Unmet medical need drives market pull
Global obesity is projected to increase significantly
In 2030 it is projected that as many as 1 in 2 adults will have obesity (BMI>30) and 1 in 4 adults will have severe obesity (BMI>35) in the US, the Middle East and North Africa (MENA) region.
A recent study suggested that the female obese population in the MENA region in 2016 was 11% higher than the world average. Since then, numbers have been growing. The number of individuals with severe obesity in Europe has stabilized at around 11 million people.
The increasing prevalence of obesity has resulted in a growing number of bariatric (anti-obesity) surgeries performed in order to tackle the severe obesity pandemic. The most common bariatric surgeries are Sleeve Gastrectomy and Roux-en-Y Gastric Bypass (RYGB).
RYGB leads to a degree of malabsorption of calcium and vitamin D leading to decreased bone calcification, and an increased risk for osteoporosis and consequent fractures.
RYGB-patients are routinely prescribed nutritional supplements including calcium and vitamin D. The effect of these supplements, however, is not sufficient to prevent the decrease in intestinal calcium uptake.
There is a need to save patients having undergone RYGB from decalcification of bone tissues and risk of osteoporosis at a young age.
Gastric bypass surgery – an increased risk of osteoporosis
To compensate for the impaired intestinal absorption of calcium, bone turnover increases shortly after RYGB, releasing calcium from bone to keep the levels of calcium in the blood stable. Studies have shown that there is an increased risk of fractures and accelerated osteoporosis even in a younger patient population, only a few years after surgery.
Bariatric surgery patients of all ages are almost twice as likely to have a bone fracture compared to individuals with obesity who have not undergone weight loss surgery.
A study showed that a decade after undergoing RYGB surgery, more than 25 % of postmenopausal women and men ≥50 years of age, as well as a significant number of younger patients, were found to have osteoporosis. Fragility fractures were also commonly found within the same population.
Hence, there is an unmet need for increasing calcium absorption to prevent osteoporosis in patients who have undergone RYGB.
BAFA has the unique potential to restore the uptake of calcium and prevent the increased risk of osteoporosis and future fractures for a large and growing population of RYGB-patients.
Source: Gagnon et al. (2018) Bon Health After Bariatric Surgery, ASBMR. Blom-Høgestøl IK, Hewitt S, Chahal-Kummen M, et al. Bone metabolism, bone mineral density and low energy fractures 10 years after Roux-en-Y gastric bypass. Bone. 2019;127:436-445.
Market potential for BAFA is estimated to reach $450 million by 2041
Epicyt Pharma’s BAFA potentially and uniquely provides for osteoporosis prevention in the RYGB population of patients.
The total market potential is forecasted based on the prevalent target population of approximately 5 million RYGB-operated patients times a conservative drug pricing and adjusted by annual growth rates and penetration rates in the individual regions. In addition to the prevalence, 300,000-500,000 new RYGB surgeries are performed in EU and US each year.
By 2041, the total market of osteoporosis prevention for RYGB-patients will reach around US$ 450 million in the targeted regions. RYGB surgery is the leading treatment for severe obesity, BMI>35.
