Germany Primary Hyperoxaluria (PH) Therapeutics Market Report 2022-2030

Germany Primary Hyperoxaluria (PH) Therapeutics Market Analysis

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The Germany Primary Hyperoxaluria (PH) Therapeutics market was valued at $XX Bn in 2022 and is estimated to expand at a CAGR of 3% from 2022 to 2030 and will reach $XX Bn in 2030. One of the main reasons propelling the growth of this market is government support, aging population. The market is segmented by diagnostic method, by treatment, and by type. Some key players in this market include Sanofi S.A, Allena Pharmaceuticals, Inozyme Pharma, Evotec, Dicerna Pharmaceuticals, and Alnylam Pharmaceuticals, among others.

ID: IN10DEPH507 CATEGORY: Pharmaceuticals GEOGRAPHY: Germany AUTHOR: Nandini Shah

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Germany Primary Hyperoxaluria (PH) Therapeutics Market Executive Summary

The Germany Primary Hyperoxaluria (PH) Therapeutics market was valued at $XX Bn in 2022 and is estimated to expand at a CAGR of 3% from 2022 to 2030 and will reach $XX Bn in 2030. The rare inherited metabolic condition known as primary hyperoxaluria (PH) is characterised by the build-up of the compound oxalate in the kidneys and other organ systems of the body. A particular enzyme that typically inhibits the accumulation of oxalate is absent from affected people. The specific enzyme that is lacking distinguishes the three primary types of PH—PH types I, II, and III. Exceedingly high levels of oxalate in the body combine with calcium in the kidneys to generate calcium oxalate, the primary building block of kidney and urinary stones. Frequent signs include the development of kidney and urinary tract stones (nephrolithiasis) as well as gradually rising calcium levels in the kidneys (nephrocalcinosis).

Market Dynamics

Market Growth Drivers

Although PH is a rare genetic disorder, the incidence of the disease is increasing in Germany. According to a study, the prevalence of PH in Germany was estimated to be 1 in 462,222 which counts to 180 patients. As awareness of the condition grows and more patients are diagnosed, the demand for PH therapeutics is expected to increase. As mentioned earlier, there are currently a limited number of treatment options for PH. However, new drugs like Oxabact from OxThera are currently in clinical trials, and could provide patients with new treatment options. Additionally, advancements in kidney dialysis and transplantation techniques are also expected to drive growth in the PH therapeutics market. The German government has implemented several policies to support the development and approval of drugs for rare diseases like PH. For example, the German Medicines Act allows for accelerated approval of drugs for rare diseases, which can help to bring new treatments to market more quickly.

Market Restraints

PH is a rare disease, which means that the patient population is relatively small. This can make it difficult for companies to justify the development and commercialization of new drugs for the condition, as the potential market may not be large enough to generate significant revenue. The cost of treating PH can be high, particularly for patients who require kidney dialysis or transplantation. This can make it difficult for patients to access treatment and may limit the demand for PH therapeutics. PH is a rare disease, and many physicians may not be familiar with the condition or its symptoms. This can lead to delays in diagnosis and treatment, which can have a negative impact on patient outcomes.

Competitive Landscape

Key Players

Sanofi S.A
Allena Pharmaceuticals
Inozyme Pharma
Evotec
Dicerna Pharmaceuticals
Alnylam Pharmaceuticals

Healthcare Policies and Regulatory Landscape

Germany has a well-established healthcare policy and regulatory framework that governs the development and approval of pharmaceuticals, including those used to treat Primary Hyperoxaluria (PH). Drugs must be approved by the Federal Institute for Drugs and Medical Devices (BfArM) before they can be marketed in Germany. The approval process includes a rigorous evaluation of the drug's safety, efficacy, and quality. The pricing and reimbursement of drugs in Germany are regulated by the Federal Joint Committee (G-BA). The G-BA is responsible for setting prices and determining which drugs are covered by statutory health insurance. The processing and use of personal health data in Germany are regulated by the General Data Protection Regulation (GDPR). The GDPR sets strict guidelines for the collection, use, and sharing of personal health data.

Reimbursement Scenario

In Germany, the reimbursement of drugs for Primary Hyperoxaluria (PH) is regulated by the Federal Joint Committee (G-BA). The G-BA is responsible for determining which drugs are eligible for reimbursement by statutory health insurance, which is mandatory for most residents. The reimbursement process in Germany is based on the AMNOG (Act on the Reform of the Market for Medicinal Products) process. Under this process, new drugs are evaluated by the G-BA and assigned a value based on their added benefit over existing treatments. The value is then used to determine the drug's price and reimbursement status.

For drugs used to treat rare diseases like PH, the G-BA may grant special reimbursement status, known as "orphan drug" status. Drugs with orphan drug status are eligible for reimbursement at a higher rate than non-orphan drugs, and may also be eligible for additional incentives and support from the government.

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

Primary Hyperoxaluria (PH) Therapeutics Market Segmentation

By Diagnostic method

Blood tests & Urine tests
Stone analysis
X-ray Examination
CT scanning & MRI
Biopsy
Molecular genetic testing
DNA Testing

By Treatment

Dietary
Lifestyle
Drug
Kidney Stone Management
Dialysis
Kidney/liver transplant

By Type

Primary Hyperoxaluria Type I
Primary Hyperoxaluria Type II
Primary Hyperoxaluria Type III

Methodology for Database Creation

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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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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.
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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.