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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