CompanyGraph
Biogen Inc.
BIIB · United States
Delivers specialized drugs directly into the spinal fluid of patients with rare neurological diseases like spinal muscular atrophy and multiple sclerosis.
Biogen makes drugs that treat diseases of the brain and spinal cord, delivering them not through a standard pill or injection into the bloodstream but directly into the cerebrospinal fluid — because the active molecules cannot cross from blood into neural tissue by any other route. That chemical necessity means every patient must be treated at a specialized medical center with trained staff, FDA-approved protocols, and cold-chain storage already in place, so the number of patients Biogen can reach is capped by how many qualified sites exist, not by how much drug it can make. Neurologists at those centers are trained specifically around Biogen's approved protocols, and switching to a different therapy would require rebuilding that infrastructure from scratch around a new set of procedures, which keeps both the centers and the patients anchored. The whole system depends on Medicare Part B continuing to reimburse each dose at a level that makes the cold-chain logistics, site-qualification, and specialized sales force economically viable — if CMS reclassifies these high-cost intrathecal drugs at a lower payment rate, the economics that hold the entire commercial network together break at once.
How does this company make money?
The company earns money each time a dose of Spinraza is administered — patients receive multiple injections per year, each one billed individually as a high-priced specialty drug through specialty pharmacy distribution. Tysabri and oral multiple sclerosis therapies generate revenue through monthly prescription fills, also processed through specialty pharmacies. Both streams depend on high per-dose or per-fill prices that reflect the drugs' specialized manufacture and the narrow patient populations they treat.
What makes this company hard to replace?
Neurologists who prescribe Tysabri must complete a specialized training program for monitoring PML risk — that certification is tied to this specific drug and its protocol. Spinraza patients are treated at medical centers that have built their intrathecal injection infrastructure around the approved Spinraza protocol; switching to a different therapy would require those centers to rebuild around a new set of procedures. Multiple sclerosis patients on established regimens face real medical risk in switching, because tracking disease progression becomes more complicated every time a patient changes therapy.
What limits this company?
The company can only treat as many patients as there are qualified medical centers able to perform intrathecal injections under the FDA-approved Spinraza protocol. Adding more patients means finding and qualifying new sites — each one needs trained staff and cold-chain-compliant drug storage. More drug supply alone does not solve this. The bottleneck is the centers, not the manufacturing.
What does this company depend on?
The company cannot operate without FDA Biologics License Applications covering Spinraza and Tysabri manufacturing, EMA centralized authorization for sales across Europe, antisense oligonucleotide synthesis through Alnylam partnership facilities, and monoclonal antibody production at its own biomanufacturing sites in Research Triangle Park.
Who depends on this company?
Spinal muscular atrophy patients receiving Spinraza would face treatment discontinuation if the company stopped delivering. Specialized MS infusion centers that administer Tysabri would lose a core source of revenue. Neurologists who currently prescribe the company's therapies would be forced to move established patients — people with serious, hard-to-manage conditions — onto competitor drugs.
How does this company scale?
The antisense oligonucleotide design platforms and the CNS clinical trial methods the company has built can be pointed at new neurological targets, and the existing FDA and EMA regulatory precedent helps smooth that path. What does not scale easily is the salesforce and the relationships with academic medical centers treating rare neurological diseases — those require deep clinical expertise that takes years to develop and cannot simply be hired in bulk.
What external forces can significantly affect this company?
CMS Medicare Part B reimbursement policy is the most direct outside pressure, because Spinraza is a high-cost specialty drug and any payment reclassification hits the per-dose economics immediately. In Europe, health technology assessment reforms can restrict or delay access to CNS drugs across multiple major markets at once. On the demand side, aging populations in developed countries expand the pool of potential Alzheimer's patients, but at the same time they strain healthcare budgets in ways that put pressure on pricing for expensive therapies.
Where is this company structurally vulnerable?
If CMS restructured Medicare Part B reimbursement and cut the payment rate for high-cost intrathecal specialty drugs like Spinraza, the financial logic holding the whole system together would collapse. The revenue per dose is what pays for cold-chain synthesis, site training, and the specialized neurology sales force. Cut the per-dose payment deeply enough and none of that infrastructure can be sustained.
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