Patent Expiries of AstraZenecas Products
  • 7.11 Bayer AG
  • 7.12 Beijing Four Rings Biopharmaceuticals
    • 7.12.1 Products
  • 7.13 Bharat Serums and Vaccines Limited
  • 7.14 Biocon Ltd.
  • 7.15 Biogen Idec, Inc.
  • 7.16 Bioton SA
  • 7.17 Boehringer Ingelheim Pharmaceuticals, Inc.
  • 7.18 Bristol-Myers Squibb, Co.
  • 7.19 Celgene Corporation
  • 7.20 Celltrion, Inc.
    • 7.20.1 Technology Overview
    • 7.20.2 Biosimilars Development
    • 7.20.3 Contract Manufacturing
  • 7.21 Cipla Ltd.
    • 7.21.1 Cipla's Prescription Product Category
  • 7.22 Dr. Reddy's Laboratories Ltd.
  • 7.23 Elan Corporation, PLC
    • 7.23.1 Tysarbi
  • 7.24 Eli Lilly & Co.
  • 7.25 Gideon Richter
  • 7.26 Gilead Sciences, Inc.
  • 7.27 GlaxoSmithKline PLC
  • 7.28 Hospira, Inc.
  • 7.29 Intas Pharmaceuticals Limited
  • 7.30 Johnson & Johnson
  • 7.31 Merck & Co., Inc.
  • 7.32 Mylan, Inc.
    • 7.32.1 Mylan's Generics
    • 7.32.2 Mylan's Active Pharmaceutical Ingredients
    • 7.32.3 Mylan's Specialty
    • 7.32.4 Mylan's Anti-Retroviral Franchise
  • 7.33 Novartis AG
  • 7.34 Pfizer, Inc.
  • 7.35 Roche Holdings AG
  • 7.36 Sandoz International GmbH
  • 7.37 Sanofi
  • 7.38 Stada Arzneimittel Aktiengesellschaft
  • 7.39 Teva Pharmaceutical Industries Limited
  • 7.40 Watson Pharmaceuticals, Inc.

APPENDIX

  • Appendix 1: Biologic Medicines by Development Phase
  • Appendix 2: Declining Medicine Use in the U.S.
  • Appendix 2.1: Changes in Utilization
  • Appendix 2.2: Healthcare Costs and Spending on Medicines
  • Appendix 2.3: Total Spending on Medicines
  • Appendix 2.4: Transformations in Disease Treatment
  • Appendix 2.5: Key Breakthrough Therapies Approved in 2012
  • Appendix 2.5.1: Cystic Fibrosis: ivacaftor (Kalydeco)
  • Appendix 2.5.2: Rheumatoid Arthritis: tofacitinib (Xeljanz)
  • Appendix 2.5.3: Basal-cell carcinoma: vismodegib (Erivedge)
  • Appendix 2.5.4: Irritable bowel syndrome with constipation: linaclotide (Linzess)
  • Appendix 2.5.5: HIV: emtricitabine and tenofovir disoproxil fumarate (Truvada)
  • Appendix 2.5.6: Combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate
  • Appendix 2.6: Spending in Major Therapies
  • Appendix 2.6.1: Oncology Spending (25.9 Billion) by Area, 2012
  • Appendix 2.6.1.1: U.S. Market for Oncology Drugs
  • Appendix 2.6.1.2: U.S. Market for Rituxan
  • Appendix 2.6.1.3: U.S. Market for Avastin
  • Appendix 2.7: Mental Health Spending by Area
  • Appendix 2.7.1: U.S. Market for Mental Health Drugs
  • Appendix 2.7.2: U.S. Market for Cymbalta
  • Appendix 2.7.3: U.S. Market for Abilify
  • Appendix 2.8: Respiratory Spending by Area
  • Appendix 2.8.1: U.S. Market for Respiratory Drugs
  • Appendix 2.8.2: U.S. Market for Adavir
  • Appendix 2.8.3: U.S. Market for Singulair
  • Appendix 2.8.4: U.S. Market for Spiriva
  • Appendix 2.9: Antidiabetes Spending by Area
  • Appendix 2.9.1: U.S. Market for Antidiabetics
  • Appendix 2.9.2: U.S. Market for Januvia
  • Appendix 2.9.3: U.S. Market for Lantus
  • Appendix 2.9.4: U.S. Market for Lantus SoloSTAR
  • Appendix 2.10: Pain Spending by Area
  • Appendix 2.10.1: U.S. Market for Pain Management Drugs
  • Appendix 2.11: U.S. Market for Medicines Used in Nervous System Disorders
  • Appendix 2.11.1: U.S. Market for Oxycontin
  • Appendix 2.11.2: U.S. Market for Lyrica
  • Appendix 2.11.3: U.S. Market for Copaxone
  • Appendix 2.12: U.S. Market for Lipid Regulators
  • Appendix 2.12.1: U.S. Market for Crestor
  • Appendix 2.13: U.S. Market for Autoimmune Drugs
  • Appendix 2.13.1: U.S. Market for Humira
  • Appendix 2.13.2: U.S. Market for Enbrel
  • Appendix 2.13.3: U.S. Market for Remicade
  • Appendix 2.14: U.S. Market for Medicines Used for Multiple Sclerosis
  • Appendix 2.15: U.S. Market for Antiulcerants
  • Appendix 2.15.1: U.S. Market for Nexium
  • Appendix 2.16: U.S. Market for Neulasta
  • Appendix 2.17: U.S. Market for Epogen
  • Appendix 2.18: U.S. Market for Platelet Aggregation Inhibitors
  • Appendix 2.18.1: U.S. Market for Plavix
  • Appendix 2.19: U.S. Market for HIV Antivirals
  • Appendix 2.19.1: U.S. Market for Atripla
  • Appendix 2.19.2: U.S. Market for Truvada
  • Appendix 2.20: U.S. Market for Antibacterials
  • Appendix 2.21: U.S. Market for Antihypertensives
  • Appendix 2.21.1: U.S. Market for Diovan
  • Appendix 2.22: U.S. Market for ADHD
  • Appendix 2.23: U.S. Market for Vaccines (Pure, Comb and Others)
  • Appendix 2.24: U.S. Market for Systemic Hormonal Contraceptives
  • Appendix 2.25: Number of Treated Patients in Selected Therapies in the U.S.
  • Appendix 2.26: Top Therapeutic Classes of Drugs Prescribed in the U.S.
  • Appendix 2.27: Top Medicines Prescribed in the U.S.
  • Appendix 3: Pharma Deals in 2012
  • Appendix 4: Pharma Outsourcing in Asia
  • Appendix 4.1: Cluster One: Pharma Revenue Constraints
  • Appendix 4.2: Cluster Two: Asia Growth Forces
  • Appendix 4.3: Cluster Three: East/West Convergence/Divergence Trends
  • Appendix 4.4: Cluster Four: Technological/Business Model Forces
  • Appendix 4.5: Implications of the Four Clusters for Asia Outsourcing
  • Appendix 4.5.1: Rapid Expansion of Clinical Trials in Asia
  • Appendix 4.5.2: Manufacturing Scales
  • Appendix 4.5.3: Risk and Opportunity Overview
  • Appendix 4.5.4: Cost Ranking of Asian Territories
  • Appendix 4.5.5: Market Opportunity Ranking
  • Appendix 4.6: Outsourcing Hot Spots in Asia
  • Appendix 4.6.1: China
  • Appendix 4.6.2: India
  • Appendix 4.6.3: Singapore
  • Appendix 5: The Changing Payment Landscape for the U.S. Pharmaceutical Industry
  • Appendix 5.1: The Impetus for Defining Value
  • Appendix 5.1.1: Force I
  • Appendix 5.1.2: Force II
  • Appendix 5.1.3: Force III
  • Appendix 5.1.4: Force IV
  • Appendix 5.1.5: Force V
  • Appendix 5.2: The New Arbiters of Value
  • Appendix 5.2.1: Prescribers Looking for Value
  • Appendix 5.2.2: More Investment in Comparative Effectiveness Research
  • Appendix 5.2.3: Unleashing of Imprisoned Value
  • Appendix 5.2.4: Role of Companion Diagnostics
  • Appendix 5.2.5: Outcomes-Dependent Contracts
  • Appendix 5.2.6: Data-Sharing Agreements
  • Appendix 5.2.7: Patient-Reported Outcomes
  • Appendix 5.2.8: Evidence Needed to Secure Formulary Slots
  • Appendix 6: Medical Cost Trend in the U.S., 2013
  • Appendix 6.1: The Components of Medical Cost
  • Appendix 6.2: Leading Factors in Setting Insurance Premiums
  • Appendix 6.3: Factors Affecting 2013 Trend
  • Appendix 6.3.1: Medical Supply and Equipment Cost
  • Appendix 6.3.2: Newer Delivery Methods for Primary Care
  • Appendix 6.4: Uptick in Utilization and Expensive Advances
  • Appendix 6.4.1: Economic Utilization and Economic Growth
  • Appendix 6.4.2: Medical Advances Driving Growth
  • Appendix 6.4.3: The "New Normal"
  • Appendix 6.4.4: Current Practices by Employers
  • Appendix 6.4.4.1: Things to be considered by Employers
  • Appendix 6.5: Current Practices by Providers
  • Appendix 6.5.1: Things to be considered by Providers
  • Appendix 6.6: Current Practices by Hwealth Insurers
  • Appendix 6.6.1: Things to be considered by Health Insurers
  • Appendix 6.7: Current Practices by Pharmaceutical and Life Sciences
  • Appendix 6.7.1: Things to be considered by Pharmaceutical and Life Sciences
  • Appendix 7: Naming of Drug Molecules and Pharmaceutical Brands
  • Appendix 7.1: Names of a Drug
  • Appendix 7.1.1: Chemical Name
  • Appendix 7.1.2: Generic Name
  • Appendix 7.2: Brand Name
  • Appendix 7.2.1: Criteria for Brand Names
  • Appendix 7.3: Stories behind Some Blockbuster Molecules

INDEX OF FIGURES

  • Figure 2.1: Global R&D Spending by Pharma and Biotech Companies, 2005-2018 23
  • Figure 2.2: Worldwide Sales at Risk by Patent Expiration, 2004-2018 28
  • Figure 2.3: Immunity of Pharmaceutical Growth against Drop in GDP Growth 29
  • Figure 2.4: Falling Operating Profit Rate for Big Pharma 30
  • Figure 2.5: Global Pharmaceutical Market, 2012-2019 42
  • Figure 2.6: Global Pharmaceutical Sales by Region 43
  • Figure 2.7: North American Pharmaceutical Market, 2012-2019 44
  • Figure 2.8: European Pharmaceutical Market, 2012-2019 48
  • Figure 2.9: Pharmaceutical Market in Asia/Pacific, 2012-2019 51
  • Figure 2.10: Pharmaceutical Market in Latin America, 2012-2019 53
  • Figure 2.11: Pharmaceutical Market in Africa, 2012-2019 54
  • Figure 2.12: Pharmaceutical Market in the Middle East, 2012-2019 55
  • Figure 2.13: Worldwide Total Prescription Drug Sales, 2004-2018 56
  • Figure 3.1: The Long-Drawn R & D Process for Branded Drugs 58
  • Figure 3.2: Global Market for Branded Drugs, 2012-2019 59
  • Figure 3.3: R & D pipeline, 2001-2012 60
  • Figure 3.4: R & D Pipeline by Phase, 2007-2012 61
  • Figure 3.5: Total Number of Companies with Active R & D, 2000-2012 63
  • Figure 3.6: Global Distribution of Companies Active in Pharma R&D, 2012 64
  • Figure 4.1: Differences between Originals and Copies (Branded/Generics & Biologics/Biosimilars) 69
  • Figure 4.2: Global Market for Generics, 2012-2019 71
  • Figure 4.3: Operating Profit Rate for Top Six Generic Companies, 2006-2012 72
  • Figure 4.4: Outsourced Manufacturing of Generics by Region/Country 73
  • Figure 4.5: Generic Drug Use in International Markets 74
  • Figure 5.1: The Biologic Drug Development Process 76
  • Figure 5.2: Comparison of Small Molecule Drugs and Biologics 77
  • Figure 5.3: Concentration of Global Biopharmaceutical Manufacturing as of 2013 78
  • Figure 5.4: Share of Biologics Sales by Country/Region 79
  • Figure 5.5: Rate of Growth for Biologics by Region 80
  • Figure 5.6: Growth Rates (CAGR) of APIs and Biologics Compared 81
  • Figure 5.7: Global Installed Biopharmaceutical Manufacturing Capacity by Top Ten Companies 82
  • Figure 5.8: Biologics Market by Segment 83
  • Figure 5.9: Top Biologics Losing Patent Protection and Market Exclusivity Prior to 2018 84
  • Figure 5.10: Global Value and Number of Biologic Drugs Losing Patent Protection, 2010-2015 85
  • Figure 5.11: Top Ten Biopharmaceuticals Manufacturing Companies 85
  • Figure 5.12: Outsourcing Trends in Biological Production across All Cell-Based Platforms 86
  • Figure 5.13: The Largest Selling Biologics by Class, 2012 89
  • Figure 5.14: Global Biologic Drugs Market Trends, 2006-2012 90
  • Figure 5.15: Global Market for Biologics, 2010-2020 91
  • Figure 5.16: Global Market for Humira, 2012-2019 92
  • Figure 5.17: Humira Pen's Market by Geography 93
  • Figure 5.18: U.S. Market for Humira, 2012-2019 93
  • Figure 5.19: Global Market for Remicade, 2012-2019 95
  • Figure 5.20: Remicade's Market by Geography 96
  • Figure 5.21: U.S. Market for Remicade, 2012-2019 96
  • Figure 5.22: Global Market for Enbrel, 2012-2019 97
  • Figure 5.23: Enbrel's Market by Geography 98
  • Figure 5.24: U.S. Market for Enbrel, 2012-2019 98
  • Figure 5.25: Global Market for Simponi, 2012-2019 99
  • Figure 5.26: Global Market for Tysarbi, 2012-2019 100
  • Figure 5.27: U.S. Market for Tysabri, 2012-2019 101
  • Figure 5.28: Global Market for Lantus, 2012-2019 102
  • Figure 5.29: Lantus' Market Share by Geography 102
  • Figure 5.30: U.S. Market for Lantus, 2012-2019 103
  • Figure 5.31: Global Market for NovoRapid, 2012-2019 104
  • Figure 5.32: Market for Novolog/Novorapid by Geography 104
  • Figure 5.33: U.S. Market for NovoRapid, 2012-2019 105
  • Figure 5.34: Global Market for Victoza, 2012-2019 106
  • Figure 5.35: U.S. Market for Victoza, 2012-2019 106
  • Figure 5.36: Global Market for Levemir, 2012-2019 107
  • Figure 5.37: U.S. Market for Levemir, 2012-2019 108
  • Figure 5.38: Global Market for Humalog, 2012-2019 109
  • Figure 5.39: U.S. Market for Humalog, 2012-2019 109
  • Figure 5.40: Humalog's Market by Geography 110
  • Figure 5.41: Global Market for Neulasta, 2012-2019 111
  • Figure 5.42: Neulasta's Market Share by Geography 111
  • Figure 5.43: U.S. Market for Neulasta, 2012-2019 112
  • Figure 5.44: Global Market for Privigen, 2012-2019 113
  • Figure 5.45: Global Market for Perjeta, 2012-2019 114
  • Figure 5.46: Global Market for Xgeva/Prolia, 2012-2019 115
  • Figure 5.47: U.S. Market for Xgeva/Prolia, 2012-2019 115
  • Figure 5.48: Global Market for Soliris, 2012-2019 116
  • Figure 5.49: U.S. Market for Soliris, 2012-2019 117
  • Figure 5.50: Global Market for Botox, 2012-2019 118
  • Figure 5.51: U.S. Market for Botox, 2012-2019 118
  • Figure 5.52: Global Market for Lucentis, 2012-2019 119
  • Figure 5.53: U.S. Market for Lucentis, 2012-2019 120
  • Figure 5.54: Global Market for Eylea, 2012-2019 121
  • Figure 5.55: U.S. Market for Eylea, 2012-2019 121
  • Figure 5.56: Global Market for Avastin, 2012-2019 122
  • Figure 5.57: U.S. Market for Avastin, 2012-2019 123
  • Figure 5.58: Global Market for Rituxan, 2012-2019 124
  • Figure 5.59: Rituxan's Market Share by Geography 124
  • Figure 5.60: U.S. Market for Rituxan, 2012-2019 125
  • Figure 5.61: Global Market for Revlimid, 2012-2019 126
  • Figure 5.62: U.S. Market for Revlimid, 2012-2019 126
  • Figure 5.63: Global Market for Herceptin, 2012-2019 127
  • Figure 5.64: Herceptin's Market Share by Geography 128
  • Figure 5.65: U.S. Market for Herceptin, 2012-2019 128
  • Figure 5.67: Global Market for Prenvar 13, 2012-2019 129
  • Figure 5.68: U.S. Market for Prenvar 13, 2012-2019 130
  • Figure 5.69: Global Market for Gardasil, 2012-2019 131
  • Figure 5.70: U.S. Market for Gardasil, 2012-2019 131
  • Figure 5.71: Global Market for Fluzone/Varigrip, 2012-2019 132
  • Figure 5.72: Global Market for Varivax, 2012-2019 133
  • Figure 5.73: U.S. Market for Varivax, 2012-2019 133
  • Figure 5.74: Global Market for Stelara, 2012-2019 134
  • Figure 5.75: U.S. Market for Stelara, 2012-2019 135
  • Figure 5.76: Global Market for Actemra, 2012-2019 136
  • Figure 5.77: Global Market for Gammagard Liquid, 2012-2019 137
  • Figure 5.78: U.S. Market for Gammagard Liquid, 2012-2019 137
  • Figure 5.79: U.S. Market for Biologic Drugs, 2007-2012 145
  • Figure 5.80: The Leading Biologic Drug Classes in Terms of U.S. Sales 146
  • Figure 5.81: Top Selling Biologic Drugs in the U.S. 147
  • Figure 5.82: U.S. Sales of Biologics by Manufacturer 148
  • Figure 5.83: U.S. Sales of mAbs 149
  • Figure 5.84: U.S. Sales of Recombinant Hormones 150
  • Figure: 5.85: U.S. Sales of Blood Cell Growth Factors 151
  • Figure 5.86: U.S. Sales of Cytokines 5.16.10 152
  • Figure 5.87: U.S. sales of Blood Factors 153
  • Figure 5.89: U.S. Sales of Therapeutic Enzymes 153
  • Figure 5.90: U.S. Sales of Recombinant Vaccines 154
  • Figure 5.91: U.S. Sales of Recombinant Anticoagulants 155
  • Figure 5.92: Market for Biologics in Europe, 2012-2019 158
  • Figure 5.93: Uptake of Biologics in Europe by Drug Type 159
  • Figure 5.94: European Market for mAbs 160
  • Figure 5.95: Hemophilia Market Share by Company, 2016 161
  • Figure 6.1: Core Therapy Areas for Biosimilars 174
  • Figure 6.2: Biosimilars' Market by Geography/Country 175
  • Figure 6.3: Top Players in Biosimilars Market 180
  • Figure 6.4: Number of Biologics per Indication to Go Off Patent prior to 2020 183
  • Figure 6.5: Patent Expiration of leading mAbs 184
  • Figure 6.6: Biosimilar mAbs in Pipeline 185
  • Figure 6.7: Disease Indications for Biosimilar mAbs Currently in Clinical Trials 186
  • Figure 6.8: Global Leaders in Biosimilars, 2012 187
  • Figure 6.9: Projected Biosimilars Market Split ($10 Billions) in 2015 188
  • Figure 6.10: The Exploding Global Biosimilars Market, 2012-2020 190
  • Figure 6.11: Estimated Value and Growth Rates for Biosimilars by Type, 2015 191
  • Figure 6.12: Global Spending (%) for Biosimilars by Drug Type ($2.5 Billion), 2015 192
  • Figure 6.13: Biosimilars Market in the U.S., 2011-2019 200
  • Figure 6.14: HGH Biosimilars in the U.S. Market, June 2009-September 2012 201
  • Figure 6.15: Projected U.S. Spend on 11 Specific Biologics, 2012-2024 202
  • Figure 6.16: Biosimilar Launchable Dates in the U.S., 2012-2022 204
  • Figure 6.17: Cumulative Worldwide Sales of Reference Products, 2012-2022 205
  • Figure 6.18: Geographic Distribution of Biosimilar Companies as of 2013 207
  • Figure 6.19: Number of Products by Country as of 2013 208
  • Figure 6.20: Biosimilars/Biobetters Companies by Size Range (Revenue $ Billions) Worldwide, 2013 209
  • Figure 6.21: Biosimilars Approved in the E.U., 2012 211
  • Figure 6.22: Biosimilars Market in Europe and Japan, 2012-2019 212
  • Figure 6.23: Annual European Sales of Filgrastim Products, 2010-2012 213
  • Figure 6.24: Number of Scientific Advice from EMA by Biosimilars Firms 214
  • Figure 6.25: Biosimilars Penetration Rate (%) in Daily G-CSF Class Market, 2012 216
  • Figure 6.26: Revenue Forecast for Biosimilar Insulin Glargine in Major Seven Markets, 2009-2020 217
  • Figure 6.27: Revenue Forecast for Biosimilar HGH in the Major Seven Markets, 2009-2020 217
  • Figure 6.29: Revenue Forecast for Biosimilar IFN Beta Ia in the Major Seven Markets, 2009-2020 219
  • Figure 6.30: Revenue Forecast for Biosimilar Filgrastim in the Major Seven Markets, 2009-2020 219
  • Figure 6.31: Revenue Forecast for Biosimilar Epoetin Alpha in the Major Seven Markets, 2009-2020 220
  • Figure 6.32: Biosimilars Uptake Rates in Europe's Top Five Countries, 2012 221
  • Figure 6.33: Market for Biosimilars in China, 2012-2019 223
  • Figure 6.34: Biosimilar Market in India, 2008-2012 224
  • Figure A.2.1: Percent Change in Hospital Admissions and Office Visits, 2012 303
  • Figure A.2.2: Percent Population, Prescriptions and Per Capita Change in Prescriptions by Age 304
  • Figure A.2.3: Therapy Areas for Largest Positive and Negative Contribution to Growth 304
  • Figure A.2.4: U.S. National Respiratory Illness Estimates, 2010-2013 305
  • Figure A.2.5: Per Capita Spending Growth, 2002-2017 306
  • Figure A.2.6: Percent of Health Plan Members Ranked by Healthcare Spending ($) 307
  • Figure A.2.7: Percent of Health Plan Members Healthcare Spending ($) 308
  • Figure A.2.8: Components of Change in Total Spending ($ Billion), 2011-2012 309
  • Figure A.2.9: Protected Brand Price Spending Growth, 2008-2012 310
  • Figure A.2.10: New Brand Spending ($ Billions) 311
  • Figure A.2.11: Percent Share of Prescriptions, 2003-2012 311
  • Figure A.2.12: Comparison of Medicine Spending by Segment, 2012 312
  • Figure A.2.13: Significant Increase in Consumer-Driven Health Plans Enrollment, 2008-2012 312
  • Figure A.2.14: Average Patient Out-of-Pocket Costs by Plan Type, 2008-2012 313
  • Figure A.2.15: Average Annual Out-of-Pocket Costs for Deductibles, Co-Pay and Co-Insurance Spend 314
  • Figure A.2.16: Percent of Retail Dispensed Prescriptions by Out-of-Pocket Costs ($), 2012 315
  • Figure A.2.17: Percent of Retail Dispensed Prescriptions by Out-of-Pocket Costs ($) 315
  • Figure A.2.18: New Molecular Entities (NMEs) Launched in the U.S., 2003-2012 316
  • Figure A.2.19: New Oncology NME Launches in the U.S., 2003-2012 317
  • Figure A.2.20: Spending in Leading Therapy Areas 321
  • Figure A.2.21: Oncology Spending by Area 322
  • Figure A.2.22: U.S. Market for Oncologics, 2008-2012 323
  • Figure A.2.23: U.S. Market for Rituxan, 2008-2012 323
  • Figure A.2.24: U.S. Market for Avastin, 2008-2012 324
  • Figure A.2.25: Mental Health Spending by Area, 2012 325
  • Figure A.2.26: U.S. Market for Mental Health Medicines, 2008-2012 326
  • Figure A.2.27: U.S. Market for Cymbalta, 2008-2012 327
  • Figure A.2.28: U.S. Market for Abilify, 2008-2012 328
  • Figure A.2.29: Respiratory Spending by Area, 2012 329
  • Figure A.2.30: U.S. Market for Respiratory Agents, 2008-2012 330
  • Figure A.2.31: U.S. Market for Adavair Diskus, 2008-2012 331
  • Figure A.2.32: U.S. Market for Sigulair, 2008-2012 331
  • Figure A.2.33: Spiriva Handihaler, 2008-2012 332
  • Figure A.2.34: Antidiabetes Spending by Area, 2008-2012 333
  • Figure A.2.35: U.S. Market for Antidiabetics, 2008-2012 334
  • Figure A.2.36: U.S. Market for Januvia, 2008-2012 335
  • Figure A.2.37: U.S. Market for Lantus, 2008-2012 336
  • Figure A.2.38: U.S. Market for Lantus SoloSTAR, 2008-2012 337
  • Figure A.2.39: Pain Spending by Area, 2008-2012 337
  • Figure A.2.40: Pain Spending by Area, 2008-2012 338
  • Figure A.2.41: U.S. Market for Pain Management Drugs, 2008-2012 339
  • Figure A.2.42: U.S. Market for Medicines Used in Nervous System Disorders, 2008-2012 339
  • Figure A.2.43: U.S. Market for Oxycontin, 2008-2012 340
  • Figure A.2.44: U.S. Market for Lyrica, 2008-2012 341
  • Figure A.2.45: U.S. Market for Copaxone, 2008-2012 342
  • Figure A.2.46: U.S. Market for Lipid Regulators, 2008-2012 342
  • Figure A.2.47: U.S. Market for Crestor, 2008-2012 343
  • Figure A.2.48: U.S. Market for Autoimmune Drugs, 2008-2012 344
  • Figure A.2.49: U.S. Market for Humira, 2008-2012 345
  • Figure A.2.50: U.S. Market for Enbrel, 2008-2012 346
  • Figure A.2.51: U.S. Market for Remicade, 2008-2012 347
  • Figure A.2.52: U.S. Market for Medicines Used for Multiple Sclerosis, 2008-2012 348
  • Figure A.2.53: U.S. Market for Antiulcerants, 2008-2012 348
  • Figure A.2.54: U.S. Market for Nexium, 2008-2012 349
  • Figure A.2.55: U.S. Market for Neulasta, 2008-2012 350
  • Figure A.2.56: U.S. Market for Epogen, 2008-2012 351
  • Figure A.2.57: U.S. Market for Platelet Aggregation Inhibitors, 2008-2012 351
  • Figure A.2.58: U.S. Market for Plavix, 2008-2012 352
  • Figure A.2.59: U.S. Market for HIV Antivirals, 2008-2012 353
  • Figure A.2.60: U.S. Market for Atripla, 2008-2012 354
  • Figure A.2.61: U.S. Market for Truvada, 2008-2012 355
  • Figure A.2.62: U.S. Market for Antibacterials, 2008-2012 355
  • Figure A.2.63: U.S. Market for Antihypertensives, Plain & Combo, 2008-2012 356
  • Figure A.2.64: U.S. Market for Diovan, 2008-2012 357
  • Figure A.2.65: U.S. Market for ADHD, 2008-2012 358
  • Figure A.2.66: U.S. Market for Vaccines (Pure, Comb and Others), 2008-2012 359
  • Figure A.2.67: U.S. Market for Systemic Hormonal Contraceptives, 2008-2012 359
  • Figure A.2.68: Treated Patients in Selected Therapies in the U.S., 2012 360
  • Figure A.4.1: Ranking of Asian Territories across All Factors 371
  • Figure A.4.2: Cost Ranking of Asian Territories 372
  • Figure A.4.3: Market Opportunity Ranking of Asian Territories 373
  • Figure A.5.1: Steady Increase of Biologics as a Share of Total FDA Approval 379
  • Figure A.5.2: Proportion of Health Insurers with Plans for Implementing Novel Contracting Models 380
  • Figure A.5.3: Insurer Expectations of Clinical and Cost Evidence from the Pharma for Formulary Placement 381
  • Figure A.5.4: Data on Total U.S. Prescription Drug Spending 382
  • Figure A.5.5: Need for Aligned Efforts of Providers, Payers and Patients for Better Patient Outcomes 385
  • Figure A.5.6: Number of Companion Diagnostics Partnerships with Pharma 386
  • Figure A.5.7: Payer's Perceived Barriers to Novel Contracting Practices 387
  • Figure A.5.8: Current and Future State of Data Conversions and Analysis 389
  • Figure A.5.9: Sources of Influence for Formulary Coverage and Decision Making 390
  • Figure A.6.1: Medical Cost Trend, 2010-2013 391
  • Figure A.6.2: Private Health Insurance Benefits by Spending Category 392
  • Figure A.6.3: Percent of U.S. Patients Seeking Treatment in Retail Clinics 393
  • Figure A.6.4: Surgical Cosmetic Procedures in the U.S. 394
  • Figure A.6.5: Increase in High-Cost Insurance Claims 395
  • Figure A.6.6: Percentage of Individuals with Employer-Sponsored Coverage in a High-Deductible Plan with a Savings Option 396
  • Figure A.6.7: Percentage of Consumers Delaying Care Because of Cost 396

INDEX OF TABLES

  • Table 2.1: R&D Spending by Top 20 Companies, 2012-2018 24
  • Table 2.2: Top 20 Most Valuable Pharmaceutical R&D projects, 2018 25
  • Table 2.3: Most Valuable R&D Projects (Ranked by NPV), May 2012 and Current 26
  • Table 2.4: FDA Approval Count (NMEs & Biologics) vs. Fifth Year after Launch U.S. Product Sales 26
  • Table 2.5: Top Ten NMEs of 2012 Ranked by U.S. Consensus Sales in 2017 27
  • Table 2.6: Increasing Demand for Pharmaceuticals in Emerging Markets 29
  • Table 2.7: Top Ten Global Pharmaceutical Firms, 2011-2012 32
  • Table 2.8: Top Ten Pharmaceuticals by Sales in 2012 33
  • Table 2.9: Worldwide Prescription and OTC Sales by Therapy Area in 2018 34
  • Table 2.10: Top Ten Companies in Global Oncology Sales, 2012-2018 35
  • Table 2.11: Top Five Oncology Product Sales, 2018 35
  • Table 2.12: Top Ten Companies and Global Antidiabetic Sales, 2012-2018 36
  • Table 2.13: Top Five Anti-Diabetic Products, 2018 36
  • Table 2.14: Top Ten Companies and Global Anti-Rheumatic Sales, 2012-2018 37
  • Table 2.15: Top Five Anti-Rheumatic Products, 2012-2018 37
  • Table 2.16: Top Ten Companies and Total Global Vaccine Sales, 2012-2018 38
  • Table 2.17: Top Five Vaccine Products, 2018 38
  • Table 2.18: Top Ten Companies and Total Global Anti-Viral Sales, 2012-2018 39
  • Table 2.19: Top Five Anti-Viral Products, 2018 39
  • Table 2.20: Top 50 Global Pharmaceutical Brands in 2018 40
  • Table 2.21: M&A Transactions in 2012 41
  • Table 2.22: U.S. Prescription Drug Sales by Top 20 Companies, 2010-2012 45
  • Table 2.23: Top 50 Pharmaceutical Products in the U.S., 2012 45
  • Table 2.24: Top 50 Pharmaceutical Brands in the U.S. in 2018 47
  • Table 2.25: Prescription Drug Sales in Europe by Top 20 Companies, 2010-2012 50
  • Table 2.26: Prescription Drug Sales in Japan by the Top 20 Companies, 2010-2012 52
  • Table 2.27: Regional Prescription Drug Sales in the U.S., Europe and Japan (Top 20 Companies), 2012 55
  • Table 3.1: Patent Expiries by Country and Year, 2011-2015 58
  • Figure 3.2: Top 25 Companies by R & D Pipeline Size, 2012 62
  • Table 3.3: Top 25 Therapeutic Categories in R & D, 2011-2012 65
  • Table 3.4: Top 25 Individual Diseases in the R & D Pipeline, 2012 66
  • Table 3.5: Top 20 Mechanism of Action in 2012 R&D Pipeline 67
  • Table 3.6: Top 25 Drug Protein Targets in 2012 R&D Pipeline 68
  • Table 4.1: Top 20 Companies in Global Generics Sales, 2012 75
  • Table 5.1: Number of Biologics Available in the Global Market 79
  • Table 5.2: Global Sales of Top 12 Biologics ($67 Billion), 2012 88
  • Table 5.3: Patent Protection for Roche's Biologics 88
  • Table 5.4: Humira's Revenues, Growth Rate and Market Share, 2010-2015 94
  • Table 5.6: Humira's Revenues, Growth Rate and Market Share, 2016-2022 94
  • Table 5.7: Top U.S. Biotech Companies Ranked by Revenue, 2011-2012 138
  • Table 5.8: Sales if Neulasta/Neupogen, 2010-2012 139
  • Table 5.9: U.S. Biotechnology at a Glance, 2011-2012 143
  • Table 5.10: R & D Investment by the Top Ten Biotech Companies in the U.S., 2010-2012 144
  • Table 5.11: Cost of Commonly Used Biologics in the U.S. 155
  • Table 5.12: Biologics Used for Treating Rheumatoid Arthritis 156
  • Table 5.13: Biologics and Their Mode of Administration for Arthritis Patients 156
  • Table 5.14: Cost Comparison of Arthritis Biologics 157
  • Table 5.15: Total Hemophilia Market, 2011-2016 160
  • Table 5.16: Hemophilia A (Factor VIII) and von Willebrand Disease, Sales from Marketed Products and Late-Stage Pipeline, 2012-2016 162
  • Table 5.17: Hemophilia B, Marketed Products and Late Stage Pipeline, 2012-2016 163
  • Table 5.18: The Inhibitor Market: Products and Pipeline 163
  • Table 6.1: Definitions of Biosimilar Products 167
  • Table 6.2: Biosimilar Pipeline in the U.S. 178
  • Table 6.3: Other Key Players in Biosimilars Space 182
  • Table 6.4: Patent Expiration for Major Biologics 183
  • Table 6.5: Development Status of mAbs Biosimilars 186
  • Table 6.6: Generic Companies Active in Biosimilar Space 189
  • Table 6.7: Biosimilars Pipeline by Class, 2012 189
  • Table 6.8: Market Exclusivity Period for Specific Biologics in the U.S. 195
  • Table 6.9: Selected Biosimilars and Biobetters Currently in Development as of 2013 206
  • Table 6.10: Companies with the Largest Biosimilar Portfolios as of 2013 208
  • Table 6.11: Biosimilars Approved by the E.U. 215
  • Table 6.12: Native mAbs Developers in China 223
  • Table 6.13: Domestic Biosimilar Developers in India 225
  • Table 6.14: Celtrion's Biosimilar Pipeline 225
  • Table 6.15: Summary of Publicly Announced Biosimilar Product Transactions Through 2012 229
  • Table 7.1: Selected Generics from Apotex 245
  • Table 7.2: AstraZeneca's Development Projects 247
  • Table 7.3: Patent Expiries of AstraZeneca's Key Marketed Products 247
  • Table 7.4: Plasma Derivatives from Bharat Serums and Vaccines Limited 249
  • Table 7.5: Biogen Idec's Product Pipeline 252
  • Table 7.6: Bristol's Key Products 255
  • Table 7.7: Reddy's Product List 258
  • Table 7.8: New Products Launched by Richter in Hungary 260
  • Table 7.9: New Products Launched by Richter in Central and Eastern Europe 260
  • Table 7.10: GSK's Prescription Medicines 261
  • Table 7.11: Key Products from Intas 264
  • Table 7.12: Merck's Key Pharmaceutical Products 265
  • Table 7.13: Pfizer's Major Biopharmaceutical Products 269
  • Table A.1.1: Biologic Medicines by Development Phase, 2013 278
  • Table A.2.1: List of NMEs Launched in 2012 318
  • Table A.2.2: Other NMEs Launched in 2012 319
  • Table A.2.3: Top Therapeutic Classes by Prescriptions, 2008-2012 361
  • Table A.2.4: Top Medicines by Prescriptions in the U.S., 2008-2012 362
  • Table A.3.1: Pharmaceutical Deals in 2012 364
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