Number of pages: 100 | Report Format: PDF | Published date: March 03, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global congenital hyperinsulinism treatment market was valued at US$ 132 million in 2022 and is expected to register a revenue CAGR of 5.8% to reach US$ 219 million by 2031.
Congenital Hyperinsulinism Treatment Market Fundamentals
Congenital hyperinsulinism is a disorder that causes individuals to have abnormally high insulin levels. People with this disease frequently experience low blood sugar episodes (hypoglycemia). Lethargy, irritability, or trouble feeding are characteristics of such phases in infants and young children. Repeated low blood sugar events raise the danger of life-threatening side effects, such as breathing problems, seizures, cerebral impairment, vision loss, neurological damage, and coma. Several risk factors, including birth asphyxia, intrauterine growth delay, and maternal diabetes mellitus, as well as different overgrowth syndromes, such as Beckwith-Wiedemann syndrome, or metabolic conditions, such as inherited disorders of glycosylation, can cause congenital hyperinsulinism to be transient.
The probability of a newborn having congenital hyperinsulinism is estimated to be one in 50,000. This condition, which affects up to one in 2,500 newborns, is more prevalent in some groups. Patients with congenital hyperinsulinism may experience various symptoms, from non-specific adrenergic symptoms, such as poor feeding, hunger, palpitations, and sweating, to life-threatening neuroglycopenic symptoms, including seizures, unconsciousness, fatigue, coma, and even death due to a lack of glucose reaching the brain and impairing brain function.
Congenital hyperinsulinism is diagnosed based on the patient’s medical history, laboratory results, and genetic research. Diagnosing and treating neurologic damage promptly is crucial to prevent further complications. The treatment objective for congenital hyperinsulinism is to keep blood sugar levels near 70 mg/dL, as excess insulin may result in critically low blood sugar levels. Congenital hyperinsulinism can be treated with either medical therapy or surgical procedures. Around 50% of children diagnosed with pancreatitis respond well to medical treatment. On the other hand, the remaining 50% with partial or nearly complete removal of their pancreas may need surgical intervention.
Congenital Hyperinsulinism Treatment Market Dynamics
The increase in parenteral administration of active pharmaceutical ingredients, availability of low-cost insulin, rise in the geriatric population, and an upsurge in type 1 and type 2 diabetes population are expected to drive revenue growth in the global market during the forecast period. Increased collaborations among research and development and private pharmaceutical companies are driving market development.
The increase in the prevalence of diabetes is the key factor driving the revenue growth of the global congenital hyperinsulinism treatment market. By 2025, around 75% of the 300 million individuals with diabetes globally, with nearly one-third residing in India and China, will be in non-industrialized countries. Diabetes is a global public health issue that erupts as a pandemic. Numerous studies have found that type 2 diabetes is becoming more common among migrants. The industrialization of society and the migration of people from rural to urban areas may have had a significant impact on the environment and lifestyle, contributing to the epidemic of type 2 diabetes. The key causes of obesity include the consumption of high-calorie, high-fat, and high-sugar diets, specifically central obesity, and an increase in visceral fat due to physical inactivity, which influences the development of diabetes at a very young age, including in infants.
There is compelling evidence that most of the population has higher levels of insulin resistance and a stronger genetic susceptibility to diabetes. Lack of physical activity and higher obesity rates in adults, and more significantly children, directly impact the epidemiology of congenital hyperinsulinism. On the other hand, the soaring demand for congenital hyperinsulinism treatment owing to the increased awareness regarding congenital hyperinsulinism and its risk factors is driving the development of the global market. Additionally, promoting traditional high-fiber diets and developing strategies to achieve healthy fetal and infant development are crucial steps to combat the rise of diabetes and lessen the global disease burden in genetically predisposed groups.
However, the expensive treatment of congenital hyperinsulinism and the adverse effects of the drugs are the major restraining factors inhibiting the development of the global market. For instance, drugs used to treat hyperinsulinism in children can cause skin rashes or severe allergic reactions. Additionally, it may result in a drop in blood count. Consequently, many physicians do not favor these medications when considering children’s health.
Congenital Hyperinsulinism Treatment Market Ecosystem
The global congenital hyperinsulinism treatment market is analyzed from three perspectives: drug, distribution channel, and region.
Congenital Hyperinsulinism Treatment Market by Drug
Based on the drug, the global congenital hyperinsulinism treatment market is segmented into diazoxide, octreotide, glucagon, nifedipine, and others.
The diazoxide segment accounted for the largest revenue share of the global congenital hyperinsulinism treatment market in 2022. The first-line therapy for all types of hyperinsulinism is the oral administration of diazoxide. The Federal Drug Administration has only authorized diazoxide as a pharmacological agent for treating hyperinsulinism, making it the first-line treatment. It is a peripheral vasodilator developed as a non-diuretic benzothiadiazine to lower extreme hypertension by relaxing smooth muscle. Thus, diazoxide is prescribed to treat hyperinsulinism and reduce high blood pressure, making it the preferred drug among others. Further, diazoxide acts as a potassium channel opener. Therefore, it is a common conservative long-term treatment option for congenital hyperinsulinism in children.
The glucagon segment is expected to account for a sizable revenue share of the global congenital hyperinsulinism market during the forecast period. Glucagon is a safe and effective adjunct therapy for patients with hyperglycemia in the surgical ICU. Improved blood glucose stability is a positive outcome that enhances the safety of intensive insulin treatment. Therefore, many doctors prefer glucagon to treat hyperinsulinism in adults in a surgery setup.
Congenital Hyperinsulinism Treatment Market by Distribution Channel
Based on the distribution channel, the global congenital hyperinsulinism treatment market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.
The hospital pharmacies segment accounted for the largest revenue share of the global congenital hyperinsulinism treatment market in 2022. Hospital pharmacies play an important part in maximizing patient care by collaborating with doctors, nurses, and other healthcare professionals to provide the right drugs and supplies following established treatment procedures. It ensures better outcomes for patients, helping hospitals surpass patient satisfaction goals. According to a national survey on pharmacy practice in hospitals by the American Society of Health-System Pharmacists, hospital pharmacists play a superior role in patient care and provide more medication-related patient transition-of-care interventions, 24/7 medication order review, and medication counseling. Also, the economics of health expenses are significantly influenced by the hospital pharmacy. The hospital pharmacy now offers both drug monitoring services and medication information services. Additionally, several government initiatives, such as subsidized medicines, help patients buy expensive drugs for rare diseases, such as congenital hyperinsulinism, regardless of income. Therefore, the increasing drug costs and unavailability of medicines in retail pharmacies are resulting in an increase in patients' preference to buy medications from hospital pharmacies, leading to a significant increase in the segment's revenue share.
Congenital Hyperinsulinism Treatment Market by Region
Based on the region, the global congenital hyperinsulinism treatment market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America accounted for the largest revenue share of the global congenital hyperinsulinism treatment market in 2022. Some of the primary factors supporting the enormous revenue share of the congenital hyperinsulinism market in North America include the existence of leading players, the high prevalence of obesity and other lifestyle disorders, and the well-established healthcare infrastructure in the region. Additional variables that spur market growth include a higher prevalence of familial hyperinsulinism, favorable government initiatives, and greater awareness of the treatment in the region. The United States accounts for the largest market revenue share in North America. According to the Centers for Disease Control and Prevention, about 7% of American children and teenagers aged 6 to 19 have high total cholesterol. Thus, the prevalence of diabetes and other metabolic diseases is anticipated to increase, driving up demand for congenital hyperinsulinism treatment in North America.
The Asia Pacific is growing with significant market revenue share owing to the high prevalence of diabetes and lifestyle diseases in the region. In most Asian nations, lifestyle disorder is more prevalent due to reduced physical exercise at work due to mechanization, better-motorized transportation, and preferences for watching television and playing video games over playing outdoor games during free time. According to reports from China and India, urban and rural populations have increased their intake of foods high in energy over the past ten years. Asian populations are more prone to metabolic diseases than matched white populations as they have lower body mass index (BMI) but greater total and central adiposity for a given body weight. In Asians, metabolic fat is more prevalent, leading to chronic diseases, such as diabetes. As a result, the young population in Asia Pacific is more susceptible to developing congenital hyperinsulinism.
Congenital Hyperinsulinism Treatment Market Competitive Landscape
The global market for congenital hyperinsulinism treatment is quite competitive with product launches, mergers, and acquisitions. One of the key strategies that many businesses emphasize is the introduction of new therapeutics, getting those products approved, and engaging in other activities, such as events and patents. Moreover, several startup companies are increasing research and development efforts to develop better treatments. For instance, a startup biotech company Xinvento announced the conclusion of a seed financing round to enhance the lives of people with congenital hyperinsulinism. The business intended to develop and test its unique molecules in the pre-clinical models owing to this seed funding to find potential drug candidates. Also, the market players are adopting inorganic development strategies, such as acquisition, partnership, and collaboration, to stay ahead of the competition.
The prominent players in the congenital hyperinsulinism treatment market are:
Congenital Hyperinsulinism Treatment Market Strategic Developments
The treatment for congenital hyperinsulinism includes diazoxide, octreotide, nifedipine, glucagon, growth hormone, and glucocorticoids. They directly influence insulin production or prevent insulin secretion from the pancreas.
The rise in focus on developing new treatment strategies and an increase in the diabetic population are the key trends fueling the global congenital hyperinsulinism market revenue growth.
Zealand Pharma A/S, REZOLUTE, INC, Xeris Pharmaceuticals, Inc, Eiger BioPharmaceuticals., and RECORDATI are among the top market players.
The high cost and severe side effects of the drugs used to treat congenital hyperinsulinism may restrict the revenue growth of the global market.
The global congenital hyperinsulinism treatment market is expected to grow at a revenue CAGR of 5.8% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain