DUBLIN--(BUSINESS WIRE)--The "Global Orphan Drug Pipeline & Regulatory Insight 2025" report has been added to ResearchAndMarkets.com's offering.
The global orphan drug market opportunity is expected to surpass US$ 260 Billion by 2025
Global Orphan Drug Pipeline & Regulatory Insight 2025 report gives comprehensive insight on clinical and non-clinical parameters related to development and commercialization of orphan drug market. As per report findings, there are more than 350 orphan designated drugs commercially available in the market and more than 900 in the clinical pipeline. Most of the orphan drugs in clinical pipeline are in Phase - II trials followed by Phase - III trials. More than 30 new orphan designated drugs are further expected to enter the market in the next five years.
The orphan drug segment has emerged as a new growth frontier for pharmaceutical companies faced with issues like patent expiry, competition from generics and biosimilars, exhausting pipelines and stringent regulatory and policy framework. Increasing investment in clinical research and rapid commercialization of orphan drugs has resulted in the paradigm shift in operational strategy of pharmaceutical companies. In past, pharmaceutical companies were more focused on the research and development of essential medicines leading to high competition and low financial margins.
The exponential growth in global orphan drug market is driven by favorable regulatory and policy framework, increasing research and developmental activities, high ROI rates , government incentives for drug developmental, market exclusivity along with strong support from FDA and EU Commission in special protocols. The research and developmental activities for orphan drugs have also received impetus thrust from the pharmaceutical companies efforts to overcome the impact of revenue loss due to the patent expiry of blockbuster drugs.
In terms of therapeutic application, oncology has been predominant segment in the global orphan drug market landscape followed neurology, rheumatology, hematology, infectious diseases and others. Currently, more than 200 companies are partnering for research and development of more than 300 orphan designated drugs in oncology segment. Oncology, as a therapeutic area has also transformed from evolution to customized or precision medicine in the pharmaceutical industry. Utilizing biomarkers to develop targeted treatments and therapies is an approach which is being increasingly used in recent years, which also further explains the reasons behind this therapeutic area's majority share of orphan drug approvals.
Global Orphan Drug Pipeline & Regulatory Insight 2025 Report Highlights:
- Global Orphan Drug Market Overview: US$ 260 Billion Opportunity
- Global Orphan Drug Market by Segment
- Regulatory Landscape: USA, Europe & Asia
- Orphan Drug Designation & Reimbursement Policy: USA, Europe & Asia
- Global Orphan Drug Clinical Pipeline Insight: 973 Drugs
- Marketed Orphan Drug Clinical Insight: 366 Drugs
Key Topics Covered:
1. Orphan Drugs: Regimens For Rare Diseases
2. Drivers of Orphan Drug Commercialization
3. Global Orphan Drug Market Perspectives: Current Market Evaluations
4. Global Orphan Drug Market by Segmentation
5. Global Orphan Drug Clinical Pipeline Overview
6. Global Orphan Drug Designation Criteria
7. Global Orphan Drug Reimbursement Policy
8. FDA Regulation for Clinical Trials Orphan Designated Drugs
9. EMA Regulations for Clinical Trials of Orphan Designated Drugs
10. Asian Regulations for Clinical Trials of Orphan Designated Drugs
11. Global Orphan Drug Clinical Pipeline by Company, Indication & Phase
12. Marketed Global Orphan Drug Clinical Insight by Company & Indication
13. Competitive Landscape
- Agenus
- Alexion
- AOP Orphan
- Biogen Idec
- Bristol Myers Squibb
- Celgene
- Eli Lilly
- Genethon
- Genzyme Corporation
- Glaxosmithkline
- Merck
- Novartis Pharmaceuticals
- Orphan Europe
- Pfizer
- Prosensa
- Rare Disease Therapeutics
- Roche
- Sanofi
- Shire
- Teva Pharmaceutical
