Dublin, Dec. 02, 2024 (GLOBE NEWSWIRE) -- The "Immune Thrombocytopenia Market Insights, Epidemiology, and Market Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.
This report delivers an in-depth understanding of ITP, historical and forecasted epidemiology as well as ITP market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM ITP market size from 2020 to 2034. The report also covers current ITP treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Key Highlights
- The total market size in the 7MM for ITP was estimated to be nearly USD 4.10 billion in 2023, which is expected to grow with a significant CAGR during the forecast period.
- In 2023, the US accounted for the maximum share of the total market in the 7MM, i.e., approximately 66%.
- ITP is defined as a decrease in platelet count due to immune processes. Primary ITP, with no underlying condition, accounts for 80% of cases, while secondary ITP, linked to factors like Systemic Lupus Erythematosus (SLE), drugs, Hepatitis C, HIV, Helicobacter pylori, chronic lymphocytic leukemia, makes up the remaining 20%.
- For many years, immune-modulating therapies, such as corticosteroids, immunoglobulins (IVIg), splenectomy, and rituximab, were the mainstays of treatment in ITP.
- Splenectomy remains the only treatment that reliably provides long-term remission, with many patients achieving a year or more without therapy. It is a viable option for adults with ITP resistant to multiple treatments, as demonstrated by a recent French study showing a 46% sustained response rate in patients who failed TPO-RAs and rituximab, albeit slightly lower than historical rates from before the introduction of agonists.
- NPLATE and PROMACTA were both approved in 2008 as the first thrombopoietin receptor agonists (TPO-RAs) for treating chronic ITP, offering new options by directly stimulating platelet production.
- 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.
- VYVGART, recently approved in Japan for adults with Primary ITP, is poised to outperform competitors by delivering a superior sustained platelet response and maintaining a consistent safety profile, as demonstrated in the pivotal Phase III ADVANCE-IV trial.
- The emergence of new therapeutic classes in ITP is showing strong potential, including BTK inhibitors, anti-CD38 antibodies, CXCR5 antagonists, and BAFF/APRIL antagonists.
- There is a strong demand for disease-modifying therapies in ITP that offer sustained responses post-treatment. Since BAFF regulates B-cell differentiation and survival through BAFF-R, and autoreactive B cells play a key role in ITP, targeting BAFF-R presents a promising therapeutic approach.
- The ITP indication has a strong pipeline, with many companies actively developing ITP therapies. Key players include Sanofi/ Principia Biopharma, Novartis, GC Pharma, UCB Biopharma, Takeda (Millennium Pharmaceuticals), Pfizer, Genosco and Oscotec, Vertex/Alpine Immune Sciences, Sanofi/Bioverativ company, Roche/Chugai Pharmaceutical among others.
ITP Epidemiology
The ITP epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of ITP, age-specific diagnosed prevalent cases of ITP, and gender-specific diagnosed prevalent cases of ITP in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.
- The total number of prevalent cases of ITP in the 7MM was nearly 190,000 cases in 2023 and is projected to increase during the forecast period.
- In 2023, the diagnosed prevalent cases of ITP were highest in the US among the 7MM, with 67,000 cases.
- Among EU4 and the UK, the highest number of cases of ITP was found in the UK whereas Spain accounted for the lowest cases in 2023.
- ITP is more prevalent in females, with a notably higher prevalence compared to males.
- Patients with ITP are typically diagnosed in adults as compared to children.
ITP Drugs
The drug chapter segment of this ITP report encloses a detailed analysis of the marketed and the late, mid, and early stage (Phase III, Phase II, Phase I/II, and Phase I) pipeline drugs. The marketed drugs segment encloses drugs such as TAVALISSE/TAVLESSE (fostamatinib disodium hexahydrate), DOPTELET (avatrombopag), NPLATE/ROMIPLATE (romiplostim, AMG-531), VYVGART (efgartigimod alfa-fcab), and others. The current emerging key players and their respective drug candidates include Rilzabrutinib (Sanofi), Ianalumab (Novartis), Mezagitamab (Takeda), and others. The drug chapter also helps understand the ITP clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.
Marketed Drugs
- TAVALISSE/TAVLESSE (fostamatinib disodium hexahydrate): Rigel Pharmaceuticals, Kissei Pharmaceutical and Grifols
- DOPTELET (avatrombopag): Sobi (Dova Pharmaceuticals) and Asahi Kasei Pharma
Emerging Drugs
- Rilzabrutinib (PRN-1008): Sanofi/Principia Biopharma
- VAY736 (Ianalumab): Novartis
Drug Class Insights
The emergence of new therapeutic classes in ITP is showing strong potential, including BTK inhibitors, BAFF-R inhibitors, anti-CD38 antibodies, CXCR5 antagonists, and BAFF/APRIL antagonists. Currently, Takeda's Mezagitamab is the only anti-CD38 monoclonal antibody in clinical trials for ITP, with Phase II studies underway (NCT04278924).
ITP Market Outlook
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.
- The total market size in the US for ITP was estimated to be nearly USD 2.80 billion in 2023, which is expected to increase due to the launch of emerging therapies and the label expansion of current therapies.
- Among EU4 and the UK, the highest market share for ITP was found in the UK which was estimated to be nearly 30% of the market share in EU4 and the UK in 2023.
- The market share of Japan for ITP was estimated to be nearly USD 300 million in 2023.
- In 2023, NPLATE/ ROMIPLATE drugs captured the highest market size of approximately USD 1.70 billion in the 7MM, followed by PROMACTA/ REVOLADE.
Key Updates
- As per the news published in June 2024, Takeda anticipates initiating a Global Phase III trial of mezagitamab in ITP in the second half of 2024.
- As per the Biotest H1 half-year 2024 presentation published in August, the company launched YIMMUGO in the UK in 2024 for treating ITP.
- In March 2024, Asahi Kasei Pharma signed an agreement with Swedish Orphan Biovitrum Japan (Sobi Japan) granting it exclusive distribution rights for DOPTELET in Japan, specifically for the additional indication of ITP.
- In April 2024, Sanofi announced positive results from the LUNA 3 Phase III study demonstrating that rilzabrutinib 400 mg twice daily orally achieved the primary endpoint of durable platelet response in adult patients with persistent or chronic ITP.
- In April 2024, Vertex Pharmaceuticals Incorporated and Alpine Immune Sciences announced that the companies had entered into a definitive agreement under which Vertex acquired Alpine for USD 65 per share or approximately USD 4.9 billion in cash. The transaction was unanimously approved by both the Vertex and Alpine Boards of Directors and is anticipated to close later this quarter.
Reasons to Buy
- The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the ITP market.
- Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
- Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
- Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
- Detailed analysis and ranking of class-wise potential current and emerging therapies under the Analyst view section to provide visibility around leading classes.
- Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
- To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
- Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
For more information about this report visit https://www.researchandmarkets.com/r/rege5o
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
