In 2030 it’s projected that as many as 1 in 2 adults will have obesity
Unmet medical need and market
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 and 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 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 offsetting the positive effect on weight loss due 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 and decrease in bone calcification.
Patients having undergone RYGB suffer from decalcification of bone tissues and are at high 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 first fracture anywhere in their body 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 nutritional 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 $3B by 2030
Epicyt Pharma’s BAFA potentially and uniquely provides for osteoporosis prevention in the RYGB population of patients.
Prolia, indicated for postmenopausal osteoporosis, is used as the pricing benchmark for total market estimation*.
Prolia has an annual list price cost of US$ 2,558 in US and US$ 510 in Europe; with MENA estimated to be on par with the EU pricing.
The total market potential is forecasted based on the target population times drug pricing and adjusted by annual growth rates in the individual regions.
By 2030, the total market of osteoporosis prevention for RYGB-patients will reach around US$ 3B in the targeted regions.
Source: 1. US Prolia website; 2. UK NICE pricing info; 3. London School of Economics and Political Science (2018) Pharmaceutical pricing and reimbursement in the Middle East and North Africa region
*Even if prescribed as they would be, drugs of this class would likely not work without the restored calcium balance that epicyt-BAFA would uniquely provide.