The global primary hyperoxaluria treatment market size reached a value of about USD 18.24 million in 2022 and is expected to grow at a CAGR of 3.67% during the forecast period of 2023-2031. With the growing awareness of rare disease and genetic engineering advancement, the market is expected to reach a value of about USD 25.25 million by 2031.
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Primary hyperoxaluria (PH) is a rare genetic disease caused by glyoxylate metabolism deficiencies. The PH is autosomal recessive and is classified into three types based on the responsible genes: type 1 (AGXT) (PH-I), type 2 (GRHPR) (PH-II), and type 3 (HOGA1) (PH-III). The kidney is the primary site of oxalate deposition, which in many cases leads to end-stage renal disease.
End stage renal disease (ESRD) is a life-threatening condition that prevents the kidneys from effectively filtering fluids and waste products from the body.
Kidney stones in primary hyperoxaluria type 1 typically appear between childhood and early adulthood, and ESRD can develop at any age. The symptoms of primary hyperoxaluria type 2 are similar to those of type 1, but ESRD develops later in life. Primary hyperoxaluria type 3 patients frequently develop kidney stones in childhood, but few cases of this type have been described, so additional signs and symptoms are unknown.
Recurrent kidney stones, hematuria, and urinary tract infections (UTIs) are possible signs and symptoms. If left untreated, PH-I can progress to end-stage renal disease, which can be fatal. The disease is characterised phenotypically by the recurrent formation of kidney stones and nephrocalcinosis, which results in the gradual decline of kidney function. When renal function deteriorates, excess oxalate cannot be eliminated through the urine, and calcium oxalate crystals precipitate in various tissues, resulting in systemic oxalosis, a devastating multiorgan disease.
Changes (mutations) in the AGXT gene cause PH type I. Mutations in the GRHPR gene cause PH type II. Mutations in the HOGA1 gene cause PH type III. Genes encode instructions for the production of proteins, which are essential for many bodily functions. When a gene is mutated, the protein product may be faulty, inefficient, or absent. Depending on the functions of the specific protein, this can have an impact on many organ systems in the body.
According to the market research report, the primary hyperoxaluria treatment market can be categorised into the following segments:
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Market Breakup by Type
Market Breakup by Diagnosis Method
Market Breakup by Treatment Method
Market Breakup by Treatment Channel
Market Breakup by Region
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Males and females are equally affected by PH. These disorder’s exact incidence and prevalence are unknown. Because some cases go undiagnosed or are misdiagnosed, it is difficult to determine the true prevalence of these conditions in the general population. Young patients with recurring kidney stone formation may benefit from molecular genetic testing. However, some patients with common PH symptoms are not found to have the known genetic mutations linked to PH, implying that the true number of people with PH is likely to be underestimated. The most common form is PH type I.
According to one estimate, the prevalence of PH type I in the general population is 1-3 cases per 1,000,000 people, with fewer than 1,000 people affected in the United States, and the incidence is 1 case per 120,000 live births per year in Europe. PH is estimated to be 2.5 times more common in European Americans than in African Americans.
The population growing awareness of rare and genetic disorders is expected to drive the demand for primary hyperoxaluria treatment. During the forecast period, technological advancements in the field of genetic engineering will drive the demand for global primary hyperoxaluria treatment market.
The number of leading pharmaceutical companies with products in clinical trials for the treatment of primary hyperoxaluria will drive the market growth. In the coming decade, demand for primary hyperoxaluria treatment will rise due to an increase in diagnosis and treatment seeking. Global primary hyperoxaluria treatment market growth is hampered by a small patient population available for clinical trials.
Treatment is determined by the type, symptoms, and severity of hyperoxaluria, and by how well the patient responds to the treatment.
Treatment may necessitate the collaborative efforts of a team of specialists. Pediatricians, surgeons, specialists who assess and treat kidney problems (nephrologists), specialists who assess and treat liver problems (hepatologists), specialists who assess and treat urinary tract problems (urologists), dieticians, and other healthcare professionals may need to plan an affected child's treatment systematically and comprehensively. Genetic counselling is advised to assist families in understanding the genetics and natural history of PH, and to provide psychosocial support.
Lumasiran (Oxlumo) is a medication that reduces oxalate production in children and adults with primary hyperoxaluria. In some people with primary hyperoxaluria, prescription doses of vitamin B-6 can help reduce oxalate in the urine. Phosphate and citrate oral preparations aid in the prevention of calcium oxalate crystal formation. Depending on the other abnormalities in the urine, other medications, such as thiazide diuretics, may be considered.
The report gives an in-depth analysis of the key players involved in the global primary hyperoxaluria treatment market, sponsors manufacturing the therapies, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Type||
|Breakup by Diagnosis Method||
|Breakup by Treatment Method||
|Breakup by Treatment Channel||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
2 Research Methodology
3 Executive Summary
4 Primary Hyperoxaluria Overview
4.1 Guidelines and Stages
4.3 Screening and Diagnosis
4.4 Treatment Pathway
5 Patient Profile
5.1 Patient Profile Overview
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Current Scenario Evaluation and Regulatory Framework
6.1 Emerging Therapies and Clinical Trials
6.2 Patent Landscape
6.2.1 Patent Overview
126.96.36.199 Patent Status and Expiry
188.8.131.52 Timelines from Drug Development to Commercial Launch
184.108.40.206 New Drug Application
220.127.116.11.1 Documentation and Approval Process
6.3 Cost of Treatment
6.4 Regulatory Framework
6.4.1 Regulatory Overview
18.104.22.168 US FDA
22.214.171.124 EU EMA
126.96.36.199 INDIA CDSCO
188.8.131.52 JAPAN PMDA
7 Challenges and Unmet Needs
7.1 Treatment Pathway Challenges
7.2 Compliance and Drop- out Analysis
7.3 Awareness and Prevention Gaps
8 Global Primary Hyperoxaluria Treatment Market
8.1 Global Primary Hyperoxaluria Treatment Market Overview
8.2 Global Primary Hyperoxaluria Treatment Market Analysis
8.2.1 Market Overview
184.108.40.206 Global Historical Primary Hyperoxaluria Market Value (2016-2022)
220.127.116.11 Global Forecast Primary Hyperoxaluria Market Value (2023-2031)
8.2.2 Global Primary Hyperoxaluria Treatment Market by Type
18.104.22.168 Market Overview
22.214.171.124.1 Primary Hyperoxaluria Type I
126.96.36.199.2 Primary Hyperoxaluria Type II
188.8.131.52.3 Primary Hyperoxaluria Type III
8.2.3 Global Primary Hyperoxaluria Treatment Market by Diagnosis Method
184.108.40.206 Market Overview
220.127.116.11.1 Urine Tests
18.104.22.168.2 Blood Tests
22.214.171.124.3 Stone Analysis
126.96.36.199.4 Kidney X-ray, Ultrasound or Computerized Tomography (CT) Scan
188.8.131.52.5 DNA Testing
184.108.40.206.6 Kidney Biopsy
220.127.116.11.8 Eye Exam
18.104.22.168.9 Bone Marrow Biopsy
22.214.171.124.10 Liver Biopsy
8.2.4 Global Primary Hyperoxaluria Treatment Market by Treatment Method
126.96.36.199 Market Overview
188.8.131.52.1.1 Potassium Citrate
184.108.40.206.1.2 Thiazide Diuretics
220.127.116.11.1.3 Vitamin Supplements
18.104.22.168.2 High Fluid Intake
22.214.171.124.3 Dietary Changes
126.96.36.199.4 Kidney Stone Management
188.8.131.52.5 Dialysis and Transplantation
8.2.5 Global Primary Hyperoxaluria Treatment Market by Treatment Channel
184.108.40.206 Market Overview
8.2.6 Global Primary Hyperoxaluria Treatment Market by Region
220.127.116.11 Market Overview
18.104.22.168.1 North America
22.214.171.124.3 Asia Pacific
126.96.36.199.4 Latin America
188.8.131.52.5 Middle East and Africa
9 North America Primary Hyperoxaluria Treatment Market
9.1 Market Share by Country
9.2 United States of America
9.2.1 Historical Trend (2016-2022)
9.2.2 Forecast Trend (2023-2031)
9.3.1 Historical Trend (2016-2022)
9.3.2 Forecast Trend (2023-2031)
10 Europe Primary Hyperoxaluria Treatment Market
10.1 Market Share by Country
10.2 United Kingdom
10.2.1 Historical Trend (2016-2022)
10.2.2 Forecast Trend (2023-2031)
10.3.1 Historical Trend (2016-2022)
10.3.2 Forecast Trend (2023-2031)
10.4.1 Historical Trend (2016-2022)
10.4.2 Forecast Trend (2023-2031)
10.5.1 Historical Trend (2016-2022)
10.5.2 Forecast Trend (2023-2031)
11 Asia Pacific Primary Hyperoxaluria Treatment Market
11.1 Market Share by Country
11.2.1 Historical Trend (2016-2022)
11.2.2 Forecast Trend (2023-2031)
11.3.1 Historical Trend (2016-2022)
11.3.2 Forecast Trend (2023-2031)
11.4.1 Historical Trend (2016-2022)
11.4.2 Forecast Trend (2023-2031)
11.5.1 Historical Trend (2016-2022)
11.5.2 Forecast Trend (2023-2031)
11.6.1 Historical Trend (2016-2022)
11.6.2 Forecast Trend (2023-2031)
12 Latin America Primary Hyperoxaluria Treatment Market
12.1 Market Share by Country
12.2.1 Historical Trend (2016-2022)
12.2.2 Forecast Trend (2023-2031)
12.3.1 Historical Trend (2016-2022)
12.3.2 Forecast Trend (2023-2031)
12.4.1 Historical Trend (2016-2022)
12.4.2 Forecast Trend (2023-2031)
13 Middle East and Africa Primary Hyperoxaluria Treatment Market
13.1 Market Share by Country
13.2 Saudi Arabia
13.2.1 Historical Trend (2016-2022)
13.2.2 Forecast Trend (2023-2031)
13.3 United Arab Emirates
13.3.1 Historical Trend (2016-2022)
13.3.2 Forecast Trend (2023-2031)
13.4.1 Historical Trend (2016-2022)
13.4.2 Forecast Trend (2023-2031)
13.5 South Africa
13.5.1 Historical Trend (2016-2022)
13.5.2 Forecast Trend (2023-2031)
14 Primary Hyperoxaluria Treatment Market Dynamics
14.1 Market Drivers and Constraints
14.2 SWOT Analysis
14.3 Porter’s Five Forces Model
14.4 Key Demand Indicators
14.5 Key Price Indicators
14.6 Industry Events, Initiatives, and Trends
14.7 Value Chain Analysis
15 Supplier Landscape
15.1 Alnylam Pharmaceuticals, Inc.
15.1.1 Company Overview
15.1.2 Product Portfolio
15.1.3 Demographic Reach and Achievements
15.1.4 Mergers and Acquisitions
15.2 Tecoland Corporation
15.2.1 Company Overview
15.2.2 Product Portfolio
15.2.3 Demographic Reach and Achievements
15.2.4 Mergers and Acquisitions
15.3 Zhejiang Tianxin Pharmaceutical Co.
15.3.1 Company Overview
15.3.2 Product Portfolio
15.3.3 Demographic Reach and Achievements
15.3.4 Mergers and Acquisitions
15.4 Takeda Pharmaceuticals
15.4.1 Company Overview
15.4.2 Product Portfolio
15.4.3 Demographic Reach and Achievements
15.4.4 Mergers and Acquisitions
15.5 Wuxi Further Pharmaceutical Co Ltd
15.5.1 Company Overview
15.5.2 Product Portfolio
15.5.3 Demographic Reach and Achievements
15.5.4 Mergers and Acquisitions
15.6.1 Company Overview
15.6.2 Product Portfolio
15.6.3 Demographic Reach and Achievements
15.6.4 Mergers and Acquisitions
15.7.1 Company Overview
15.7.2 Product Portfolio
15.7.3 Demographic Reach and Achievements
15.7.4 Mergers and Acquisitions
15.8 Dicerna Pharmaceuticals, Inc.
15.8.1 Company Overview
15.8.2 Product Portfolio
15.8.3 Demographic Reach and Achievements
15.8.4 Mergers and Acquisitions
15.9 Allena Pharmaceuticals
15.9.1 Company Overview
15.9.2 Product Portfolio
15.9.3 Demographic Reach and Achievements
15.9.4 Mergers and Acquisitions
16 Primary Hyperoxaluria Treatment Market- Distribution Model (Additional Insight)
16.2 Potential Distributors
16.3 Key Parameters for Distribution Partner Assessment
17 Payment Methods (Additional Insight)
17.1 Government Funded
17.2 Private Insurance
*Additional insights provided are customisable as per client requirements.
The market attained a value of about USD 18.24 million in 2022, driven by the growing awareness of rare disease and genetic engineering advancement.
The market is expected to rise at a CAGR of 3.67% during the forecast period of 2023-2031 to attain a value of USD 25.25 million by 2031.
The increased awareness of rare diseases and advancement in the genetic engineering is a critical factor driving the market growth.
Alnylam Pharmaceuticals, Tecoland Corporation, Zhejiang Tianxin Pharmaceuticals Co., Takeda Pharmaceuticals, Wuxi Further Pharmaceutical Co Ltd, Genentech, OxThera, Dicerna Pharmaceuticals, Inc., Allena Pharmaceuticals among others are the leading companies in the market.
Small population available for the clinical trials will restrain the growth of the market.
Primary hyperroxaluria has no known cure. The goal is to protect the kidneys by preventing the formation of kidney stones and the formation and deposit of calcium oxalate in other body tissues.
Lumasiran (Oxlumo) is a medication that reduces oxalate production in children and adults with primary hyperoxaluria. In some people with primary hyperoxaluria, prescription doses of vitamin B-6 can help reduce oxalate in the urine.
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