Segments - Activated Phosphoinositide 3 Kinase Delta Syndrome (APDS) Market by Diagnosis (Genetic Testing and Clinical Evaluation), Treatment (Antibiotic Prophylaxis, Immunoglobulin Replacement Therapy, and Selective pi3kδ Inhibitor [idelalisib]), and Region (Asia Pacific, North America, Latin America, Europe, and Middle East & Africa) - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2024 – 2032
The global activated phosphoinositide 3 kinase delta syndrome (APDS) market size was USD XX Million in 2023 and is likely to reach USD XX Million by 2032, expanding at a CAGR of XX% during 2024–2032. The market growth is attributed to the growing awareness of APDS and regulatory approvals for the research of APDS.
Activated phosphoinositide 3 kinase delta syndrome (APDS) is a rare, inherited condition that affects the immune system. It leads to various symptoms, including frequent upper respiratory tract infections, sinus infections, ear infections, bronchitis, and pneumonia. Most individuals with APDS experience their first infection in early childhood; however, symptoms manifest at any age. Other symptoms include gastrointestinal irritation, lymph node swelling, enlarged liver and spleen, and an increased risk for lymphoma. Over time, recurrent ear and respiratory infections result in permanent hearing loss and lung scarring (bronchiectasis).
According to a report published by Allergy, Asthma & Clinical Immunology in February 2022, activated phosphoinositide 3 kinase (PI3K) δ syndrome (APDS) is a rare form of primary immunodeficiency with 243 known cases mentioned in the report.
The market for activated phosphoinositide 3 kinase delta syndrome is characterized by high therapeutic costs due to a lack of available treatments and a high unmet medical need. Government support and financing for APDS research and development impact the market.
Artificial intelligence (AI) is transforming the healthcare sector, impacting every stage from drug discovery to patient care. AI algorithms analyze vast datasets to identify novel drug targets within the Pi3kδ pathway, expediting the development of effective therapies. Virtual drug screening through AI accelerates the selection of promising drug candidates specifically targeting APDS-causing mutations. Additionally, AI predicts the efficacy and safety of potential drugs, allowing researchers to prioritize the most suitable candidates for clinical trials.
AI assists in analyzing complex genetic data for accurate identification of APDS mutations, leading to early diagnosis. AI also analyzes patient data to predict the risk of complications and enable personalized treatment plans. AI further improves APDS treatment by matching patients with suitable clinical trials for emerging therapies.
The future of APDS treatment involves personalized medicine using AI, as it helps categorize patients into subgroups based on their genetic mutation and disease presentation. This allows for tailored treatment approaches. AI algorithms are also used to predict how patients respond to different medications, including Leniolisib, leading to effective treatment decisions.
Growing awareness of ADPS among healthcare professionals is driving the global market. Healthcare practitioners are becoming aware of APDS, which results in early and accurate diagnoses and a possible increase in the number of patients who are diagnosed. This, in turn, boosts the demand for diagnostic equipment and available treatments for ADPS.
Rising regulatory approvals for ADPS drugs are boosting the market. Recent FDA approval of Leniolisib (Joenja) marks a significant milestone in the APDS market. Favorable reimbursement policies by insurance companies for diagnostic tools and emerging APDS treatments significantly influence the market by increasing accessibility for patients.
Side effects associated with Jeonja are expected to impede the global market in the coming years. Atopic dermatitis, sinusitis, and headache are the most frequent side effects of Joenja. It can harm the fetus. Thus, patients are required to be informed about the risks and confirm their pregnancy status before starting treatment.
High cost of ADPS diagnostics and treatment due to limited treatment options and the unavailability of alternatives is hindering the market. Emerging targeted therapies such as Leniolisib require significant investments for both patients and healthcare systems. The high cost of these treatments limits patient access and hinders the market. Advanced genetic testing for APDS diagnosis is also expensive, potentially creating a barrier for patients and affecting the market.
Advancements in gene therapy, including CRISPR-Cas9 and improved delivery methods, have the potential to correct genetic mutations causing APDS, which creates immense opportunities in the market. Novel targeted therapies targeting specific mutations in APDS and combining them with other treatments offer personalized and effective treatments, thereby tailoring to individual patient needs.
Non-invasive diagnostic tests and multi-gene panel testing simplify APDS diagnosis, enabling early detection and intervention. This drives the demand for diagnostic tools and improves diagnostic accuracy.
The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Attributes |
Details |
Report Title |
Activated Phosphoinositide 3 Kinase Delta Syndrome (APDS) Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast |
Base Year |
2023 |
Historic Data |
2017–2022 |
Forecast Period |
2024–2032 |
Segmentation |
Diagnosis (Genetic Testing and Clinical Evaluation) and Treatment (Antibiotic Prophylaxis, Immunoglobulin Replacement Therapy, and Selective pi3kδ Inhibitor [leniolisib]) |
Regional Scope |
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
Report Coverage |
Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast |
Key Players Covered in the Report |
CSL Behring; Genentech, Inc.; Gilead Sciences, Inc.; GlaxoSmithKline Plc.; Grifols SA; LFB Biomedicaments; Novartis AG; Pfizer Inc.; Pharming Group NV; and Takeda Pharmaceuticals U.S.A. Inc. |
Based on diagnosis, the activated phosphoinositide 3 kinase delta syndrome (APDS) market is bifurcated into genetic testing and clinical evaluation. The genetic testing segment is expected to expand at a significant growth rate during the projection period. Genetic testing is crucial to diagnose APDS, as curative treatments are unavailable. This allows for early intervention and symptom control and also provides valuable information for future targeted therapies that are under development. While clinical evaluation remains essential for initial diagnosis and assessing symptoms, the absence of established treatments necessitates genetic testing for APDS diagnosis, thereby propelling the segment.
On the basis of treatment, the global market is segregated into antibiotic prophylaxis, immunoglobulin replacement therapy, and selective pi3kδ inhibitor [leniolisib]. The selective pi3kδ inhibitor [leniolisib] segment is anticipated to register a considerable CAGR in the coming years due to the rising drug approvals by several regulatory bodies, such as the FDA. Joenja, the first treatment option, is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3 kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients. Furthermore, the unavailability of alternative treatment options is driving the segment.
In terms of region, the global activated phosphoinositide 3 kinase delta syndrome (APDS) market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period owing to the availability of advanced healthcare technologies in the region. The availability of state-of-the-art technologies in the region for studying genetic disorders is supporting research and development activities in the field.
Increased diagnosis rates and rising awareness about APDS in the region contribute to the market growth. The robust healthcare system and high healthcare spending in North America fuel the market. Furthermore, the rising development of effective treatments and drug discovery due to the stable regulatory environment and a well-established pharmaceutical industry boosts the regional market.
The activated phosphoinositide 3 kinase delta syndrome (APDS) market has been segmented on the basis of
Key players competing in the global activated phosphoinositide 3 kinase delta syndrome (APDS) market are CSL Behring; Genentech, Inc.; Gilead Sciences, Inc.; GlaxoSmithKline Plc.; Grifols SA; LFB Biomedicaments; Novartis AG; Pfizer Inc.; Pharming Group NV; and Takeda Pharmaceuticals U.S.A. Inc.
These companies adopt several development strategies, including mergers, acquisitions, partnerships, collaboration, product launches, and production expansion, to expand their consumer base worldwide. For instance,
In March 2023, Skyepharma Production SAS announced that the FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3 kinase delta syndrome in adult and pediatric patients 12 years of age and above. Patients weighing at least 45 kg take 70 mg orally twice a day, approximately 12 hours apart.