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세계의 희귀의약품 임상 파이프라인 인사이트

Global Orphan Drug Clinical Pipeline Insight 2022

리서치사 PNS Pharma
발행일 2016년 12월 상품 코드 405244
페이지 정보 영문 2200 Pages
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세계의 희귀의약품 임상 파이프라인 인사이트 Global Orphan Drug Clinical Pipeline Insight 2022
발행일 : 2016년 12월 페이지 정보 : 영문 2200 Pages

세계의 희귀의약품 임상 파이프라인을 조사했으며, 희귀질환 및 희귀의약품의 개요, 각 지역의 희귀의약품 지정 기준, 개발 단계별 파이프라인 분석, 지역별 시장 규모 추이와 예측, 주요 사업자 개요 등을 정리하여 전해드립니다.

제1장 세계의 희귀의약품 시장 : 시장 개요

  • 시장 개요
  • 임상 파이프라인의 개요

제2장 세계의 희귀의약품 지정 기준

  • 미국 FDA
  • 유럽 EMA
  • 일본
  • 대만
  • 한국 KFDA(Korean Food and Drug Administration)
  • 호주

제3장 희귀의약품 개발 단계 : 불명

  • 개요
  • 임상 파이프라인에 관한 인사이트

제4장 희귀의약품 개발 단계 : 연구 단계

  • 개요
  • 임상 파이프라인에 관한 인사이트

제5장 희귀의약품 개발 단계 : 전임상 단계

  • 개요
  • 임상 파이프라인에 관한 인사이트

제6장 희귀의약품 개발 단계 : 임상 단계

  • 개요
  • 임상 파이프라인에 관한 인사이트

제7장 희귀의약품 개발 단계 : 제0상

  • 개요
  • 임상 파이프라인에 관한 인사이트

제8장 희귀의약품 개발 단계 : 제I상

  • 개요
  • 임상 파이프라인에 관한 인사이트

제9장 희귀의약품 개발 단계 : 제I/II상

  • 개요
  • 임상 파이프라인에 관한 인사이트

제10장 희귀의약품 개발 단계 : 제II상

  • 개요
  • 임상 파이프라인에 관한 인사이트

제11장 희귀의약품 개발 단계 : 제II/III상

  • 개요
  • 임상 파이프라인에 관한 인사이트

제12장 희귀의약품 개발 단계 : 제III상

  • 개요
  • 임상 파이프라인에 관한 인사이트

제13장 희귀의약품 개발 단계 : 신청 단계

  • 개요
  • 임상 파이프라인에 관한 인사이트

제14장 희귀의약품 개발 단계 : 승인 단계

  • 개요
  • 임상 파이프라인에 관한 인사이트

제15장 출시 희귀의약품의 임상적 인사이트 : 기업·적응증·단계별

  • 개요
  • 임상 파이프라인에 관한 인사이트

제16장 개발 중지·정지 희귀의약품 : : 기업·적응증·단계별

  • 개발 상황 보고 없음
  • 중지
  • 승인전 신청 취소
  • 시장 철수
  • 일시중지

제17장 경쟁 환경

  • AOP Orphan
  • Agenus
  • Alexion
  • Bristol Myers Squibb
  • Biogen Idec
  • Celgene
  • Eli Lilly
  • Genethon
  • Genzyme Corporation
  • Glaxosmithkline
  • Merck
  • Novartis Pharmaceuticals
  • Orphan Europe
  • Pfizer
  • Prosensa
  • Rare Disease Therapeutics
  • Roche
  • Sanofi
  • Shire
  • Teva Pharmaceutical
KSA 16.12.22

“Global Orphan Drug Clinical Pipeline Insight 2022” report gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.

As of 2016, almost 30 million people in the U.S. and 350 million people worldwide suffer from rare ailments known as “Orphan Diseases.” The name comes from the treatment meted out for such diseases, wherein the pharma industry was reluctant to develop drugs for such illnesses due to their economic unviability.

Elaborating the concept, a rare disease or orphan diseases are the one's which affects only a small population. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the United States and less than 5 in 10,000 in the EU. Consequently, in earlier times such truncated prevailed diseases were least attractive to the researchers and the investors. Previously, the market for orphan drugs was not as lucrative as it is today.

Nevertheless, the Scenario has changed after the Orphan Drug Act (ODA), 1983 was passed in United States and later various countries enacted similar laws. The number of requests for orphan drug designation received by FDA's Office of Orphan Products Development (OOPD) has grown dramatically in recent years and is prompting FDA to adjust its timeframes for reviewing orphan drug designations in order to meet the demand.

The Orphan drug Market has seen a tremendous growth in last 2 decades. There has been a paradigm shift in the pharma or biopharmaceutical market with focus on research and development for unmet medical / clinical needs, investing resources in developing drugs to treat rare clinical conditions thus targeting small pool of patients. More than 7000 diseases have been given the designation of being rare. Subsequently, the global market is ever growing for the orphan drugs due to many factors including tax credits, grants, waived FDA fees, reduced timelines for clinical development and a higher probability of regulatory approval. Other aspects such as the patent expirations, generic completions and drying pipelines are also enhancing the market growth.

Orphan drugs are not merely lifesavers for patients suffering from these debilitating diseases, but also a huge growth opportunity for the pharma industry. With ROIs nearly twice that of non-orphan drugs, R&D activity for newer orphan drugs is expected to witness an exponential increase in the near future. Most big pharma players are capitalizing on rare disease treatments by enhancing their pipelines or by acquiring promising molecules of smaller companies. While the orphan drug market is mostly restricted to the U.S. and Europe now, pharma companies are likely to start tapping into the Asian market which has a high population of untreated rare diseases. It seems growth of the global orphan drug market is inevitable.

Table of Contents

1. Global Orphan Drug Market Overview

  • 1.1. Market Overview
  • 1.2. Global Orphan Drug Clinical Pipeline Overview

2. Global Orphan Drug Designation Criteria

  • 2.1. US Food and Drug Administration (US FDA)
  • 2.2. European Medicines Agency (EMA)
  • 2.3. Japan
  • 2.4. Taiwan
  • 2.5. Korean Food and Drug Administration (KFDA)
  • 2.6. Australia

Global Orphan Drug Clinical Pipeline by Company, Indication & Phase

3. Orphan Drug Development Phase: Unknown

  • 3.1. Overview
  • 3.2. Clinical Pipeline Insight

4. Orphan Drug Development Phase: Research

  • 4.1. Overview
  • 4.2. Clinical Pipeline Insight

5. Orphan Drug Development Phase: Preclinical

  • 5.1. Overview
  • 5.2. Clinical Pipeline Insight

6. Orphan Drug Development Phase: Clinical

  • 6.1. Overview
  • 6.2. Clinical Pipeline Insight

7. Orphan Drug Development Phase: Phase-0

  • 7.1. Overview
  • 7.2. Clinical Pipeline Insight

8. Orphan Drug Development Phase: Phase - I

  • 8.1. Overview
  • 8.2. Clinical Pipeline Insight

9. Orphan Drug Development Phase: Phase - I/II

  • 9.1. Overview
  • 9.2. Clinical Pipeline Insight

10. Orphan Drug Development Phase: Phase - II

  • 10.1. Overview
  • 10.2. Clinical Pipeline Insight

11. Orphan Drug Development Phase: Phase - II/III

  • 11.1. Overview
  • 11.2. Clinical Pipeline Insight

12. Orphan Drug Development Phase: Phase - III

  • 12.1. Overview
  • 12.2. Clinical Pipeline Insight

13. Orphan Drug Development Phase: Preregistration

  • 13.1. Overview
  • 13.2. Clinical Pipeline Insight

14. Orphan Drug Development Phase: Registered

  • 14.1. Overview
  • 14.2. Clinical Pipeline Insight

15. Marketed Orphan Drug Clinical Insight by Company, Indication & Phase

  • 15.1. Overview
  • 15.2. Clinical Pipeline Insight

16. Discontinued & Suspended Orphan Drugs in Clinical Pipeline by Company, Indication & Phase

  • 16.1. No Development Reported
  • 16.2. Discontinued
  • 16.3. Preregistration Submission Withdrawal
  • 16.4. Marketed Withdrawal
  • 16.5. Suspended

17. Competitive Landscape

  • 17.1. AOP Orphan
  • 17.2. Agenus
  • 17.3. Alexion
  • 17.4. Bristol Myers Squibb
  • 17.5. Biogen Idec
  • 17.6. Celgene
  • 17.7. Eli Lilly
  • 17.8. Genethon
  • 17.9. Genzyme Corporation
  • 17.10. Glaxosmithkline
  • 17.11. Merck
  • 17.12. Novartis Pharmaceuticals
  • 17.13. Orphan Europe
  • 17.14. Pfizer
  • 17.15. Prosensa
  • 17.16. Rare Disease Therapeutics
  • 17.17. Roche
  • 17.18. Sanofi
  • 17.19. Shire
  • 17.20. Teva Pharmaceutical

List of Figures

  • Figure 1-1: Global Orphan Drugs Market Value (US$ Billion), 2015-2022
  • Figure 1-2: US - Orphan Drugs Market Value (US$ Billion), 2015-2022
  • Figure 1-3: Europe - Orphan Drugs Market Value (US$ Billion), 2015-2022
  • Figure 1-4: Asia* - Orphan Drugs Market Value (US$ Billion), 2015-2022
  • Figure 1-5: Global - Orphan Drug Clinical Pipeline by Phase (%), 2016 till 2022
  • Figure 1-6: Global - Orphan Drug Clinical Pipeline by Phase (Numbers), 2016 till 2022
  • Figure 1-7: Global - Orphan Drug Clinical Pipeline by Phase (%),2016 till 2022
  • Figure 1-8: Global - Orphan Drug Clinical Pipeline by Phase (Numbers), 2016 till 2022
  • Figure 17-1: AOP Orphan
  • Figure 17-2: Agenus Pipeline
  • Figure 17-3: Genethon Drug Pipeline
  • Figure 17-4: Genzyme Drug Pipeline
  • Figure 17-5: Orphan Europe Pipeline
  • Figure 17-6: Prosensa Drug Pipeline
  • Figure 17-7: Shire Drug Pipeline
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