Mismatch Repair Deficiency Market Forecasts Strong Expansion During the Forecast Period (2025-2034) Driven by Rising Diagnostics and Immuno-Oncology Advances | DelveInsight
The mismatch repair deficiency market is experiencing significant growth, driven by increasing awareness and adoption of genetic testing for cancer diagnostics. Rising prevalence of dMMR/MSI-H tumors and expanding indications for immunotherapies, particularly PD-1 inhibitors, are fueling demand. Additionally, the launch of therapies such as Zimberelimab + Domvanalimab (Arcus Biosciences/Gilead Sciences), HRO761 (Novartis), MDNA11 (Medicenna Therapeutics), RO7589831 (Roche), and others are expected to sustain robust growth in the coming years.
LAS VEGAS, Oct. 23, 2025 /PRNewswire/ -- DelveInsight's Mismatch Repair Deficiency Market Insights report includes a comprehensive understanding of current treatment practices, mismatch repair deficiency emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
Mismatch Repair Deficiency Market Summary
- The market size for mismatch repair deficiency in the leading markets is expected to grow significantly by 2034.
- The United States accounted for the highest mismatch repair deficiency treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
- Colorectal cancer shows dMMR in about 10–15% of cases, with variations depending on cohort and geography; some studies report up to 26% in some settings, but typically 13–15% is most consistent for unselected CRC.
- Leading mismatch repair deficiency companies developing emerging therapies, such as Arcus Biosciences, Gilead Sciences, Medicenna Therapeutics, Novartis, Roche, and others, are developing new therapy for mismatch repair deficiency that can be available in the mismatch repair deficiency market in the coming years.
- The promising mismatch repair deficiency therapies in clinical trials include Zimberelimab + Domvanalimab, MDNA11, HRO761, RO7589831, and others.
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Key Factors Driving the Growth of the Mismatch Repair Deficiency Market
Rising Prevalence of dMMR-Associated Cancers
Mismatch repair deficiency is a hallmark of various cancers, including colorectal, endometrial, and gastric cancers. The increasing incidence of these cancers has heightened the demand for targeted therapies.
Advancements in Immunotherapy and Biomarker Testing
The approval of immune checkpoint inhibitors (ICIs), such as Bristol Myers Squibb's OPDIVO, for treating dMMR cancers has revolutionized treatment approaches. These therapies exploit the high mutational burden in dMMR tumors to enhance immune system targeting. The pan-tumor indication for immunotherapy in dMMR/MSI-H cancers has broadened treatment options and emphasized the importance of biomarker testing.
Expanding dMMR Clinical Trial Activities
The treatment pipeline for dMMR is strong, with new therapies in development, such as Zimberelimab combined with Domvanalimab (Arcus Biosciences/Gilead Sciences), HRO761 (Novartis), MDNA11 (Medicenna Therapeutics), RO7589831 (Roche), and others, aimed at delivering safe and effective therapeutic options.
Mismatch Repair Deficiency Market Analysis
dMMR/MSI-H cancers continue to represent a high-value segment in immuno-oncology, driven by widespread testing and durable responses to PD-1 inhibitors. On the commercial front, KEYTRUDA (pembrolizumab, Merck) anchors the space with its tumor-agnostic US approval now fully implemented, allowing treatment across unresectable or metastatic MSI-H/dMMR solid tumors. OPDIVO (nivolumab, BMS), including the nivolumab + ipilimumab combination, has expanded in dMMR/MSI-H metastatic colorectal cancer, reinforcing PD-1 leadership. Approvals of dostarlimab (GSK) and durvalumab (AstraZeneca) in dMMR endometrial cancer are moving checkpoint therapy earlier in treatment lines and into combination regimens, broadening the patient population.
Looking forward, competition is intensifying with next-generation combinations such as zimberelimab (anti-PD-1) + domvanalimab (anti-TIGIT) and novel mechanisms like HRO761 (Novartis), a first-in-class WRN helicase inhibitor matched to MSI-H/dMMR tumors. As MSI testing penetration grows and multiple first-line and peri-operative studies report outcomes, revenue is expected to remain robust despite PD-1 class crowding. Key differentiators will be earlier-line use, combination efficacy, and biomarker-guided patient selection. Challenges include pricing pressure, biosimilar competition, and intellectual property considerations around formulation lifecycle strategies. Overall, the dMMR/MSI-H franchise is positioned for continued growth and label expansion across multiple tumor types.
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Mismatch Repair Deficiency Competitive Landscape
The pipeline for treating dMMR is robust, with emerging therapies such as Zimberelimab + Domvanalimab (Arcus Biosciences/Gilead Sciences), HRO761 (Novartis), MDNA11 (Medicenna Therapeutics), RO7589831 (Roche), and others currently in development to provide safe and effective treatment options.
Arcus Biosciences/Gilead Sciences' Zimberelimab, a PD-1 inhibitor, and domvanalimab, a TIGIT inhibitor, are being developed by Arcus Biosciences in partnership with Gilead and are under investigation as a combined dual checkpoint blockade therapy. Zimberelimab works by reactivating T-cells through PD-1 inhibition, while domvanalimab targets the TIGIT pathway. This dual immunotherapy approach is also being evaluated in biomarker-selected cancers, including those with dMMR or MSI-H.
Novartis' HRO761, is a first-in-class WRN helicase inhibitor aimed at treating cancers with dMMR and MSI-H. Tumors with these features accumulate DNA errors and rely heavily on WRN helicase for survival, creating a synthetic lethality opportunity. By selectively inhibiting WRN, HRO761 is intended to eliminate dMMR/MSI-H tumor cells while minimizing effects on normal tissue, providing a targeted therapy option beyond conventional immunotherapy.
The anticipated launch of these emerging therapies are poised to transform the mismatch repair deficiency market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the mismatch repair deficiency market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about therapy for mismatch repair deficiency @ Mismatch Repair Deficiency Clinical Trials
What is Mismatch Repair Deficiency?
dMMR describes a malfunction in the cellular system that corrects errors occurring during DNA replication. Normally, the mismatch repair (MMR) mechanism detects and fixes mismatched base pairs or small insertions/deletions that arise during DNA synthesis or recombination. When this system loses functionality, DNA mutations accumulate, leading to genomic instability and a higher risk of cancer.
Diagnosis of dMMR involves examining tumor tissue for the absence of key MMR proteins (MLH1, MSH2, MSH6, PMS2) through immunohistochemistry or assessing microsatellite instability (MSI) via molecular tests. If dMMR is found, additional analyses, such as MLH1 promoter methylation or BRAF mutation testing, help differentiate between hereditary and sporadic cases. Germline genetic testing can confirm inherited syndromes like Lynch syndrome. This stepwise diagnostic process enables accurate identification of dMMR, informs cancer treatment decisions, and provides important information about familial risk.
Mismatch Repair Deficiency Epidemiology Segmentation
The mismatch repair deficiency epidemiology section provides insights into the historical and current mismatch repair deficiency patient pool and forecasted trends for the leading markets. Endometrial cancer has the highest rate, with dMMR found in about 20–30% of cases, and some reports up to 40%.
The mismatch repair deficiency market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:
- Indication-specific Incident Cases of Mismatch Repair Deficiency
- Total Incident Cases of Mismatch Repair Deficiency
- Stage-specific Incident Cases of Mismatch Repair Deficiency
- Total Treatable Cases of Mismatch Repair Deficiency
| Mismatch Repair Deficiency Market Report Metrics |
Details |
| Study Period |
2020–2034 |
| Mismatch Repair Deficiency Market Report Coverage |
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
| Mismatch Repair Deficiency Epidemiology Segmentation |
Indication-specific Incident Cases of Mismatch Repair Deficiency, Total Incident Cases of Mismatch Repair Deficiency, Stage-specific Incident Cases of Mismatch Repair Deficiency, and Total Treatable Cases of Mismatch Repair Deficiency |
| Key Mismatch Repair Deficiency Companies |
Arcus Biosciences, Gilead Sciences, Medicenna Therapeutics, Novartis, Roche, Merck, Bristol Myers Squibb, and others |
| Key Mismatch Repair Deficiency Therapies |
Zimberelimab + Domvanalimab, MDNA11, HRO761, RO7589831, KEYTRUDA, OPDIVO, and others |
Scope of the Mismatch Repair Deficiency Market Report
- Therapeutic Assessment: Mismatch Repair Deficiency current marketed and emerging therapies
- Mismatch Repair Deficiency Market Dynamics: Key Market Forecast Assumptions of Emerging Mismatch Repair Deficiency Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Mismatch Repair Deficiency Market Access and Reimbursement
Download the report to understand which factors are driving mismatch repair deficiency therapeutics market trends @ Mismatch Repair Deficiency Market Trends
Table of Contents
| 1 |
Mismatch Repair Deficiency Market Key Insights |
| 2 |
Mismatch Repair Deficiency Market Report Introduction |
| 3 |
Epidemiology and Market Forecast Methodology |
| 4 |
Mismatch Repair Deficiency (dMMR): Market Overview at a Glance |
| 4.1 |
Total Market Share (%) Distribution of Mismatch Repair Deficiency (dMMR) by Therapies in 2024 |
| 4.2 |
Total Market Share (%) Distribution of Mismatch Repair Deficiency (dMMR) by Therapies in 2034 |
| 5 |
Executive Summary |
| 6 |
Key Events |
| 7 |
Disease Background and Overview: Mismatch Repair Deficiency (dMMR) |
| 7.1 |
Introduction |
| 7.2 |
Mismatch Repair Deficiency Causes |
| 7.3 |
Mismatch Repair Deficiency Pathophysiology |
| 7.4 |
Mismatch Repair Deficiency Symptoms |
| 7.5 |
Mismatch Repair Deficiency Risk Factor |
| 7.6 |
Mismatch Repair Deficiency Diagnosis |
| 8 |
Mismatch Repair Deficiency Treatment and Management |
| 8.1 |
Mismatch Repair Deficiency Treatment Guidelines |
| 9 |
Epidemiology and Patient Population |
| 9.1 |
Key Findings |
| 9.2 |
Assumptions and Rationale |
| 9.3 |
Total Diagnosed Incident cases of Mismatch Repair Deficiency:7MM |
| 9.4 |
The United States |
| 9.4.1 |
Indication-specific Diagnosed Incident Cases of Mismatch Repair Deficiency in the United States |
| 9.4.2 |
Total Diagnosed Incident Cases of Mismatch Repair Deficiency in the United States |
| 9.4.3 |
Stage-specific Diagnosed Incident Cases of Mismatch Repair Deficiency in the United States |
| 9.4.6 |
Total Treatable Cases of Mismatch Repair Deficiency in the United States |
| 9.5 |
EU4 and the UK |
| 9.6 |
Japan |
| 10 |
Patient Journey of Mismatch Repair Deficiency (dMMR) |
| 11 |
Marketed Mismatch Repair Deficiency Drugs |
| 11.1 |
Key Competitors |
| 11.2 |
KEYTRUDA (pembrolizumab): Merck |
| 11.2.1 |
Product Description |
| 11.2.2 |
Regulatory Milestones |
| 11.2.3 |
Other Developmental Activities |
| 11.2.4 |
Safety and Efficacy |
| 11.2.5 |
Analyst Views |
| 11.3 |
OPDIVO (nivolumab): Bristol Myers Squibb |
| 12 |
Emerging Mismatch Repair Deficiency Therapies |
| 12.1 |
Key Cross Competition |
| 12.2 |
Zimberelimab + Domvanalimab: Arcus Biosciences/Gilead Sciences |
| 12.2.1 |
Product Description |
| 12.2.2 |
Other Development Activities |
| 12.2.3 |
Clinical Development Activities |
| 12.2.4 |
Safety and Efficacy |
| 12.2.5 |
Analyst View |
| 12.3 |
HRO761: Novartis |
| 13 |
Mismatch Repair Deficiency (dMMR): Market Size |
| 13.1 |
Key Findings |
| 13.2 |
Mismatch Repair Deficiency Market Outlook |
| 13.3 |
Conjoint Analysis |
| 13.4 |
Key Mismatch Repair Deficiency Market Forecast Assumptions |
| 13.5 |
Total Mismatch Repair Deficiency Market Analysis: 7MM |
| 13.6 |
United States Mismatch Repair Deficiency Market Size |
| 13.6.1 |
Total Market Size of Mismatch Repair Deficiency in the United States |
| 13.6.2 |
Market Size of Mismatch Repair Deficiency by Therapies in the United States |
| 13.7 |
EU4 and the UK Mismatch Repair Deficiency Market Size |
| 13.8 |
Japan Mismatch Repair Deficiency Market Size |
| 14 |
Unmet Needs of Mismatch Repair Deficiency (dMMR) |
| 15 |
SWOT Analysis of Mismatch Repair Deficiency (dMMR) |
| 16 |
KOL Views of Mismatch Repair Deficiency (dMMR) |
| 17 |
Mismatch Repair Deficiency Market Access and Reimbursement |
| 17.1 |
United States |
| 17.2 |
EU4 and the UK |
| 17.3 |
Japan |
| 18 |
Bibliography |
| 19 |
Mismatch Repair Deficiency Market Report Methodology |
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SOURCE DelveInsight Business Research, LLP
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