Dublin, Aug. 06, 2021 (GLOBE NEWSWIRE) -- The "Global Markets for Orphan Drugs" report has been added to ResearchAndMarkets.com's offering.
The Global Orphan Drug Market is Set to Grow to $191 billion by 2019, Demonstrating a CAGR of 9.2% during the forecast period (2014 to 2019)
The scope of this study includes orphan drugs used in the global pharmaceutical markets. This report analyzes the therapeutic applications of orphan drugs in rare and orphan diseases as well as examines the regulatory framework, patents, and recent innovations in the industry.
The report also analyzes each submarket and its applications, projections and market shares. Technological issues include the latest trends and developments.
This report covers the U.S. and European markets, and emerging global markets such as India, Japan, China, Singapore, Taiwan, Korea, Canada, Brazil, Africa, Australia and New Zealand.
This report also analyzes the regulatory framework for the clinical trials of orphan drugs in rare and orphan diseases. The report examines the trends and characteristics of clinical trials conducted on rare diseases from 1999-2018, using information from various sources. In addition, this report provides an overview of the global orphan drugs market and its competitive landscape.
Analyses of the global market trends, with data from 2020, estimates for 2021 and projections of compound annual growth rates (CAGRs) through 2026
Estimation of market size and revenue forecast for biological and non-biological orphan drugs, and corresponding market share analysis by product type, therapeutic category and geographic region
Emphasis on the regulation of clinical trials on orphan designated drugs by leading regulatory authorities including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) of Japan
Review of the current status and trends in clinical trials for the development of drugs in rare diseases among the three registries from the U.S., EU and Japan
Discussion of successful orphan medicinal products, rising influence of pharmacogenomics in the ODs market, information on specific rare diseases for which orphan drugs exist
Assessment of the most promising therapeutic areas in the industry and leading orphan drugs in these areas
Highlights of the industry structure for orphan drugs, pricing and reimbursement policies, COVID-19 impact assessment and market share analysis of the top 20 manufacturers of orphan drugs
Descriptive company profiles of the market leading participants, including AbbVie Inc., Eli Lilly, Johnson & Johnson, Merck & Co., Pfizer Inc. and Sanofi-Aventis
Key Topics Covered:
Chapter 1 Introduction
Chapter 2 Summary and Highlights
Chapter 3 Definitions and Background
Types of Orphan Drugs
Biological Orphan Drugs
Chemical or Non-biological 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
Controlled Substances Act
Special Protocol Assessments
New Surveillance and Safety Requirements
Regulation of Clinical Trials in Orphan-Designated Drugs
Content and Format of a Sponsor's Request
Providing Written Recommendations
Refusal to Provide Written Recommendations
Orphan Drug Designation
Orphan Drug Exclusive Approval
Chapter 5 European Regulation of Clinical Trials in Orphan-Designated Drugs
European Orphan Regulation
Applying for Orphan Designation
Application Challenges and Maintenance
Demonstrating Significant Benefit
Activities After Orphan Designation: Annual Reports
Activities During Marketing Authorization Application
Maintenance of the Orphan Drug Status
Chapter 6 Asian Regulation of Clinical Trials in Orphan-Designated Drugs
Orphan Drug Designation System in Japan
Orphan Drug/Medical Device Designation Procedure
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 by Region
Biological Orphan Drugs
Market by Region
Non-biological Orphan Drugs
Market by Region
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
Orphan Drug Act and Similar Legislation
Technological Advances and Genetic Codes
Innovations in Manufacturing Technologies
Collaborations and Licensing Agreements
Lack of Trained Professionals
Vulnerable Target Groups
Chapter 10 Orphan Drug Exclusivity and Pricing Policies
Reimbursed Price of ODs: Current Strategies and Potential Improvements
Comprehensive Value Assessment
Innovative Reimbursement Approaches
Societal Participation in Producing ODs
Chapter 11 Company Profiles
Astellas Pharma Inc.
Eisai Co., Ltd.
Eli Lilly And Co.
F. Hoffmann-La Roche Ltd.
Gilead Sciences Inc.
Johnson & Johnson
Merck & Co.
Takeda Pharmaceutical Co., Ltd.
Teva Pharmaceutical Industries Ltd.
Chapter 12 Clinical Trials in Drugs for Rare Diseases
For more information about this report visit https://www.researchandmarkets.com/r/dye3lv
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