United States Hypophosphatasia Treatment Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

Global Hypophosphatasia Treatment Market reached US$ 841.9 million in 2023 and is expected to reach US$ 2785.10 million by 2031, growing at a CAGR of 16.1% during the forecast period 2024-2031.

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Key Development:

United States: Recent Hypophosphatasia Treatment Developments

✅ In September 2025, Rallybio received a $12.5 million equity milestone payment from Recursion tied to advancement of the REV102 development program, reflecting investor confidence in next‐gen HPP therapies.

✅ In May 2025, BE Biopharma reported new preclinical data for BE‐102, an engineered B cell‐based therapy designed to provide sustained tissue‐nonspecific alkaline phosphatase production and potentially reduce dosing frequency compared with traditional enzyme replacement.

✅ In July 2025, Recursion Pharmaceuticals completed its acquisition of full rights to REV102, an orally available ENPP1 inhibitor candidate for HPP, advancing plans toward IND‐enabling and Phase 1 studies as a potential novel oral treatment.

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Japan: Recent Hypophosphatasia Treatment Developments

✅ In December 2025, Alexion (AstraZeneca) submitted a regulatory application in Japan for asfotase alfa (ALXN1850) as a new drug for hypophosphatasia, seeking approval to expand treatment options for Japanese HPP patients.

✅ In November 2025, a Phase 3 trial of ALXN1850 (recombinant alkaline phosphatase) completed recruitment of adolescent and adult HPP patients in Japan, evaluating efficacy and safety of this next‐generation therapeutic candidate.

✅ In November 2025, Japan's regulatory initiatives accelerated evaluation pathways for rare disease therapies after asfotase alfa received priority review designation, reinforcing support for innovative HPP treatments.

✅ In October 2025, EU approvals and priority review outcomes for HPP enzyme therapies (including pediatric approvals) influenced Japanese regulatory alignment, underscoring global momentum in HPP treatment accessibility.

Key Players:

=> Purec Global, Alexion Pharmaceuticals, Inc, AM-Pharma B.V., Aastrom Biosciences, Inc, Rallybio, Biomarin, Pfizer Inc, Protalix Biotherapeutics, Sanofi among others.

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Key Segments:

By Type

Odontohypophosphatasia - ~35% share

Rare inherited disorder affecting teeth mineralization; enzyme replacement therapy (ERT) is the primary treatment.

Pseudohypophosphatasia - ~30% share

Characterized by low alkaline phosphatase activity with clinical features of hypophosphatasia; supportive and targeted therapies are commonly used.

Others - ~35% share

Includes atypical or less common forms of hypophosphatasia; treatment approaches vary depending on severity and symptomatology.

By Therapy Type

Enzyme Replacement Therapy (ERT) - ~40% share

Gold-standard treatment for severe hypophosphatasia; improves bone mineralization and reduces mortality.

Supportive Therapies - ~25% share

Includes physical therapy, nutritional supplements, and symptom management; primarily used alongside primary treatment.

Analgesic-antiphlogistic therapy - ~15% share

Pain management and anti-inflammatory therapies for bone and joint discomfort.

Bone-targeted treatment - ~10% share

Includes bisphosphonates or bone anabolic agents in select cases to enhance skeletal health.

Others - ~10% share

Experimental or adjunct therapies, including gene therapy and investigational drugs.

By End User

Hospitals - ~40% share

Major point of care for diagnosis, treatment, and long-term management; high adoption of ERT.

Specialty Clinics - ~25% share

Focus on rare bone disorders; provide enzyme replacement and supportive therapies.

Homecare Settings - ~15% share

Patients receive enzyme therapy or supportive care at home; growing adoption due to chronic management needs.

Research Institutes - ~20% share

Clinical trials, rare disease research, and development of novel therapies.

By Region

North America - ~35% share

Leading market due to advanced healthcare infrastructure, availability of ERT, and high awareness.

U.S. - Largest regional share; early adoption of therapies and active clinical research.

Canada - Moderate growth; government reimbursement supports treatment access.

Mexico - Emerging market; growing awareness and availability of specialized care.

Europe - ~30% share

Strong adoption in rare disease centers; reimbursement policies support enzyme therapies.

Germany, UK, France, Italy, Spain - Major contributors with established specialty care centers.

Rest of Europe - Moderate adoption with growth potential through awareness and clinical trials.

Asia-Pacific - ~25% share

Increasing diagnosis rates and growing access to ERT in developed countries; Japan and South Korea lead adoption.

China, India, Japan, South Korea - Key markets; adoption driven by urban healthcare infrastructure.

Rest of Asia-Pacific - Emerging adoption with potential growth via research initiatives.

South America - ~5% share

Growing awareness of rare bone disorders; Brazil and Argentina are key contributors.

Middle East & Africa - ~5% share

Nascent market; limited access to therapies but increasing awareness and rare disease programs.

FAQ

What is the current size of the Hypophosphatasia Treatment Market?

A: In 2023, the Hypophosphatasia Treatment Market was valued at US$ 841.9 million , reflecting its strong industry presence.

Q2: How large is the Hypophosphatasia Treatment Market expected to be by 2031?

A: By 2031, industry forecasts suggest the Hypophosphatasia Treatment Market will grow to around US$ 2785.10 million , demonstrating significant expansion.

Q3: What is the growth rate of the Hypophosphatasia Treatment Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 16.1% during the forecast period from 2024 to 2031.

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