Fresenius SE & Co. KGaA

Polpharma Biologics International AG announced that the U.S. Food and Drug Administration and the European Medicines Agency have accepted for review the Biologics License Application and Marketing Authorisation Application, respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda's Entyvio. The applications cover a lyophilized vial for intravenous administration for adults with moderately to severely active ulcerative colitis and Crohn's disease. PB016 was developed and will be manufactured by Polpharma Biologics, with Fresenius Kabi holding exclusive global commercialization rights outside the Middle East and North Africa pending regulatory approvals. The biosimilar development program included a Phase 1 trial in healthy volunteers and a Phase 3 trial in ulcerative colitis patients. Inflammatory bowel disease affects approximately 2.4 million patients in the US and 2.5 to 3 million in Europe.

The global apheresis market is projected to grow from USD 3.02 billion in 2026 to USD 4.41 billion by 2031, at a compound annual growth rate of 7.9%. Disposables hold the largest product share, driven by recurring demand from blood collection and therapeutic procedures. Plasmapheresis leads by procedure, supported by rising demand for plasma-derived therapies and increasing plasma donations. North America maintained the largest regional market share in 2025, reflecting high disease prevalence and broad adoption of apheresis technologies. Key players include Terumo Corporation, Fresenius SE & Co. KGaA, Haemonetics Corporation, and Becton, Dickinson and Company.

The global IV equipment market is projected to grow from USD 17.82 billion in 2026 to USD 23.92 billion by 2031, at a compound annual growth rate of 6.1%, according to a new report added to ResearchAndMarkets.com. Growth is driven by rising chronic disease prevalence, increasing hospitalizations, and a shift toward home-based and outpatient care, with technological advancements such as needle-free connectors and smart infusion pumps boosting adoption. North America leads the market due to robust healthcare infrastructure and high adoption of medical technologies. Key players include Becton, Dickinson and Company, B. Braun SE, and Fresenius SE.

The global therapeutic apheresis market is projected to grow from USD 3.84 billion in 2025 to USD 8.94 billion by 2035, at a compound annual growth rate of 7.9%, according to a new report by Healthcare Foresights. The market was valued at approximately USD 4.18 billion in 2026. Growth is driven by the rising prevalence of chronic and autoimmune diseases, technological advancements in automated apheresis systems, and expanding applications in regenerative medicine and CAR-T therapies. North America currently holds the largest market share, while the Asia Pacific region is expected to exhibit the highest growth rate due to increasing healthcare spending and infrastructure investments. Key players include Terumo BCT, Fresenius Kabi, Haemonetics, and B. Braun Melsungen.