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Global Orphan Cancer Drug Market & Clinical Pipeline Insight

出版商 KuicK Research 商品編碼 306543
出版日期 內容資訊 英文 969 Pages
商品交期: 最快1-2個工作天內
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世界稀有癌症治療藥物市場、臨床產品管道分析 Global Orphan Cancer Drug Market & Clinical Pipeline Insight
出版日期: 2014年06月26日 內容資訊: 英文 969 Pages



第1章 介紹:稀有疾病藥品

  • 稀有疾病用藥品是?
  • 稀有疾病藥品必要性

第2章 稀有疾病藥品指定基準:美國、歐洲、亞洲

第3章 稀有疾病藥品專利保護、獨家權力

第4章 稀有疾病藥品法律

  • FDA指南
  • EMA指南

第5章 稀有疾病藥品補償政策:美國、歐洲、亞洲

第6章 世界稀有癌症治療藥市場預測

  • 市場概要
  • 稀有癌治療藥臨床產品管道分析

第7章 稀有癌治療藥臨床產品管道:期數、國家、症狀分類

  • 不明
  • 前臨床
  • 臨床
  • 第一期
  • 第一/二期
  • 第二期
  • 第二/三期
  • 第三期
  • 登錄前
  • 已登錄

第8章 已上市的稀有癌治療藥

第9章 開發延期、中止的稀有癌治療藥

  • 沒有進展
  • 中止

第10章 競爭環境

  • Bristol Myers Squibb
  • Celgene
  • Eli Lilly
  • Enzon-Pharmaceuticals
  • Endocyte
  • Glaxosmithkline
  • Merck
  • Novartis Pharmaceuticals
  • Nerviano Medical Sciences
  • Pfizer
  • Roche
  • Sanofi



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.

“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

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

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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