Grifols

Grifols received FDA approval for its Fibrin Sealant (FS) to treat surgical bleeding in pediatric patients in the U.S., marketed as VISTASEAL™ in the U.S./Canada and VERASEAL™ in Europe. The plasma-protein based solution, combining fibrinogen and thrombin, demonstrated >95% efficacy in achieving hemostasis within four minutes in a phase 3b study involving 178 patients across 18 centers. Distributed through a strategic collaboration with Johnson & Johnson MedTech, the product is available in 18 countries.

The hemophilia drugs market focuses on treatments for hemophilia A and B, including factor replacement, gene therapy, and bypassing agents. Key drivers are the increasing prevalence of hemophilia, advances in biotechnology, and heightened awareness of early diagnosis. Major companies include Grifols SA, CSL Behring, and Pfizer, Inc. The market is segmented by treatment type, product, route of administration, and geography, with North America and Europe leading due to advanced healthcare infrastructure and supportive regulatory frameworks. Asia-Pacific is expected to see rapid growth due to improving healthcare facilities and increasing awareness.

The immunoglobulin market, valued at US$ 13.36 billion in 2023, is projected to reach US$ 28.70 billion by 2034, driven by its use in treating immunodeficiency and other applications. Key growth factors include immunodeficiency disorders, infections, and thrombocytopenia. North America leads with a 46% share, while Asia-Pacific is expected to grow fastest due to increased health spending and prevalence of autoimmune diseases. Recent advancements include subcutaneous injection therapies and acquisitions by major pharmaceutical companies.

Dry Eye Syndrome Market to reach USD 4,808 Million by 2033, growing at a CAGR of 5.9%. North America dominates with a 38.9% share. Emerging trends include precision medicine, advanced diagnostics, and innovative drug delivery systems. Challenges include limited treatment options and high prevalence, especially in aging populations.

The Europe molecular diagnostics market is projected to grow at a CAGR of 10.2% from 2024 to 2034, reaching $17.3 billion by 2034. Factors driving growth include the rise in POCT adoption, AI applications, integration of companion diagnostics with targeted therapies, non-invasive tests like liquid biopsies, and dPCR technologies. Key players include Roche Diagnostics, Abbott Laboratories, and Siemens Healthineers.

European stock markets closed higher; Stoxx Europe 600 gained 0.72%, Swiss Market Index rose 0.46%, France's CAC increased 0.41%, FTSE up 0.39%, and Germany's DAX closed 0.92% higher. Eurostat reported a 0.3% decline in euro area industrial production and a 2.6% job vacancy rate in Q2. France's consumer price index rose 0.5% in August. HSBC discusses selling its South African unit, Grifols seeks consultancy for minority investors, GSK's Blenrep gets breakthrough therapy designation in China, and Ascendis Pharma reports clinical activity in ovarian cancer trial.

Grifols' Xembify®, a 20% subcutaneous immunoglobulin, received FDA approval for an expanded label to include treatment-naïve patients with primary humoral immunodeficiencies (PI), becoming the first 20% SCIg with this extended label. The approval includes biweekly dosing, supported by phase 4 clinical trial data showing non-inferiority in total Ig levels compared to weekly administration. No unique safety issues were identified, and the tolerability profiles were consistent between biweekly and weekly administration. The phase 4 trial was a multicenter, single-sequence, open-label study that included 27 subjects across 18 U.S. sites.