Rapid Expansion of Cell and Gene Therapy Manufacturing is Driving the Global Biosensor Market

Rapid expansion of cell and gene therapy (CGT) manufacturing is a major structural driver of the CGT biosensors market. As therapies transition from clinical-scale to commercial production, manufacturers are under increasing pressure to deploy real-time monitoring, in-line analytics, and automated process analytical technology (PAT). Because CGT processes are highly sensitive to variability in cell growth, vector yield, and metabolite balance, biosensors are becoming indispensable for ensuring batch consistency, sterility, and regulatory compliance.

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Data Bridge Market Research analyses that the Global Biosensor Market is expected to reach USD 3.16 billion by 2033 from USD 1.84 billion in 2024, growing with a CAGR of 7.6% in the forecast period of 2026 to 2033.

Key Findings of the Study

Shift Toward Real-Time and Continuous Bioprocess Monitoring

The global biosensor market for Cell and Gene Therapy (CGT) is undergoing a fundamental transformation, moving away from labor-intensive offline sampling toward Real-Time and Continuous Bioprocess Monitoring. Historically, CGT manufacturing relied on discrete "grab-sampling," where media was manually extracted and sent to a lab for analysis, a process that introduces contamination risks and "dead time" where critical deviations can occur unnoticed. As of 2026, the industry is adopting Process Analytical Technology (PAT) to achieve "Pharma 4.0" standards, where biosensors are integrated directly into closed-loop systems to provide instantaneous feedback on cell health and metabolic activity. The demand for real-time monitoring is fueled by the need to reduce the high cost of goods (COGS) in CGT, where a single failed batch of CAR-T cells can represent a loss of $300,000 to $500,000 in manufacturing costs alone. Government regulatory bodies, led by the U.S. FDA, have issued specific guidance to encourage the adoption of continuous monitoring to ensure product safety and "Quality by Design" (QbD).

Report Scope and Market Segmentation

Segment Analysis

The global biosensor market is segmented into two notable segments based on the therapy modality and analytical sensor.

• On the basis of therapy modality, the global biosensor market is segmented into biosensors for cell therapies and biosensors for gene therapies.

In 2026, the biosensors for cell therapies segment is expected to dominate the global biosensor market

In 2026, the biosensors for cell therapies segment is expected to dominate the global biosensor machine market with 70.57% due to driven by the rapid expansion of advanced cell-based treatments such as CAR-T, stem cell therapies, and regenerative medicine applications.

• On the basis of analytical sensors, the global biosensor market is segmented into upstream bioprocess monitoring, downstream processing & purification analytics, critical quality attribute (CQA) monitoring, and potency & functional activity assays.

In 2026, the upstream bioprocess monitoring segment is expected to dominate the global biosensor market

In 2026, the upstream bioprocess monitoring segment is expected to dominate the market with the market share 43.89%, owing to the growing emphasis on optimizing cell culture performance, improving yield efficiency, and reducing batch failures in biopharmaceutical production. Upstream processes, including cell line development, media optimization, and fermentation, are highly sensitive to parameters such as pH, dissolved oxygen, temperature, and nutrient concentration.

Major Players

Data Bridge Market Research analyzes some of the major market players operating in the market are Merck KGaA (Germany), F. Hoffmann La Roche Ltd (Switzerland), YSI a Xylem brand (U.S.), Abbott Laboratories (U.S.), Bio Rad Laboratories, Inc. (U.S.), Aber Instruments Ltd (U.K.).

Market Developments

• In May 2025, Sartorius AG announced the launch of the Octet R8e biolayer interferometry (BLI) system, expanding its label-free biomolecular analysis portfolio. The new platform delivers enhanced sensitivity and broader dynamic range, enabling accurate detection of low-molecular-weight and low-abundance analytes for complex biologics workflows. It supports both 96- and 384-well plate formats with sample volumes as low as 40 µL, improving throughput and cost efficiency. The system also incorporates advanced evaporation control for up to 16-hour runtimes, positioning the Octet R8e as a high-performance solution for drug discovery, process development, and biopharmaceutical research.
• In March 2025, Agilent Technologies announced that its xCELLigence Real-Time Cell Analysis (RTCA) platform was applied in support of the FDA approval of the CAR-T therapy AUCATZYL by Autolus Therapeutics. The RTCA technology was used to develop and validate a label-free potency assay, enabling precise real-time monitoring of cell activity critical for regulatory submission. The platform delivers continuous, impedance-based measurements that improve assay robustness and reproducibility. Its successful use in the approval process highlights the growing role of RTCA systems in cell therapy development and quality control workflows.
• In December 2025, Agilent Technologies announced the launch of 21 CFR Part 11 compliance software for its xCELLigence RTCA eSight system, strengthening the platform’s suitability for regulated environments. The upgrade introduces enhanced security features—including secure user authentication, electronic signatures, and full audit trails—enabling deployment not only in drug discovery laboratories but also in GMP-regulated manufacturing and quality control settings. This development responds to growing demand for regulatory-ready digital lab tools in biopharma and cell therapy workflows, while supporting data integrity, audit readiness, and seamless continuity across the drug development lifecycle.
• In July 2025, Bio Rad Laboratories has broadened its digital PCR offerings by launching four new Droplet Digital PCR (ddPCR) platforms, including the new QX Continuum system and three models in the QX700 series, expanding its genomics research and clinical diagnostics lineup with advanced multiplexing, high throughput and streamlined workflows. This expansion strengthens Bio Rad’s position in the competitive ddPCR market and enhances its appeal to research and clinical labs, likely helping drive future sales growth.
• In July 2025, Cytiva is investing about $1.6 billion in global expansion projects to grow its bioprocessing infrastructure and improve local manufacturing capacity “in region, for region,” with new facilities and upgrades across Asia, Europe, and the U.S. to better serve customers developing advanced therapeutics and shorten supply chains. This large investment will boost Cytiva’s manufacturing footprint and supply resilience, helping it meet rising demand for biopharmaceutical materials.

Regional Analysis

Geographically, the country covered in the global biosensor market report is U.S., Canada, Mexico, Germany, U.K., France, Italy, Spain, Russia, Turkey, Netherlands, Norway, Finland, Denmark, Sweden, Poland, Switzerland, Belgium, Rest of Europe, China, Japan, India, South Korea, Australia, Indonesia, Thailand, Malaysia, Singapore, Philippines, Rest of Asia-Pacific, Brazil, Argentina, rest of South America. U.A.E., Saudi.

As per Data Bridge Market Research analysis:

North America is the dominant region in the global biosensor market

North America leads the global biosensor market due to its strong healthcare infrastructure, high adoption of advanced medical technologies, and significant investment in research and development. The region benefits from a high prevalence of chronic diseases such as diabetes and cardiovascular disorders, which drives sustained demand for continuous monitoring and point-of-care diagnostic solutions. Favorable reimbursement policies, early adoption of wearable and implantable biosensors, and widespread use of digital health platforms further support market growth. Additionally, the presence of major biosensor manufacturers, active collaborations between academia and industry, and strong funding from public and private sources accelerate innovation and commercialization. Regulatory support for novel diagnostic technologies, along with growing consumer awareness of preventive healthcare and personalized medicine, collectively positions North America as the leading region in the global biosensor market.

Asia-Pacific is estimated to be the fastest-growing region in the global biosensor market

Asia-Pacific is expected to be the fastest-growing region in the global biosensor market from 2026 to 2033, driven by rising prevalence of chronic diseases such as diabetes and cardiovascular disorders, which is significantly increasing the demand for continuous glucose monitoring (CGM) systems and point-of-care diagnostic devices.

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