Autosomal Dominant Polycystic Kidney Disease - Market Insight, Epidemiology and Market Forecast - 2032

This ‘Autosomal Dominant Polycystic Kidney Disease (ADPKD) - Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of Autosomal Dominant Polycystic Kidney Disease, historical and forecasted epidemiology as well as Autosomal Dominant Polycystic Kidney Disease trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Autosomal Dominant Polycystic Kidney Disease market report provides current treatment practices, emerging drugs, market share of the individual therapies, and the current and forecasted 7MM Autosomal Dominant Polycystic Kidney Disease market size from 2019-2032. The report also covers current Autosomal Dominant Polycystic Kidney Disease treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Autosomal Dominant Polycystic Kidney Disease Understanding and Treatment Algorithm

Autosomal Dominant Polycystic Kidney Disease Overview

Autosomal dominant polycystic kidney disease, also called “adult PKD” is the most common inherited kidney disorder characterized by the growth of cysts in the kidneys, which eventually leads to kidney failure. A monogenetic disorder, Autosomal Dominant Polycystic Kidney Disease is caused by mutations in either the PKD1 gene found on chromosome 16 or the PKD2 gene found on chromosome 4. Mutations in PKD1 are more common and account for about 85% of all Autosomal Dominant Polycystic Kidney Disease cases.

Autosomal Dominant Polycystic Kidney Disease is characterized by bilateral renal cysts, kidney pain, frequent urinary tract infection, hematuria, nephrolithiasis, hypertension, and progressive renal failure due to progressive enlargement of cysts and fibrosis. It is one of the leading causes of renal replacement and end-stage renal disease.

Aside from renal cysts, patients frequently have extra renal diseases, which consist of cysts in the liver, seminal vesicle, pancreas, arachnoid membrane, and connective tissue abnormalities like mitral valve prolapse, intracranial aneurysms, diverticular disease, and abdominal hernia; hypertension and left ventricular hypertrophy, and hypertension and left ventricular hypertrophy. Other cardiovascular abnormalities include aortic and arachnoid aneurysms. Recognition of these extra renal manifestations (ERM) reduces diagnostic uncertainty and majorly influences the treatment administered.

Autosomal Dominant Polycystic Kidney Disease Diagnosis

Ultrasound is the most reliable, inexpensive, and non-invasive way to diagnose PKD. If someone at risk for PKD is older than 40 years and has a normal ultrasound of the kidneys, they probably do not have PKD. Occasionally, a CT scan (computed tomography scan) and MRI (magnetic resonance imaging) may detect smaller cysts that ultrasound cannot find. MRI is mostly used to measure and monitor the volume and growth of kidneys and cysts. In some situations, genetic testing might also be done. This involves a blood test that checks for abnormal genes that cause the disease. Genetic testing is not recommended for everyone. The test is costly, and it also fails to detect PKD in about 15% of people who have it.

Autosomal Dominant Polycystic Kidney Disease Treatment

In the case of treatment, there is no proper cure for ADPKD. However, treatment of hypertension in patients with ADPKD commonly includes nonpharmacological interventions, such as exercise, weight reduction, and dietary salt restriction. Excluding additional secondary causes of hypertension, such as primary hyperaldosteronism, pheochromocytoma, or obstructive sleep apnea, should all be considered with clinical suspicion of their existence. Also, inhibition of the RAAS using angiotensin-converting enzyme (ACE) inhibitors is favored, as well as the use of angiotensin-receptor blockers (ARBs) and β-blockers. The findings from the early studies with small cohorts of patients demonstrated that ACE inhibitors reduce the severity of proteinuria and left ventricular mass compared to diuretics and calcium channel blockers. In contrast, ARBs resulted in a greater reduction in proteinuria than calcium channel blockers.

Currently, there is only one approved therapy for the treatment of ADPKD, i.e., tolvaptan, which is a vasopressin V2 receptor antagonist. It is the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing ADPKD. But this comes with a black box warning as well. It is mentioned in the label that Jynarque (tolvaptan) can cause serious and potentially fatal liver injury. In addition, acute liver failure requiring liver transplantation has been reported in some patients. However, novel strategies to limit cyst burden have provided encouraging results, but the treatment of hypertension and proteinuria remains the main idea for the medical management of ADPKD

Autosomal Dominant Polycystic Kidney Disease Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent cases of Autosomal Dominant Polycystic Kidney Disease, Age-specific cases of Autosomal Dominant Polycystic Kidney Disease, and Mutation-specific cases of Autosomal Dominant Polycystic Kidney Disease, the scenario of Autosomal Dominant Polycystic Kidney Disease in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• Total diagnosed prevalent cases of Autosomal Dominant Polycystic Kidney Disease in the 7MM were found to be approximately 367,042 cases in the year 2021. The diagnosed prevalent cases of Autosomal Dominant Polycystic Kidney Disease are likely to change by 2032 in the forecast period 2022─2032.
• The United States accounted for approximately 142,709 diagnosed prevalent cases of Autosomal Dominant Polycystic Kidney Disease in the year 2021.
• In 2021, the total reported diagnosed prevalent cases of Autosomal Dominant Polycystic Kidney Disease in EU-5 countries were approximately 193,161 cases which are expected to rise by 2032.
• In 2021, the UK accounted for the highest number of Autosomal Dominant Polycystic Kidney Disease diagnosed prevalent cases (67,419), followed by France (61,282) among EU-5 countries. In contrast, Italy accounts for the lowest number of cases of Autosomal Dominant Polycystic Kidney Disease diagnosed prevalent population in EU-5.
• As perthe analysis, in Japan, Autosomal Dominant Polycystic Kidney Disease cases in the age groups < 5, 5-14, 15-24, 25-44, 45-64, and ≥65 years were observed to be approximately 62, 62, 125, 3,429, 19,576, and 7,918, respectively in 2021. The age-specific cases are expected to change by 2032.

Autosomal Dominant Polycystic Kidney Disease Epidemiology

The epidemiology segment also provides the Autosomal Dominant Polycystic Kidney Disease epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Autosomal Dominant Polycystic Kidney Disease Drug Chapters

The drug chapter segment of the Autosomal Dominant Polycystic Kidney Disease report encloses the detailed analysis of Autosomal Dominant Polycystic Kidney Disease marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Autosomal Dominant Polycystic Kidney Disease clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

Autosomal Dominant Polycystic Kidney Disease Marketed Drugs
Jynarque/Jinarc/Samsca (tolvaptan): Otsuka Pharmaceutical
Jynarque (Jinarc/Samsca), developed by Otsuka Pharmaceutical, is a selective vasopressin V2-receptor antagonist to treat adults with Autosomal Dominant Polycystic Kidney Disease.

Tolvaptan inhibits vasopressin receptors in the kidneys and retards kidney function decline in adults at risk of rapidly progressing Autosomal Dominant Polycystic Kidney Disease. It has a 29 times higher affinity for V2-receptor than for V1a, and this is 1.8 times the affinity of natural arginine vasopressin (AVP) for V2, which helps regulate urine volume and osmolality, serum sodium levels, and free water clearance rate. It is conducting Phase III trials to evaluate the effect of tolvaptan on the need for renal replacement therapy in pediatric subjects (28 days to less than 12 weeks old at the time of enrollment) with ARPKD.

List of products to be continued in the report…

Autosomal Dominant Polycystic Kidney Disease Emerging Drugs

Tesevatinib/KD019: Sanofi
Tesevatinib is an oral small-molecule tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGF receptor), a part of signaling pathways known to promote cyst growth in Autosomal Dominant Polycystic Kidney Disease. Tesevatinib accumulates in the kidneys, 15‑fold greater than in the blood. Tesevatinib has been demonstrated to inhibit the growth of kidneys and preserve kidney function in PKD animal models.

Tesevatinib recently completed its evaluation in a randomized parallel-group Phase II study in subjects with Autosomal Dominant Polycystic Kidney Disease.

RGLS8429: Regulus Therapeutics
RGLS8429 is a novel, next-generation oligonucleotide for the treatment of Autosomal Dominant Polycystic Kidney Disease designed to inhibit miR-17 and preferentially target the kidney. Administration of RGLS8429 has shown robust data in preclinical models, where clear improvements in kidney function, size, and other measures of disease severity and a superior pharmacologic profile, have been demonstrated along with a superior pharmacologic profile in preclinical studies compared to Regulus' first-generation compound.

Following the SAD study, the company plans to initiate a Phase Ib multiple ascending doses (MAD) study to assess the safety, tolerability, and pharmacokinetics of RGLS8429 in adult patients with Autosomal Dominant Polycystic Kidney Disease, and to evaluate the efficacy of RGLS8429 treatment across three different dose levels including changes in polycystins, cystic kidney volume (htTKV), and overall kidney function.

List of products to be continued in the report…

Autosomal Dominant Polycystic Kidney Disease Market Outlook

Autosomal dominant polycystic kidney disease also called “adult PKD” is the most common inherited kidney disorder characterized by the growth of cysts in the kidneys, which eventually leads to kidney failure. A monogenetic disorder, Autosomal Dominant Polycystic Kidney Disease is caused by mutations in either the PKD1 gene found on chromosome 16 or the PKD2 gene found on chromosome 4. Mutations in PKD1 are more common and account for about 85% of all Autosomal Dominant Polycystic Kidney Disease cases. These genes encode for proteins of the polycystin signaling complex, which regulates different signals, including 3',5'-cyclic adenosine monophosphate (cAMP), mammalian target of rapamycin (mTOR), and epidermal growth factor receptor pathways.

There is currently no effective curative treatment for Autosomal Dominant Polycystic Kidney Disease, and most efforts are aimed at mitigating the complications and progression or reducing cyst growth and delaying the eventual progression to kidney failure. Tolvaptan (Jynarque/Jinarc/Samsca), developed by Otsuka Pharmaceuticals, is the only approved drug available globally for treating Autosomal Dominant Polycystic Kidney Disease in adults. It inhibits vasopressin receptors in the kidneys and retards kidney function decline by reducing adenylate cyclase activity in adults at risk of rapidly progressing Autosomal Dominant Polycystic Kidney Disease.

Nonetheless, being the only approved drug for the indication gives Otsuka an early mover advantage which is studying the effectiveness of Tolvaptan in pediatric subjects (28 days to less than 12 weeks old at the time of enrollment) with ARPKD. Besides this, Otsuka, along with Mario Negri Institute for Pharmacological Research, Italy, has also conducted trials to assess the effectiveness of tolvaptan plus octreotide LAR combination therapy, a vasopressin antagonist, and somatostatin analog combination, in Autosomal Dominant Polycystic Kidney Disease patients with normal kidney function or hyperfiltration.

Key Findings

• The market size of Autosomal Dominant Polycystic Kidney Disease in seven major markets was USD 1,077 million in 2021, which is further expected to increase significantly by 2032 in the forecast period 2022─2032.
• The expected launch of potential therapies may increase market size in the coming years, assisted by an increase in the diagnosed prevalent population of Autosomal Dominant Polycystic Kidney Disease.
• The United States accounts for the largest market size for Autosomal Dominant Polycystic Kidney Disease, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
• Upcoming therapies such as Bardoxolone methyl, Tesevatinib/KD019, and RGLS8429 have the potential to create a significant positive shift in the Autosomal Dominant Polycystic Kidney Disease market size.
• Among the EU5 countries, the United Kingdom had the highest market size with USD 79 million in 2021.

The United States Market Outlook

This section provides the total Autosomal Dominant Polycystic Kidney Disease market size and market size by therapies in the United States.

EU-5 Market Outlook

The total Autosomal Dominant Polycystic Kidney Disease market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Autosomal Dominant Polycystic Kidney Disease market size and market size by therapies in Japan are provided.

Autosomal Dominant Polycystic Kidney Disease Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Autosomal Dominant Polycystic Kidney Disease market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Autosomal Dominant Polycystic Kidney Disease market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and the reasons behind the maximal use of new drugs and allow the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Autosomal Dominant Polycystic Kidney Disease Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Autosomal Dominant Polycystic Kidney Disease emerging therapies.

Reimbursement Scenario in Autosomal Dominant Polycystic Kidney Disease

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitively and market Intelligence analysis of the Autosomal Dominant Polycystic Kidney Disease market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Autosomal Dominant Polycystic Kidney Disease, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Autosomal Dominant Polycystic Kidney Disease epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Autosomal Dominant Polycystic Kidney Disease is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Autosomal Dominant Polycystic Kidney Disease market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Autosomal Dominant Polycystic Kidney Disease market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing diagnosed prevalence will positively drive the Autosomal Dominant Polycystic Kidney Disease market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Autosomal Dominant Polycystic Kidney Disease R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Autosomal Dominant Polycystic Kidney Disease. The launch of emerging therapies will significantly impact the Autosomal Dominant Polycystic Kidney Disease market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Autosomal Dominant Polycystic Kidney Disease Report Insights

• Patient Population
• Therapeutic Approaches
• Autosomal Dominant Polycystic Kidney Disease Pipeline Analysis
• Autosomal Dominant Polycystic Kidney Disease Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Autosomal Dominant Polycystic Kidney Disease Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Autosomal Dominant Polycystic Kidney Disease Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Autosomal Dominant Polycystic Kidney Disease Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the Autosomal Dominant Polycystic Kidney Disease market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Autosomal Dominant Polycystic Kidney Disease total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings of the market across the 7MM and which country will have the largest Autosomal Dominant Polycystic Kidney Disease market size during the forecast period (2022-2032)?
• At what CAGR, the Autosomal Dominant Polycystic Kidney Disease market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Autosomal Dominant Polycystic Kidney Disease market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Autosomal Dominant Polycystic Kidney Disease market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Autosomal Dominant Polycystic Kidney Disease?
• What is the historical Autosomal Dominant Polycystic Kidney Disease patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Autosomal Dominant Polycystic Kidney Disease at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Autosomal Dominant Polycystic Kidney Disease?
• Out of the above-mentioned countries, which country would have the highest population of Autosomal Dominant Polycystic Kidney Disease during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Autosomal Dominant Polycystic Kidney Disease along with the approved therapy?
• What are the current treatment guidelines for the treatment of Autosomal Dominant Polycystic Kidney Disease in the US and Europe?
• What are the Autosomal Dominant Polycystic Kidney Disease marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of Autosomal Dominant Polycystic Kidney Disease?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Autosomal Dominant Polycystic Kidney Disease?
• What are the key collaborations (Industry-Industry, Industry-Academia), mergers and acquisitions, and licensing activities related to the Autosomal Dominant Polycystic Kidney Disease therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Autosomal Dominant Polycystic Kidney Disease and their status?
• What are the key designations that have been granted for the emerging therapies for Autosomal Dominant Polycystic Kidney Disease?
• What is the 7MM historical and forecasted market for Autosomal Dominant Polycystic Kidney Disease?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving Autosomal Dominant Polycystic Kidney Disease.
• To understand the future market competition in the Autosomal Dominant Polycystic Kidney Disease market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Autosomal Dominant Polycystic Kidney Disease in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Autosomal Dominant Polycystic Kidney Disease market.
• To understand the future market competition in the Autosomal Dominant Polycystic Kidney Disease market.