世界の希用薬市場動向2018...市場調査レポートについてご紹介

1. Introduction to Orphan Drugs
1.1 Orphan Drug Defined
1.2 Rising Popularity of Orphan Drugs

2. Why Shift from Non-Orphan to Orphan Drugs?
2.1 Exhausting Product Pipelines
2.2 Profitability of Orphan Drugs
2.3 Increasing R&D Investment
2.4 Role of Economic Incentives
2.5 Patent Protection & Market Exclusivity

3. Global Orphan Drug Market Outlook
3.1 Market Overview
3.2 Biological & Non-Biological Orphan Drugs
3.3 Therapeutic Segmentation
3.4 Regional Segmentation

4. US Orphan Drug Market Outlook
4.1 Orphan Drug Designation Criteria
4.2 Market Overview
4.3 Reimbursement Policy
4.4 Regulatory Framework

5. Europe Orphan Drug Market Outlook
5.1 Orphan Drug Designation Criteria
5.2 Market Overview
5.3 Reimbursement Policy
5.4 Regulatory Framework

6. Asia Orphan Drug Market Outlook
6.1 Orphan Drug Designation Criteria
6.2 Market Overview
6.3 Reimbursement Policy
6.4 Regulatory Framework

7. Global Orphan Drug Pipeline Insight by Phase, Orphan Designated Disease & Country
7.1 Clinical Phase: Research
7.2 Clinical Phase: Preclinical
7.3 Clinical Phase: Phase I
7.4 Clinical Phase: Phase I/II
7.5 Clinical Phase: Phase II
7.6 Clinical Phase: Phase II/III
7.7 Clinical Phase: Phase III
7.8 Clinical Phase: Preregistration
7.9 Clinical Phase: Registered

8. Key Issue to be Resolved
8.1 High Initial Investment
8.2 Clinical Study Hurdles
8.3 Regulatory Hurdles
8.4 Different Reimbursement Policy
8.5 Distribution Challenges

9. Competitive Landscape
9.1 Pfizer
9.2 Roche
9.3 Sanofi
9.4 Rare Disease Therapeutics
9.5 Glaxosmithkline
9.6 Merck
9.7 Novartis Pharmaceuticals
9.8 Alexion
9.9 Celgene
9.10 Biogen Idec
9.11 Eli Lilly
9.12 Bristol Myers Squibb

Figure 2-1: Orphan v/s Non-Orphan Drugs -Phase II to Launch Clinical Development Time
Figure 2-2: Probability of Regulatory Success of Orphan v/s Non-Orphan Drugs
Figure 3-1: Global Orphan Drugs Market Value (US$ Billion), 2012-2018
Figure 3-2: Biological & Non Biological Orphan Drug Segment (%), 2012 & 2018
Figure 3-3: Biological & Non Biological Orphan Drug Market (US$ Billion), 2012-2018
Figure 3-4: Global Orphan Drugs Market by Therapeutic Area, 2012 & 2018
Figure 3-5: Regional Markets for Orphan Drugs, 2012 & 2018
Figure 4-1: US Market for Orphan Drugs (US$ Billion), 2012-2018
Figure 4-2: US – Orphan Drug Development by Clinical Phase (%)
Figure 4-3: US – Number of Orphan Drug by Clinical Phase
Figure 5-1: European Market for Orphan Drugs (US$ Billion), 2012-2018
Figure 5-2: Europe – Orphan Drug Development by Clinical Phase (%)
Figure 5-3: Europe – Number of Orphan Drug by Clinical Phase
Figure 6-1: Asia- Orphan Drug Development by Clinical Phase (%)
Figure 6-2: Asia – Number of Orphan Drug by Clinical Phase
Figure 6-3: Japan Orphan Drug/Medical Device Designation System
Figure 6-4: Japan Orphan Drug/Device Designation Process
Figure 7-1: Global – Orphan Drug Development by Clinical Phase (%)
Figure 7-2: Global – Number of Orphan Drug by Clinical Phase
Figure 7-3: Global – Number of Orphan Drug by Clinical Phase & Region
Figure 8-1: Orphan Drug Regulatory Hurdles

Table 2-1: Drugs Patent Expiry in 2014
Table 2-2: Drugs Patent Expiry in 2015
Table 2-3: Drugs Patent Expiry in 2016
Table 2-4: Orphan Drugs in the US and their Costs
Table 2-5: Orphan Drugs in the EU and their Costs
Table 2-6: Incentives for the Development of Orphan Drugs
Table 2-7: Orphan Drug Incentives by Country
Table 7-1: Global – Orphan Drugs in Clinical Development Phase: Research
Table 7-2: Global -Orphan Drugs in Clinical Development Phase: Preclinical
Table 7-3: Global – Orphan Drugs in Clinical Development Phase I
Table 7-4: Global – Orphan Drugs in Clinical Development Phase I/II
Table 7-5: Global – Orphan Drugs in Clinical Development Phase II
Table 7-6: Global – Orphan Drugs in Clinical Development Phase II/III
Table 7-7: Global – Orphan Drugs in Clinical Development Phase III
Table 7-8: Global – Orphan Drugs in Clinical Development Phase: Preregistration
Table 7-9: Global – Orphan Drugs in Clinical Development Phase: Registered