Report Overview

According to the deep-dive market assessment study by Growth Plus Reports, the global activated phosphoinositide 3-kinase delta syndrome (APDS) market is expected to register a revenue CAGR of 6.2% from 2022 to 2030.

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market Fundamentals

Activated phosphoinositide 3-kinase delta syndrome (APDS) is a rare genetic disorder caused by mutations in the PIK3CD gene. The PIK3CD gene gives instructions to the body to produce a protein called phosphoinositide-3-kinase delta (PI3Kδ), which plays a critical role in the immune system by regulating the growth and survival of immune cells. Mutations in the PIK3CD gene lead to overactivity of the PI3Kδ protein, which causes the immune system to overreact to infections and other stimuli, leading to chronic inflammation and a variety of other health problems. Symptoms of APDS can vary widely and include recurrent infections, inflammation of the lymph nodes and other lymphoid organs, fever, rashes, eczema, and diarrhea. APDS can also lead to serious health problems, such as chronic obstructive pulmonary disease, type 1 diabetes, and cancer. 

Currently, there are no FDA-approved treatments for APDS. However, some patients may be treated with immunosuppressive drugs or biologics. As research on APDS is still ongoing, new therapies may become available in the future. The treatment options mainly focus on managing the symptoms, and the treatment plans are tailored to the individual patient. The diagnosis of APDS is based on clinical presentation and genetic testing. Research on APDS is still ongoing, and more studies are needed to better understand the disorder and develop effective treatments. Collaborations between pharmaceutical companies, biotech firms, and academic institutions are important to increase knowledge and provide better treatment options for people with APDS.

The market for activated phosphoinositide 3-kinase delta syndrome is characterized by high unmet medical needs and limited treatment options, leading to high therapy prices. Additionally, government funding and support for APDS research and development can also impact the market.

However, the activated phosphoinositide 3-kinase delta syndrome market is likely to be small, as the number of people affected by this disorder is relatively low. The small patient population and limited funding for research may hinder the development of new treatments for APDS. 

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market Dynamics

With the advancement of genetic testing, more cases of APDS are being diagnosed, leading to an increase in demand for treatments, which is driving the revenue growth of the activated phosphoinositide 3-kinase delta syndrome (APDS) market.

Governments worldwide have recognized the need to support the development of treatments for APDS. They are providing funds and support for research and development in this area. With the increasing number of clinical trials, the availability of funding for these trials has improved. This has led to a growing number of treatments being developed for APDS. Moreover, strong product pipelines, such as Leniolisib and Nemiralisib, also propelled the revenue growth of the activated phosphoinositide 3-kinase delta syndrome (APDS) market. There is a significant unmet need for treatments for APDS as currently this condition has limited treatment options, which are boosting the revenue growth of the phosphoinositide 3-kinase delta syndrome (APDS) market.

Pharmaceutical companies, biotech firms, and academic institutions are collaborating more frequently to develop treatments for APDS. This factor is also expected to fuel the revenue growth of the activated phosphoinositide 3-kinase delta syndrome (APDS) market during the forecast period.

However, the small patient population results in a limited market size, making it less financially viable for pharmaceutical companies to invest in the development of APDS treatments, restricting the activated phosphoinositide 3-kinase delta syndrome (APDS) market revenue growth. The lack of awareness of APDS among healthcare professionals is also cramping the revenue growth of the activated phosphoinositide 3-kinase delta syndrome (APDS) market.

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market Ecosystem

The global activated phosphoinositide 3-kinase delta syndrome (APDS) market has been analyzed from two perspectives: treatment and region.

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market by Treatment

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Based on the treatment, the global activated phosphoinositide 3-kinase delta syndrome (APDS) market is segmented into antibiotic prophylaxis, immunoglobulin replacement therapy, and selective pi3kδ inhibitor (idelalisib).

The antibiotic prophylaxis segment dominated the activated phosphoinositide 3-kinase delta syndrome (APDS) market in 2021. The antibiotic prophylaxis segment is further sub-segmented into rituximab, rapamycin, and others. Antibiotic prophylaxis can reduce the frequency of infections in individuals with APDS. By lowering the risk of infections, prophylaxis can improve the quality of life for individuals with APDS, thus boosting the segment’s revenue growth. Antibiotics can help preserve the immune function of individuals with APDS by reducing the burden of infections. Additionally, antibiotic prophylaxis is often a cost-effective way to manage infections in individuals with APDS, propelling the market revenue growth. Regular usage of antibiotics can help prevent complications from infections in individuals with APDS, which is fueling the treatment demand.

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market by Region

Based on the region, the global activated phosphoinositide 3-kinase delta syndrome (APDS) market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World.

North America dominated the global activated phosphoinositide 3-kinase delta syndrome (APDS) market in 2021, followed by Europe and Asia Pacific. The presence of advanced technology and research facilities for genetic disorders in North America is boosting research and development in the region. The growing awareness of the condition and improved regional diagnosis rates boost regional revenue growth. Moreover, strong healthcare infrastructure and high expenditure on healthcare in North America also propel market growth. Furthermore, a well-established pharmaceutical industry and a favorable regulatory environment are also driving regional revenue growth. This aside, increasing collaboration between pharmaceutical companies in North America is also expected to fuel regional growth.

Europe accounted for the second-largest revenue share of the global activated phosphoinositide 3-kinase delta syndrome (APDS) market in 2021. Growing focus on the development of new and innovative treatments for APDS, including biologics and small molecule inhibitors, is propelling the revenue growth of the Europe market. Similarly, there is a rise in the adoption of combination therapies, where APDS inhibitors are used in combination with other drugs to enhance their efficacy. The increasing demand for effective treatments for APDS in the region drives the growing investment in R&D for new drugs and therapies. Additionally, pharmaceutical companies, academic institutions, and government organizations are collaborating to develop new drugs to treat APDS. 

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market Competitive Landscape

The prominent players operating in the global activated phosphoinositide 3-kinase delta syndrome (APDS) market are:

• Genentech, Inc.
• Pfizer Inc.
• Pharming Group NV
• Novartis AG
• Gilead Sciences, Inc.
• Grifols SA
• GlaxoSmithKline Plc.
• CSL Behring
• Takeda Pharmaceuticals U.S.A., Inc.
• LFB Biomedicaments

Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Market Strategic Developments

• In December 2022, Pharming Group N.V. announced the positive results of the Phase 3 clinical trial of the investigational drug leniolisib, an oral selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, in adult and adolescent patients with APDS. For 12 weeks, patients were provided a 2:1 random assignment to receive either a 70 mg dose of leniolisib or a placebo. The co-primary objectives assessed lymph node size reduction and increase in naive B cells, showing the influence on immunological dysregulation and correcting immunodeficiency in these individuals, respectively, showed improvement over the placebo.
• In September 2022, Pharming Group N.V. announced that the US Food and Drug Administration (FDA) has accepted for priority review of its New Drug Application (NDA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to treat the rare primary immunodeficiency APDS in adults and adolescents with 12 years of age and older in the US.

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