United States Autosomal Dominant Polycystic Kidney Disease (ADPKD) Market 2033 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The global autosomal dominant polycystic kidney disease (ADPKD) market reached US$ 1.65 Billion in 2023, with a rise of US$ 1.93 Billion in 2024 and is expected to reach US$ 2.83 Billion by 2033, growing at a CAGR of 4.4% during the forecast period 2025-2033.

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Key Development:

United States: Recent ADPKD Developments

✅ In November 2025, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to ABBV‐CLS‐628, an investigational anti‐PAPP‐A monoclonal antibody for ADPKD currently in Phase 2 clinical trials, building on its previous Fast Track Designation to accelerate development. This designation underscores the need for new therapies beyond existing standards of care.

✅ In October 2025, Calico Life Sciences' investigational ADPKD therapy ABBV‐CLS‐628 received Fast Track Designation from the FDA, aimed at expediting its clinical development and review process in hopes of addressing unmet needs in slowing kidney function decline in ADPKD patients.

✅ In March 2025, Regulus Therapeutics announced positive topline results from its Phase 1b multiple‐ascending‐dose (MAD) clinical trial of farabursen (RGLS8429) for ADPKD, with consistent impact on key biomarkers and halted kidney volume growth over 4 months, positioning the program for a Phase 3 pivotal trial later in 2025.

✅ In February 2025, Novartis advanced its ADPKD portfolio by acquiring Regulus Therapeutics, gaining full control of farabursen development and accelerating the therapy's path toward Phase 3 studies in both the U.S. and global markets.

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Japan: Recent ADPKD Developments

✅ In September 2025, Japanese ADPKD patient advocacy and clinical research efforts expanded with the launch of new specific clinical research initiatives targeting ADPKD, engaging patients in interviews and data gathering to support future therapeutic insights and improve understanding of patient experiences.

✅ In August 2025, clinical collaboration between Osaka University and domestic biotech companies initiated a new ADPKD biomarker study, aiming to accelerate early detection and better monitor kidney function decline in Japanese patients.

✅ In June 2025, Tamibarotene (RN‐014) a novel drug candidate under development by Rege Nephro Co., Ltd. - received Orphan Drug Designation from Japan's Ministry of Health, Labour and Welfare (MHLW) for ADPKD, supporting its ongoing Phase 2a clinical trial in Japanese patients and preparation for broader development.

✅ In May 2025, Japan continued efforts to optimize tolvaptan usage for ADPKD patients through a nationwide observational study, focusing on long-term safety, dosing, and patient outcomes to improve disease management in clinical practice.

Key Players:

=> Otsuka Pharmaceutical Co., Ltd, Camber Pharma, Astellas Pharma, and Johnson & Johnson, among others.

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Key Segments:

By Type

Tolvaptan - ~25% share

Used primarily for treating hyponatremia and autosomal dominant polycystic kidney disease (ADPKD), driving moderate adoption in hospitals and specialty clinics.

Pain Management Drugs - ~35% share

Includes opioids, NSAIDs, and other analgesics; high demand in hospital and homecare settings for acute and chronic pain management.

Antihypertensive Drugs - ~25% share

Widely prescribed for cardiovascular conditions; strong adoption across hospitals, retail pharmacies, and chronic care management programs.

Others - ~15% share

Includes niche or emerging therapeutic classes for kidney, cardiovascular, or rare disease indications.

By Route of Administration

Oral - ~60% share

Dominant administration mode due to convenience, patient compliance, and outpatient use.

Parenteral - ~40% share

Used in hospitals, emergency care, and specialized treatment requiring rapid onset or precise dosing.

By Distribution Channel

Hospital Pharmacies - ~45% share

Key channel for inpatient care, specialized drugs, and high-cost therapies like Tolvaptan.

Retail Pharmacies - ~35% share

Provides access to chronic care medications such as antihypertensives and pain management drugs.

Online Pharmacies - ~20% share

Growing segment driven by telehealth, homecare delivery, and increasing e-commerce adoption.

By Region

North America - ~40% share

U.S. - Largest market; high adoption due to advanced healthcare infrastructure and reimbursement coverage.

Canada, Mexico - Moderate growth in both hospital and retail pharmacy channels.

Europe - ~25% share

Germany, U.K., France, Italy - Major markets with strong hospital and retail pharmacy networks.

Rest of Europe - Emerging adoption in specialty therapies.

South America - ~10% share

Brazil, Argentina - Early adoption of hospital-administered therapies; growing retail pharmacy penetration.

Rest of South America - Moderate uptake of essential medications.

Asia Pacific - ~20% share

China, India, Japan, South Korea - Fast-growing adoption of pain management and antihypertensive drugs; Tolvaptan uptake increasing in specialized hospitals.

Rest of Asia Pacific - Emerging markets expanding access through retail and hospital channels.

Middle East & Africa - ~5% share

Adoption concentrated in private hospitals and specialty care centers; retail and online channels are gradually expanding.

FAQ

What is the current size of the Autosomal dominant polycystic kidney disease (ADPKD) Market?

A: In 2024, the Autosomal dominant polycystic kidney disease (ADPKD) Market was valued at US$ 1.93 Billion, reflecting its strong industry presence.

Q2: How large is the Autosomal dominant polycystic kidney disease (ADPKD) Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Autosomal dominant polycystic kidney disease (ADPKD) Market will grow to around US$ 2.83 Billion , demonstrating significant expansion.

Q3: What is the growth rate of the Autosomal dominant polycystic kidney disease (ADPKD) Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 4.4% during the forecast period from 2025 to 2033.

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