DASATINIB DRUGS MARKET ANALYSIS

The global dasatinib drugs market size is projected to reach US$ 2,198.7 Mn by 2030, from US$ 1,465.0 million in 2023, growing at a CAGR of 6% during the forecast period 2023-2030. Dasatinib is a second-generation tyrosine kinase inhibitor (TKI) used to treat chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL). It is also used to treat Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in adults and children.

Dasatinib Drugs Market Regional Insights

• North America: North America is expected to be the largest market for dasatinib drugs market during the forecast period, accounting for over 41.3% of the market share in 2023. This is due to the high prevalence of CML and ALL in the region, as well as the increasing adoption of dasatinib as a first-line therapy for these conditions.
• Europe: Europe is expected to be the second-largest market for dermatology devices market, accounting for over 23.1% of the market share in 2023. This is due to the increasing prevalence of CML and ALL in the region, as well as the increasing availability of dasatinib through government programs and private insurance.
• Asia Pacific: Asia Pacific is expected to be the fastest-growing market for rescue inhaler, with a CAGR of 7.2% during the forecast period. This is due to the rising incidence of CML and ALL in the region, as well as the increasing adoption of dasatinib as a first-line therapy for these conditions.

Figure 1. Global Dasatinib Drugs Market Share (%), by Region, 2023

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Analysts’ Views on the Global Dasatinib Drugs Market

Dasatinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in adults who can no longer benefit from other leukemia medications including imatinib (Gleevec) or in those who cannot take these medications because of side effects. Dasatinib is also used to treat a certain type of chronic CML in children 1 year of age or older. The rising number of patient population with cancer, especially chronic myeloid leukemia (CML), offers opportunity for manufactures to offer dasatinib drugs of various type, thus driving the market growth

Dasatinib Drugs Market Drivers

• Increasing prevalence of cancer: Dasatinib is primarily used in the treatment of certain types of cancer, such as chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). With the growing incidence of these cancers globally, there is a rising demand for effective therapies like dasatinib, which drives the market growth. For instance, in April 2023, according to the data published by the American Society of Clinical Oncology (ASCO), about 15% of all leukemia is chronic myeloid leukemia (CML). In 2023, an estimated 8,930 people (5,190 men and 3,740 women) in the U.S. will be diagnosed with CML. Most of these will be adults, with an average age of diagnosis at 64 years. Nearly 50% of cases occur in people over age 65.
• Favorable clinical outcomes: Dasatinib has demonstrated significant efficacy and improved survival outcomes in patients with CML and Ph+ ALL. It inhibits the activity of specific proteins involved in cancer growth, thereby reducing tumor burden. The positive clinical results and favorable safety profile of dasatinib contribute to its market demand.
• Expansion of approved indications: Over time, the approved indications for dasatinib have expanded. Initially approved for CML, dasatinib's approval has been extended to include Ph+ ALL and certain types of solid tumors, such as gastrointestinal stromal tumors (GIST). The broadening of indications enhances the market potential for dasatinib drugs.
• Increasing product approval by regulatory authority: Dasatinib belongs to a class of drugs known as tyrosine kinase inhibitors (TKIs). TKIs are a significant advancement in cancer treatment as they specifically target cancer cells while sparing healthy cells, leading to fewer adverse effects. Thus, increasing product approval by regulatory authorities is expected to drive the market growth. For instance, in August 2022, Lupin, a pharmaceutical company, in partnership with Pharmascience Inc., a pharmaceutical company, received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dasatinib tablets

Dasatinib Drugs Market Opportunities

• Expansion into emerging markets: There is a significant opportunity for dasatinib drugs to penetrate and expand in emerging markets. These regions often have a growing incidence of cancer and an increasing focus on improving healthcare infrastructure. Pharmaceutical companies can capitalize on these opportunities by expanding their market presence, establishing strategic partnerships, and addressing the unmet medical needs of these markets.
• Combination therapies: Dasatinib has shown promise in combination with other targeted therapies or conventional chemotherapy agents. Combination therapies have the potential to enhance treatment efficacy, overcome drug resistance, and improve patient outcomes. Pharmaceutical companies can explore and invest in clinical trials to evaluate dasatinib in combination with other drugs, opening up new opportunities in the market.
• Pediatric indications: Currently, dasatinib is primarily approved for adult patients with specific types of cancer. However, there is an opportunity to explore the use of dasatinib in pediatric oncology. Conducting clinical trials and seeking regulatory approvals for pediatric indications can expand the patient population and increase market opportunities for dasatinib drugs.
• Development of generic versions: As the patent exclusivity of branded dasatinib drugs expires, it creates an opportunity for the development and launch of generic versions. Generic drugs can offer cost savings to patients and healthcare systems, making treatment more affordable and accessible. Pharmaceutical companies can explore the development of generic dasatinib drugs to tap into this market opportunity.

Dasatinib Drugs Market Trends

• Rising adoption of targeted therapies: The trend towards targeted therapies in oncology has significantly impacted the dasatinib drugs market. Dasatinib belongs to a class of targeted therapies known as tyrosine kinase inhibitors (TKIs), which specifically inhibit the activity of specific proteins involved in cancer growth. As targeted therapies continue to gain acceptance and demonstrate favorable clinical outcomes, the demand for dasatinib and other TKIs is expected to increase.
• Shift towards precision medicine: Precision medicine involves tailoring treatments based on individual patient characteristics, including genetic and molecular profiles. Dasatinib's efficacy has been linked to specific genetic mutations and biomarkers. As precision medicine approaches gain momentum, there is a growing emphasis on identifying biomarkers and genetic alterations that can predict response to dasatinib. This trend drives the development of companion diagnostics and personalized treatment strategies.
• Increased focus on combination therapies: Combination therapies involving dasatinib are gaining attention in the field of oncology. Combining dasatinib with other targeted therapies, immunotherapies, or conventional chemotherapy agents has shown potential for synergistic effects and improved treatment outcomes. Pharmaceutical companies and researchers are exploring different combinations to enhance treatment efficacy and overcome drug resistance, thereby driving the trend of combination therapies.
• Emergence of biosimilars: With the expiration of patents for dasatinib, there is a growing market for biosimilar versions of the drug. Biosimilars are highly similar versions of approved biologic drugs and offer cost-effective alternatives to the reference product. As the market for biosimilars expands, it presents both challenges and opportunities for original manufacturers of dasatinib and generic/biosimilar manufacturers.

Dasatinib Drugs Market Restraints

• High cost of treatment: Dasatinib drugs can be expensive, leading to affordability issues for patients, especially in regions with limited healthcare resources or inadequate insurance coverage. The high cost of treatment can act as a barrier to access, limiting the market potential of dasatinib drugs.
• Stringent regulatory requirements: Regulatory processes for drug approval can be lengthy and complex, requiring extensive clinical trials and data submissions. The stringent regulatory requirements can result in delays in market entry and increased costs for manufacturers. These challenges may impede the availability of dasatinib drugs in certain regions or for specific indications.
• Potential adverse effects: While dasatinib is generally well-tolerated, it can cause adverse effects, including myelosuppression, fluid retention, cardiovascular events, and pulmonary arterial hypertension. These adverse effects may limit the use of dasatinib in certain patient populations or necessitate careful monitoring, impacting its market utilization.
• Increasing product recall: Over time, some patients may develop resistance to dasatinib treatment, leading to disease progression and reduced efficacy. Increasing product recall by regulatory authority is expected to hamper the market growth. For instance, in October 2022, Dr. Reddy’s Laboratories, a pharmaceutical company, announced the recalled of dasatinib 50 mg film coated tablet blister pack because the tablet may not dissolve properly and this can result in incomplete release of the medicine.

Figure 2. Global Dasatinib Drugs Market Share (%), by Indication, 2023

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Recent Developments

New product launches and research and development activities

• On October 2, 2023, Stanford University in collaboration with Kite Pharma, a pharmaceutical company, started a clinical trial for the safety and efficacy of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia. The study is expected to be completed in August 2025.
• On August 17, 2023, Bristol Myers Squibb Company, a biopharmaceutical company, announced that the Japanese regulatory approval for an authorized generic (AG) version of its tyrosine kinase inhibitor Sprycel (dasatinib)
• In April 2020, Reddy’s Laboratories Ltd., a pharmaceutical company, announced the launch of Invista, a formulation of Dasatinib in India. It is indicated for the treatment of chronic accelerated or myeloid or lymphoid blast phase and newly diagnosed in chronic phase adult patients with Chronic Myeloid Leukemia (CML) in India.

Partnership and Acquisition

• In January 2020, St. Jude Children’s Research Hospital and the Chinese Children’s Cancer Group announced a partnership first randomized, Phase III clinical trial comparing targeted therapies for acute lymphoblastic leukemia (ALL) driven by the Philadelphia chromosome. Results showed that the drug dasatinib provides more benefit than the standard of care, which led to changes in the way this leukemia is treated

Top Companies in Dasatinib Drugs Market

• Bristol-Myers Squibb Company
• MSN Labs
• Lupin
• Reddy’s Laboratories
• Gilead Sciences, Inc.
• Hetero Labs
• MANUS AKTTEVA BIOPHARMA LLP
• Alembic Pharma
• JINLAN Pharm-Drugs Technology Co., Ltd.
• Zhejiang Hisun Pharma

Definition: The dasatinib drugs market refers to the market for pharmaceutical products that contain the active ingredient dasatinib. Dasatinib is a tyrosine kinase inhibitor used in the treatment of certain types of cancer, such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The market includes the production, distribution, and sales of dasatinib drugs by pharmaceutical companies, as well as their utilization by healthcare providers for patient treatment.