Chronic Kidney Disease Market: 5 Emerging Therapies to Watch as the Treatment Landscape Expected to Evolve by 2036 | DelveInsight

The chronic kidney disease market in the U.S., EU4, U.K. and Japan was valued at approximately $5 billion in 2025 and is projected to grow significantly through 2036, supported by higher diagnosis rates, combination-therapy adoption and novel treatments. Key pipeline programs include AstraZeneca's zibotentan/dapagliflozin, which reduced proteinuria by up to 52.5% in Phase IIb with Phase III topline data due in 2027, and Boehringer Ingelheim's vicadrostat plus empagliflozin, which reduced albuminuria by up to 39.5% in Phase II. Cell therapy rilparencel, APOL1 inhibitor MZE829, Mineralys' lorundrostat and Disc Medicine's anemia candidate DISC-0974 could broaden CKD treatment beyond established SGLT2 inhibitor and MRA therapies.

Analysis

This is a competitive-intensity signal, not an earnings-revision event. The investable implication is that CKD value will increasingly accrue to therapies that can show hard eGFR-slope or kidney-failure endpoint benefits on top of standard-of-care, rather than incremental albuminuria reductions alone. That raises the evidentiary bar for MLYS and PROK while favoring AZN, whose commercial infrastructure can turn a successful fixed-dose combination into formulary access and primary-care penetration more efficiently than a single-asset biotech could.

Near term (days to 3 months), the release should not alter estimates: it is promotional market research and provides no new pivotal efficacy, safety, reimbursement, or regulatory information. Over 12-24 months, greater use of multidrug renal-protection regimens could pressure BAYN's KERENDIA duration and share if aldosterone-synthase inhibition proves to preserve efficacy with a cleaner hyperkalemia profile. The more important read-through for AZN is whether combination treatment expands the treated population rather than cannibalizes FARXIGA; a combination priced as an outcome-improving escalation therapy would be incrementally accretive, while a replacement regimen would mainly shift mix.

The contrarian issue is endpoint translation. Proteinuria is an accepted directional biomarker but has repeatedly failed to guarantee durable kidney-outcome benefit or tolerability, especially where blood-pressure lowering, volume depletion, hyperkalemia, or adrenal-hormone effects drive discontinuation. PROK has the most asymmetric narrative but also the highest execution burden: autologous cell processing, site throughput, procedure adoption, and a credible control-arm-adjusted renal endpoint all must work before dialysis avoidance can be valued. Any eventual delay in dialysis is structurally negative for FRE and dialysis-equipment exposure, but only on a multi-year horizon and likely immaterial to consolidated earnings initially.

Key Decisions for Investors

• Do not chase MLYS or PROK on this item; treat both as clinical-event positions only. For MLYS, require full renal-function, potassium, and discontinuation data versus active standard-of-care before underwriting CKD revenue; exit or avoid if safety offsets undermine chronic-use persistence.
• Maintain a 12-18 month relative long AZN / short BAYN basket only if upcoming renal-outcomes evidence supports combination adoption without material safety attrition. The upside is multiple expansion from a broader renal franchise; the key falsifier is evidence that add-on use merely substitutes for existing SGLT2 prescriptions or fails to improve hard outcomes.
• Place a catalyst alert for AZN's 2027 renal readout and for PROK pivotal updates. For PROK, a position is warranted only after confirmation of enrollment integrity, manufacturing consistency, and a predefined eGFR/dialysis endpoint; binary clinical and financing risk makes pre-data sizing unsuitable for a core book.
• Watch FRE on a 6-18 month basis as a second-order hedge candidate rather than an immediate short. Escalate only if multiple late-stage programs demonstrate reproducible dialysis-delay effects and payer adoption; current dialysis-volume exposure is too diversified for this pipeline discussion alone to change estimates.