Global Hypophosphatasia Treatment Market Report and Forecast 2024-2032

Global Hypophosphatasia Treatment Market Outlook

The global primary hypophosphatasia treatment market is expected to grow at a CAGR of 5.10% during the forecast period of 2024-2032. The market is driven due to the growing awareness of the rare disease, a strong product pipeline, and increased financial support for researchers developing new innovative drugs for hypophosphatasia.

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Hypophosphatasia Insights

Hypophosphatasia (HPP) is a rare genetic disorder characterised by impaired bone and tooth mineralization (calcification). Mineralization is the process by which bones and teeth absorb the calcium and phosphorus required for proper hardness and strength.

The six major clinical forms are distinguished primarily by the age at which symptoms appear and a diagnosis is made like perinatal HPP, infantile HPP, childhood HPP, adult HPP, odontohypophosphatasia, and pseudohypophosphatasia. These forms are referred to by their decreasing severity.

Mutations in the ALPL gene can cause HPP. Genes encode instructions for the production of proteins that serve vital functions in the body. When a protein is mutated, it can become faulty, inefficient, or even absent, as in HPP. Depending on the function of the protein, one or more organ systems of the body may be jeopardised.

HPP is diagnosed by identifying its symptoms and complications, which begins with a thorough patient history. A thorough clinical examination reveals HPP signs, which are supported by routine x-rays and a variety of laboratory tests, including biochemical studies. For those who are familiar or experienced with this disorder, HPP is frequently easy to identify. 

Most physicians, understandably, have little or no knowledge of HPP which leads to a frustrating delay in diagnosis. Commercial laboratories now offer genetic mutation analysis of the ALPL gene to support a diagnosis of HPP.

According to the market research report, the hypophosphatasia treatment market can be categorised into the following segments:

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Market Breakup by Type

• Perinatal

• Infantile

• Childhood

• Adult

• Odontohypophosphatasia

• Pseudohypophosphatasia

Market Breakup by Diagnosis Method

• X-rays

• Biochemical Tests

• Chorionic Villus Sampling (CVS)

• Ultrasounds

• Vitamin B6 Test

Market Breakup by Treatment Method

• Medications
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Vitamin B6
  • Others
• Dental Care

• Physical Therapy

• Occupational Therapy

Market Breakup by Treatment Channel

• Public

• Private

Market Breakup by Region

• North America
  • United States of America
  • Canada
• Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • ASEAN
  • Australia
  • Others
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Others
• Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • Nigeria
  • South Africa
  • Others

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Hypophosphatasia Treatment Market Epidemiology

HPP affects both men and women equally. Severe HPP is estimated to affect one in every 100,000 live births in Canada. The overall incidence and prevalence of the various forms of HPP are unknown or poorly understood. Milder cases may go undetected or be misdiagnosed. HPP is most common in the Mennonite population of Canada, is relatively common in Japan, and appears to be rare in people of Black ancestry.

Global Hypophosphatasia Therapeutic Landscape

Asfotase alfa (Strensiq) was approved by the US Food and Drug Administration (FDA) as the first medical treatment for perinatal, infantile, and juvenile-onset HPP. In the United States, patients of any age with pediatric-onset HPP are eligible for this bone-targeted tissue-nonspecific alkaline phosphatase (TNSALP) replacement therapy administered subcutaneously.

Global Hypophosphatasia Treatment Market Drivers

The growing number of hypophosphatasia patients, a family history of hypophosphatasia, a strong product pipeline, and increased financial support for researchers developing new innovative drugs for hypophosphatasia treatment are expected to drive the hypophosphatasia market during the forecast period. Furthermore, an increase in special designation from regulatory authorities to provide treatment to patients as soon as possible is boosting the market.

Hypophosphatasia Investigational Therapies

Teriparatide, a type of parathyroid hormone, has been given "off-label" to several adults with HPP complicated by metatarsal stress fractures or femoral pseudo fractures, resulting in fracture healing. Children are not permitted to use the drug. More research is required to determine teriparatide's long-term safety and effectiveness in the treatment of HPP. To treat severe HPP, bone marrow cell transplantation has been used. 

Preliminary short-term results from the use of an anti-sclerostin antibody for HPP have also been reported. Sclerostin is a protein found in osteocytes, which are cells embedded in bone. Sclerostin aids in the reduction (downregulation) of osteoblasts. Sclerostin-specific antibodies have been shown to increase bone mass in osteoporosis patients.

Competitive Landscape

The report gives an in-depth analysis of the key players involved in the global hypophosphatasia treatment market, sponsors manufacturing the therapies, and putting them through trials to get FDA approvals. The companies included in the market are as follows:  

• Kirin Holdings Company

• Vericel Corporation

• Mereo BioPharma Group plc

• Novartis AG

• Bayer AG

• AM-Pharma B.V.

• Alexion

• Pfizer, Inc.

Key Highlights of the Report