Contract development and manufacturing organizations (CDMO) for biopharmaceuticals are expressing high expectations for new drugs to treat degenerative brain diseases like Alzheimer's disease and Parkinson's disease being developed by global big pharma companies. If these new drugs succeed, they could become a significant source of future business for contract manufacturing.
At the 2025 Bio International Convention (BioUSA) held in Boston, USA, from 16th to 19th, the heads of Samsung Biologics and Lotte Biologics showed a strong willingness to secure contracts in the Alzheimer's disease and Parkinson's disease treatment markets.
John Lim, CEO of Samsung Biologics, told reporters, "The target for antibody therapies is expanding to include Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS)," and noted, "The production capacity required for CDMO companies will continue to increase in the future."
President Lim explained, "In particular, many companies are developing bispecific and trispecific antibody therapies," adding that "bispecific antibodies require double the capacity compared to monospecific antibodies." He said, "If commercial production occurs, even more capacity will be needed."
James Park, CEO of Lotte Biologics, also stated, "Lotte Biologics will expand contract manufacturing orders with a dual engine strategy focusing on antibody pharmaceuticals and antibody-drug conjugates (ADCs)."
President Park explained, "Developing treatments for Alzheimer's disease and Parkinson's disease is not easy, but securing contracts could lead to significant profits in this field," adding, "Due to the nature of brain disease medications, large doses (with 1 dose being the amount for a single administration) are required, so we can expect large-scale production orders when securing contract manufacturing."
Currently, the approved Alzheimer's disease drugs launched by the U.S. Food and Drug Administration (FDA) are Leqembi (generic name: lecanemab), developed by Japan’s Eisai and the U.S. company Biogen, and Donanemab (brand name: Eli Lilly), both of which are monospecific antibody medications focused on removing amyloid beta. Amyloid beta is originally meant to protect nerve cells, but if it leaks outside of brain cells and aggregates, it actually destroys nerve cells.
However, existing treatments have side effects such as brain swelling and bleeding, and can only be applied restrictively to early-stage Alzheimer's patients. Additionally, both drugs have a limitation in that the quantity that can pass through the blood-brain barrier is low, so their effectiveness is not significant.
The National Institute for Health and Care Excellence (NICE) in the UK announced guidelines on the 19th (local time) stating that it "does not recommend the use of these treatments within the National Health Service (NHS)." The reason was that the treatment effects were not sufficient to justify the expenses that the NHS would incur.
To overcome these limitations, big pharma companies have turned to developing bispecific antibody treatments. Bispecific antibodies can recognize two different antigens simultaneously and have higher therapeutic effects than monospecific antibodies, which can only bind to one antigen.
In particular, bispecific antibody treatments are being developed by utilizing the principle of passing through the blood-brain barrier. The blood-brain barrier serves as a protective shield that blocks harmful substances and factors from entering the brain, but it is considered a major obstacle in developing treatments for degenerative brain diseases.
The Alzheimer's disease treatment candidate, Troncinemab, which is being developed by the Swiss pharmaceutical company Roche, has improved the permeability of the blood-brain barrier by attaching to other substances. In April, British GlaxoSmithKline (GSK) acquired the ‘Grabody-B’ technology for bispecific antibody-based blood-brain barrier penetration from the domestic company ABL Bio. French Sanofi is also developing the bispecific antibody treatment candidate ABL301, which it acquired from ABL Bio in 2022.