PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1877420
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1877420
Host Cell Protein Testing Market size was valued at US$ 2,567.98 Million in 2024, expanding at a CAGR of 8.4% from 2025 to 2032.
Host cell protein (HCP) testing refers to the analysis and quantification of proteins that are naturally produced by the cells (host cells) used in the manufacturing process of biologic drugs or biopharmaceuticals. The global host cell protein (HCP) testing market is expected to see significant growth during the forecast period. The key growth drivers include the increasing demand for biologics and biosimilars due to the surge in chronic diseases, advancements in HCP testing technologies, and the rapid integration of these methods into the drug development process. However, the high cost and capital consumption associated with advanced testing technologies is hampering market growth. Additionally, there are challenges related to standardizing assays and adapting new methodologies across different manufacturing processes, which can slow widespread adoption despite regulatory pressures.
Host Cell Protein Testing Market- Market Dynamics
The increasing prevalence of chronic diseases
Chronic diseases require long-term and targeted treatment options, often involving biologic drugs like monoclonal antibodies, recombinant proteins, and other advanced therapeutics. These biologics are produced using living host cells, making HCP testing essential to detect and quantify residual host cell proteins that can impact the safety and efficacy of the final drug product. As chronic diseases continue to rise globally, the consumption of biologic therapies is growing rapidly. This surge in biologics demand necessitates stringent testing protocols to meet regulatory standards and ensure patient safety by minimizing impurities such as HCPs. According to data published by CDC (Centers for Disease Control and Prevention), in February 2025, diabetes ranks as the eighth leading cause of death in United States, representing one of the most severe health challenges the country faces. Currently, over 38 million adults in the U.S. were living with diabetes, and nearly 98 million adults have prediabetes, a condition that increases the risk of developing type 2 diabetes. This widespread prevalence underscored the urgent public health concern posed by diabetes and its complications. Therefore, growing prevalence of chronic diseases such as cancer, diabetes, autoimmune disorders, and cardiovascular diseases is a significant factor driving the demand for host cell protein (HCP) testing.
Host Cell Protein Testing Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 8.4% over the forecast period (2025-2032)
Based on Type segmentation, ELISA-Based Assays is predicted to show maximum market share in the year 2024
Based on Expression System segmentation, Mammalian Cells is the leading Expression System in 2024
Based on Product Stage segmentation, Clinical is the leading Product Stage in 2024
Based on Application segmentation, Monoclonal Antibodies (mAbs) is the leading Application in 2024
Based on End User segmentation, Bio-Pharmaceutical Companies is the leading End User in 2024
On the basis of region, North America is the leading revenue generator in 2024
The Global Host Cell Protein Testing Market is segmented on the basis of Type, Expression System, Product Stage, Application, End User, and Region.
The market is divided into four categories based on Type: PCR-Based Assays, ELISA-Based Assays, Mass Spectrometry-Based Assays, and Others. PCR-Based Assays detect genetic material related to host cells. ELISA-Based Assays are the most common, using antibodies to quantify total HCP levels with high sensitivity. Mass Spectrometry-Based Assays identify and quantify individual HCPs with high precision, offering detailed protein profiles. Other methods include techniques like Western blotting and electrophoresis, which provide qualitative or semi-quantitative analysis of HCP presence.
The market is divided into four categories based on Expression System: Mammalian Cells, Microbial Cells, Insect Cells, and Others. Mammalian cells offer complex protein modifications similar to humans. Microbial cells provide fast, cost-effective production, however lack complex modifications. Insect cells balance advanced modifications and lower costs than mammalian systems.
Host Cell Protein Testing Market- Geographical Insights
North America leading in market share due to its strong pharmaceutical R&D infrastructure and robust regulatory environment. The U.S. and Canada drive growth here, supported by strict regulatory mandates from agencies like the FDA, which promote rigorous HCP testing to ensure drug safety and compliance. Europe holds a significant share fueled by government initiatives and substantial R&D spending in countries such as Germany and the UK. The Asia Pacific region is expected to experience the fastest growth, propelled by increasing biologics production, expanding healthcare infrastructure, and improved regulatory frameworks in countries like China and India. Latin America and the Middle East & Africa are emerging markets showing steady growth due to rising biopharmaceutical activities and healthcare investments. Thus, it is concluded that rising chronic disease prevalence, expanding biologics production, and stringent regulatory requirements across these regions collectively bolster the global HCP testing market expansion.
The Host Cell Protein (HCP) Testing Market is highly competitive and dominated by several key global players focused on innovation and strategic collaborations. The key market players invest significantly in research and development to enhance testing methods like ELISA, mass spectrometry, and PCR-based assays, aiming to improve sensitivity, speed, and regulatory compliance. The market is driven by growing biologics demand, strict regulatory frameworks, and the need for faster, cost-effective testing solutions. Companies are also engaging in partnerships to expand their product portfolios and geographic reach. In June 2021, Bio-Rad Laboratories, Inc. declared a partnership with Seegene, Inc. to develop advanced PCR systems for faster clinical approvals. The competitive landscape is characterized by a focus on technological advancements, compliance with global regulatory standards, and expansion into emerging markets. As biologics continue to dominate new drug approvals, these companies are positioned to capitalize on the growing need for reliable HCP testing throughout drug development and production processes. Market players also emphasize customization of assays to fit diverse biologic products, boosting demand from biopharmaceutical firms worldwide.
In August 2024, Cygnus Technologies, LLC collaborated with TriLink BioTechnologies, a Maravai LifeSciences company, to commercialize AccuRes host cell DNA quantification kits. This AccuRes Host Cell DNA kits utilize probe-based quantification to specifically target DNA from the intended host cell line, minimizing detection of off-target DNA.
In May 2025, Biogenes GmbH introduced the CHO PRDX1 ELISA Kit, designed to detect peroxiredoxin 1 (PRDX1), a high-risk HCP due to its immunogenic potential. This kit enhances CHO-specific HCP analysis.