世界のバイオシミラー市場動向と予測（～2018）：Updated Version...市場調査レポートについてご紹介

Table Of Contents

1 Introduction (Page No. – 26)
1.1 Objectives Of The Study
1.2 Report Description
1.3 Markets Covered
1.4 Stakeholders
1.5 Market Scope
1.6 Research Methodology
1.6.1 Market Size Estimation And Data Triangulation
1.6.2 Market Share
1.6.3 Key Data Points From Secondary Sources
1.6.4 Key Data Points From Primary Sources
1.6.5 Assumptions

2 Executive Summary (Page No. – 38)

3 Premium Insights (Page No. – 42)
3.1 Biosimilars Market Vs. Biologic Market
3.2 Global Biosimilars Market
3.2.1 Market Dynamics
3.2.2 Product Market
3.2.3 Application Market
3.3 Geographic Analysis, By Country
3.4 Market Share Analysis

4 Market Overview (Page No. – 49)
4.1 Introduction
4.2 Evolution
4.3 Market Segmentation
4.4 Market Dynamics
4.4.1 Drivers
4.4.1.1 Growing Pressure To Cut Healthcare Expenditure, An Impetus To The Demand Of Biosimilars
4.4.1.2 Off-Patent Biologic Products To Boost The Biosimilars Market
4.4.1.3 Rise In Aging Population Triggers The Incidences Of Chronic Disorders And Thus Boosts The Biosimilars Market
4.4.1.4 Growing Demand For Biosimilars Drugs Due To Their Cost Effectiveness
4.4.1.5 Rising Incidences Of Various Diseases To Boost The Biosimilars Market
4.4.1.6 Strategic Collaborations Lead To Increased Productivity And Clinical Trial Activities For Biosimilars
4.4.1.7 Government Support And Initiatives Propel The Biosimilars Market
4.4.2 Restraints
4.4.2.1 High Manufacturing Complexities And Costs, A Significant Entry Barrier For Companies
4.4.2.2 Stringent Regulatory Requirements In Countries To Adversely Affect Investments In Biosimilars
4.4.2.3 Innovative Strategies By Biologic Drug Manufacturers To Restrict Entry Into The Biosimilars Market
4.4.3 Opportunities
4.4.3.1 Emerging Countries
4.4.3.2 Untapped Indications
4.4.4 Challenges
4.4.4.1 Requirement Of Complex Infrastructure For Manufacturing As Well As Extensive Clinical Trials For Obtaining Approval
4.4.4.2 Bulk Production To Meet Market Demand Is A Challenge For Smaller Manufacturers
4.5 Winning Imperatives
4.5.1 Partnerships & Agreements To Gain Competitive Advantage
4.5.2 Sandoz’s In-House Capabilities Made It The Global Leader
4.6 Burning Issues
4.6.1 Opportunities For New Entrants In The Biosimilars Market
4.6.2 Product Withdrawals Provide Significant Opportunities For New Entrants
4.6.3 Termination Of Joint Ventures Allows Companies To Focus On Core Competencies
4.6.4 Discontinuation Of Patent By Roche Provides Opportunities To Other Players
4.7 Biosimilars Pipeline Analysis
4.7.1 About 50 Biosimilars Of Monoclonal Antibody In The Pipeline

5 Industry Analysis (Page No. – 82)
5.1 Introduction
5.2 Research & Development Investment Analysis
5.3 Industry Trend Analysis
5.3.1 Forthcoming Patent Expirations
5.3.2 Manufacturing Agreement
5.4 Porter’s Five Forces Analysis
5.4.1 Threat Of New Entrants
5.4.2 Threat Of Substitutes
5.4.3 Competitor Rivalry
5.4.4 Bargaining Power Of Suppliers
5.4.5 Bargaining Power Of Buyers

6 Global Biosimilars Market, By Product (Page No. – 90)
6.1 Introduction
6.1.1 Biosimilars Demand To Grow Owing To High Efficacies & Low Prices
6.2 Recombinant Non-Glycosylated Proteins
6.2.1 Insulin Biosimilars Will Drive The Recombinant Non-Glycosylated Proteins Segment
6.2.2 Insulin
6.2.2.1 Insulin Glargine, Lispro, And Aspart Will Go Off-Patent In 2014
6.2.3 Recombinant Human Growth Hormone (RHGH)
6.2.4 Granulocyte Colony-Stimulating Factor (Filgrastim)
6.2.4.1 Strong Biosimilars Pipeline To Boost The Filgrastim Market
6.2.5 Interferons
6.2.5.1 Biosimilars Of Interferon Available Only In Asia-Pacific And Row Regions Due To Less Stringent Regulatory Pathway
6.3 Recombinant Glycosylated Proteins
6.3.1 Erythropoietin (EPO)
6.3.1.1 Cost Effectiveness Of Epo Biosimilars, One Of The Major Driving Factors
6.3.2 Monoclonal Antibodies (MAB)
6.3.2.1 Monoclonal Antibodies Market, A Lucrative Opportunity For Companies
6.3.3 Follitropin
6.3.3.1 New Biosimilars Of Follitropin ‘Ovaleap’ Received Marketing Authorization In Europe In 2014
6.4 Recombinant Peptides
6.4.1 Glucagon
6.4.1.1 Glucagen, The First Fop Approved In U.S.
6.4.2 Calcitonin
6.4.2.1 U.S. Fda Does Not Support Miacalcin As A Treatment For Osteoporosis

7 Global Biosimilars Market, By Application (Page No. – 122)
7.1 Introduction
7.2 Oncology
7.2.1 Growing Cost Burden Of Cancer Will Stimulate The Demand For Mabs & Filgrastim
7.3 Blood Disorders
7.3.1 Rise In Incidences Of Anemia, Leukemia, Myeloma & Lymphoma Will Enhance The Need For Biosimilars
7.4 Chronic And Autoimmune Diseases
7.4.1 Monoclonal Antibodies To Boost The Application Of Biosimilars In Autoimmune Diseases
7.5 Growth Hormone Deficiency
7.5.1 About 10,000 New Patients Are Diagnosed Annually With Growth Hormonal Disorders
7.6 Infectious Diseases
7.6.1 Growing Cases Of Hepatitis, A Boost For The Interferon Biosimilars Market
7.7 Others (Female Infertility, Hypoglycaemia, Myocardial Infarction, Postmenopausal Osteoporosis & Chronic Kidney Failure)

8 Global Biosimilars Service Market (Page No. – 138)
8.1 Introduction
8.1.1 R&D And Manufacturing Issues Provide Significant Opportunities To CRO & CMO
8.2 Contract Manufacturing Organizations
8.2.1 CMO Provide Considerable Opportunities To Companies Planning To Enter Biosimilars Market
8.3 Contract Research Organizations
8.3.1 Lack Of Expertise With The Biosimilars Players, A Prospect For Cro
8.4 Others (Non-Clinical & Bioinformatics)

9 Geographic Analysis (Page No. – 148)
9.1 Introduction
9.1.1 Europe Dominates The Global Biosimilars Market Due To Its Well Defined Regulatory Guidelines
9.2 North America
9.2.1 Rise In Pressure To Cut Healthcare Cost & A Leading Biologic Market Will Increase The Demand For Low Priced Biosimilars
9.2.2 Regulatory Outlook
9.2.2.1 U.S.
9.2.2.2 Canada
9.2.3 Market Analysis
9.2.3.1 U.S.
9.2.3.1.1 Financial Support By U.S. Government To FDA For Review Of Biosimilars Will Add Significant Growth To Biosimilars Industry
9.2.3.2 Canada
9.3 Europe
9.3.1 Europe Is The Pioneer For The Development Of Biosimilars
9.3.2 Regulatory Outlook
9.3.3 Market Analysis
9.3.3.1 U.K.
9.3.3.1.1 Well-Developed Generics Market & Growing Pressure To Decrease Drug Prices To Drive The Biosimilars Market
9.3.3.2 Germany
9.3.3.2.1 Reference Pricing System Of Germany Leads To Faster Adoption Of Biosimilars
9.3.3.3 France
9.3.3.3.1 Biosimilars Not Considered As Generic Drugs & Are Excluded From The French Substitution List
9.3.3.4 Spain
9.3.3.4.1 Effect Of Recession On Branded Drugs Will Shift The Market Towards Biosimilars Drugs
9.3.3.5 Italy
9.3.3.5.1 Adoption Of Biosimilars Low Compared To Branded Versions
9.3.3.6 Rest Of Europe (ROE)
9.3.3.6.1 Substitution Status Varies In Different Countries
9.3.3.6.2 Reference Pricing System Of Denmark Will Proliferate The Biosimilars Market
9.4 Asia-Pacific
9.4.1 APAC, A Blue-Eyed Market For Investors In Biosimilars Owing To Less Stringent Regulatory Pathway
9.4.2 Growing Medical Tourism & Low Manufacturing Cost Will Propel The Biosimilars Market
9.4.3 Regulatory Outlook
9.4.3.1 China
9.4.3.2 India
9.4.3.3 Japan
9.4.3.4 South Korea
9.4.4 Market Analysis
9.4.4.1 China
9.4.4.1.1 Lack Of Government Regulation & Low Ip Protection For Biologic Compounds Will Drive The Biosimilars Market
9.4.4.2 India
9.4.4.2.1 Semi-Regulatory Environment For Approving Similar Biologic Drugs Propels The Biosimilars Market
9.4.4.3 Japan
9.4.4.4 South Korea
9.4.4.4.1 Government Support & Strong Biosimilar Pipeline, An Impetus To The Biosimilars Market
9.4.4.5 Rest Of Asia-Pacific (ROAP)
9.4.4.5.1 Australia & Malaysia To Aggressively Promote The Adoption Of Biosimilars
9.5 Rest Of The World (ROW)
9.5.1 Latam Provides High Growth Opportunities For Biosimilars Player
9.5.2 Regulatory Outlook
9.5.2.1 Brazil
9.5.2.2 Mexico
9.5.2.3 Argentina
9.5.2.4 Saudi Arabia
9.5.3 Market Analysis
9.5.3.1 Latin America
9.5.3.1.1 Strong Economic Condition & Government Support Will Strengthen The Biosimilar Industry In Brazil
9.5.3.2 Africa
9.5.3.3 Middle East

10 Competitive Landscape (Page No. – 218)
10.1 Introduction
10.1.1 Agreements & Partnerships Was The Key Strategy Adopted By Biosimilar Players
10.2 Market Share Analysis
10.3 Agreements, Joint Ventures, Partnerships, & Collaborations
10.4 Acquisitions
10.5 New Product Launches
10.6 Others (Regulatory Approvals)

11 Company Profiles (Overview, Financials, Products & Services, Strategy, & Developments)* (Page No. – 238)
11.1 Actavis, Inc.
11.2 Amgen, Inc.
11.3 Biocon Ltd.
11.4 Celltrion, Inc.
11.5 Cipla Ltd.
11.6 Dr. Reddy’s Laboratories Ltd.
11.7 Emcure Pharmaceuticals Ltd.
11.8 Hospira, Inc.
11.9 Lg Life Sciences Ltd.
11.1 Merck Kgaa
11.11 Mylan, Inc.
11.12 Ranbaxy Laboratories Ltd.
11.13 Roche Holding Ltd.
11.14 Sandoz International GMBH (Division Of Novartis International Ag)
11.15 Stada Arzneimittel Ag
11.16 Synthon
11.17 Teva Pharmaceutical Industries Ltd.
11.18 Wockhardt Ltd.

*Details On Financials, Product & Services, Strategy, & Developments Might Not Be Captured In Case Of Unlisted Companies.