본 보고서에서는 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본에서 포스포이노시티드 3 키나아제(PI3K) 억제제 시장을 조사했으며, 시장 배경, 시장 동향, 기존 약 및 신흥약의 개요, 경쟁 구도, 시장 점유율, 환자수, 시장 규모 추이와 예측, 언메트 메디컬 니즈와 시장 접근 및 상환 동향 등을 정리하고 있습니다.
PI3K 억제제 보고서의 주요 강점
PI3K 억제제 보고서 평가
DelveInsight's " Phosphoinositide 3-kinase inhibitors (PI3K) - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the PI3K inhibitors, historical and Competitive Landscape as well as the PI3K inhibitor market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The PI3K inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM PI3K inhibitors market size from 2020 to 2040. The report also covers current PI3K inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
PI3K Inhibitors Understanding
PI3K Inhibitors Overview
PI3K inhibitors are targeted cancer therapies designed to block the PI3K/AKT/mTOR pathway, a critical signaling cascade that regulates cell growth, survival, and metabolism. This pathway is tightly controlled in healthy cells but often becomes overactive in cancer due to genetic mutations or other alterations, leading to uncontrolled cell proliferation and tumor growth.
Classes of PI3K kinases
Class I PI3Ks are heterodimers with four isoforms (p110a, B, Y, δ) PIK3CA (p110a) is most often mutated in cancer.
Class II PI3Ks are monomers with three isoforms (C2a, C2B, C2Y) PI3KC2a is linked to breast cancer invasiveness.
Class III PI3Ks (VPS34) regulate autophagy and phagocytosis by forming protein complexes.
An important trend is the growing attention to solid tumors in the realm of PI3K inhibitors. While initially approved for hematological cancers, there's optimism that advancements in tolerability and efficacy might broaden their application to include solid tumors as well.
Further details are provided in the full report
PI3K Inhibitors Target Population
The PI3K inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by target pool (Incident Cases by Indication, Eligible and Treatable Cases by Indication) in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the PI3K inhibitors report encloses a detailed analysis of PI3K inhibitors marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the PI3K inhibitor's clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
ITOVEBI (inavolisib): Roche/Genentech
ITOVEBI is an investigational, oral targeted treatment with best-in-class potential that could provide well-tolerated, durable disease control and potentially improved outcomes for people with PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, who often have a poor prognosis and are in urgent need of new treatment options. ITOVEBI has been designed to help minimize the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and its unique mechanism of action that facilitates the degradation of mutated PI3K alpha.
In October 2024, the US FDA approved Genentech's ITOVEBI, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PI3KCA mutation.
ZYDELIG (idelalisib): Gilead Sciences
ZYDELIG developed by Gilead Sciences is a first-in-class inhibitor of PI3K delta indicated for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
In January 2022, Gilead Sciences had voluntarily withdrawn ZYDELIG's indications for patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma (SLL) who had undergone at least two prior systemic therapies.
Emerging Drugs
Paxalisib: Kazia Therapeutics
Kazia Therapeutics is developing paxalisib, a drug designed to penetrate the brain and block the PI3K/Akt/mTOR pathway. This drug is being developed to treat various types of brain cancer. Kazia licensed paxalisib from Genentech in late 2016. In 2021, a completed Phase II study in glioblastoma showed early signs that the drug might be effective. Currently, a major study called GBM AGILE is underway to test paxalisib in glioblastoma, with final results expected in the first half of 2024. Additionally, other clinical trials are testing paxalisib in brain metastases, diffuse midline gliomas, and primary CNS lymphoma. Some of these trials have already reported promising early results.
In January 2025, Kazia Therapeutics announced the launch of the ABC-Pax Phase 1b clinical trial, evaluating the combination of paxalisib with immunotherapy agents KEYTRUDA (pembrolizumab) or LYNPARZA (olaparib) in women with triple-negative breast cancer (TNBC).
Paxalisib received an Orphan Drug Designation (ODD) from the FDA for glioblastoma in February 2018, and Fast Track Designation (FTD) for glioblastoma in August 2020. It was also given Rare Pediatric Disease Designation (RPDD) and ODD for diffuse intrinsic pontine glioma (DIPG) in August 2020. Later, in June 2022 and July 2022, paxalisib was granted ODD for atypical teratoid/rhabdoid tumors. These designations help speed up the development and review of the drug for these serious conditions.
The PI3K pathway is crucial in driving various cancers, and numerous PI3K-targeted therapies have been explored in oncology trials. This led to the regulatory approval of the isoform-selective inhibitor ZYDELIG for specific blood cancers, including relapsed/refractory (r/r) third-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and third-line follicular lymphoma. Although PI3K inhibitors have shown effectiveness in treating r/r CLL, their usage has been restricted due to the management complexities associated with PI3K inhibitor-related adverse events. For instance, ZYDELIG and COPIKTRA carry black box warnings for severe risks such as hepatotoxicity, diarrhea/colitis, pneumonitis, infections, and intestinal perforation.
There is an increasing focus on applying PI3K inhibitors to solid tumors. Initially approved for hematological cancers, these inhibitors are now being considered for solid tumors due to potential advancements in their tolerability and efficacy. Targeting the PI3Kδ isoform is particularly seen as a promising strategy for hematological malignancies.
The PI3K delta inhibitors landscape is rapidly evolving. 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 because of significant adverse effects, including infections and liver toxicity, along with 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 era of PI3K-targeting drugs with novel mechanisms of action. Emerging therapies in the pipeline hold the potential to transform the drug approval market. As these new treatments advance, they could significantly change the available therapy landscape. Additionally, there is growing interest in combination therapies, which 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 addressing the needs of patients with hematological malignancies.
This section focuses on the uptake rate of potential approved and emerging PI3K inhibitors expected to be launched in the market during 2025-2034. The addition of inavolisib to the standard of care treatment significantly delayed disease progression in the first-line setting and has the potential to extend survival for people with metastatic breast cancers that harbor PIK3CA mutations.
PI3K Inhibitors Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. The presence of numerous drugs under different stages is expected to generate immense opportunity for PI3K inhibitors market growth over the forecast period.
Pipeline development activities
The report covers information on designation, collaborations, acquisitions and mergers, licensing, and patent details for PI3K inhibitors emerging therapies. The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion.
KOL Views
To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the PI3K inhibitor evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Cancer Research UK Barts Centre in London, and Rutgers University, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or PI3K inhibitors market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
NICE Decision for PIQRAY (alpelisib)
Alpelisib plus fulvestrant is recommended as an option for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced, or metastatic breast cancer in adults only if:
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
ASCO 2024 Updates on PI3K Inhibitor
The abstract list is not exhaustive, and will be provided in the final report...
PI3K Inhibitors Report key strengths
PI3K Inhibitors report assessment
List to be continued in the full report
List to be continued in the full report