PI3K Market Size Will Witness Robust Growth with Emerging Therapies by 2034 | DelveInsight

Companies working in the market are Gilead Sciences, Novartis, Roche/Genentech, Kazia Therapeutics, and others.

LAS VEGAS, NV, UNITED STATES, December 10, 2024 /EINPresswire.com/ --
The PI3K market is projected to experience rapid growth due to the expansion of indications for already approved therapies, increased R&D activities. Additionally, the competitive landscape is relatively sparse and the regulatory pathway for approval will likely involve extensive clinical trials to demonstrate safety and efficacy.

DelveInsight’s PI3K Market Insights report includes a comprehensive understanding of current treatment practices, emerging PI3K, market share of individual therapies, and current and forecasted PI3K market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Takeaways from the PI3K Market Report
As per DelveInsight’s analysis, the PI3K market is anticipated to grow at a significant CAGR by 2034.
Leading PI3K companies such as Gilead Sciences, Novartis, Roche/Genentech, Kazia Therapeutics, and others are developing novel PI3K that can be available in the PI3K market in the coming years.
Some of the key PI3K in the pipeline include IOA-244, FASLODEX, PIQRAY , and others.
In May 2024, the FDA granted priority review to inavolisib for the treatment of advanced HR-positive, HER2-negative breast cancer with a PIK3CA mutation. The FDA's decision is expected by the target action date of November 27, 2024.
The first success is Novartis’ PI3K inhibitor PIQRAY (alpelisib), which was approved in 2019 for breast cancer in combination with FASLODEX. Emerging drugs are currently active in solid tumors.
Currently, PIQRAY leads the market for PI3K inhibitors in HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, mainly for solid tumors.

Discover which therapies are expected to grab the PI3K market share @ PI3K Market Report

PI3K Market Dynamics

The PI3K market is shaped by a range of dynamics, driven by advancements in medical research and a growing understanding of complement system-related diseases. As research progresses, the pipeline for PI3K inhibitors is expanding, with several candidates undergoing clinical trials, which is expected to significantly impact market growth.

In the 7MM, the United States had the largest eligible pool of promising indications for PI3K inhibitors in oncology in 2023, followed by the EU4 countries and the UK. Peripheral T-cell lymphoma (PTCL) is more common in Asia than in North America and Europe, accounting for approximately 25% of all non-Hodgkin lymphoma (NHL) cases in Japan.

Learn more about the FDA-approved PI3K @ PI3K Drugs

Key Marketed PI3K and Companies

ZYDELIG (idelalisib) – Gilead Sciences

ZYDELIG, developed by Gilead Sciences, is a first-in-class PI3K delta inhibitor approved for the treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab. It is specifically indicated for patients where rituximab monotherapy is deemed appropriate due to coexisting medical conditions. In January 2022, Gilead Sciences voluntarily withdrew ZYDELIG's indications for relapsed follicular B-cell non-Hodgkin lymphoma (NHL) and relapsed small lymphocytic lymphoma (SLL) in patients who had received at least two prior systemic therapies.

PIQRAY (alpelisib) – Novartis

PIQRAY, developed by Novartis, is an oral alpha-specific PI3K inhibitor. It has demonstrated the ability to inhibit the PI3K pathway and exert antiproliferative effects in breast cancer cell lines harboring PIK3CA mutations. Studies have shown that cancer cell lines with these mutations are more sensitive to alpelisib (BYL719) compared to those without the mutation across various cancers. In July 2019, PIQRAY was launched in the United States as part of combination therapy for advanced or metastatic breast cancer, primarily as a second-line treatment or later.

Emerging Drugs in the PI3K Inhibitors Market

Paxalisib – Kazia Therapeutics

Paxalisib, the lead program of Kazia Therapeutics, is a brain-penetrant inhibitor targeting the PI3K/Akt/mTOR pathway. It is being developed for the treatment of various brain cancers. Originally licensed from Genentech in late 2016, the drug demonstrated early signs of clinical activity in glioblastoma during a completed Phase II trial in 2021. A pivotal study, GBM AGILE, is ongoing, with final data anticipated in the first half of 2024. Additionally, clinical trials are underway for indications such as brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several reporting promising interim results.

Paxalisib has received multiple regulatory designations from the FDA, including:
- Orphan Drug Designation (ODD) for glioblastoma (February 2018).
- Fast Track Designation (FTD) for glioblastoma (August 2020).
- Rare Pediatric Disease Designation and ODD for diffuse intrinsic pontine glioma (August 2020).
- ODD for atypical teratoid/rhabdoid tumors (June and July 2022).

Inavolisib – Roche/Genentech

Inavolisib, developed by Roche/Genentech, is an investigational oral treatment with potential best-in-class status. It aims to provide durable disease control and improved outcomes for patients with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited effective treatment options.

Inavolisib is designed to minimize treatment burden and toxicity, offering a high degree of specificity and potency for the PI3K alpha isoform compared to others. Its unique mechanism of action promotes the degradation of mutated PI3K alpha, distinguishing it from other PI3K inhibitors.

To know more about PI3K clinical trials, visit @ PI3K Treatment Drugs

PI3K Overview

Phosphatidylinositol 3-Kinases (PI3Ks) are key regulators of intracellular signaling and play a central role in cell functions such as proliferation, growth, survival, motility, and metabolism. Dysregulation of PI3K signaling is a major contributor to oncogenesis and is frequently implicated in various human cancers. These lipid kinases are activated by growth factors, cytokines, and other environmental signals, which leads to the activation of downstream pathways, including tyrosine kinases, GTPases, and GPCRs. There are three main classes of PI3K enzymes: Class I, Class II, and Class III, with Class II and Class III being less well-studied. Given the widespread alterations in PI3K activity across different cancer types, these enzymes represent important therapeutic targets.

Classes of PI3K Inhibitors

Class I PI3Ks: These are activated as heterodimers composed of a regulatory subunit (p85) and a catalytic subunit (p110). Class I PI3Ks activate downstream signaling through tyrosine kinases, GTPases, and GPCRs. There are four isoforms of the catalytic subunit (p110α, p110β, p110γ, and p110δ), each encoded by the PIK3CA, PIK3CB, PIK3CG, and PIK3CD genes, respectively. Among these, mutations in PIK3CA (encoding p110α) are the most commonly observed in cancers, particularly in early-stage colon and breast cancer.

Class II PI3Ks: Activated as monomers, Class II PI3Ks consist of three catalytic isoforms (C2α, C2β, and C2γ) and lack a regulatory subunit. While less studied, these enzymes play significant roles in both normal cellular processes and disease. For example, PI3KC2α and PI3KC2β are broadly expressed in the human body, with PI3KC2α specifically implicated in promoting breast cancer invasiveness by disrupting mitotic spindle formation.

Class III PI3Ks: The Class III PI3K, VPS34, is involved in processes like macrophage phagocytosis and autophagy. It forms a complex with both catalytic and regulatory subunits, and upon activation, it modulates downstream signaling by interacting with various protein kinases rather than directly activating traditional signaling pathways.

In conclusion, the dysregulation of PI3K signaling pathways in cancer highlights the therapeutic potential of targeting these enzymes.

PI3K Inhibitors Market Outlook

The PI3K pathway plays a critical role in driving various cancers, prompting extensive exploration of PI3K inhibitor therapies in oncology trials. This research has led to the regulatory approval of isoform-selective inhibitors like ZYDELIG, indicated for specific blood cancers, including relapsed/refractory (r/r) third-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and third-line follicular lymphoma. While PI3K inhibitors have demonstrated efficacy in r/r CLL, their clinical use has been limited due to the challenges of managing PI3K inhibitor-related adverse events. For example, both ZYDELIG and COPIKTRA carry black box warnings for severe risks, including hepatotoxicity, diarrhea/colitis, pneumonitis, infections, and intestinal perforation.

Recently, there has been a shift toward investigating the application of PI3K inhibitors in solid tumors. Originally approved for hematologic malignancies, these inhibitors are now being evaluated for solid tumors due to advancements in tolerability and efficacy. In hematological cancers, targeting the PI3Kδ isoform remains a promising strategy.

The PI3K delta inhibitor landscape, however, is undergoing rapid change. Established therapies such as ALIQOPA (copanlisib), COPIKTRA (duvelisib), and ZYDELIG (idelalisib), which have been used for relapsed follicular lymphoma, CLL, and SLL, are experiencing a decline in market presence. This trend is driven by significant adverse effects, including infections and liver toxicity, alongside the rise of more effective alternatives.

At the September 2023 UK Biochemical Society meeting in Barcelona, experts highlighted the evolving understanding of PI3K biology and signaling. They emphasized the potential for a new generation of PI3K-targeted drugs with novel mechanisms of action. Emerging therapies in the development pipeline could redefine the treatment landscape and reshape the drug approval market.

The future of PI3K inhibitors may be revitalized through innovative approaches in drug development and combination therapies. These strategies aim to improve efficacy while minimizing adverse effects, particularly for patients with hematological malignancies. As research progresses, these advancements could significantly enhance patient outcomes and expand the utility of PI3K inhibitors across cancer types.

Scope of the PI3K Market Report
Study Period: 2020–2034
PI3K Report Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key PI3K Companies:
Key PI3K:
PI3K Therapeutic Assessment: PI3K current marketed and emerging therapies
PI3K Market Dynamics: Conjoint Analysis of Emerging PI3K Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
PI3K Unmet Needs, KOL’s views, Analyst’s views, PI3K Market Access and Reimbursement

Discover more about PI3K drugs in development @ PI3K Clinical Trials

https://www.delveinsight.com/sample-request/pi3k-market-forecast?utm_source=einpresswire&utm_medium=pressrelease&utm_campaign=kpr

Table of Contents
1. PI3K Market Key Insights
2. PI3K Market Report Introduction
3. Executive Summary of PI3K
4. Key Events
5. PI3K Market Forecast Methodology
6. PI3K Market Overview at a Glance in the 7MM
7. PI3K: Background and Overview
8. PI3K Target Patient Pool
9. PI3K Marketed Drugs
10. PI3K Emerging Drugs
11. Seven Major PI3K Market Analysis
12. PI3K Market Access and Reimbursement
13. SWOT Analysis
14. KOL Views
15. PI3K Unmet Needs
16. Appendix
17. DelveInsight Capabilities
18. Disclaimer
19. About DelveInsight
Latest Reports by DelveInsight
About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Kritika Rehani
Email: info@delveinsight.com
Contact No.: +14699457679
City: 304 S. Jones Blvd #2432, Las Vegas
State: Nevada (89107)
Country: United States
Website: https://www.delveinsight.com/consulting

Kritika Rehani
DelveInsight Business Research LLP
+1 469-945-7679
email us here