CRISPR’s ability to deliver results in under 30 minutes, combined with its low-cost potential, makes it ideal for low-resource settings. The aging population and rising cancer incidence, with 19.2 million new cases in 2020, further fuel demand for precise genetic diagnostics. The global CRISPR-based diagnostics market is estimated at USD 1.8-3.0 billion in 2025, with a compound annual growth rate (CAGR) of 13%-19% through 2030.
Regional Market Trends
- North America: The U.S. leads with strong investment in biotech and regulatory support, while Canada focuses on POC diagnostics for remote communities.
- Europe: Germany, France, and the UK drive growth with advanced research infrastructure, emphasizing infectious disease and cancer diagnostics.
- Asia Pacific: China and India see rapid adoption due to high infectious disease prevalence, with Japan prioritizing precision medicine applications.
- Rest of the World: Africa expands CRISPR diagnostics for tuberculosis and HIV, while Latin America invests in affordable POC solutions.
Application Analysis
- Hospitals and Clinics Diagnostic: Expected growth of 13.5%-19.5%, driven by rapid pathogen detection needs. Trends focus on POC devices for emergency diagnostics.
- Laboratories: Projected growth of 13.2%-19.2%, linked to high-throughput testing. Advances emphasize multiplexed pathogen detection.
- Pharmaceutical and Biotechnology Companies: Anticipated growth of 13.0%-19.0%, tied to drug development and companion diagnostics. Trends highlight genetic mutation screening.
- Others: Expected growth of 12.8%-18.8%, covering public health surveillance. Developments prioritize low-cost field testing.
Type Analysis
- Cas9: Expected growth of 13.3%-19.3%, valued for its precision in DNA detection. Trends focus on integration with isothermal amplification.
- Cas12: Projected growth of 13.6%-19.6%, favored for its collateral cleavage activity, ideal for POC diagnostics. Advances emphasize lateral flow readouts.
- Others: Anticipated growth of 12.9%-18.9%, covering Cas13 and novel systems. Trends highlight RNA detection for viral diagnostics.
Key Market Players
- Sherlock Biosciences: Develops rapid POC CRISPR diagnostics for infectious diseases.
- Mammoth Biosciences: Offers DETECTR platform for pathogen and mutation detection.
- CrisprBits: Focuses on affordable diagnostics for low-resource settings.
- Thermo Fisher Scientific: Provides CRISPR tools for research and diagnostics.
- Molbio Diagnostics: Integrates CRISPR with portable PCR systems.
Porter’s Five Forces Analysis
- Threat of New Entrants: Moderate, due to high R&D costs and intellectual property barriers, but open-source CRISPR tools lower entry hurdles.
- Threat of Substitutes: Moderate, with PCR and NGS competing, but CRISPR’s speed and simplicity offer advantages in POC settings.
- Bargaining Power of Buyers: Moderate, as hospitals seek cost-effective diagnostics, but specialized CRISPR applications limit options.
- Bargaining Power of Suppliers: Low, with multiple providers of reagents and enzymes.
- Competitive Rivalry: High, with players competing on speed, cost, and multiplexing capabilities.
Market Opportunities and Challenges
Opportunities:
- Addressing infectious diseases, with 10.8 million TB cases annually, using rapid CRISPR tests.
- Leveraging COVID-19-driven demand for POC diagnostics, as seen with Sherlock’s FDA-approved kits.
- Supporting cancer and genetic disease diagnostics, with 19.2 million cancer cases in 2020.
- Utilizing portable devices like DETECTR for low-resource settings.
- Aligning with WHO’s genomic strategy for standardized diagnostics.
- Attracting investment, with health tech funding up 15% from 2020-2023.
Challenges:
- High development costs for multiplexed assays.
- Regulatory delays, with FDA approvals taking 1-2 years.
- Intellectual property disputes limiting commercialization.
- Limited infrastructure in low-income regions.
- Competition from established PCR and NGS technologies.
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Table of Contents
Companies Mentioned
- Sherlock Biosciences
- Mammoth Biosciences
- CrisprBits
- Thermo Fisher Scientific
- Molbio Diagnostics
- Horizon Discovery
- Integrated DNA Technologies
- Synthego Corporation
- ToolGen
- Caribou Biosciences