【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:世界のバイオシミラー市場■ 英文:Global Biosimilars Industry
■ 発行日:2013年12月
■ 調査会社:Taiyou Research
■ 商品コード:TAYU40206057
■ 調査対象地域:世界
- 世界の鉱業分析:Analyzing the Global Mining IndustryThe financial crisis of 2008 and 2009 had a major impact on the global mining industry. However, the year 2010 saw the industry recover strongly and this growth rate continued well into 2011 and the first half of 2012 as well. The global mining industry has been seeing a steady rise in mergers and acquisitions amongst the major players with the recent Xstrata and Glencore International deal making …
- 自動車用アームレストの世界市場2019-2023Global Automotive Armrest Market: About this market Technavio’s automotive armrest market analysis considers sales from passenger vehicles and commercial vehicles. Our analysis also considers the sales of the automotive armrest in APAC, Europe, North America, South America, and MEA. In 2018, the passenger vehicles segment had a significant market share, and this trend is expected to continue over …
- オフショア支援船(OSV)の世界市場:アンカーハンドリング・タグサプライ船(AHTS)、プラットフォーム・サプライ船(PSV)、多目的作業船(MPSV)等The global offshore support vessel market is expected to grow owing to the need to satisfy rising marine logistics demand. The lucrative and high-investment areas of offshore regions such as North Sea, U.S Gulf of Mexico and new discoveries in West Africa are the key driving factors for the high growth of offshore support vessel market. The offshore support vessels or OSVs are vessels used in the …
- ヨーロッパの鉄道貨物輸送市場2016-2020About Rail Freight Transportation Market in Europe Rail freight transportation is used for the movement of heavy goods such as coal, metals, and oils. Often, rail freight service providers go beyond logistics and provide value-added services such as loading and unloading, documentation services, door-to-door delivery, and packaging. They also provide strategic and operational value to many shipper …
- 髭グルーミング製品の世界市場:製品種類別(ひげ油、ひげシャンプー、シェービングクリーム、トリマー、シェービングジェル)、エンドユーザー別(個人、商業)、流通経路別(ハイパーマーケット/スーパーマーケット、専門店、オンラインストア、その他)The beard grooming market size was valued at $24.1 billion in 2018 and is expected to reach $43.1 billion by 2026, registering a CAGR of 7.7% from 2019 to 2026. The rise in number of health conscious consumers is one of the key factors driving the growth of the global beard grooming market. The global beard grooming market is segmented on the basis of product type, distribution channel, and region …
- 食物繊維の世界市場:水溶性食物繊維、不溶性食物繊維About Dietary Fibers Dietary fibers are widely present in fruits, vegetables, and grains. They include all parts of plant foods that cannot be digested or absorbed by the body and are also known as roughage or bulk. Though indigestible, they are proven extremely useful in maintaining bowel regularity and preventing constipation and other bowel abnormalities. Technavio's analysts forecast the globa …
- HORIBA, Ltd.:市場シェア分析HORIBA, Ltd. Market Share Analysis Summary GlobalData’s new report, “HORIBA, Ltd. Market Share Analysis” provides in-depth information on Horiba, Ltd.’s market position in the different medical equipment markets it operates in. The report provides Horiba, Ltd. market share information in one key market category – Haematology. The report also provides data and information on the overall competitive …
- 世界のイメージングバイオマーカー市場動向:Global Imaging Biomarkers Market 2014-2018TechNavio's analysts forecast the Global Imaging Biomarkers market to grow at a CAGR of 15.09 percent over the period 2013-2018. One of the key factors contributing to this market growth is the increasing prevalence of cancer. The Global Imaging Biomarkers market has also been witnessing the emergence of personalized medicines. However, the poor regulatory and reimbursement systems could pose a ch …
- 石油・ガス部門におけるビッグデータの世界市場2018-2022About Big Data Market in the Oil and Gas Sector Big data includes software and services that are utilized to handle extremely massive volumes of information stored inside enterprise systems. Big data analytics helps enterprises optimize their business decisions and innovate new business models, products, and services offerings based on the data collected. Technavio’s analysts forecast the Global B …
- 産業用高剪断ミキサーの世界市場2019-2023About this market The inefficiencies in mixing operations can lead to various issues such as long cycle time, frequent rework: and low product quality. Hence, the process industries prefer processing equipment such as industrial high-shear mixers to improve the mixing operations in processing plants. Industrial high-shear mixers can be easily be connected to any mixing vessel outlet, and the flow …
- 成人用おむつの中東・アフリカ市場2019-2023About this marketThe rise in innovative product offerings is one of the key factors expected to trigger the adult diapers market growth in MEA during the forecast period. Product innovations are leading to the development of comfortable, thin adult diapers, convenient diapers with excessive retention capacity and increased fluid absorption. Vendors are also introducing several innovative designs o …
- ATVコイルオーバー・ショックの世界市場ABSTRACTAbout ATV Coilover Shock A coilover shock is a suspension device that comprises a shock absorber along with a coil spring encircled over it. The coil springs, along with the shock absorbers, are replaced as a unit if there is leakage in the shock absorbers. Coilover shocks are stiffened shocks and provide damping without torsional loads. Coilover shock is a suspension device that consists …
- 自動車用ステアリングコラムの世界市場2019-2023About this market Steering systems in the automotive industry have been recording continuous advances. They have evolved from purely mechanical hydraulic steering to completely electronic steer-by-wire systems. The market has witnessed recent advances help in enhancing the ease of driving and bolstering on-road safety. Apart from these, the demand for high fuel economy is one of the major drivers …
- 世界のグリーン建設(緑の建築)市場動向• The report presents an in-depth analysis of industry executives’ opinions about the adoption of green construction • The report identifies key reasons for companies not to undertake green construction projects • The report highlights the key priorities of industry executives with regards to the transformation of green construction activities in their future construction projects • The report asc …
- Fallopian Tube Cancer:グローバル臨床試験レビューH2, 2013Fallopian Tube Cancer Global Clinical Trials Review, H2, 2013 Summary GlobalData's clinical trial report, “Fallopian Tube Cancer Global Clinical Trials Review, H2, 2013" provides data on the Fallopian Tube Cancer clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Fallopian Tube Cancer. It includes an overview of the trial numbers and the …