The CDK4/6 inhibitors market is expected to grow significantly in the coming years. This is mainly due to the increasing incidence of HR+/HER2 breast cancer, the type for which CDK4/6 inhibitors are majorly prescribed.CDK4/6 inhibitors are now an established class, with all three approved CDK4/6 inhibitors reaching blockbuster status. An increasing number of emerging therapies are under clinical trials, whereas the approved ones are gearing up for label expansions.
DelveInsight’sCDK4/6 Inhibitors Market Insightsreport includes a comprehensive understanding of current treatment practices, emerging CDK4/6 inhibitors, market share of individual therapies, and current and forecasted CDK4/6 inhibitorsmarket size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
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Key Takeaways from the CDK4/6 Inhibitors Market Report
— As per DelveInsight’s analysis, the total market size of CDK4/6 inhibitors is expected to grow significantly by 2034.
— The total incident cases of HR+/HER2- breast cancer in the 7MM comprised approximately 475,500 cases in 2023.
— CDK4/6 inhibitors were initially approved for the Metastatic setting, comprising ˜6% of denovo metastatic cases and 30% of patients who progressed from Localized and Regional cases to Metastatic cases. Earlier, Lilly’s VERZENIO was the only one approved for high-risk early-stage patients, however recently in September 2024, Novartis’ KISQALI has joined the race.
— Novartis’ NATALEE also expands KISQALI’s scope to include node-negative patients, and this strategic move positions Novartis to potentially treat a wider range of breast cancer patients. Whereas VERZENIO’s first-mover benefits in node-negative patients could be a perk, even though it recently failed to provide significant benefits in prostate cancer patients.
— While Novartis is all set to give competition to VERZENIO in adjuvant breast cancer settings, It is also investigating KISQALI in pediatric patients with relapsed or refractory neuroblastoma.
— As far as sales performance is concerned, VERZENIO’s revenue almost doubled from 2020 to 2022, mainly attributed to its success in early-stage breast cancer. KISQALI’s sales surged globally, driven by its proven overall survival benefit. Whereas, even though IBRANCE is a leader in the CDK4/6 inhibitors class, its sales declined primarily due to reduced global demand from competitive pressure, fewer international clinical trial purchases, and planned price reductions in selected developed markets.
— Emerging CDK4/6 inhibitorcompanies such as Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, and others are developing novel CDK4/6 inhibitors that can be available in the CDK4/6 inhibitors market in the coming years.
— Trilaciclib (G1 Therapeutics), SPH4336 (Shanghai Pharma Biotherapeutics), Dalpiciclib (Jiangsu Hengrui Pharmaceuticals), PRT3645 (Prelude Therapeutics)and Euthare-155008 (Shengke Pharmaceuticals) are the other emerging CDK4/6 inhibitors being investigated in early stage (Phase II and I) for several indications.
— In May 2024, G1 Therapeutics and Pepper Bio announced a global licensing agreement (excluding Asia-Pacific) for lerociclib, a selective CDK4/6 inhibitor. Using their COMPASS platform, Pepper Bio identified CDK4/6 as key targets for Hepatocellular carcinoma, with preclinical models showing superior efficacy. Lerociclib is now advancing to Phase II trials.
Discover which therapies are expected to grab the CDK4/6 inhibitorsmarket share @ CDK4/6 Inhibitors Market Report
CDK4/6 Inhibitors Market Dynamics
The CDK4/6 inhibitors market has experienced significant growth in recent years, primarily driven by the increasing incidence/prevalence of cancer, particularly breast cancer. CDK4/6 inhibitors, such as palbociclib, ribociclib, and abemaciclib, have emerged as critical therapeutic agents in the treatment of HR+, HER2- advanced or metastatic breast cancer. The rising incidence of breast cancer, coupled with the demand for more effective and targeted therapies, has fueled the expansion of the CDK4/6 inhibitors market.
The competitive landscape of the CDK4/6 inhibitors market is marked by the presence of several key players, including Pfizer, Novartis, and Eli Lilly, who have established themselves as leaders through extensive research and development activities. These companies have invested heavily in clinical trials to expand the indications of their CDK4/6 inhibitors beyond breast cancer, exploring potential applications in other malignancies such as lung cancer and pancreatic cancer. Additionally, collaborations and partnerships with academic institutions and biotechnology firms have been instrumental in accelerating the development of next-generation CDK4/6 inhibitors, further intensifying the competition within the market.
Market dynamics are also influenced by regulatory approvals and the reimbursement landscape. The approval of CDK4/6 inhibitors by regulatory agencies such as the FDA and the EMA has been pivotal in their widespread adoption. However, the high cost of these therapies poses a challenge, necessitating favorable reimbursement policies to ensure patient access. Health insurance providers and government healthcare programs play a crucial role in determining the affordability and accessibility of CDK4/6 inhibitors, impacting their market penetration and overall growth.
Emerging markets in Asia-Pacific and Latin America present significant opportunities for the expansion of the CDK4/6 inhibitors market. These regions are witnessing a rise in cancer incidence rates, coupled with improving healthcare infrastructure and increasing awareness about advanced cancer therapies. However, challenges such as limited healthcare budgets and varying regulatory frameworks may pose obstacles to market growth in these regions. Nonetheless, strategic initiatives by pharmaceutical companies, such as establishing local manufacturing units and engaging in patient assistance programs, are expected to drive market expansion in these emerging economies.
In conclusion, the CDK4/6 inhibitors market is poised for continued growth, driven by the increasing burden of cancer, advancements in drug development, and strategic collaborations among key players. While challenges related to cost and accessibility remain, ongoing efforts to expand indications and penetrate emerging markets are likely to bolster the market’s trajectory. As research in oncology progresses, the CDK4/6 inhibitors market is expected to evolve, offering new hope for cancer patients worldwide.
CDK4/6 Inhibitors Treatment Market
Until now, the FDA has approved three CDK4/6 inhibitors for breast cancer only: IBRANCE (Pfizer), VERZENIO (Eli Lilly), and KISQALI (Novartis). Given their effectiveness in treating HR+/HER2- metastatic breast cancer, these drugs are being investigated for use in various other cancers too. Preclinical studies have suggested that CDK4/6 inhibitors can enhance tumor cell immunogenicity, prompting research into their combination with immune checkpoint inhibitors (ICIs). Additionally, CDK4/6 inhibitors, either as monotherapy or in combination, have shown promising results in preclinical and clinical trials for small-cell lung cancer treatment.
COSELAis a CDK4/6 inhibitor approved to reduce chemotherapy-induced myelosuppression in adult patients when administered before platinum/etoposide-containing or topotecan-containing regimens for extensive-stage small-cell lung cancer. The FDA granted Fast Track designation to investigate COSELA (trilaciclib) for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer in July 2021.
In February 2021, the FDA authorized COSELA (trilaciclib), a kinase inhibitor, for adult patients to decrease the incidence of chemotherapy-induced myelosuppression when administered before platinum/etoposide-containing or topotecan-containing regimens for extensive-stage small-cell lung cancer.
KISQALI is a CDK4/6 inhibitor sanctioned by the FDA to treat HR+/HER2- metastatic breast cancer in adults. It is approved for use in conjunction with an aromatase inhibitor as initial endocrine therapy or with fulvestrant as initial therapy, as well as after disease progression on endocrine therapy in postmenopausal women or men. The European Commission (EC) broadened KISQALI’s indication in December 2018, after its initial approval by the FDA in 2017. Additionally,in September 2024, the FDA expanded its label by including high-risk early-stage HR+/HER2- breast cancer patients.
Learn more about the FDA-approved CDK4/6 inhibitors @ CDK4/6 Inhibitors Drugs
Key Emerging CDK4/6 Inhibitors and Companies
Several key players, including Pfizer, G1 Therapeutics, and others, are involved in developing drugs for CDK4/6 inhibitors for various indications such as Prostate cancer, breast cancer, lung cancer, and others. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of CDK4/6 inhibitors and define their role in the therapy of cancer.
PF-07220060is a cutting-edge, highly selective inhibitor of CDK4, with minimal effect on CDK6. Its superior selectivity for CDK4 over CDK6 results in reduced neutropenia in in vivo models, allowing for higher dosing to achieve plasma concentrations beyond those reported for dual CDK4/6 inhibitors. This leads to enhanced CDK4 target engagement in tumors and better inhibition of tumor growth in CDK4-driven in vivo models of human breast cancer and other tumor types. The drug is currently undergoing evaluation in a pivotal Phase III trial for the treatment of second-line HR+ metastatic breast cancer.
Lerociclib is an oral CDK4/6 inhibitor with unique features such as increased selectivity and potency for CDK4 and CDK6, and a shorter half-life. Initial clinical data in HR+/HER2- breast cancer have shown that continuously dosed lerociclib offers a differentiated clinical profile compared to currently marketed CDK4/6 inhibitors, with better tolerability and less neutropenia while maintaining strong clinical activity. Lerociclib has been licensed to Genor Biopharma for the Asia-Pacific region (excluding Japan) and is under review by the National Medical Products Administration in China for first-line and second-line HR+/HER2- breast cancer. In March 2024, G1 Therapeutics and Pepper Bio announced a global (excluding Asia-Pacific) license agreement for lerociclib.
The anticipated launch of these emerging therapies are poised to transform the CDK4/6 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 CDK4/6 inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about CDK4/6 inhibitors clinical trials, visit @ CDK4/6 Inhibitors Treatment Drugs
CDK4/6 Inhibitors Overview
CDK4/6 inhibitors are a class of targeted cancer therapies designed to impede the activity of cyclin-dependent kinases 4 and 6. These kinases play a critical role in cell cycle regulation, particularly the transition from the G1 to the S phase, a point at which cells commit to DNA replication. By inhibiting CDK4/6, these drugs effectively halt cell division in cancer cells, leading to growth arrest and apoptosis. This targeted mechanism of action makes CDK4/6 inhibitors particularly effective in treating hormone receptor-positive, HER2-negative breast cancers, among other malignancies. Palbociclib, ribociclib, and abemaciclib are some of the most well-known drugs in this class, each showing significant efficacy in clinical trials.
In addition to their direct anti-proliferative effects, CDK4/6 inhibitors have been found to enhance the immune response against tumors. By modulating the tumor microenvironment, these inhibitors can improve the efficacy of immunotherapies, offering a promising avenue for combination treatments. However, their use is also associated with a range of side effects, such as neutropenia, anemia, and fatigue, which require careful management. Ongoing research aims to optimize the use of CDK4/6 inhibitors, identifying biomarkers for better patient selection and exploring novel combinations to overcome resistance mechanisms. These efforts are crucial for maximizing the therapeutic potential of CDK4/6 inhibitors and improving outcomes for patients with cancer.
CDK4/6 Inhibitors Epidemiology Segmentation
The total incident cases of HR+/HER2- Breast Cancer in the 7MM were ~480,000 in 2023, which is expected to reach up to ˜530,000 by 2034. In fact, among all current therapies being currently used in this patient setting, CDK4/6 inhibitors occupy more than 70% of the market share. With breast cancer is the leading indication, this class is also being evaluated in other cancer types such as neuroblastoma, hepatocellular carcinoma (HCC), Ewing sarcoma, endometrial cancer, brain cancer, and more.
The CDK4/6 inhibitors market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:
— Total Cases of Selected Indication For CDK4/6 Inhibitor
— Total Eligible Patient Pool of Selected Indications For CDK4/6 Inhibitors
— Total Treated Cases In Selected Indication for CDK4/6 Inhibitors
CDK4/6 Inhibitors Report Metrics Details Study Period 2020-2034 CDK4/6 Inhibitors ReportCoverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key CDK4/6 Inhibitors Companies Pfizer, Novartis, Eli Lilly, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, Astex Pharmaceuticals, and others Key CDK4/6 Inhibitors IBRANCE, KISQALI, VERZENIO, Atirmociclib (PF-07220060), Lerociclib, PRT3645, and others
Scope of the CDK4/6 InhibitorsMarket Report
— CDK4/6 Inhibitors Therapeutic Assessment: CDK4/6 Inhibitors current marketed and emerging therapies
— CDK4/6 InhibitorsMarket Dynamics: Conjoint Analysis of Emerging CDK4/6 Inhibitors Drugs
— Competitive Intelligence Analysis:SWOT analysis and Market entry strategies
— Unmet Needs, KOL’s views, Analyst’s views, CDK4/6 Inhibitors Market Access and Reimbursement
Discover more about CDK4/6 inhibitorsin development @ CDK4/6 Inhibitors Clinical Trials
Table of Contents
1 Key Insights 2 Report Introduction 3 Key Highlights from the Report 4 Executive Summary of CDK4/6 Inhibitors 5 Key Events 6 Epidemiology and Market Forecast Methodology 7 CDK4/6 Inhibitors Market Overview at a Glance in the 7MM 7.1 Market Share (%) Distribution by Therapies in 2020 7.2 Market Share (%) Distribution by Therapies in 2034 7.3 Market Share (%) Distribution by Indication in 2020 7.4 Market Share (%) Distribution by Indication 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 Cases in Selected Indications for CDK4/6 Inhibitors in the 7MM 9.3.2 Total Eligible Patient Pool of Selected Indications for CDK4/6 Inhibitors in the 7MM 9.3.3 Total Treated Cases in Selected Indications for CDK4/6 Inhibitors in the 7MM 10 Marketed Drugs 10.1 Key Competitors 10.2 KISQALI: Novartis 10.2.1 Product Description 10.2.2 Regulatory milestones 10.2.3 Others developmental activities 10.2.4 Safety and efficacy 10.2.5 Product Profile 10.3 COSELA: G1 Therapeutics 10.3.1 Product Description 10.3.2 Regulatory milestones 10.3.3 Others developmental activities 10.3.4 Safety and efficacy 10.3.5 Product Profile List to be continued in the report 11 Emerging Drugs 11.1 Key Competitors 11.2 Atirmociclib (PF-07220060): Pfizer 11.2.1 Product Description 11.2.2 Other developmental activity 11.2.3 Clinical developmental activities 11.2.3.1 Clinical trial information 11.2.4 Safety and efficacy 11.3 Lerociclib: G1 therapeutics and Pepper bio 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 PRT3645: Prelude Therapeutics 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 report 12 CDK4/6 Inhibitors: 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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