comentarios de Morningstar en una nota sobre CSL respecto a las alternativas al plasma:"One major threat to plasma products is recombinant products. Recombinants are quickly replacing plasma products in haemophilia treatment despite being more expensive. CSL has an excellent R&D track record and has developed recombinant products for haemophilia. However, we expect modest revenue growth in the haemophilia segment based on competitor Roche’s recombinant Hemlibra.Immunoglobulin product sales are key to CSL. The use of immunoglobulins is currently growing due to improved diagnosis, rising affordability, and gaining approval for increased indications. CSL and competitors are pursuing R&D in Fc receptor-targeting therapyto treat autoimmune diseases.However, gene therapy represents the biggest risk to the plasma industry as it aims to cure rather than treat diseases. While the potentially prohibitive cost may result in slow adoption, CSL has strategically expanded its scope via the acquisition of Calimmune in fiscal 2018 and licensing a late-stage Haemophilia B gene therapy, Hemgenix, from UniQure in fiscal 2020......CSL spends roughly 9% of its revenue on R&D compared with competitor Grifols’ 6% and benefits from a wide and diverse product portfolio with multiple key products in each segment. CSL has also expanded its R&D pipeline beyond plasmatherapies, including recombinant products and gene therapies, thus mitigating some risk fromchanging market dynamics.While we think it’s unlikely that emerging gene therapies and alternative recombinant therapeutics will cause significant disruption in the next decade, these potential threats still preclude us from assigning the CSL Behring division a wide moat. Gene therapies aim to cure underlying diseases that are currently being treated on an ongoing basis with plasma products. However, as gene therapies are only suitable to treat genetic disorders, the potential impact is limited to the primary immunodeficiency, or PID, portion of CSL’s immunoglobulin business, haemophilia, and hereditary angioedema, or HAE, which together made up roughly 30% of fiscal 2020 revenue. Within PIDs, which made up roughly 12% of group revenue in fiscal 2020, there are over 350 chronic indications being treated by immunoglobulins.The most common is CVID, which we estimate to be 20% of PIDs. Potential new therapies would likely need to be individually developed for each disease type, with channel checks suggesting gene therapy for PIDs being particularly difficult given the range of genetic defects identified and possible mutations.Gene therapies targeting PIDs or HAE are very early in clinical stages. Gene therapies withinhaemophilia are a more near-term threat, but the segment is also a relativelysmall 12% of grouprevenue. In addition, the exorbitant cost of currently approved gene therapies treating other medical conditions indicates that fast widespread adoption is unlikely. Moreover, CSL itself is investing in R&D and gene therapies and signed a licence agreement with uniQure for haemophilia B gene therapy Hemgenix, which launched in fiscal 2024. CSL is also researching gene therapies for a few PIDs, including Wiskott-Aldrich syndrome, but clinical trials are still in early phases.Firms such as argenx are treating a subset of autoimmune diseases with Fc receptor-targetingalternatives that offer significantly reduced dosage. Accordingly, we forecast CSL’s immunoglobulins revenue growth to slow, but overall think CSL will be largely undisrupted. First, the potential diseases these recombinant therapeutics can treat account for roughly 38% of CSL’s immunoglobulins revenue, or 15% of group revenue. We think CSL will still be left with significant demand remaining when the diagnosis and range of secondary immunodeficiency indications continue to expand. CSL is also in partnership with Momenta for its own Fc receptor products that are also in clinical trials. Finally, the commercial success and long-term safety and effectiveness of these products are largely unproven. Notall patients are responsive to this alternative therapy, the dosage is still relatively high for recombinants, and competitors would need to compete with physicians already experienced with CSL’s proven products."
