-
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
- Global Public Health
- 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™
-
IQVIA AI Assistant
-
Human Data Science Cloud
-
IQVIA Innovation Hub
-
Decentralized Trials
-
Patient Experience Solutions with Apple devices
WHO WE ARE
- Our Story
- Our Impact
- Commitment to Public Health
- Code of Conduct
- Sustainability
- 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
Meet the IQVIA AI Assistant
Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
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 with Apple devices
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
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
2019 R&D Achievements
New product launches, clinical trial activity, and investments
Apr 30, 2020
About the Report
The remarkable advances in basic science combined with improvements in translational science and approaches to clinical development have resulted in record levels of novel medicines reaching patients in recent years. While the COVID-19 pandemic has caused disruption of clinical trial activity with expected delays in trial programs and subsequent filings and launches, the pandemic has simultaneously unleashed a flurry of new innovations.
It has also prompted unprecedented collaboration and decisions by regulatory authorities to adapt review and approval processes. For example, the expanded adoption of approaches driven by data, analytics, and technology - such as the use of home health patient services and connected devices, direct to patient delivery of lab tests and trial drugs, remote data monitoring, and virtual study support services for sites - are enabling clinical research to continue in some instances.
Longer-term, COVID-19 will provide an opportunity to learn as Human Data Science paves the way for new and different approaches to research and human health. There will likely be a general uplift in discovery and R&D leading to new breakthroughs in novel therapies and vaccines, particularly in infectious diseases, which are likely to remain an area of focus. The elevated agility and urgency toward R&D in infectious diseases by regulators, investigators, study sponsors and supporting service providers will have a halo effect on pharmaceutical and regulatory innovation across all critically important disease areas.
Report Summary
This report assesses the current status in the R&D of medicines at the end of 2019. It provides an analysis of the number of initiated clinical trials and insight into the success rate of products as they more through phases of development. The current state of innovation is explored by examining the record numbers of new active substances (NAS) launched in 2019, analyzing their features and development path, as well as the significant contributions of both NAS and non-NAS therapies.
As levels of life science venture capital activity and large pharma R&D spend continue to grow, this report also investigates the expanding pipeline of therapies still under development, examines trends among therapy areas, and analyzes the growing number of Next- Generation Biotherapeutic products, which include cell, gene, and nucleotide therapies.
Key Findings
New Product Launches
The cohort of 50 new drugs launched in 2019 are being impacted by COVID-19 in terms of the awareness, education and patient use of these novel medicines. Engagement with healthcare professionals to make them aware and educate them about these new drugs is being transitioned from in-person to virtual interactions.
Attributes of Pivotal and Accelerated Approval Requirement Trials for 2019 NAS with Accelerated Approval
On average, 40 new active substances (NAS) in the United States were launched per year over the time period of 2009 through 2019. In 2019, 50 NAS reached patients, down slightly from 59 in 2018, but higher than the historical average. However, development time has not shifted significantly despite an increased number of specialty drugs and orphan indications among NAS in 2019, with the median development time from first patent filing to launch being 13.7 years for NAS products in 2019.
The overall percentage of NAS receiving expedited approval has increased steadily since 2015, and in 2019, 37 NAS products (74%) had at least one expedited review designation. On average, post-marketing requirements for accelerated approvals included more than three times the number of subjects and six times the number of patient years. In addition, 40% of NAS launches in 2019 were identified by the FDA as first-in-class – drugs noted by the FDA as innovative therapies with mechanisms of action different from those of existing therapies – almost double the number in 2011.
Advances in patient care also occurred around new and expanded uses of currently approved products in 2019, with notable examples in infectious disease, cardiovascular/metabolic, oncology, and central nervous system disorders, expanding access to new patient populations and improving patient value through simplified dosing or formulation.
Investments
Venture capital investments in early stage innovation companies may be impacted due to delays in decision-making and reassessment of capital markets, but investors appear to remain committed to their life sciences investment thesis.
U.S. Life Science Venture Capital Deal Value in US$Bn and Number of Deals Closed by Type, 2006-2019
Life science venture capital deal activity topped $20 billion in 2019 with average deal values growing at a five-year CAGR of 12%. Approximately a third of the deals were in the angel investor and seed funding category, up from 18% of deals in 2009, demonstrating a shift in the mix of venture capital life science deals from later to earlier stages of development. Large pharma R&D spending grew 26% over the past five years, topping over 100 billion for the second year in a row, although expenditure was up only modestly in 2019 over 2018 levels.
Clinical Trial Activity
We have seen the rapid initiation of clinical trials for COVID-19 vaccines and therapeutics around the world. The clinical research community has worked together to accelerate the design, planning, and implementation of these research programs.
Number of Clinical Trials with Pharmacogenomic Biomarkers in Total and by Select Therapy Areas, 2010-2019
The number of clinical trials increased with a CAGR of 5.8% from 2014 to 2019, however, the overall number of clinical trials initiated in 2019 did not increase significantly over 2018, due in part to a modest decrease in the number of initiated Phase III trials. The number of clinical trials tagged as having pharmacogenomic (PGX) patient preselection/stratification–those trials that constitute precision medicines–have increased over 50% since 2014 to a total of 972 trials. The percent of trials that include a predictive biomarker increased only modestly from 14% to 17% over 10 years, indicating challenges remain both in identifying novel biomarkers and testing them in clinical development. The composite success rate, which describes the likelihood of bringing a drug candidate through regulatory approval, fell from 11.1% in 2018 to 7.6% in 2019, well below the average of 12.9% for the period of 2009-2019, due to drops in success across all development stages.
New Product Pipeline
The pharmaceutical and healthcare communities have quickly mobilized to leverage both existing resources and to implement novel processes to explore and develop both symptomatic treatments and vaccines for COVID-19.
Next-Generation Biotherapeutics Pipeline by Phase and Therapy Area Percentage of Total
The late-stage active pipeline has grown 50% since 2014, reflecting a continued push for therapies in oncology, infectious disease, and neurology. Overall, the total late-stage pipeline now comprises 3,169 products with a growth of 10% from 2018 and a CAGR of 8% over the past five years. Of noe, Next-Generation Biotherapeutics (NGB), defined as cell, gene, and nucleotide therapies, now make up nearly 12% of the late-stage pipeline.
There has been a 76% increase in oncology products in the late-stage pipeline over the past five years, and in 2019, oncology products account for 30% of the late-stage pipeline. The gastrointestinal pipeline has seen a significant increase in NASH products, growing from 10 products in 2014 to 45 in 2019, and the number of gastrointestinal therapies in the late-stage pipeline have grown 73% in the past five years and represent 7% of the 2019 late-stage pipeline. Infectious disease represents 6% of the 2019 late-state active pipeline, growing 13% over the past five years.