The immune thrombocytopenia (ITP) market across the seven major countries of the US, France, Germany, Italy, Spain, the UK and Japan, is set to grow from $928 million in 2015 to $985 million by 2025, representing a very modest overall compound annual growth rate of 0.6%, according to research and consulting firm GlobalData.
The company’s latest report states that the ITP space will see reasonable growth at the beginning of the forecast period, reaching $1.16 billion by 2023.
This growth can be attributed to increasing uptake of Amgen’s Nplate (romiplostim) and Novartis’ Promacta/Revolade (eltrombopag), a rising diagnosed prevalence of adult ITP, and the launch of Rigel Pharmaceuticals’ fostamatinib, which will offer a new mechanism of action (MOA) for ITP treatment.
From 2023, however, market value will start declining because of the patent expiration and subsequent generic/biosimilar launch of Nplate, Promacta and Roche’s Rituxan/MabThera (rituximab). The declining treatment rate of paediatric ITP patients, and the stagnant treatment paradigm caused by a lack of late-stage pipeline activities are also the major barriers of market growth.
Fenix Leung, DPhil, Healthcare Analyst for GlobalData, explains: “Companies are looking into drugs with novel MOAs, which may help to improve response rate and safety. GlobalData identified two promising approaches: spleen tyrosine kinase inhibitors, including the Phase III fostamatinib, and CD40/CD40 ligand antagonists.”
“As Rigel has manged to complete two pivotal Phase III trials for fostamatinib, GlobalData expects drugs offering new MOAs to be essential for companies to successfully develop new ITP therapies moving forward.”
GlobalData has determined that the ITP market has a weak pipeline. Since the approval of Nplate and Promacta, there have been only two pipeline agents to reach Phase III development: avatrombopag and fostamatinib.
Avatrombopag has encountered difficulties in clinical trial participant recruitment, and GlobalData believes that its development in ITP has been halted. As a result, only fostamatinib is expected to launch during the forecast period.
Leung concludes: “Despite the harsh market environment, GlobalData sees ample opportunity for pharmaceutical companies to develop a drug for the 10% of ITP patients who are multiple refractory and do not respond to available therapies. Even though the eligible patient population is small, the unmet need for these patients is high, and a drug that works in multiple refractory patients is likely to command a premium price.”
“Ultimately, the ITP market is looking for curative therapies that offer long-term remission for patients, as current treatment options are either palliative or have a suboptimal response rate.”
“Key opinion leaders have expressed high interest in drugs that can demonstrate long-term remission within a definite period of treatment. If successfully developed, they are expected to enjoy high patient penetration and premium price.”