Digital PCR Market Use in Gene Expression and Copy Number Variation Studies

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Digital PCR Market Use in Gene Expression and Copy Number Variation Studies

Kanesmith11
The Global Digital PCR Market Size is expected to be worth around USD 1,803 Million by 2032 from USD 450 Million in 2022, growing at a CAGR of 15.3% during the forecast period from 2023 to 2032.

In 2025, the Digital PCR Market is booming within pharmaceutical manufacturing and biotech quality control, where strict process validation is essential. Biologics producers are integrating dPCR into batch-release workflows to quantify viral vector copy number, residual host-cell DNA, and contaminant detection with high precision. Cellular therapy manufacturing labs use digital PCR to confirm gene-editing efficiency and clonal purity in CAR-T and CRISPR-edited cell products.

Single-use and droplet digital PCR assays ensure reproducibility and regulatory compliance with stringent international quality standards. As regulatory scrutiny intensifies around biologics and gene-modified products, dPCR is asserting its role as a core QC tool—helping ensure product consistency, safety, and traceability across the supply chain.

Click here for more information: https://market.us/report/digital-pcr-market/


Key Takeaways
n 2022, instruments represented 34% of revenue generated across product categories.
Technology-wise, digital droplet PCR holds the largest market share.
By indication, genetic disorders have emerged as the leader of this market and experienced the highest compound annual compound annual compound growth from 2023 to 2032.
By end-user segment, academic & research organizations held the greatest share of the market.
North America held the highest revenue share with 42%.
Europe will experience sustained compound annualized growth between 2023-2032.
Key Market Segments
Based on Product
Instruments
Reagents & Consumables
Based on Technology
Droplet Digital PCR (ddPCR)
Chip-Based Digital PCR
Other Technologies
Based on Indication
Genetic Disorders
Oncology
Infectious Diseases
Other Applications
Based on End-User
Hospitals & Clinics
Academic & Research Organization
Diagnostic Centers
Pharmaceutical & Biotechnology Industries
Other End-Users
Emerging Trends
Digital PCR validation of viral vector concentration in gene therapy batches.
Residual host-DNA quantification for biologics batch release.
Gene-editing efficiency measurement in CAR-T and CRISPR treatments.
Adoption of single-use dPCR reagents and platforms for GMP workflows.
Use Cases
A gene therapy developer uses dPCR to quantify AAV titer before clinical formulation.
Biologic manufacturers test cell-free DNA levels to comply with regulatory thresholds.
A cell therapy lab confirms CRISPR-editing success in CAR-T cell batches via dPCR.
A CDMO switches to single-use dPCR assays to validate sterility and contamination absence.