(PharmaNewsWire.Com, April 13, 2020 ) Market Overview • The Global Growthhormonedeficiency Market is expected to grow at a CAGR of 8.6% during the forecasting period (2019-2026).
• Growth hormone deficiency (GHD) is a rare endocrine disorder that occurs due to impaired secretion of somatropin, a peptide growth hormone (GH) from the pituitary gland which is responsible for the growth and cell reproduction. GHD is classified into three categories: congenital, acquired, or idiopathic. Congenital GHD is present at the time of birth and can be caused either by genetic mutations or structural abnormality in the brain. Acquired GHD occurs in later stages of life as a result of trauma, infection, or tumors, among many other causes. Idiopathic GHD has unknown or undiagnosed causes. Children with GHD have retarded growth and sometimes delayed puberty. The predominant symptom of GHD in children is abnormally shorter height than other children of the same age with or without compromise in the cognitive intelligence while in adults, GHD may lead to fatigue, tiredness, anxiety, and depression. In addition to height, growth hormone ensures regulation of carbohydrate metabolism, protein metabolism, and fat metabolism. Without treatment, GHD in adults can affect the patients’ working capacity, mental alertness, and memory. GHD can also have adverse effects on body composition like an increased amount of body fat, an increase in total cholesterol, and a rise in osteoporosis.
• The over secretion of GH leads to gigantism, and its deficiency causes dwarfism. Recombinant DNA technology is used in the manufacturing of human GH drugs.
Market Drivers • The market is driven by an increase in the incidences of GHD, the introduction of technologically advanced drugs with improved patient compliance and increased awareness of the disease.Approximately 150,000 children are referred with short stature (SS) based on a cut-off of the fifth percentile. The most important endocrine and treatable cause of SS is GHD. Rising cases of GHD globally requires technological advancements in the treatment. Technological advancements such as development of recombinant human growth hormones (rhGH) like Nutropin Depot®, Zomajet®, Serojet®, and NordiFlex® by prominent market players like Pfizer and Nova Nordisk is further expected to boost the market growth in coming years. Major rhGH available in the U.S. market are Norditropin, Humatrope, Nutropin-AQ, Genotropin, Saizen, Tev-tropin, and Omnitrope.
• Market Restraints • The high cost of treatment for GHD is the only reason that is expected to restrain the market growth over the period of forecast.
Market Pipeline • There are three major drugs in the pipeline of growth hormone deficiency market that is expected to be launched in the market within the next 4-5 years. These are:
• TransCon-hGH by Ascendis Pharma is being developed as once a week therapy for children with GHD. TransCon hGH is currently being evaluated in phase 3 clinical trial, the heiGHt Trial that is comparison with daily hGH in pediatric GHD. Based on these results and data from the ongoing fliGHt and enliGHten Trials, the company is expected to file a Biologics License Agreement (BLA) in the first half of 2020.
• In September 2018, Somapacitan, by Novo Nordisk, an investigational novel growth hormone derivative for once-weekly administration of growth hormone, matched the therapeutic profile of once-daily Norditropin in a phase 2 trial in children with GHD. There are currently no approved once-weekly treatments for GHD. NVO's somapacitan, the most promising among the competition, is lagging by almost five years, with a phase 3 trial started in 2019, and set to complete in 2024.
• Opko Health Inc. has completed enrollment in the Company’s global pivotal Phase 3 study in growth hormone deficient children in August 2018, evaluating a single weekly injection of its developmental long-acting GHD product, somatrogon, delivered in a multi-dose disposable pen. Somatrogon (hGH-CTP) is a new molecular entity that helps to maintain the natural sequence of growth hormone, fused with a C-terminus peptide to extend its half-life.
Market Segmentation • The global growth hormone deficiency market can be segmented by treatment type as Surgery and Growth Hormone Therapy, by the end user as Hospitals, Clinics, and Homecare settings and by distribution channels as Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies.
• Adult Growth Hormone Deficiency (AGHD) is increasing globally due to increase in diseases such as pituitary tumors, neuropsychiatric-cognitive, neuromuscular, cardiovascular, skeletal abnormalities and metabolic abnormalities. The Society for Endocrinology estimates that the prevalence of adult-onset GH deficiency is approximately 1 in 10,000 of the adult UK population. If adults with childhood-onset GH deficiency are also considered, the prevalence may be as high as 3 in 10,000 of the adult population. This equates to approximately 12,600 adult patients with GH deficiency in England and Wales. Surgery is rarely an option for GHD, most of these disorders can be reversed with growth hormone therapy.
Geographical Analysis • Geographically, the global growth hormone deficiency market is divided into North America, Europe, South America, Asia-Pacific, and the Middle East and Africa.
• North America is expected to account for the largest market share in the forecast period due to affordability for costly medicine, the presence of robust pipeline and local presence of key market players. According to Boston Children’s Hospital, about one in 4,000 to 10,000 children have growth hormone deficiency in the US, and approximately 50,000 adults have a growth hormone deficiency, with about 6,000 new adult patients diagnosed every year.
• Europe is expected to account for the second largest market in the world because rising cases of GHD, according to European Medicine Agency, in 2018, GHD affected approximately 4.7 in 10,000 people in the European Union (EU). The rise in investment by major companies and growth in research and development are some other reasons helping the growth of the market.
• Asia Pacific is anticipated to witness the fastest growth during the forecast period as the demand for GH is rising in the emerging countries. Japan, Australia, China, and India are the major contributing countries in the region. Investment by market players is increasing in the region due to the growing demand is one of the major factors for market growth.
Competitive Analysis • Sandoz International GmbH, Sanofi-Aventis, Pfizer, Novo Nordisk A/S, Teva Pharmaceutical Industries Limited, Ranbaxy, EMD Serono, Inc., Sun Pharmaceutical Industries Ltd., Eli Lilly and Company, Ferring Holding SA, Genentech, Inc., Merck & Co., Inc., Ipsen, GeneScience Pharmaceuticals Co., Ltd., and Roche Holdings, Inc. are some of the prominent key players in the market.
• Most of the companies in the market are trying to produce novel drugs for better treatment of GHD. These companies have strong pipeline drugs that can change the course of treatment within the next five years.
• In September 2018 Lumos Pharma Inc. announced that the company has acquired the license for LUM-201 from Ammonett Pharma LLC. LUM-201 is an investigational orally administered small molecule for promoting the secretion of growth hormone from the pituitary gland. The companies together have planned to initiate a Phase II b trial in 2019 within the patients suffering from Pediatric Growth Hormone Deficiency.
• In October 2017, Ferring entered an agreement with Antares Pharma Inc. for worldwide rights to ZomaJet™ needle-free injector device. ZomaJet is used to deliver Ferring’s Zomacton® (somatropin), indicated to treat Growth Hormone Deficiency in children and Turner Syndrome in girls.
Why purchase the report? • Visualize the composition of the growth hormone deficiency market across each indication, in terms of type and by type highlighting the key commercial assets and players. • Identify commercial opportunities in growth hormone deficiency by analyzing trends and co-development deals. • Excel data sheets with thousands of data points of growth hormone deficiency market- level 4/5 segmentation. • PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study. • Product mapping in excel for the key products of all major market players.
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