MSI high/dMMR cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

Mismatch repair deficient (or dMMR) and microsatellite instability-high (or MSI-H) tumor biomarkers have recently attracted attention due to growing awareness of genetic or genomic abnormalities that have been identified in numerous cancer types. In tumors that display the dMMR or MSI-H biomarker, the normal repair mechanism of the DNA within our cells is disrupted. The incidence of MSI-H was calculated to be 9% (3%-17%) and 3% (1%-7%), respectively, in Stages 3 and 4. In cancers in Stages 1/2, the incidence of MSI-H was pegged at 15% (8-23%). The incidence of dMMR overall was estimated to be 16% (11%-22%) across 13 tumor types based on 54 papers and 20,383 patients. Chemotherapy is currently used as first-line therapy for patients with metastatic colorectal cancer (mCRC) with microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR). Immune-checkpoint inhibitors are only presently authorized as second- or later-line therapies, despite the possibility of long-term survival.

Description

Mismatch repair deficient (or dMMR) and microsatellite instability-high (or MSI-H) tumor biomarkers have recently attracted attention due to growing awareness of genetic or genomic abnormalities that have been identified in numerous cancer types. In tumors that display the dMMR or MSI-H biomarker, the normal repair mechanism of the DNA within our cells is disrupted. DNA or genes help maintain the health of our body's cells by repairing any improper activity in healthy cells. Cancers that express the dMMR biomarker, though, lack the genes necessary to normally correct these errors, rendering the aberrant cells incapable of being repaired. This could cause cancer to develop or spread. Similar to MSI-H, an MSI-H tumor lacks some typical DNA characteristics, resulting in an abundance of microsatellites in the patient's cells. Regular DNA activity is unable to correct this error, which leads to cancer. Patients with endometrial cancer, colorectal cancer, or other gastrointestinal malignancies are most frequently found to have the dMMR and MSI-H biomarkers. About 5% of people with metastatic (spreading to other organs) colorectal cancer have the dMMR or MSI-H biomarker.

MSI high/dMMR cancer (Epidemiology)

The incidence of MSI-H was calculated to be 9% (3% -17%) and 3% (1%-7%), respectively, in Stages 3 and 4. In cancers in Stages 1/2, the incidence of MSI-H was pegged at 15% (8-23%). The incidence of dMMR overall was estimated to be 16% (11%-22%) across 13 tumor types based on 54 papers and 20,383 patients. In contrast to Korea or Japan, the US had a higher incidence of MSI-H. Since dMMR frequently occurs in Lynch syndrome (LS) patients, patients with MSI-H or dMMR tumors can use MSI-related tests to predict LS. The majority of these tumors were normal adenocarcinomas, villous adenomas, adenomas larger than 1 cm in diameter, and highly dysplastic adenomas. Patients with LS over the age of 60 had a higher incidence of MSI-H. MSI and colorectal cancer (CRC) are closely related, and some studies have found MS loci that are linked to CRCB. High-level microsatellite instability colorectal cancer patients' tumors exhibit a substantial cytotoxic T cell infiltrate in comparison to MSS tumors. The significance of NR-21, BAT-26, and BAT-25 markers in CRC MSI status determination. MSI has variable long-term effects on lymph nodes, distant CRC metastasis, and patient prognosis. A good prognosis, a high 5-year survival rate, a low recurrence rate, and a low rate of deterioration are reported in patients with stage I and stage II MSI colorectal cancer, but the opposite is true for stage III MSI colorectal cancer patients.

MSI high/dMMR cancer -Current Market Size & Forecast Trends

The market for microsatellite instability-high (MSI-H) and deficient mismatch repair (dMMR) cancer is anticipated to grow significantly, with current estimates suggesting a market size of approximately USD 5 billion in 2023, projected to reach around USD 10 billion by 2035, reflecting a compound annual growth rate (CAGR) of about 7%. This growth is primarily driven by the increasing recognition of MSI-H/dMMR as a critical biomarker for determining eligibility for immune checkpoint inhibitors (ICIs) in various malignancies, including colorectal, gastric, and endometrial cancers. The rising incidence of these cancers and advancements in diagnostic techniques, such as next-generation sequencing (NGS), are also contributing to market expansion. Furthermore, the development of new therapeutic strategies targeting MSI-H/dMMR tumors is expected to enhance treatment options and improve patient outcomes. Overall, the MSI-H/dMMR cancer market is well-positioned for substantial growth through 2035, driven by ongoing research and the increasing adoption of immunotherapy in clinical practice.

Chemotherapy is currently used as first-line therapy for patients with metastatic colorectal cancer (mCRC) with microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR). Immune-checkpoint inhibitors are only presently authorized as second- or later-line therapies, despite the possibility of long-term survival. Pembrolizumab (Keytruda) was given accelerated approval by the US-FDA in 2017 for the treatment of solid tumors in children and adults with high levels of microsatellite instability (MSI) or low levels of mismatch repair (MMR). Patients with unresectable or metastatic tumors who have advanced after prior treatments are eligible for this treatment, as are colorectal cancer patients who have advanced after receiving fluoropyrimidine, oxaliplatin, and irinotecan. Pembrolizumab was approved based on results from five single-arm multi-cohort trials. There were 149 patients in total, 90 of whom had colorectal cancer, and who had tumors with MSI-high or MMR-deficient scores. The remaining patients had cancers from 14 other types. Pembrolizumab's safety and effectiveness in treating MSI-high central nervous system cancers have not been proven in pediatric patients, though.

Report Highlights

MSI high/dMMR cancer - Current Market Trends

MSI high/dMMR cancer - Current & Forecasted Cases across the G8 Countries

MSI high/dMMR cancer - Market Opportunities and Sales Potential for Agents

MSI high/dMMR cancer - Patient-based Market Forecast to 2035

MSI high/dMMR cancer - Untapped Business Opportunities

MSI high/dMMR cancer - Product Positioning Vis-a-vis Competitors' Products

MSI high/dMMR cancer - KOLs Insight