A post-pandemic pharma report from CPhI predicts the next few years will deliver strong growth in pharma innovation, with oncology and rare diseases potentially the biggest beneficiaries of positive Covid-19 legacies – including accelerated development timelines, remote trials and new technologies in genetic and target screening.
The report anticipates breakthroughs in multi-modal disease therapies within five years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in IND applications, with 75 annual FDA approvals expected by 2025.
This new analysis combines insights from experts covering perspectives from biologics and CMC analysts to CROs and innovators. One major positive to emerge for CPhI attendees was the growth in contract services – both CRO and CDMO – with providers predicted to see an imminent knock-on effect from the recent surge in IND applications.
“This will be crucial in sustaining industry growth and bringing increasing numbers of therapies to patients. These findings show pharma companies now need to use platforms like CPhI much earlier to make sure they have the right suppliers and development partners to meet future demand and bring on additional contingencies. Despite the challenges of the pandemic era, industry-wide partnering and collaboration is flourishing, and it is a dynamic time with potential record levels of growth and innovation expected in the medium term,” commented Nicola Souden, Brand Manager at Informa Markets.
The FDA received 3806 Investigational New Drug Applications (INDs) in April-June 2020, more than in the previous eight years combined (3576 in 2012-2019). Dr. Valdas Jurkauskas, VP, Technical Operations at Black Diamond Therapeutic, who compiled the FDA figures, expects to see an increase of contract demand from phase I to phase II. “So, we now see large volumes of studies and the majority of them are on accelerated regulatory pathways. How fast can the CDMOs and CROs expand? How do you grow those resources? With accelerated pathways, you get a massive jump in scale because there is this aspiration to file an application in phase I. Therefore, the increase of services demand is very rapid from phase I to phase II.”
This surge of new targets entering the market is complemented by quicker approvals, faster trials, and improved target identification using AI. The report’s CRO insider identified decentralised trials, remote patient monitoring, and data collection as the key to not only running more trials at once, but potentially also at a lower cost.
The CPhI report also highlights the potential significance of mRNA vaccines. While the initial breakthrough was secured for Covid-19, the CPhI experts expect this to be a watershed moment as the technologies validated use opens new doors.
Bikash Chatterjee, Chief Executive Officer for Pharmatech Associates, explained: “Perhaps the biggest prediction I can make is that in the next four to five years we’re going to see drug therapies come out for one of the multi-modal disease states that have been incredibly difficult to gain traction on, such as multiple sclerosis or ALS.”
Parrish Galliher, Managing Director, BioProcess Technology Group, a division of BDO USA, said: “With the many new drugs coming in, there is a big push to increase the efficiency of manufacturing through automation and, for instance, applying AI to reactor operations. So, process efficiency, process productivity and yield through the application of genetics and automation and novel unit operations together could bring step changes in the cost and numbers of candidates advancing.”
The report’s authors’ advice is that all pharma companies need to be selecting partners early so they don’t get caught out by lack of demand when they need it. Additionally, a range of strategic partner agreements should be sought ahead of any future manufacturing or development needs.
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