Immune Thrombocytopenia Market
DelveInsight’s ‘Immune Thrombocytopenia Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the ITP, historical and forecasted epidemiology as well as the ITP market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The ITP market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM ITP market size from 2017 to 2030. The Report also covers current ITP treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2017–2030
Immune Thrombocytopenia (ITP) Disease Understanding and Treatment Algorithm
Immune Thrombocytopenia (ITP) Overview
Immune Thrombocytopenia (ITP), previously called immune thrombocytopenic purpura or idiopathic thrombocytopenic purpura, is an autoimmune disorder that occurs when the body attacks its platelets and destroys them too quickly. ITP is a disorder that affects the overall number of blood platelets rather than their function. Many of the symptoms of ITP stem from a low platelet count leading to excessive bleeding. In severe cases, frequent bleeding episodes may result in low levels of circulating red blood cells (anemia), which may cause fatigue and impair response to exertion. In rare cases, serious bleeding into the brain (intracranial hemorrhage) may occur.
The two main types of ITP are acute (short term) and chronic (long term). ITP is also categorized as primary and secondary based on the cause of the disease. ITP in the absence of other causes or disorders that may be associated with the thrombocytopenia is known as primary ITP, whereas, secondary ITP refers to immune-mediated thrombocytopenia with an underlying cause, including drug-induced, or associated with systemic illness (e.g., systemic lupus erythematosus, infection [e.g., HIV], immune deficiency [e.g., common variable immunodeficiency or autoimmune lymphoproliferative syndrome], and other causes).
Immune Thrombocytopenia (ITP) Diagnosis
The diagnosis of ITP is made by excluding other causes of thrombocytopenia, including certain medications or disorders that affect the bone marrow and reduce platelet production, such as acute leukemia and aplastic anemia. It is diagnosed by complete blood count (CBC), additional blood and urine tests to measure bleeding time and detect possible infections, careful examination of medical history, and/or bone marrow aspiration.
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Immune Thrombocytopenia (ITP) Treatment
The major goal for the treatment of ITP is to provide a platelet count that prevents major bleeding rather than correcting the platelet count to normal levels. The management of ITP varies widely and current international guidelines recommend several first- and second-line options, including some medicinal products that have not been approved in the EU for this particular condition.
First-line treatment options include corticosteroids, intravenous immunoglobulin (IVIg) and intravenous anti-D immunoglobulin (the latter only for non-splenectomized Rhesus-D positive patients). Patients who fail to respond or who relapse face the options of treatment with second-line drug therapy or splenectomy but there is no clear evidence to support the best approach. Splenectomy can provide long term efficacy in around 60% of cases. Second-line drug therapies include high dose dexamethasone or methylprednisolone, high-dose IVIg or anti-D Ig, vinca alkaloids and danazol, the immunosuppressants cyclophosphamide, azathioprine, cyclosporine or mycophenolate mofetil, and the anti-CD-20 monoclonal antibody rituximab.
Immune Thrombocytopenia (ITP) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Population of ITP, Total Diagnosed Prevalent Population of ITP, and Gender-specific Diagnosed Prevalent Population of ITP scenario of ITP in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2030.
- Assessments as per DelveInsight’s analysts show that the majority of cases of ITP are females as compared to males. There was a total of 32,364 female and 20,998 male diagnosed cases of ITP in 2017 in the United States.
- DelveInsight’s estimations suggest that the total prevalent population ITP in the seven major markets was approximately 180,498 in 2017.
- The total diagnosed prevalent cases in the 7MM was estimated to be approximately 147,174 in 2017.
- In 2017, there were around 63,725 prevalent cases and approximately 53,362 diagnosed prevalent cases of ITP in the United States. Out of the total diagnosed cases, approximately 49,640 cases account for adult ITP and approximately 3,723 cases were diagnosed prevalence population in children in 2017 in the United States.
- Japan had 27,005 prevalent cases of ITP in 2017.
- Among the European countries, the United Kingdom had the highest prevalent population of ITP with approximately 26,274 cases, followed by Italy which had a prevalent population of approximately 18,604 in 2017. On the other hand, Spain had the lowest prevalent population of approximately 12,207 cases in 2017.
Immune Thrombocytopenia (ITP) Epidemiology
The epidemiology segment also provides the ITP epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Immune Thrombocytopenia (ITP) Drug Chapters
The drug chapter segment of the ITP report encloses the detailed analysis of ITP marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the ITP clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Immune Thrombocytopenia (ITP) Marketed Drugs
Nplate (AMG-531): Amgen
Nplate (Romiplostim) is a synthetic protein medicine used when certain other medicines, or surgery to remove the spleen, have not worked well enough to treat low blood platelet counts in adults with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate keeps the platelet count about 50,000 per microliter to lower the risk of bleeding. Nplate is not used to normalize the platelet count. The safety and efficacy of Nplate are not known in people under the age of 18 years. Nplate works by increasing the platelet production through binding and activation of the thrombopoietin (TPO) receptor whose mechanism is analogous to endogenous TPO. In Japan, this drug is also approved for the treatment of patients with severe aplastic anemia.
Products detail in the report…
Doptelet (Avatrombopag): Dova Pharmaceuticals
Avatrombopag is an orally administered thrombopoietin receptor agonist (TPO-RA) being developed by Dova Pharmaceuticals for the treatment of thrombocytopenia. The company recently completed two identically designed pivotal Phase III clinical trials that evaluated avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD), undergoing non-emergent minimally to moderate invasive medical procedures. The company believes that the efficacy and safety profile of avatrombopag in combination with its convenient oral dosing has the potential to provide advantages over other treatments for patients with thrombocytopenia. Moreover, the pharmacokinetic and pharmacodynamic profile, as well as its metabolic characteristics, are the core attribute that differentiates it from currently marketed TPO-RAs and makes it a compelling treatment option for patients with thrombocytopenia.
Products detail in the report…
Tavalisse (fostamatinib disodium hexahydrate): Rigel Pharmaceuticals
Fostamatinib disodium (also known as Tavalisse; R-985788) is an orally-bioavailable investigational agent being developed by Rigel pharmaceuticals and approved for the treatment of 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. The company is focusing on the fostamatinib ITP program specifically on the chronic form of this disease targeting the underlying autoimmune cause of the disease rather than stimulating platelet production. Moreover, fostamatinib is also being evaluated for autoimmune hemolytic anemia, IgA nephropathy, graft-versus-host disease, and ovarian cancer.
In June 2017, the company filed for the New Drug Application to the USFDA for the use of fostamatinib in chronic ITP patients. Later in October 2017, Rigel Pharmaceuticals indicated that the FDA anticipated the Prescription Drug User Fee Act (PDUFA) action date for the application review in April 2018. And in April 2018, Tavalisse got approved for the treatment of Idiopathic Thrombocytopenic Purpura.
Products detail in the report…
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Immune Thrombocytopenia (ITP) Emerging Drugs
BT-595 (IgG Next Generation) is an intravenously administered, novel polyvalent immunoglobulins (IVIG) designed specifically to treat primary immune deficiencies, secondary antibody deficiency syndromes, and several autoimmune disorders. Currently, the company is developing this therapeutic molecule in the Phase III stage of development for the treatment of patients with Immune Thrombocytopenic Purpura (ITP).
Products detail in the report…
Rozanolixizumab: UCB Biopharma
Rozanolixizumab (also known as UCB7665) is UCB Biopharma’s intravenously and subcutaneously administered, investigational humanized monoclonal IgG antibody being developed by UCB for the treatment of idiopathic thrombocytopenic purpura and myasthenia gravis (MG). The body’s immune system produces antibodies that normally help fight off infections and threats. In MG patients, pathogenic IgG autoantibodies mistakenly attack healthy cells and tissues, causing weakness and fatigue of voluntary muscles. High concentrations of pathogenic IgG autoantibodies in the circulation occur due to the action of the neonatal Fc receptor (FcRn) that bind to IgG, inhibiting its degradation. Rozanolixizumab works by binding with high affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.
Products detail in the report…
Efgartigimod (ARGX-113): Argenx
Efgartigimod (ARGX-113) is an investigational therapy for IgG-mediated autoimmune diseases and was designed to exploit the natural interaction between IgG antibodies and the recycling receptor FcRn. The company has designed Efgartigimod to degrade circulating disease-causing autoimmune antibodies and has potential in many large and orphan indications namely multiple sclerosis, ITP, systemic lupus erythematosus, myasthenia gravis, and skin blistering diseases.
Products detail in the report…
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Immune Thrombocytopenia (ITP) Market Outlook
The US Food and Drug Administration (FDA) has approved three Thrombopoietin receptor agonist (TPO-RA) therapies: romiplostim (Nplate), eltrombopag (Promacta), and avatrombopag (Doptelet). For Europe and Japan, only two TPO-RAs is approved, i.e., Nplate and Promacta. Promacta and Nplate will lose their patent in 2022 in the US, whereas, in Europe and Japan, Nplate loses the patent in 2019 and Promacta will lose patent in 2025. Due to their patent expiry, it is expected that the approval of Doptelet is likely to cover a major patient pool.
From 2023, the market value will start declining due to the patent expiration and subsequent launch of generic/biosimilar of Nplate and Promacta. So till 2022 Doptelet will continue to compete with both these drugs and after the patent expiry, Doptelet will not have any competitor in the market.
Apart from TPO-RAs, various drugs like, Takecab and Nexium capsules are approved in Japan that is indicated for the eradication of Helicobacter pylori in patients with idiopathic thrombocytopenic purpura.
Broadly, two categories of agents are available for the treatment of ITP: those that rapidly and transiently interfere with the process of platelet destruction for management of acute bleeding or bleeding risk (front-line therapies), and those with the potential to provide a more durable improvement in the platelet count (second-line therapies).
The first-line options for therapy of ITP disease include the use of corticosteroids, IVIG, and anti-D immunoglobulin. There are three classes of second-line therapies that include: splenectomy, rituximab, and thrombopoietin receptor agonists (TPO-RA).
At present, there have been few well-designed randomized trials targeted at reducing chronic ITP in adults and children. Further prospective trials may be able to enhance the approach and improve overall outcomes. Adequate long-term follow-up will be necessary to determine whether relapse is truly averted or simply delayed. It will also be important to select novel composite outcomes that account for clinical events as well as evaluate the cost and the added adverse events of combined therapies.
In addition to clinical trials, essential research should focus on identifying patients who would benefit from more intensive therapy: for example, the ability to determine those patients who will develop persistent or chronic ITP or identification of markers predictive of who would benefit most from a specific therapy.
According to DelveInsight, ITP 7MM is expected to change in the study period 2017–2030.
- The market size of ITP in the 7MM was found to be USD 2,527.72 million in 2017.
- The United States accounts for the highest market size of Immune Thrombocytopenia (ITP), in comparison to the other major markets i.e., EU5 countries, and Japan
- Among the EU5 countries, the UK had the highest market size with USD 247.89 million in 2017, while Spain had the lowest market size of ITP with USD 115.08 million in 2017.
- From 2023, the market value will start declining due to the patent expiration and subsequent launch of generic/biosimilar of Nplate and Promacta. So till 2022 Doptelet will continue to compete with both these drugs and after the patent expiry, Doptelet will not have any competitor in the market. Doptelet has contributed USD 15.50 million of the total market size of the disease in 2019.
The United States Market Outlook
This section provides the total ITP market size and; market size by therapies in the United States.
EU-5 Market Outlook
The total ITP market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total ITP market size and market size by therapies in Japan are provided.
Immune Thrombocytopenia (ITP) Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the ITP market or expected to get launched in the market during the study period 2017–2030. The analysis covers ITP market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Immune Thrombocytopenia (ITP) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing and patent details for ITP emerging therapies.
Reimbursement Scenario in Immune Thrombocytopenia (ITP)
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the ITP market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
• The report covers the descriptive overview of ITP, explaining its causes, signs and symptoms, pathophysiology and currently available therapies.
• Comprehensive insight has been provided into the ITP epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for ITP is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the ITP market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM ITP market.
• The increasing prevalence of the disease along with promising emerging pipeline therapies will positively drive the ITP market.
• The companies and academics are working to assess challenges and seek opportunities that could influence ITP R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for ITP. Launch of emerging therapies will significantly impact the ITP market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
Immune Thrombocytopenia (ITP) Report Insights
• Patient Population
• Therapeutic Approaches
• ITP Pipeline Analysis
• ITP Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies
Immune Thrombocytopenia (ITP) Report Key Strengths
• Eleven Years Forecast
• 7MM Coverage
• ITP Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake
Immune Thrombocytopenia (ITP) Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• What was the ITP market share (%) distribution in 2017 and how it would look like in 2030?
• What would be the ITP total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest ITP market size during the forecast period (2020–2030)?
• At what CAGR, the ITP market is expected to grow at the 7MM level during the forecast period (2020–2030)?
• What would be the ITP market outlook across the 7MM during the forecast period (2020–2030)?
• What would be the ITP market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What is the disease risk, burden and unmet needs of ITP?
• What is the historical ITP patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of ITP at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to ITP?
• Out of the above-mentioned countries, which country would have the highest prevalent population of ITP during the forecast period (2020–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
• What are the current options for the treatment of ITP along with the approved therapy?
• What are the current treatment guidelines for the treatment of ITP in the US and Europe?
• What are the ITP marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of ITP?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of ITP?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the ITP therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for ITP and their status?
• What are the key designations that have been granted for the emerging therapies for ITP?
• What are the 7MM historical and forecasted market of ITP?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the ITP.
- To understand the future market competition in the ITP market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for ITP in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the ITP market.
- To understand the future market competition in the ITP market.
What is Immune Thrombocytopenia?
Immune Thrombocytopenia is an autoimmune disorder that occurs when the body attacks its platelets and destroys them too quickly. It affects the overall number of blood platelets rather than their function.
What was the Immune Thrombocytopenia market size in the 7MM in 2017?
Immune Thrombocytopenia market size in the 7MM was USD 2,527.72 million in 2017.
What was the total prevalence of Immune Thrombocytopenia in the 7MM in 2020?
The total Immune Thrombocytopenia prevalent population in 7MM was 184,676 in 2020.
Which are the emerging therapies in the Immune Thrombocytopenia market?
BT-595, GC5107A, LIV-Gamma SN Inj, Hetrombopag Olamine, Efgartigimod (ARGX-113), SKI-O-703, KZR-616, Rozanolixizumab, BMS-986004 (Letolizumab), PRN-1008, PRTX-100 are the emerging therapies in the Immune Thrombocytopenia market.
Which are the leading companies in the Immune Thrombocytopenia market?
Biotest, GC Pharma, SK Plasma, Jiangsu HengRui Medicine, Argenx, Genosco, Kezar Life Sciences, UCB Biopharma, Bristol-Myers Squibb, Principia Biopharma, Protalex are the leading companies in the Immune Thrombocytopenia market.
How is epidemiology segmented for Immune Thrombocytopenia?
Immune Thrombocytopenia (ITP) epidemiology is segmented as Total Prevalent Population of ITP, Total Diagnosed Prevalent Population of ITP, and Gender-specific Diagnosed Prevalent Population of ITP in the 7MM from 2017 to 2030.