New York, USA, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Primary Hyperoxaluria Market to Exhibit Substantial Growth Rate by 2032, Assesses DelveInsight | Leading Companies - Alnylam Pharmaceuticals, Dicerna Pharmaceuticals, OxThera, Allena Pharmaceuticals, Biocodex
The primary hyperoxaluria market is anticipated to witness an upsurge in growth in the coming years due to factors such as the increase in the patient pool and the expected entry of emerging.
DelveInsight’s Primary Hyperoxaluria Market Insights report includes a comprehensive understanding of current treatment practices, primary hyperoxaluria emerging drugs, market share of individual therapies, and current and forecasted primary hyperoxaluria market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].
Key Takeaways from the Primary Hyperoxaluria Market Report
- According to DelveInsight’s analysis, the market size for primary hyperoxaluria reached USD 81 million in 2021 across the 7MM and is expected to grow with a significant CAGR by 2032.
- DelveInsight’s analysis reveals that the overall prevalent population of primary hyperoxaluria in the 7MM was reported as ~12K in 2021.
- Prominent companies working in the domain of primary hyperoxaluria, including Alnylam Pharmaceuticals, Dicerna Pharmaceuticals, OxThera, Allena Pharmaceuticals, Biocodex, and others, are actively working on innovative drugs for primary hyperoxaluria. These novel primary hyperoxaluria therapies are anticipated to enter the primary hyperoxaluria market in the forecast period and are expected to change the market.
- Some of the key therapies for primary hyperoxaluria treatment include Lumasiran, DCR-PHXC, Oxabact (OC5-DB-02), Reloxaliase (ALLN-177), Stiripentol (Diacomit), and others.
Discover which therapies are expected to grab the primary hyperoxaluria market share @ Primary Hyperoxaluria Market Report
Primary Hyperoxaluria Overview
Primary hyperoxaluria is a rare genetic disorder arising from deficiencies in glyoxylate metabolism. Generally inherited in an autosomal recessive manner, primary hyperoxaluria manifests in three distinct types associated with specific genes: type 1 (AGXT) (PH-I), type 2 (GRHPR) (PH-II), and type 3 (HOGA1) (PH-III). The primary site of oxalate deposition is the kidneys, often leading to end-stage renal disease in a significant portion of cases. Primary hyperoxaluria symptoms may encompass recurrent kidney stones, hematuria, and urinary tract infections. Without intervention, PH-I can progress to life-threatening end-stage renal disease. Phenotypically, the disease is characterized by the repeated formation of kidney stones and nephrocalcinosis, contributing to a gradual decline in kidney function. The diagnosis of primary hyperoxaluria relies on identifying distinctive symptoms, a comprehensive patient history, a thorough clinical assessment, and various specialized tests. Screening for primary hyperoxaluria is recommended in children with nephrocalcinosis or kidney stones.
Primary Hyperoxaluria Epidemiology Segmentation
The primary hyperoxaluria epidemiology section provides insights into the historical and current primary hyperoxaluria patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The primary hyperoxaluria market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
- Prevalent Cases of Primary Hyperoxaluria
- Diagnosed Prevalent Cases of Primary Hyperoxaluria
- Gender-specific Diagnosed Prevalent Cases of Primary Hyperoxaluria
- Age-specific Diagnosed Prevalent Cases of Primary Hyperoxaluria
- Type-specific Diagnosed Prevalent Cases of Primary Hyperoxaluria
Download the report to understand which factors are driving primary hyperoxaluria epidemiology trends @ Primary Hyperoxaluria Epidemiological Insights
Primary Hyperoxaluria Treatment Market
The objective of treating primary hyperoxaluria is to reduce oxalate levels in the body and prevent the formation of calcium oxalate crystals in the kidneys and other tissues. Early intervention is crucial, focusing on diminishing urinary saturation of calcium oxalate through increased fluid intake and the use of inhibitors to prevent crystallization. Despite advancements in understanding the molecular mechanisms and pathophysiology of the disease, conservative treatments for primary hyperoxaluria have not progressed in the last two decades. However, a significant development occurred in November 2020 with the approval of Oxlumo (lumasiran), a small interfering ribonucleic acid therapy, in the US and EU. This approval allows the treatment of PH1 to lower urinary oxalate levels in both pediatric and adult patients. Notably, this breakthrough has not yet received approval in Japan. Alnylam Pharmaceuticals aims to seek approval in other countries, marking a pivotal moment in the management of primary hyperoxaluria.
The usual approach to treatment initiates with the administration of citrates, vitamin B6, and increased fluid intake. Following this, iRNA therapies are introduced. Individuals experiencing advanced kidney failure may opt for kidney transplantation. The specific transplantation methods are tailored based on the primary hyperoxaluria type and the individual patient. For PH1, the preferred method is a combined liver and kidney transplantation, while isolated kidney transplantation is the preferred choice for PH2.
Learn more about the FDA-approved drugs for primary hyperoxaluria @ Drugs for Primary Hyperoxaluria Treatment
Primary Hyperoxaluria Emerging Drugs and Companies
Some drugs such as Stiripentol (Biocodex), Reloxaliase (ALLN-177) (Allena Pharmaceuticals), Oxabact (OxThera), and others are being developed for the treatment of primary hyperoxaluria. Stiripentol (Diacomit) developed by Biocodex, is a medication used as an adjunct therapy for epilepsy, typically alongside Clobazam and Valproic acid. In June 2020, the European Commission granted Biocodex orphan designation (EU/3/20/2290) for stiripentol in the treatment of primary hyperoxaluria. Subsequently, in February 2021, the US FDA also awarded Stiripentol orphan drug designation for the same condition. Biocodex initiated a Phase II study in May 2019 to assess the effectiveness of stiripentol as monotherapy for primary hyperoxaluria, which concluded in March 2021. However, there have been no recent updates on its development.
The progress of a different medication, reloxaliase (ALLN-177), undergoing Phase II trials for primary hyperoxaluria by Allena Pharmaceutical, and awarded Orphan Drug status by both the US FDA and European Commission for treating primary hyperoxaluria, was halted due to Allena Pharmaceuticals closing down. This occurred as the company's liquidation plan took effect on June 20, 2023.
The other therapies for primary hyperoxaluria treatment in the pipeline include
- Lumasiran: Alnylam Pharmaceuticals
- DCR-PHXC: Dicerna Pharmaceuticals
The anticipated launch of these emerging therapies for primary hyperoxaluria are poised to transform the food allergy market landscape in the coming years. Moreover, several methods are currently in pre-clinical investigation, concentrating on orally administered formulations aimed at breaking down oxalate in the digestive system. These formulations share a common objective of diminishing oxalate levels in the gut, primarily for treating secondary hyperoxaluria. However, there is potential for these medications to also aid patients with primary hyperoxaluria. This speculation is reinforced by a study involving primary hyperoxaluria patients on dialysis, who saw improvements in clinical symptoms and lower plasma oxalate levels after receiving prolonged Oxalobacter treatment. Several therapies for primary hyperoxaluria have demonstrated promising results in preclinical trials but have yet to advance to clinical use. These therapies encompass enzyme restoration therapy (ERT), CRISPR-Cas9 SRT and ERT, and inhibition of the inflammasome.
To know more about primary hyperoxaluria clinical trials, visit @ Primary Hyperoxaluria Treatment Drugs
Primary Hyperoxaluria Market Dynamics
The primary hyperoxaluria market dynamics are anticipated to change in the coming years. The rising global population is expected to lead to a surge in treatment options, subsequently driving primary hyperoxaluria market growth in the coming years. Increased clinical trial activity for emerging therapies and potential successes are poised to further bolster the primary hyperoxaluria market, while the existing shortfall of approved therapies creates a favorable space for the introduction of emerging therapies.
Furthermore, many potential therapies are being investigated for the treatment of primary hyperoxaluria, and it is safe to predict that the treatment space will significantly impact the primary hyperoxaluria market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the primary hyperoxaluria market in the 7MM.
However, several factors may impede the growth of the primary hyperoxaluria market. The limited understanding of the clinical course and clinical relevance may lead to a missed opportunity for making the correct diagnosis, as most available pharmacological therapies only offer temporary relief and are restricted to a specific population (PH-I). The challenges in diagnosing primary hyperoxaluria include misdiagnosis due to similarities with other types of hyperoxaluria, such as enteric and idiopathic, delayed diagnosis, and the absence of genetic testing.
Moreover, primary hyperoxaluria treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the primary hyperoxaluria market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the primary hyperoxaluria market growth.
| Primary Hyperoxaluria Report Metrics | Details |
| Study Period | 2019–2032 |
| Primary Hyperoxaluria Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Primary Hyperoxaluria Market Size in 2021 | USD 81 Million |
| Key Primary Hyperoxaluria Companies | Alnylam Pharmaceuticals, Dicerna Pharmaceuticals, OxThera, Allena Pharmaceuticals, Biocodex, and others |
| Key Primary Hyperoxaluria Therapies | Lumasiran, DCR-PHXC, Oxabact (OC5-DB-02), Reloxaliase (ALLN-177), Stiripentol (Diacomit), and others |
Scope of the Primary Hyperoxaluria Market Report
- Primary Hyperoxaluria Therapeutic Assessment: Primary Hyperoxaluria current marketed and emerging therapies
- Primary Hyperoxaluria Market Dynamics: Attribute Analysis of Emerging Primary Hyperoxaluria Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Primary Hyperoxaluria Market Access and Reimbursement
Discover more about primary hyperoxaluria drugs in development @ Primary Hyperoxaluria Clinical Trials
Table of Contents
| 1. | Primary Hyperoxaluria Market Key Insights |
| 2. | Primary Hyperoxaluria Market Report Introduction |
| 3. | Primary Hyperoxaluria Market Overview at a Glance |
| 4. | Primary Hyperoxaluria Market Executive Summary |
| 5. | Disease Background and Overview |
| 6. | Primary Hyperoxaluria Treatment and Management |
| 7. | Primary Hyperoxaluria Epidemiology and Patient Population |
| 8. | Patient Journey |
| 9. | Primary Hyperoxaluria Marketed Drugs |
| 10. | Primary Hyperoxaluria Emerging Drugs |
| 11. | Seven Major Primary Hyperoxaluria Market Analysis |
| 12. | Primary Hyperoxaluria Market Outlook |
| 13. | Potential of Current and Emerging Therapies |
| 14. | KOL Views |
| 15. | Unmet Needs |
| 16. | SWOT Analysis |
| 17. | Appendix |
| 18. | DelveInsight Capabilities |
| 19. | Disclaimer |
| 20. | About DelveInsight |
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About DelveInsight
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