Cell-Based Assays Global Market estimated to be worth $20.1 billion by 2025

Over the past few years, there has been a trend of adopting cell-based assays when compared to biochemical assays, ligand binding assays and animal experiments as they mimic real-life models in drug discovery, development, manufacturing of small molecules and biologics to reduce developmental time and operational cost. The necessity for the robust cell-based assays is growing with the increase in the approvals of biologics, biosimilars and the need to meet the regulatory requirements. Thus, the demand for robust target specific bioassays is the need of the hour to accelerate, shorten development and manufacturing timelines of drug products. With several blockbuster biologics going off-patent such as Herceptin (Trastuzumab) and Avastin (Bevacizumab) 2019, and Aranesp (Darbepoetin Alfa) and Enbrel (Etanercept) in 2024 and 2028 respectively, there is a huge opportunity for the development of off-the-shelf and custom cell-based potency assays. The cell-based assays also plays an important role in basic research, cosmetics testing, medical device, chemical, materials, agriculture products, food & beverages, and environmental testing through various assays such as reporter gene assays, second messenger assay, cell growth assays, cell death and motility assays.

According to IQ4I analysis, the cell-based assays global market is estimated to grow at CAGR of 8.0% to reach $20.1 billion by 2025. The factors driving the market are rising use of the cell-based assay in drug discovery and development, increasing focus on biologics, technological advancements favoring the adoption of cell-based assays, the growing availability of funds for research. Whereas, factors such as lack of skilled professionals, ethical concerns over the use of raw materials from animal sources, high cost of instruments, lack of standardization, consistency and reproducibility issues are restraining the market growth.

The cell-based assays market is segmented based on products, applications, and geography. The products market includes consumables, instruments, software and services, among them, consumables segment commanded the largest share in 2018 and is projected to grow at the high single digit CAGR from 2018 to 2025. According to IQ4I analysis, among consumables about 21.1 million microplates were consumed during 2018, this number is expected to reach XX million by 2025 growing at mid single digit CAGR from 2018 to 2025. Reporter gene assays are employed to study gene regulations, transcriptional regulation of cells, promoter activity, cell signaling, gene expression in diagnostics, cancer research and environmental testing is driving the assay kits market in consumables segment. Similarly, reagents market which includes, media sera, dyes, stains and specialty chemicals occupies the largest share in consumables.

In the applications market, the Pharma and Biotech commanded the largest revenue 2018 and is expected to grow at a high single digit CAGR to reach $12.1 billion by 2025. Rise of discovery, development and manufacturing activity in biologics and biosimilar is driving the growth of the pharma and biotech segment. Drug discovery market is expected to grow at a high single digit CAGR. Increasing collaboration of basic research institutes with companies and CROs for the development of disease models such as cancer, cardiovascular diseases, neurodegenerative diseases (Alzheimer’s, dementia, Parkinson’s, Huntington’s, Bipolar disorder, multiple sclerosis etc.), drug development, manufacturing, diagnostic, medical devices testing, cosmetic testing and eco-toxicity study where cell-based assays are utilized is driving the growth of cell-based assay applications market.

Technological advancements in a cell-based assay such as platforms for High Throughput Screening (HTS), High-content screening (HCS), novel microscopy-based technologies, increased automation in liquid handling instruments, and advanced software for automation and data acquisition and analysis have proven to be valuable in drug discovery efforts. In addition, advancements such as predictive toxicology, virtual screening, 3D bio-printing, gene editing tools, are favoring the adoption of cell-based assays. Improvements in cellular models, such as cell lines, primary cells, stem cells are being used as models for basic research and drug discovery. Advancement in label-free technology such as dynamic mass redistribution (DMR)-based on optical biosensors, and cellular dielectric spectroscopy (CDS)- based on impedance biosensors are supporting the implementation of cell-based assay in basic research.

The growing concern on the use of animals for toxicology and efficacy studies and advantage of the cell-based assay in reducing time, cost and increasing accuracy, reproducibility are fueling the adoption of in-vitro (animal-free) testing for regulatory toxicology and to address efficacy concerns in the cosmetics, chemical, pharmaceutical and household product industries. Several companies offer in-vitro tissue models and different tissue specific testing services. For instance, Mattek Corp. offers various tissue models derived from human primary cells for researcher to evaluate raw materials and final product formulations. They also offer GLP and non-GLP toxicity testing services such as skin irritation, corrosion, eye irritation, and phototoxicity.

Companies in this market are employing organic strategies such as new product launches, approvals, collaborations and partnerships. For instance, in November 2018, Eurofins Scientific, a global leader in biopharmaceutical products testing services, signed an outsourcing agreement with Astellas to outsource one of its internal testing laboratories, expanding its geographic presence in Japan. An inorganic strategy such as acquisition expands product offering or help in gaining access to new markets. On April 2019, Charles River Laboratories acquisition of Citoxlab, a CRO specialized in regulated safety assessment services, non-regulated discovery services, and medical device testing with operations in Europe and North America.

The cell-based assay geographical market consists of North America, Europe, Asia-Pacific and RoW, where, North America dominates the market with largest share in 2018 due to high R&D funding and presence of major pharma and biotech companies. The Asia-Pacific market is expected to show strong growth from 2018 to 2025 due to increase in outsourcing of drug development research and the emergence of this region as the manufacturing of hub for biologics drugs.

Some of the key players in Cell-based assays market are Danaher  (U.S.), ThermoFisher Scientific  (U.S.), Merck KGaA (Germany.), Becton, Dickinson and Company (U.S.), Perkin Elmer, Inc. (U.S.), Lonza (Switzerland), Corning, Inc. (U.S.), Tecan (Switzerland), Bio-Rad Laboratories, Inc. (U.S.), Biotek (U.S.), Promega Corporation (U.S.) and GE Healthcare (U.S.)