DASATINIB DRUGS MARKET ANALYSIS

Market Challenges And Opportunities

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 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.