Primary Hyperoxaluria Treatment Market

Primary Hyperoxaluria Treatment Market Snapshot (2023 to 2033)

The global primary hyperoxaluria treatment market is expected to garner a market value of USD 18 million in 2023 and is expected to accumulate a market value of USD 41.07 million by registering a CAGR of 8.6% in the forecast period 2023 to 2033.

The market for primary hyperoxaluria treatment registered a CAGR of 5.2% in the historical period 2018 to 2022.

Primary hyperoxaluria (PH) is a rare genetic disorder that affects the liver's ability to metabolize oxalate, leading to the formation of kidney stones and progressive kidney damage. The primary hyperoxaluria treatment market includes drugs and therapies aimed at reducing the production of oxalate in the body, managing symptoms, and preventing complications.

Some of the primary hyperoxaluria treatments available in the market include Lumasiran (Oxlumo), an RNA interference (RNAi) therapeutic that works by blocking the production of the enzyme that produces oxalate in the liver.

The drug was approved by the FDA in 2020 for the treatment of PH type 1 in children and adults; Oxalate-degrading enzymes that can break down oxalate in the gut, reducing the amount of oxalate that is absorbed into the bloodstream; Kidney stone management and Dialysis and kidney transplant.

The primary hyperoxaluria treatment market is relatively small due to the rarity of the disease, but with the approval of Lumasiran, there is a growing focus on developing new therapies for the condition. Some companies currently working on PH treatments include Dicerna Pharmaceuticals, Alnylam Pharmaceuticals, and Allena Pharmaceuticals.

Report Attribute	Details
Expected Market Value (2023)	USD 18 million
Anticipated Forecast Value (2033)	USD 41.07 million
Projected Growth Rate (2023 to 2033)	8.6% CAGR

2018 to 2022 Primary Hyperoxaluria Treatment Market Demand Analysis vs. Forecast 2023 to 2033

According to market research and competitive intelligence provider, Future Market Insights- the market for Primary Hyperoxaluria Treatment reflected a value CAGR of 5.2% during the historical period, 2018 to 2022.

One of the key drivers of market growth is the increasing prevalence of primary hyperoxaluria. While the condition is rare, its incidence has been steadily increasing in recent years, which is expected to drive demand for effective treatments.

The approval of Lumasiran in 2020 has also been a major boost to the market, as it represents the first targeted therapy for primary hyperoxaluria type 1. The drug has shown promising results in clinical trials, and its approval is expected to drive further research and development in the field.

In addition, the growing focus on precision medicine and personalized treatments is expected to drive innovation in the primary hyperoxaluria treatment market. With the increasing availability of genetic testing and personalized medicine, there is an opportunity to develop targeted therapies that are tailored to individual patients' genetic profiles.

The primary hyperoxaluria treatment market is expected to continue to grow in the coming years as new treatments are developed and approved, and as the demand for effective therapies for this rare disease continues to increase. Overall, the market for Primary Hyperoxaluria Treatment is expected to register a CAGR of 8.6% in the forecast period ranging from 2023 to 2033.

Which are Some Prominent Drivers of the Primary Hyperoxaluria Treatment Market?

Increasing Prevalence of Primary Hyperoxaluria to push market growth

The increasing prevalence of primary hyperoxaluria is expected to be a significant driver of market growth in the primary hyperoxaluria treatment market. While the condition is considered rare, its incidence has been steadily increasing in recent years.

Primary hyperoxaluria is a genetic disorder that affects the liver's ability to metabolize oxalate, which can lead to the formation of kidney stones and progressive kidney damage. According to the National Institutes of Health (NIH), the estimated prevalence of primary hyperoxaluria ranges from 1 in 100,000 to 1 in 1,000,000 individuals worldwide.

However, recent studies have suggested that the actual prevalence of the condition may be higher than previously thought. For example, a study published in the American Journal of Kidney Diseases in 2019 estimated that the incidence of primary hyperoxaluria in the United States is closer to 1 in 45,000 individuals.

As the prevalence of primary hyperoxaluria continues to increase, there is likely to be greater demand for diagnosis and treatment of the condition, which is expected to drive growth in the primary hyperoxaluria treatment market. In addition, as more people are diagnosed with the condition, there is likely to be greater interest and investment in research and development of new treatments, which could further boost market growth.

Overall, the increasing prevalence of primary hyperoxaluria is expected to be a significant driver of market growth, as it is likely to lead to greater demand for effective treatments and increased investment in the development of new therapies.

What are the Challenges Faced by the Primary Hyperoxaluria Treatment Market?

Expensive Cost of Treatment to restrict Market Growth

One of the significant challenges faced by the PKU therapeutics market is the lack of awareness and underdiagnosis of the disorder. Primary hyperoxaluria is a rare disease, and as a result, there is limited awareness of the condition among healthcare providers and the general public. This can lead to delays in diagnosis and treatment, which can negatively impact patient outcomes.

Moreover, developing new treatments for rare diseases such as primary hyperoxaluria can be challenging, as the regulatory environment can be complex and uncertain.

This can lead to delays in bringing new therapies to market. Overall, while there have been some recent advances in the primary hyperoxaluria treatment market, there are still several challenges that need to be addressed to improve patient outcomes and ensure the development of more effective and accessible treatments.

Region-Wise Insights

How is the Primary Hyperoxaluria Treatment Market Turning Out in the South & East Asia Region?

Increasing awareness and diagnosis of the condition Shaping Landscape for Primary Hyperoxaluria Treatment in South & East Asia

The primary hyperoxaluria treatment market is still developing in the South & East Asia region, and there is limited data available on the prevalence and treatment of the condition in the region. However, there have been some recent developments that suggest that the market is starting to grow in this region.

For example, in 2020, the pharmaceutical company Alnylam Pharmaceuticals announced that its drug Lumasiran, the first targeted therapy for primary hyperoxaluria type 1, had received regulatory approval in Japan.

This was a significant development, as Japan is a major market in the South & East Asia region and has a well-established healthcare system. The approval of Lumasiran in Japan is likely to increase awareness of primary hyperoxaluria in the region and could lead to greater demand for diagnosis and treatment of the condition.

In addition, there have been some recent studies that suggest that the prevalence of primary hyperoxaluria may be higher in certain parts of the South & East Asia region than previously thought.

For example, a study published in the Journal of the American Society of Nephrology in 2020 found that the prevalence of primary hyperoxaluria type 1 was higher in parts of India than previously reported. This suggests that there may be a significant unmet need for primary hyperoxaluria treatment in the region.

Overall, while the primary hyperoxaluria treatment market is still developing in the South & East Asia region, recent developments suggest that there is growing interest and investment in this area. As awareness of the condition increases and more effective treatments become available, it is likely that the market will continue to grow in the region.

What are the Factors Boosting the Market for Primary Hyperoxaluria Treatment in North America?

Increasing Focus on Technological Advancements shaping Landscape for Primary Hyperoxaluria Treatment in North America

The market for primary hyperoxaluria treatment in North America is expected to grow due to several factors. One of the primary drivers of market growth is the relatively high prevalence of primary hyperoxaluria in the region, particularly primary hyperoxaluria type 1.

According to the National Institutes of Health (NIH), the estimated prevalence of primary hyperoxaluria type 1 in the United States is approximately 1 in 100,000 individuals. This high prevalence of the condition is expected to drive demand for effective treatments in the region.

Another factor that is contributing to market growth in North America is the increasing awareness and diagnosis of primary hyperoxaluria. There is growing recognition of the condition among healthcare professionals, which is leading to more accurate diagnosis and treatment of the condition.

This is particularly true for primary hyperoxaluria type 1, which is often diagnosed in childhood. As more people are diagnosed with the condition, there is likely to be greater demand for effective treatments.

Advances in the development of treatments for primary hyperoxaluria are also driving market growth in North America. Lumasiran, a drug that targets the underlying genetic cause of primary hyperoxaluria type 1, was approved by the USA Food and Drug Administration (FDA) in 2020. This has led to greater interest and investment in the development of new therapies, which is expected to boost market growth.

In addition, favorable reimbursement policies in North America are making primary hyperoxaluria treatment more accessible to patients. For example, kidney transplantation, which is a treatment option for some patients with end-stage renal disease caused by primary hyperoxaluria, is typically covered by insurance in North America. This makes it easier for patients to access the treatment they need.

Finally, North America has a strong healthcare infrastructure that is able to support the development and delivery of new treatments for primary hyperoxaluria.

This includes specialized centers for the treatment of rare diseases, which can provide comprehensive care for patients with the condition. The strong healthcare infrastructure in North America is expected to contribute to continued growth in the primary hyperoxaluria treatment market in the region.

Overall, the combination of high prevalence, increasing awareness and diagnosis, advances in treatment options, favorable reimbursement policies, and a strong healthcare infrastructure is expected to drive growth in the primary hyperoxaluria treatment market in North America.

Category-Wise Insights

By Route of Administration, Which Segment is Likely to Account for a Significant Share?

Parenteral route of administration to hold a significant share and push market growth

The injectable route of administration is likely to account for a significant share of the Primary Hyperoxaluria Treatment market. Currently, the only approved therapy for the treatment of primary hyperoxaluria is Lumasiran, which is administered via subcutaneous injection. Therefore, the subcutaneous injection route of administration is expected to account for a significant share of the primary hyperoxaluria treatment market.

However, there are also other therapies currently in development for the treatment of primary hyperoxaluria that may use different routes of administration. For example, some gene therapy approaches are being developed that would involve the delivery of a therapeutic gene via a viral vector. These therapies may use an intravenous infusion or other routes of administration. Overall, while the subcutaneous injection route of administration is currently dominant in the primary hyperoxaluria treatment market, the development of new therapies may lead to the use of different routes of administration in the future.

By Distribution Channel, Which Segment is Likely to Account for a Significant Share?

Hospital pharmacies segment to hold a significant share and push market growth

Hospitals and specialty clinics are often the first point of contact for patients with Primary Hyperoxaluria, as they provide specialized care and access to diagnostic tools and treatments. These facilities also have the expertise and resources to provide comprehensive care to patients with complex or severe cases of Primary Hyperoxaluria.

In addition, many of the treatments for Primary Hyperoxaluria require specialized administration or monitoring, such as intravitreal injections or electroretinography testing, which are typically performed in hospitals or specialty clinics. This further contributes to the dominance of these distribution channels in the Primary Hyperoxaluria Treatment market.

Overall, hospitals and specialty clinics are likely to continue to account for a significant share of the Primary Hyperoxaluria Treatment market, driven by the specialized care and expertise they provide. However, as patient preferences and healthcare delivery models continue to evolve, the market share of the various distribution channels may shift over time.

Market Competition

Key players in the market include companies such as Competition Deep Dive, Alnylum Pharma, OxThera, Dicerna Pharmaceuticals, Inc., Allena Pharmaceuticals, Biocodex, Tecoland Corporation, Zhejiang Tianxin Pharmaceutical Co., Takeda Pharmaceuticals, Wuxi Further Pharmaceutical Co Ltd, Genentech, along with healthcare providers and technology companies among other global players.

• In 2020, The United States Food and Drug Administration (FDA) gave the green light to Oxlumo (lumasiran) as the initial treatment for primary hyperoxaluria type 1 (PH1), a rare hereditary disorder. This groundbreaking approval is the culmination of the work of specialists and community members coordinated by the Oxalosis & Hyperoxaluria Foundation and the Kidney Health Initiative.
• The approval of Oxlumo was a result of input from patients, treating physicians, experts, and sponsors at a patient-focused drug development meeting and through other collaborative efforts. Oxlumo's function is to reduce the production of oxalate in patients with PH1. The drug was evaluated in two separate trials in PH1 patients: a randomized, placebo-controlled trial in patients aged six years and older, and an open-label study in patients under six years old. The patients ranged in age from four months to 61 years at the start of treatment.

Report Scope

Report Attribute	Details
Market Value in 2023	USD 18 million
Market Value in 2033	USD 41.07 million
Growth Rate	CAGR of 8.6% from 2023 to 2033
Base Year for Estimation	2022
Historical Data	2018 to 2022
Forecast Period	2023 to 2033
Quantitative Units	Revenue in USD Million and CAGR from 2023 to 2033
Report Coverage	Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis
Segments Covered	Type, Route of Administration, Distribution Channel, Drug Class, Region
Regions Covered	North America; Latin America; Europe; South Asia; East Asia; Oceania; Middle East & Africa
Key Countries Profiled	United States, Canada, Brazil, Mexico, Germany, United Kingdom, France, Spain, Italy, Malaysia, Singapore, India, Thailand, China, Japan, South Korea, Australia, New Zealand, GCC Countries, South Africa, Israel
Key Companies Profiled	Alnylum Pharma; OxThera; Dicerna Pharmaceuticals Inc.; Allena Pharmaceuticals; Biocodex; Tecoland Corporation; Zhejiang Tianxin Pharmaceutical Co.; Takeda Pharmaceuticals; Wuxi Further Pharmaceutical Co Ltd; Genentech
Customization	Available Upon Request

Key Segments Profiled in the Primary Hyperoxaluria Treatment Industry Survey

Type:

• Type 1
• Type 2
• Type 3

Drug Class:

• Pyridoxine
• Potassium Citrate
• Thiazides
• Orthophosphates

Route of Administration:

• Oral
• Intravenous

Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Region:

• North America
• Latin America
• Europe
• East Asia
• South Asia
• Oceania
• Middle East & Africa

Frequently Asked Questions

How Big is the Primary Hyperoxaluria Treatment Market?

The market value reaches USD 18 million in 2023.

What are the Projected Dimensions of the Market by 2033?

The market is anticipated to surpass USD 41.07 million by 2033, with a CAGR of 8.6%.

Which is the Top Trend in the Primary Hyperoxaluria Treatment Market?

Advancing innovative enzyme replacement therapies is the current market trend.

Which Country Holds High Lucrativeness for Primary Hyperoxaluria Treatment?

The United States shines as a lucrative primary hyperoxaluria treatment hub.

How was the Historical Performance of the Primary Hyperoxaluria Treatment Market?

The market experienced a CAGR of 5.2% between 2018 and 2022.