Colorectal Cancer Diagnostics And Therapeutics Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 29.89 Billion |
| Market Size (2030) | USD 38.09 Billion |
| Growth Rate (2025 - 2030) | 4.95% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
Colorectal Cancer Diagnostics And Therapeutics Market Analysis by Mordor Intelligence
The colorectal cancer diagnostics and therapeutics market is valued at USD 29.89 billion in 2025 and is forecast to reach USD 38.09 billion by 2030, advancing at a 4.95% CAGR. The current expansion is paced by precision medicine, AI-enabled screening, and the steady roll-out of immunotherapy options that raise survival outcomes while sustaining premium pricing. Non-invasive tests—stool DNA, blood-based assays, and AI-assisted colonoscopy—bring previously unscreened populations into clinical pathways, while dual-checkpoint blockade reshapes first-line therapy for biomarker-defined patients. Reimbursement alignment in the United States and policy convergence in Europe accelerate uptake, and Asia Pacific leapfrogs legacy bottlenecks through government-funded technology programs. Cost pressures and capacity constraints persist, yet the colorectal cancer diagnostics and therapeutics market continues to monetize innovation faster than screening volumes plateau in mature economies.
Key Report Takeaways
- By modality, diagnostics techniques held 27.9% of colorectal cancer diagnostics and therapeutics market share in 2024, while therapeutics are on track to post the fastest 13.6% CAGR through 2030.
- By geography, North America led with 34.6% revenue share in 2024, whereas Asia Pacific is projected to grow at a 7.70% CAGR through 2030.
Global Colorectal Cancer Diagnostics And Therapeutics Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Rising Incidence and Prevalence Of Colorectal Cancer | +1.20% | Global, with highest impact in APAC and MEA | Long term (≥ 4 years) |
| Rapid Adoption Of Next-Generation Stool-DNA And Blood-Based Screening Tests | +0.80% | North America & EU, expanding to APAC | Medium term (2-4 years) |
| Technological Leaps In Targeted Therapies & Immunotherapy Pipelines | +1.10% | Global, led by North America and Europe | Medium term (2-4 years) |
| Expansion Of Guideline-Based Screening To 45-Year-Olds In Key Markets | +0.60% | North America, Europe, select APAC countries | Short term (≤ 2 years) |
| Molecular Residual-Disease (MRD) Tests Reshaping Adjuvant-Therapy Decisions | +0.40% | North America, Europe, premium APAC markets | Long term (≥ 4 years) |
| Value-Based Reimbursement That Rewards Early Detection | +0.30% | North America, select European markets | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Rising Incidence of Colorectal Cancer
Early-onset incidence climbed from 5.43 to 6.13 per 100,000 between 1990 and 2021, and modeling signals continued acceleration through 2030.[1]B. Siegel et al., “Global Trends in Early-Onset Colorectal Cancer,” bmcmedicine.biomedcentral.com High-income settings see lifestyle convergence that elevates risk at younger ages, while Asia Pacific records incidence rates of 7.51 per 100,000 for males and 6.22 for females. Longer survivorship boosts lifetime screening and follow-up demand, anchoring sustained revenue visibility in the colorectal cancer diagnostics and therapeutics market.
Rapid Adoption of Next-Generation Stool-DNA and Blood-Based Screening Tests
FDA approvals for Shield (83.1% sensitivity), Cologuard Plus (93.9%), and ColoSense (94.4%) in 2024 expanded the non-invasive testing toolkit.[2]FDA, “Blood-Based and Stool-Based Colorectal Cancer Screening Tests,” fda.gov These modalities address the 40% of eligible adults who have historically skipped colonoscopy, potentially adding 15–20 million U.S. lives to the annual screening pool. Investor confidence solidified with Geneoscopy’s USD 105 million Series C round in January 2025.
Technological Leaps in Targeted Therapies and Immunotherapy Pipelines
KRAS G12C inhibitor combinations cleared in 2024–2025, unlocked options for 40% of mutation-positive tumors, while dual-checkpoint blockade (Opdivo + Yervoy) delivered median progression-free survival not yet reached versus 39.3 months for monotherapy in MSI-H disease.[3]Bristol Myers Squibb, “Opdivo + Yervoy Receives FDA Approval for Metastatic Colorectal Cancer,” bms.com Companion diagnostics are now embedded in prescribing workflows, elevating demand for biomarker assays within the colorectal cancer diagnostics and therapeutics market.
Expansion of Guideline-Based Screening to 45-Year-Olds in Key Markets
Medicare’s 2025 adoption and private-payer alignment opened screening eligibility to 19 million additional Americans, improving cost-per-QALY ratios across risk cohorts. The Netherlands and Denmark mirrored the policy, underscoring trans-Atlantic momentum for earlier detection.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| High Drug Cost & Treatment-Related Toxicities | -0.70% | Global, most severe in emerging markets | Medium term (2-4 years) |
| Sub-Optimal Screening Adherence In Low-Resource Settings | -0.50% | APAC, MEA, Latin America | Long term (≥ 4 years) |
| Limited Immunotherapy Efficacy In MSS Tumors Causing High Trial Attrition | -0.40% | Global, particularly North America and Europe | Medium term (2-4 years) |
| Data-Integration & Privacy Hurdles For AI-Driven Diagnostics Platforms | -0.30% | North America, Europe, select APAC markets | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
High Drug Cost and Treatment-Related Toxicities
Targeted therapy regimens average USD 150,000–200,000 per year, a burden that curtails uptake where out-of-pocket spending exceeds 60% of total healthcare costs. Combination immunotherapy requires intensive safety monitoring as grade 3/4 adverse events can reach 81%, stretching oncology budgets and care infrastructure in the colorectal cancer diagnostics and therapeutics industry.
Sub-Optimal Screening Adherence in Low-Resource Settings
Screening rates range from 75% in Denmark to 6.3% in countries lacking organized programs. In Saudi Arabia, 62% of eligible individuals have never been screened, mainly due to colonoscopy anxiety and limited geographic access. These gaps translate into late-stage presentations that raise mortality and dampen growth prospects for the colorectal cancer diagnostics and therapeutics market.
Segment Analysis
By Modality: Therapeutics Drive Growth Despite Diagnostics Dominance
Therapeutics generated strong tailwinds, posting a 13.6% CAGR that outpaced screening activity. Opdivo + Yervoy secured first-line status for MSI-H/dMMR disease and reset revenue expectations at premium price points. KRAS, EGFR, and HER2 targets widen addressable pools, boosting the colorectal cancer diagnostics and therapeutics market size for personalized regimens. Diagnostics retained 27.9% of colorectal cancer diagnostics and therapeutics market share in 2024, underwritten by multitarget stool DNA, blood biomarkers, and AI colonoscopy that make screening more convenient. Medtronic’s GI Genius raised adenoma detection by 14.4% and secured a three-year VA contract for nearly 100 additional units. Shield and ColoSense advanced blood and RNA-based testing, yet payers still calibrate coverage for their higher per-test costs.
Diagnostics monetization pivots from volume to diversification. Exact Sciences rolled out Cologuard Plus with 93.9% sensitivity, reducing false positives and reinforcing its leadership. Blood-based assays grow fast among younger cohorts who prefer needle sticks to invasive scopes, an alignment that improves adherence. Molecular residual-disease tests extend value across the treatment continuum by flagging minimal disease after surgery, further enlarging colorectal cancer diagnostics and therapeutics market size opportunities through follow-up testing.
Note: Segment shares of all individual segments available upon report purchase
Geography Analysis
North America’s leadership is anchored in reimbursement breadth and innovation velocity. Medicare coverage for CT colonography in 2025 removes a procedural cost hurdle, complementing blood and stool tests already reimbursed under preventive codes. Sixty percent of colorectal cancer drug trials run in U.S. and Canadian centers, accelerating FDA clearances that ripple worldwide. VA deployment of 100 GI Genius units underscores institutional migration to AI diagnostics. Regulatory pathways such as Breakthrough Device and Priority Review condense timelines, yet rising scrutiny on therapy cost inflates time-to-profit hurdles for recent launches.
Asia Pacific outruns all regions at 7.70% CAGR. Government programs extend screening to rural China and subsidize AI colonoscopy in Japan, helping technology leapfrog traditional bottlenecks. Incidence rates of 7.51 per 100,000 for males and 6.22 for females press policymakers to act. Manufacturing clusters reduce equipment costs while medical tourism funnels regional patients to technology hubs in Thailand and India, amplifying demand inside the colorectal cancer diagnostics and therapeutics market.
Europe’s trajectory is stable, fueled by well-established national programs. Utilization still varies: 75% in Denmark yet under 10% in lower-income members. EMA centralized approvals elongate pipeline timelines compared with the FDA; however, once clearance is granted, reimbursement coverage through universal systems leads to rapid penetration. Middle East & Africa promise future upside, especially in GCC states where oil revenues finance cancer centers equipped with AI imaging and immunotherapies.
Competitive Landscape
Competitive intensity is moderate. Exact Sciences, Guardant Health, and Bristol Myers Squibb collectively represented more than 42% of the 2024 revenue within the colorectal cancer diagnostics and therapeutics market size. Exact Sciences grew Q1 2025 revenue to USD 707 million with 14% Cologuard volume growth. Guardant Health’s Shield blood test challenges stool DNA incumbency, targeting non-compliant patients with an 83.1% sensitivity profile.
On the therapy side, Bristol Myers Squibb extended its immuno-oncology franchise with dual-checkpoint blockade that reduces progression risk by 79% over chemotherapy. Johnson & Johnson’s RYBREVANT program addresses EGFR-driven disease and posted a 49% overall response in RAS/BRAF wild-type tumors. Medtronic leverages AI differentiation, with GI Genius cutting missed polyp rates by 50% in clinical practice and winning VA expansion awards.
Emerging entrants focus on molecular residual disease, multiomics, and digital pathology. Tagomics secured GBP 860,000 Innovate UK funding to validate an epigenetic panel, while PathPresenter earned FDA 510(k) clearance for a cloud viewer that streamlines pathology workflows. M&A remains active as Merck completed Prometheus Biosciences to strengthen precision-medicine pipelines in colorectal indications. The field favors firms that integrate diagnostics and therapeutics under single commercialization umbrellas.
Colorectal Cancer Diagnostics And Therapeutics Industry Leaders
-
Epigenomics AG
-
Abbott Laboratories
-
F. Hoffmann-La Roche AG
-
Novigenix SA
-
Amgen Inc
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- June 2025: Tagomics was awarded a GBP 860,000 (USD 1.1 million) Innovate UK Biomedical Catalyst grant to develop a multiomics platform for early colorectal cancer detection.
- June 2025: PathPresenter receives FDA 510(k) clearance for a digital pathology viewer compatible with Hamamatsu NanoZoomer S360MD.
- April 2025: Bristol Myers Squibb wins FDA approval for Opdivo + Yervoy in first-line MSI-H/dMMR metastatic colorectal cancer.
- March 2025: Mainz Biomed enrolls the first patient in eAArly DETECT 2 to advance RNA-based colorectal cancer diagnostics.
- January 2025: Geneoscopy closes USD 105 million Series C funding led by Bio-Rad to commercialize ColoSense and expand into IBD testing.
Global Colorectal Cancer Diagnostics And Therapeutics Market Report Scope
As per the scope of the report, colorectal cancer, also known as bowel cancer, colon cancer, or rectal cancer, is any form of cancer that affects the colon and the rectum. The diagnostics and therapeutics used for managing colorectal cancer are various screening tests, kits, and medical devices.
The colorectal cancer diagnostics and therapeutics market is segmented by modality (diagnostics techniques (stool tests, immunohistochemistry, colonoscopy, flexible sigmoidoscopy, and other diagnostics techniques) and therapeutics (chemotherapy, immunotherapy, and other therapeutics)) and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major regions globally.
The report offers the value (in USD) for the above segments.
| Diagnostics Techniques | Stool-Based Tests | Fecal Immunochemical Test (FIT) |
| guaiac-FOBT | ||
| Multi-target Stool-DNA (mt-sDNA) | ||
| Blood-Based Biomarker Tests | ctDNA assays | |
| Epigenetic methylation panels | ||
| Endoscopy-Based Imaging | Colonoscopy | |
| AI-assisted Colonoscopy | ||
| Flexible Sigmoidoscopy | ||
| Radiology & Molecular Endoscopy | ||
| Histopathology / Digital Pathology | ||
| Therapeutics | Chemotherapy | Fluoropyrimidines (5-FU, Capecitabine) |
| Oxaliplatin-based regimens (FOLFOX) | ||
| Irinotecan-based regimens (FOLFIRI) | ||
| Targeted Therapy | Anti-EGFR (Cetuximab, Panitumumab) | |
| Anti-VEGF (Bevacizumab, Aflibercept) | ||
| BRAF / HER2 / KRAS G12C inhibitors | ||
| Immunotherapy | PD-1 / PD-L1 inhibitors | |
| CTLA-4 combos | ||
| CAR-T / Oncolytic Viruses | ||
| Other Therapeutics (Radioembolization, Vaccines) | ||
| North America | United States |
| Canada | |
| Mexico | |
| Europe | Germany |
| United Kingdom | |
| France | |
| Italy | |
| Spain | |
| Rest of Europe | |
| Asia Pacific | China |
| Japan | |
| India | |
| South Korea | |
| Australia | |
| Rest of Asia Pacific | |
| Middle East & Africa | GCC |
| South Africa | |
| Rest of Middle East & Africa | |
| South America | Brazil |
| Argentina | |
| Rest of South America |
| By Modality | Diagnostics Techniques | Stool-Based Tests | Fecal Immunochemical Test (FIT) |
| guaiac-FOBT | |||
| Multi-target Stool-DNA (mt-sDNA) | |||
| Blood-Based Biomarker Tests | ctDNA assays | ||
| Epigenetic methylation panels | |||
| Endoscopy-Based Imaging | Colonoscopy | ||
| AI-assisted Colonoscopy | |||
| Flexible Sigmoidoscopy | |||
| Radiology & Molecular Endoscopy | |||
| Histopathology / Digital Pathology | |||
| Therapeutics | Chemotherapy | Fluoropyrimidines (5-FU, Capecitabine) | |
| Oxaliplatin-based regimens (FOLFOX) | |||
| Irinotecan-based regimens (FOLFIRI) | |||
| Targeted Therapy | Anti-EGFR (Cetuximab, Panitumumab) | ||
| Anti-VEGF (Bevacizumab, Aflibercept) | |||
| BRAF / HER2 / KRAS G12C inhibitors | |||
| Immunotherapy | PD-1 / PD-L1 inhibitors | ||
| CTLA-4 combos | |||
| CAR-T / Oncolytic Viruses | |||
| Other Therapeutics (Radioembolization, Vaccines) | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia Pacific | China | ||
| Japan | |||
| India | |||
| South Korea | |||
| Australia | |||
| Rest of Asia Pacific | |||
| Middle East & Africa | GCC | ||
| South Africa | |||
| Rest of Middle East & Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
Key Questions Answered in the Report
How large is the colorectal cancer diagnostics and therapeutics market in 2025?
The market is valued at USD 29.89 billion in 2025 and is set to reach USD 38.09 billion by 2030 at a 4.95% CAGR.
Which segment is growing fastest?
Therapeutics lead growth with a 13.6% CAGR through 2030, propelled by immunotherapy and targeted small-molecule approvals.
What share does North America hold?
North America accounts for 34.6% of global revenue, a position supported by broad reimbursement and high innovation density.
Why is Asia Pacific expanding quickly?
Government-funded screening programs, AI-enabled colonoscopy adoption, and cost-efficient manufacturing drive a 7.70% CAGR in Asia Pacific.
What are the main cost challenges?
Targeted therapy courses average USD 150,000–200,000 annually and carry high toxicity management costs that strain emerging-market budgets.
Page last updated on:
