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Acromegaly and gigantism are rare disorders of the pituitary gland characterized by the hypersecretion of growth hormone (GH). This GH excess is often a result of a benign GH-secreting pituitary adenoma. Rarely, tumors in other organs can secrete growth hormone-releasing hormone (GHRH), leading to elevation in GH levels in the serum. This triggers the release of anti-apoptotic and mitogenic peptide hormone, insulin-like growth factor 1 (IGF-1). While both acromegaly and gigantism are complications of uncontrolled GH levels, the presentation of the two hormonal diseases is very different. GH excess beginning in adulthood is known as acromegaly and is characterized by an insidious onset and a delayed diagnosis, whereas GH excess beginning during childhood is known as gigantism and is characterized by a dramatic acceleration of growth, leading to an unusually tall stature.
Symptoms of acromegaly and gigantism include the development of abnormally large hands and feet, an enlarged tongue, hyperhidrosis, joint pain, tiredness, and headaches. Surgery to remove the pituitary tumor is often offered to patients with acromegaly or gigantism. Pharmacotherapeutic approaches may be employed to increase the efficacy of surgery, or as a monotherapeutic strategy in cases where surgical procedures are not appropriate for the patient. Somatostatin is a cyclic polypeptide hormone that inhibits the secretion of a number of hormones, including that of GH. First-line pharmaceutical products used to treat acromegaly and gigantism are typically somatostatin analogs (SSAs) because the natural version of the hormone has a very short half-life and cannot bring about sustained suppression of GH.
In 1988, Novartis’ Sandostatin, became the first SSA to be approved by the FDA. The therapy, which is injected up to four times daily marked the advent of a new effort by drug developers to produce products that are administered less frequently. Since then, the SSA drug class has expanded to include therapies such as Novartis’ Sandostatin LAR (long-acting repeatable) Depot (octreotide acetate for injectable suspension), Novartis’ Signifor LAR (pasireotide), and Ipsen’s Somatuline (lanreotide acetate) Depot which are all injected on a monthly basis. Although SSAs dominate the treatment landscape, Pfizer’s GH inhibitor Somavert (pegvisomant) and dopamine agonists, bromocriptine mesylate and cabergoline have also penetrated the market and are used in combination with first-line drugs.
The seven pharmaceutical markets (7MM) covered in this report and forecast model are the US, France, Germany, Italy, Spain, the UK, and Canada. GlobalData estimates that drug sales for acromegaly and gigantism in 2019 were approximately $1.4B across the 7MM. Over the 10-year forecast period, the market is expected to reach $2.2B in 2029, increasing at a CAGR of 4.4%. Growth in the market will be driven by the launch of longer-acting somatostatin analogs, oral therapies, and growth hormone receptor inhibitors, which are used in combination with first-line drugs to provide an effective treatment option for patients with intractable disease.
- The acromegaly and gigantism market was worth $1.4B in 2019. The market is expected to grow at a CAGR of 4.4% from 2019 to 2029, reaching a global value of $2.2B. GlobalData projects that the marketed for acromegaly and gigantism will experience growth driven by the launch of oral therapies, injectable somatostatin analogs that are administered less frequently than the market-leading product, which is Novartis’ Sandostatin LAR Depot.
- Low disease awareness and delayed diagnosis is the most significant unmet need in this therapy area. Lack of physician and patient education means that a large percentage of patients treat the symptoms of these conditions without being able to address the cause of the endocrinological abnormalities for many years. Additionally, more patients are expected to undergo surgery which effectively cures the disease in patients whose pituitary tumors can be successfully excised. Market exclusivity for major brands such as Novartis’ Signifor (pasireotide) and Ipsen’s Somatuline Depot (lanreotide acetate), will also be lost during the forecast window, which will allow competitor drug developers to consider producing generic formulations of these market-dominating somatostatin analogs.
- No drugs are being specifically developed for gigantism which means that some pipeline agents will not benefit from being used to treat pediatric patients. Oral therapies such as Chiasma’s Mycapssa (octreotide acetate) and Crinetics’ paltusotine are expected to be used to treat younger patients who may not be candidates for surgery or intramuscular injections. For this reason, and the fact that both of these drugs will launch in multiple markets, Mycapssa and paltusotine are expected to become some of the top-selling therapeutics that will enter the acromegaly market between 2019 and 2029. Growth in the market will be driven by the launch of growth hormone receptor inhibitors. Only one marketed drug (Pfizer’s Somavert/pegvisomant) targets this signaling pathway. Although Pfizer’s Somavert is highly effective in inducing biochemical control of acromegaly, the high cost of therapy has led some regulatory bodies to restrict its use, denying a subset of patients from access to this treatment option. Antisense Therapeutics’ atesidorsen sodium, and Ionis Pharma’s IONIS-GHRLRx are growth hormone receptor inhibitors that are expected to be injected less frequently than Pfizer’s Somavert. Furthermore, these drug candidates represent a new molecule type entering the market within the forecast window, as no antisense therapies are currently available for the management of acromegaly and gigantism.
- A disadvantage of the market-leading drug, Sandostatin LAR, is that this therapy is injected via the intramuscular route of administration which is associated with pain and discomfort. Furthermore, patients typically receive injections in a clinical setting which is can be inconvenient for individuals who do not live within easy reach of their healthcare provider.
- Drug developers are also focusing on producing self-administrable therapies that can increase patients’ compliance. These therapeutics will reduce the need for patients to attend frequent hospital appointments in order to receive treatment.
- The top selling drug to enter the market in the forecast period will be Camurus’ octreotide LA, which is expected to become the first long-acting subcutaneously administrable formulation of octreotide. The largest pharmacotherapy market for acromegaly and gigantism in 2019 was the US, which made up 75% of sales in the base year of the forecast window. The dominance of this market will continue, as most patients with acromegaly in the 7MM are diagnosed and treated in the US. In 2029, the US will generate $1.6B.
Key Questions Answered
- What were the key treatments for acromegaly and gigantism 2019?
- When will the late stage pipeline products launch in each of the 7MM?
- What are the major clinical and environmental unmet needs in the acromegaly and gigantism market?
- What are the key opportunities for pharmaceutical companies developing drug candidates for acromegaly and gigantism?
- Overview of acromegaly and gigantism, including epidemiology, etiology, pathophysiology, symptoms, diagnosis of the diseases, and treatment strategies.
- Annualized acromegaly and gigantism therapeutics market revenue and sales forecast, including discussion of treatment usage patterns in individual patient populations.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the acromegaly and gigantism market.
- Pipeline analysis: comprehensive assessment of emerging trends, molecule types represented in the pipeline, and drug delivery systems being developed by pharmaceutical companies. All drug candidates at Phase II and Phase III stages of development are extensively profiled.
- Analysis of the current and future market competition, and an insightful review of the key market drivers, opportunities, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
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