Global Orphan Cancer Drug Market & Clinical Pipeline Insight 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.
Oncology has emerged as the most promising and revenue generating segment of global orphan drug market in recent years. A major reason for such a high level of concentration of oncology particularly is that the underlying genetic aberration of oncology generally helps in
the process of identification of the disease. Oncology, as a therapeutic area has also
transformed from evolution to customized or precision medicine in the pharmaceutical industry. Utilizing biomarkers to develop targeted treatments and therapies is an approach which is being increasingly used in recent years, which also further explains the reasons behind this therapeutic area’s majority share of orphan drug approvals.
Owing to high level of demand for better treatments for multiple types of cancer, there has
been a shift in focus of the pharmaceutical and biotechnology companies towards the Oncology sector. The global oncology market is experiencing a paradigm shift in terms of
targeted therapy methods, which would be used for patients in the coming decade. Specifically, breast cancer and non-small cell lung cancer (NSCLC) would continue to drive high levels of R&D due to the high incidence and subsequent potential for market success.
With the oncology pipeline for orphan drugs being very promising, it is expected that over the
next few years, many drugs are likely to be developed over a range of indications including the commonly diagnosed lung and colorectal cancer types. With the introduction of these products in the market, it is likely that there would be a significant improvement in the survival rates of the patients.
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Global Orphan Cancer Drug Market & Clinical Pipeline Insight
“Global Orphan Cancer Drug Market & Clinical Pipeline Insight” Report Highlights: • • • • • • • • •
Orphan Cancer Drug Market Outlook
Orphan Drug Designation Criteria: US, Europe & Asia
Reimbursement Policy: US, Europe & Asia
Regulatory Framework: FDA & EMA Guidelines
Orphan Cancer Drugs Clinical Pipeline by Phase, Country & Target Indications
Orphan Cancer Drug Patent Analysis
Orphan Cancer Drug in Development Phase: 235
Majority of Orphan Cancer Drugs in Phase-II: 81
Marketed Orphan Cancer Drugs: 70
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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
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Global Orphan Cancer Drug Market & Clinical Pipeline Insight 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
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Global Orphan Cancer Drug Market & Clinical Pipeline Insight
List of Figures 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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