-
Americas
-
Asia & Oceania
-
A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
-
Americas
-
Asia & Oceania
-
Europe
-
Middle East & Africa
-
Americas
-
Asia & Oceania
-
Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
-
Research & Development
-
Real World Evidence
-
Commercialization
-
Safety & Regulatory Compliance
-
Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
- Information Partner Services
- Financial Institutions
- Public Health and Government
- Patient Associations
- Payers
- Providers
THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases and Vaccines
- Oncology
- Pediatrics
- Rare Diseases
- View All
Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MORE
Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
Research & Development OverviewResearch & Development Quick Links
Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
REAL WORLD EVIDENCE OVERVIEWReal World Evidence Quick Links
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWCommercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWSafety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWTechnology Quick Links
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
FEATURED INNOVATIONS
-
IQVIA Connected Intelligence™
-
IQVIA Healthcare-grade AI™
-
Human Data Science Cloud
-
IQVIA Innovation Hub
-
Decentralized Trials
-
Patient Experience powered by Apple
WHO WE ARE
- Our Story
- Our Impact
- Commitment to Public Health
- Code of Conduct
- Environmental Social Governance
- Privacy
- Executive Team
NEWS & RESOURCES
Unlock your potential to drive healthcare forward
By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
LEARN MORE
IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
LEARN MORE
Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
LEARN MORE
Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
LEARN MORE
Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
LEARN MORE
IQVIA Patient Experience Solutions powered by Apple
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.
LEARN MOREWORKING AT IQVIA
Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORELIFE AT IQVIA
Careers, culture and everything in between. Find out what’s going on right here, right now.
LEARN MORE
WE’RE HIRING
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSInstitute Report
The Prospects for Biosimilars of Orphan Drugs in Europe
Current Landscape and Challenges Ahead
Jul 21, 2020
About the Report
The landscape for biosimilars is rapidly changing. In Europe, many biologic products with orphan designations are reaching the end of their market exclusivity, allowing for the potential of affordable biosimilars to enter the market to the benefit of healthcare systems and patients alike. This report investigates the challenges biosimilar manufacturers are likely to encounter with clinical development and commercialization of orphan biosimilars as well as the implications of these products to European health systems.
Report Summary
The availability and access to treatments for rare diseases is of critical importance to European patients and healthcare systems. The introduction of biosimilars has the potential to result in savings, sustainably lower costs, and broader patient access to rare disease medicines. For example, five orphan biologics contributing approximately €501 million in total spending are losing market exclusivity by 2024. However, the clinical development of biosimilars brings different challenges for manufacturers than small molecule generics, such as the need to conduct comparative analytical and clinical testing, which can pose recruiting challenges in rare disease patient populations. Specifically, total development costs could run in the range of $40-50 million per orphan biosimilar. Similarly, there are a number of commercialization challenges for orphan drug biosimilars due to their limited potential market size. For example, only about 12% of the 42 currently designated biologic orphan products are likely to have a commercial market size across Europe in excess of €100 million per year, limiting commercial opportunity for biosimilars in this space. Despite limited market size and risks, as orphan drugs assume a greater role in healthcare, the contribution of orphan biosimilars will become more important for the long-term stability and sustainability of health systems.
Key Findings
Of the total number of drugs with active orphan status, 39% are biologics, which are medicinal products derived from living organisms.
Current Orphan Designated Drugs Available in the EU by Type
- This share has increased from 25% five years ago, driven by the effectiveness and specificity of biologic medicines coupled with supportive regulations for orphan medicines
- The growing pipeline of orphan drugs – both small and large molecule – portends even greater stress on tightly managed drug budgets in the near future.
In Europe, 156 products are approved, registered, and commercially available, treating a variety of rare diseases with over a third available as biologics.
The Landscape of Orphan Drugs in Europe
- Orphan drugs typically have 10–12 years of market exclusivity before generic or biosimilar competition can enter the market.
- Forty-eight orphan drugs have already lost market exclusivity, including 14 biologics, and during the period 2020 through 2029, 34 additional biologic orphan drugs are expected to lose exclusivity.
- The five orphan biologics losing exclusivity by 2024 contributed about €501 million in total spending across Europe in 2019 alone.
Commercial challenges for orphan biosimilar products include a limited market size, with the majority of orphan drugs reaching sales under €100 million per year.
Average Sales for Newly Approved Orphan Medicines in Europe, 2019
- 80% of orphan drugs had sales of less than €100 million in 2019, with the average biologic sales in 2019 being significantly lower at €61 million.
- In addition to a small market size, the cost of developing a biosimilar product is typically higher than the cost of developing a generic small molecule product.
- Despite challenges in clinical development and commercialization, orphan drugs continue to assume a greater role in healthcare, and biosimilars offer a means of reducing costs and increasing access supporting the long-term stability and sustainability of health systems.