Immune Thrombocytopenic Purpura Market to Grow at a Paltry CAGR of 1.9% During the Forecast Period (2025–2034) | DelveInsight
The recent approval of Sanofi’s WAYRILZ has shifted the dynamics of the immune thrombocytopenic purpura market. This approval has also led to competition among other companies, such as Principia Biopharma, Novartis, Takeda (Millennium Pharmaceutical), Pfizer, Genosco, and Oscotec, who are currently working on their lead assets to capture a significant share of the immune thrombocytopenic purpura market expansion.
New York, USA, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Immune Thrombocytopenic Purpura Market to Grow at a Paltry CAGR of 1.9% During the Forecast Period (2025–2034) | DelveInsight
The recent approval of Sanofi’s WAYRILZ has shifted the dynamics of the immune thrombocytopenic purpura market. This approval has also led to competition among other companies, such as Principia Biopharma, Novartis, Takeda (Millennium Pharmaceutical), Pfizer, Genosco, and Oscotec, who are currently working on their lead assets to capture a significant share of the immune thrombocytopenic purpura market expansion.
DelveInsight’s Immune Thrombocytopenic Purpura Market Insights report includes a comprehensive understanding of current treatment practices, emerging immune thrombocytopenic purpura drugs, market share of individual therapies, and current and forecasted immune thrombocytopenic purpura market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
Immune Thrombocytopenic Purpura Market Summary
- In August 2025, Sanofi’s WAYRILZ secures US approval as the first BTK inhibitor for treating immune thrombocytopenia.
- The market size for immune thrombocytopenic purpura was found to be USD 3.8 billion in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan] in 2024.
- The United States accounts for the largest market size of immune thrombocytopenic purpura, i.e., 66%, in comparison to EU4 (Germany, Italy, France, and Spain), the UK, and Japan.
- In 2024, NPLATE/ROMIPLATE drugs captured the highest market size in the 7MM, followed by PROMACTA/ REVOLADE.
- In 2024, the total cases of ITP were approximately 186K cases in the 7MM, which is expected to increase by 2034 during the forecast period.
- Key immune thrombocytopenic purpura companies, including Novartis, Takeda (Millennium Pharmaceutical), Pfizer, Genosco, Oscotec, and others, are actively working on innovative immune thrombocytopenic purpura drugs.
- Some of the key immune thrombocytopenic purpura therapies in clinical trials include Ianalumab (VAY736), Mezagitamab (TAK-079), PF-06835375, Cevidoplenib, and others. These novel immune thrombocytopenic purpura therapies are anticipated to enter the immune thrombocytopenic purpura market in the forecast period and are expected to change the market.
Discover which immune thrombocytopenic purpura medications are expected to grab the market share @ Immune Thrombocytopenic Purpura Market Report
Key Factors Driving the Growth of the Immune Thrombocytopenic Purpura Market
Approval of Sanofi’s WAYRILZ
Sanofi’s WAYRILZ (rilzabrutinib) has achieved a significant regulatory milestone, becoming the first FDA-approved BTK inhibitor for immune thrombocytopenia. The approval is supported by results from the Phase III LUNA trial (NCT04562766), which showed a rapid and sustained platelet response along with improvements in other ITP symptoms.
Growing Immune Thrombocytopenic Purpura Diagnosed Patient Pool
The diagnosed patient pool for ITP is expected to grow from 186K cases in the leading markets (the US, EU4, UK, and Japan) in 2024 due to improved disease awareness, better diagnostic techniques, and expanded access to healthcare. Rising adoption of advanced platelet count monitoring and differential diagnosis is leading to earlier and more accurate identification of cases.
Immune Thrombocytopenic Purpura Competitive Landscape
With WAYRILZ’s approval, competition to secure a strong foothold in the ITP market has intensified. Key companies such as Novartis (Ianalumab), Takeda (Mezagitamab), Pfizer (PF-06835375), Genosco/Oscotec (Cevidoplenib), and others are actively working on their lead candidates.
Emergence of New Drug Classes in the ITP Market
The introduction and clinical adoption of novel modalities, such as BAFF-R inhibitor (Novartis’ Ianalumab), CXCR5 antagonist (Pfizer’s PF-06835375), Anti-CD38 (Takeda’s Mezagitamab), and others, are also fueling the growth of the immune thrombocytopenic purpura market.
How will Sanofi’s WAYRILZ approval impact the ITP Market?
Sanofi’s US FDA approval of WAYRILZ (rilzabrutinib) marks a pivotal moment in the immune thrombocytopenia market, as it becomes the first Bruton’s tyrosine kinase (BTK) inhibitor cleared for this indication. Based on the pivotal LUNA 3 Phase III trial, Wayrilz delivered a statistically significant, durable platelet response, 23% at week 25 versus 0% for placebo, along with faster onset (median 36 days) and longer duration of response (around 7 weeks versus 0.7 weeks). Beyond these clinical endpoints, patients reported improvements in quality of life measures. Taken together, these results suggest that Wayrilz offers a more targeted and sustained therapeutic option for adult ITP patients who have not responded to existing treatments.
From a market perspective, the introduction of a first-in-class oral BTK inhibitor substantially enhances the ITP treatment ecosystem. With an estimated U.S. prevalence of 66K patients across the seven major markets, WAYRILZ stands to become a key growth driver in a market that historically lacked durable therapeutic options. Priced at $17,500 per month, the drug reflects typical orphan drug economics and positions itself as a potential blockbuster. Additionally, WAYRILZ’s multiple orphan drug designations, including for ITP, warm autoimmune hemolytic anemia, IgG4-related disease, and sickle cell disease, offer Sanofi up to 14 years of US market exclusivity and pave the way for future expansion into other rare immunologic conditions
Learn more about the WAYRILZ market potential @ Immune Thrombocytopenic Purpura Treatment Market
Immune Thrombocytopenic Purpura Competitive Landscape
The potential ITP therapies that can mark a significant change during the forecast period include Ianalumab (Novartis), Mezagitamab (Takeda), PF-06835375 (Pfizer), Cevidoplenib (Genosco/Oscotec), and others, which are being evaluated in the advanced stage of clinical development.
Novartis’ Ianalumab is a novel, fully human IgG1 monoclonal antibody that binds to the BAFF receptor and works through a dual mechanism: inducing B-cell depletion via antibody-dependent cellular cytotoxicity and suppressing B-cell differentiation, proliferation, and survival by blocking BAFF-R signaling. It is currently being evaluated in Phase III clinical trials as both a first- and second-line therapy for ITP.
In Novartis’ Q2 2025 update, the company highlighted two key trials: NCT05653349 (VAYHIT1) for first-line treatment, with results expected in 2026, and NCT05653219 (VAYHIT2) for second-line therapy, anticipated in 2025. Regulatory submission for ianalumab in first- and second-line ITP is projected for 2027.
Takeda’s Mezagitamab is another fully human IgG1 monoclonal antibody that selectively targets CD38-expressing cells, including plasmablasts, plasma cells, and natural killer cells, leading to their depletion. Its mechanism is intended to provide rapid, durable improvements in platelet response and restore platelet counts to functional ranges.
The U.S. FDA has granted mezagitamab Orphan Drug Designation for ITP and Fast Track Designation for chronic or persistent ITP. It remains an investigational therapy and has not yet been approved by any regulatory authority.
The anticipated launch of these emerging immune thrombocytopenic purpura therapies are poised to transform the immune thrombocytopenic purpura market landscape in the coming years. As these cutting-edge immune thrombocytopenic purpura therapies continue to mature and gain regulatory approval, they are expected to reshape the immune thrombocytopenic purpura market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about new treatment for immune thrombocytopenic purpura, visit @ Immune Thrombocytopenic Purpura Management
Recent Developments in the Immune Thrombocytopenic Purpura Market
- In August 2025, the FDA granted approval to WAYRILZ (rilzabrutinib) for use in adults with chronic or persistent immune thrombocytopenia (ITP) who did not respond adequately to prior therapy.
- In July 2025, Sobi announced that the US Food and Drug Administration (FDA) has approved DOPTELET (avatrombopag) for the treatment of thrombocytopenia in pediatric patients aged one year and older with persistent or chronic ITP who have had an insufficient response to prior therapy.
- In June 2025, Novartis presented an oral abstract (Abstract #S312) of Phase II results from the VAYHIT3 study, evaluating Ianalumab in patients with primary ITP previously treated with at least two lines of therapy.
What is Immune Thrombocytopenic Purpura?
Immune thrombocytopenic purpura (ITP) is an acquired, immune-driven disorder marked by isolated thrombocytopenia without any identifiable underlying conditions or external causes. Its annual incidence is about 100 cases per million people, with nearly half occurring in children. While pediatric ITP often resolves on its own, in adults, it tends to follow a more persistent and chronic course. The likelihood of bleeding is directly linked to the degree of thrombocytopenia. Clinical presentation ranges from being asymptomatic or having minor bleeding to experiencing severe hemorrhages, such as mucosal, intracranial, gastrointestinal, or genitourinary bleeding. Severe bleeding is more common among older individuals, those on antiplatelet therapy, and patients with additional comorbidities.
Immune Thrombocytopenic Purpura Epidemiology Segmentation
The immune thrombocytopenic purpura market forecast is derived using patient-based forecasts and analysis. The report offers in-depth analysis of the historical and current immune thrombocytopenic purpura patient pool and forecasted trends for the leading markets (the US, EU4, UK, and Japan). It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The immune thrombocytopenic purpura market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets (the US, EU4, UK, and Japan) segmented into:
- Total Prevalent Cases of ITP
- Age-specific Diagnosed Prevalent Cases of ITP
- Gender-specific Diagnosed Prevalent Cases of ITP
Download the report to understand which factors are driving immune thrombocytopenic purpura epidemiology trends @ Immune Thrombocytopenic Purpura Treatment Algorithm
| Immune Thrombocytopenic Purpura Market Report Metrics | Details |
| Study Period | 2020–2034 |
| Immune Thrombocytopenic Purpura Market Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Immune Thrombocytopenic Purpura Market CAGR | 1.9% |
| Immune Thrombocytopenic Purpura Market Size in 2024 | USD 3.8 Billion |
| Key Immune Thrombocytopenic Purpura Companies | Sanofi, Principia Biopharma, Novartis, Takeda (Millennium Pharmaceutical), Pfizer, Genosco, Oscotec, Rigel Pharmaceuticals, Kissei Pharmaceutical, Grifols, Sobi (Dova Pharmaceuticals), Asahi Kasei Pharma, Amgen, Argenx, Zenyaku Kogyo, Chugai Pharmaceutical, and others |
| Key Immune Thrombocytopenic Purpura Therapies | Ianalumab (VAY736), Mezagitamab (TAK-079), PF-06835375, Cevidoplenib, TAVALISSE/TAVLESSE, DOPTELET, NPLATE/ROMIPLATE, VYVGART, RITUXAN, WAYRILZ, and others |
Scope of the Immune Thrombocytopenic Purpura Market Report
- Immune Thrombocytopenic Purpura Therapeutic Assessment: Immune Thrombocytopenic Purpura current marketed and emerging therapies
- Immune Thrombocytopenic Purpura Market Dynamics: Conjoint Analysis of Emerging Immune Thrombocytopenic Purpura Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Immune Thrombocytopenic Purpura Market Unmet Needs, KOL’s views, Analyst’s views, Immune Thrombocytopenic Purpura Market Access and Reimbursement
Discover more about immune thrombocytopenic purpura drugs in development @ Immune Thrombocytopenic Purpura Clinical Trials
Table of Contents
| 1 | Immune Thrombocytopenic Purpura Market Key Insights |
| 2 | Immune Thrombocytopenic Purpura Market Report Introduction |
| 3 | Executive Summary |
| 4 | Key Events |
| 5 | Immune Thrombocytopenic Purpura Epidemiology and Market Forecast Methodology |
| 6 | Immune Thrombocytopenic Purpura Market Overview at a Glance |
| 6.1 | Market Landscape Analysis |
| 6.2 | Emerging Landscape Analysis (By Phase, RoA, and Molecule Type) |
| 6.3 | Market Share (%) Distribution of ITP by Therapies in 2020 |
| 6.4 | Market Share (%) Distribution of ITP by Therapies in 2034 |
| 6.5 | Market Share (%) Distribution of ITP by Class in 2020 |
| 6.6 | Market Share (%) Distribution of ITP by Class in 2034 |
| 7 | Disease Background and Overview |
| 7.1 | Introduction |
| 7.2 | Immune Thrombocytopenic Purpura Signs and symptoms |
| 7.3 | Immune Thrombocytopenic Purpura Pathogenesis |
| 7.4 | Immune Thrombocytopenic Purpura Classification |
| 7.5 | Immune Thrombocytopenic Purpura Causes |
| 7.6 | Immune Thrombocytopenic Purpura Diagnosis |
| 7.7 | Immune Thrombocytopenic Purpura Treatment and Management |
| 8 | Epidemiology and Patient Population |
| 8.1 | Key Findings |
| 8.2 | Assumptions and Rationale:7MM |
| 8.2.1 | The United States |
| 8.2.2 | EU4 and the UK |
| 8.2.3 | Japan |
| 8.3 | Epidemiology Scenario: 7MM |
| 8.4 | Total Prevalent Cases of ITP in the 7MM |
| 8.5 | The United States |
| 8.5.1 | Total Prevalent Cases of ITP in the US |
| 8.5.2 | Age-specific Diagnosed Prevalent Cases of ITP in the US |
| 8.5.3 | Gender-specific Diagnosed Prevalent Cases of ITP in the US |
| 8.6 | EU4 and the UK |
| 8.7 | Japan |
| 9 | Immune Thrombocytopenic Purpura Patient Journey |
| 10 | Marketed Immune Thrombocytopenic Purpura Drugs |
| 10.1 | Key Cross of Immune Thrombocytopenic Purpura Marketed Drug |
| 10.2 | TAVALISSE/TAVLESSE (fostamatinib disodium hexahydrate): Rigel Pharmaceuticals, Kissei Pharmaceutical and Grifols |
| 10.2.1 | Product Description |
| 10.2.2 | Regulatory Milestones |
| 10.2.3 | Other Developmental Activity |
| 10.2.4 | Clinical Developmental Activities |
| 10.2.5 | Analyst Views |
| 10.3 | DOPTELET (avatrombopag): Sobi (Dova Pharmaceuticals) and Asahi Kasei Pharma |
| 10.4 | NPLATE/ROMIPLATE (romiplostim, AMG-531): Amgen |
| 10.5 | PROMACTA/REVOLADE (eltrombopag): Novartis |
| 10.6 | VYVGART (efgartigimod alfa-fcab, ARGX-113): Argenx |
| 10.7 | YIMMUGO (BT-595): Grifols (Biotest) |
| 11 | Emerging Immune Thrombocytopenic Purpura Therapies |
| 11.1 | Key Cross Competition |
| 11.2 | Rilzabrutinib (PRN-1008): Sanofi/Principia Biopharma |
| 11.2.1 | Product Description |
| 11.2.2 | Other Developmental Activities |
| 11.2.3 | Clinical Development |
| 11.2.4 | Clinical Trial Information |
| 11.2.5 | Analyst Views |
| 11.3 | VAY736 (lanalumab): Novartis |
| 11.4 | TAK-079 (mezagitamab): Takeda (Millennium Pharmaceuticals) |
| 11.5 | PF-06835375: Pfizer |
| 11.6 | Cevidoplenib (SKI-O-703): Genosco (Oscotec) |
| 11.7 | RYSTIGGO (rozanolixizumab, UCB7665): UCB Biopharma and Parexel International |
| 12 | Immune Thrombocytopenic Purpura Market: 7MM Analysis |
| 12.1 | Key Findings |
| 12.2 | Immune Thrombocytopenic Purpura Market Outlook |
| 12.3 | Key Immune Thrombocytopenic Purpura Market Forecast Assumptions |
| 12.4 | Conjoint Analysis |
| 12.5 | Total Market Size of ITP in the 7MM |
| 12.6 | Market Size of ITP by Class in the 7MM |
| 12.7 | The United States Immune Thrombocytopenic Purpura Market Size |
| 12.7.1 | Total Market Size of ITP in the US |
| 12.7.2 | Total Market Size of ITP by Therapies in the US |
| 12.7.3 | Total Market Size of ITP by Class in the US |
| 12.8 | EU4 and the UK Immune Thrombocytopenic Purpura Market Size |
| 12.9 | Japan Immune Thrombocytopenic Purpura Market Size |
| 13 | Immune Thrombocytopenic Purpura Market Unmet Needs |
| 14 | Immune Thrombocytopenic Purpura Market SWOT Analysis |
| 15 | KOL Views on Immune Thrombocytopenic Purpura |
| 16 | Immune Thrombocytopenic Purpura Market Access and Reimbursement |
| 16.1 | United States |
| 16.2 | EU4 and the UK |
| 16.3 | Japan |
| 16.4 | Market Access and Reimbursement of ITP |
| 17 | Bibliography |
| 18 | Immune Thrombocytopenic Purpura Market Report Methodology |
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