The Strategic Case for Investing in Alzheimer's Innovation: Leqembi's Canadian Approval and Global Scalability

The global fight against Alzheimer's disease is entering a transformative phase, driven by breakthroughs in amyloid-targeting therapies and an aging population fueling demand for effective treatments. At the forefront of this revolution is Leqembi (lecanemab), a monoclonal antibody developed by Eisai and Biogen, with BioArctic AB as a key collaborator. With Health Canada approval in October 2025, Leqembi's regulatory expansion into Canada-coupled with its growing global footprint-positions Biogen and BioArctic as pivotal players in a market projected to grow at a compound annual rate of 8% through 2030, according to a dementia market forecast. This article evaluates the investment potential of these firms, emphasizing Leqembi's clinical differentiation, market scalability, and financial implications.

Leqembi's Canadian Approval: A Strategic Milestone

Health Canada's conditional approval of Leqembi under a Notice of Compliance with Conditions (NOC/c) marks a critical step in its global commercialization, Eisai and Biogen said. The drug is authorized for adults with early Alzheimer's disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes and have confirmed amyloid pathology. This targeted approach, validated by the Phase 3 Clarity AD trial's 27% reduction in cognitive decline over 18 months, as noted by Health Canada, underscores Leqembi's therapeutic value. While the conditional approval requires Eisai to submit real-world data, it also reflects Health Canada's recognition of the unmet need in early Alzheimer's treatment-a market segment expected to expand as dementia prevalence rises.

Canada's aging demographic is a key driver. Over 771,000 individuals currently live with dementia in the country, a number projected to surge to 1.7 million by 2050. Leqembi's entry into this market, despite its narrow patient criteria, positions it as a first-in-class therapy with significant pricing power. For Biogen and BioArctic, this approval reinforces their leadership in a sector where regulatory hurdles have historically stifled innovation.

Financial and Market Dynamics: Biogen's Revenue Catalyst

Biogen's Q3 2025 earnings outlook highlights Leqembi's growing contribution to its top line. Analysts project revenue of $2.34 billion for the quarter, driven by Leqembi's expansion into new markets and the launch of the subcutaneous autoinjector version, Leqembi Iqlik, according to Nasdaq analysis. This formulation, which improves patient convenience, is expected to broaden adoption and mitigate competition from older Alzheimer's therapies.

The drug's commercial success is further bolstered by its presence in 51 countries, including the U.S., EU, and Japan, with regulatory applications pending in nine additional markets. Biogen's 50% share of Leqembi's net product revenues, combined with declining sales of older products like Tecfidera and Tysabri, makes the drug a critical offset to portfolio erosion. For investors, this dynamic underscores Biogen's ability to pivot toward high-growth, innovative therapies-a strategic shift that could stabilize its revenue base amid industry-wide pressures.

BioArctic's Role: Royalty Growth and Strategic Partnerships

While Biogen leads commercialization, BioArctic's financial performance reveals its unique value proposition. In Q2 2025, the Swedish firm earned SEK 162.5 million in royalties from Leqembi sales, a 280% increase compared to the same period in 2024, according to a sales report. This surge, driven by global demand and a one-time stockpiling effect in China, highlights BioArctic's exposure to the drug's scalability.

BioArctic's collaboration with Eisai since 2005, including a 2015 agreement for a Leqembi back-up antibody, ensures long-term revenue streams. The company also retains commercialization rights in the Nordic region, where it plans to co-market Leqembi with Eisai. Financially, BioArctic's high profit margin (57.37%) and strong liquidity (current ratio of 8.63), according to financial metrics, position it to capitalize on Alzheimer's market growth without overleveraging. A strategic partnership with Novartis further diversifies its pipeline, reducing reliance on a single asset.

Global Dementia Market: A $28 Billion Opportunity by 2030

The dementia treatment market's projected growth to $28.11 billion by 2030, according to Grand View Research, provides a tailwind for Leqembi's commercialization. North America, led by the U.S., remains the largest contributor, but emerging markets like China and Japan are gaining importance. Leqembi's conditional approval in Canada aligns with its expansion into these regions, where regulatory frameworks are increasingly accommodating for amyloid-targeting therapies.

For Biogen and BioArctic, the drug's success hinges on its ability to demonstrate long-term clinical benefits. While the conditional approval requires real-world data, the Phase 3 Clarity AD results have already established a strong foundation. If post-marketing studies confirm sustained efficacy, Leqembi could become a standard of care, further accelerating market share gains.

Conclusion: A Compelling Investment Thesis

Biogen and BioArctic represent two distinct but complementary investment opportunities in the Alzheimer's innovation space. Biogen's deep commercialization expertise and Leqembi's global reach make it a high-conviction play for investors seeking exposure to a transformative therapy. BioArctic, with its royalty-driven model and strong financials, offers a more defensive position, leveraging its partnership structure to benefit from Leqembi's scalability.

As the dementia market expands and regulatory barriers ease, both firms are well-positioned to capitalize on a paradigm shift in Alzheimer's treatment. For investors, the strategic case for investing in this sector is clear: Leqembi's approval in Canada is not just a regulatory win-it's a harbinger of a new era in neurodegenerative disease management.