Australia Primary Hyperoxaluria (PH) Therapeutics Market Analysis

Australia Primary Hyperoxaluria (PH) Therapeutics Market Analysis


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Australia's Primary Hyperoxaluria (PH) therapeutics market was valued at $2.1 Bn in 2022 and is estimated to expand at a CAGR of 19% from 2022 to 2030 and will reach $8.8 Bn in 2030. One of the main reasons propelling the growth of this market is Increasing awareness about rare and genetic disorders and an increase in clinical trial activity. The market is segmented by diagnostic method, treatment, and type. Some key players in this market are Biocodex, Chinook Therapeutics, Bridgebio Pharma, BioMarin Pharmaceuticals, Amarna Therapeutics, and others.

ID: IN10AUPH507 CATEGORY: Pharmaceuticals GEOGRAPHY: Australia AUTHOR: Nandini Shah

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Australia Primary Hyperoxaluria (PH) Therapeutics Market Executive Summary

Australia's Primary Hyperoxaluria (PH) Therapeutics market was valued at $2.1 Bn in 2022 and is estimated to expand at a CAGR of 19% from 2022 to 2030 and will reach $8.8 Bn in 2030. Currently, there is only 1 FDA-approved drug Oxlumo, launched in 2021 in Australia. An uptake of the drug is assumed, considering the higher adoption rate of this drug and the novel drug in the upcoming years. Primary hyperoxaluria (PH) is a rare inherited (genetic) condition present at birth. In PH, oxalates are overproduced. Excess oxalate is eliminated through the kidneys, in urine. The extra oxalate combines with calcium to create kidney stones and crystals, which damage the kidneys and cause renal failure. PH1 is the most common and the most severe form, accounting for 80% of all cases. Primary hyperoxaluria type 2 is milder than type 1 and PH3 is considered milder than PH types 1 or 2, mainly due to lower urinary oxalate excretion. In some of the cases, patients show signs and symptoms typical of PH but lack any identifiable mutation in the known associated genes AGXT, GRHPR, or HOGA1.

Australia PH Market

Market Dynamics

Market Growth Drivers

Increasing awareness among the general population about rare and genetic disorders such as primary hyperoxaluria is expected to increase demand for the primary hyperoxaluria treatment market. The Australian Government is providing $3.3 Mn to support the approximately 2 Mn Australians living with rare diseases, providing them with support, raising awareness, and creating new educational programs to Increase the clinical trial activity. The Primary Hyperoxaluria market has witnessed an increase in clinical trial activity with novel therapeutic assets in the investigation in different stages of development, which is expected to bring different therapies to the market. To address the pressing need to evaluate new treatments for primary hyperoxaluria, the Kidney Health Initiative (KHI), in partnership with the Oxalosis and Hyperoxaluria Foundation (OHF), initiated a project to identify endpoints that could be used in clinical trials. Financial Support to the Researchers for Developing Novel Interventions. Many organizations such as Oxalosis & Hyperoxaluria Foundation disburse grants and funding to researchers who study the causes of hyperoxaluria and its treatment.

Market Restraints

One of the major challenges in the Australian PH market is the lack of awareness of the disease, leading to delayed diagnosis. Many patients are misdiagnosed, and the disease may progress, resulting in irreversible kidney damage. Currently, there is no cure for PH, and the available treatments are limited. The only curative option is liver transplantation, which is associated with significant risks and complications. Moreover, there are no approved drugs for the treatment of PH in Australia, which limits the options for patients. Due to the rarity of the disease, the cost of treatment is high, which makes it challenging for patients to access appropriate care. This can be especially problematic for those who do not have access to health insurance or are unable to afford out-of-pocket expenses. There are limited specialized centers in Australia that offer comprehensive care for PH patients. This can result in delayed diagnosis, limited access to appropriate treatment, and poor outcomes. Due to the rarity of the disease, there is limited research on PH in Australia. This makes it challenging to develop new treatments and improve patient outcomes.

Competitive Landscape

Key Players

  • Alnylam Pharmaceuticals
  • Dicerna Pharmaceuticals
  • OxThera
  • Biocodex
  • Chinook Therapeutics
  • Bridgebio Pharma
  • BioMarin Pharmaceuticals
  • Amarna Therapeutics

Healthcare Policies and Regulatory Landscape

Medicare, Australia's national health insurance program, is the main source of funding for the country's healthcare system. All Australian citizens and permanent residents have access to Medicare, which covers the majority of medical expenses up to a predetermined amount. It is funded by taxes collected by the country's Life-Saving Drugs Program (LSDP).

Australian citizens have government-funded universal health care, hence kidney transplant is publicly funded, and patients have no out-of-pocket costs for the transplant surgery and associated hospitalization.

Reimbursement Scenario

Reimbursement under the primary program in Australia that subsidizes access to medicines to treat rare conditions – the Life-Saving Drugs Program (LSDP), which applies the far more stringent definition of less than 1 in 50,000, which could be considered ‘ultra-rare’ Dialysis.

Dialysis is available to all patients without cost, through the Medicare system. It is funded through an activity-based funding stream that covers numerous expenses, including equipment and consumables, power and waste management, specialist medical services, nursing care, and routine laboratory tests.

The payment is paid to the provider of the public dialysis service and generally does not apply to a patient undergoing dialysis while hospitalized for other conditions. Patients on home dialysis are currently funded through a capitation payment to the patient’s specialist renal service, currently $ 56,649 per patient per year pro rata Transplant. Transportation from remote or rural places to the facility for patients is also reimbursed by the government Immunosuppression.

Immunosuppression is often provided at no charge from transplant hospitals in an effort to remove any financial barriers to adherence.  For those who choose to get their prescription (script) from private pharmacies, or whose transplant hospitals do not offer such a service, a copayment is required. A patient with a concession card gets a max of $ 6.6 per script while a patient without a card gets $41.3 per script.

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

Australia 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

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

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Last updated on: 09 April 2024
Updated by: Keta Vora

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