【レポートの概要（一部）】
1. Introduction to Orphan Drug
2. Favorable Market Dynamics for Orphan Drugs Commercialization
2.1 Economic Viability
2.2 Drug Patent Expiry
2.3 Financial & Non-Financial Incentives
2.4 Patent & Market Exclusivity
2.5 R&D Investment
3. Global Orphan Drug Market Overview
4. Global Orphan Drug Market Segment Analysis
4.1 Biological & Non-Biological Orphan Drugs
4.2 Therapeutic Segmentation
4.3 Regional Segmentation
5. Global Orphan Drug Clinical Pipeline Overview
6. US Orphan Drug Market Overview
6.1 Orphan Drug Designation Criteria
6.2 Market Overview
6.3 Reimbursement Policy
7. Europe Orphan Drug Market Overview
7.1 Orphan Drug Designation Criteria
7.2 Market Overview
7.3 Reimbursement Policy
8. Asia Orphan Drug Market Overview
8.1 Orphan Drug Designation Criteria
8.2 Market Overview
8.3 Reimbursement Policy
9. FDA Regulation for Clinical Trials Orphan Designated Drugs
9.1 Content & Format of a Request for Written Recommendations
9.2 Provision for Granting & Refusing Written Recommendations
9.3 Content and Format of a Request for Orphan Drug Designation
9.4 Verification of Orphan Drug Status & Resident Agent for Foreign Sponsor
9.5 Timing of Requests for Orphan Drug Designation & Designation of Already Approved Drugs
9.6 Deficiency Letters and Granting Orphan Drug Designation
9.7 Refusal to Grant Orphan Drug Designation
9.8 Amendment & Change in Ownership to Orphan Drug Designation
9.9 Publication & Revocation of Orphan Drug Designations
9.10 Annual Reports of Holder of Orphan Drug Designation
9.11 Scope & FDA Recognition of Orphan Drug Exclusive Approval
9.12 Protocols for Investigations & Availability of Information
10. EMA Regulations for Clinical Trials of Orphan Designated Drugs
10.1 Committee for Orphan Medicinal Products
10.2 How to Apply for Orphan Designation in Europe
10.3 Marketing Authorization & Market Exclusivity
10.4 Transferring an Orphan Designation to another Sponsor
10.5 Mandatory Submission of Annual Report On Development
10.6 Incentives for Micro, Small and Medium-Sized Enterprises
10.7 Fee Reductions for Designated Orphan Medicinal Products
10.8 Procedure for Orphan Designation & Incentives for R&D (Regulation (EC) No 141/2000)
11. Asian Regulations for Clinical Trials of Orphan Designated Drugs
11.1 Taiwan Rare Disease and Orphan Drug Act
11.2 Japan Orphan Drug Regulation
12. Global Orphan Drugs Clinical Pipeline Insight & Patent Analysis by Company, Country, Indication & Phase
12.1 Unknown
12.2 Research
12.3 Preclinical
12.4 Clinical
12.5 Phase-I
12.6 Phase-I/II
12.7 Phase-II
12.8 Phase-II/III
12.9 Phase-III
12.10 Preregistration
12.11 Registered
13. Marketed Orphan Drugs Clinical Insight & Patent Analysis by Company, Country & Indication
14. Discontinued & Suspended Orphan Drugs in Clinical Trials
14.1 No Development Reported
14.2 Discontinued
14.3 Preregistration-Submission Withdrawal
14.4 Market Withdrawal
14.5 Suspended
15. Competitive Landscape
15.1 AOP Orphan
15.2 Agenus
15.3 Alexion
15.4 Bristol Myers Squibb
15.5 Biogen Idec
15.6 Celgene
15.7 Eli Lilly
15.8 Genethon
15.9 Genzyme Corporation
15.10 Glaxosmithkline
15.11 Merck
15.12 Novartis Pharmaceuticals
15.13 Orphan Europe
15.14 Pfizer
15.15 Prosensa
15.16 Rare Disease Therapeutics
15.17 Roche
15.18 Sanofi
15.19 Shire
15.20 Teva Pharmaceutical
【レポート販売概要】
■ タイトル：希少疾病用医薬品の世界市場動向■ 英文：Global Orphan Drug Market Future Outlook 2020
■ 発行日：2015年6月
■ 調査会社：KuicK Research
■ 商品コード：KUIK506191
■ 調査対象地域：グローバル
- ベビーキャリアの世界市場2016-2020About Baby Carriers Baby carriers provide mobility and hands-free convenience of carrying babies while performing other activities. The global baby carriers market is growing at significant rates in APAC and ROW. An increase in the number of dual-income families and the increased awareness about child health and safety have led to the high demand in these regions. The global market will grow at a …
- オンライン宝石販売の世界市場2017-2021ABSTRACTAbout Online Jewelry Retail Jewelry items include necklaces, brooches, rings, bracelets, and earrings. These may be attached to the body or clothes. The term "jewelry" is restricted to durable ornaments, excluding flowers. A key growth factor over the forecast period will be the compatibility of consumers with social and digital platforms. In addition, services such as free shipping and pr …
- ノートパソコン用CPU開発および主要メーカーの戦略The increasingly intense market competition from low-cost tablets is straining the shrunken global notebook PC market even further in 2014, and the effect is spilling over to the notebook PC supply chain, including CPUs (Central Processing Units). The processor manufacturers - which have long held a dominant position in the personal PC industry - are profoundly affected by the declining sales of n …
- エラストマー塗料の世界市場：アクリル系エラストマー塗料、ポリウレタン系エラストマー塗料、シリコーン系エラストマー塗料、ブチル系エラストマー塗料The global elastomeric coating market is projected to reach USD 13.58 Billion by 2021, registering a CAGR of 15.19% between 2016 and 2021. The global elastomeric coating market, along with its types and applications, witnessed a significant growth in the past few years and is estimated to continue in the coming years. An increase in demand from the construction industry because of its superior per …
- バルブのグローバル市場（～2019）The industry report Global Valve Market to 2019 - Market Size, Development, and Forecasts offers the most up-to-date market data on the actual market situation, and future outlook for valves in the world. The research includes historic market data from 2008 to 2014 and forecasts until 2019 which makes the report an invaluable resource for industry executives, marketing, sales and product managers, …
- フランスの使い捨て病院用品市場見通し（～2021）France Disposable Hospital Supplies Market Outlook to 2021 Summary GlobalData’s new report, "France Disposable Hospital Supplies Market Outlook to 2021", provides key market data on the France Disposable Hospital Supplies market. The report provides value, in millions of US dollars, volume (in units) and average price data (in US dollars), within market segments - Procedure Kits and Trays, Gloves, …
- 世界の画像診断（医療機器）市場2014：主要企業の戦略的分析Complete report $14,500. Individual company assessments $2,450. The report is available by company, section, market segment, and can be custom-tailored to your specific information needs and budget. This unique study is designed to provide diagnostic imaging industry executives with strategically significant competitor information, analysis and insight crucial to the development and im …
- 世界の水産飼料市場Fish require energy and essential nutrients for body-maintenance, movement, normal metabolic functions, and growth. Fish can obtain their energy and nutrients from natural food in ponds, from feed supplied by the farmers or from a combination of both the sources. Feed is a major expenditure for fish farmers as it accounts for 40% - 50% of the production cost. The global aquafeeds market is estimat …
- 医療産業におけるLBS（位置情報サービス）の世界市場2016-2020About the Location-Based Services (LBS) in the healthcare industry The use of LBS in the healthcare industry can improve the operational efficiency of small and large hospitals worldwide. The growth of the market is driven by several factors such as the increased deployment of RTLS tags inside hospitals and the improvement in Wi-Fi and wireless land area network (WLAN) infrastructure of hospitals. …
- 産業用安全センサの世界市場2017-2021ABSTRACTAbout Industrial Safety Sensors Industrial safety sensors are products used to reduce workplace accidents. These can sense the presence of human or object within the field/perimeter and slows down the process or stops, depending on the configuration. Safety light curtains, safety laser scanners, and safety edges are taken into consideration in the report scope. The global industrial safety …
- すず（Tin）の世界市場動向2014/2015The report presents a thorough study of tin, covering both global and regional markets. It aims to give a proper picture of the market, its trends, perspectives and opportunities. Comprehensive data showing tin worldwide production, consumption, trade statistics and prices are provided. Each country’s market overview covers the following: tin production in the country, major manufacturers, tin con …
- 多嚢胞性卵巣症候群(Polycystic Ovarian Syndrome)の治療薬パイプライン動向（2015年上半期版）Polycystic Ovarian Syndrome - Pipeline Review, H1 2015 Summary Global Markets Direct’s, ‘Polycystic Ovarian Syndrome - Pipeline Review, H1 2015’, provides an overview of the Polycystic Ovarian Syndrome’s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Polycystic Ovarian Syndrome, complete with comparative analysis at various stages, therapeut …
- 防火機器の世界市場：火炎検知器、煙検知器、熱感知器、スプリンクラー、消火器、非常用照明器具、火災通報装置、火災警報器などThe fire protection systems (FPS) play crucial role preventing the fire hazards. The increased risk of fire accidents is driving the demand for fire protection systems market globally. The fire protection systems market has experienced continuous advancement in fire protection technology. The FPS manufacturers are investing significant amounts on R&D, and are offering innovative and efficient fire …
- 体型改善（ボディコントゥーリング）の世界市場2016-2020About the Body Contouring Market Body contouring refers to the procedures used to remove excess fat, skin, or both to alter the shape of the body and achieve a desirable shape. These procedures provide obese and overweight people with quick and immediate results to avoid further complications. Body contouring is mostly performed on body areas that contain high fat deposits such as the torso, chest …
- 卵管がん(Fallopian Tube Cancer)：治療薬開発パイプライン動向（2015年上半期版）Fallopian Tube Cancer - Pipeline Review, H1 2015 Summary Global Markets Direct’s, ‘Fallopian Tube Cancer - Pipeline Review, H1 2015’, provides an overview of the Fallopian Tube Cancer’s therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Fallopian Tube Cancer, complete with comparative analysis at various stages, therapeutics assessment by drug t …
