Prader-Willi Syndrome Market to Reach New Heights in Growth by 2034, DelveInsight Predicts | Novo Nordisk, Pfizer, Sandoz, Harmony Biosciences, Soleno Therapeutics, Harmony Biosciences, ACADIA Pharma

DelveInsight's "Prader-Willi Syndrome Market Insights, Epidemiology, and Market Forecast-2034′′ report offers an in-depth understanding of the Prader-Willi Syndrome, historical and forecasted epidemiology as well as the Prader-Willi Syndrome market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

The Prader-Willi Syndrome market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Prader-Willi Syndrome pipeline products will significantly revolutionize the Prader-Willi Syndrome market dynamics.

To Know in detail about the Prader-Willi Syndrome market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Prader-Willi Syndrome Market Forecast https://www.delveinsight.com/sample-request/prader-willi-syndrome-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key facts of the Prader-Willi Syndrome Market Report:
• The Prader-Willi Syndrome market size was valued ~USD 600 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
• In April 2025, The US Food and Drug Administration (FDA) approved VYKATTM XR, marking it as the first approved treatment for hyperphagia in Prader-Willi syndrome (PWS). This milestone follows the FDA's approval of Growth Hormone Treatment (GHT) nearly 25 years ago. The approval was based on comprehensive FDA evaluation, including data from clinical trials, such as a randomized withdrawal study.
• In March 2025, Soleno Therapeutics received US Food and Drug Administration (FDA) approval for diazoxide choline, to be marketed as Vykat XR, for treating severe hunger in patients with Prader-Willi syndrome. The approval follows a three-month delay, during which the FDA categorized Soleno's responses as a "major amendment" to its new drug application (NDA), necessitating extra time for review.
• In March 2025, Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company focused on developing innovative treatments for rare diseases, has announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, for treating hyperphagia in adults and children aged 4 and older with Prader-Willi syndrome (PWS).
• In March 2025, The FDA has granted approval to Soleno Therapeutics' diazoxide choline (DCCR) extended-release tablets, branded as Vykat XR, for the treatment of Prader-Willi syndrome (PWS) in patients aged 4 years and older with hyperphagia. DCCR, a unique extended-release formulation containing diazoxide choline (the crystalline salt of diazoxide), is administered once daily and becomes the first treatment specifically targeting hyperphagia in PWS.
• The overall market size for PWS in the US was projected to be approximately USD 500 million in 2023, with expectations for growth throughout the forecast period (2024-2034).
• In EU4 and the UK, Germany held the largest market share, with a market size of approximately USD 30 million in 2023, and this is anticipated to increase during the forecast period (2024-2034).
• There is significant uncertainty regarding the therapies from Gedeon Richter and Palobiofarma due to a lack of substantial evidence on their safety and efficacy. In contrast, Palobiofarma's PBF-999 is anticipated to be launched first in Spain.
• In 2023, the US had the highest number of prevalent cases of PWS among the 7MM, totaling approximately 22,600 cases, which are projected to rise during the forecast period.
• In 2023, Germany had the highest number of total prevalent cases of PWS among the EU4 and the UK, whereas Spain recorded the lowest number of cases.
• Estimates indicate that in Japan, PWS was most commonly seen in the 18-40 age group, representing over 38% of all cases in 2023.
• In 2023, within the United States, the paternal microdeletion subtype represented the largest share of genetic subtype-specific cases of PWS, comprising around 70% of cases, while the translocation subtype was the least prevalent.
• Key Prader-Willi Syndrome Companies: Novo Nordisk, Pfizer, Sandoz, Harmony Biosciences, Soleno Therapeutics, Harmony Biosciences, ACADIA Pharmaceuticals, Aardvark Therapeutics, Gedeon Richter, Palobiofarma, ConSynance Therapeutics, and others
• Key Prader-Willi Syndrome Therapies: NORDITROPIN, GENOTROPIN, OMNITROPE, WAKIX (pitolisant), Diazoxide Choline Controlled-Release (DCCR), WAKIX (pitolisant), DCCR (diazoxide choline), Carbetocin (LV-101), ARD-101, RGH-706, PBF-999, CSTI-500, and others
• The Prader-Willi Syndrome market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Prader-Willi Syndrome pipeline products will significantly revolutionize the Prader-Willi Syndrome market dynamics.

Prader-Willi Syndrome Overview
Prader-Willi Syndrome (PWS) is a complex genetic disorder that affects many parts of the body. The condition is characterized by weak muscle tone (hypotonia) and feeding difficulties in infancy, followed by excessive eating and gradual development of obesity. Individuals with Prader-Willi Syndrome typically have intellectual disability, behavioral problems, and distinctive physical features such as almond-shaped eyes, a narrowing of the head at the temples, and a turned-down mouth.

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Prader-Willi Syndrome Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

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

Download the report to understand which factors are driving Prader-Willi Syndrome epidemiology trends @ Prader-Willi Syndrome Epidemiology Forecast
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Prader-Willi Syndrome Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Prader-Willi Syndrome market or expected to get launched during the study period. The analysis covers Prader-Willi Syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Prader-Willi Syndrome Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Prader-Willi Syndrome Therapies and Key Companies
• NORDITROPIN: Novo Nordisk
• GENOTROPIN: Pfizer
• OMNITROPE: Sandoz
• WAKIX (pitolisant): Harmony Biosciences
• Diazoxide Choline Controlled-Release (DCCR): Soleno Therapeutics
• WAKIX (pitolisant): Harmony Biosciences
• DCCR (diazoxide choline): Soleno Therapeutics
• Carbetocin (LV-101): ACADIA Pharmaceuticals
• ARD-101: Aardvark Therapeutics
• RGH-706: Gedeon Richter
• PBF-999: Palobiofarma
• CSTI-500: ConSynance Therapeutics

Discover more about therapies set to grab major Prader-Willi Syndrome market share @ Prader-Willi Syndrome Treatment Landscape
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Scope of the Prader-Willi Syndrome Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Prader-Willi Syndrome Companies: Novo Nordisk, Pfizer, Sandoz, Harmony Biosciences, Soleno Therapeutics, Harmony Biosciences, ACADIA Pharmaceuticals, Aardvark Therapeutics, Gedeon Richter, Palobiofarma, ConSynance Therapeutics, and others
• Key Prader-Willi Syndrome Therapies: NORDITROPIN, GENOTROPIN, OMNITROPE, WAKIX (pitolisant), Diazoxide Choline Controlled-Release (DCCR), WAKIX (pitolisant), DCCR (diazoxide choline), Carbetocin (LV-101), ARD-101, RGH-706, PBF-999, CSTI-500, and others
• Prader-Willi Syndrome Therapeutic Assessment: Prader-Willi Syndrome current marketed and Prader-Willi Syndrome emerging therapies
• Prader-Willi Syndrome Market Dynamics: Prader-Willi Syndrome market drivers and Prader-Willi Syndrome market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Prader-Willi Syndrome Unmet Needs, KOL's views, Analyst's views, Prader-Willi Syndrome Market Access and Reimbursement

To know more about Prader-Willi Syndrome companies working in the treatment market, visit @ Prader-Willi Syndrome Clinical Trials and Therapeutic Assessment
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Table of Contents
1. Prader-Willi Syndrome Market Report Introduction
2. Executive Summary for Prader-Willi Syndrome
3. SWOT analysis of Prader-Willi Syndrome
4. Prader-Willi Syndrome Patient Share (%) Overview at a Glance
5. Prader-Willi Syndrome Market Overview at a Glance
6. Prader-Willi Syndrome Disease Background and Overview
7. Prader-Willi Syndrome Epidemiology and Patient Population
8. Country-Specific Patient Population of Prader-Willi Syndrome
9. Prader-Willi Syndrome Current Treatment and Medical Practices
10. Prader-Willi Syndrome Unmet Needs
11. Prader-Willi Syndrome Emerging Therapies
12. Prader-Willi Syndrome Market Outlook
13. Country-Wise Prader-Willi Syndrome Market Analysis (2020-2034)
14. Prader-Willi Syndrome Market Access and Reimbursement of Therapies
15. Prader-Willi Syndrome Market Drivers
16. Prader-Willi Syndrome Market Barriers
17. Prader-Willi Syndrome Appendix
18. Prader-Willi Syndrome Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

Related Reports:

Prader-Willi Syndrome Pipeline https://www.delveinsight.com/report-store/prader-willi-syndrome-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
"Prader-Willi Syndrome Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Prader-Willi Syndrome market. A detailed picture of the Prader-Willi Syndrome pipeline landscape is provided, which includes the disease overview and Prader-Willi Syndrome treatment guidelines.

Prader-Willi Syndrome Epidemiology https://www.delveinsight.com/report-store/prader-willi-syndrome-epidemiology-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
DelveInsight's 'Prader-Willi Syndrome Epidemiology Forecast to 2034' report delivers an in-depth understanding of the disease, historical and forecasted Prader-Willi Syndrome epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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