Cell Counting Is Growing More Important Amid Advanced Therapy's Rise

By Pankaj Singh, Global Market Insights

Cell counting is a fundamental technique used across the life sciences, from medical testing to pharmaceutical research. It refers to the process of quantifying the number of cells in a biological sample. By determining cell counts, scientists can monitor cell growth, measure the effects of drugs and toxins, and ensure quality control in biomanufacturing processes.

Cell counting is an important emerging market due to several factors. First, there is a growing demand for biologics in the treatment of chronic and infectious diseases, which requires accurate and efficient cell counting. Cell counting plays a crucial role in various aspects of biotechnology and biopharmaceutical industries, such as drug discovery, development, and manufacturing processes.

Second, advancements in cell-based research and diagnostics are driving the need for accurate and reliable cell counting methods. Cell counting is essential in cell-based research for understanding cell growth, viability, and response to various stimuli.

There are a few key applications where cell counting provides vital data:

Bioprocessing

In biotechnology and pharmaceutical manufacturing, cell cultures are needed to produce biological products like vaccines and protein therapeutics. Cell counting monitors these production cell lines to optimize growth, productivity, and product quality control. By tracking cell density in real time, processors can ensure cultures remain in log phase growth and maximize bioreactor productivity.

In the biotechnology and pharmaceutical manufacturing industry, accurate and efficient cell counting and cell-based bioassays in GMP (good manufacturing practice) settings are crucial for optimizing production processes and ensuring product quality control. Here are some recent trends and innovations in cell counting and cell-based bioassays for GMP settings:

• Emergence of Automated Cell Counters: Advanced automated cell counting technologies have been increasingly integrated into GMP settings, allowing for real-time monitoring and analysis of cell cultures. These systems often come equipped with sophisticated software for data management and analysis, enabling seamless integration with bioreactor systems and facilitating rapid adjustments to optimize cell growth and productivity.

For instance, PerkinElmer introduced its Cellaca PLX image cytometry solution in 2022 to strengthen its automated cell counting offerings for streamlining cell and gene therapy research and manufacturing. It combines image cytometer hardware, software, validated consumables, and trackable data reporting, eliminating the need for complex calibration or extensive training.

• Integration of Microfluidic Technology: The integration of microfluidic technology into cell counting and bioassay platforms has enabled precise and automated handling of small sample volumes, reducing reagent consumption and waste generation. This trend has particularly benefited GMP settings by offering more efficient and cost-effective solutions for cell counting and bioassay applications.

• Innovations in Cell-based Bioassays: GMP facilities are adopting advanced cell-based bioassays that utilize high-content screening and multi-parametric analysis techniques. These assays enable the evaluation of multiple cellular parameters simultaneously, providing a more comprehensive understanding of cellular responses to various stimuli and drug candidates, ultimately contributing to improved product quality control and process optimization.

Cell Therapy Applications

Cell counting is crucial in cell therapy and regenerative medicine. These treatments involve introducing live cells into a patient's body to replace or regenerate tissues. To ensure safety and efficacy, the administered cells must be quantified precisely. Cell counting confirms the appropriate cell dose is delivered.

In the context of cancer treatment, cell counting is particularly relevant for certain cell-based therapies, such as CAR T cell therapy. The American Cancer Society has predicted over 2 million new cancer cases in the country during 2024, highlighting the importance of critical therapies.

During research and development, scientists must count and analyze cells to understand growth rates, behavior, and responses to experimental conditions. Highly accurate counts help optimize protocols. In manufacturing, precise cell counts enable quality control and appropriate dosing. Cells must be counted during expansion to track growth.

Toxicity Testing

Cell counting assays are incorporated into cytotoxicity and genotoxicity tests. By evaluating changes in cell proliferation and viability, researchers can determine if compounds and drug candidates are toxic to cells. This helps identify safety issues early in the drug development process. High-throughput screening is commonly used in toxicity testing. Cells are exposed to varying concentrations of a test compound, and cell counters provide a fast way to determine the compound's impact on viability and proliferation.

Toxicity evaluation is a crucial step in the pharmaceutical drug development process, as it helps identify potential adverse effects that a drug candidate may have on a patient. With a consistent rise in drug development expenditure, the need for cell counting will witness a proportionate increase. For instance, Sanofi recently said that it would spend over $754 million in 2024 for drug developments, part of a global trend.

Cell counters are ideal for performing assays like MTT, LDH release, ATP quantification, and annexin V staining that provide quantitative data on cell death pathways like apoptosis and necrosis. The automation and accuracy of cell counters enable testing on a much larger scale compared to slow, error-prone manual counting.

Complete Blood Count Testing

One of the most common uses of cell counting is in the complete blood count (CBC), which is a routine blood test for evaluating the cells in blood. In fact, during 2023 the CBC segment held over 47% share of the global cell counting industry. The CBC provides critical information about red blood cells, white blood cells, and platelets. Cell counting allows doctors to check for conditions like anemia, infections, and bleeding disorders.Enhancements in technologies used in the blood count testing market can have a significant impact on biomanufacturing processes. For example, advances in flow cytometry, which is commonly used in blood count testing, have the potential to improve the monitoring and quality control of biomanufactured products. It can be used particularly when producing complex biologics, such as monoclonal antibodies.

Additionally, advances in automated cell counters used in blood count testing can significantly improve the accuracy and speed of cell counting in biomanufacturing processes. For example, automated cell counters, such as the Vi-CELL cell viability analyzer from Beckman Coulter, can count cells using fluorescent dyes and provide detailed information about cell size, morphology, and concentration in minutes. Such information can be vital in the biomanufacturing process for precise cell culture monitoring and maintaining cell health.

Other Research Applications

Cell counting plays an important role in many areas of biological and medical research.

Stem cell and cancer research

Stem cells and cancer cells are characterized by their ability to self-renew through rapid cell division. Quantifying cell growth via cell counting allows researchers to study stem cell characteristics and cancer cell biology. This aids the development of stem cell therapies and cancer treatments.

Cell-based assays

Cell-based assays that quantify cell viability and proliferation are widely used in drug discovery. Researchers perform cell counts on cell cultures exposed to experimental drug compounds to evaluate effects on growth and survival.

Growth Of The Cell Counting Market

According to Global Market Insights, the cell counting market value will exceed $20.5 billion by 2032. The substantial growth over the coming years will be driven by increased funding for biomedical research, as well as the expansion of end-user markets such as hospitals, diagnostic labs, and pharmaceutical companies, which are adopting cell counting systems for medical applications.

Some notable trends fueling the cell counting market outlook include:

Increased R&D Funding: Governments and private organizations are investing more funds into biomedical research, especially in areas like cancer research and regenerative medicine. This leads to rising demand for cell counting instruments and reagents from academic and industry labs. For example, the Health Innovation 2030 plan launched by France in 2021 included around 1 billion euros ($1.08 billion) for biomedical research alone.

Geographical Trends: With more than 38% share, North America dominates the cell counting market, due to high research spending and advanced healthcare infrastructure. However, the Asia Pacific market is expected to grow rapidly in the coming years as countries like China and India increase investments in life sciences.

In a recent development, an Indian company, ImmunoACT, received the approval by Central Drugs Standard Control Organization for the first humanized CD19-targeted CAR T cell therapy product, aimed at relapsed or refractory B cell lymphomas and leukemia. Cell counting is essential during the manufacturing of CAR T cell therapies to ensure the appropriate expansion and characterization of T cells to achieve optimal therapeutic outcomes.

As such, the approval of ImmunoACT's CAR T cell therapy product is likely to increase the demand for cell counting equipment and services. The manufacturing process of CAR T cell therapies requires accurate and efficient cell counting to determine cell concentration, viability, and phenotype. This information is crucial for quality control, dose calculation, and product release.

It is estimated that the healthcare sector in China alone could be worth over $2.4 trillion by 2030, indicating the tremendous scope for the cell counting industry in the Asia-Pacific region.

Image Analysis for Cell Counting: Image analysis software has become an essential tool for cell counting in research and clinical applications. Microscope imaging combined with analysis software enables researchers to accurately count and characterize cells in samples. Traditional manual cell counting using a hemocytometer is tedious, time-consuming, and prone to human error and inconsistency.

AI-powered image analysis tools now allow for fully automated cell counting, removing human subjectivity. These tools can rapidly count cells in images captured from microscopes, with some software able to differentiate and categorize cells based on morphology. AI algorithms are trained on annotated image data sets to recognize cells. Some advanced systems can distinguish live vs. dead cells and identify specific cell types.

• A team of researchers at the University of Leicester recently demonstrated SSRNet, a deep learning network to predict cell counts and segment cell distribution contours with high precision. The AI-based approach involves capturing a cell sample as an image, processing it to enhance cell clarity, and feeding it into the AI counting system, which generates the cell count and distribution within the image.
• By leveraging the power of AI and innovative spatial-based super-resolution reconstruction techniques, this approach will offer unprecedented precision and efficiency in predicting cell numbers and distributions, benefiting biomanufacturing operations.
• Further refinements and applications of this AI-powered method are expected to reshape the landscape of cell analysis, streamline bioprocessing, reduce human error, and facilitate scientific progress. Machine learning capabilities can have the potential to optimize the design and development of biologically derived products, leading to enhanced manufacturing processes, faster development cycles, and improved product quality.

Key Players In The Cell Counting Market

The cell counting market is dominated by several major vendors and manufacturers offering a range of automated cell counters and consumables.

• Thermo Fisher offers the Countess II FL automated cell counter along with preloaded slides and reagents. It also provides the Invitrogen EVOS M7000 imaging system for cell counting and analysis.
• Danaher Corporation operates the Beckman Coulter business, which provides a suite of automated cell counters including the Vi-CELL BLU, Vi-CELL XR, and others. Beckman Coulter is a pioneer in cell counting technology.
• Merck KGaA offers the LUNA automated cell counter line along with reagents and disposables. It uses fluorescence optics and image analysis.
• Bio-Rad Laboratories provides cell counting systems such as the TC20 automated cell counter and the more advanced TC10. It offers dedicated solutions for counting blood cells, sperm cells, and yeast cells.
• Logos Biosystems manufactures automated cell counters driven by proprietary TrueCount technology. Its product line includes Luna II, Luna FX, Luna FL, and others for rapid and accurate cell counting.
• DeNovix is an emerging company offering automated cell counters, cell characterization, and analysis software. Its products include CellDrop automated cell counters, CellSight characterization systems, and others.

Challenges And Opportunities

Cell counting instruments and related consumables can be expensive, posing a challenge for smaller research labs and facilities with limited budgets. Affordability remains a significant concern that can limit the widespread adoption of cell counting technologies.

Some cell counting methods, such as flow cytometry or manual counting using hemocytometers, can be complex and require skilled operators. The accuracy and reproducibility of results may depend on the expertise of the user, which can be a challenge, particularly for less experienced technicians.

The cell counting market has opportunities for further automation and technological advancements. The development of automated cell counters and image analysis software has already made significant progress – improving accuracy, speed, and reproducibility while reducing operator dependence.

The emerging field of cell-based therapies, such as stem cell therapies and CAR T cell therapies, requires accurate and precise cell counting for cell manufacturing processes, quality control, and therapeutic efficacy assessment. This provides an opportunity for the cell counting market to cater to the specific needs of this expanding field.

About The Author:

Pankaj Singh is a writer at Global Market Insights who writes about business, technology, trade, and finance.