openPR Logo
Press release

Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026

03-12-2020 12:59 PM CET | Health & Medicine

Press release from: PNS Pharma

"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights:

o Global Orphan Drug Market Opportunity: US$ 300 Billion
o US Dominates Global Orphan Drug Market: 50% Market Share
o US Orphan Drug Opportunity To Surpass: US$ 150 Billion
o Global Orphan Drug Clinical Insight: More Than 900 Drugs
o Clinical Insight on Marketed Orphan Drugs: More Than 400 Drugs
o Oncology To Dominate Orphan Drug Development: 35% Share
o FDA & EMA Regulations For Orphan Drugs
o Orphan Drug Designation Criteria & Reimbursement Policy by Country

Download Report: https://www.pnspharma.com/buy-report.php?reporttitle=Global-Orphan-Drug-Clinical-Trials%2C-Patent-%26-Guidelines-Insight-2026

The research report "Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" discusses about the recent trends and opportunities that the orphan drug market has brought into the pharmaceutical sector. The information related to the current status of the evolving market strategies and ongoing clinical studies by the companies involved in development of the orphan drugs is elaborately discussed in the report. The research report shares the information related to drugs that have been successfully designated as orphan drugs by respective approval authorities, with an exclusive insight on clinical uniqueness and patent information. In addition to the commercial information, the report brings a deep insight about the efforts that have been put to establish the market as it is now.

" Global Orphan Drug Market Is Estimated To Witness 150% Market Growth By 2026 As Compare To 2018"

Orphan drugs market has been recently recognized as a promising therapeutic market as the diseases that are covered under the market are life-threatening diseases. The FDA & EMA have designated a drug as orphan drug for which the cases in the US are less than 0.2 Million and not more than 5 in 10,000 people across the EU. Earlier the orphan drug segment was overlooked by the big pharmaceutical companies as developing and marketing of these drugs was considered not so profitable. Majority of the research and development activities related to orphan drugs were done by small size pharmaceutical firms and less than 25% of the orphan drugs were being researched and developed by the big firms.

The enactment of 1983 US Orphan Drug Act, as well as similar Acts in 1991 in Singapore, 1993 in Japan, 1997 in Australia and in 2000 by the European Union led to rapid transformation of global orphan drug market landscape which was earlier neglected by the multiple stake holders of the pharmaceutical industry. The structured regulatory and policy framework favoring the research and development of orphan designated drugs resulted in the much needed thrust for the development of global orphan drug market. These laws allowed the various financial incentives, market exclusivity, patent protection, high price allotment and government grants, which resulted in favorable economic environment for the entry of big pharmaceutical companies in the orphan drug segment.

The entry of mid and large size pharmaceutical companies helped in the speeding up the clinical research activities related to orphan drugs. The number of clinical trials increased drastically in last 10 years to more than 500 for orphan drugs as compared to few hundred trials in beginning of 21st century. Currently, more than 400 orphan designated drugs are commercially available in the marketed and close to 1000 drugs are undergoing clinical trials. The number of clinical trials covering the rare diseases has been observed to increase in the recent years with a major participation of the players such as Roche, Celgene, AbbVie, Johnson & Johnson, Shire, Alexion, Novo Nordisk, Sanofi and Bayer. The various major key players and the rising demand of the orphan drugs clearly depicts about the escalation that the market will experience in the future.

The availability of large number of orphan drugs by limited firms provides an excellent fundamental benefit to the emerged market in the present as well as in future. The dynamic interest scenario that has been delivered by the users since its arrival has completely changed the landscape of the market. The drastic change from few users in the past to millions of users till now has been successful in proving the importance of orphan drugs in the market. It is well witnessed from analyzing the market value of orphan drugs that clinicians as well as rare disease patients are now more inclined towards its use, thereby, promoting a form of treatment that is more mainstream.

As per report findings, the orphan drug market is open to serve the globe with an approach that is about to bring a fresh new era for the life threatening diseases. The ongoing clinical research at preclinical and clinical levels and the major trends followed by the regions such as North America and Europe are about to introduce a drastic change in overall scenario of the approach. The market is driven by the anticipation of the players and the huge commercial success that the market has foreseen in few years. The enhancement and the shape that the market has developed since years is about to get evolved as a serious option for rare diseases.

Contact:
Rajesh Arora
rajesh@pnspharma.com

Delhi
India

PNS Pharma is a pioneer in offering exclusive research reports for the pharmaceuticals industry. PNS Pharma offers Syndicated Research Reports on Drug Pipeline and Company Pipeline Analysis. These reports include comprehensive information related to the development of various drugs across clinical pipeline. Further, the reports include details on the originator, Owner, License, Chemical Formula, Patent Information, Phase of development, and Phase of development by country for each specific drug. The reports on company pipeline include all the drugs developed by particular companies across different therapeutic segments and phases and in different countries.

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026 here

News-ID: 1964562 • Views:

More Releases from PNS Pharma

Global Gene Therapy Market Opportunity By Clinical Trials Pipeline sales Kymriah …
"Global Gene Therapy Market Opportunity & Clinical Trials Insight 2026" Report Highlight: o Global Gene Therapy Market Opportunity: > US$ 8 Billion o Global Gene Therapy Clinical Pipeline: > 1000 Therapies In Clinical Trials o Commercially Available Gene Therapies: 11 o USA Dominates Global Gene Therapy Pipeline: > 500 Therapies In Clinical Trials o Cancer Accounts For 50% of Global Gene Therapy Trials Download Report: https://www.pnspharma.com/buy-report.php?reporttitle=Global-Gene-Therapy-Market-Opportunity-%26-Clinical-Trials-Insight-2026 Over the years, gene therapy has been highly responsible for decreasing the mortality rate
Global Orphan Drug Market Clinical Trials Pipeline Report Market Study 2026
"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights: o Global Orphan Drug Market Opportunity: US$ 300 Billion o US Dominates Global Orphan Drug Market: 50% Market Share o US Orphan Drug Opportunity To Surpass: US$ 150 Billion o Global Orphan Drug Clinical Insight: More Than 900 Drugs o Clinical Insight on Marketed Orphan Drugs: More Than 400 Drugs o Oncology To Dominate Orphan Drug Development: 35% Share o FDA & EMA Regulations For Orphan Drugs o Orphan Drug Designation Criteria
Global Rare Disease Drug Market Opportunity To Surpass US$ 300 Billion By 2026
"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights: o Global Orphan Drug Market Opportunity: US$ 300 Billion o US Dominates Global Orphan Drug Market: 50% Market Share o US Orphan Drug Opportunity To Surpass: US$ 150 Billion o Global Orphan Drug Clinical Insight: More Than 900 Drugs o Clinical Insight on Marketed Orphan Drugs: More Than 400 Drugs o Oncology To Dominate Orphan Drug Development: 35% Share o FDA & EMA Regulations For Orphan Drugs o Orphan Drug Designation Criteria
Global Orphan Drug Market Opportunity To Surpass US$ 300 Billion By 2026
"Global Orphan Drug Clinical Trials, Patent & Guidelines Insight 2026" Report Highlights: o Global Orphan Drug Market Opportunity: US$ 300 Billion o US Dominates Global Orphan Drug Market: 50% Market Share o US Orphan Drug Opportunity To Surpass: US$ 150 Billion o Global Orphan Drug Clinical Insight: More Than 900 Drugs o Clinical Insight on Marketed Orphan Drugs: More Than 400 Drugs o Oncology To Dominate Orphan Drug Development: 35% Share o FDA & EMA Regulations For Orphan Drugs o Orphan Drug Designation Criteria

All 5 Releases


More Releases for Drug

Alcohol Testing And Drug Testing Equipment Market 2025 Segmentation, Application …
Market Study Report, LLC, has compiled an exhaustive research study of the ‘Alcohol Testing And Drug Testing Equipment market’, detailing every single market driver and intricately analyzing the business vertical. This ‘Alcohol Testing And Drug Testing Equipment market’ study will aid in seeking out new business opportunities and fine-tuning existing marketing strategies through insights regarding SWOT analysis, market valuation, competitive spectrum, regional share, and revenue predictions. Alcohol abuse and drug
How much Diabetes Drug Market Impact Worldwide Medical Drug Industry?
Diabetes Drug Market From an insight perspective, the market report focuses on various levels of analyses — industry analysis, market rank analysis, and company profiles, which together comprise and discuss basic views on the competitive landscape, high-growth regions, and countries as well as their respective regulatory policies, Types ,Applications and opportunities in the market.  Diabetes is a metabolic disorder in which the body glucose level is elevated. There are two types of diabetes
Hepatitis Drug Market Hepatitis Drug Clinical Pipeline Report 2023
For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990 Report Table of Contents 1. Introduction to Hepatitis Disease 1.1 Prologue 1.1.1 History of Hepatitis 1.1.2 Causes of Hepatitis Disease 1.2 Types of Viruses which are Responsible for Hepatitis Disease 2. Global Prevalence of Hepatitis Infection 3. Available Drug Classes for Hepatitis Disease Treatment 3.1 Interferon Alfa Therapy 3.2 Protease Inhibitors Therapy 3.3 Polymerase
Microcapsules Drug Delivery Market Microcapsules Drug Delivery Sales Report 2022
For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990 Report Table of Contents 1. Indispensable Advent of Microcapsules 1.1 Trajectory of Microencapsulation 1.2 Why and wherefores for Microencapsulation 2. Characterization of Microcapsules 2.1 Composition of Microcapsules 2.2 Parameters Influencing Microcapsules 3. Engineering Technology of Microcapsules 3.1 Physical Manufacturing Technologies 3.2 Physicochemical and Chemical Technologies 4. Applicability of Microcapsules 4.1 Microcapsules in Pharmaceuticals 4.2 Microcapsules in Nutraceuticals
AstraZeneca’s NMOSD Drug receives orphan drug designation
April 18, 2017 Orphan Drug European Medicine Agency has Announced orphan drug designation for inebilizumab (earlier known as MEDI-551) developed by AstraZeneca PLC (AZN) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The drug has already received orphan drug status from US Food and Drug Administration (FDA). NMOSD, also called Devic’s disease, is a rare, autoimmune disorder of the central nervous system (CNS) that affects the functioning
Drug Discovery Strategies, PBPK Modeling and Drug-Drug Interaction Explored and …
This year’s 12th annual ADMET conference and exhibition promises to deliver appearances from experienced pharmaceutical professionals from ADME and PK/PD organisations such as AbbVie, GSK, Roche and Bayer when it returns to London this June. The carefully selected speaker line up will be addressing early ADME application strategies and discussing the latest technologically advanced screening and testing models along with exploring ADMET technologies which will identify properties of a drug