Primary Hyperoxaluria Market Size Growth to Shore Up at a Substantial CAGR of 40.40% During the Study Period 2018-30 in the 7MM | DelveInsight

LAS VEGAS, Aug. 5, 2021 /PRNewswire/ -- DelveInsight's Primary Hyperoxaluria (PH) Market report offers comprehensive coverage of the current treatment practices, pipeline drugs, Primary Hyperoxaluria market share of the individual therapies, current and forecasted Primary Hyperoxaluria market size from 2018 to 2030 segmented into 7MM (the USA, EU5 (the UK, Italy, Spain, France, and Germany), and Japan).

Some of the key takeaways from the Primary Hyperoxaluria Market report:

• The total Primary Hyperoxaluria prevalent population in 7MM was 11,918 in 2020. Moreover, DelveInsight estimates that the PH prevalence is anticipated to increase by 2030. 
• Male accounts for the maximum number of diagnosed prevalent cases as compared to females. 
• The United States occupies the largest PH market share in the 7MM, with the market size worth USD 16 million in 2020.
• Japan accounted for the smallest Primary Hyperoxaluria market share of the 7MM PH market.
• The current Primary Hyperoxaluria therapeutic market mainly offers lumasiran, alkaline citrate, orthophosphate, magnesium, liver, and kidney transplant. 
• The recent approval of Oxlumo is a breakthrough in the Primary Hyperoxaluria type 1 (PH1) therapy market. As it is the only approved treatment for PH type 1.
• Key pharma and biotech players, including Oxthera, Dicerna Pharmaceuticals, Inc., Allena Pharmaceuticals, Biocodex, among others are proactively working in the Primary Hyperoxaluria therapy market.
• Primary Hyperoxaluria pipeline comprises Oxabact, Nedosiran (DCR-PHXC), ALLN-177, Stiripentol (Biocodex), and several others expected to be launched in the near future. 
• The expected launch of Oxabact and Nedosiran is anticipated to impact the Primary Hyperoxaluria market size of Oxlumo owing to a vast patient pool and all types of PH the therapies are targeting. 
• Major unmet needs in the market are limited therapy options, lack of clear understanding of the disease as well as diagnostics modalities.
• The expected launch of PH pipeline therapies and an increase in the clinical trial activity are set to boost the PH market size in the next decade.

Discover more about therapy set to grab substantial market share @ Primary Hyperoxaluria Market Share

Primary Hyperoxaluria: Overview

Primary Hyperoxaluria (PH) is a rare genetic disorder caused by deficiencies in glyoxylate metabolism leading to oxalate deposition primarily in kidneys causing end-stage renal disease. It is an inherited autosomal recessive disorder and can be of three types based on the different responsible genes: type 1 (AGXT) (PH-I), type 2 (GRHPR) (PH-II), and type 3 (HOGA1) (PH-III). Signs and symptoms may include recurrent kidney stones, hematuria, and urinary tract infections (UTIs).

Discover more about the disease, causes, signs & symptoms, and diagnosis @  Primary Hyperoxaluria Signs & Symptoms and Diagnosis

Primary Hyperoxaluria Epidemiology 

DelveInsight estimates that the diagnosed Primary Hyperoxaluria prevalent population in the US is expected to increase at a CAGR of 3.80% for the study period, i.e. 2018–2030. The Primary Hyperoxaluria market report puts forward the epidemiological analysis for the study period 2018-30 in the 7MM segmented into: 

• Primary Hyperoxaluria Prevalent Cases
• Diagnosed Primary Hyperoxaluria Prevalent Cases 
• Gender-specific Primary Hyperoxaluria Diagnosed Prevalent Cases
• Age-specific Diagnosed Primary Hyperoxaluria Prevalent Cases 
• Type-specific Diagnosed Primary Hyperoxaluria Prevalent Cases 

Primary Hyperoxaluria Epidemiology assessment showed that the US accounts for approximately 74.0% of the total diagnosed prevalent population among the 7MM in 2020. Approximately 70-80% of patients remain undiagnosed. The diagnosed prevalent cases of Primary Hyperoxaluria are expected to increase during the forecast period.

Among the European countries, the UK had the highest diagnosed PH prevalent population with 198 cases, followed by Germany which had a diagnosed prevalent population of 171 in 2020. On the other hand, Spain had the lowest diagnosed Primary Hyperoxaluria prevalent population.

Download report to understand which demographic factors are guiding the CRC epidemiology trends @ Primary Hyperoxaluria Epidemiological Insights

Primary Hyperoxaluria Therapy Market

The goal of Primary Hyperoxaluria treatment is to lower the levels of oxalate in the body and prevent calcium oxalate crystals from forming in the kidneys and other body tissues. The PH treatment market includes crystallization inhibitor regimens, supportive measures, shockwave therapy, hemodialysis or, even more so, peritoneal dialysis, and ultimately kidney transplantation.

In November 2020, Alnylam Pharmaceuticals received the USFDA approval for its small interfering ribonucleic acid (RNAi) therapy, Oxlumo (lumasiran) for PH1 to lower urinary oxalate levels in pediatric and adult patients. The therapy is also approved in Europe, however, not in Japan. 

Unmet Needs in the PH Market Landscape

The Primary Hyperoxaluria treatment market comprises conservative treatment options that have not improved during the last 20 years. The PH therapy market has several unmet needs including limited therapy options, unclear diagnostic approaches, a better understanding of the clinical course, need to lessen the burden on patients due to less effective and high-cost therapies, need to develop biomarkers, and reasonable clinical trial endpoints. 

Learn more about available treatments @ Primary Hyperoxaluria Drugs & Therapies  

Primary Hyperoxaluria Market Landscape

The Primary Hyperoxaluria market landscape is anticipated to change during the forecasted period attributable to the launch of emerging therapies and the influx of several pharma and biotech companies in the PH market during the forecasted period of 2021–2030. 

Presently, the PH pipeline comprises two therapies in Phase III of the clinical trial namely Oxabact (OxThera) and Nedosiran (Dicerna Pharmaceuticals). The therapies are expected to enter the Primary Hyperoxaluria market in 2022. With increasing cases and awareness, more companies are focusing on the therapeutic pipeline-related PH and its subtypes. In the upcoming years, several new products such as Nedosiran (Dicerna Pharmaceuticals) and Oxabact (OxThera) are expected to enter the market.

Alnylyam's has many competitors but the company will have the advantage of providing effective treatment for PH1 and being first in the market. Dicerna Pharmaceuticals is developing an RNAi therapy (Nedosiran) to treat all three known types of PH, which will compete with Oxlumo. In October 2020, a Phase III study was initiated to evaluate the long-term safety and efficacy of DCR-PHXC in patients with PH, wherein around 92% of all participants achieved normal Uox excretion at one or more visits through Day 180 and the mean maximum reduction in Uox excretion for all participants was 70.9%. The drug was well-tolerated, and no serious safety concerns were reported. If approved, the drug is anticipated to capture a large market due to a wide targeted pool. It also has the potential to become the first therapy for the treatment of all types of PH.

Nedosiran and Oxabact are being investigated for all types of PH, being a tough competitor to Oxlumo. Moreover, in comparison, the results of the former seem to be more promising and might capture a higher market size than the latter.

Primary Hyperoxaluria Market: Drivers and Barriers 

An increase in the PH prevalence is a major driving force behind the surge of the PH market size growth in the coming years. The Primary Hyperoxaluria market has also witnessed an increase in the clinical trial activity with novel therapeutic assets in the investigation in different stages of development, which is further expected to bring different therapies in the market. 

However, the PH market is juggling with comparatively a high number of undiagnosed or unreported cases as well as differential diagnoses owing to a lack of clear understanding and awareness of the condition leading. Thus, there is a need for better understanding and diagnostics methodologies including genetic testing and novel biomarkers to improve the therapeutic outcomes. 

Nevertheless, limited therapy options in the Primary Hyperoxaluria therapeutic market, although a major hurdle, managed to reap opportunities for pharma and biotech players to grab. Pharma players are devotedly working to develop medications that are low-cost and less time-consuming with better adherence in patients, especially pediatric patients. However, the launch of emerging therapies is expected to face strict pricing and reimbursement policies and tough competition from the off-label therapies (e.g. vitamin B6, etc.). 

Learn more about the future market trends @ Primary Hyperoxaluria Market Landscape and Forecast 

Scope of the Primary Hyperoxaluria Market Report 

Coverage: 7MM (the US, EU5, and Japan)
Study Period: 2018-30
Key Companies: Oxthera, Dicerna Pharmaceuticals, Inc., Allena Pharmaceuticals, Biocodex, and others. 
Key Primary Hyperoxaluria Pipeline Therapies: Oxabact, Nedosiran (DCR-PHXC), ALLN-177, Stiripentol (Biocodex), and others. 
Primary Hyperoxaluria Market Segmentation: By Geography, By Primary Hyperoxaluria Therapies
Analysis: Comparative and conjoint analysis of Primary Hyperoxaluria emerging therapies
Tools used: SWOT analysis, Conjoint Analysis, Porter's Five Forces, PESTLE analysis, BCG Matrix analysis methods.
Case Studies
KOL's Views
Analyst's Views

Interested in knowing which Pharma Company is expected to establish a major hold in the market? Drop your query at [email protected] 

Table of Contents 

Discover more about the report offerings @ Primary Hyperoxaluria Market Forecast 

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