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미국의 희귀의약품 임상 파이프라인 분석

US Orphan Drug Clinical Pipeline Insight 2014

리서치사 PNS Pharma
발행일 2014년 08월 상품 코드 310696
페이지 정보 영문 2000 Pages
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미국의 희귀의약품 임상 파이프라인 분석 US Orphan Drug Clinical Pipeline Insight 2014
발행일 : 2014년 08월 페이지 정보 : 영문 2000 Pages

미국의 희귀의약품 연구개발(R&D)은 공공 프로그램, 정부 규제 및 정책에 의해서 촉진되고 있습니다. 희귀의약품 R&D 계획에는 보조금, 연구 지원, 제경비 면제, 세제 우대조치 및 희귀의약품 시장의 독점권 등이 포함됩니다. 2013년 미국의 희귀의약품 시장 가치는 490억 달러로 추정됩니다. 시장은 정부 지원, 높은 수익성 등의 요인에 의해 2018년까지 600억 달러를 넘어설 것으로 예측됩니다.

미국의 희귀의약품(Orphan Drug) 시장에 대해 조사하고, 시장 개요, 단계·국가별 임상시험 분석, 출시약, 임상시험이 정지·중지된 약제 개요 및 경쟁 구도 등의 정보를 전해드립니다.

제1장 미국의 희귀의약품 시장 : 서론

  • 시장 개요
  • 임상 파이프라인 분석

제2장 미국의 희귀의약품 규제 체제

  • 희귀의약품 지정 기준
  • 희귀의약품의 의료비 상환 정책
  • FDA 규제

제3장 미국의 희귀의약품 임상 파이프라인 : 단계 및 국가별

  • 단계 불명
  • 연구
  • 전임상
  • 임상
  • 단계 I
  • 단계 I/II
  • 단계 II
  • 단계 II/III
  • 단계 III
  • 사전 등록
  • 등록 완료

제4장 출시된 희귀의약품 임상 분석 : 적응증 및 기업별

제5장 임상 파이프라인에서 정지 및 중지된 희귀의약품 : 단계, 적응증 및 기업별

  • 미개발
  • 중지
  • 시장 철수
  • 정지

제6장 경쟁 구도

  • Alexion
  • Biogen Idec
  • Bristol Myers Squibb
  • Celgene
  • Eli Lilly
  • Glaxosmithkline
  • Merck
  • Novartis Pharmaceuticals
  • Pfizer
  • Roche
  • Rare Disease Therapeutics
  • Sanofi

도표

KSM 14.09.03

Rare diseases are also known as Orphan diseases. These diseases are generally categorized as chronic, degenerative, and life-threatening in nature. The rare diseases normally include certain cancers, metabolic conditions, diseases of the nervous system and musculoskeletal disorders, which are extremely life-threatening. As per the official definition, rare diseases are classified as those that affect fewer than 200,000 in the US and less than 5 in 10,000 in the EU.

The orphan drugs enjoy significant competitive advantages owing to the market exclusivity period after the drug has been authorized. Through this clause, the manufacturer of orphan drugs is given a monopoly status in the market because according to the law, no other company is allowed to market the orphan drugs during the exclusivity period. Additionally, this monopolistic power is further strengthened with the fact that no other alternative health technology exists for many orphan drugs.

In US, the research & development of orphan drugs is facilitated by public programs, government regulations, and policies. The major incentives for research & development of orphan drug include grants, research support, fee waivers, tax incentives, and orphan drug market exclusivity. In a highly specialized market like that of orphan drugs, though the impact of market exclusivity in the US has been positive yet relatively modest, a special platform for continued orphan drug development has been laid down by the economic incentives and public support mechanisms. In 2013, the US market for orphan drugs was estimated worth US$ 49 Billion. With factors like government support, high profitability and many more, this market is expected to surpass US$ 60 Billion by 2018.

"US Orphan Drug Pipeline Insight 2014" Report Highlight:

  • US Orphan Drug Market Insight & Orphan Drug Designation Criteria
  • Reimbursement Policy & FDA Regulatory Framework
  • US Orphan Drug Pipeline by Phase, Indication & Company
  • Marketed Orphan Drug Clinical Insight
  • US Orphan Drug Clinical Pipeline: 570 Drugs
  • Marketed Orphan Drugs in US: 203 Drugs
  • Majority Orphan Drugs in PHASE-II Development: 207 Drugs

Table of Contents

1. Introduction to US Orphan Market

  • 1.1 Market Overview
  • 1.2 Clinical Pipeline Overview

2. US Orphan Drug Regulatory Framework

  • 2.1 Criteria for Orphan Drug Designation
  • 2.2 Reimbursement Policy for Orphan Drugs
  • 2.3 FDA Regulation
    • 2.3.1 Content & Format for Written Recommendations
    • 2.3.2 Provision for Granting & Refusing Written Recommendations
    • 2.3.3 Content & Format for Orphan Drug Designation
    • 2.3.4 Verification of Orphan Drug Status & Resident Agent for Foreign Sponsor
    • 2.3.5 Requests for Orphan Drug Designation & Designation of Already Approved Drugs
    • 2.3.6 Deficiency Letters & Granting Orphan Drug Designation
    • 2.3.7 Refusal of Grant Orphan Drug Designation
    • 2.3.8 Amendment & Change in Ownership to Orphan Drug Designation
    • 2.3.9 Publication & Revocation of Orphan Drug Designations
    • 2.3.10 Annual Reports of Holder of Orphan Drug Designation
    • 2.3.11 Scope & FDA Recognition of Orphan Drug Exclusive Approval
    • 2.3.12 Protocols for Investigations & Availability of Information

3. US Orphan Drug Clinical Pipeline by Phase, Indication & Company

  • 3.1 Unknown
  • 3.2 Research
  • 3.3 Preclinical
  • 3.4 Clinical
  • 3.5 Phase-I
  • 3.6 Phase-I/II
  • 3.7 Phase-II
  • 3.8 Phase-II/III
  • 3.9 Phase-III
  • 3.10 Preregistration
  • 3.11 Registered

4. Marketed Orphan Drugs Clinical Insight by Indication & Company

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

  • 5.1 No development reported
  • 5.2 Discontinued
  • 5.3 Market Withdrawal
  • 5.4 Suspended

6. Competitive Landscape

  • 6.1 Alexion
  • 6.2 Biogen Idec
  • 6.3 Bristol Myers Squibb
  • 6.4 Celgene
  • 6.5 Eli Lilly
  • 6.6 Glaxosmithkline
  • 6.7 Merck
  • 6.8 Novartis Pharmaceuticals
  • 6.9 Pfizer
  • 6.10 Roche
  • 6.11 Rare Disease Therapeutics
  • 6.12 Sanofi

List of Figures

  • Figure 1-1: US Orphan Drug Market (US$ Billion), 2013-2018
  • Figure 1-2: US Share in Global Orphan Drug Market, 2013 & 2018
  • Figure 1-3: Biological & Non Biological Orphan Drug Segment (%), 2013 & 2018
  • Figure 1-4: Biological & Non Biological Orphan Drug Market (US$ Billion), 2013-2018
  • Figure 1-5: US - Orphan Drug Pipeline by Phase (%)
  • Figure 1-6: US - Orphan Drug Pipeline by Phase (Number)
  • Figure 1-7: US - No Development Reported in Orphan Drug Pipeline by Phase (%)
  • Figure 1-8: US - No Development Reported in Orphan Drug Pipeline by Phase (Number)
  • Figure 1-9: US - Discontinued Orphan Drug in Pipeline by Phase (%)
  • Figure 1-10: US - Discontinued Orphan Drug in Pipeline by Phase (Number)
  • Figure 1-11: US - Suspended Orphan Drug in Pipeline by Phase (%)
  • Figure 1-12: US - Suspended Orphan Drug in Pipeline by Phase (Number)
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