Host Cell Contaminant Testing Market Analysis

Host Cell Contaminant Testing Market Overview

Host Cell Contaminant Testing Market Size was valued at USD 0.29 Billion in 2023. The Global Host Cell Contaminant Testing industry is projected to grow from USD 0.31 Billion in 2024 to USD 0.51 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6.65% during the forecast period (2024 - 2032). Host cell contaminants are proteins found in the host cell that can cause immunogenicity, diminish a drug's stability or efficacy, and put the patient's safety in danger. Host cell proteins are proteins encoded by the host organisms that create recombinant therapeutic proteins, such as yeast, E.coli, and mammals. During biopharmaceutical manufacturing, host cell impuritiesareacritical step in the purification of the biopharmaceutical products.One of the most difficult aspects of biopharmaceutical development is the removal of host cell proteins. It has the ability to have an impact on both the safety and efficacy of a medicine. Factors such as advancements in biopharmaceuticals and rising demand for personalized medicine are driving the global host cell contaminant testing market.

The companies investing in host cell contaminant testing are entering into partnership deals.For instance, in June 2021, Bio-Rad Laboratories, Inc. (US), a global leader in life science research and clinical diagnostic products, announced a partnership with Seegene, Inc. (South Korea), a global leader in multiplex molecular diagnostics. In June 2019, Cygnus Technologies (US), a Maravai LifeSciences company, announced an expansion of its service offerings for host cell protein (HCP) analysis. A pioneer in tools for detectingCygnus also offers services to discover and quantify HCP impurities in biopharmaceuticals and vaccines, which can affect the efficacy and stability of the treatment.

COVID-19 Analysis

The pandemic COVID-19 has affected the global host cell contaminant testing market. It is affected global economies and the US and may also directly affect the operations of many companies and third-party players on which the companies rely. The players operating in the host cell contaminant testing market are focusing on different business strategic alliances such as mergers, acquisitions, agreements, and collaborations to manage their business in this pandemic condition. This pandemic has also affected the supply and demand of the host cell contaminant testing products in major regions due to the strict government regulations on the transportation of goods and services.The companies are facing volatile demand flow fluctuation by regional markets. They are also in regular contact with government authorities to maintain the product supply across the border.

The biopharmaceutical and biotechnology companies are heavily focusing on avoiding contamination from the host cell during manufacturing. COVID-19 pandemic is positively affected the host cell contaminant testing market. During vaccine manufacturing, host cell contaminant testing is an important quality assurance measure to ensure patient safety.The viruses can be transferred from contaminated vaccines to humans. There are several well-documented historical instances of virus transmission to humans through contaminant vaccines. These viruses can be detected with the help of host cell contaminant testing. This will create high demand for host cell contaminant testing in the future.

Host Cell Contaminant Testing Market Trends

Drivers

• Development in the field of biopharmaceuticals

Biopharmaceutical drugs are used to treat a broad spectrum of diseases and are increasingly used in nearly all branches of medicine, such as cardiology and neurology.The biopharmaceutical industry has a lot of potential because of the tremendous demand for biopharmaceutical drugs. The biopharmaceuticalmarket has developed much faster than the market for all drugs.

Biopharmaceuticals, also known as biological medical products, are complex medicines made from living cells or organisms. Biopharmaceuticals require products to be free of host cell protein contaminants. Host cell proteins and host cell DNA levels are contaminants present in biopharmaceuticals. This is creating a demand for host cell contaminant testing to minimize the contamination in the final products.

• Rising demand for personalized medicines

Personalized medicine is the modification of medical treatment to the individual characteristics of each patient, such as using targeted therapies to treat specific types of cancer cells. Physicians are using personalized medicinesto treat lung cancer, colon cancer, skin cancer, and pancreatic cancer.

Personalized medicines have great potential to improve overall patient care, surgical outcomes, and the treatment of diseases such as COVID-19. In the year 2019, 25% of the new personalized medicines were approved by the FDA.In 2019, Pretomanid (pretomanid), a customised medicine, become permitted to deal with substantial pulmonary drug-resistant, treatment-intolerant, or non-responsive multidrug-resistant tuberculosis. The selection to apply this product is knowledgeable via way of means of XDR and/or MDR biomarker statuses in patients.

Restraints

• High cost of the testing

Removal of the host cell contamination in pharmaceutical products is a big challenge for drug manufacturers. Any contamination in the drug manufacturing process can cause severe side effects on the patient's health and disturb manufacturer and customer relations. It leads to financial loss to the company.

The high cost of the host cell contaminant testing is a restraining factor for the market. The companies are investing heavily in contaminant testing during the manufacturing process to prevent future financial damage to the companies.The cost of contaminant testing is high. This is hampering the growth of the host cell contaminant testing market.

Market Opportunities

• Increasing Incidences of chronic diseases such as cancer

The increasing prevalence of chronic diseases such as cancer is creating future opportunities for the players involved in the market. According to the International Agency for Research on Cancer (IARC), 17.0 million new cancer cases were diagnosed in 2018 and 9.5 million people died from cancer. It is also estimated that the global burden of cancer cases is expected to be 27.5 million new cancer cases, as per IARC.

Host cell contaminant testing has application in contaminant testing in the development of cancer drugs. An increasing number of cancer cases around the globe is creating demand for host cell contaminant testing products.

• Increasing R&D activities

Technology Analysis

Host cell contaminant testing is used to detect the concentration of host cell proteins in samples from drug substances and downstream purification. The company is developing assay kits that enable biotech and pharmaceutical companies to detect and identify impurities in host cells, which is an important step in regulatory and quality control processes. PCR-based assay kits are designed and developed specifically to enable sensitive and accurate quantitation of residual host cell DNA. In July 2021, Gyros Protein Technologies (Sweden), a pioneer in automatic nanoliter-scale immunoassays and the main company of peptide synthesizers and reagents, has introduced the subsequent step in its ongoing collaboration with Cygnus Technologies (US), a MaravaiLifeSciences company, and the release of a new HEK 293 HCP immunoassay solution. The Cygnus HEK 293 HCP assay reagent set for Gyrolab is the primary in a deliberate collection of ready-to-use bioprocess impurity reagent units for detecting residual Host Cell Protein (HCP) from HEK 293 cells, a mobileular line normally utilized in viral vector manufacturing for mobileular and gene therapies, in addition to vaccine manufacturing.

Host Cell Contaminant Testing Market Segment Overview

Host Cell Contaminant Testing Type Insights

• Host Cell Protein Assay

The host cell protein assay is further sub-segmented into ELISA, ILA, SDS-PAGE, and immunoblotting. A multi-analyte Enzyme-Linked Immunosorbent Assay (ELISA) is the workhorse method for host cell protein testing due to its high throughput, sensitivity, and selectivity.Immuno Ligand Assay(ILA) measures a wide range of analytes such as proteins, drugs, and microorganisms for biopharmaceutical development and production. SDS-PAGE is a method for separating proteins according to their molecular weight. SDS-PAGE uses sodium dodecyl sulfate and polyacrylamide gel. Immunoblotting is a highly sensitive method for the identification of proteins, including antigens of viruses and other plant pathogens.

• Host Cell DNA Assay

Host Cell DNAs or residual DNAs are low/trace quantities of DNA originating from the organisms used in the production process of biopharmaceutical products. These residual DNAs can transmit viral infections that cause a potential risk for oncogenesis or adverse reactions.The host cell DNA assay is sub-segmented into quantitative PCR and Dot-Blot-hybridization. Quantitative PCR-based assaysare designed and developed specifically to enable sensitive and accurate quantitation of residual host cell DNA. Dot-Blot-Hybridization is a nucleic acid hybridization technique in molecular biology used to detect proteins. This technique is the most commonly used procedure for testing a large number of samples.

Host Cell Contaminant Testing End User Insights

• Biopharmaceutical Companies

Host cell contaminant testing is used in biopharmaceutical companies. Biopharmaceuticals such as recombinant proteins and therapeutic antibodies are produced in generally engineered host cells. Host cell contaminant testing effectively removes host cell contaminants from the production cell lines to ensure product safety.

• Contract Research Organizations

Host cell contaminant testing is also 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.

• Contract Manufacturing Organizations

Contract manufacturing organizations provide drug manufacturing services in the pharmaceutical industry on a contract basis. Host cell contaminant testing is an important process for contaminant-free drug manufacturing.

• Academic & Research Institutes

Academic & research institutes specialize in basic research or are directed toward applied research. Host cell contaminant testing has wide applications in research. It is used for the R&D process in critical diseases such as cancer.

Host Cell Contaminant Testing Regional Insights

• North America

Development in the biopharmaceutical industriesacross the region is driving the North American host cell contaminant testingmarket

North America dominated thehost cell contaminant testingmarket in 2020, owing to development in the biopharmaceutical industries such as the development of new processes, new products, and improved existing ones, increasing investment in the R&D activities by companies, and improved healthcare infrastructure in the region.The increasing focus of companies to develop novel techniques for host cell contaminant testing inrecent years in the region is also fueling the market growth.

• Europe

Well-established R&D facilities across the regionaredriving the Europehost cell contaminant test

The factors such as well-established R&D facilities across the region, the presence of supportive regulatory systems, and the development of innovative and cost-effective host cell contaminant testing solutions by the companies in the market are fueling the host cell contaminant testing market in Europe. The presence of a high number of biopharmaceutical companies also booststhe market growth.

• Asia-Pacific

Presence of a large target population suffering from chronic diseasesis fueling the Asia-Pacific host cell contaminant testingmarket

The Asia-Pacific is projectedto be the fastest-growing regional market for host cell contaminant testingdue to the presence of a large target population suffering from chronic diseases such as cancer and increasing government investment in healthcare infrastructure.Other factors supporting the host cell contaminant testing market include increasing awareness about chronic diseases.Host cell contaminant testing is used in the R&D process and the introduction of new drugs for chronic diseases, fuelingthe market growth.

• Rest of the World

Increasing investment by the major players in the region is driving the Rest of the World host cell contaminant testing market.

The host cell contaminant testing market in the region is likely to witness growth due to increasing investment by the major players such as GE Healthcare(US) in the region, technological advancements in medical science, and increasing funding for the development of healthcare infrastructure throughout the region.

Competitive Landscape

Some of the key vendors in the global host cell contaminant testing market are Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific (US), and GE Healthcare (US). Bio-Rad Laboratories, Inc. (US) is one of the leading players in the host cell contaminant testing market, offering products in host cell contaminant testing applications. The company is one of the leading players engaged in developing, manufacturing, and marketing a wide range of innovative products for the life science research and clinical diagnostic markets that help advance the discovery process and improve healthcare.

Host cell contaminant testing market players are pursuing a variety of business strategies to increase their market share. They are launching innovative host cell contaminant testing with advanced techniques to gain a competitive advantage. They have made significant investments in research and development to bring new products to market.This will help them to increase their customer base.

List of companies with HQ

• BioGenes GmbH (Germany)


• Bio-Rad Laboratories, Inc. (US)


• Cisbio Bioassays SAS (France)


• Cygnus Technologies LLC (US)


• Enzo Life Sciences, Inc. (US)


• ForteBio (US)


• GE Healthcare (US)


• Molecular Devices LLC (US)


• ProteinSimple (US)


• Thermo Fisher Scientific, Inc. (US)

Recent Developments

• In June 2021, Bio-Rad Laboratories, Inc. (US) announced a partnership with Seegene, Inc. (South Korea), a global leader in multiplex molecular diagnostics, for the clinical development and commercialization of infectious disease molecular diagnostic products.


• In February 2021, Thermo Fisher Scientific Inc.(US) announced the acquisition of Mesa Biotech, Inc. (US), a privately held point-of-care molecular diagnostic company.

Report Overview

The study covers the existing short-term and long-term market effects, as well as helping decision-makers to draught 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.

Scope of the Report

The scope of the global host cell contaminant testing market study includesthe market size analysis and a detailed analysis of the manufacturer's products and strategies. The market has been segmented based ontype, end user, and region.

Global Host Cell Contaminant Testing Type Outlook

• Host Cell Protein Assays
  
  
  
  • ELISA
  
  
  • ILA
  
  
  • SDS-PAGE
  
  
  • Immunoblotting
  
  
  
  


• Host Cell DNA Assays
  
  
  
  • Quantitative PCR
  
  
  • Dot-Bot Hybridization
  
  
  
  

Global Host Cell Contaminant Testing End User Outlook

• Biopharmaceutical Companies


• Contract Research Organizations


• Contract Manufacturing Organizations


• Academic & Research Institutes

Global Host Cell ContaminantTesting Region Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


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


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


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America