The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points.
Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen.
The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl fumarate) for multiple sclerosis, and Spinraza (nusinersen) for spinal muscular atrophy.
Due to the broadness of the label, all Alzheimer’s patients are eligible for treatment. Potentially millions of doses could be sold, and with a list price of $56,000 analysts are estimating peak sales to be anywhere between $10 billion and $50 billion a year.
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But the new of the approval is not just a major payday for Biogen as the potential blockbuster is expected to further grow the bioproduction space – a sector already experiencing regular double-digit growth, additionally propelled by a COVID019 tailwind.
Even modest Aduhelm sales estimates would see a noticeable bump in the top lines of services firms contracted by Biogen.
At the lower end of the sales range, $10 billion, “we estimate the approval could add 1-2% per year to overall bioprocessing industry market growth (which was +8-12% pre-aducanumab) over next few years,” Jefferies analyst Michael Yee said in a note.
“For manufacturing, the initial direct beneficiary is Samsung Biologics,” he added.
Samsung Biologics has never publicly been named as Biogen’s contract development and manufacturing organization (CDMO) for aducanumab. But the Korean third party has regularly vocalized its readiness to support such large-patient population biologics through its large-scale production facilities in Incheon, and even announced construction plans for a fourth biomanufacturing plant – a ‘Super Plant’ with 256,000 L of cell culture capacity – the day after the FDA granted a priority review on Biogen’s aducanumab application.
Shares in Samsung Biologics rose following the news of Aduhelm’s approval.
But the approval will also benefit other service providers, including those offering bioprocessing equipment and tools, and fill/finish capabilities. Yee said those in the best positions to benefit include Danaher Corporation (including Cytiva and Pall), Avantor, Regeneron, and Catalent. On the contract research organization (CRO) side, he named Syneos health and PRA Health Sciences as likely beneficiaries.