CRISPR-Based Diagnostics Market Projected to Reach US$12.09 Billion by 2033, Growing at 16.7% CAGR During 2025-2033 | DataM Intelligence

Leander, Texas and Tokyo, Japan - Nov 17, 2025
The CRISPR-based diagnostics market size reached US$3.04 billion in 2024 and is expected to reach US$12.09 billion by 2033, growing at a CAGR of 16.7% during the forecast period 2025-2033. This robust growth is propelled by the increasing demand for rapid, accurate, and portable diagnostic solutions, the rising prevalence of infectious diseases, technological advancements in CRISPR-Cas systems, and growing applications in point-of-care testing across healthcare settings worldwide.

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Recent Developments (November 2025)

✅ FDA Emergency Use Authorization Expansion - The US FDA granted EUA for 15 new CRISPR-based rapid tests for emerging infectious diseases, reducing detection time from hours to minutes.

✅ WHO Global Health Initiative - World Health Organization launched a $500 million program to deploy CRISPR diagnostics in low-resource settings, targeting 50 million tests annually in developing countries.

✅ Multiplex Detection Breakthrough - Researchers developed a single CRISPR test capable of detecting 10 different pathogens simultaneously, revolutionising syndromic testing approaches.

✅ Point-of-Care Integration - Major diagnostic companies introduced smartphone-connected CRISPR devices enabling lab-quality testing in remote and home settings.

✅ Cancer Screening Advancement - First CRISPR-based liquid biopsy test received regulatory approval for early cancer detection, achieving 95% sensitivity in clinical trials.

Market Trends & Drivers

The CRISPR-Based Diagnostics Market is experiencing rapid growth driven by the convergence of molecular biology, microfluidics, and digital health technologies. Key trends include the development of instrument-free testing platforms, integration with artificial intelligence for result interpretation, and expansion into non-infectious disease applications. The COVID-19 pandemic legacy, increasing antimicrobial resistance concerns, and demand for decentralized testing are significantly accelerating market adoption and innovation.

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Competitive Landscape

The market features dynamic competition between biotechnology pioneers, established diagnostic companies, and academic spin-offs.

1. Mammoth Biosciences launched the DETECTR® Platform with 30-minute detection capability, securing $300 million in partnerships with global health organizations and reporting 120% revenue growth.

2. Sherlock Biosciences introduced the INSPECTRTM RNA detection system, achieving 99% accuracy in pathogen identification and capturing 35% market share in respiratory disease testing.

3. Caribou Biosciences developed the next-generation CRISPR chip technology, enabling multiplex detection of 15 targets simultaneously and securing FDA clearance for sepsis panel testing.

4. CRISPR Therapeutics expanded into diagnostics with the CTX110 platform, focusing on cancer monitoring applications and securing $250 million in pharmaceutical collaborations.

5. ToolGen Inc. partnered with major diagnostic companies to integrate its CRISPR-Cas12 technology into automated testing systems, capturing 25% of the hospital diagnostic market.

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Segmentation Analysis

By Technique
• Recombinase Polymerase Amplification (RPA) dominates the market, valued for its isothermal amplification enabling rapid, instrument-free testing
• Loop-mediated Isothermal Amplification (LAMP) shows strong growth with high sensitivity and specificity for low-resource settings
• Both techniques are driving the shift away from traditional PCR-based methods toward faster, simpler diagnostic solutions

By Product
• Kits represent the largest segment, providing complete solutions for specific disease detection with minimal setup requirements
• Buffer Solutions and consumables show consistent growth as essential components of CRISPR diagnostic workflows
• Software emerges as a critical segment for result interpretation, data management, and quality control

By Application
• Infectious Diseases dominates the market, with widespread adoption for COVID-19, HIV, tuberculosis, and sexually transmitted infections
• Non-Infectious Diseases represents the fastest-growing segment, expanding into cancer monitoring, genetic disorders, and chronic disease management
• The technology's versatility enables rapid expansion into new disease areas and applications

By End User
• Diagnostic Centers lead market adoption, implementing CRISPR tests for routine screening and specialized testing services
• Hospitals show rapid growth with integration into emergency departments, ICUs, and outpatient settings
• Biotechnology Companies drive innovation through R&D investments and development of novel applications
• Academic and Research Institutes maintain strong presence as centers of technological advancement and validation studies

Key Growth Drivers:

1. Speed and Accuracy: Significantly faster results compared to traditional molecular methods with maintained high accuracy
2. Point-of-Care Capability: Enabling testing in decentralized settings without sophisticated laboratory infrastructure
3. Cost-Effectiveness: Lower per-test costs and reduced equipment requirements compared to PCR-based methods
4. Multiplexing Potential: Ability to detect multiple targets simultaneously from a single sample
5. Regulatory Support: Accelerated approval pathways for novel CRISPR-based diagnostic platforms
6. Global Health Needs: Critical demand for rapid diagnostics in pandemic preparedness and outbreak response

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Regional Analysis:

North America dominates the CRISPR-based diagnostics market, driven by strong regulatory frameworks, advanced healthcare infrastructure, and significant investments in biotechnology innovation. Europe shows robust growth with harmonised regulatory approvals and increasing adoption in clinical settings.

The Asia-Pacific region exhibits the fastest growth rate, fueled by large population needs, rising healthcare expenditure, and growing manufacturing capabilities in China, India, and South Korea. Latin America and the Middle East & Africa demonstrate significant potential with increasing focus on infectious disease control and point-of-care testing expansion.

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2. Point-of-Care Diagnostics Market - https://www.datamintelligence.com/research-report/point-of-care-diagnostics-market?jd
3. Companion Diagnostics Market - https://www.datamintelligence.com/research-report/companion-diagnostics-market?jd

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Sai Kiran
DataM Intelligence 4market Research LLP
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This release was published on openPR.