Global Cancer CDK Inhibitors Market - 2021-2028
Market Overview
The Global Cancer CDK Inhibitors Market size was worth US$ XX billion in 2020 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
A CDK (cyclin-dependent kinase) inhibitor is a chemical that inhibits the function of CDKs. They are used to treat cancers by preventing the over proliferation of cancer cells. CDK4/6 inhibitors are a newer class of drugs used to treat certain types of metastatic breast cancer, which is cancer that has spread to other parts of the body, such as the bones or liver. These drugs interrupt the process through which breast cancer cells divide and multiply by targeting specific proteins known as cyclin-dependent kinases 4 and 6. They are also used in various types of cancers lung cancers, breast cancers, Thyroid cancer. Currently there are three CDK4/6 inhibitors used to treat metastatic breast cancer Ibrance (palbociclib), Kisqali (ribociclib), Verzenio (abemaciclib) approved by US FDA.
Market Dynamics
The global Cancer CDK Inhibitors market growth is driven by the growing incidence of cancer cases, presence of strong clinical pipeline, Advancement in R&D are among the key factors driving the market growth.
Increasing incidence of Cancer Cases, is expected to drive the global Cancer CDK Inhibitors market during the forecast period.
According to the World Health Organisation (WHO), Cancer is the second-most leading cause of death worldwide, accounting for over 18.1 million cases were diagnosed in 2018. The most common cancers occurring in the U.S include lung cancer, breast cancer, prostate cancer, colorectal Cancer, thyroid cancer, pancreatic Cancer, non-Hodgkin lymphoma, melanoma, renal pelvis cancer, kidney cancer and leukemia. In 2020, around 19 Mn new cancer cases were diagnosed across the world as per the WHO. Likewise, the American Cancer Society reported that 89,500 cases were diagnosed in the U.S. in 2020. This number has led to an increase in the adoption of cancer CDK inhibitors.
Presence of strong clinical pipeline, is expected to drive the global Cancer CDK Inhibitors market during the forecast period.
In August 2020: ARC Therapeutics, a development-stage pharmaceutical company developing small molecule inhibitors of cyclin-dependent kinases (CDKs) to treat advanced and resistant cancers, launched with a $6 million financing led by founding investor Eshelman Ventures LLC. ARC Therapeutics has executed an exclusive license agreement with G1 Therapeutics for its preclinical CDK2 inhibitor program with this financing. It will utilize the remaining proceeds to advance this program into the clinic.
As of February 2017, Trilaciclib (G1T28, CDK4/6 inhibitor, G1 Therapeutics) is in multiple phase II clinical trials, and the drug is being tested as a method for reducing the adverse effects of chemotherapy. In August 2019, it received breakthrough therapy designation for its ability to minimize chemotherapy-induced bone marrow suppression. As of August 2020, the drug is under Food and Drug Administration (FDA) priority review for small-cell lung cancer with an application decision date of February 15, 2021. Trilaciclib was approved for medical use in the United States in February 2021.
Major side effects of drugs is likely to hinder the market growth
CDK inhibitors will replace conventional therapies in many situations and have a unique set of side effects. Therefore, it is essential to understand their side effects and drug interactions as they increasingly represent a therapeutic choice for selected patients with breast and other cancers.
The most common side effect is neutropenia, a low level of white blood cells, which can increase the chance of infection. Neutropenia is temporary and dose-dependent, with the white blood count usually returns to normal with dose interruption or dose reduction of the drug. Other side effects include leukopenia may also occur, although anemia and thrombocytopenia are less common. In general, diarrhea, fatigue, nausea, and alopecia (hair loss) are usually mild and reversible by reducing the dose and taking regular breaks. These factors restrict the market growth.
COVID-19 Impact Analysis
In the pessimistic scenario, it could assume that the COVID-19 pandemic has lowered the CDK inhibitors market, especially for research purposes, and also reduced clinical trials. It would have resumed early post the stringent regulations imposed in the first and second quarter of 2020 in many parts of the world. However, clinical trials were disrupted during this period and have not fully recovered in the post-lockdown period. Could affect the future demand for CDK inhibitors in the negative scenario.
Segment Analysis
Based on the Type, the global Cancer CDK Inhibitors market is segmented into
Phase 0, Phase 1, Phase 2, Phase 3, Phase 4.
Phase 1 and Phase 2, accounts largest share in the market as many number of the drugs are in these phases.
Phase 0
Eli Lilly and Company- A Phase 0 Study of LY3214996 (ERK Inhibitor) in Combination with Abemaciclib (CDK4 and 6 Inhibitor) in Recurrent Glioblastoma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration
Phase 1
Genentech, Inc- A Phase 1 AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor, Fulvestrant, Palbociclib for Patients with Metastatic Breast Cancer.
Phase 2
On July 08, 2020 — Sermonix Pharmaceuticals Inc., a privately-held biopharmaceutical company focused on the development of female oncology products in the precision drug metastatic breast cancer area, announced a collaboration with Eli Lilly and Company to study Sermonix's lead investigational drug, lasofoxifene, in combination with Lilly's FDA-approved CDK 4 and 6 inhibitor, abemaciclib under Phase 2 clinical trial, which is projected to begin enrollment in the third quarter of 2020, will evaluate the safety of lasofoxifene in combination with abemaciclib for the treatment of pre-and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2- breast cancer and an ESR1 mutation.
Phase 3
G1 Therapeutics, Inc- Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered before FOLFOXIRI/bevacizumab in patients with pMMR/MSS mCRC who have not received systemic therapy for metastatic Colorectal Cancer.
Phase 4
Eli Lilly and Company- A Phase 4 study's primary purpose is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer.
Based on Distribution channel, the hospital pharmacy are expected to dominate the Global Colorectal Cancer Drugs market during the forecast period
The hospital pharmacies held the largest share in the global colorectal cancer drugs market. This is mainly owing to increasing number of patients suffering from conditions which are treated in hospitals equipped with advanced infrastructure and adequate facilities. Moreover, growing number of hospitals along with adequate reimbursement policies is also contributing to the growth of this segment.
Geographical Analysis
North America expected to hold a major market share in the global Next Generation Cancer Diagnostic Device market due to the rising prevalence of cancer in the U.S. is likely to boost cancer diagnostics demand. Cancer is the second-leading cause of death in the United States. As per the American cancer society, In 2020, approximately 89,500 cancer cases were diagnosed, and around 9,300 cancer deaths in adolescents and young adults (AYAs) aged 15 to 39 years in the U.S. Favorable healthcare policies, high per capita healthcare spending, high healthcare infrastructure created the adoption of advanced cancer diagnostic technologies such as imaging in the U.S. Also, significant players' presence is supporting growth in the U.S. Strategies undertaken by these companies include product launches and mergers, expansion plans, which will continue aiding overall expansion in the U.S.
The Asia Pacific is expected to be the fastest-growing market over the forecast period owing to increasing prevalence rate, increasing focus on preventive care, and government initiatives promoting technological innovations.
Competitive Landscape
The Global Cancer CDK Inhibitors Market is quite competitive with some key competitors like Pfizer, Sanofi-Aventis, Merck & Co, Eli-Lilly and Company, Bayer Pharmaceuticals, Piramal Life, Amgen, Novartis AG, G1 Therapeutics, AstraZeneca. The key players are adopting various growth strategies such as product launch, acquisitions and investments in multiple sectors. For instance, Dinaciclib (SCH-727965) is an experimental drug that inhibits cyclin-dependent kinases (CDKs), and it is being evaluated in Phase 3 clinical trials for various cancer indications. Dinaciclib is being developed by Merck & Co.. In 2023, Pfizer’s drug Palbociclib patent is going to be expire which is a great opportunity for other key players to introduce generic version.
Pfizer Inc.
Overview: Pfizer Inc. (Pfizer), incorporated on June 2, 1942, is a research-based global biopharmaceutical company. The Company is engaged in the discovery, development and manufacture of healthcare products. Its global portfolio includes medicines and vaccines. The Company manages its commercial operations through two business segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). IH focuses on developing and commercializing medicines and vaccines that improve patients' lives. IH therapeutic areas include internal medicine, vaccines, oncology, inflammation and immunology and rare diseases. EH includes legacy brands, branded generics, generic sterile injectable products, and biosimilars and infusion systems. EH also includes a research and development (R&D) organization, as well as its contract manufacturing business. The Company sold its products in over 125 countries.
Product Portfolio: The Company’s port folio comprised of include internal medicine, vaccines, oncology, inflammation and immunology and rare diseases and others.
Pfizer- Ibrance or Palbociclib first received an accelerated approval in February 2015, becoming the first CDKs inhibitor to receive approval for breast cancer therapy.
Key developments:
Compound Name - PF-07104091 , Therapeutic Area: Oncology, Mechanism of Action: CDK2 Inhibitor
Indication - Breast Cancer Metastatic
Phase - Phase 1
Submission type - New Molecular Entity
Compound Type - Small Molecule
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