Prader-Willi syndrome (PWS) is a rare genetic disorder characterized by low muscle tone, short stature, incomplete sexual development, cognitive disabilities, problem behaviors, and a chronic feeling of hunger that can lead to excessive eating and life-threatening obesity. According to DelveInsight's recent study, the Prader-Willi syndrome market size is expected to grow significantly over the next decade, surpassing USD 3 billion by 2030.
PWS occurs in approximately 1 in 10,000 to 30,000 births globally. Its prevalence is estimated to be similar worldwide, affecting both males and females equally. However, many cases remain undiagnosed or misdiagnosed due to lack of awareness and complexities surrounding early diagnosis.
The two major drivers spurring growth in the PWS market are the rising diagnosed prevalence and the introduction of promising pipeline therapies. While prevalence has remained relatively stable, improved genetic testing capabilities and diagnostic criteria in recent years have led to more confirmed PWS cases. In tandem, research has brought greater understanding of PWS genetics and pathogenesis, enabling progression of several novel treatments like DCCR agonists, GLP-1 analogs and oxytocin analogs through clinical development.
The frontrunner in the PWS pipeline is SOL-716, an oxytocin receptor agonist by BridgeBio Pharma’s affiliate Soleno Therapeutics. SOL-716 has shown remarkable improvements in hyperphagia and other PWS symptoms over placebo in Phase III trials. It is expected to emerge as the first FDA-approved therapy for PWS patients in early 2023 and spearhead near-term growth of the PWS market.
Other key pipeline agents like Zafgen’s ZGN-1258, Saniona’s Tesomet and Levo Therapeutics’ LV-101 may enter markets over the next 5-8 years if trials continue to yield positive results. The launches of these upcoming therapies will broaden the PWS armamentarium, unlock new market segments for treatment and bolster longer-term projections.
However, the Prader-Willi Syndrome market outlook is not without challenges. The rarity of PWS makes conducting large enough studies difficult for statistical significance and market viability of new drugs. Payer restrictions due to PWS’s orphan status also constrain access to patients in certain countries. Lastly, the multi-system nature of PWS requires combination or staged therapies targeting different symptoms, which adds complexities to development.
Nevertheless, the unmet need created by PWS’s devastating comorbidities and lack of approved options today outweigh the deterrents for most drug makers. With no signs of research slowing down, DelveInsight estimates the PWS market revenue potential to multiply by nearly 15 times over the next ten years. Realization of this growth relies heavily on execution by emerging players to deliver novel therapies that can change the status quo for PWS management.
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