• The critical limb ischemia (CLI) market is expected to grow from $1.4 billion in 2024 to $2.5 billion by 2035, with a CAGR of 6.66%, fueled by advances in early detection technologies and personalized medicine approaches.
• Novel therapies in development include oxygen carriers (YQ23), autologous stem cell treatments (ASCT-01, CLBS12, ACP-01), and cell-based therapies (REX-001), all aimed at promoting angiogenesis and improving tissue perfusion in ischemic limbs.
• The United States represents the largest CLI market, with significant growth driven by FDA regulatory support through fast-track designations and regenerative medicine advanced therapy approvals for innovative treatments.