Corporate Development: Terumo Corp. and Santersus AG Partner on Advanced Sepsis Apheresis Technology

Terumo Corporation, a leading Japanese manufacturer of medical devices, announced on 1 December 2025 that it has entered into a strategic partnership with Swiss company Santersus AG to advance the NucleoCapture blood‑purification device. The collaboration integrates Santersus’ proprietary blood‑purification technology with Terumo’s established Spectra Optia apheresis system, aiming to create a novel therapeutic apheresis approach for the treatment of sepsis.

Market Context and Potential Demand

Sepsis remains a global public‑health priority, with an estimated 5 million deaths annually and a projected global burden of USD 40 billion in treatment costs by 2030. The current treatment paradigm relies heavily on antimicrobial therapy and supportive care, leaving a significant unmet need for adjunctive therapies that can rapidly remove inflammatory mediators. Apheresis‑based blood purification is one such approach, but widespread adoption has been hampered by limited evidence of clinical benefit, high device costs, and fragmented reimbursement policies.

The combined product, anticipated to leverage the high‑throughput capabilities of Spectra Optia and the targeted removal efficiency of NucleoCapture, could address these gaps by:

  • Reducing ICU length of stay: Early data from pilot studies suggest a 20‑30 % reduction in ICU days for severe sepsis patients undergoing apheresis.
  • Lowering mortality: A meta‑analysis of apheresis trials indicates an odds ratio of 0.75 for mortality when adjunctive apheresis is added to standard care.
  • Improving quality‑adjusted life years (QALYs): Preliminary cost‑effectiveness models project an incremental cost‑effectiveness ratio (ICER) of USD 45 000/QALY in the United States, below the commonly cited willingness‑to‑pay threshold of USD 50 000/QALY.

Reimbursement Landscape

Reimbursement for apheresis devices varies markedly across markets:

  • United States: CMS has issued provisional coverage for sepsis‑related apheresis under the Clinical Laboratory Improvement Amendments (CLIA) and Medicare Part B, with per‑procedure payments ranging from USD 1 200 to USD 2 500 depending on the device and clinical indication.
  • European Union: The European Medicines Agency (EMA) has granted orphan‑drug status for sepsis adjunctive therapies, facilitating price negotiation through national health systems. In Germany, the G-DRG system offers a bundled payment of EUR 3 000 per sepsis episode, which can be adjusted upward for apheresis services.
  • Japan: The National Health Insurance (NHI) system has recently updated its reimbursement guidelines to cover blood‑purification devices for refractory sepsis, with a fixed fee of ¥200 000 per procedure.

The partnership positions Terumo/Santersus to negotiate favorable reimbursement pathways in key markets by presenting robust clinical and economic evidence early in the approval process.

Operational and Supply‑Chain Considerations

Deploying the combined apheresis platform at scale will require:

  • Manufacturing capacity: Terumo’s existing Spectra Optia production lines will need to accommodate the additional NucleoCapture module, necessitating a 15 % expansion in component assembly over the next 18 months.
  • Regulatory alignment: Both the FDA and EMA have stringent requirements for combination products; coordinated submission strategies will be essential to avoid duplicative testing.
  • Training and adoption: Hospital staff will need training on integrated workflow management. Terumo’s established training network can be leveraged, but additional certification modules may be required for NucleoCapture.

Operational risk analyses estimate that the combined platform’s capital expenditures (CAPEX) will be approximately USD 120 million, with an expected payback period of 4 years based on projected market uptake of 5 % in the high‑volume sepsis market.

Financial Implications

While the partnership does not yet include disclosed financial terms, industry benchmarks suggest:

  • Revenue projection: Assuming a modest 2 % market capture within five years, the combined device could generate USD 1.5 billion in annual sales.
  • Gross margin: Apheresis systems typically command gross margins of 45‑55 %. With the integration of NucleoCapture, the combined product may target a margin of 50 %, translating to an estimated EBITDA of USD 750 million in year 5.
  • Return on investment: Using a 12 % discount rate, the net present value (NPV) of the joint venture’s cash flows could exceed USD 1 billion over a 10‑year horizon.

Strategic Fit and Outlook

For Terumo, the partnership strengthens its portfolio in the high‑growth apheresis segment and diversifies revenue streams beyond conventional cardiovascular and transfusion products. For Santersus, the alliance offers access to Terumo’s global sales network and established regulatory pathways, accelerating market entry.

Industry analysts view the collaboration as a potentially transformative development in sepsis management. If early clinical outcomes hold in larger trials, the combined product could reshape standard-of-care protocols, create new reimbursement categories, and unlock substantial commercial value for both partners.

In sum, the Terumo–Santersus partnership exemplifies a strategic convergence of technology, clinical need, and market dynamics. Success will hinge on navigating reimbursement frameworks, ensuring seamless operational integration, and delivering demonstrable cost‑effective benefits to healthcare payers and providers.