Spain ADPKD (Autosomal dominant polycystic kidney disease) Therapeutic Market Report 2022 to 2030

Spain Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

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The Spain Autosomal Dominant Polycystic Kidney Disease Therapeutics Market was valued at US $21 Mn in 2022, and is predicted to grow at (CAGR) of 4.8% from 2023 to 2030, to US $31 Mn by 2030. The key drivers of this industry include the upward trend in the incidence of autosomal dominant polycystic kidney disease, strong healthcare infrastructure, and other factors. The industry is primarily dominated by players such as Otsuka, Sanofi, Pfizer, Palladio, Reata, Xortx, Janssen among others

ID: IN10ESPH425 CATEGORY: Pharmaceuticals GEOGRAPHY: Spain AUTHOR: Riddhi Solanki

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Spain Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

The Spain Autosomal Dominant Polycystic Kidney Disease Therapeutics Market is at around US $21 Mn in 2022 and is projected to reach US $31 Mn in 2030, exhibiting a CAGR of 4.8% during the forecast period.

A rare genetic disease called ADPKD attacks multiple organs, fuelled by mutations in the PKD1 and PKD2 genes. This triggers the growth of fluid-filled cysts in the kidneys, causing them to swell (renomegaly) and often leading to kidney failure (ESKD). Pain, frequent infections, and fatigue are common symptoms. While no cure exists for this challenging disease, the focus lies on preventing complications and managing symptoms. Tolvaptan (Jinarc) manufactured by Otsuka Pharmaceuticals, stands as the only approved drug, working as a vasopressin blocker to slow cyst growth in some patients. Other options involve pain management and lifestyle changes to improve overall well-being.

The prevalence of ADPKD is around 1/10,000 individuals in Spain. However, due to lack of awareness and diagnostic services like genetic testing, the actual prevalence estimates are believed to be higher and increasing steadily. The market is therefore driven by major factors like the increased prevalence of cases, the unmet medical needs of the patient population, and government initiatives supporting several programs in the industry. However, conditions such as high costs of treatment, health system disparities, limited research and development, and others hinder the growth and potential of the market.

Market Dynamics

Market Growth Drivers

Surge in the prevalence of ADPKD: The prevalence of ADPKD ranges from 1/8,000 to 1/10,000 individuals in Spain. The actual estimates are believed to be higher due to underdiagnosis in several cases. These numbers are anticipated to result in patients requiring advanced treatments, resulting in the growth of the market.

Increased awareness and diagnosis: Increasing public awareness campaigns and efforts by patient advocacy groups result in earlier diagnosis and detection of ADPKD patients, expanding the pool of those seeking treatment. Progress in diagnostic technologies aids quicker and more precise diagnoses, additionally bolstering market expansion.

Unmet Medical Need: Present treatments for ADPKD primarily centre on symptom management and delaying disease advancement, revealing a considerable gap in curative or more potent therapies. This gap fuels research and development endeavours, potentially culminating in a range of innovative medications and treatment strategies, fostering market expansion in Spain

Government initiatives: The Spanish government has implemented initiatives targeted towards rare diseases, including ADPKD, and launched the Spanish Society of Nephrology and the Spanish PKD Association. They focus on the development of orphan drugs that support ADPKD research and pave the way for the potential market entry of innovative therapies by different companies. Efficient regulatory protocols can accelerate the approval of new ADPKD medications, enhancing market expansion.

Market Restraints

High costs of treatment: Treatments for ADPKD, such as Tolvaptan, can be costly, causing a considerable financial burden on both patients and the healthcare system. These out-of-pocket expenditures hinder treatment, especially for those with inadequate insurance coverage, and can result in patient non-compliance, treatment delays, and poor outcomes, distorting the growth of the market in Spain.

Health system disparities: The inequitable distribution of specialized nephrologists and advanced diagnostic resources across various Spanish regions results in uneven patient care and treatment options. These disparities may contribute to unequal patient outcomes and impede market expansion in underserved areas.

Healthcare system inefficiencies: Spain's intricate healthcare system, with diverse regional distinctions and administrative protocols, can pose challenges for new entrants in terms of navigating referrals, licensures, and reimbursements, impacting the adoption of treatments in the market.

Limited research and development: In contrast to some other European nations, Spain's involvement in ADPKD research is said to be comparatively limited, potentially leading to a slower pace in developing and providing new treatment options for patients.

Notable updates

August, 2023, Spanish health authorities initiated a trial program enabling early access to innovative therapies for severe or uncommon conditions, possibly laying the groundwork for expedited availability of advanced ADPKD treatments in the time ahead.

July, 2023, A reputed Spanish research facility has begun enrolling patients for a late-phase clinical trial focusing on a hopeful gene therapy method for ADPKD. This marks a promising chance for Spain to contribute to pioneering research and potentially introduce upcoming treatment alternatives.

Healthcare Policies and Regulatory Landscape

Spain's healthcare policy and regulatory framework are overseen by the Spanish National Health System (SNS), which is primarily a publicly-oriented system. The SNS is based on the principles of universality, free access, equity, and fairness of financing, covering majority of the population. The system operates through the management of Spain's 17 autonomous regions, which have significant authority over healthcare affairs, including the provision of public healthcare services and associated financial aspects. The SNS relies on Social Security funds and combines health promotion, disease prevention initiatives, and medical services

The healthcare regulatory framework, including pharmaceutical approval, falls solely under the central government's jurisdiction. Acquiring a license for healthcare products in Spain entails securing administrative authorization for each pharmaceutical product beforehand from the Spanish Agency of Medicines and Medical Devices (AEMPS). Spain adheres to EU healthcare regulations, and the different regions possess the autonomy to implement this system within their territories

The SNS is viewed as an opportunity offering potential for private investors, despite the strong public healthcare system.

Competitive Landscape

Key Players

Otsuka Pharmaceutical Co., Ltd
Janssen Pharmaceuticals
Reata Pharmaceuticals
AbbVie Inc
Exelixis
Sanofi
Pfizer Inc
Palladio Biosciences
Xortx Therapeutics
Pano Therapeutics

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Spain Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Segmentation

By Treatment

Pain & Inflammation Treatment
Kidney Stone Treatment
Urinary Tract Infection Treatment
Kidney Failure Treatment

By Route of Administration

Oral
Parenteral
Others

By End User

Hospitals
Speciality Clinics
Surgical Centres
Others

Methodology for Database Creation

Our database offers a comprehensive list of healthcare centers, meticulously curated to provide detailed information on a wide range of specialties and services. It includes top-tier hospitals, clinics, and diagnostic facilities across 30 countries and 24 specialties, ensuring users can find the healthcare services they need.

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How Do We Get It?

Our database is created and maintained through a combination of secondary and primary research methodologies.

1. Secondary Research

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Analyzing historical proprietary data collected from multiple projects.
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With extensive experience in the field, we have developed a proprietary GenAI-based technology that is uniquely tailored to our organization. This advanced technology enables us to scan a wide array of relevant information sources across the internet. Our data-gathering process includes:

Searching through academic conferences, published research, citations, and social media platforms
Collecting and compiling diverse data to build a comprehensive and detailed database
Continuously updating our database with new information to ensure its relevance and accuracy

2. Primary Research

To complement and validate our secondary data, we engage in primary research through local tie-ups and partnerships. This process involves:

Collaborating with local healthcare providers, hospitals, and clinics to gather real-time data.
Conducting surveys, interviews, and field studies to collect fresh data directly from the source.
Continuously refreshing our database to ensure that the information remains current and reliable.
Validating secondary data through cross-referencing with primary data to ensure accuracy and relevance.

Combining Secondary and Primary Research

By integrating both secondary and primary research methodologies, we ensure that our database is comprehensive, accurate, and up-to-date. The combined process involves:

Merging historical data from secondary research with real-time data from primary research.
Conducting thorough data validation and cleansing to remove inconsistencies and errors.
Organizing data into a structured format that is easily accessible and usable for various applications.
Continuously monitoring and updating the database to reflect the latest developments and trends in the healthcare field.

Through this meticulous process, we create a final database tailored to each region and domain within the healthcare industry. This approach ensures that our clients receive reliable and relevant data, empowering them to make informed decisions and drive innovation in their respective fields.