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US Orphan Drug Market Outlook 2018

Table of Contents

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. US Orphan Drug Market Outlook
3.1 Orphan Drug Designation Criteria
3.2 Market Overview
3.3 Reimbursement Policy for Orphan Drugs

4. US Orphan Drug Regulatory Framework
4.1 Content & Format of a Request for Written Recommendations
4.2 Provision for Granting & Refusing Written Recommendations
4.3 Content & Format of a Request for Orphan Drug Designation
4.4 Verification of Orphan Drug Status & Resident Agent for Foreign Sponsor
4.5 Timing of Requests for Orphan Drug Designation & Designation Of Already Approved Drugs
4.6 Deficiency Letters &Granting Orphan Drug Designation
4.7 Refusal to Grant Orphan Drug Designation
4.8 Amendment & Change in Ownership to Orphan Drug Designation
4.9 Publication & Revocation of Orphan Drug Designations
4.10 Annual Reports of Holder of Orphan Drug Designation
4.11 Scope & FDA Recognition of Orphan Drug Exclusive Approval
4.12 Protocols for Investigations & Availability of Information

5. US Orphan Drug Pipeline Insight by Phase & Indication
5.1 Research
5.2 Preclinical
5.3 Phase I
5.4 Phase I/II
5.5 Phase II
5.6 Phase II/III
5.7 Phase III
5.8 Preregistration
5.9 Registered

6. Marketed Orphan Drugs in US: Brand Name & Indication

7. Key Issue to be Resolved
7.1 High Initial Investment
7.2 Clinical Study Hurdles
7.3 Regulatory Hurdles
7.4 Different Reimbursement Policy

8. Competitive Landscape
8.1 Pfizer
8.2 Roche (Genentech)
8.3 Sanofi
8.4 Rare Disease Therapeutics
8.5 Glaxosmithkline
8.6 Merck
8.7 Novartis Pharmaceuticals
8.8 Alexion
8.9 Celgene
8.10 Biogen Idec
8.11 Eli Lilly
8.12 Bristol Myers Squibb

List of Tables

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 Cost
Table 2-5: Orphan Drugs in the EU and their Cost
Table 2-6: Incentives for the Development of Orphan Drugs
Table 2-7: Orphan Drug Incentives by Country
Table 5-1: US - Orphan Drugs in Research Phase
Table 5-2: US - Orphan Drugs in Preclinical Phase
Table 5-3: US - Orphan Drugs in Clinical Phase I
Table 5-4: US - Orphan Drugs in Clinical Phase I/II
Table 5-5: US - Orphan Drugs in Clinical Phase II
Table 5-6: US - Orphan Drugs in Clinical Phase II/III
Table 5-7: US - Orphan Drugs in Clinical Phase III
Table 5-8: US - Orphan Drugs in Preregistration Phase
Table 5-9: US – Registered Orphan Drugs
Table 6-1: US – Marketed Orphan Drugs by Indication & Brand Name
Table 7-1: Orphan Drug Clinical Study Hurdles

List of Figures

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: US Orphan Drug Market (US$ Billion), 2012-2018
Figure 3-2: US Share in Global Orphan Drug Market, 2012 & 2018
Figure 3-3: Biological & Non Biological Orphan Drug Segment (%), 2012 & 2018
Figure 3-4: Biological & Non Biological Orphan Drug Market (US$ Billion), 2012-2018
Figure 5-1: US- Orphan Drug Development by Clinical Phase (%), 2014
Figure 5-2: US - Number of Orphan Drug by Clinical Phase, 2014
Figure 5-3: US – Number of Suspended & Discontinued Number of Orphan Drug, 2014
Figure 5-4: US - Number of Discontinued Orphan Drug by Clinical Phase, 2014
Figure 5-5: US - Number of Suspended Orphan Drug by Clinical Phase, 2014
Figure 5-6: US - Number of No Development Reported Orphan Drug by Clinical Phase, 2014
Figure 7-1: Orphan Drug Regulatory Hurdles
Figure 8-1: Genzyme Drug Pipeline Chart

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Published By :Kuick Research
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