PI3K Inhibitors Market to Observe Stunning Growth During the Study Period (2020-2034) | DelveInsight

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Aug 21, 2024, 14:25 ET

The PI3K inhibitors market is projected to witness remarkable growth by 2034, driven by advancements in cancer treatment and the increasing prevalence of oncological disorders. Enhanced research and development activities, along with strategic collaborations, are expected to further propel market expansion.

LAS VEGAS, Aug. 21, 2024 /PRNewswire/ -- DelveInsight's PI3K Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging PI3K inhibitors, market share of individual therapies, and current and forecasted PI3K inhibitors 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 Inhibitors Market Report

As per DelveInsight's analysis, the current market size of PI3K Inhibitors is anticipated to grow significantly in the 7MM by 2034.
While the first approved PI3K inhibitors were limited to hematological cancer, the therapeutic window has now broadened towards solid tumors as well.
Approximately 40% of people with HR-positive breast cancer have a PIK3CA mutation and often face poorer prognosis and resistance to endocrine treatment.
The first success is Novartis' PI3K inhibitor PIQRAY (alpelisib), which was approved in 2019 for breast cancer in combination with FASLODEX. Now, Roche's Inavolisib is the strongest player in the pipeline expected to address the first line HR-positive, HER2-negative PI3K mutated Breast Cancer patients
Currently, PIQRAY leads the market for PI3K inhibitors in HR-positive, HER2-negative, and PIK3CA-mutated advanced or metastatic breast cancer, mainly for solid tumors.
Accelerated approvals in certain indications for four approved products have all been voluntarily withdrawn because of problems with confirmatory trials: Gilead Sciences' ZYDELIG; Bayer's ALIQOPA; Secura's COPIKTRA; and TG Therapeutics' UKONIQ.
Leading PI3K inhibitor companies such as Novartis, Roche, Genentech, Celcuity, Kazia Therapeutics, Rhizen Pharmaceuticals, and others are developing novel PI3K inhibitors that can be available in the PI3K inhibitors market in the coming years.
Some of the emerging key PI3K inhibitors include Inavolisib, Gedatolisib, Paxalisib, Tenalisib, and others.

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

PI3K Inhibitors Market Dynamics

The PI3K inhibitors market is characterized by dynamic growth and a rapidly evolving landscape driven by advancements in cancer research, increasing incidence of cancer, and rising awareness about targeted therapies. This market has garnered significant attention from pharmaceutical companies and researchers alike due to its potential to provide more effective and less toxic treatment options compared to conventional chemotherapy.

As cancer remains one of the leading causes of mortality worldwide, there is a pressing need for new and innovative treatment options. PI3K inhibitors offer a promising approach by specifically targeting cancer cells, thereby minimizing damage to normal cells and reducing side effects. The growing understanding of the molecular mechanisms underlying cancer progression has led to the identification of the PI3K pathway as a critical target, further propelling the market.

The regulatory landscape also plays a crucial role in shaping the dynamics of the PI3K inhibitors market. The approval of several PI3K inhibitors by regulatory bodies such as the FDA and the EMA has boosted the market's growth. These approvals are often based on robust clinical trial data demonstrating the efficacy and safety of PI3K inhibitors in treating specific cancer types. However, the regulatory environment is also marked by challenges, including stringent approval processes and the need for comprehensive post-marketing surveillance to monitor long-term effects and potential adverse events.

Competition within the PI3K inhibitors market is intense, with numerous pharmaceutical companies investing heavily in research and development to bring new and improved therapies to market. Key players are focusing on expanding their product portfolios through strategic collaborations, acquisitions, and partnerships. Additionally, the market is witnessing a surge in clinical trials aimed at exploring the efficacy of PI3K inhibitors in combination with other therapies, such as immune checkpoint inhibitors and other targeted therapies. These combination approaches hold promise for overcoming resistance mechanisms and enhancing treatment outcomes.

Despite the promising outlook, the PI3K inhibitors market faces several challenges, including high development costs, complex regulatory requirements, and the emergence of resistance to PI3K inhibitors. Addressing these challenges requires continued investment in research and development, as well as collaboration between industry, academia, and regulatory bodies. As the understanding of cancer biology continues to advance, the PI3K inhibitors market is poised for significant growth, offering hope for improved treatment options for cancer patients worldwide.

PI3K Inhibitors Treatment Market

The PI3K pathway plays a key role in driving various cancers, and numerous PI3K-targeted therapies have been tested in oncology trials. This has led to the regulatory approval of the isoform-selective inhibitor ZYDELIG for certain blood cancers, such as relapsed/refractory third-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and third-line follicular lymphoma. While PI3K inhibitors have shown effectiveness in treating R/R CLL, their use has been limited due to the complex management of PI3K inhibitor-related side effects. For instance, ZYDELIG and COPIKTRA carry black box warnings for serious risks like hepatotoxicity, diarrhea/colitis, pneumonitis, infections, and intestinal perforation.

There is growing interest in using PI3K inhibitors for solid tumors. Initially approved for blood cancers, these inhibitors are now being considered for solid tumors due to potential improvements in their tolerability and efficacy. Targeting the PI3K delta isoform is particularly promising for hematological malignancies.

The landscape of PI3K delta inhibitors is rapidly changing. Previously prominent treatments like ALIQOPA (copanlisib), COPIKTRA (duvelisib), and ZYDELIG (idelalisib) were used for relapsed follicular lymphoma, chronic lymphocytic leukemia, and small lymphocytic lymphoma. However, their market presence is declining due to significant side effects, including infections and liver toxicity, and the emergence of more effective therapies.

At the September 2023 meeting of the UK Biochemical Society in Barcelona, experts discussed the PI3K pathway and suggested that advancing the understanding of PI3K biology and signaling could lead to a new generation of PI3K-targeting drugs with novel mechanisms of action. Emerging therapies in the pipeline have the potential to transform the drug approval market. As these new treatments progress, they could significantly alter the available therapy landscape. Additionally, there is increasing interest in combination therapies that aim to enhance efficacy while reducing adverse effects. The future of PI3K inhibitors may be revitalized through innovative drug development and strategic combination regimens, better meeting the needs of patients with hematological malignancies.

Learn more about the FDA-approved PI3K inhibitors @ PI3K Inhibitors Drugs

Key Emerging PI3K Inhibitors and Companies

Key emerging players in the PI3K inhibitors market include Roche, Genentech, Celcuity, Rhizen Pharmaceuticals, Kazia Therapeutics, and others.

Kazia Therapeutics' lead program is paxalisib, a brain-penetrant inhibitor targeting the PI3K/AKT/mTOR pathway, intended to treat various brain cancers. This drug, licensed from Genentech in late 2016, showed early signs of clinical efficacy in a completed Phase II glioblastoma study in 2021. Currently, it is undergoing a pivotal study in glioblastoma called GBM AGILE, with final data anticipated in the first half of 2024. Additionally, paxalisib is being tested in clinical trials for brain metastases, diffuse midline gliomas, and primary CNS lymphoma, with several trials showing promising interim results.

The FDA granted paxalisib Orphan Drug Designation (ODD) for glioblastoma in February 2018 and Fast Track Designation (FTD) for glioblastoma in August 2020. Furthermore, the FDA awarded it Rare Pediatric Disease Designation and ODD for diffuse intrinsic pontine glioma in August 2020, and for atypical teratoid/rhabdoid tumors in June and July 2022, respectively.

Inavolisib is an investigational oral targeted therapy with the potential to be best-in-class, offering well-tolerated and durable disease control with potentially better outcomes for individuals with PIK3CA-mutated, HR+/HER2-advanced, or metastatic breast cancer. These patients often have a poor prognosis and urgently need new treatment options. Inavolisib is designed to minimize the overall treatment burden and toxicity, setting it apart from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform and its unique mechanism that aids in the degradation of mutated PI3K alpha.

In May 2024, the FDA granted priority review to inavolisib for advanced HR+/HER2-breast cancer with a PIK3CA mutation. The target date for the FDA's decision is November 27, 2024.

Other PI3K inhibitors in the pipeline include

Gedatolisib: Celcuity
Tenalisib: Rhizen Pharmaceuticals

The anticipated launch of these emerging therapies are poised to transform the PI3K inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the PI3K inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

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

PI3K Inhibitors Overview

Phosphoinositide 3-kinases (PI3Ks) are a family of enzymes involved in cellular functions such as growth, proliferation, and survival. Dysregulation of the PI3K pathway is commonly associated with various cancers, making PI3K inhibitors a significant focus in oncology. These inhibitors target the PI3K/AKT/mTOR signaling pathway, which is often overactive in cancer cells, leading to uncontrolled cell growth and survival. By inhibiting PI3K, these drugs can effectively reduce tumor growth and enhance the efficacy of other treatments. Several PI3K inhibitors have been developed and approved for clinical use, with some being specifically tailored to target certain isoforms of the enzyme to minimize side effects and maximize therapeutic efficacy.

Despite their promise, PI3K inhibitors face challenges such as drug resistance and toxicity. Resistance can occur through various mechanisms, including mutations in the PI3K pathway or activation of alternative signaling pathways. Toxicity is another concern, as PI3K inhibitors can affect normal cells, leading to side effects such as hyperglycemia, rash, and gastrointestinal issues. Ongoing research aims to overcome these hurdles by developing more selective inhibitors, combination therapies, and personalized treatment strategies based on genetic profiling. The evolving understanding of PI3K biology and its role in cancer continues to drive the innovation and optimization of PI3K inhibitors in the fight against cancer.

PI3K Inhibitors Target Population

In the 7MM, the highest eligible pool of promising indications for PI3K inhibitors in oncology was seen in the United States, followed by EU4 and the UK in 2023. The PI3K inhibitors market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Incident Cases of Selected Indications for PI3K inhibitors
Eligible Patient Pool of Selected Indications
Treatable Cases of Selected indications for PI3K inhibitors

PI3K Inhibitors Report Metrics	Details
Study Period	2020–2034
PI3K Inhibitors Report Coverage	7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key PI3K Inhibitors Companies	Gilead Sciences, Secura Bio, Novartis, Roche, Genentech, Celcuity, Kazia Therapeutics, Rhizen Pharmaceuticals, and others
Key PI3K Inhibitors	ZYDELIG, COPIKTRA, PIQRAY, Inavolisib, Gedatolisib, Paxalisib, Tenalisib, and others

Scope of the PI3K Inhibitors Market Report

PI3K Inhibitors Therapeutic Assessment: PI3K Inhibitors current marketed and emerging therapies
PI3K Inhibitors Market Dynamics: Conjoint Analysis of Emerging PI3K Inhibitors Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's views, Analyst's views, PI3K Inhibitors Market Access and Reimbursement

Discover more about PI3K inhibitors in development @ PI3K Inhibitors Clinical Trials

Table of Contents

1	Key Insights
2	Report Introduction
3	Key Highlights from the Report
4	Executive Summary of PI3K Inhibitors
5	Key Events
6	Epidemiology and Market Forecast Methodology
7	PI3K Inhibitor Market Overview at a Glance in the 7MM
7.1	Market Share (%) Distribution by Therapies in 2023
7.2	Market Share (%) Distribution by Therapies in 2034
7.3	Market Share (%) Distribution by Indications in 2023
7.4	Market Share (%) Distribution by Indications in 2034
8	Background and Overview
8.1	Introduction
8.2	Treatment
9	Target Patient Pool
9.1	Key Findings
9.2	Assumptions and Rationale: 7MM
9.3	Epidemiology Scenario in the 7MM
9.3.1	Total Incident Cases in Selected Indications for PI3K Inhibitor in the 7MM
9.3.2	Total Eligible Patient Pool for PI3K Inhibitor in Selected Indications in the 7MM
9.3.3	Total Treated Cases in Selected Indications for PI3K Inhibitor in the 7MM
10	Marketed Drugs
10.1	Key Cross of Marketed Therapies
10.2	ZYDELIG (idelalisib): Gilead Sciences
10.2.1	Product description
10.2.2	Regulatory milestones
10.2.3	Other developmental activities
10.2.4	Ongoing clinical developmental activities
10.2.5	Safety and efficacy
10.2.6	Product profile
10.3	PIQRAY (alpelisib): Novartis
10.3.1	Product description
10.3.2	Regulatory milestones
10.3.3	Others developmental activities
10.3.4	Ongoing clinical developmental activities
10.3.5	Safety and efficacy
10.3.6	Product profile
*List to be continued in the full report
11	Emerging Drugs
11.1	Key Competitors
11.2	Paxalisib: Kazia Therapeutics
11.2.1	Product description
11.2.2	Other developmental activity
11.2.3	Clinical developmental activities
11.2.3.1	Clinical trial information
11.3	Inavolisib: Roche/Genentech
11.3.1	Product description
11.3.2	Other developmental activity
11.3.3	Clinical developmental activities
11.3.3.1	Clinical trial information
11.3.4	Safety and efficacy
11.4	Roginolisib: iOnctura
11.4.1	Product description
11.4.2	Other developmental activity
11.4.3	Clinical developmental activities
11.4.3.1	Clinical trial information
11.4.4	Safety and efficacy
*List to be continued in the full report
12	PI3K Inhibitor: 7MM analysis
12.1	Key Findings
12.2	Market Outlook
12.3	Conjoint Analysis
12.4	Key Market Forecast Assumptions
12.4.1	Cost Assumptions and Rebates
12.4.2	Pricing Trends
12.4.3	Analogue Assessment
12.4.4	Launch Year and Therapy Uptakes
12.5	Market Size by Indications in the 7MM
12.6	Market Size by Therapies in the 7MM
12.7	United States Market Size
12.7.1	Market Size by Indications in the US
12.7.2	Market Size by Therapies in the US
12.8	EU4 and the UK Market Size
12.8.1	Market Size by Indications in EU4 and the UK
12.8.2	Market Size by Therapies in EU4 and the UK
12.9	Japan Market Size
12.9.1	Market Size by Indications in Japan
12.9.2	Market Size by Therapies in Japan
13	Unmet Needs
14	SWOT Analysis
15	KOL Views
16	Market Access and Reimbursement
17	Appendix
17.1	Bibliography
17.2	Report Methodology
18	DelveInsight Capabilities
19	Disclaimer
20	About DelveInsight

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