Follow us on LinkedIn. – Demand for safer and effective human growth hormone drugs continues to increase, driven by the growing prevalence of pediatric and adult growth hormone deficiency (GHD) disorders and rare pediatric disorders linked with GH deficiency, such as Idiopathic Short Stature, Noonan Syndrome, Prader-Willi Syndrome, Turner Syndrome, Short Stature Homeobox Gene, Small for Gestational Age, Chronic Renal Insufficiency, and Short Bowel Syndrome. In addition, the high prevalence of HIV/AIDS in developed and developing countries is also buoying demand for hGH formulations to treat anorexia, fatigue, weakness, cachexia, and muscle atrophy.

Pediatric GHD continues to remain the main end-use indication for hGH drugs, while adult growth hormone deficiency still remains a largely untreated condition. The global somatropin market is dominated by daily-dose Sustained-Release hGH drugs (SRhGH), such as Genotropin, Humatrope, Norditropin, Nutropin/Nutropin AQ, Omnitrope, Saizen, and Tev-Tropin that are developed and marketed by a handful of major pharma companies.

Continuous development of next generation hGH products is critical for manufacturers of originator drugs, given the emergence of biosimilars and impending patent expiries. The biosimilar market is nascent and adoption is largely limited to new patients rather than the total prescribable market, since healthcare providers often refrain from switching drug regimens for existing patients already on treatment. The launch of biobetters or follow-on branded biologic drugs has played a critical role in restricting the penetration of biosimilars.

Longer-acting formulations are growing in popularity as a result of the increased focus on minimizing frequency of injections. Somatropin Biopartners, a recombinant human growth hormone (rhGH) drug developed jointly by LG Life Sciences and BioPartners GmbH, is the first of a new emerging line of long-acting hGH drugs with once-weekly or once-monthly dosage with the potential to alter the dynamics of the hGH market. New delivery methods, such as transdermal and oral are touted to be the next game changers in the hGH market. Besides creating a pathway for innovation and product differentiation, particularly in saturated markets such as Europe, the needleless injector devices and related disposables segment has emerged as a major revenue generator, complementing the gains realized through the sales of hGH drugs.

Despite the opportunities for growth, the market will confront challenges manifested in the form of complexities involved in drug delivery, high cost of hGH therapy, difficulty in securing reimbursement, and limited pharmacological differentiation among formulations currently available in the market. In addition, the impending emergence of new biosimilars and generics with discounted prices will also threaten sales of hGH drugs in the near term. The proliferation of off-label and non-therapeutic use of hGH drugs for sports performance enhancement and anti-ageing treatment, is also emerging as a major concern for health authorities across the globe.

As stated by the new market research report on Human Growth Hormone Drugs, the United States represents the single largest market worldwide. Asia-Pacific ranks as the fastest growing market with a CAGR of 4.4% over the analysis period, fuelled by macro factors such as population growth, increased healthcare spending, favorable regulatory scenario, and increasing accessibility and affordability of hGH drugs and therapies.

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