US Orphan Drug Market Sales Revenue Opportunity Report 2018

In the largest market for orphan drugs, USA, there was a shortage of adequate therapies for treating many rare diseases. These therapies were not developed as companies did not expect these drugs to be highly profitable. Hence there was a lack of interest and thus investment on the part of pharma companies in the USA. Therefore, the FDA introduced incentives for developing such drugs. This step taken by the FDA was successful in creating a thriving market for orphan drugs.

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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

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

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 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 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

Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas. By translating research answers into strategic insight and direction, we not only rate the success potential of your products and/or services, but also help you identify the opportunities for growth in new demographies and find ways to beat competition.

Neeraj Chawla
neeraj@kuickresearch.com
KuicK Research
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