The global growth hormone deficiency market size was valued at USD 4,294 million in 2022. It is estimated to reach USD 6,327 million by 2031, growing at a CAGR of 4.40% during the forecast period (2023–2031).
Human growth hormone often referred to as somatotropin, is a peptide hormone generated by the pituitary gland that controls cell growth, renewal and repair, reproduction, and metabolism—all processes necessary for healthy human development. Stress, physical activity, sleep deprivation, and low blood sugar levels can all affect human growth hormone levels, which should be suitable for optimum growth. Human growth hormones also help to control bodily fluids, the metabolism of sugar and fat, the development of muscles and bones, and the healing of injuries. It also enhances muscle strength and performance. Further, growth hormone deficiency (GHD) is a rare disorder in which the pituitary gland produces insufficient growth hormone. GHD can be congenital or developed in a later stage. To remedy this human deficiency, recombinant human growth hormone is subcutaneously administered.
According to the published article in NCBI in March 2017, the estimated prevalence of GHD is approximately 2-3 in the 10,000 population. GHD is caused by structural pituitary disease or cranial irradiation and occurs in the context of additional features of hypopituitarism. Pituitary adenomas are reported to cause adult-onset GHD followed by craniopharyngiomas, which account for approximately 57% of cases.
In addition, childhood-onset growth hormone deficiency (CO-GHD) is one of the complex endocrine conditions that may impact throughout life, starting in childhood and continuing till adulthood. Most CO-GH is reported to be congenital. The main co-morbidities and symptoms of GHD in adults and children are obesity, diabetes mellitus, hypertension, cerebrovascular diseases, cardiovascular diseases, and liver diseases. This increasing morbidity of GH disease in children and adults is expected to drive the growth of the growth hormone deficiency market.
Rising Number of Clinical Trials for GH Deficiency
The market players are carrying out clinical trials to test the safety and efficacy of GH deficiency, which is boosting the market growth of the growth hormone deficiency market. For instance, Opko Health reported in June 2020 that the Japan Phase 3 clinical trial had achieved both its primary and secondary goals and had proven the efficacy and safety of weekly somatrogon administration. After 12 months of treatment, it was comparable to GENOTROPIN (somatropin) for injection provided once daily in terms of yearly height velocity in Japanese pre-pubertal children with GHD.
Furthermore, in September 2019, Novo Nordisk reported positive data from the Phase II REAL 3 clinical trial of somapacitan in children suffering from GHD. After one year, the drug candidate demonstrated safety, efficacy, and tolerability compared to Norditropin (somatropin). Improved efficacy was reported for the highest somapacitan dose. Hence, these studies by the established market players focused on the understanding that GHD is rapidly driving the market growth.
According to a published article in SpringerLink in 2016, a research study was conducted to evaluate the online market of no-prescription somatropin products and analyze and document Internet pharmacy characteristics, distribution, and pharmaceutical quality. Somatropin injections are sold on shady websites without a doctor's prescription. Customers are potentially putting their health at risk while purchasing parenteral medications through e-commerce mode. The study concluded that seventeen Internet vendor websites distributed somatropin products directly to patients, of which 94% did not require a valid medical prescription before dispensing the products. Therefore, this unprofessional distribution and handling will likely hamper patient health and limit the growth of the GHD market.
Strong Pipeline of Hormonal Drugs and Easy Availability of Pharma Drugs on Retail E-Commerce Platforms
The rising demand for growth hormone therapy and lucrative growth opportunities have strived industry participants to engage in research to manufacture innovative drugs. For instance, in March 2017, Novo Nordisk initiated a Phase III trial of Somapacitan (NNC0195-0092). The drug is designed to treat AGHD. The development of this new drug is likely to boost the global growth hormone market soon. Apart from this, many other companies, such as Pfizer Inc., Teva Pharmaceutical Industries Ltd, and Ascendis Pharma, are involved in developing various growth hormones.
The growing popularity of e-commerce also facilitates a significant increase in online pharmacies, leading to the easy availability of pharmaceutical drugs. For instance, in July 2017, Amazon, the US-based retail giant, entered the Middle Eastern market. Amazon acquired the Middle Eastern e-commerce firm Souq.com to expand its products and services. E-commerce distribution channels account for a significant share of the global growth hormone market, opening opportunities for many GHD market players.
Based on the brand, the global growth hormone deficiency market is divided into Norditropin, Genotropin, Humatrope, Saizen, Omnitrope, and others.
The Norditropin segment is responsible for the largest market share and is anticipated to grow at a CAGR of 6.05% over the forecast period. Novo Nordisk's Norditropin HGH injections are conveniently preloaded pen systems that are premixed and prefilled. The market share for this brand is attributed to the brand value, product quality, convenience, and simplicity of administration. Moreover, Norditropin is convenient to store while traveling as it does not require refrigeration after activation, which increases its preference among patients.
Eli Lily and Company manufacture Humatrope. The market share of Humatrope is attributed to the brand recognition of Eli Lily and Company. Apart from offering the standard vial and syringe method for administering HGH to the body, this brand is also available in the Humatropen device. However, all forms of Humatrope require continual refrigeration, making them unsuitable for individuals who frequently travel without the ability to keep their medications always cool. This factor can hamper the market growth of the Humatrope brand.
Based on application, the global growth hormone deficiency market is segmented into Pediatric Growth Hormone Deficiency, Idiopathic Short Stature (ISS), Small for Gestational Age, Turner syndrome, adult Growth Hormone Deficiency, Prader-Willi syndrome, and others.
The pediatric growth hormone deficiency segment is the highest contributor to the market and is expected to grow at a CAGR of 4.49% over the forecast period. Pediatric growth hormone deficiency is an endocrine disorder characterized by the low secretion of growth hormones in children. The market share for the pediatric growth hormone deficiency segment is due to the growing prevalence of GHD in children, increasing penetration of drugs by prominent market players, and raising awareness about the disease. Moreover, an increasing engagement of significant market players in developing growth hormone products is likely to drive market growth.
Idiopathic short stature (ISS) refers to children with shortening body growth where the reason behind the physical condition is unknown. Moreover, the ISS segment's market share is rising due to the increasing awareness about short stature. Additionally, according to The Endocrine Society, approximately 60–80% of all children across the globe with short stature fit into the category of ISS. Factors such as the heavy investment in research and development, suitable reimbursement conditions, and a growing patient population living with ISS will likely contribute to the market's growth.
Based on the route of administration, the global growth hormone deficiency market is segmented into subcutaneous, intravenous, and intramuscular.
The subcutaneous segment owns the market and is expected to grow at a CAGR of 4.12% over the forecast period. The subcutaneous segment growth is increasing, leading to a significant rise in patient growth rates and a low incidence of antibody development. Most GHD drugs are administered through subcutaneous ROA (Route of Administration). For instance, brands such as Norditropin, Genotropin, Humatrope, Omnitrope, Nutropin, and Saizen are administered subcutaneously. These ROA injections are reported to be less painful and easier to self-administer. It is also the preferred ROA in children and adults, eventually using the easy-to-use pen-type delivery devices (e.g., Novo Nordisk Norditropin FlexPro Pen; Eli Lilly Humatrope Pen). Moreover, the subcutaneous route is highly preferred for chronic growth hormone therapy. These subcutaneous ROA advantages over other ROA propel this segment's growth.
The intramuscular route can give growth hormone therapy. Although the subcutaneous route of administration is preferred, many companies are developing growth hormone products administered through the intramuscular route. This factor is likely to contribute to the growth of this segment. For instance, Saizen [Somatotropin (rDNA) for injection] by Merck KGaA can be administered as an intramuscular or subcutaneous injection.
Based on distribution channels, the global growth hormone deficiency market is segmented into hospital pharmacies, retail pharmacies, online pharmacies, and specialty pharmacies. The hospital pharmacies segment is the highest contributor to the market and is expected to grow at a CAGR of 4.12% over the forecast period. Recombinant growth hormone is a prescription made available only with a prescription from a physician. Moreover, most hospitals have a policy that patients should buy medications that practitioners prescribe from their premises. Additionally, high investments by governments in developing advanced healthcare centers and hospitals in various countries contribute to the distribution of growth hormone medicines through hospital pharmacies.
The increasing number of clinics in developing regions and the growing number of clinicians are driving the growth of the clinics' segment. The development of the clinics' segment is mainly due to the growing preference and increasing number of diagnoses of growth hormone deficiencies in clinics. Additionally, clinics are equipped with the latest technology and provide necessary care, which increases their preference for the population.
Based on region, the global growth hormone deficiency market is divided into the Americas, Europe, Asia-Pacific, and the Middle East and Africa.
Americas is the most significant shareholder in the global growth hormone deficiency market and is anticipated to grow at a CAGR of 4.60% during the forecast period. The growth hormone deficiency market in the Americas is estimated to hold a significant share owing to the growing prevalence of growth hormone deficiency and Turner syndrome, the affordability of costly hormonal therapy, and a well-established healthcare sector. According to the data mentioned in the Human Growth Foundation, more than 50,000 adults in the US are growth hormone deficient, and 6,000 new cases are reported each year. Moreover, the rising government funding for the healthcare sector will likely propel the market's growth in this region.
Europe is estimated to grow at a CAGR of 4.52% over the forecast period. The European growth hormone deficiency market comprises Eastern Europe and Western Europe. Western Europe includes Germany, the UK, France, Italy, and Spain. The European market is expected to be the second-largest growth hormone deficiency market. The market growth in this region is attributed to the rising occurrences of growth hormone deficiencies, increasing preference for growth hormones in the treatment of idiopathic short stature (ISS), and rising government expenditure for the healthcare sector. According to the data suggested by the Eurostat, it is observed that among the EU member states, healthcare expenditure in France and Germany was equivalent to 11.3% of GDP in 2017, a larger share than in any other EU member state. The following highest ratio was observed in Sweden (11.0%).
Asia-Pacific is anticipated to be the fastest-growing market owing to the growing healthcare expenditure and a large patient pool. Growing investments by market players in the region due to the increasing demand are expected to contribute to the market's growth. For instance, in March 2017, Novo Nordisk initiated a phase 3 clinical trial of somapacitan (NNC0195-0092) for Adult Growth Hormone Deficiency (AGHD) in Japan. Additionally, the rising awareness about the efficiency of growth hormone therapy in short stature will likely increase the demand for growth hormone products in this region.
The Middle East and African market have increasing healthcare expenditures, rising investments by major market players, and a growing patient pool in this region. For instance, according to the International Trade Administration, health expenditure in the UAE was USD 17 billion in 2017 and is expected to reach USD 21.3 billion by 2021. The increasing prevalence of growth hormones will likely contribute to the market's growth. Furthermore, the prevalence of Turner syndrome in Saudi Arabia was 0.2 per 10,000 children in 2016, according to a National Center for Biotechnology Information (NCBI) study. The growth hormone deficiency market in Africa is expected to grow due to increasing disposable income, the development of healthcare infrastructure, and a growing patient pool. According to the Health Financing Profile: South Africa by the World Bank, in 2016, 48.3% of the total health expenditure was from the public sector, 49.8% from private sources, and 1.9% from donors.
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