New medical innovations. Technological advances. Mega acquisitions. The changing regulatory landscape. The pharma world never stops turning…and growing!

Referencing a recent IQVIA report in his article, “A Changing Healthcare Landscape,” Vetter Pharma’s Peter Soelkner says the annual growth of the global pharmaceutical market over the next five years is estimated to be 3-6%. Within the biologics sector, drug sales are forecast to increase from $241 billion in 2018 to $524 billion by 2025, representing a compounded annual growth rate of 12%.

As 2020 gets under way, pharmaceutical manufacturers will continue to find themselves under constant pressure to innovate smarter and faster to increase the speed at which drugs can leap regulatory hurdles and hit the market. The faster they do so, the faster drug firms can begin the recoup the staggering and still skyrocketing costs it takes to get medicines made. The estimated cost of developing a successful first-in-class therapy is more than $2 billion!

To lower that cost, innovation is ongoing among drug regulators as well as drug developers and manufacturers, pushing the pharma industry forward to meet the complex challenges of today’s complex healthcare systems.

On the regulatory front, for example, FDA last year launched a new initiative to fast track generics with a guidance document titled, “Competitive Generic Therapies (CGT)” that discusses a new regulatory pathway aimed at promoting development, expedited review and timely market entry of generic drugs. The biggest advantage of drugs designated as CGT by the FDA is that these drugs are eligible for 180-day marketing exclusivity. This new step of FDA is expected to increase competition for drugs that have less generic competition and also to decrease the potential for drug shortages.

In terms of drug discovery, which is the most costly and time-consuming area of pharma, advances in artificial intelligence (AI) and machine learning (ML) applications are paving the way forward. For instance, data capture tools are being used increasingly during the drug discovery process. Several pharma companies are using this type of AI-based software to fast track drug screening processes and expedite the crucial clinical decision making for drugs in trials.

Applications of AI and ML in healthcare are expected to grow to nearly $8 billion by 2022, up from $667.1 million in 2016, and almost half of global life science professionals say they are either using or interested in using AI in their research, according to Accenture’s, “Artificial Intelligence: Healthcare’s New Nervous System.”

On the manufacturing side of the pharma industry, the Internet of Things (IoT) continues to gain steam, disrupting old models and creating innovation designed to benefit manufacturers and ultimately patients. IoT technologies enable standardization within a pharmaceutical manufacturing plant by effectively connecting network, equipment, and systems across the plant. Moreover, using IoT, pharma companies can gain access to real-time data and visibility of operations through the entire manufacturing process.

From detecting problems early on in the drug discovery process, as well as on the production line and beyond down the pharma supply chain, the digital health revolution is transforming the pharma industry. I’m excited to see what new innovations and technologies are on tap in 2020!


Tim Wright, Editor
twright@rodmanmedia.com