Technology in healthcare is in a constant and rapid evolution. These are the Pharma Landscape and FDA frameworks that created impact in Pharma & Healthcare Industry on 2018.

2018 Pharma Landscape

Innovation & Competitive Dynamics

• Specialty & Targeted Therapies
• The rise of Disruptive Approaches (Cell & Gene)
• Novel Application Technologies
• Biosimilars 2nd Wave


 The Regulatory Challenge

• Payer & Policy Maker Influence on Budgets
• Compliance from Molecule to Market
• Data Protection (GDPR)
• Falsified Medicine Initiative


Digital Opportunities

• Health Apps
• Digitally Enabled Devices &
• Digital Biomarkers


 Evolving Commercial Model

• Commercial Organization of the Future
• Orchestrated Customer Engagement
• Intense Patient Focus


Highlights of the Year

» Real-World data (RWD) and Real-World Evidence (RWE) played an increasing role in healthcare decisions

This year in order to support regulatory submissions and drug safety monitoring, the FDA* issue a framework addressing the potential for Real-World Evidence.

It was expected to be paired with existing clinical trial data for more collaborative approaches between FDA and life sciences companies.


FDA Guidance on RWE

Approval of New Indications

• Cases where a “traditional” clinical trial may be impractical or excessively challenging to conduct

• As a means to supplement control groups

• Evidence derived from off-label use

• Patient subgroup analyses


Post Approval Environment 

• Medicines undergoing accelerated approval or other drugs approved with few patient exposures

• Use by sponsors to demonstrate compliance with regulatory requirements

• Safety surveillance

• Preclude the need for post-market surveillance studies

• Provide supplementary data in cases where the FDA identifies an issue

*Food and Drug Administration federal agency of the United States Department of Health and Human Services


» Adopt Moble Health apps for patient population was the treatment guidelines from major medical professional groups

The adoptions of mobile apps integrated into providers workflow offer: potential to improve outcomes for patients; support healthcare value; reinforce payer reimbursements.

Telehealth visits account for about 3.5% of visits. Over the next five years, that numbers are expected to grow up to 7.5%.  All U.S private patient had access to some kind of Telehealth in 2018.

» Real net per capita spending on medicines in the U.S. declined in 2018 and will remain almost unchanged at about $800 per person through 2022.

According to IQVIA Institute for Human Data Science, the "Spending will remain flat after factoring in the robust pipeline of new drugs, moderating brand price increases, and the impact of brand losses of exclusivity (generic drugs prescriptions), which will be greater in the next five years than the last five".  


Globally 2018 has been a year with a lot of challenges and innovation, especially for Pharma & Healthcare market, that continue to develop in an unusually rapid pace.

Manufacturing and Healthcare Providers has been dealing with many different challenges due to new regulations, drugs, and therapy forms, as well as market growth and the progressing demand for digitalization.


Bonus: So what to expect for this industry in the next few years? It's all about Data-Readiness and you can check on our next article.