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Hypophosphatasia Therapeutics Market Size in the 7MM was ~USD 997 million in 2023, is expected to grow by 2034, estimates DelveInsight

06-19-2025 02:45 PM CET | Health & Medicine

Press release from: DelveInsight Business Research LLP

Hypophosphatasia Market

Hypophosphatasia Market

DelveInsight's "Hypophosphatasia Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Hypophosphatasia, historical and forecasted epidemiology as well as the Hypophosphatasia market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

To Know in detail about the Hypophosphatasia market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Hypophosphatasia Market Forecast- https://www.delveinsight.com/sample-request/hypophosphatasia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Key Takeaways from the Hypophosphatasia Market Report
• In June 2025, Alexion Pharmaceuticals Inc. announced a study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.
• According to DelveInsight's epidemiology model, in the 7MM, the total hypophosphatasia Diagnosed Prevalent Cases of were 6,193 in 2023, which are expected to increase at a CAGR of 0.8% by 2034.
• In the US, there were 5,572 total diagnosed prevalent cases of hypophosphatasia in 2023; which are expected to increase at a CAGR of 0.9% to 5,600 by 2034.
• In EU4 and the UK, the total diagnosed prevalent cases of hypophosphatasia were 481 in 2023. Of these, nearly 122 cases were found in Germany, followed by 119 cases in France and 117 in the UK. These cases are expected to change during the study period.
• In 2023, there were 780 mild cases, 4,736 moderate cases, and 56 severe cases of hypophosphatasia reported in the US, based on severity-specific diagnosed Hypophosphatasia prevalence. These numbers are projected to increase to 784 mild cases, 4,760 moderate cases, and 56 severe cases by 2034.
• Japan had the second-highest number of diagnosed prevalent cases of hypophosphatasia among the 7MM, with 141 cases in 2023.
• The leading Hypophosphatasia Companies such as PuREC, AstraZeneca, Ultragenyx Pharmaceutical Inc., Alexion, and others
• Promising Hypophosphatasia Pipeline Therapies such as REC-01, ALXN1850, BPS804, asfotase alfa, and others

Get a Free sample for the Hypophosphatasia Market Report @ https://www.delveinsight.com/sample-request/hypophosphatasia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Hypophosphatasia Epidemiology Segmentation in the 7MM
The Hypophosphatasia market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
• Total Prevalence of Hypophosphatasia
• Prevalent Cases of Hypophosphatasia by severity
• Gender-specific Prevalence of Hypophosphatasia
• Diagnosed Cases of Episodic and Chronic Hypophosphatasia

Download the report to understand which factors are driving Hypophosphatasia epidemiology trends @ Hypophosphatasia Epidemiology Forecast- https://www.delveinsight.com/sample-request/hypophosphatasia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Hypophosphatasia Marketed Drugs
• STRENSIQ (asfotase alfa): AstraZeneca
STRENSIQ (asfotase alfa), developed by Alexion Pharma (now part of AstraZeneca), is a TNSALP indicated for the treatment of patients with perinatal, infantile- and juvenile-onset hypophosphatasia. STRENSIQ is a soluble glycoprotein composed of two identical polypeptide chains, which consists of the catalytic domain of human TNSALP, the human immunoglobulin G1 Fc domain, and a deca-aspartate peptide used as a bone-targeting domain. Two disulfide bonds covalently link the two polypeptide chains. By replacing the deficient ALP, STRENSIQ reduces the elevated enzyme substrate levels and improves bone mineralization. In October 2015, the US FDA approved STRENSIQ for treating patients with perinatal-, infantile- and juvenile-onset hypophosphatasia. Earlier the drug had received approval from EMA and PMDA in August 2015 and July 2015, respectively.

Hypophosphatasia Emerging Drugs
• ALXN1850 (efzimfotase alfa): AstraZeneca (Alexion Pharmaceuticals)
ALXN1850 (efzimfotase alfa) is an enzyme replacement therapy that substitutes for deficient alkaline phosphatase (ALP) activity. It targets ALP substrates to enhance bone mineralization and alleviate systemic disease manifestations. This next-generation therapy for hypophosphatasia offers higher activity, greater bioavailability, and a longer half-life compared to STRENSIQ (asfotase alfa). ALXN1850 is formulated for subcutaneous administration. A Phase III trial has been initiated to evaluate efzimfotase alfa in adolescent and adult hypophosphatasia patients who have not previously been treated with STRENSIQ, with results anticipated beyond 2025. In November 2020, Alexion submitted an IND for ALXN1850 to the FDA and received approval to proceed with a Phase I study in hypophosphatasia patients.

• Ilofotase alfa: AM Pharma
Ilofotase alfa is a proprietary recombinant alkaline phosphatase constructed from two human isoforms of alkaline phosphatase that is well tolerated, stable, and highly active in multiple clinical trials in acute kidney injury and hypophosphatasia. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as lipopolysaccharide (LPS), ATP, ADP, and other extracellular substrates that drive acute inflammation and microvascular ischemia found in acute kidney injury. In hypophosphatasia, ilofotase alfa addresses elevated levels of pyridoxal-5'-phosphate (PLP), inorganic pyrophosphates (PPi), two disease-related biomarkers that are related to, for example, bone mineralization and pain sensation.

• REC-01: PuREC
PuREC specializes in regenerative cell therapy using mesenchymal stem cells (MSCs). MSCs are multipotent cells that differentiate into various mesenchymal lineage cells, including bone. MSCs have low immunogenicity and are a promising candidate for human cell therapy. Advancements in human bone marrow cell isolation have led to the extraction of an extremely pure and rapidly expanding MSC population. This clonal isolation is achieved by selecting cell surface markers related to enriched clonogenic cells.

Discover more about therapies set to grab major Hypophosphatasia market share @ Hypophosphatasia Treatment Market- https://www.delveinsight.com/sample-request/hypophosphatasia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Hypophosphatasia Drugs Market Insights
STRENSIQ is an ERT using bone-targeting recombinant alkaline phosphatase, addressing the main cause for manifestation. It is a human, recombinant TNSALP replacement therapy that replaces deficient TNSALP activity in patients with and reduces the accumulation of extracellular TNSALP substrate. It improves skeletal mineralization, motor capabilities, and respiratory function while reducing mortality compared to historically untreated patients with more severe perinatal, infantile, and childhood forms of hypophosphatasia.

Hypophosphatasia Market Strengths
• Advancements in understanding the pathophysiology and genetics of Hypophosphatasia, thereby elucidating new targets for treatment
• The approval of ERT by various regulatory authorities is a game changer, improving clinical manifestations, survival, and QoL

Hypophosphatasia Market Barriers
• Developing specific biochemical biomarker-based assays with an increased understanding of differential diagnosis among physicians will lead to improvements in diagnosis, thus opening the windows of opportunity for new treatment options
• There is a need for pharmacotherapeutic interventions for milder adult-onset of disease, which has little mortality and a high disease burden

Scope of the Hypophosphatasia Market Report
• Study Period: 2020-2034
• Coverage: 7MM
• Key Hypophosphatasia Companies: PuREC, AstraZeneca, Ultragenyx Pharmaceutical Inc., Alexion, and others
• Key Hypophosphatasia Therapies: REC-01, ALXN1850, BPS804, asfotase alfa, and others
• Hypophosphatasia Therapeutic Assessment: Hypophosphatasia current marketed and Hypophosphatasia emerging therapies
• Hypophosphatasia Market Dynamics: Hypophosphatasia market drivers and Hypophosphatasia market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Hypophosphatasia Unmet Needs, KOL's views, Analyst's views, Hypophosphatasia Market Access and Reimbursement

To know more about Hypophosphatasia companies working in the treatment market, visit @ Hypophosphatasia Clinical Trials and Therapeutic Assessment- https://www.delveinsight.com/sample-request/hypophosphatasia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Contents
1. Hypophosphatasia Market Report Introduction
2. Executive Summary for Hypophosphatasia
3. SWOT analysis of Hypophosphatasia
4. Hypophosphatasia Patient Share (%) Overview at a Glance
5. Hypophosphatasia Market Overview at a Glance
6. Hypophosphatasia Disease Background and Overview
7. Hypophosphatasia Epidemiology and Patient Population
8. Country-Specific Patient Population of Hypophosphatasia
9. Hypophosphatasia Current Treatment and Medical Practices
10. Hypophosphatasia Unmet Needs
11. Hypophosphatasia Emerging Therapies
12. Hypophosphatasia Market Outlook
13. Country-Wise Hypophosphatasia Market Analysis (2020-2034)
14. Hypophosphatasia Market Access and Reimbursement of Therapies
15. Hypophosphatasia Market Drivers
16. Hypophosphatasia Market Barriers
17. Hypophosphatasia Appendix
18. Hypophosphatasia Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

Company Name: DelveInsight Business Research LLP
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