CPHI post-pandemic report forecasts explosion of contract services growth

During the next 12 months, demand for early-stage contract projects could quickly exceed supply

The report anticipates breakthroughs in multi-modal disease therapies within 5 years, mRNA platforms to transform many new non-infectious disease treatment options, and huge growth in contract services due to the recent surge in investigational new drug (IND) applications, with 75 annual FDA approvals expected by 2025.

This new analysis combines detailed insights from leading experts covering perspectives from biologics and CMC analysts to contract research organizations (CROs) and innovators. One major positive to emerge is 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.

The FDA received 3806 Investigational INDs in April–June 2020, more than in the previous 8 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 in contract demand from Phase I to Phase II.

This surge of new targets entering the market is complemented by speedier approvals, faster trials, and improved target identification using AI. In fact, the report’s CRO insider identified decentralized trials, remote patient monitoring, and data collection as the key to running more trials at once and potentially at a lower cost. Expanding competition for experienced CROs in rare disease will see mid- and small-size sponsors competing to partner with CROs, rather than simply outsourcing services. And access to the best sites and expertise will be a key component in which sponsors advance fastest.

The report also highlights the wider potential significance of mRNA vaccines. Although the initial breakthrough was secured for COVID-19, the CPHI experts expect this to be a watershed moment as the technologies validated use opens many new doors.

Automation was a more immediate effect highlighted and its use is growing rapidly in manufacturing, with smart factories improving efficiencies and enabling real-time remote monitoring. Parrish Galliher, Managing Director, BioProcess Technology Group, a division of BDO USA, suggested the coming together of all these factors will lead to the industry achieving record levels of development.

Galliher forewarned, however, that as CDMO capacity becomes constrained inevitably biotechs advancing targets may now need to look at alternative manufacturing strategies and perhaps use the improved venture capital markets to build their own facilities.

During the next 12 months, demand for early-stage contract projects could quickly exceed supply and innovators will need to start conversations with outsourcing partners much earlier, with a view to further accelerating conversations quickly in Q3 and Q4 of 2021. The report advises that all pharma companies now need to be selecting partners very early so they don’t get caught out by a lack of demand when they need it. And, for those who can afford to, a range of strategic partner agreements should be sought ahead of any future manufacturing or development needs.

Download a copy of the report here