Australia Primary Hyperoxaluria (PH) Market Analysis

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  • Type: Rare Disease Area
  • Published : April 2021
  • Region: APAC
  • Country: Australia
  • Report ID : 4112

  • Format: PPT, PDF

Australian Primary Hyperoxaluria Therapeutics Market: Segmented by Diagnosis, Drugs, Treatment, and Distribution Channel – Size, Share, Impact, Growth, Trends, and Forecasts (2020 – 2028F)

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Report Overview

The Australian Primary Hyperoxaluria Therapeutics Market size stood at around USD xx billion in 2020 and is projected to reach USD xx billion by 2028, exhibiting a CAGR of xx% during the forecast period.

Primary Hyperoxaluria (PH) is an ultra-orphan disease caused by genetic mutations, which results in the build-up of overproduction and accumulation of oxalate in the body. This results in the deposition of calcium oxalate crystals in the kidneys and urinary tract, resulting in urolithiasis, nephrocalcinosis, and ultimately kidney failure. As a result of systemic oxalosis, multi-organ damage occurs which affects bones, eyes, skin and the heart.

Affected individuals lack functional levels of a specific enzyme that normally prevents the accumulation of oxalate. In the kidneys, excess oxalate binds with calcium to form a hard compound (calcium oxalate) that is the main component of kidney and urinary stones. Common symptoms include the formation of stones throughout the urinary tract (urolithiasis) and kidneys (nephrolithiasis) and progressively increased levels of calcium in the kidneys (nephrocalcinosis).

There are three main types of PH that are inherited in an autosomal recessive pattern: PH1, PH2 and PH3. PH1 is the most severe primary hyperoxaluria and accounts for approximately 80% of cases. Primary hyperoxaluria has an estimated prevalence of 1 to 3 cases per 1 million population and an incidence rate of approximately 120,000 live births per year. It accounts for 1-2% of paediatric end-stage kidney disease but higher values are reported in specific populations with a high rate of consanguinity.

Market Growth Drivers

Increasing prevalence of Primary Hyperoxaluria disease is one of the major market drivers. However, with rising awareness and increased diagnostic facilities, demand for Primary Hyperoxaluria drugs is expected to be triggered over the forecast period. High investment in research & development by leading industry participants is expected to open new growth window for them. With strong research and development initiative, most of the companies are focusing on innovative and cost-effective drug development

Increase in special designation from the regulatory authority is propelling the growth of PH market. Huge financial support to the researchers for developing novel intervention is boosting the market growth. High demand of disease specific novel treatment can also act as a market driver. The competitive scenario of market and strategic collaborations may also boost the market position during the forecast period.

Market Restraints

However, the high cost of treatment for Primary Hyperoxaluria acts as a major restraint for the market growth. Additionally, limited operating revenue opportunities for research and development of targeted therapies by many market players will be considered as a challenging factor for the growth of the PH market.

1. Australian Primary Hyperoxaluria Therapeutics Market Overview………………………………………………………………………………………………………………
A. Market Size
2. Market Growth Drivers and Restraints……………………………………….…
Market Growth Drivers
A. Increase in Special Designation from the Regulatory Authority
B. Huge Financial Support to the Researchers for Developing Novel Interventions
C. High Demand of Disease Specific Novel Treatment
Market Restraints
A. Higher Cost of Treatment
B. Limited Operating Revenue Opportunities by many Market Players
3. Major Types of Hyperoxaluria…………………………………………………………………….
A. Primary Hyperoxaluria
B. Secondary Hyperoxaluria
4. Primary Hyperoxaluria Therapeutics Market Segmentation…………………..
A. By Diagnosis
I. Blood & Urine Tests
II. X-ray Examination
III. CT scanning
IV. MRI Technique
V. Molecular genetic testing
B. Drugs
I. Calcium Oxalate Urinary Inhibitors
II. Thiazides
III. Pyridoxine
C. By Treatment
I. Shock wave lithotripsy
II. Percutaneous nephrolithotomy
III. Ureteroscopy
IV. Combined liver-kidney transplantation
V. Isolated kidney transplant
VI. Isolated liver transplant
D. By Distribution Channel
I. Hospital Pharmacies
II. Retail Pharmacies
III. Online Pharmacies
5. Primary Hyperoxaluria Major Drugs Market Share………………………………
A. Market Analysis, Insights and Forecast – By Revenue Type
6. Competitive Landscape…………………………………………………………………
A. Major Players
B. Products in Pipeline
7. Key Company Profiles………………………………………………………………….
A. Sanofi- Aventis Company overview, Product & Services, Strategies & Financials
B. Fresenius Kabi Company overview, Product & Services, Strategies & Financials
C. Cipla Company overview, Product & Services, Strategies & Financials
8. Healthcare Policies and Regulatory Landscape……………………………………
A. Policy changes and Reimbursement scenario
9. Factors Driving Future Growth…………………………………………………………
A. New Trends and Development of Primary Hyperoxaluria Therapeutics Market
B. Future Opportunities
10. Conclusion

Market Segmentation

By Diagnosis:

On the basis of diagnosis, the Primary Hyperoxaluria Therapeutics market can be classified into

  • Blood Tests
  • Urine Tests
  • X-ray Examination
  • CT scanning
  • MRI Technique
  • Biopsy
  • Molecular genetic testing
  • Others

Investigation for PH includes measuring urine and plasma oxalate levels, ruling out the major causes of high oxalate levels. X-ray examinations can reveal the presence of kidney stones or calcium oxalate deposits in tissue. Computed tomography (CT) scanning, a specialized imaging technique, uses a computer and x-rays to create a film showing cross-sectional images of certain tissue structures such as kidney tissue. MRI can detect the severity of systemic oxalosis by imaging the retina, heart, and bone in greater detail. A biopsy involves the surgical removal and microscopic examination of a piece of affected tissue, can also reveal the abnormal accumulation of oxalate. Molecular genetic testing for mutations in the specific genes known to cause PH confirms the diagnosis of PH.

By Drugs:

Based on the drugs, the Primary Hyperoxaluria Therapeutics market can be classified  into

  • Calcium Oxalate Urinary Inhibitors
  • Thiazides
  • Pyridoxine

Oxlumo is synthetic double-stranded siRNA oligonucleotide; indicated for the treatment of primary hyperoxaluria in all age groups, has been anticipated to attain higher market share over the forecast period. Calcium Oxalate Urinary Inhibitors, like magnesium and orthophosphates are most commonly preferred. Additionally, Thiazides used to decrease calcium in the urine and pyridoxine (vitamin B6) is known to reduce the body’s production of oxalate, have been advocated to prevent kidney stones.

By Treatment:

Based on the treatment, the Primary Hyperoxaluria Therapeutics market can be classified into

  • Shock wave lithotripsy
  • Percutaneous nephrolithotomy
  • Ureteroscopy
  • Combined liver-kidney transplantation
  • Sequential liver-kidney transplant
  • Isolated kidney transplant
  • Isolated liver transplant

Treatment for kidney stones may involve shock wave lithotripsy, percutaneous nephrolithotomy, and ureteroscopy. Combined liver-kidney transplantation is an option whether pre-emptive or after development of end-stage kidney damage. Depending on response to other treatments and the disease severity, options may include combined liver-kidney transplant; sequential liver-kidney transplant; an isolated kidney transplant, or an isolated liver transplant. Transplantation requires life-long immune suppression and carries significant mortality risk.

By Distribution Channels:

In terms of distribution channel, the Primary Hyperoxaluria Therapeutics market can be classified into

  • Hospital pharmacies
  • Retail pharmacies
  • Online pharmacies

In terms of value, the hospital pharmacies accounted for the leading market share in 2020, which is attributable to the fact that the majority of the medications for primary hyperoxaluria treatment are dispensed by the prescription and can only be done by trained medical professionals. Hence, the hospital pharmacies segment is anticipated to enhance the market share over the forecast period.

Top Major Players

The Australian Primary Hyperoxaluria Therapeutics market is a highly competitive market and major key players are adopting strategies; organic as well as inorganic market strategies. The prominent key players prevailing in the Australian market are Alnylam Pharmaceuticals, Fresenius Kabi Australia Pty Ltd., Sanofi-Aventis Healthcare Pty Ltd., Teva Pharma Australia Pty Ltd., Baxter Healthcare Pty Ltd., and Cipla Australia Pty Ltd. among others.

Research Methodology

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

  1. Market overview
  2. Market growth drivers & restraints
  3. Epidemiology or 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

Based on our many years of experience, we believe that these are the parameters that are critical to decision making for business stakeholders. Our focused approach to develop reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

Our analysis methodology involves three critical stages:

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The top-down approach mainly used for new product forecasting and bottom-up approach is used for demand estimation of any product for different countries summed up to form total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and Africa for the period of 2020 to 2028. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape and policy and regulatory scenario and the quantitative analysis covers different market estimates and forecasts.

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We make sure to finalize the numbers in alignment to the market research. Firstly, our internal experts ensure thorough validation and checking to ensure the accurate and precise analysis and then validation is also done using multiple data analysis model.  Two level validation is done and entails finalization of report scope and to way of representation pattern.

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analysed and synthesized. A second series of interviews are done if necessary to check and validate. The future opportunities are analysed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results are then, interpreted by considering following parameters: (a partial list)

  • Establishing market drivers and trends
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The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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