Polycystic Kidney Disease Drugs Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Germany, China, UK, Canada - Size and Forecast 2024-2028

Polycystic Kidney Disease Drugs Market Size 2024-2028 

The polycystic kidney disease drugs market size is estimated to grow by USD 326 million at a CAGR of 4.5% between 2023 and 2028. The market is experiencing significant growth due to the high prevalence of chronic kidney diseases, particularly PKD, which affects an estimated 12.5 million people worldwide. The lack of approved drugs for PKD, a leading cause of end-stage renal disease, presents a substantial opportunity for market expansion. Increasing research funding, driven by the unmet medical need and potential market size, is fueling the development of novel therapies. Key players in the market include Otsuka Pharmaceutical, FibroGen, and Vertex Pharmaceuticals, among others. Market trends include the exploration of gene therapy and RNA-based therapies, as well as the development of combination therapies to address the complexities of PKD. Despite these advancements, challenges remain, including the high cost of drug development and the need for long-term safety and efficacy data.

What will be the Size of the Market During the Forecast Period?

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Market Dynamic and Customer Landscape

Polycystic kidney disease (PKD) is a genetic disorder characterized by the growth of numerous cysts in the kidneys, leading to kidney enlargement, high blood pressure, renal failure, and chronic kidney disease. The PKD drugs market is driven by the increasing prevalence of this condition and the growing need for effective medications to manage its symptoms. Two main types of medications are used to treat PKD: oral and parenteral. Oral medications include Empagliflozin, which is an SGLT2 inhibitor used to manage blood sugar levels and has been shown to slow the progression of kidney damage in patients with PKD. Parenteral medications are administered intravenously or through injections and are used to manage symptoms such as pain and high blood pressure. Diagnosis of PKD typically involves imaging tests such as ultrasound, CT scan, and MRI scan. Treatment options for PKD also include surgery, such as nephrectomy or transplantation, and dialysis for advanced cases. Pharmaceutical firms and research institutions are investing in the development of new drugs and technologies, including artificial intelligence and machine learning, to improve the diagnosis and treatment of PKD. The PKD drugs market is expected to grow due to increasing healthcare expenditure and the rising number of patients with genetic abnormalities and kidney cysts. The market is also driven by the growing number of hospitals, specialty clinics, hospital pharmacies, and retail pharmacies offering treatments for PKD. Despite these trends, the PKD drugs market faces challenges such as high costs and limited reimbursement policies for PKD treatments. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Key Market Driver

The high prevalence of chronic kidney diseases is notably driving the market growth. Polycystic kidney disease (PKD) is a genetic condition characterized by the growth of numerous cysts in the kidneys, leading to kidney enlargement, high blood pressure, and potential renal failure. The prevalence of chronic kidney diseases, including PKD, has been on the rise due to the increasing incidence of diabetes, hypertension, and heart disease. Approximately 10% of the global population is affected by chronic kidney diseases, and millions die each year due to a lack of affordable treatment. In the US alone, 15% of adults, or 37 million people, are estimated to have chronic kidney disease. PKD is a significant contributor to chronic kidney diseases and can cause kidney failure. Although rare, PKD affects a substantial number of people, and its prevalence is increasing. Diagnosis of PKD involves various imaging techniques such as ultrasound and CT scan. Medications, both oral and parenteral, are used to manage symptoms and slow down the progression of the disease. Surgery is another treatment option for managing PKD, especially in severe cases.

Furthermore, hospitals and specialty clinics are the primary points of care for patients with PKD, with hospital pharmacies and retail pharmacies providing the necessary medications. Pharmaceutical firms are investing heavily in research to develop new drugs for PKD. Monash Biotech Business and Cystence Bio are some of the companies leading the way in PKD drug development. The use of artificial intelligence and machine learning in drug development, PKD pathophysiology, high-output screening, computational modeling, genomics, and biomarker discovery is becoming increasingly common. The production of PKD drugs is taking place at various production sites with increasing production capacities, and new product launches are dominating the market. The dominance of pharmaceutical firms in the PKD drugs market is expected to continue due to their significant investment in research and development. The healthcare expenditure on genetic diseases, including PKD, is projected to increase significantly in the coming years. Thus, such factors are driving the growth of the market during the forecast period.

Significant  Market Trends

Increasing research funding is the key trend in the market. Polycystic kidney disease is a genetic condition characterized by the growth of numerous cysts in the kidneys, leading to renal dysfunction and potential renal failure. While there is currently one approved medication, tocilizumab, for the treatment of this disease, the unmet medical need for effective therapeutics is significant due to the increasing prevalence of this chronic condition. The market is witnessing intense research and development activities by various players, including pharmaceutical firms and research institutes, to address this need. However, the market faces challenges, as a considerable number of these entities are small or mid-sized organizations that lack the necessary funding to successfully conduct clinical trials and bring new drugs to market. Consequently, they rely on grants from research funding organizations to advance their research. In the meantime, diagnostic tools such as ultrasound and CT scans remain essential for early detection and monitoring of the disease.

Furthermore, healthcare expenditure on genetic diseases, including polycystic kidney disease, is anticipated to increase, providing potential opportunities for investment in research and production sites. Advancements in technology, such as artificial intelligence and machine learning, are also being explored to aid in drug development through high-output screening, computational modeling, genomics, and biomarker discovery. For instance, Cystence Bio and Monash Biotech Business are actively engaged in research on a CFTR1 inhibitor for the treatment of polycystic kidney disease. Despite the challenges, the dominance of pharmaceutical firms in the market is expected to continue, with product launches and expansion of production capacities shaping the competitive landscape. Thus, such trends will shape the growth of the market during the forecast period.

Major Market Challenge

Lack of approved drugs is the major challenge that affects the growth of the market. Polycystic kidney disease (PKD) is a genetic condition characterized by the growth of numerous cysts in the kidneys, leading to renal failure. The market for drugs to treat PKD is currently limited due to the complexities of the disease's pathophysiology and the rarity of the condition. JYNARQUE/JINARC is the only approved branded medication for PKD, primarily used to slow the progression of kidney damage. However, the market is heavily influenced by the off-label use of various medications, such as antibiotics, drugs for hypertension, and non-steroidal anti-inflammatory drugs (NSAIDs), to alleviate symptoms like pain, hematuria, and frequent urination.

Furthermore, diagnostic tools like ultrasound and CT scans are essential in identifying PKD, while hospitals and specialty clinics are the primary channels for medication distribution. Healthcare expenditure on genetic diseases, including PKD, is increasing, leading to investment in research by pharmaceutical firms like Monash Biotech Business and Cystence Bio. Drug development for PKD involves advanced technologies like artificial intelligence, machine learning, computational modeling, genomics, and biomarker discovery. A CFTR1 inhibitor is a promising drug under development for PKD treatment. Despite the challenges, the market is expected to witness significant growth due to the increasing prevalence of PKD and the need for effective treatments for chronic kidney disease, renal failure, and dialysis. Hence, the above factors will impede the growth of the market during the forecast period

Key Market  Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

AstraZeneca Plc - The company offers polycystic kidney disease drugs such as Forxiga.

The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Apotex Inc.
• AstraZeneca Plc
• Dr Reddys Laboratories Ltd.
• Galapagos NV
• Johnson and Johnson Services Inc.
• Merck and Co. Inc.
• Novartis AG
• Otsuka Holdings Co. Ltd.
• Palladio Biosciences Inc.
• Reata Pharmaceuticals Inc.
• Regulus Therapeutics Inc.
• Sanofi SA
• Teva Pharmaceutical Industries Ltd.
• Vertex Pharmaceuticals Inc.
• XORTX Therapeutics Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Segmentation

By Type 

The ADPKD segment is estimated to witness significant growth during the forecast period. Polycystic Kidney Disease (PKD), an autosomal dominant genetic condition, is characterized by the growth of numerous cysts in the kidneys. Two primary gene mutations, Polycystic Kidney Disease 1 (PKD1) and Polycystic Kidney Disease 2 (PKD2), are responsible for the development of this condition, with approximately 85-90% of cases linked to PKD1. ADPKD is the most common form of PKD, affecting one in every 400 to 1,000 individuals globally. 

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The ADPKD segment was the largest segment and was valued at USD 760.30 million in 2018. Diagnosis typically occurs between the ages of 30 and 50, making it also known as adult polycystic kidney disease. As the disease progresses, patients may experience various symptoms, including high blood pressure, renal failure, and the need for dialysis. Medications, both oral and parenteral, are used to manage symptoms and slow down the disease's progression. Surgery, such as nephrectomy, may be required for larger cysts. Diagnosis relies on imaging techniques like ultrasound and CT scans. Healthcare expenditure on genetic diseases, including PKD, is significant. Pharmaceutical firms have invested in research to develop new treatments. Monash Biotech Business and Cystence Bio are some companies actively involved in PKD drug development. Advancements in technology, such as artificial intelligence and machine learning, have led to high-output screening, computational modeling, genomics, and biomarker research. A CFTR1 inhibitor, Empagliflozin, has shown potential in treating PKD pathophysiology. Product launch and dominance in the market are crucial for these firms. Hospitals and specialty clinics, as well as hospital and retail pharmacies, play essential roles in the distribution and administration of medications. Production sites and capacities are continually expanding to meet the growing demand for PKD treatments.

By Region

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Asia is estimated to contribute 44% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

Another region offering significant growth opportunities to vendors is North America. The market growth in North America is primarily attributed to the increased cases of polycystic kidney disease in the region. Polycystic kidney disease causes chronic kidney disease, which can result in kidney failure or end-stage renal disease. The prevalence of kidney failure is very high in the US. Polycystic kidney disease causes about 2% to 5 % of the cases of kidney failure in the US every year. For instance, according to the Centers for Disease Control and Prevention (CDC), almost 15% of the geriatric population suffers from kidney failure, and the US has about 12.55%-15.18% of the geriatric population. Although only 2%-5% of the population suffers kidney failure due to polycystic kidney disease, the actual number of affected people is high. About 400,000 people in the US have polycystic kidney disease, and around one in five adults with high blood pressure has chronic renal failure. New research activities resulted in the approval of curative therapy for the treatment of ADPKD in the US. The first and only recent approval of JYNARQUE (tolvaptan) offered by Otsuka has increased the option for the treatment of the condition for US residents. JYNARQUE (tolvaptan) was approved by the US FDA for the treatment of ADPKD in the country. Therefore, factors such as advances in research and development of PKD will support the growth of the market in North America. Furthermore, the market in this region is driven by the increasing number of support programs conducted by vendors and various organizations. Such programs encourage people with polycystic kidney disease to undergo treatment using various drug therapies and other treatment options.

Segment Overview

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million " for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• Type Outlook
  • ADPKD
  • ARPKD

• Region Outlook 
  • APAC
    • China
    • India
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • Rest of the Middle East & Africa

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Market Analyst Overview

Polycystic Kidney Disease (PKD) is a genetic disorder characterized by the growth of numerous cysts in the kidneys, leading to kidney enlargement, high blood pressure, renal failure, and chronic kidney disease. The PKD drugs market is driven by the increasing prevalence of genetic abnormalities and the need for effective medication to manage the symptoms. The market comprises oral and parenteral medications, used in hospitals, specialty clinics, Hospital pharmacy, and retail pharmacy. Key players in the market include Monash Biotech Business and Cystence Bio, who are investing in research and production sites to increase production capacities and launch new products. Empagliflozin, a SGLT2 inhibitor, is a promising drug for PKD treatment, as it helps reduce the progression of kidney damage.

Furthermore, drug development in PKD is focused on understanding PKD pathophysiology through high-output screening, computational modeling, genomics, and biomarker discovery. Artificial intelligence and machine learning are also being used to improve diagnosis and treatment, making the market more dynamic. The market's growth is influenced by the increasing healthcare expenditure on genetic diseases and the dominance of pharmaceutical firms in the industry. CT Scans and Ultrasounds are commonly used for diagnosis, while dialysis is used for managing advanced stages of the disease. The market is expected to witness significant product launches and growth in the coming years.

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What are the Key Data Covered in this Market Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting of the market between 2024 and 2028
• Precise estimation of the size of the market size and its contribution to the parent market
• Accurate predictions about upcoming market trends and analysis and changes in consumer behavior
• Growth of the market industry across Europe, North America, APAC, South America, and Middle East and Africa
• Thorough market growth analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive market analysis and report on the factors that will challenge the market research and growth of market companies