Major players in the biosimilar hormones market are Teva Pharmaceutical, Gedeon Richter, Intas Pharmaceuticals, Biocon, Mylan, Sanofi, Sandoz (Novartis), LG Life Sciences, Ferring Pharmaceuticals and GC Pharma.
The global biosimilar hormones market is expected to decline from $2.05 billion in 2019 to $1.94 billion in 2020 at a compound annual growth rate (CAGR) of -5.18%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $4.10 billion in 2023 at a CAGR of 28.34%.
The biosimilar hormones market consists of sales of biosimilar hormones by entities that engage in manufacturing biosimilar hormones. These hormones are used when patients have a drop in hormones in their bodies or are unbalanced. Only goods and services traded between entities or sold to end consumers are included.
In March 2018, BRAIN AG, a technology company in the field of industrial biotechnology, developing microorganisms, natural substances and enzymes for industrial use, acquired Biocatalysts for an undisclosed amount. The strategic acquisition of a majority stake in Biocatalysts is intended to accelerate product-driven growth in the fast-growing specialty enzyme market and broaden the portfolio of the enzyme business of BRAIN. Biocatalysts is a US-based biotechnology company focused on the development, production and distribution of specialty enzymes for various industries such as food and fine chemicals.
The biosimilar hormones market covered in this report is segmented by type into teriparatide biosimilars; follitropin alfa biosimilars; insulin biosimilars; somatropin biosimilars; others and by application into research & biotechnology; diagnostics; biocatalysts; therapeutics; others.
Stringent regulations imposed on the approval of hormone biosimilars limits the growth of the biosimilar hormones market. Biosimilars are approved on the same standard of pharmaceutical quality, efficacy, and safety that apply to all biologics approved in the European Union. There should be a similarity between the biologics and biosimilars, and as the process of manufacturing differs, the approval process becomes expensive and likely hinders the growth of the biosimilar hormones market.
Key players operating in the biosimilar hormones market are undertaking various strategic initiatives such as new product launch in untapped regions to make the drug accessible to a large population. The companies are focusing on launching their products across various locations to boost sales and maximize profits. For instance, in October 2019, Biocon Biologics and Mylan N.V. announced the launch of biosimilar hormones in Australia to treat the polygenic disorder.
The prevalence of deficiencies in growth hormones and metabolic hormones contributes to the market. The treatments required for hormone-related conditions are evolving over the years and the prevalence of hormonal deficiencies is generating higher demand for the hormone biosimilars market. For instance, according to the Italian Journal of Pediatrics, the prevalence of growth hormone deficiency (GHD) in childhood widely varies between 1 out of 3480 and 1 out of 30,000 children annually. In children, the growth hormone can influence bone mineralization and lead to several metabolic effects, including glucose and lipid homeostasis. Annually, about 6,000 adults are diagnosed with growth hormone (GH) deficiency in the USA. The growing need to treat patients with prevailing hormonal deficiencies drives the biosimilar hormones market.
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