Host Cell Protein Testing Market Research Report: Information by Type (PCR-based Assays, ELISA-based Assays), by End User (CROs, Biopharmaceutical Companies), by and Region (North America, Europe, Asia-Pacific, and Rest of the World) - Forecast till 2027

Host Cell Protein Testing Market Forecast

The global host cell protein testing market is expected to reach USD 1,621.18 million by 2027 and register a CAGR of 5.80% during the forecast period of 2021 to 2027.

Market Overview:

Host Cell Proteins (HCPs) are low-level, process-related protein impurities found in therapeutic products received from the host organism during biotherapeutic production. During the manufacture of a recombinant protein medication, many endogenous proteins can be produced by host cell systems. These HCPs are eliminated throughout the product purification steps as their presence, even in low residual quantities, could affect the recombinant product's safety and efficacy. The growth of the global host cell protein testing market is expected to be driven by the developments in the biopharmaceutical field, and growing R&D activities. Also, introduction of automated mass spectrometry for host cell protein detection is creating opportunities for the host cell protein testing market.

Impact of COVID-19

The spread of the lethal coronavirus across the globe has affected the transportation of goods across different continents and regions. The viral outbreak affected the entire supply chain, from the delivery of raw materials to the transportation of the finished goods. The providers have set up a special team to evaluate the overall supply chain of the raw materials and final consumables. The special team is liable to assess the cross-border situations and regulations related to the trade during the pandemic period. Moreover, the manufacturers have enhanced the transport facilities and have upgraded their packaging infrastructure to meet the guidelines.

Market Dynamics

• Developments in the biopharmaceutical field

The increasing demand for drugs for various types of cancer and inflammatory diseases has forced the market players to transform biopharmaceutical research facilities and manufacturing units. Additionally, such demand led to the expansion in biopharmaceutical capabilities, further increasing the volume of drug production. In January 2021, the government authorities such as the US Department of Health and Human Services launched biopharmaceutical development programs to advance the innovation of investigational biological products. This program offers analytical technologies and advanced techniques for the production, extraction, and elimination of antibodies, peptides, proteins, viral vaccines, gene therapy products, DNA, oncolytic viruses, cell therapy, and other biological agents. Under the biopharmaceutical development program, more than 260 products were released for clinical utilization, more than 170 distinct biopharmaceuticals were manufactured, above 65 human clinical trials were carried out, and more than 14 products were prepared for the license. Moreover, according to the Manchester Institute of Biotechnology, the pharmaceutical sector's best-selling products belong to the protein-based category.

• Growing R&D activities

• Concerns pertaining to immunogenicity

Immunogenicity poses a major threat to market growth. On the administration of therapeutic proteins in the individual, the immune system generates antibodies against the formulated proteins. In addition, the immune system may develop antibodies against endogenous proteins that are similar to the host-cell proteins. The immunogenicity may affect the patient's receiving the therapy by altering the functioning of the other neighboring proteins with the same composition and shape. Moreover, host cell impurities may adversely impact the efficacy of the final product. Such concerns might hinder the market growth of the host cell protein testing in the forecast period.

• Issues related to the efficiency and accuracy of the test kits 
  

• Introduction of automated mass spectrometry for host cell protein detection

The future of host cell protein testing is automation. The industry players are investing in technologies to automate the detection of host cell protein in commercially produced antibodies. Scientists have developed a mass spectrometry technique to detect the levels of host cell protein. In addition, scientists have innovated an advanced liquid chromatography-tandem mass spectrometry (LC-MS/MS) system to augment the throughput analysis of host cell proteins. Moreover, the new technique is enabled to detect low host cell protein levels in monoclonal antibodies. The technique was innovated to minimize the possibility of the presence of host cell proteins during drug development. The presence of HCPs at a low level might affect the quality, stability, and safety of the drugs. Henceforth, the emergence of automated low-level host cell protein detection will accurately identify the protein level in medicines. These systems are capable of detecting host cell protein under 100 ppm.

Value Chain Analysis

The global host cell protein testing market is showing positive growth due to the increasing clinical trials for the production of life-saving drugs, the rising volume of generic medicine manufacturing, and growing demand for advanced and efficient host cell protein testing kits and devices. The value chain analysis for the market comprises four major components, which start with the R&D and designing, followed by manufacturing, distribution & sales, and post-sales review.

Segment Overview:

• PCR-based Assays

PCR-based assays are used to detect genetic material from a specific organism, such as a virus. These assays are primarily used for rapid and highly specific diagnosis of infectious diseases such as those caused by viruses or bacteria. It is also used for the identification of on-cultivable or slow-growing microorganisms such as anaerobic bacteria, mycobacteria, or viruses from tissue culture assays and animal models. It allows the detection of small numbers of disease organisms, dead or alive, in convenient samples. There are different types of PCR-based assays, including standard single PCR, allele-specific PCR, multiplex PCR, and real-time PCR.

• ELISA-based Assays

The ELISA-based assay is a plate-based assay technique used for the detection and quantification of soluble substances such as proteins, peptides, hormones, and antibodies. There are four types of ELISA, including direct ELISA, indirect ELISA, sandwich ELISA, and competitive ELISA. In the direct ELISA assay, an antigen-coated on a multi-well plate is detected by an antibody that has been directly conjugated to an enzyme. It is a quick method used for detection, and cross-reactivity of secondary antibodies is eliminated. Sandwich ELISA is a type of enzyme-linked immunosorbent assay that uses two antibodies involving a detection antibody and a capture antibody. It has various advantages such as high specificity, suitability for complex samples, flexibility, and sensitivity. Competitive ELISA is a surface/plate-based assay, where the plate is coated with capture antibodies reactive to the molecule of interest. In a competitive ELISA assay, no sample processing is required, and crude or impure samples can be used.

• Mass Spectrometry-based Assays

A mass spectrometry-based assay has emerged as a powerful analytical tool for the identification, characterization, and quantification of various biomolecules in biological specimens. It has been gaining rising attention and interest for the quantitative bioanalysis of proteins in recent years. It has various advantages, such as the ability to measure multiple analytes in a single analytical run, ease of development of new assays, low volume requirements, and low reagent costs. There is an increasing demand for the quantitative bioanalysis of protein therapeutics in drug development.

• Contract Research Organizations

Host cell protein testing is in demand from contract research organizations. A contract research organization is an outsourcing company that provides support to pharmaceutical and biotechnology companies through outsourced pharmaceutical research services. According to IBIS World, there are 4,087 contract research organizations businesses in the US in 2021. Host cell protein testing is used by contract research organizations for developing new medicines and drugs. It helps in biological assay development, preclinical research, and clinical trials management. It helps in moving new drugs from their conception to FDA/EMA marketing approval.

• Biopharmaceutical Companies

Host cell protein testing is used in biopharmaceutical companies. Biopharmaceutical drugs are used for the treatment of a broad spectrum of diseases such as cardiovascular diseases, diabetes, and cancer. It can be produced from mammalian cell lines, microbial cells, and plant cell cultures. Biopharmaceuticals such as recombinant proteins and therapeutic antibodies are produced in generally engineered host cells. Host cell protein testing effectively removes host cell contaminants from the production cell lines to ensure product safety.

Regional Analysis

The global host cell protein testing market has been segmented, on the basis of region, into North America, Europe, Asia-Pacific, and rest of the world.

• North America

North America dominated the global host cell protein testing market due to various factors, such as developments in the biopharmaceutical industries, increasing investment in R&D activities, and well-established healthcare infrastructure in the region. North America is divided into the US and Canada. The US is the World's leader in biopharmaceutical R&D and the largest market for biopharmaceuticals, driving the demand for host cell protein testing products in the region. The US biopharmaceutical industry has been the global leader in developing new medicines for more than 30 years. Moreover, the collaboration and partnerships of the market players are expected to bring about highly innovative, industry-leading products driving the demand for host cell protein testing across the region. Canada also has a high number of biotechnology companies. According to the Canadian Life Sciences Database, currently, the number of biotech companies in Canada is 1,042. This is fueling the growth of the host cell protein testing market in the region.

• Europe

Europe has also evolved as a prominent market for host cell protein testing, with well-established R&D facilities across the region, the presence of supportive regulatory systems, development of innovative and cost-effective host cell protein testing solutions by the companies. According to Statista, in 2020, USD 1,232.07 million (1,045 million euros) were spent on R&D by listed biotechnology companies. The UK has a unique worldwide health and life sciences ecosystem and a strong track record of scientific breakthroughs with next-generation technologies and services. The government provides an R&D platform for the companies in the market. Government initiatives and research funding are also fueling the growth of this market.

• Asia-Pacific

Asia Pacific presents lucrative opportunities for players operating in the host cell protein testing market, attributed to the presence of a large target population suffering from chronic diseases such as cancer, increasing government investment in healthcare infrastructure, and increasing awareness about chronic diseases. According to the World Health Organization, chronic diseases are responsible for approximately 70% of deaths worldwide. China accounted for 24% of newly diagnosed cases and 30% of all cancer-related deaths worldwide in 2020. According to the Indian Council of Medical Research (ICMR) and the National Centre for Disease Informatics and Research (NCDIR), India's cancer cases could increase by 12% in the next five years. The governments are launching various schemes to create awareness among the population. In India, Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) was announced with the objectives of correcting regional imbalances in the availability of affordable/ reliable tertiary healthcare services and augmenting facilities for quality medical education in the country.

Competitive Landscape

The global host cell protein testing market is characterized by the presence of many global, regional, and local players. Developments in the biopharmaceutical field and growing R&D activities make the host cell protein testing market lucrative. To expand their reach and optimize their operational costs, the major players focus on obtaining regulatory authorizations from government agencies for their products and emphasize acquisitions and product launches to gain a substantial market share. The growth of market players is dependent on market conditions, government support, and industry development. Thus, manufacturers should focus on expanding geographically and improving their products. They primarily focus on the development of novel products. Although international players dominate the market, regional and foreign players with small market shares also have a considerable presence in the global host cell protein testing market.

Key Players

The prominent players in the global host cell protein testing market are Enzo Life Sciences, Inc. (US), Cytiva (US), Thermo Fisher Scientific Inc. (US), Bio-Rad Laboratories, Inc. (US), Cygnus Technologies, Llc (US), Biogenes Gmbh (Germany), Cisbio Bioassays (Europe), Charles River Laboratories International, Inc. (US), Rockland Immunochemicals, Inc. (US) and Abcam Plc (UK).

Recent Developments

• In June 2021, Bio-Rad Laboratories, Inc. partnered with Seegene (South Korea) for the clinical development and commercialization of infectious disease molecular diagnostic products.


• In February 2021, Thermo Fisher Scientific Inc. acquired Mesa Biotech, Inc (US). The acquisition will accelerate the growth of Thermo Fisher’s PCR-based assay and diversify its product offerings in the host cell protein testing segment. Mesa Biotech has developed the Accula System, a point-of-care PCR-based testing tool for infectious disease diagnosis that is both economical and simple to use.


• In October 2020, Thermo Fisher Scientific Inc. launched the OmniPATH COVID-19 Total Antibody ELISA test. These new test for detecting COVID-19 antibodies and are designed to meet the need for open ELISA and automated workflows.

Report Overview

The study covers the existing short-term and long-term market effects, helping decision-makers draft short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, value chain, and impact of COVID-19 on the market.

Market Segmentation

Global Host Cell Protein Testing Market, by Type

• PCR-based Assays


• ELISA-based Assays


• Mass Spectrometry-based Assays

Global Host Cell Protein Testing Market, by End User

• Hospitals and Diagnostic Centers


• Pharmacy


• Research Labs & Institutes


• Others

Global Host Cell Protein Testing Market, by Region

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • Japan
  
  
  • China
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa