CDK4/6 억제제 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• CDK4/6 inhibitors are effective treatments for prostate cancer, HR+/HER2-breast cancer, and other malignancies like small-cell lung cancer, hepatocellular carcinoma, and triple-negative breast cancer. However, it is primarily utilized for HR+/HER2- breast cancer treatment.
• The development and approval of CDK4/6 inhibitors have transformed the treatment landscape of HR+/HER2-metastatic breast cancer. Currently, three selective CDK4/6 inhibitor agents, including IBRANCE (palbociclib), KISQALI (ribociclib), and VERZENIO (abemaciclib), combined with endocrine therapy. They have been the preferred 1L treatment for many years but now NCCN has recommended KISQALI in 1L metastatic.
• VERZENIO has been noted to be the most potent CDK4/6 inhibitor, with excellent central nervous system activity due to its structure, allowing it to cross the blood-brain barrier and remain on target longer. This may be beneficial for patients with brain metastases.
• IBRANCE continues to be a leader in the CDK4/6 inhibitors class, with ~70% of patients in the US who are prescribed CDK4/6 inhibitors receiving an IBRANCE prescription.
• There is promising potential for expanding CDK4/6 inhibitor applications beyond HR+/HER2- advanced breast cancer.
• Patients who develop resistance to combined CDK4/6 inhibitors and endocrine treatments often switch to conventional chemotherapy due to disappointing outcomes with single-agent fulvestrant.
• The emerging pipeline is filled with therapies like Atirmociclib (Pfizer), BGB-43395 (BeiGene), PRT3645 (Prelude Therapeutics), BTX-9341 (Biotheryx), RGT-419B (Regor Pharmaceuticals/Roche), and others.
• G1 Therapeutics discontinued the investigation of COSELA for patients with metastatic Triple-negative Breast Cancer (TNBC) after a Phase III trial failed to meet the primary endpoint.
• CDK4/6 inhibitors have shown tremendous improvements in outcomes for women diagnosed with advanced breast cancer when used in conjunction with endocrine therapy.

DelveInsight's "CDK4/6 inhibitors - Target Population, Competitive Landscape, and Market Forecast - 2036" report delivers an in-depth understanding of the CDK4/6 inhibitors, historical and competitive landscape as well as the CDK4/6 inhibitors market trends in the US, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The CDK4/6 inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted CDK4/6 inhibitors 7MM market size from 2022 to 2036. The report also covers current CDK4/6 inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2022-2036

CDK4/6 Inhibitors Disease Understanding and Treatment Algorithm

CDK4/6 Inhibitors Overview

CDKs are proline-binding serine/threonine protein kinases. Based on the sequence of the kinase domain, CDKs are called cyclin-dependent protein kinases, mitogen-activated protein kinases, glycogen synthase kinases, or CDC-like kinases (CMGC). The CDK4/6 inhibitors act at the G1-to-S cell cycle checkpoint. This checkpoint is tightly controlled by the D-type cyclins and CDK4 and CDK6. When CDK4 and CDK6 are activated by D-type cyclins, they phosphorylate the retinoblastoma-associated protein (pRb). This releases pRb's suppression of the E2F transcription factor family and ultimately allows the cell to proceed through the cell cycle and divide. In HR+ breast cancer, cyclin D overexpression is common, and loss of pRb is rare, making the G1-to-S checkpoint an ideal therapeutic target. The CDK4/6 inhibitors prevent progression through this checkpoint, leading to cell cycle arrest.

Currently, the US FDA approved three CDK4/6 inhibitors IBRANCE, VERZENIO, and KISQALI for breast cancer. Considering the effectiveness of CDK4/6 inhibitors in HR + /HER2- metastatic breast cancer treatment, these drugs are under investigation for various cancers in different clinical scenarios. For instance, several preclinical studies have indicated that CDK4/6 inhibitors can boost tumor cell immunogenicity, leading to the exploration of CDK4/6 inhibitors and Immune Checkpoint Inhibitor (ICI) combinations. CDK4/6 inhibitors, either alone or in combination therapy, have been studied in preclinical and clinical trials for Small-cell lung cancer treatment, yielding promising results.

CDK4/6 Inhibitors Epidemiology

The CDK4/6 inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indications for CDK4/6 inhibitor, total eligible patient pool of selected indications for CDK4/6 inhibitors, total treated cases in selected indications for CDK4/6 inhibitors in the 7MM covering the US, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan from 2022 to 2036.

• The total incident cases of HR+/HER2- breast cancer in the 7MM comprised approximately 480,350 cases in 2024.
• Most cases of HR+/HER2- breast cancer occur in people aged 60-79 years.
• In 2024, in the US, the total cases of metastatic Castration-sensitive Prostate Cancer (mCSPC) and metastatic Castration-resistant Prostate Cancer (mCRPC) were around 70,300 and 52,600, respectively.
• The total incident cases of TNBC in the US comprised around 13,843 cases in 2024.
• Most cases of prostate cancer occur in people aged 54 years and older.

CDK4/6 Inhibitors Drug Chapters

The drug chapter segment of the CDK4/6 inhibitors reports encloses a detailed analysis of marketed drugs and late-stage (Phase III and Phase I/II) pipeline drugs. It also helps to understand the CDK4/6 inhibitor's clinical trial details, 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

COSELA (trilaciclib): G1 Therapeutics

COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage SCLC. The US FDA granted Fast Track Designation (FTD) to COSELA investigation for use in combination with chemotherapy to treat locally advanced or metastatic triple-negative breast cancer in July 2021.

In February 2021, the US FDA authorized COSELA for use in adult patients to reduce the occurrence of chemotherapy-induced myelosuppression when given before a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage SCLC.

KISQALI (ribociclib): Novartis and Astex Pharmaceuticals

KISQALI is a kinase inhibitor, approved by the US FDA for treating adult patients with HR+/HER2- metastatic breast cancer. It can be used in combination with an aromatase inhibitor as initial endocrine-based therapy with fulvestrant as initial endocrine-based therapy, or after disease progression on endocrine therapy in postmenopausal women or men. The European Commission (EC) expanded its indication for KISQALI in December 2018, following its initial approval by the FDA in 2017.

In September 2024, the US FDA approved KISQALI, an aromatase inhibitor for the adjuvant treatment of adults with HR+ HER2-negative stage II and III early breast cancer at high risk of recurrence. Additionally, the FDA also approved the KISQALI and letrozole co-pack for the same indication.

Emerging Drugs

Atirmociclib (PF-07220060): Pfizer

PF-07220060 is a next-generation highly selective CDK4 inhibitor with significant sparing of CDK6. Because of its greater selectivity for CDK4 over CDK6, PF-07220060 leads to less neutropenia in vivo models and, consequently, can be dosed higher to attain tolerated plasma concentrations that exceed those reported for dual CDK4/6i. This results in greater projected CDK4 target coverage in tumors and improved tumor growth inhibition by PF-07220060 across CDK4-driven in vivo models of human breast cancer and other tumor types. Currently, the drug is being evaluated in a Pivotal Phase III trial for the treatment of second-line HR+ metastatic breast cancer.

BGB-43395: BeiGene

BGB-43395 is a CDK4 inhibitor BGB-43395 for the treatment of metastatic HR+/HER2- breast cancer or other advanced solid tumors who received BGB-43395 either as monotherapy or in combination with fulvestrant or letrozole. It is being investigated in the Phase I.

Recent Developments in the CDK4/6 Inhibitors Market

• In September 2026, the FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant) in combination with abemaciclib, palbociclib, or ribociclib for HR-positive/HER2-negative locally advanced or metastatic breast cancer when an ESR1 mutation emerges during aromatase inhibitor plus CDK4/6 inhibitor therapy. The approval is based on the Phase III SERENA-6 study.
• In August 2026, the European Commission approved Kisqali (ribociclib) for adjuvant treatment of patients with HR-positive/HER2-negative early breast cancer at high risk of recurrence, further strengthening CDK4/6 inhibitors' role beyond metastatic disease.
• In August 2026, Updated Phase III NATALEE analyses examined the safety and treatment duration of ribociclib plus a nonsteroidal aromatase inhibitor in HR-positive/HER2-negative early breast cancer, adding longer-term evidence around adjuvant CDK4/6 inhibitor treatment.

CDK4/6 Inhibitors Market Outlook

The market for CDK4/6 inhibitors is expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of CDK4/6 inhibitors, and the increasing number of CDK4/6 inhibitors that are under clinical trials and filed for approval by various companies.

Endocrine therapy is a common first-line treatment in advanced or metastatic breast cancer, and resistance inevitably develops. Some patients may develop resistance to endocrine therapy with one agent class, and a response to treatment may occur with exposure to another class. Sequential endocrine therapy is preferred in postmenopausal women with HR+, HER2- metastatic breast cancer. Guidelines currently recommend aromatase inhibitors with the CDK4/6 inhibitors, IBRANCE, KISQALI, or FASLODEX as a first-line endocrine therapy option. As a second-line endocrine therapy option, fulvestrant in combination with IBRANCE or VERZENIO is recommended for patients with prior adjuvant endocrine therapy exposure or patients who received ET in the metastatic setting.

key players, including Pfizer, BeiGene, Biotheryx, 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.

CDK4/6 inhibitors Drugs Uptake

The incorporation of CDK4/6 inhibitors into the adjuvant treatment of patients with HR+ positive, HER2- early-stage breast cancer has introduced an additional strategy to reduce recurrence risk following standard multimodal therapy. In October 2021, the FDA approved VERZENIO in combination with endocrine therapy for the treatment of patients with HR-positive, HER2-negative, early-stage breast cancer at high risk of recurrence and a Ki67 score of 20% or greater based on results from the Phase III monarchE trial. Notably, the FDA's subsequent expansion of this indication in March removed the Ki-67 score requirement for patient selection. In September 2024, the FDA approved KISQALI plus an aromatase inhibitor for the treatment of patients with HR-positive, HER2-negative stage II/III early breast cancer at high risk of recurrence, based on data from the Phase IIIa NATALEE.

This section focuses on the uptake rate of potential approved and emerging CDK4/6 inhibitors expected to be launched in the market during 2026-2036.

CDK4/6 Inhibitors Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase I/II. It also analyzes key players involved in developing targeted therapy.

The presence of numerous drugs under different stages is expected to generate immense opportunity for CDK4/6 inhibitors market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for CDK4/6 inhibitor therapies.

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 CDK4/6 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 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University Hospital in Munich and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or CDK4/6 inhibitor 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. 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.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

Eli Lilly's VERZENIO Continuous Care Program provides access to the patients to its different programs, such as savings card through which commercially insured and eligible patients may pay as little as USD 0 a month, Companion in Care program that provides patients with help from the same person every time, and MyRightDose program simplifies midcycle dose reductions for patients and at no cost to them.

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.

Key Updates CDK4/6 Inhibitors

• In March 2025, Pfizer presented preliminary analysis of an ongoing Phase I/IIa study evaluating the safety, tolerability, and efficacy of atirmociclib (PF-07220060) in combination with letrozole demonstrating preliminary antitumor activity and a favorable safety profile in treatment-naive patients with HR+, HER2-negative metastatic breast cancer at the 42nd Annual Miami Breast Cancer Conference.
• In December 2024, BeiGene shared new data of BGB-43395 following its first-ever presentations at the San Antonio Breast Cancer Symposium (SABCS).

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the CDK4/6 inhibitor, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the 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 CDK4/6 inhibitor market, historical and forecasted market size, 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 CDK4/6 inhibitors market.

CDK4/6 Inhibitors Report Insights

• CDK4/6 inhibitors Targeted Patient Pool
• Therapeutic Approaches
• CDK4/6 Inhibitors Pipeline Analysis
• CDK4/6 Inhibitors Market Size and Trends
• Existing and future Market Opportunity

CDK4/6 Inhibitors Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions
• CDK4/6 Inhibitors Report Assessment
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the CDK4/6 inhibitor total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2036? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2036?
• Which are the most lucrative CDK4/6 inhibitors?
• What are the pricing variations among different geographies for approved therapies?
• How has the reimbursement landscape for CDK4/6 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 CDK4/6 inhibitors? What will be the growth opportunities across the 7MM for the patient population of CDK4/6 inhibitors?
• What are the key factors hampering the growth of the CDK4/6 inhibitor market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What regulatory have CDK4/6 inhibitors received, and how do these designations impact their development and approval?"?
• 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:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the CDK4/6 inhibitor 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) and 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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Key Highlights

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 2022
• 7.2. Market Share (%) Distribution by Therapies in 2036
• 7.3. Market Share (%) Distribution by Indication in 2022
• 7.4. Market Share (%) Distribution by Indication in 2036

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

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. BGB-43395: BeiGene
  • 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

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