Number of pages: 100 | Report Format: PDF | Published date: April 04, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
Report Attribute |
Details |
Market Size Value in 2022 |
US$ 603.2 million |
Revenue Forecast in 2031 |
US$ 2,155.6 million |
CAGR |
15.2% |
Base Year For Estimation |
2022 |
Forecast Period |
2023-2031 |
Historical Year |
2021 |
Segments Covered |
Drug Class, Distribution Channel, and Region |
Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global warm autoimmune hemolytic anemia market was valued at US$ 603.2 million in 2022 and is expected to register a revenue CAGR of 15.2% to reach US$ 2,155.6 million by 2031.
Warm Autoimmune Hemolytic Anemia Market Fundamentals
An inflammatory condition known as warm autoimmune hemolytic anemia (wAIHA) causes healthy red blood cells to be prematurely hemolyzed. The most prevalent form of autoimmune hemolytic anemia is wAIHA; it can strike anyone at any age and affects 1 to 3 individuals out of every 100,000 annually. As the antibodies are active and induce hemolysis at body temperature, unlike in other types of autoimmune hemolytic anemia, the illness is known as "warm" autoimmune hemolytic anemia. There have not been many randomized and prospective clinical trials; instead, treatment has been determined by expert judgment or retrospective research. Although first-line treatment is effective for most patients with autoimmune hemolytic anemia, many also have a chronic relapsing cause that necessitates additional therapies. There is an increased chance of infection and immunosuppression with second and third-line treatments for autoimmune hemolytic anemia. Hemolysis can also happen quickly, severely, and fatally. For wAIHA, there is not presently an approved treatment. The first therapy for treating people with cold agglutinin disease received FDA approval on February 4th, 2022. There is still a significant unmet medical need for brand-new, secure, and efficient treatments for wAIHA. Novel targeted therapies focusing on the underlying mechanism of hemolytic anemia and the treatment of resistant disease have been developed due to recent breakthroughs in understanding the pathophysiology of immunologic processes that result in red cell destruction. Although the approval of the first therapy for the treatment of cold agglutinin disease represents a major advancement in managing autoimmune hemolytic anemia, it also emphasizes the need for ongoing study and the creation of treatments for other types of autoimmune hemolytic anemia. There is hope for developing more focused and efficient treatments as our knowledge of the disease progresses.
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Warm Autoimmune Hemolytic Anemia Market Dynamics
An annual incidence of 1 to 3 per 100,000 individuals is recorded for the rare disease of autoimmune hemolytic anemia. The disease wAIHA is the most prevalent form of autoimmune hemolytic anemia, accounting for 70% to 80% of adult cases and 50% of adolescent cases yearly. The demand for autoimmune hemolytic anemia treatment choices is anticipated to increase as autoimmune diseases become more common, boosting the size of the global market. Additionally, developments in medical technology and rising healthcare costs are expected to support market expansion. The rising usage of medications, like corticosteroids, for people with wAIHA is the main factor driving the worldwide market revenue for warm autoimmune hemolytic anemia. To reduce complications like osteoporosis, diabetes, obesity, and uncontrolled hypertension, corticosteroids are frequently chosen. Additionally, it is expected that the prevalence of autoimmune diseases will increase during the forecast period, along with knowledge of the available treatment options.
There are not many medications accessible for treating warm autoimmune hemolytic anemia. To create novel therapies like parsaclisib and fostamatinib, biotechnology experts and pharmaceutical firms have invested in research and development. The worldwide market revenue for warm autoimmune hemolytic anemia is also expected to be driven by an increase in demand for the creation of combination therapies and anemia therapeutics in patient assistance programs. Additionally, it is expected that rising immunosuppressive drug use and the use of monoclonal antibodies to treat warm autoimmune hemolytic anemia will support market revenue expansion. Furthermore, in the future, market players will benefit financially from the increasing emphasis on precision medicine and personalized treatment methods.
However, high costs associated with treatment and the need for reimbursement policies in some regions may hinder the global market revenue growth.
Warm Autoimmune Hemolytic Anemia Market Ecosystem
The global warm autoimmune hemolytic anemia market is analyzed from three perspectives: drug class, distribution channel, and region.
Warm Autoimmune Hemolytic Anemia Market by Drug Class
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Based on the drug class, the global warm autoimmune hemolytic anemia market is segmented into corticosteroids, monoclonal antibodies, and others.
The corticosteroids segment accounted for the largest revenue share of the global warm autoimmune hemolytic anemia market in 2022. Until now, corticosteroids have been the mainstay of treatment for primary autoimmune hemolytic anemia of the warm variety, i.e., warm autoimmune hemolytic anemia. However, many patients do not react to treatment as expected, and those may experience severe side effects from immunosuppression that is unchecked, mixed, or long-lasting. The first-line treatment for warm autoimmune hemolytic anemia is corticosteroids, successful in 70–85% of patients and should be gradually tapered over 6–12 months. In addition to having anti-inflammatory properties, corticosteroids have extensive and diverse metabolic effects. These substances alter the body's immune reaction to various triggers. In the case of autoimmune hemolytic anemia, glucocorticoids, such as prednisone, are typically the first line of therapy. Though steroids are usually regarded as the first-line therapy in warm autoimmune hemolytic anemia, a long-lasting beneficial effect is only experienced by less than 15% to 20% of patients who receive treatment. The lengthy history of steroid use in autoimmune hemolytic anemia, the absence of an alternative, and the abrupt effect may be realized within a few days in rare cases or within 1-3 weeks in most cases.
But for patients who do not respond to corticosteroids or experience significant side effects, other treatments like rituximab, splenectomy, and immunosuppressive drugs like azathioprine and mycophenolate mofetil may be considered. Future treatment options might also be offered by creating fresh targeted therapies.
Warm Autoimmune Hemolytic Anemia Market by Distribution Channel
The global warm autoimmune hemolytic anemia market is segmented based on the distribution channels into hospital pharmacies, retail pharmacies, and online pharmacies.
The hospital pharmacies segment accounted for the largest revenue share of the global warm autoimmune hemolytic anemia market in 2022. Hospital pharmacists are essential in enhancing patient care by collaborating with doctors, nurses, and other healthcare providers to supply the necessary medications and supplies per established treatment protocols. By keeping track of drug interactions, educating patients on medication use, and keeping up-to-date medication records, hospital pharmacists also ensure the safe and effective use of pharmaceuticals. On the other hand, the most common conventional second-line treatment for warm autoimmune hemolytic anemia is splenectomy, recommended for patients who cannot tolerate corticosteroids and need higher daily doses of prednisone for maintenance or have experienced multiple relapses. Surgery-related side effects from splenectomy procedures include pulmonary embolism, intra-abdominal hemorrhage, abdominal abscess, and abdominal wall hematoma. Therefore, hospitals significantly improve treatments for the numerous issues associated with warm autoimmune hemolytic anemia. As a result, hospital pharmacists are directly managing warm autoimmune hemolytic anemia reports at a notable revenue increase. Splenectomy may raise the risk of infection, long-term thromboembolic events, and surgical consequences. Hospitals are investing in developing alternative therapies for warm autoimmunity hemolytic anemia to eliminate the necessity for splenectomy and its hazards. This could improve patient outcomes and boost income for hospital pharmacies.
Additionally, various government initiatives, including the subsidized medicine program, assist patients in purchasing overpriced therapies for exceptional ailments regardless of their financial circumstances. Due to increased medicine prices and an inadequate supply of pharmaceuticals in retail pharmacies, consumers prefer hospital pharmacies, which has led to significant growth in revenue. Hospital pharmacies have also expanded their offerings due to this trend to keep up with the rising demand, such as by adding home delivery and online buying alternatives. To ensure that all patients have fair access to pharmaceuticals, governments must tackle the underlying causes of escalating drug costs.
Warm Autoimmune Hemolytic Anemia Market by Region
The global warm autoimmune hemolytic anemia market is segmented based on the region into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America accounted for the largest revenue share of the global warm autoimmune hemolytic anemia market in 2022. Due to the rising incidence of warm autoimmune hemolytic anemia, North America's warm autoimmune hemolytic anemia market revenue is growing with a high revenue share. Warm autoantibodies cause 60-70% autoimmune hemolytic anemia, with an annual incidence of 1/35,000 - 1/80,000 in North America and Western Europe. The availability of patient support programs and a rise in research and development activities for discovering novel medicines are expected to boost the North American warm autoimmune hemolytic anemia market. For instance, in March 2023, Zenas BioPharma (USA), LLC posted the phase III clinical trial for Obexelimab to treat warm autoimmune hemolytic anemia. Furthermore, the rising frequency of autoimmune illnesses and increased public knowledge regarding the diagnosis and treatment of hemolytic anemia will likely contribute to expanding the market revenue in this area. Furthermore, favorable reimbursement policies and enhanced healthcare infrastructure will drive market revenue expansion.
Also, Europe accounted for the fastest revenue growth of the global warm autoimmune hemolytic anemia market. High prevalence and increased research and development activities are crucial factors for the global warm autoimmune hemolytic anemia market.
Competitive Landscape of the Global Warm Autoimmune Hemolytic Anemia Market
Due to new product launches, mergers, and acquisitions, the global warm autoimmune hemolytic anemia market is growing with a significant revenue share. Some of the primary development tactics that many organizations prioritize include the introduction of novel therapies, securing approval for new drugs, and taking part in additional initiatives, including awareness projects. Moreover, the market categorized partnerships, acquisitions, and numerous other forms of collaboration as better growth tactics. With the expanding global market demand for warm autoimmune hemolytic anemia, these actions have raised the chance of having profitable revenue growth prospects in the future.
Notable market participants operating in the global warm autoimmune hemolytic anemia market include:
Strategic Development in Warm Autoimmune Hemolytic Anemia Market
Warm Autoimmune hemolytic anemia (wAIHA) is a rare and heterogeneous disease caused by warm autoantibodies (w-AIHA), i.e., antibodies that react with their antigens on the red blood cell optimally at 37°C, causing hemolysis.
The increased prevalence of warm autoimmune hemolytic anemia and increased healthcare expenditure are the key factors driving the growth of the global market.
The inflated cost and complications are restraining the growth of the global warm autoimmune hemolytic anemia market.
Key companies operating the global warm autoimmune hemolytic anemia market are Rigel Pharmaceuticals, Apellis Pharmaceuticals Inc., Alexion Pharmaceuticals, Johnson & Johnson Private Limited, and Sanofi, Incyte Corporation.
The global warm autoimmune hemolytic anemia market is expected to grow at a revenue CAGR of 15.2% during the forecast period from 2023 to 2031.
*Insights on financial performance are subject to the availability of information in the public domain