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(Albany, US), October 24, 2026 – DelveInsight’s “Immune Thrombocytopenic Purpura (ITP) Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of ITP, historical and forecasted epidemiology, as well as the ITP market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Immune Thrombocytopenic Purpura Market Report

• The total market size in the 7MM for ITP was estimated to be nearly USD 3,800 million in 2024, which is expected to grow with a significant CAGR during the forecast period.

• In 2024, the US accounted for the maximum share of the total market in the 7MM, i.e., approximately 66%.

• The total market size of ITP in Japan was nearly USD 200 million in 2024, which is expected to increase by 2034.

• In 2024, the total cases of ITP were approximately 186,000 in the 7MM, which is expected to increase by 2034 during the forecast period.

• In the current market, the majority of the share was accounted for by Thrombopoietin Receptor Agonists (TPO-RAs) in 2024. NPLATE/ROMIPLATE captured the highest market size in the 7MM, followed by PROMACTA/REVOLADE.

• Primary ITP, with no underlying condition, accounts for 80% of cases, while secondary ITP, linked to factors such as Systemic Lupus Erythematosus (SLE), drugs, Hepatitis C, HIV, Helicobacter pylori, and chronic lymphocytic leukemia, makes up the remaining 20%.

• There is a strong demand for disease-modifying therapies in ITP that offer sustained responses post-treatment, and targeting BAFF-R presents a promising therapeutic approach given the key role of autoreactive B cells in the disease.

• The leading Immune Thrombocytopenic Purpura Companies include Rigel Pharmaceuticals, Kissei Pharmaceutical, Grifols, Sobi (Dova Pharmaceuticals), Asahi Kasei Pharma, Amgen, Argenx, Novartis, Sanofi/Principia Biopharma, Takeda (Millennium Pharmaceuticals), Pfizer, Genosco, Oscotec, and others.

• Promising Immune Thrombocytopenic Purpura Therapies include Rilzabrutinib (PRN-1008), Ianalumab (VAY736), Mezagitamab (TAK-079), PF-06835375, Cevidoplenib (SKI-O-703), and others.

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Immune Thrombocytopenic Purpura Overview

Immune thrombocytopenic purpura (ITP) is an acquired immune-mediated disorder characterized by isolated thrombocytopenia and the absence of other conditions or agents known to induce thrombocytopenia. The incidence is 100 cases per 1 million persons annually, and approximately 50% of cases occur in children. ITP in children often resolves spontaneously but is more insidious and chronic in adults. ITP can be acute or chronic: acute ITP is the most common form and usually affects children between 2 and 6 years old, while chronic ITP affects persons of any age, most often women, and lasts for at least 6 months. The risk of bleeding correlates with the severity of thrombocytopenia, and patients may present without symptoms, with minimal bleeding, or with serious haemorrhage. A careful history, physical examination, CBC, and review of the blood smear make a presumptive diagnosis of ITP, while response to initial treatment with corticosteroids, intravenous immunoglobulin (IVIg), or anti-RhD supports the diagnosis. Additional investigation is necessary to exclude secondary ITP and to assist with patient management.

Immune Thrombocytopenic Purpura Epidemiology Segmentation in the 7MM

Total Prevalent Cases of Immune Thrombocytopenic Purpura

Age-specific Diagnosed Prevalent Cases of Immune Thrombocytopenic Purpura

Gender-specific Diagnosed Prevalent Cases of Immune Thrombocytopenic Purpura

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Immune Thrombocytopenic Purpura Epidemiology Key Findings

Among the 7MM, the United States accounted for the highest prevalent cases of ITP compared to EU4, the UK, and Japan.

Among EU4 and the UK, the highest number of ITP cases was found in Germany, at around 19,000 cases in 2024, whereas Spain accounted for the fewest cases.

ITP is more prevalent in females, with a notably higher prevalence compared to males.

Patients with ITP are typically diagnosed as adults as compared to children.

Approved Therapies for Immune Thrombocytopenic Purpura

Current treatment options for ITP include thrombopoietin receptor agonists (PROMACTA, NPLATE, and DOPTELET), anti-CD20 antibodies (RITUXAN), Syk inhibitors (TAVALISSE/TAVLESSE), neonatal Fc receptor inhibitors (VYVGART), and various immunomodulatory agents.

• TAVALISSE/TAVLESSE (fostamatinib disodium hexahydrate): Rigel Pharmaceuticals, Kissei Pharmaceutical and Grifols

TAVALISSE is an orally bioavailable agent developed by Rigel Pharmaceuticals and approved for treating patients with persistent/chronic adult ITP. It inhibits FcR-triggered, Syk-dependent cytoskeletal rearrangement during phagocytosis, and has a unique mechanism of action, blocking IgG receptor signaling in both macrophages and B-cells via SYK kinase. TAVALISSE was approved by the US FDA in April 2018 for thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to previous treatment. It gained European approval in January 2020, launching in Germany and the UK by July 2020, and in Japan, the MHLW approved it in December 2022, with market launch in April 2023.

• DOPTELET (avatrombopag): Sobi (Dova Pharmaceuticals) and Asahi Kasei Pharma

DOPTELET is an orally administered thrombopoietin receptor agonist that mimics the biological effects of thrombopoietin in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count. It received FDA approval in June 2019 and EMA approval in January 2021 for treating chronic ITP in adults unresponsive to other therapies, and is currently the subject of a Phase III clinical study in Japan by Sobi.

Immune Thrombocytopenic Purpura Pipeline Analysis

• Rilzabrutinib (PRN-1008): Sanofi/Principia Biopharma

Rilzabrutinib is an orally administered reversible covalent inhibitor of BTK, being developed for adults and adolescents with persistent or chronic ITP. In April 2024, the company announced positive results from the LUNA 3 Phase III study, in which Rilzabrutinib 400 mg twice daily achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic immune thrombocytopenia. The drug is under regulatory review in the US, the EU, and China for ITP, and was granted fast track designation for ITP by the FDA.

• Ianalumab (VAY736): Novartis

Ianalumab is a novel, fully human immunoglobulin G1 monoclonal antibody that targets the BAFF receptor, with a unique dual mechanism of action: direct antibody-dependent cellular cytotoxicity-mediated B-cell depletion and inhibition of B-cell differentiation, proliferation, and survival via blockade of BAFF-R-mediated signaling. It is currently in Phase III clinical development for 1st and 2nd line treatment of ITP, and Novartis anticipates submission in 1st and 2nd line ITP in 2027.

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Immune Thrombocytopenic Purpura Market Outlook

Corticosteroids are the primary first-line treatment for ITP, often combined with IVIg or anti-Rh(D) to boost platelet counts in urgent cases. However, durable remissions are rare, and steroid-related side effects usually limit their use to about four weeks, leading many patients to progress to persistent or chronic ITP. Long-term management typically involves cycling through various treatments, including splenectomy, TPO-RAs, and immunosuppressants like rituximab, with no clear consensus on treatment sequencing. The ITP market is positioned for substantial growth, driven by the introduction of novel therapies, including biologics, small molecules, and targeted treatments. Factors such as increased awareness, enhanced diagnostic capabilities, and a broader range of treatment options are propelling market expansion. New therapeutic classes, including BTK inhibitors, BAFF-R inhibitors, anti-CD38 antibodies, CXCR5 antagonists, and BAFF/APRIL antagonists, are showing strong potential. The total market size is anticipated to grow by 2034, driven by extensive market penetration of approved therapies due to label expansions and the entry of new emerging therapies. Among EU4 and the UK, the UK held the highest market share, at nearly 30% in 2024.

Immune Thrombocytopenic Purpura Treatment Landscape

The main goal of ITP treatment is to prevent death and disability caused by bleeding. Mild cases may not need treatment, as a normal platelet count is unnecessary to prevent bleeding. Current guidelines recommend treatment initiation for platelet counts below 20–30 × 10⁹/L, regardless of bleeding, while for counts between 20–30 × 10⁹/L and 50 × 10⁹/L, treatment is typically not advised unless specific situations arise, such as bleeding, surgery, or the need for antiplatelet or anticoagulant therapy. For many years, corticosteroids, immunoglobulins (IVIg), splenectomy, and rituximab were the mainstays of treatment. Splenectomy remains the only treatment that reliably provides long-term remission, and NPLATE and PROMACTA were both approved in 2008 as the first TPO-RAs for chronic ITP.

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Scope of the Immune Thrombocytopenic Purpura Market Report

• Coverage- 7MM

• Study Period- 2020-2034

• Forecast Period- 2025-2034

• Immune Thrombocytopenic Purpura Companies- Rigel Pharmaceuticals, Kissei Pharmaceutical, Grifols, Sobi (Dova Pharmaceuticals), Asahi Kasei Pharma, Amgen, Argenx, Novartis, Sanofi/Principia Biopharma, Takeda (Millennium Pharmaceuticals), Pfizer, Genosco, Oscotec, and others.

• Immune Thrombocytopenic Purpura Therapies- Rilzabrutinib (PRN-1008), Ianalumab (VAY736), Mezagitamab (TAK-079), PF-06835375, Cevidoplenib (SKI-O-703), and others.

• Immune Thrombocytopenic Purpura Market Dynamics: Immune Thrombocytopenic Purpura market drivers and market barriers

• Immune Thrombocytopenic Purpura Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis

• Immune Thrombocytopenic Purpura Unmet Needs, KOL Views, Reimbursement

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Immune Thrombocytopenic Purpura (ITP) Market Overview at a Glance

7. Disease Background and Overview

8. Epidemiology and Patient Population

9. Patient Journey

10. Marketed Products

11. Emerging Therapies

12. ITP Seven Major Market Analysis

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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