目次

Chapter- 1: Introduction
Study Goals and Objectives
Reasons for Doing This Study
What's New in This Update
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports

Chapter- 2: Summary and Highlights
Table Summary : Global Market for Orphan Drugs, by Product Type, Through 2026
Figure Summary : Global Market for Orphan Drugs, by Product Type, 2020-2026

Chapter- 3: Definitions and Background
Types of Orphan Drugs
Global Definitions of Rare Diseases by Country/Region

Chapter- 4: FDA Regulation of Clinical Trials in Orphan-Designated Drugs
Regulation of Drugs and Biologics
Regulation of Clinical Trials in Orphan-Designated Drugs

Chapter- 5: European Regulation of Clinical Trials in Orphan-Designated Drugs
European Orphan Regulation
Application Challenges and Maintenance
Activities After Orphan Designation: Annual Reports
Activities During Marketing Authorization Application

Chapter- 6: Asian Regulation of Clinical Trials in Orphan-Designated Drugs
Orphan Drug Designation System in Japan
Regulation of Rare Diseases and Orphan Drugs in Taiwan
Regulation of Rare Diseases and Orphan Drugs in South Korea

Chapter- 7: Trends in Clinical Trials for Drug Development in Rare Diseases
NCT, EUCTR and JPRN Registry Characteristics
The Relationship Among Clinical Trials, Diseases and Drugs
Characteristics of the Three Registries and Disease-Drug Relationships

Chapter- 8: Global Orphan Drug Market Analysis
Market Overview
Market Revenue
Market Shares
Market by Region
Biological Orphan Drugs
Non-biological Orphan Drugs
Global Market by Product Type
Global Orphan Drug Sales by Therapeutic Category

Chapter- 9: Industry Structure and Current Trends
Impact of COVID-19 on the Orphan Drug Market
Factors Boosting the Orphan Drug Market
Challenges
Table 22 : Market Shares of Top 20 Companies, 2020

Chapter- 10: Orphan Drug Exclusivity and Pricing Policies
Reimbursed Price of ODs: Current Strategies and Potential Improvements
Table 23 : Orphan Drug Approvals and Exclusivity, 2020

Chapter- 11: Company Profiles
ABBVIE INC.
ASTELLAS PHARMA INC.
ASTRAZENECA PLC
BRISTOL-MYERS SQUIBB
EISAI CO., LTD.
ELI LILLY AND CO.
F. HOFFMANN-LA ROCHE LTD.
GILEAD SCIENCES INC.
JOHNSON & JOHNSON
MERCK & CO.
NOVARTIS AG
PFIZER INC.
SANOFI-AVENTIS
TAKEDA PHARMACEUTICAL CO., LTD.
TEVA PHARMACEUTICAL INDUSTRIES LTD.

Chapter- 12: Clinical Trials in Drugs for Rare Diseases
List of Clinical Trials in Drugs for Rare Diseases

Chapter- 13: Appendix: References and Acronyms
References
Acronyms