Global Orphan Cancer Drug Market Sales Revenue Clinical Trials Pipeline Report

The drug development strategies of the pharmaceutical companies is undergoing a paradigm shift from manufacturing traditional essential medicines to orphan drugs due to significant competition from generics and the associated economic situation. The returns on investment from orphan drugs are expected to help the pharma companies to overcome the impact of revenue loss due to expiry of patents of blockbuster drugs. The major drivers for companies to increasingly invest in orphan drugs include government incentives for drug development and strong support from the FDA and EU Commission in special protocols. Inspite of pharma companies facing many obstacles in this field, this segment of orphan drugs is likely to have the potential to provide the key to recovery and stability within the market.

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"Global Orphan Cancer Drug Market & Clinical Pipeline Insight" Table of Contents

1. Introduction to Orphan Drugs
1.1 What are Orphan Drugs?
1.2 Why Need for Orphan Drugs?

2. Orphan Drug Designation Criteria: US, Europe & Asia

3. Orphan Drug Patent Protection & Market Exclusivity

4. Orphan Drug Regulatory Framework
4.1 FDA Guidelines
4.2 EMA Guidelines

5. Orphan Drug Reimbursement Policy: US, Europe & Asia

6. Global Orphan Cancer Drug Market Outlook
6.1 Market Overview
6.2 Orphan Cancer Drug Clinical Pipeline Analysis

7. Orphan Cancer Drugs Clinical Pipeline by Phase, Country & Target Indications
7.1 Phase Unknown
7.2 Preclinical
7.3 Clinical
7.4 Phase I
7.5 Phase I/II
7.6 Phase II
7.7 Phase II/III
7.8 Phase III
7.9 Preregistration
7.10 Registered

8. Marketed Orphan Cancer Drugs

9. Suspended & Discontinued Orphan Cancer Drugs in Clinical Pipeline
9.1 No Development Reported
9.2 Discontinued

10. Competitive Landscape
10.1 Bristol Myers Squibb
10.2 Celgene
10.3 Eli Lilly
10.4 Enzon-Pharmaceuticals
10.5 Endocyte
10.6 Glaxosmithkline
10.7 Merck
10.8 Novartis Pharmaceuticals
10.9 Nerviano Medical Sciences
10.10 Pfizer
10.11 Roche
10.12 Sanofi

Figure 1-1: Orphan v/s Non-Orphan Drugs -Phase II to Launch Clinical Development Time
Figure 1-2: Cancer Drug Approval Time (Years)
Figure 1-3: Percentage of Cancer Drug Approved
Figure 1-4: Probability of Regulatory Success of Orphan v/s Non-Orphan Drugs
Figure 1-5: Time Approval for Medicine With Special & Non Special Status
Figure 1-6: Number of Orphan Cancer & Non-Cancer Drug Approval (2002, 2007-2011)
Figure 1-7: Orphan Drug Designation V/s Orphan Drug Approval
Figure 3-1: Orphan Drug Market Exclusivity by Country
Figure 6-1: Global Orphan Drugs Market Value (US$ Billion), 2012-2018
Figure 6-2: Global Orphan Drugs Market by Therapeutic Area, 2012 & 2018
Figure 6-3: Orphan Cancer Drug Market (US$ Billion), 2012-2018
Figure 6-4: Orphan Cancer Drug Pipeline by Clinical Phase (%), 2014
Figure 6-5: Orphan Cancer Drug Pipeline by Clinical Phase (Number), 2014
Figure 6-6: Discontinued & No Development Reported in Orphan Cancer Drug Pipeline, 2014

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Neeraj Chawla
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KuicK Research
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