PLK1 Inhibitor Market Forecast

• The PLK Targeted Therapies Market Size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• Polo-like-kinases (PLKs) are a group of mitotic kinases involved in the regulation of the cell cycle. PLK-1, the most studied member of the PLK family, is a serine/threonine kinase that regulates transition into mitosis and maintains the G2/M checkpoint.
• The fundamental importance of PLK-1 lies in its ability to precisely control cell division, thereby ensuring genomic stability during mitosis, spindle formation, and appropriate response for DNA damage. Consequently, PLK-1 acts as an oncogene in multiple cancers with its overexpression being correlated with poor prognosis and its knockdown leading to death of cancer cells.
• PLK-1 inhibitors work by inhibiting the PLK-1 and as a result disrupt the essential functions of cells such as mitotic progression, leading to cell cycle arrest and ultimately cell death.
• PLK-1 therapies are not approved by any regulatory bodies yet, however, multiple PLK-1 inhibitors are currently being evaluated in clinical trials such as Cardiff Oncology’s Onvansertib is in Phase II and is anticipated to receive approval during the forecast period.
• In 2019, Oncoheroes Biosciences and Boehringer Ingelheim signed an exclusive licensing agreement for volasertib. Moreover, global development and commercialization rights to volasertib in adult disease indications were acquired by Notable from Oncoheroes Biosciences in 2021.
• During randomized clinical trials, Volasertib displayed substantial clinical response among a subgroup of participants in both phase 2 and phase 3 trials, with response rates ranging from 25% to 27%. However, another subset of patients did not experience therapeutic benefits from Volasertib and still encountered adverse effects. 
• Despite the phase 2 trial achieving statistical significance, the absence of a predictive biomarker to identify responsive patients led to the phase 3 trial failing to demonstrate statistically significant results.
• In an upcoming and redesigned phase 2 trial, Notable Labs will leverage its proprietary predictive precision medicine platform (PPMP) to identify and select volasertib-responsive patients before their treatment, enroll precisely the predicted clinical responders, and fast-track volasertib's clinical development in this patient population.
• Volasertib received rare pediatric disease designation (RPDD) and orphan drug designation (ODD) from the United States Food and Drug Administration (FDA) in 2020 for the treatment of pediatric rhabdomyosarcoma.
• Notable Labs, Cardiff Oncology, and others are currently engaged in the development and production of selective PLK-1 inhibitors, which have the potential to significantly impact and enhance the PLK-1i market.

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DelveInsight’s “PLK Targeted Therapies Market, Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the PLK-1 inhibitors, historical and forecasted epidemiology, competitive landscape as well as the PLK-1 inhibitors therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The PLK-1 Inhibitors Drugs Market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM PLK-1 inhibitors market size from 2020 to 2034. The report also covers current PLK-1 inhibitors treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

PLK Targeted Therapies Treatment Market

PLK-1 Inhibitors Drugs, a cell cycle regulating kinase, has been shown to have oncogenic function in several cancers. Polo‐like kinases (PLKs) consist of a family of five serine/threonine kinases (PLKs1-5) with distinct functions and expression patterns in cells. PLK1 is the most extensively studied family member, with critical functions in cell cycle progression, especially in G2-M checkpoint, mitosis, and cytokinesis. PLK1 activity is tightly regulated during cell cycle progression via binding to other phosphorylated scaffold proteins.

PLK1 was found to be overexpressed in various human tumors including head and neck squamous cell carcinomas, oropharyngeal carcinomas, non-small cell lung cancer, melanomas, ovarian and endometrial carcinomas, and others. The observed overexpression of PLK1 and its oncogenic role in several cancers has led to the development of PLK1-specific inhibitors, which have been studied in preclinical and clinical settings.

PLK-1 Inhibitors Treatment Landscape

PLK-1 inhibitors treatment refers to the use of drugs that target and inhibit the activity of polo-like kinase 1 (PLK-1), a protein involved in regulating cell division and proliferation. These inhibitors are being explored in various clinical settings, including cancer therapy, due to their potential to disrupt tumor cell growth and survival. In cancer treatment, PLK-1 inhibitors have shown promise in preclinical studies and early-phase clinical trials. By blocking PLK-1 activity, these inhibitors interfere with the cell cycle, leading to cell cycle arrest and ultimately inducing cell death in cancer cells.

PLK-1 inhibitors are being investigated for their efficacy in various types of cancer, including solid tumors and hematological malignancies. Research is ongoing to further understand their mechanisms of action, identify predictive biomarkers for patient selection, and optimize their therapeutic potential either as standalone treatments or in combination with other anticancer therapies. The development of PLK-1 inhibitors represents an exciting area of research in oncology, with the potential to offer new treatment options for patients with cancer. However, further clinical studies are needed to fully evaluate their safety, efficacy, and optimal use in different cancer types and patient populations.

PLK-1 Inhibitors Drugs Analysis

The PLK-1 Inhibitors Drugs Market chapter segment of the PLK-1 Inhibitors Market Outlook Report encloses a detailed analysis of PLK-1 inhibitors marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the PLK-1 inhibitors' 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.

PLK Targeted Therapies Market Emerging Drugs

• Onvansertib: Cardiff Oncology

Onvansertib is an Oral, well-tolerated PLK1-selective inhibitor. Currently, it is being tested in Phase II clinical trial as a combination therapy with various drugs for the treatment of metastatic colorectal cancer (mCRC), metastatic pancreatic ductal adenocarcinoma (mPDAC), triple-negative breast cancer (TNBC), and as a monotherapy for the treatment of small-cell lung cancer (SCLC).

• Volasertib: Notable Labs

Volasertib is a PLK-1 inhibitor with demonstrated activity in acute myeloid leukemia (AML) and other tumor types, including solid tumors, with significant unmet medical needs. Volasertib was originally developed and manufactured by Boehringer Ingelheim but currently, Notable Labs has exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers. Currently, Volasertib is in Phase II for the treatment of acute myeloid leukemia, and in Phase I for pediatric leukemia and myelodysplastic syndromes (MDS).

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PLK-1 Inhibitors Market Outlook

The PLK-1 Inhibitors Market Outlook is expected to grow significantly in the coming years. This is due to the increasing incidence of cancer, the growing awareness about PLK-1 inhibitors, and the increasing number of PLK-1 inhibitors that are under clinical trials. Till now, regulatory bodies have not approved any PLK-I inhibitor therapies.

Multiple PLK-1 inhibitors including BI2536, BI6727 (volasertib), GSK461364, and NMS-1286937(onvansertib) have been evaluated in clinical trials. All of these PLK1 inhibitors are ATP-competitive inhibitors and share a similar profile of action. Among these, GSK461364, BI2536, and BI6727 interact with Cys133, while NMS-1286937 interacts with Glu131 in addition to Cys133. Although PLK1 inhibitors, such as BI2536, BI6727 (volasertib), and NMS-1286937 (onvansertib) are generally well-tolerated with a favorable pharmacokinetic profile, clinical successes are limited due to partial responses in cancer patients, especially those in advanced stages. Recently, combination therapies targeting multiple pathways are being tested for cancer management.

Although PLK1 inhibition-based monotherapy has shown promise in clinical trials, it was not able to achieve a complete response for all patients. To address this problem, researchers have started combining PLK1 inhibitors with other agents. The rationale for using combination therapy in cancer treatment is mostly based on tumor characteristics of plasticity and heterogeneity. Combination therapy provides opportunities for targeting more than two pathways so it may eliminate cancer cells with various genetic backgrounds and impart superior or synergistic anticancer effects resulting in a rapid elimination before the development of drug resistance.

Volasertib exhibited significant clinical response in a portion of patients during both phase 2 and phase 3 randomized clinical trials, with response rates ranging from 25% to 27%. However, another subgroup of patients did not derive benefits from volasertib treatment and experienced adverse effects. Despite achieving statistical significance in the phase 2 trial, the phase 3 trial failed to demonstrate statistically significant outcomes due to the absence of a predictive biomarker to identify and stratify responsive patients. However, Notable Labs is planning to leverage its predictive precision medicine platform (PPMP) to identify and select volasertib-responsive patients and start Phase II trial.

Several key PLK1 Inhibitor Companies, including Notable Labs, Cardiff Oncology, and others, are involved in developing PLK-1 inhibitors for various indications such as metastatic colorectal cancer, acute myeloid leukemia, myelodysplastic syndromes, triple-negative breast cancer, small cell lung cancer, and others. To summarize, this is an exciting new class of agents that has seen some setbacks like a failure of volasertib in the Phase III trial but further study in selected patients is required to understand its safety and efficacy.

PLK-1 Inhibitors Drugs Market Uptake

This section focuses on the uptake rate of potential approved and emerging PLK-1 inhibitors expected to be launched in the market during 2020–2034.

PLK-1 Inhibitors Pipeline Development Activities

The PLK1 Inhibitor pipeline report provides insights into PLK1 Inhibitor clinical trials within Phase II, and Phase I. It also analyzes key PLK1 Inhibitor Companies involved in developing targeted therapeutics. The presence of numerous drugs under different stages is expected to generate immense opportunity for PLK-1i market growth over the forecasted period.

PLK-1 Inhibitors Pipeline Development Activities

The PLK1 Inhibitor market size report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PLK-1 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. For example, In November 2021, Oncoheroes Biosciences out-licensed the worldwide adult rights of volasertib to Notable Labs. Under the terms of this agreement, Oncoheroes will retain the license for the development and commercialization of volasertib for pediatric cancers and continue its commitment to childhood cancer. Notable Labs will have exclusive rights to develop and commercialize volasertib in adult cancer indications. Financial details of this deal are not disclosed.

KOL Views on PLK-1 Inhibitors

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 PLK-1 inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility. DelveInsight’s analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or PLK-1 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.

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PLK-1 Inhibitors Report Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Key Updates on PLK-1 Inhibitors Market

• In January 2024, Cardiff Oncology announced the publication of data from Phase Ib study in second-line mutated mCRC in Clinical Cancer Research. Findings highlight the safety and promising efficacy of onvansertib in combination with standard-of-care.
• Notable Labs revealed in its SEC filing that in both phase 2 and phase 3 trials, volasertib yielded significant clinical responses in a subgroup, with response rates ranging from 25% to 27%. However, the lack of a predictive biomarker led to inconsistent outcomes, with some patients experiencing toxicity without benefit, and the phase 3 trial failing to reach statistical significance.
• Global development and commercialization rights to volasertib in adult disease indications were acquired by Notable from Oncoheroes Biosciences in 2021.

Scope of the PLK1 Inhibitor Market Forecast Report

• The PLK Targeted Therapies Market Report covers a segment of key events, an executive summary, and a descriptive overview, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the PLK-1 Inhibitors Drugs Market Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the PLK-1 inhibitors market, historical and forecasted PLK1 Inhibitor market size, PLK1 Inhibitor market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM PLK-1 inhibitors market.

PLK-1 Inhibitors Market Outlook Report Insights

• PLK-1 Inhibitors Targeted Patient Pool
• Therapeutic Approaches for PLK Targeted Therapies Market
• PLK-1 Inhibitors Pipeline Analysis
• PLK-1 Inhibitors Market Size and Trends
• Existing and future Market Opportunity

PLK1 Inhibitor Market Forecast Report Key Strengths

• Eleven years Forecast in PLK Targeted Therapies Market
• The 7MM Coverage for PLK-1 Inhibitors Drugs Market
• Key Cross Competition 
• PLK1 Inhibitor Drugs Uptake
• Key PLK1 Inhibitor Market Forecast Assumptions

PLK Targeted Therapies Market Report Assessment

• Current PLK1 Inhibitor Treatment Market Practices
• PLK-1 Inhibitors  Unmet Needs
• PLK1 Inhibitor Pipeline Product Profiles
• PLK1 Inhibitor Market Attractiveness
• Qualitative Analysis (SWOT)
• PLK1 Inhibitor Market Drivers
• PLK1 Inhibitor Maret Barriers

Key Questions Answered In The PLK1 Inhibitor Market Report

• What was the PLK-1 inhibitor market size, the PLK1 Inhibitor market size by therapies, PLK1 Inhibitor market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for PLK-1 inhibitors?
• Which drug segment accounts for maximum PLK-1 inhibitor sales?
• What are the pricing variations among different geographies for approved therapies?
• How has the reimbursement landscape for PLK-1 inhibitors evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with PLK-1 inhibitors? What will be the growth opportunities across the 7MM for the patient population of PLK-1 inhibitors?
• What are the key factors hampering the growth of the PLK-1 inhibitors market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for PLK-1 inhibitors?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? 

Reasons to Buy PLK1 Inhibitor Market Forecast Report

• The PLK Targeted Therapies Market Report will help develop business strategies by understanding the latest trends and changing dynamics driving the PLK-1 inhibitors Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

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