Cyclin-Dependent Kinase CDK6 inhibitors are small molecules that block the activity of cyclin-dependent kinase 6 (CDK6), a key enzyme involved in cell cycle progression. By inhibiting CDK6, these drugs prevent the phosphorylation of retinoblastoma protein (Rb) and subsequent release of E2F transcription factors, leading to cell cycle arrest and suppression of cell proliferation. This mechanism of action makes CDK6 inhibitors promising therapeutic agents for the treatment of various cancers such as leukemia, sarcoma, breast cancer, adenocarcinoma, etc. Due to their potential efficacy in treating various types of cancer, particularly breast cancer, and, the growing understanding of CDK6’s role in cell cycle regulation and tumor progression, the growth rate of the CDK6 inhibitor market is expected to reach new heights in the forecast period. According to the Centers for Diseases Control and Prevention, breast cancer is the second most common cancer among women in the USA, which accounts for 264,000 new cases and 42000 deaths every year. Companies such as Pfizer, Amgen, Eli Lilly, Novartis, Sino Pharmaceutical, Otsuka, G1 Therapeutics, Simcere, EQRx, and Walvax currently cater to breast cancer, hematological malignancy, and other related carcinoma segments. Ibrance is one of the prominent drugs by Pfizer which is being used to treat lymphoma, leukemia, and breast carcinoma. Moreover, Verzenio by Eli Lilly and Kisqali by Novartis are other prominent drugs that are used extensively in cases of cholangiocarcinoma and Glioblastoma respectively, apart from getting used in before mentioned indications. Moreover, many companies are coming up with new molecules in this space. For instance, Pfizer is one such company that is currently conducting a clinical trial of the drug PF-06873600 for the treatment of metastatic breast cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Key Developments:
- In October 2021, USFDA approved Eli Lilly and Company’s Verzenio (Abemaciclib), in combination with endocrine therapy(Tamoxifen) for HR(+) HER2(–) high-risk breast cancer
- In November 2020, Arvinas Inc entered into a collaboration and supply agreement with Pfizer in connection with a planned phase Ib cohort expansion evaluating ARV 471 in combination with Pfizer’s Ibrance (Palbociclib), an oral CDK 6 inhibitor
- In March 2019, Pfizer released a statement that the USFDA has approved Ibrance (Palbociclib) for the treatment of men with HR(+), HER2(-) metastatic breast cancer.
Approved CDK6 Inhibitors
- Palbociclib (Ibrance)
- Abemaciclib (Verzenio)
- Ribociclib (Kisqali)
- Trilaciclib (Cosela)
Pipeline Molecules - CDK6 Inhibitors
- TQB3616 (Sino biopharmaceutical)- Phase- II/III
- FCN-437 (Fosun Pharmaceuticals)- Phase II/III
- BPI-16350 (Betta Pharmaceuticals)-Phase I/III
- PF-06873600 (Pfizer)- Phase-II
- GLR2007 (Gan & Lee Pharmaceuticals)- Phase II
- SPH4336 (Shanghai Pharmaceuticals)-Phase II
- PF-06842847 (Pfizer)-Phase I
- TY-302 (TYK Medicines)- Phase-I
Clinical Activity and Development of CDK6 Inhibitor
In the CDK6 inhibitor space, approximately 33 companies are focusing on 268 disease indications, and more than 480 clinical trials are being conducted in this category of drugs. For instance,
- In July 2022, Novartis started a phase IV post-trial access roll-over study with 137 participants to evaluate the long-term safety of Ribociclib, which is estimated to get completed on February 2028
- In May 2021, AstraZeneca started a phase III randomized study of Capivasertib plus CDK6 and Fulvestrant versus placebo plus CDK6 and Fulvestrant in HR(+) and HER2(-) locally advanced, unresectable, or metastatic breast cancer.
Target Indication Analysis of CDK6 Inhibitor
The CDK6 inhibitors are primarily used to treat breast cancer, leukemia, lymphoma, and adenocarcinoma. CDK6 inhibitors also help to prevent myelosuppression. For instance, Cosela is one drug by G1 Therapeutics which is used 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 small cell lung cancer (ES-SCLC). In the treatment of acute lymphocytic leukemia and immunoproliferative disorders, CDK6 inhibitor Palbociclib is used widely. Through research and development, the indications in which CDK6 inhibitors can be used are getting expanded. For instance, according to a PubMed publication of March 2022, CDK 6 inhibitors can also be used in adjuvant settings other than metastatic settings in the treatment of HR (+), and HER2(-) breast cancer.
Regional Analysis of CDK6 Inhibitor
CDK6 Inhibitors Market
The global CDK6 inhibitor market is segmented into five major regions that are North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. The North American CDK6 inhibitor market reveals a promising landscape for the pharmaceutical industry. The market in North America is driven by factors such as the high prevalence of cancer, advanced healthcare infrastructure, and a strong emphasis on research and development. Major countries contributing to the North American market for CDK6 inhibitors include the United States and Canada. The United States, being a frontrunner in the healthcare industry, holds a significant share of the market. According to the American Cancer Society, about 1 in every 8 US women is going to develop invasive breast cancer in the course of life. The country boasts a robust pharmaceutical sector, extensive clinical trial networks, and a large patient population. Canada, on the other hand, is known for its well-established healthcare system and supportive regulatory framework, making it an attractive market for CDK6 inhibitors. These countries are increasingly adopting CDK6 inhibitors due to their efficacy and potential to improve patient outcomes. On the other hand, the CDK6 inhibitor market in Europe has witnessed significant growth in recent years. Major countries driving this market include Germany, France, the United Kingdom, Italy, and Spain. These countries have a robust pharmaceutical industry and a high prevalence of cancer, which is a key indication for CDK6 inhibitors. The market is characterized by a well-established healthcare infrastructure, strategic collaborations between pharmaceutical companies, and growing awareness about targeted therapies. With the ongoing advancements in drug development and personalized medicine approaches, the Europe regional market for CDK6 inhibitors is expected to continue its upward trajectory.
Latin America
Europe
Asia Pacific
Middle East
North America
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- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
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Frequently Asked Questions
The approved molecules of CDK6 inhibitors are Palbociclib, Abemaciclib, Ribociclib, and Trilaciclib.
The increasing prevalence of breast cancer, advanced healthcare infrastructure, and a strong emphasis on research and development are the primary drivers for market growth.
The major players in this space are Pfizer, Amgen, Eli Lilly, Novartis, Sino Pharmaceuticals, Fosun Pharmaceuticals, Otsuka, G1 therapeutics, Simcere, Shanghai Pharmaceuticals, Jiangsu Hengrui Pharmaceuticals, Betta Pharmaceuticals, Walvax, EQRx.
The emergence of alternative treatment options, such as other targeted therapies or combination therapies, and stringent reimbursement policies in some regions as well as the high cost of drugs can limit their use and impact market growth.
- Pfizer
- Amgen
- Eli Lilly
- Novartis
- Sino Pharmaceuticals
- Fosun Pharmaceuticals
- Otsuka
- G1 therapeutics
- Sino Pharmaceuticals
- Simcere
- Shanghai pharma
- Jiangsu Hengrui Pharmaceuticals
- Betta Pharmaceuticals
- Walvax
- EQRx