Global Markets for Orphan Drugs

Aug 2021| PHM038F| BCC Publishing
Report Overview

Report Highlights

The global orphan drugs market should reach $248.2 billion by 2026 from $190.8 billion in 2021 at a compound annual growth rate (CAGR) of 5.4% for the forecast period of 2021 to 2026.

Report Includes

  • 26 tables
  • An updated review of the global markets for orphan drugs (ODs) within the healthcare industry
  • 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

Report Scope

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.

Analyst Credentials

BCC Publishing Staff comprises expert analysts who are skilled in conducting primary research, secondary research and data analysis and have decades of combined experience covering a wide range of industries, including healthcare, advanced materials and emerging technologies. Collectively, the team represents a diverse set of educational achievements with individual graduate work completed in fields such as microbiology, electrical engineering, business administration and surgery, among others.

Table of Contents & Pricing

All reports provided in PDF format. For shared licensing options (5+ Users), please call a representative at (+1) 781-489-7301 or contact us at info@bccresearch.com
Title/Chapter NamePagesPrice Member Price
Full Report: Global Markets for Orphan Drugs128 $5,500 Free
Chapter- 1: Introduction5Free DownloadFree
Chapter- 2: Summary and Highlights2$250Free
Chapter- 3: Definitions and Background3$132Free
Chapter- 4: FDA Regulation of Clinical Trials in Orphan-Designated Drugs15$660Free
Chapter- 5: European Regulation of Clinical Trials in Orphan-Designated Drugs7$308Free
Chapter- 6: Asian Regulation of Clinical Trials in Orphan-Designated Drugs7$308Free
Chapter- 7: Trends in Clinical Trials for Drug Development in Rare Diseases7$308Free
Chapter- 8: Global Orphan Drug Market Analysis13$572Free
Chapter- 9: Industry Structure and Current Trends5$220Free
Chapter- 10: Orphan Drug Exclusivity and Pricing Policies10$440Free
Chapter- 11: Company Profiles6$264Free
Chapter- 12: Clinical Trials in Drugs for Rare Diseases45$1,980Free
Chapter- 13: Appendix: References and Acronyms3$132Free
Published - Sep-2015| Analyst - Shalini Shahani Dewan| Code - PHM038E

Report Highlights

The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019, demonstrating a compound annual growth rate (CAGR) of 9.2% during the forecast period (2014 to 2019).

Report Includes

  • An overview of orphan drug criteria, the history of the Orphan Drug Act and its influence, advantages inherent in orphan drug designation, and future growth trends.
  • Analyses of global market trends, with data from 2013 and 2014, and projections of compound annual growth rates (CAGRs) through 2019.
  • Detailed discussion of successful orphan products.
  • Detailed analysis of blockbuster orphan drugs.
  • The rising influence of pharmacogenomics in the orphan drug market.
  • A discussion of specific rare diseases for which orphan drugs exist.
  • Analysis of the most promising therapeutic areas in the industry and leading orphan drugs in these areas.
  • An outline of legislation and regulation, including public and private agencies involved in support and development.
  • Technology trends analysis within the orphan drug market.
  • Comprehensive company profiles of major players in the industry.

Published - Jun-2013| Analyst - Shalini Shahani Dewan| Code - PHM038D

Report Highlights

The global market for orphan drugs reached nearly $86.1 billion in 2012. The market is expected to reach $112.1 billion in 2017 for a compound annual growth rate (CAGR) of 5.4%.

Report Includes

  • An overview of orphan drug criteria, the history of the Orphan Drug Act and its influence, advantages inherent in orphan drug designation, and future growth trends
  • Analyses of global market trends, with data from 2011 and 2012, and projections of compound annual growth rates (CAGRs) through 2017
  • Detailed discussion of successful orphan products
  • Detailed analysis of blockbuster orphan drugs
  • The rising influence of pharmacogenomics in the orphan drug market
  • A discussion of specific rare diseases for which orphan drugs exist
  • Analysis of the most promising therapeutic areas in the industry and leading orphan drugs in these areas
  • An outline of legislation and regulation, including public and private agencies involved in support and development
  • Technology trends analysis within the orphan drug market
  • Comprehensive company profiles of major players in the industry.

Published - May-2010| Analyst - Syamala Ariyanchira| Code - PHM038C

Report Highlights

  • Worldwide, the orphan drug market reached $84.9 billion in 2009. The market is expected to grow at a compound annual growth rate (CAGR) of nearly 6% to reach $112.1 billion by 2014. The U.S. accounted for 51% of the market in 2009 and is expected to grow at a CAGR of 8.9% to reach $65.9 billion by 2014.
  • Biologic drugs accounted for a major share (64.3%) of the orphan drug market with sales of $54.6 billion in 2009, up from $51.4 billion in 2008.  The size of the biologic orphan drug market is projected to grow at a 6.9% CAGR to reach $76.2 billion by 2014.
  • Orphan drugs for the cancer sector generated the largest amount of revenues, $30.6 billion in 2009, accounting for 36% of the market.  Revenues for cancer-related orphan drugs are expected to grow at a CAGR of 10% to reach $49.7 billion in 2014.
Published - Sep-2007| Analyst - Syamala Ariyanchira| Code - PHM038B

Report Highlights

  • The global orphan drugs market reached $58.7 billion in 2006, growing by 8% from $54.5 billion in 2005. It is expected to grow at a compounded annual growth rate (CAGR) of 7% to reach $81.8 billion by 2011.
  • Regionally, U.S. revenues in the market grew to $32.5 billion accounting for 55% of the market in 2006. The U.S. market is expected to grow at a CAGR of 8% to reach $47.8 billion by 2011.
  • Biologic drugs account for over 60% of the orphan drug market with sales of $35.3 billion in 2006, up from $30.2 billion in 2005. The market size of biologic orphan drugs is projected to grow at a 9% CAGR to reach $53.4 billion by 2011.
Published - Feb-2004| Analyst - Lynn Gray| Code - PHM038A

Report Highlights

  • The total worldwide market for orphan drugs, including sales for nonorphan applications, exceeded $28 billion in 2003.
  • This market is expected to rise at an AAGR (average annual growth rate) of 9.1% to reach $43.6 billion in 2008.
  • As a percentage of overall global drug sales, orphans are expected to increase their share from 7.0% in 2003 to 7.5% in 2008, as growth of the orphan market outpaces that of the total market.
  • As of mid-2003, 221 orphan drugs had been developed for the treatment of rare diseases affecting about 11 million patients.
  • Some orphan products have sales in excess of $1 billion annually.

Global Markets for Orphan Drugs

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