Autosomal Dominant Polycystic Kidney Disease Market Set for Significant Expansion Through 2036 Driven by Rising Disease Burden and Emerging Disease-Modifying Therapies | DelveInsight

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Autosomal Dominant Polycystic Kidney Disease Market Set for Significant Expansion Through 2036 Driven by Rising Disease Burden and Emerging Disease-Modifying Therapies | DelveInsight
The ADPKD market is witnessing substantial growth driven by increasing diagnosed patient populations, advancements in genetic testing and diagnostic technologies, rising awareness regarding chronic kidney diseases, and growing adoption of disease-modifying therapies. Additionally, the anticipated launch of promising pipeline therapies such as XRx-008 (Xortx Therapeutics), and others is expected to significantly transform the ADPKD treatment landscape over the coming years.

DelveInsight, a leading market research and business consulting firm, has released its latest report, “Autosomal Dominant Polycystic Kidney Disease (ADPKD) Market Insights, Epidemiology, and Market Forecast – 2036.” The report provides comprehensive insights into ADPKD epidemiology, evolving treatment paradigms, market trends, competitive landscape, and forecast analysis across the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.

Key Takeaways from the ADPKD Market

  • The ADPKD market across the 7MM is expected to grow steadily through 2036, driven by increasing disease awareness, improved diagnosis rates, and the launch of emerging disease-modifying therapies.

  • In 2025, the United States accounted for the largest ADPKD market size among the 7MM, reaching approximately USD 799 million, and is projected to expand significantly during the forecast period.

  • According to DelveInsight estimates, approximately 147,000 diagnosed prevalent cases of ADPKD were reported in the United States in 2025, with the patient population expected to increase through 2036.

  • The report highlights that PKD1 mutations account for nearly 85% of ADPKD cases, while PKD2 mutations contribute to approximately 15% of cases, with PKD1-associated disease generally demonstrating more aggressive progression.

  • According to Thet et al. (2021), the crude prevalence of ADPKD was estimated at 42.6 per 100,000 persons, with comparable prevalence observed among males and females.

  • As per Orphanet (2020), ADPKD remains the most common inherited renal disease in Europe, with an estimated prevalence of 1 in 2,500 individuals.

  • In the United States, ADPKD contributes to nearly 5% of new dialysis cases annually, highlighting the significant long-term clinical and economic burden associated with disease progression to end-stage renal disease (ESRD).

  • Leading ADPKD companies, including Otsuka Pharmaceutical, Xortx Therapeutics, Novartis, Calico Life Sciences, and others, are actively focused on developing innovative therapeutic approaches targeting disease progression and cyst growth.

  • Emerging ADPKD therapies such as XRx-008, ABBV-CLS-628, and Farabursen are expected to reshape the competitive landscape by targeting key biological pathways involved in cystogenesis and kidney function decline.

Unlock strategic insights into the rapidly evolving ADPKD treatment landscape @ ADPKD Market Forecast Report

Key Factors Driving the ADPKD Market

  • Increasing Diagnosed Patient Population and Improved Genetic Testing: Advancements in genetic testing technologies, growing awareness among physicians, and improved diagnostic methodologies are enabling earlier identification of ADPKD cases, significantly expanding the diagnosed patient pool globally.

  • Growing Demand for Disease-Modifying Therapies: The current treatment landscape remains highly limited, with JYNARQUE/JINARC (tolvaptan) serving as the only approved disease-modifying therapy for rapidly progressing ADPKD. The strong unmet need for effective therapies capable of slowing kidney decline is fueling investment and innovation in this therapeutic area.

  • Rising Burden of Chronic Kidney Disease and ESRD: ADPKD remains one of the leading inherited causes of ESRD globally. Increasing progression to dialysis and kidney transplantation continues to create substantial healthcare burden, driving demand for therapies that can delay renal decline and improve long-term outcomes.

  • Emergence of Novel Mechanism-Based Therapies: The growing development of therapies targeting vasopressin signaling, microRNA pathways, uric acid metabolism, and PAPP-A inhibition is expected to diversify treatment options and improve disease management outcomes in the coming years.

ADPKD Competitive Landscape

Several emerging ADPKD therapies are expected to intensify market competition during the forecast period, including XRx-008 (Xortx Therapeutics), ABBV-CLS-628 (Calico Life Sciences), and Farabursen (Novartis).

These therapies target diverse disease pathways, including xanthine oxidase inhibition, PAPP-A inhibition, and microRNA-17 suppression, aiming to reduce cyst growth, preserve kidney function, delay ESRD progression, and improve long-term clinical outcomes compared to currently available treatment options.

Explore therapies expected to capture significant ADPKD market share @ Emerging ADPKD Therapies

Recent Developments in the ADPKD Market

  • In February 2026, Xortx Therapeutics announced plans to initiate registration trials of XRx-008 for ADPKD using accelerated approval and orphan drug designation pathways.

  • In November 2025, Calico Life Sciences announced that the US FDA granted Orphan Drug Designation (ODD) to ABBV-CLS-628 for the treatment of ADPKD.

  • In April 2025, Novartis announced the acquisition agreement for Regulus Therapeutics, whose lead asset Farabursen is being developed as a next-generation oligonucleotide therapy targeting miR-17 for ADPKD treatment.

  • In November 2025, Novartis presented new clinical data for Farabursen at ASN Kidney Week and the American Heart Association Scientific Sessions, highlighting promising efficacy and safety findings.

  • In May 2025, Lupin Limited launched a generic alternative to JYNARQUE in the United States, expanding accessibility to tolvaptan therapy for adults with rapidly progressing ADPKD.

What is Autosomal Dominant Polycystic Kidney Disease (ADPKD)?

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a chronic inherited renal disorder characterized by the progressive development of fluid-filled cysts in the kidneys, leading to kidney enlargement, hypertension, declining renal function, and ultimately end-stage renal disease.

The disease is primarily caused by mutations in the PKD1 and PKD2 genes and is associated with multiple complications, including chronic pain, kidney infections, liver cysts, cardiovascular disease, and intracranial aneurysms. ADPKD significantly impacts quality of life and remains one of the most common inherited causes of kidney failure worldwide.

ADPKD Epidemiology Segmentation

The ADPKD epidemiology section provides insights into historical and forecasted patient trends across the 7MM from 2022–2036, segmented into:

  • Total Diagnosed Prevalent Cases of ADPKD

  • Age-specific Diagnosed Prevalent Cases of ADPKD

  • Mutation-specific Diagnosed Prevalent Cases of ADPKD

  • Total Treated Cases of ADPKD

  • Country-specific ADPKD Patient Population

Scope of the ADPKD Market Report

  • Therapeutic Assessment: Current marketed and emerging ADPKD therapies

  • ADPKD Market Dynamics: Key market drivers, barriers, and forecast assumptions

  • Key Companies: Otsuka Pharmaceutical, Xortx Therapeutics, Novartis, Calico Life Sciences, and others

  • Key Therapies: JYNARQUE/JINARC (tolvaptan), XRx-008, ABBV-CLS-628, Farabursen, and others

  • Competitive Intelligence Analysis: SWOT analysis, launch strategies, and market positioning

  • Market Access and Reimbursement Assessment across the 7MM

  • KOL Insights, Analyst Views, and Unmet Needs Analysis

Gain comprehensive insights into ADPKD clinical development and commercial opportunities @ ADPKD Clinical Trials and Emerging Drugs

Table of Contents

  1. ADPKD Market Report Introduction

  2. Executive Summary of ADPKD

  3. ADPKD Epidemiology and Market Methodology

  4. ADPKD Market Overview at a Glance

  5. ADPKD Epidemiology and Patient Population

  6. Country-specific ADPKD Epidemiology Analysis

  7. ADPKD Current Treatment Landscape

  8. ADPKD Emerging Therapies

  9. ADPKD Market Size and Forecast Analysis

  10. ADPKD Market Access and Reimbursement

  11. ADPKD SWOT Analysis

  12. ADPKD KOL Views

  13. ADPKD Market Drivers and Barriers

  14. ADPKD Appendix

  15. Report Methodology

  16. DelveInsight Capabilities

  17. Disclaimer

  18. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharmaceutical and biotech companies by providing comprehensive end-to-end market intelligence and strategic solutions to improve business performance. Get hassle-free access to healthcare and pharma market research reports through DelveInsight’s subscription-based platform PharmDelve.

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