【レポートの概要（一部）】
1. Executive Summary
2. What are Biosimilars?
3. Emergence of Biosimilars
3.1 Role of the Biologics Price Competition and Innovation (BPCI) ACT
3.2 Issue of Data Exclusivity
4. Industry Definition
4.1 Defining Biosimilars
4.2 Specificity of Biosimilars
4.3 Categories of Biologics
4.4 Importance of Biosimilars
4.5 Comparing Biosimilars with Generics
4.6 Branded Product Business Model
5. Overview of the Biopharmaceutical Industry
5.1 Market Profile
5.2 Biopharmaceutical Manufacturing Process
6. Global Biosimilars Market Statistics
6.1 Market Profile
6.2 Market Size
6.3 Market Value of Branded Biologics Facing Patent Expiry
6.4 Operating Margin for Biosimilar Manufacturers
6.5 Investor Concerns regarding Biosimilars
6.6 Commercial Impact of the European Biosimilars Industry
7. Key Success Factors for Biosimilars
7.1 Long Term Strategy
7.2 Developing Competitive Intelligence
7.3 Proper Financial Structure
7.4 Developing Key Biomanufacturing Competencies
7.5 Developing Clinical Capabilities and Regulatory Expertise
7.6 Well Developed Sales and Distribution Channels
8. Factors Impacting the Global Biosimilars Industry
8.1 Growth of the Industry in Developed Countries
8.2 Growth of the Industry in BRIC Countries
8.3 High Cost of Biologics
8.4 Use of Branded Biologics to Increase
8.5 Introduction of Approval Pathways in the US and Japan
8.6 EU’s Draft on Biosimilar Monoclonal Antibody Guidance
8.7 Unfavorable Tendering Procedures
8.8 Problem of Reference Pricing
8.9 Strategy of Biosimilar Companies with Regards to Hospital and Retail Setting
8.10 Issue of Biosimilar Comparability
8.11 Lack of Incentives, Service Agreements and Marketing Costs
8.12 Availability of Second Generation Branded Biologics
8.13 No Automatic Substitution of Branded Biologics
8.14 Cost-containment to Boost Uptake of Biosimilars
8.15 Lack of Proper IP Protection in Emerging Countries
8.16 Ease of Market Entry in BRIC Countries
8.17 Strong Biologic Capabilities in BRIC Countries
8.18 Restricted Market Access for Domestic Players in Emerging Countries
8.19 Problem of Low Purchasing Power in Emerging Markets
9. Biosimilar Market Drivers & Challenges
9.1 Factors Driving Growth of Biosimilars
9.1.1 Need to Lower Healthcare Costs
9.1.2 Lower Development Costs of Biosimilars as compared to New Biologic Drug
9.1.3 Lower Cost of Treatment with Biosimilars
9.1.4 Upcoming Patent Expiries for Blockbuster Biologics
9.1.5 Large Sales of Biologic Drugs
9.1.6 Greater Profitability of Biosimilars as compared to Generic Drugs
9.2 Factors Restraining the Growth of Biosimilars
9.2.1 Lack of Automatic Substitution
9.2.2 High Cost of Development and Manufacturing as compared to Generics
9.2.3 High Entry Barriers to the Biosimilar Industry
9.2.4 Emergence of Second Generation Biologic Drugs
9.2.5 Patent Protection for Biologic Drugs
10. Regulatory Framework
10.1 Regulatory Framework in Europe
10.1.1 EMEA’s Current Position
10.1.2 Bolar Type Provision
10.1.3 Comparability Exercises
10.1.4 Approval Process for Biosimilars
10.2 Regulatory Framework in Japan
10.2.1 Current Position on Biosimilars
10.3 Regulatory Framework in the USA
10.3.1 BPCIA and the Approval Pathway for Biosimilars
10.3.1.1 Role of Biosimilarity and Interchangeability
10.3.1.2 FDA Regulations Biosimilars Approval and Regulation
10.3.1.3 Demonstration on Basis of Data
10.3.1.4 12 Years of Market and Data Exclusivity
10.3.1.5 Resolution to Patent Dispute
10.3.1.6 Notice of Commercial Marketing to Reference Product Sponsor
10.3.1.7 Substitution of Small Molecular Products
10.4 Differences between FDA & the EMEA
10.5 Issues with Momenta
11. Factors Determining Market Entry in the Global Biosimilar Industry
11.1 Long Drawn-out Biosimilar Clinical Development Timeline
11.2 Approval Pathways for Biosimilars
11.3 High Development Costs of Biosimilars
11.3.1 Costs in Developed Markets
11.4 Biosimilars Manufacturing in Developing Countries – Pros & Cons
11.4.1 Issues with Regulatory Approval
11.4.2 Clinical Trials
11.4.3 Cost of Research & Development
11.4.4 Manufacturing Barriers
11.5 Proving of ‘Biosimilarity’
11.6 Issues with EMA Draft Guidelines for Biosimilar MAb Approval
11.7 Challenges with Patents
11.8 Role of Market Exclusivity for Branded Biologics
11.9 Strategic Partnerships Driving the Industry
11.9.1 Role of M&A Deals
11.9.1.1 Merck & Co.
11.9.1.2 Pfizer
11.10 Lack of Proper Safety Regulations
12. Biosimilar Approval Pathways in the US and Europe
13. Competitive Landscape
13.1 Key Industry Players
13.2 Key Industry Suppliers
13.3 Generic Drug Producers
13.4 Key Investors in the Industry
13.5 Major Stakeholders in the Industry
13.6 Developed versus Emerging Markets
13.7 Biosimilar Launches
13.8 Analysis by Markets
13.8.1 Biosimilars in Australia
13.8.2 Biosimilars in BRIC Countries
13.8.3 Biosimilars in the European Union (France, Germany, Italy, Spain, the UK)
13.8.4 Biosimilars in Japan
13.8.5 Biosimilars in United States
14. Analysis of Major Biosimilars
14.1 Epoetin
14.2 Filgrastim
14.3 Somatropin
15. Upcoming Patent Expiries and Opportunities for Biosimilars
16. Strategies of Big Pharma to Combat Biosimilars
17. Country-wise Biosimilar Market Analysis
17.1 France
17.1.1 Overview of the Healthcare System
17.1.2 Pricing and Reimbursement
17.1.3 Drivers & Challenges for Biosimilars in France
17.2 Germany
17.2.1 Overview of the Healthcare System
17.2.2 Pricing and Reimbursement
17.2.3 Drivers & Challenges for Biosimilars in Germany
17.3 India
17.4 Italy
17.4.1 Overview of the Healthcare System
17.4.2 Pricing and Reimbursement
17.4.3 Drivers & Challenges for Biosimilars in Italy
17.5 Japan
17.6 Spain
17.6.1 Overview of the Healthcare System
17.6.2 Pricing and Reimbursement
17.6.3 Drivers & Challenges for Biosimilars in Spain
17.7 United Kingdom
17.7.1 Overview of the Healthcare System
17.7.2 Pricing and Reimbursement
17.7.3 Drivers & Challenges for Biosimilars in the UK
17.8 United States
18. Major Industry Players
18.1 Dr. Reddy’s Laboratories Limited
18.1.1 Company Overview
18.1.2 Business Segments
18.1.3 Presence in Biosimilars Market
18.1.4 SWOT Analysis
18.2 Hospira Inc
18.2.1 Company Overview
18.2.2 Business Segments
18.2.3 Presence in Biosimilars Market
18.2.4 SWOT Analysis (Brief Analysis)
18.3 Sandoz International
18.3.1 Company Overview
18.3.2 Business Segments
18.3.3 Presence in Biosimilars Market
18.3.4 SWOT Analysis
18.4 STADA Arzneimittel AG
18.4.1 Company Overview
18.4.2 Business Segments
18.4.3 Presence in Biosimilars Market
18.4.4 SWOT Analysis
18.5 Teva Pharmaceutical Industries
18.5.1 Company Overview
18.5.2 Business Segments
18.5.3 Presence in Biosimilars Market
18.5.4 SWOT Analysis
18.6 Watson Pharmaceuticals
18.6.1 Company Overview
18.6.2 Business Segments
18.6.3 Presence in Biosimilars Market
18.6.4 SWOT Analysis
18.7 3SBio Inc.
18.8 Biocon Limited
18.9 Biopartners Gmbh
18.10 Celltrion Inc
18.11 Intas Biopharmaceuticals
18.12 Kyowa Hakko Kirin Co., Ltd.
18.13 Reliance Life Sciences
18.14 Shanghai Fosun Pharmaceutical (Group) Co., Ltd
18.15 Wockhardt
19. Global Biosimilars Market Outlook
19.1 Market Outlook
19.2 Forecast for Biosimilar Sales
19.3 Forecast for US Biosimilars Market
19.4 Forecast for European Biosimilars Market
19.5 Forecast for Japanese Biosimilars Market
19.6 Forecast for Biosimilars
19.6.1 Biosimilars for Monoclonal Antibodies against Cancer
19.6.2 Erythropoietin (EPO) Biosimilars Markets
19.6.3 Human Growth Hormone (hGH) Biosimilars Markets
19.6.4 Granulocyte – Colony Stimulating Factor (G-CSF) Biosimilars Markets
19.6.5 Insulin and Insulin Analogs Biosimilars
19.6.6 Interferon alfa Biosimilars
19.6.7 Interferon beta Biosimilars
19.6.8 TNF alfa Inhibitor Biosimilars
20. Appendix
21. Glossary
【レポート販売概要】
■ タイトル：バイオシミラーのグローバル市場動向■ 英文：Global Biosimilars Industry
■ 発行日：2014年5月
■ 調査会社：Taiyou Research
■ 商品コード：Taiyou-40619074
■ 調査対象地域：グローバル
- LTE市場：インフラ別、デバイス別、キャリアサービス別分析（LTE Market by Infrastructure, Devices and Operator Services 2012 – 2016）The growing demand for mobile broadband services is driving an ever increasing number of commercial LTE network deployments. This surge has seen the number of LTE subscriptions already surpass 7 Million subscriptions worldwide, and over 300+ commercial LTE user device launches. As the market gained momentum, the LTE industry witnessed revenues for over $ 19.1 Billion in 2011 alone. Projected to gr …
- グローバル電子請求（e-Invoicing）市場動向（2014-2018）About e-invoicing E-invoicing is the exchange of bills and related invoice documents between enterprises and their clients in an integrated electronic format, usually using the internet. Also known as e-billing, e-invoicing is a part of electronic data interchange transactions that include data from the enterprise in a format that can be integrated into the client's financial system without the in …
- グローバル鉱業サーベイ（2013-2014）：市場動向、マーケティング戦略Why was the report written? This report is the result of an extensive survey drawn from ICD Research’s exclusive panel of leading global mining industry executives. The report provides data and analysis on global mining industry suppliers’ media spend, marketing and sales strategies, and practices and business planning within the global mining industry. This report includes key topics such as medi …
- ケニアの太陽光発電市場2016：発電能力、生産、投資動向、制度、企業Solar Photovoltaic (PV) in Kenya, Market Outlook to 2030 - Capacity, Generation, Levelized Cost of Energy (LCOE), Investment Trends, Regulations and Company Profiles Summary "Solar Photovoltaic (PV) in Kenya, Market Outlook to 2030 - Capacity, Generation, Levelized Cost of Energy (LCOE), Investment Trends, Regulations and Company Profiles” is the latest report from GlobalData, the industry analysi …
- スマート及びコネクティッド・オフィスの世界市場：スマート照明、セキュリティ・アクセス制御システム、エネルギー管理システム、HVAC制御システム等Global smart and connected office market is witnessing an impressive growth due to the increase in need to have a cohesively networked office. As the name suggests, smart and connected office is a concept where network based devices are used for all the work in the company offices. This concept enables employees to undertake routine office tasks more efficiently and effectively due to reduced powe …
- タイヤ由来燃料（TDF）の世界市場2019-2023Global Tire-Derived Fuel Market: About this market Tire-derived fuel is derived from scrap or end-of-life tires. Scrap tires can either be whole tires or tires shredded into uniform pieces according to the requirements of the end-users. Technavio’s tire-derived fuel market analysis considers sales from cement kilns, pulp and paper mills, and utility and industrial boilers. Our analysis also consid …
- ゲノム編集/ゲノム工学の世界市場予測（～2021年）：細胞株工学、動物遺伝子工学、植物遺伝子工学The genome editing market is projected to reach USD 5.54 Billion by 2021 from USD 2.84 Billion in 2016, growing at a CAGR of 14.3% in the next five years (2016 to 2021). Owing to factors such as high prevalence rate of infectious diseases and cancer among patients, technological advancements, rising government funding and growth in the number of genomics projects, increasing demand for synthetic g …
- 屋根材用接着剤世界市場2017-2021ABSTRACTAbout Roofing Adhesive Roofing is the process of covering the uppermost surface and supporting structures of a building with materials such as shingles, membranes, insulating glass, and cement. There are two main types of roofing defined by the pitch or slope of the roof: steep-slope roofing and low-sloped or flat roofing. Roofing adhesives are substances used to bind the roof surfaces, th …
- Santos Ltd.：石油・ガスの開発・生産動向及びコスト分析- Q3, 2013Santos Ltd. Oil & Gas Exploration and Production Operations and Cost Analysis - Q3, 2013 Summary Santos Ltd. Oil & Gas Exploration and Production Operations and Cost Analysis is the latest report from GlobalData, the industry analysis specialists, that offers comprehensive information on the operational and financial performance of the company. The report is an essential source for key operational …
- 食料品輸送サービスの世界市場2015-2019About Groceries Transportation Grocery transportation is the movement of various F&B commodities, raw materials, and other household supplies from one place to another. It helps the grocery industry maintain a continuous supply of durable and non-durable goods from different suppliers and distributors across various locations. Sometimes, companies may also outsource transportation if it is cost-ef …
- ロボット手術システムの世界市場：器具・アクセサリー、システム、サービスGlobal Robotic Surgery System Market: About this market Robotic surgery system is a minimally invasive surgery (MIS) device that assists surgeons in performing complex surgical procedures with high precision, flexibility, and control. Technavio’s robotic surgery system market analysis considers sales from hospitals and ASCs - Ambulatory Surgery Centers. Our analysis also considers the sales of rob …
- 発電機レンタルの世界市場About Power Rental Over the past decade, the demand for power has been increasing worldwide. However, meeting the world's growing power need has become a critical challenge. Increased demand for power is mainly driven by factors such as rising population, growing income of people, and rapid industrialization and urbanization. As a result of low investments in the Power sector, governments and util …
- テレビ用ディスプレイドライバIC（DDIC）の世界市場2016-2020About the Display Driver IC (DDIC) Market for TVs DDICs deliver predefined currents and analog voltages that activate the pixels to exhibit pixel images on displays. DDICs include gate and source drivers with a range of interfaces, frequencies, voltage, and packages. DDICs are key to higher resolution displays. Technavio’s analysts forecast the global DDIC market for TVs to grow at a CAGR of 19.54 …
- Antidepressants (片頭痛/Migraine)：医薬品市場予測及び分析（～2023）Antidepressants (Migraine) - Forecast and Market Analysis to 2023 Summary The migraine market is saturated with generic drugs, and the remaining branded products already on the market are expected to lose exclusivity during the next few years, with the exception of Botox for chronic migraine, which is expected to maintain its leading position in terms of sales. However, reformulations of mature pr …
- ドローンサービスの世界市場予測（～2022）：産業別、用途別（空中撮影＆リモートセンシング、データ収集、分析）、ドローン種類別、サービス期間別、地域別The drone services market is estimated to be USD 705.3 Million in 2016 and is projected to reach USD 18,022.7 Million by 2022, at a CAGR of 71.62% from 2016 to 2022. One of the major factors expected to fuel the growth of the drone services market is the increasing demand for drone services for monitoring and inspection across various industries. Based on industry, the infrastructure segment of th …
