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PUBLISHER: DelveInsight | PRODUCT CODE: 1605426

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PUBLISHER: DelveInsight | PRODUCT CODE: 1605426

Immune Thrombocytopenia Market Insights, Epidemiology, and Market Forecast - 2034

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Key Highlights:

  • The total market size in the 7MM for ITP was estimated to be nearly USD 4,100 million 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.
  • Current guidelines recommend treatment initiation for platelet counts below 20-30 X 10?/L, regardless of bleeding. For counts between 20-30 X 10?/L and 50 X 10?/L, treatment is typically not advised unless specific situations arise, such as bleeding, surgery, or the need for antiplatelet or anticoagulant therapy.
  • 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.

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 ITP market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The ITP market 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.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

ITP Understanding and Treatment Algorithm

ITP 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. Immune thrombocytopenic purpura in children often resolves spontaneously but is more insidious and chronic in adults. The risk of bleeding correlates to the severity of thrombocytopenia. Patients may present without symptoms, minimal bleeding, or serious haemorrhage (e.g., mucosal, intracranial, gastrointestinal, genitourinary). Older patients, patients on antiplatelet therapy, and patients with comorbid conditions may have severe bleeding manifestations.

ITP can be acute or chronic. Acute ITP is the most common form of the disease and usually affects children between 2 and 6 years old. In these patients, symptoms can develop after a viral infection and disappear after a few weeks to 6 months. Chronic ITP affects persons of any age, most often women, and lasts for at least 6 months. This form of ITP can recur, so continuous medical monitoring is required.

ITP Diagnosis

A careful history, physical examination, CBC, and review of the blood smear make a presumptive diagnosis of ITP. Response to initial treatment with corticosteroids, intravenous immunoglobulin (IVIg), or anti-RhD supports the diagnosis and confirms the immune nature of thrombocytopenia. However, additional investigation is necessary to exclude secondary ITP and to provide additional information to assist with patient management.

Occasionally, a low platelet count may be detected incidentally by blood tests such as a CBC ordered for other purposes, and the individual is without apparent symptoms (asymptomatic). Inspection of the blood smear under the microscope will verify if the platelets are truly reduced in number and not simply clumped (stuck together, so they are too big to be counted by automated machines as platelets) and that the platelets are not uniformly small or exceeding large (giant platelets approximating the size of red blood cells). The red and white blood cells are normal in number and appear normal to the eye. This helps exclude consideration of leukemia and/or aplastic anemia, among other causes of thrombocytopenia. The presence of unusual cells in the blood or additional abnormalities in the blood counts might indicate the need for a bone marrow biopsy to exclude other causes of impaired platelet production and/or consideration of secondary ITP.

ITP Treatment

Treatment for thrombocytopenia depends on its cause and severity. The main goal of treatment is to prevent death and disability caused by bleeding.

If the condition is mild, the patient may not need treatment. A normal platelet count is unnecessary to prevent bleeding, even with severe cuts or accidents.

Thrombocytopenia often improves when its underlying cause is treated. People who inherit the condition do not usually need treatment. If a reaction to a medicine is causing a low platelet count, the doctor may prescribe another medicine. Most people recover after the initial medicine has been stopped. For heparin-induced thrombocytopenia (HIT), stopping the heparin is not enough. Often, the patients need another medicine to prevent blood clotting. If the immune system is causing a low platelet count, the doctor may prescribe medicines to suppress the immune system.

One treatment approach is to direct treatment to the etiology of thrombocytopenia (e.g., discontinuation of the drug that caused thrombocytopenia, treatment of the underlying infection, immunoglobulin G (IgG) replacement, chemotherapy directed at CLL). Unfortunately, only in a minority of cases is the etiology of thrombocytopenia clear and the cause found. In addition, in some cases, "curing" the underlying medical cause of the ITP may not change the platelet count. In the case of severe bleeding, if the etiology of thrombocytopenia is unknown but not thought to be immunologic, platelet transfusion can provide an immediate platelet increase. In contrast, if the underlying cause is immune, the effect from platelet transfusion may be minimal and, at best, very short-lived. It should be reserved for life-threatening bleeding (ideally transfused following intravenous immunoglobulin to "protect" the platelets).

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 Drug Chapters

The drug chapter segment of the 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

TAVALISSE is an orally bioavailable investigational agent developed by Rigel Pharmaceuticals and approved for treating patients suffering from persistent/chronic adult idiopathic thrombocytopenic purpura. The therapeutic candidate inhibits FcR-triggered, Syk-dependent cytoskeletal rearrangement during phagocytosis. As stated by Rigel Pharmaceuticals, fostamatinib 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 the treatment of 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. In Japan, the MHLW approved TAVALISSE in December 2022, with its 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. For the treatment of ITP, DOPTELET has been approved in the US, Europe, etc., and is currently the subject of a Phase III clinical study in Japan by Sobi. DOPTELET received FDA approval in June 2019 and EMA approval in January 2021 for treating chronic ITP in adults unresponsive to other therapies (e.g., corticosteroids and immunoglobulins). In the Q2 2024 report, Sobi announced plans for regulatory submission in Japan and pediatric submissions in the US and EU in the second half of 2024.

Emerging Drugs

Rilzabrutinib (PRN-1008): Sanofi/Principia Biopharma

Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- or best-in-class treatment of several immune-mediated diseases. BTK, expressed in B cells, mast cells, and other cells from the innate immune system, plays a critical role in inflammatory pathways and multiple immune-mediated disease processes. With the application of Sanofi's TAILORED COVALENCY technology, rilzabrutinib can selectively inhibit the BTK target.Currently trhe drug is being investigated in Phase III trial.

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. As per the news published in April 2024, Sanofi anticipates regulatory submissions of rilzabrutinib in the US and EU by year-end.

VAY736 (Ianalumab): Novartis

Ianalumab is a novel, fully human immunoglobulin G1 monoclonal antibody that targets the BAFF receptor and has 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. Currently, ianalumab is in Phase III of the clinical trial for 1st and 2nd line treatment of ITP.

In Novartis' Q2 2024 presentation, the company projected the upcoming results of two important trials: NCT05653349 (VAYHIT1) for first-line therapy, expected in 2026, and NCT05653219 (VAYHIT2) for second-line therapy, anticipated in 2025.

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).

Spleen tyrosine kinase (SYK) inhibitor

TAVALISSE/TAVLESSE (fostamatinib) is a highly selective SYK inhibitor with significant immunomodulatory potential, targeting Fc and B-cell receptor signaling pathways. It competes with various existing therapies and emerging drug candidates for ITP treatment. Notably, post-hoc data analysis suggests that TAVALISSE achieves higher response rates when used as a second-line therapy. In October 2022, Grifols' TAVLESSE (fostamatinib) received a NICE recommendation for treating refractory chronic immune thrombocytopenia. Currently, TAVALISSE is the sole FDA-approved SYK inhibitor, while Genosco/Oscotec's SKI-O-703 (cevidoplenib) is under investigation in Phase II trials.

Neonatal Fc receptor inhibitor

VYVGART (efgartigimod alfa) shows promise in treating various IgG-mediated autoimmune diseases, and patients in Japan now have access to this new treatment option for ITP. In March 2024, the FDA approved VYVGART for adults with primary immune thrombocytopenia, based on findings from the global Phase III ADVANCE-IV trial, published in the September 2023 issue of The Lancet. The trial met its primary endpoint, revealing that a greater percentage of chronic ITP patients treated with VYVGART achieved a sustained platelet count response compared to those on placebo. Moreover, VYVGART was well-tolerated during the 24-week study, with its safety and tolerability profile aligning with results from previous clinical trials.

ITP Market Outlook

Corticosteroids are the primary first-line treatment for ITP, often combined with Intravenous Immunoglobulin (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, requiring alternative therapies. Long-term management of chronic ITP typically involves cycling through various treatments, including splenectomy, Thrombopoietin-Receptor Agonists (TPO-RAs), and immunosuppressants like rituximab. The varied mechanisms and inconsistent response rates of these therapies complicate comparisons, and there is no clear consensus on treatment sequencing. Despite these options, many patients experience prolonged thrombocytopenia, increasing their risk of spontaneous or trauma-induced bleeding. TAVLESSE offers a novel mechanism of action, adding a valuable option to the current ITP treatment landscape. Other FDA-approved therapies in the US that promote platelet production through TPO receptor binding include PROMACTA, NPLATE, and DOPTELET. VYVGART is approved for ITP in Japan, and YIMMUGO (BT-595) is available in Germany from 2022 for chronic ITP in adults.

Anti-RhD immunoglobulin has been successfully used in the setting of both acute and chronic ITP. Anti-RhD comprises immunoglobulin G (IgG) prepared from the plasma of repeatedly immunized human RhD-negative donors. Anti-RhD IgG itself contains >90% polyclonal immunoglobulin G anti-RhD.

Thrombopoietin receptor agonists (TPO-RAs) are new promising drugs in ITP treatment. Thrombopoietin is the primary factor responsible for platelet production. Hence, TPO-RAs are able not only to promote platelet production from existing megakaryocytes but can also enhance the proliferation of megakaryocytes in the bone marrow. This has been investigated in both in vitro studies and clinical trials. Amgen's ROMIPLATE and Novartis' REVOLADE are TPO-RAs approved by the European Commission for ITP patients. Both agents increase the platelet level in ITP patients and healthy volunteers.

New therapies featuring innovative mechanisms of action-such as FcRn inhibitor, BTK inhibitor, SYK inhibitor, and CD38 targeting-offer more personalized management strategies for refractory ITP. Rilzabrutinib, a BTK inhibitor, addresses both Fc? receptor-mediated functions and autoantibody production, while Ianalumab (VAY736), an anti-BAFF-R monoclonal antibody, and Mezagitamab, an anti-CD38 monoclonal antibody, are in late and mid-stage trials, respectively. Additionally, Cevidoplenib (SKI-O-703), a SYK inhibitor, shows promising efficacy in refractory cases. Together, these therapies represent significant advancements in addressing unmet needs in ITP, offering patients more tailored and effective treatment options.

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 2,800 million 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 1,700 million 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.

ITP Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of ITP treatment has experienced a profound transformation with the uptake of novel drugs. Rilzabrutinib (PRN-1008), an innovative BTK inhibitor developed by Sanofi, anticipated to enter the market in 2025. Rilzabrutinib is anticipated to take medium fast uptake in the ITP.

ITP Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on designation, collaborations, acquisitions and mergers, licensing, and patent details for ITP emerging therapy. For Example, In March 2024, the FDA granted cevidoplenib (SKI-O-703 an ODD for the treatment of patients with ITP. The designation was given after the results of a Phase II clinical study that demonstrated the efficacy of cevidoplenib in patients with chronic ITP.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on ITP's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including oncologists, radiation oncologists, surgical oncologists, and others.

Delveinsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as - Massachusetts General Hospital & Harvard Medical School, Graduate School in Hospital Pharmacy, Queen Mary University of London, Massachusetts General Hospital, Harvard Medical School, Boston, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or ITP market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

? TAVALISSE/TAVLESSE (fostamatinib)

Rigel Pharma's, Kissei Pharmaceutical's, and Grifols' TAVALISSE/TAVLESSE is the only oral Spleen Tyrosine Kinase (SYK) inhibitor for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment. TAVALISSE was approved in the US and EU in 2018 and 2020, respectively. It was also approved in Japan for marketing authorization in 2022 and was launched in 2023.

Rigel offers services and support for TAVALISSE. Rigel OneCare provides dedicated support for patients and practices. Rigel OneCare will help patients get started with TAVALISSE eligibility and limitations:

Eligible patients may receive TAVALISSE at a USD 15 co-pay for each prescription if they pay through commercial insurance.

  • Patients must have a valid prescription for TAVALISSE and have commercial insurance.
  • Patients must be 18 years of age or older.
  • This offer is not valid for prescriptions reimbursed under Medicare, Medicaid, TriCare, or any other federal or state program or where prohibited by law.
  • The patient will be responsible for any out-of-pocket expenses after the USD 25,000 annual cap.
  • This offer is not insurance, and the offer is valid only for prescriptions filled in the United States and Puerto Rico.
  • Not valid for cash-paying patients.

? DOPTELET (avatrombopag)

DOPTELET is a small molecule thrombopoietin receptor agonist that increases platelet production. DOPTELET is a prescription medicine used to treat low blood platelet counts in adults with chronic ITP when other treatments have not worked well. DOPTELET is not used to make platelet counts normal in adults with chronic liver disease or chronic ITP. The company has stated that the price of avatrombopag is GBP 640.00 or GBP 960.00 per 5-day treatment course for the 40,000 to below 50,000 and below 40,000 platelets per µL of blood groups, respectively.

DOPTELET is available for 97% of commercial and 75% of Medicare-insured patients nationwide.

Dova Pharmaceutical's DOPTELET USD 0 Co-pay Program assists patients in getting DOPTELET at 0 cost. Eligible commercially insured patients may qualify for the DOPTELET USD 0 Co-pay Program. Eligible patients pay USD 0 for each DOPTELET prescription-annual maximum benefit up to USD 15,000.

Eligibility

  • Have commercial insurance that covers DOPTELET.
  • Not be enrolled in any state or federal healthcare program such as Medicare, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD), or TRICARE.
  • Be 18 years of age or older.
  • Be a resident of the United States or a US Territory.

Terms and condition

  • Patients pay as little as USD 0 per prescription. Maximum benefit of up to USD 5,000 per DOPTELET prescription. The patient is responsible for any remaining out-of-pocket costs that exceed USD 5,000 per prescription. The Co-pay Assistance Program has an annual calendar cap of USD 15,000.
  • The Co-pay Assistance Program is void where prohibited by law, taxes, or restricted.
  • This offer is non-transferable, no substitutions are permissible, and this offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription.
  • Sobi reserves the right to rescind, revoke, or amend this offer at any time without notice.
  • The Co-pay Assistance Program for DOPTELET is not insurance and is not intended to substitute for insurance.
  • Patients, pharmacists, and healthcare providers must not seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this Co-pay Assistance Program. Patients must not seek reimbursement from any health savings, flexible spending, or other healthcare reimbursement accounts for the amount of assistance received from the Co-pay Assistance Program.
  • Certain information about using the Co-pay Assistance Program will be shared with Sobi, the sponsor of the Co-pay Assistance Program. The information disclosed will include the date the prescription is filled, the number of pills or products dispensed by the pharmacists, and the amount of your co-pay that will be paid for by using this Co-pay Assistance Program.
  • Acceptance in this Co-pay Assistance Program is not conditioned on any past, present, or future purchase, including additional doses.
  • Enrollment for the Co-pay Assistance Program is valid through the calendar year.
  • Sobi reserves the right to change program terms at any time.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, and a descriptive overview of ITP, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
  • Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
  • Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
  • A detailed review of the ITP market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM ITP market.

ITP Report Insights

  • Patient Population
  • Therapeutic Approaches
  • ITP Pipeline Analysis
  • ITP Market Size and Trends
  • Existing and Future Market Opportunity

ITP Report Key Strengths

  • Eleven Years Forecast
  • The 7MM Coverage
  • ITP Epidemiology Segmentation
  • Key Cross Competition
  • Drugs Uptake and Key Market Forecast Assumptions

ITP Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT Analysis and Conjoint Analysis)

FAQs:

  • What was the ITP market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
  • What are the pricing variations among different geographies for approved therapies?
  • What can be the future treatment paradigm of ITP?
  • What are the disease risks, burdens, and unmet needs of ITP? What will be the growth opportunities across the 7MM concerning the patient population with ITP?
  • Who is the major competitor of TAVALISSE/TAVLESSE in the market?
  • Which class is performed better and generate highest revenue in 2024?
  • What are the current options for the treatment of ITP? What are the current guidelines for treating ITP in the US, Europe, and Japan?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?

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.
Product Code: DIMI1715

Table of Contents

1. Key Insights

2. Report Introduction

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

  • 3.1. Market Share (%) Distribution of ITP by Therapies in 2020
  • 3.2. Market Share (%) Distribution of ITP by Therapies in 2034
  • 3.3. Market Share (%) Distribution of ITP by Class in 2020
  • 3.4. Market Share (%) Distribution of ITP by Class in 2034

4. Executive Summary of Immune Thrombocytopenic Purpura (ITP)

5. Key Events

6. Disease Background and Overview

  • 6.1. Introduction
  • 6.2. Immune Thrombocytopenic Purpura (ITP)
    • 6.2.1. Classification of ITP
    • 6.2.2. Causes of ITP
    • 6.2.3. Signs and symptoms of ITP
    • 6.2.4. Pathogenesis of ITP
    • 6.2.5. Diagnosis of ITP

7. Treatment of ITP

  • 7.1. Treatment Guidelines of ITP
    • 7.1.1. American Society of Hematology (ASH) 2019 guidelines for ITP
    • 7.1.2. Treatment algorithm for ITP

8. Methodology

9. Epidemiology and Patient Population

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
    • 9.2.1. The United States
    • 9.2.2. EU4 and the UK
    • 9.2.3. Japan
  • 9.3. Epidemiology Scenario: 7MM
  • 9.4. Total Prevalent Cases of ITP in the 7MM
  • 9.5. The United States
    • 9.5.1. Total Prevalent Cases of ITP in the US
    • 9.5.2. Age-specific Diagnosed Prevalent Cases of ITP in the US
    • 9.5.3. Gender-specific Diagnosed Prevalent Cases of ITP in the US
  • 9.6. EU4 and the UK
    • 9.6.1. Total Prevalent Cases of ITP in EU4 and the UK
    • 9.6.2. Age-specific Diagnosed Prevalent Cases of ITP in EU4 and the UK
    • 9.6.3. Gender-specific Diagnosed Prevalent Cases of ITP in EU4 and the UK
  • 9.7. Japan
    • 9.7.1. Total Prevalent Cases of ITP in Japan
    • 9.7.2. Age-specific Diagnosed Prevalent Cases of ITP in Japan
    • 9.7.3. Gender-specific Diagnosed Prevalent Cases of ITP in Japan

10. Patient Journey

11. Marketed Products

  • 11.1. Key Cross Competition
  • 11.2. TAVALISSE/TAVLESSE (fostamatinib disodium hexahydrate): Rigel Pharmaceuticals, Kissei Pharmaceutical and Grifols
    • 11.2.1. Product Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activity
    • 11.2.4. Safety and Efficacy
  • 11.3. DOPTELET (avatrombopag): Sobi (Dova Pharmaceuticals) and Asahi Kasei Pharma
    • 11.3.1. Product Description
    • 11.3.2. Regulatory milestones
    • 11.3.3. Other Developmental Activity
    • 11.3.4. Clinical Developmental Activities
    • 11.3.5. Safety and efficacy
  • 11.4. NPLATE/ROMIPLATE (romiplostim, AMG-531): Amgen
    • 11.4.1. Product Description
    • 11.4.2. Regulatory Milestones
    • 11.4.3. Other Developmental Activity
    • 11.4.4. Safety and Efficacy
  • 11.5. PROMACTA/REVOLADE (eltrombopag): Novartis
    • 11.5.1. Product Description
    • 11.5.2. Regulatory Milestones
    • 11.5.3. Other Developmental Activity
    • 11.5.4. Safety and Efficacy
  • 11.6. VYVGART (efgartigimod alfa-fcab, ARGX-113): Argenx
    • 11.6.1. Product Description
    • 11.6.2. Regulatory Milestones
    • 11.6.3. Other Developmental Activity
    • 11.6.4. Clinical Development
    • 11.6.5. Safety and efficacy
  • 11.7. YIMMUGO (BT-595): Grifols (Biotest)
    • 11.7.1. Product Description
    • 11.7.2. Regulatory Milestones
    • 11.7.3. Other Developmental Activity
    • 11.7.4. Safety and Efficacy
  • 11.8. RITUXAN (rituximab): Zenyaku Kogyo and Chugai Pharmaceutical
    • 11.8.1. Product Description
    • 11.8.2. Regulatory Milestones
    • 11.8.3. Other Developmental Activity
    • 11.8.4. Safety and efficacy

12. Emerging Therapies

  • 12.1. Key Cross Competition
  • 12.2. Rilzabrutinib (PRN-1008): Sanofi/Principia Biopharma
    • 12.2.1. Product Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
    • 12.2.4. Safety and Efficacy
  • 12.3. VAY736 (lanalumab): Novartis
    • 12.3.1. Product Description
    • 12.3.2. Other developmental activities
    • 12.3.3. Clinical Development
  • 12.4. TAK-079 (mezagitamab): Takeda (Millennium Pharmaceuticals)
    • 12.4.1. Product Description
    • 12.4.2. Other Developmental Activities
    • 12.4.3. Clinical Development
    • 12.4.4. Safety and Efficacy
  • 12.5. PF-06835375: Pfizer
    • 12.5.1. Product Description
    • 12.5.2. Clinical Development
  • 12.6. Cevidoplenib (SKI-O-703): Genosco (Oscotec)
    • 12.6.1. Product Description
    • 12.6.2. Other Developmental Activities
    • 12.6.3. Safety and Efficacy
  • 12.7. RYSTIGGO (rozanolixizumab, UCB7665): UCB Biopharma and Parexel International
    • 12.7.1. Product Description
    • 12.7.2. Other developmental activity
    • 12.7.3. Safety and Efficacy
  • 12.8. Povetacicept (APLN-303): Vertex Pharmaceuticals Incorporated (Alpine Immune Sciences)
    • 12.8.1. Product Description
    • 12.8.2. Other developmental activity
    • 12.8.3. Clinical Development

13. ITP Seven Major Market Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook
  • 13.3. Conjoint Analysis
  • 13.4. Key Market Forecast Assumptions
  • 13.5. Seven Major Market Size
    • 13.5.1. Total Market Size of ITP in the 7MM
    • 13.5.2. Total Market Size of ITP by Class in the 7MM
  • 13.6. The United States Market Size
    • 13.6.1. Total Market Size of ITP in the US
    • 13.6.2. Total Market Size of ITP by Therapies in the US
    • 13.6.3. Total Market Size of ITP by Class in the US
  • 13.7. EU4 and the UK Market Size
    • 13.7.1. Total Market Size of ITP in EU4 and the UK
    • 13.7.2. Total Market Size of ITP by Therapies in EU4 and the UK
    • 13.7.3. Total Market Size of ITP by Class in EU4 and the UK
  • 13.8. Japan Market Size
    • 13.8.1. Total Market Size of ITP in Japan
    • 13.8.2. Total Market Size of ITP by Therapies in Japan
    • 13.8.3. Total Market Size of ITP by Class in Japan

14. Market Access and Reimbursement

  • 14.1. United States
    • 14.1.1. Centre for Medicare and Medicaid Services (CMS)
  • 14.2. EU4 and the UK
    • 14.2.1. Germany
    • 14.2.2. France
    • 14.2.3. Italy
    • 14.2.4. Spain
    • 14.2.5. United Kingdom
  • 14.3. Japan
    • 14.3.1. MHLW
  • 14.4. Market Access and Reimbursement of ITP

15. Unmet Needs

16. SWOT Analysis

17. KOL Views

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

Product Code: DIMI1715

List of Tables

  • Table 1: Summary of ITP, Market, and Epidemiology (2020-2034)
  • Table 2: Total Prevalent cases of ITP in the 7MM (2020-2034)
  • Table 3: Total Prevalent Cases of ITP in the US (2020-2034)
  • Table 4: Age-specific Diagnosed Prevalent Cases of ITP in the United States (2020-2034)
  • Table 5: Gender-specific Diagnosed Prevalent Cases of ITP in the United States (2020-2034)
  • Table 6: Total Prevalent Cases of ITP in EU4 and the UK (2020-2034)
  • Table 7: Age-specific Diagnosed Prevalent Cases of ITP in EU4 and the UK (2020-2034)
  • Table 8: Gender-specific Diagnosed Prevalent Cases of ITP in EU4 and the UK (2020-2034)
  • Table 9: Total Prevalent Cases of ITP in Japan (2020-2034)
  • Table 10: Age-specific Diagnosed Prevalent Cases of ITP in Japan (2020-2034)
  • Table 11: Gender-specific Diagnosed Prevalent Cases of ITP in Japan (2020-2034)
  • Table 12: Marketed Drug Key Cross
  • Table 13: DOPTELET (avatrombopag), Clinical Trial Description, 2024
  • Table 14: VYVGART (efgartigimod alfa-fcab, ARGX-113); Clinical Trial Description, 2024
  • Table 15: Comparison of Emerging Drugs Under Development
  • Table 16: Rilzabrutinib (PRN-1008); Clinical Trial Description, 2024
  • Table 17: VAY736 (Ianalumab); Clinical Trial Description, 2024
  • Table 18: TAK-079 (mezagitamab); Clinical Trial Description, 2024
  • Table 19: PF-06835375; Clinical Trial Description
  • Table 20: Povetacicept (APLN-303); Clinical Trial Description, 2024
  • Table 21: Key Market Forecast Assumptions for Rilzabrutinib
  • Table 22: Key Market Forecast Assumptions for Efgartigimod (ARGX-113)
  • Table 23: Key Market Forecast Assumptions for TAVALISSE
  • Table 24: Key Market Forecast Assumptions for DOPTELET
  • Table 25: Market Size of ITP in the 7MM, USD million (2020-2034)
  • Table 26: Market Size of ITP by Class in the 7MM, in USD million (2020-2034)
  • Table 27: Market Size of ITP in the US, USD million (2020-2034)
  • Table 28: Market Size of ITP by Therapies in the US, in USD million (2020-2034)
  • Table 29: Market Size of ITP by Class in the US, in USD million (2020-2034)
  • Table 30: Market Size of ITP in EU4 and the UK, USD million (2020-2034)
  • Table 31: Market Size of ITP by Therapies in EU4 and the UK, in USD million (2020-2034)
  • Table 32: Market Size of ITP by Class in EU4 and the UK , in USD million (2020-2034)
  • Table 33: Market Size of ITP in Japan, USD million (2020-2034)
  • Table 34: Market Size of ITP by Therapies in Japan, in USD million (2020-2034)
  • Table 35: Market Size of ITP by Class in Japan, in USD million (2020-2034)
  • Table 36: NICE Decisions for ITP Therapies
  • Table 37: IQWiG Assessment for ITP Therapies
  • Table 38: Haute Autorite de Sante (HAS) Decisions for ITP Therapies
  • Table 39: AIFA Assessment for ITP Therapies

List of Figures

  • Figure 1: Pathogenesis of ITP and Sites of Drug Action
  • Figure 2: Algorithm for the Selection of Second-Line Therapy in Adults with ITP
  • Figure 3: Total Prevalent Cases of ITP in the 7MM (2020-2034)
  • Figure 4: Total Prevalent Cases of ITP in the US (2020-2034)
  • Figure 5: Age-specific Diagnosed Prevalent Cases of ITP in the United States (2020-2034)
  • Figure 6: Gender-specific Diagnosed Prevalent Cases of ITP in the United States (2020-2034)
  • Figure 7: Total Prevalent Cases of ITP in EU4 and the UK (2020-2034)
  • Figure 8: Age-specific Diagnosed Prevalent Cases of ITP in EU4 and the UK (2020-2034)
  • Figure 9: Gender-specific Diagnosed Prevalent Cases of ITP in EU4 and the UK (2020-2034)
  • Figure 10: Total Prevalent Cases of ITP in Japan (2020-2034)
  • Figure 11: Age-specific Diagnosed Prevalent Cases of ITP in Japan (2020-2034)
  • Figure 12: Gender-specific Diagnosed Prevalent Cases of ITP in Japan (2020-2034)
  • Figure 13: Market Size of ITP in the 7MM, USD millions (2020-2034)
  • Figure 14: Market Size of ITP by Class in the 7MM, USD million (2020-2034)
  • Figure 15: Market Size of ITP in the US, USD millions (2020-2034)
  • Figure 16: Market Size of ITP by Current and Emerging Therapies in the US, USD million (2020-2034)
  • Figure 17: Market Size of ITP by Class in the US, USD million (2020-2034)
  • Figure 18: Market Size of ITP in EU4 and the UK, USD million (2020-2034)
  • Figure 19: EU4 and the UK Market Size of ITP by Current and Emerging Therapies, in USD million (2020-2034)
  • Figure 20: Market Size of ITP by Class in EU4 and the UK, USD million (2020-2034)
  • Figure 21: Market Size of ITP in Japan, USD millions (2020-2034)
  • Figure 22: Market Size of ITP by Current and Emerging Therapies in Japan, USD million (2020-2034)
  • Figure 23: Market Size of ITP by Class in Japan, USD million (2020-2034)
  • Figure 24: Health Technology Assessment
  • Figure 25: Reimbursement Process in Germany
  • Figure 26: Reimbursement Process in France
  • Figure 27: Reimbursement Process in Italy
  • Figure 28: Reimbursement Process in Spain
  • Figure 29: Reimbursement Process in the United Kingdom
  • Figure 30: Reimbursement Process in Japan
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