CPhI Worldwide has released its beginning of year pharma market predictions for 2022 combining research from more than 350 pharma executives and expert views from 10 CPhI contributors, as per a statement from CPhI.
The findings of the prediction suggest that there will be over 30 FDA new drug approvals in the next year, more than five commercial COVID vaccines – resulting in a production squeeze at CDMOs and consequentially higher margins and profits for supply-side companies – with mRNA, advanced therapies and biologics seeing the fastest growth rates. Overall, the findings suggest a robust and prosperous year ahead for the contract services industry, the statement said.
Speaking in this regard, Dan Stanton, Editor, BioProcess Insider, said, “With the race to develop and manufacture vaccines in their billions, the pandemic has put immense pressure on the global manufacturing capacity and stretched capacity for equipment and consumables further, with vials and single-use components, filters and bags particularly affected.”
The statement also added that the wider industry expects CDMO capacity to continue to be constrained throughout 2022 for biologics (54 per cent), advanced therapies (46 per cent), and API (44 per cent), with 70 per cent of respondents also stating there is a ‘global shortage of CMC personal’ that could run for the next two years and potentially slow down development timelines.
It is anticipated that in the first half of 2022, pharma and medical supplies factories will see continued higher prices, limited availability and delayed deliveries for many raw materials and therefore a continuation of the dynamic supply chain issues prevalent in 2021 according to Stephan Schmidinger, Partner, Kemiex.
As per Manjit Singh, Chair, Pharmaceutical Supply Chain Initiative (PSCI), one of the many key positive developments rapidly gaining traction is the global rise of sustainable sourcing. He forecasts 2022 will see an acceleration of transparency and sustainability strategies.
In a further boost for patients and sustainability, Yasemin Bettina Karanis, Senior Consultant Thought Leadership, IQVIA, predicted that home administration will continue to increase, and the challenge for device manufacturers will be how best to demonstrate the value and impact of their new devices. For example, she added this might be in the “form of quantifying the carbon footprint of self-administration versus travelling to a hospital or demonstrating improved adherence and patient experience.”
Significantly, the industry expects continued high levels of approvals by the FDA with 29 per cent predicting the FDA will approve 21-30 new drug applications in 2022, 35 per cent expecting 31-50 NDAs, and 15 per cent suggesting there could be a record 50+ approvals in the year ahead. Perhaps, unsurprisingly, given the validation, the technology has revived via the approvals of both Moderna and Pfizer vaccines, 65 per cent believe mRNA technologies will be the biggest investment opportunities in 2022 followed by cell and gene therapies (45 per cent) and biologics (43 per cent), the statement notified.
According to the statement, 25 per cent of the industry believes there could be as many as over 10 new COVID vaccine approvals in 2022 – with the majority (45 per cent) expecting five to 10, and 29 per cent one to five approvals.
2022 could also bring about significant regulatory changes as the EU embarks upon its once-in-every-20-years pharmaceutical policy revisions, with Adrian van den Hoven, Director General, Medicines for Europe suggesting that COVID has ‘sprung’ European policy makers into action to address many long-standing issues.
“The pharmaceutical industry made some outstanding progress in 2021 in how it managed to speed up time to market and eke out efficiencies along the supply chain in order to meet the huge demand for COVID vaccines,” said Tara Dougal, Head, Content and Insights, Pharma, Informa Markets.
Dougal added, “The CPhI Pharma Trends 2022 Report not only addresses some of the major tensions and obstacles that the industry will face in 2022, but also the innovative solutions that it is developing to overcome them.”
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