Capillary Electrophoresis Market - Growth Drivers and Challenges
Growth Drivers
- Rising biopharmaceutical industry growth: There has been consistent progress in the expansion of the biopharmaceutical sector, particularly in terms of biologics and biosimilars, which is remarkably increasing the demand for capillary electrophoresis systems. As per the report from Research Nester, the biosimilars market is projected to exceed USD 128.4 billion by the end of 2034, growing at a CAGR of 16.2% during the forecast period from 2025 to 2034, which in turn drives demand for advanced analytical techniques such as CE to ensure product purity, consistency, and regulatory compliance.
- Advancements in CE instruments: The escalating advancements in capillary electrophoresis instrumentation, which include automation, enhanced sensitivity, and integration with mass spectrometry, have broadened applications in this field. For instance, in June 2025, Shimadzu Corporation declared that its MultiNA II MCE-301 microchip electrophoresis system received the most prominent Red Dot Design Award 2025 for its enhanced functionality, usability, and innovative design, which automates the entire electrophoresis process, reducing the time needed for genetic analysis workflows.
- Quality control mandates: This is one of the primary drivers for the market since the mandates imposed by the administrative bodies must be adhered to by pharmaceutical giants, creating an extensive demand for CE. As of the August 2025 article published by the U.S. FDA, its Office of Pharmaceutical Quality is dedicated to ensuring that high-quality medicines are available to U.S. citizens by integrating assessment, inspection, surveillance, policy, and research activities across the world. OPQ also promotes a unified drug quality program across all manufacturing sites and product types, including new drugs, biologics, generics, and biosimilars.
Global Cancer Incidence and Age-Standardized Rates (ASR) by Sex - 2022
|
Category |
Total |
Men |
Women |
|
Total cancer cases (including NMSC) |
19,976,499 |
10,311,610 |
9,664,889 |
|
ASR (per 100,000) |
196.9 |
212.6 |
186.3 |
|
Total cases (excl. NMSC) |
18,741,066 |
9,566,825 |
9,175,141 |
|
ASR (per 100,000) |
186.5 |
198.6 |
178.9 |
Source: WCRF
Industry Collaborations and Innovations Driving Advancements in Capillary Electrophoresis Technology 2024
|
Company |
Announcement |
Key Details |
|
Sysmex & Hitachi High-Tech |
Collaboration on Genetic Testing Systems |
Developing cost-efficient CE sequencer-based genetic testing systems for clinical use, oncology focus. |
|
Waters Corporation |
Launch of Rapid Screening-DSC |
Thermal stability testing for biologics: 24x faster, 25x less sample volume, disposable microfluidic chips |
Source: Company Official Press Releases
Challenges
- High initial capital & maintenance expenses: This aspect in the market poses a major obstacle, especially for the small-scale manufacturers. The advanced systems, especially those integrated with mass spectrometry or fluorescence detection, necessitate extensive upfront investment, making them less accessible for smaller research laboratories or institutions that have limited budgets. Furthermore, the ongoing maintenance costs, which include calibration, consumables, and technical support, restrict widespread adoption in this field.
- Limited throughput for high volume applications: Despite the existence of high resolution, the throughput of capillary electrophoresis remains considerably limited when compared to techniques such as high-performance liquid chromatography. Further, this causes challenges for industries that require rapid analysis of numerous samples, such as pharmaceutical and clinical diagnostics. Hence, this processing of numerous samples can be restrictive in such instances.
Capillary Electrophoresis Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
5.5% |
|
Base Year Market Size (2025) |
USD 377.2 million |
|
Forecast Year Market Size (2035) |
USD 632.8 million |
|
Regional Scope |
|