Host Cell Contaminant Testing Market by Type (Microbial, Mammalian), Test (PCR, Immunoassay), End-User (Pharmaceutical & Biotechnology Industries, Academic & Research Institutes, Diagnostic Centers), & Region for 2024-2031

Host Cell Contaminant Testing Market Valuation – 2024-2031

The increasing need for biologics, such as recombinant proteins and monoclonal antibodies is the key driver propelling the host cell contaminant testing market. As the manufacturing of these biologics develops, so does the demand for effective testing methods to detect and remove host cell impurities, which drives market expansion. According to the analyst from Market Research, the host cell contaminant testing market is estimated to reach a valuation of USD 589.49 Million By 2031 over the forecast subjugating around USD 275 Million valued in 2024.

The rising prevalence of chronic diseases, such as cancer, is a major driver of the host cell contaminant testing market. This trend opens up new potential for market participants, as the development of innovative and cost-effective host cell contaminant testing technologies becomes critical for verifying the safety and efficacy of biologics. It enables the market to grow at a CAGR of 10% from 2024 to 2031.

Host Cell Contaminant Testing MarketDefinition/ Overview

Host Cell Contaminant Testing is the process of detecting and measuring residual host cell proteins (HCPs) and host cell DNA that may be present in biopharmaceutical products, such as monoclonal antibodies and recombinant proteins, following purification. Even at low levels, these pollutants may cause an immunological response in patients or have a direct impact on the quality of the therapeutic product.

Furthermore, the primary applications of host cell contaminant testing include confirming the safety and efficacy of biologics, demonstrating HCP removal throughout downstream processing, and meeting regulatory standards established by bodies such as the FDA and EMA.

What are the Key Factors Supporting the Host Cell Contaminant Testing Market’s Growth?

The growth of the biopharmaceutical industry is a major driver of the host cell contaminant testing market. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the FDA approved 55 new medicines in 2021, including 36 innovative pharmaceuticals and biologics. The FDA’s Center for Biologics Evaluation and Research (CBER) authorized 10 biological license applications in 2021, up from eight in 2020. This surge in biopharmaceutical approvals needs stringent host cell contaminant testing to assure product safety and quality.

Regulatory agencies are enforcing more strict rules for biopharmaceutical production, increasing the demand for host cell contaminant testing. The FDA’s advice on “Chemistry, Manufacturing, and Controls (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)” underlines the significance of testing for host cell proteins and DNA. According to the Parenteral Drug Association (PDA), the number of regulatory observations involving host cell protein contaminants grew by 35% between 2015 and 2020, indicating increasing regulatory attention on this market.

Furthermore, the rising prevalence of chronic diseases, which frequently require biological treatments, is indirectly driving the host cell contaminant testing market. According to the World Health Organization (WHO), chronic diseases account for 71% of all deaths worldwide, killing 41 million people each year. This increase in biologics manufacturing coincides with a greater demand for host cell contaminant testing.

What are the Challenges Influencing the Demand of the Market?

The host cell contaminant testing method requires advanced analytical techniques and expensive equipment, resulting in high total expenses. These costs are especially costly for small and medium-sized biopharmaceutical companies, which may limit their ability to do comprehensive testing. The high costs have an impact on the pricing of final biopharmaceutical goods, thereby limiting market expansion and accessibility.

Furthermore, host cell contaminant testing processes are complicated and time-consuming, necessitating specialist knowledge and equipment. This intricacy causes lengthier development times for biopharmaceutical drugs, potentially delaying market launch. The sophisticated structure of these tests also raises the possibility of errors or inconsistencies, necessitating retesting and delaying product development and release.

Category-Wise Acumens

How Does the Increase in Biopharmaceutical Production Contribute to Demand for Mammalian Testing?

According to analysis, the mammalian segment is estimated to hold the largest market share during the forecast period. Mammalian cell lines, particularly Chinese Hamster Ovary (CHO) cells, are commonly employed in biopharmaceutical development because of their capacity to synthesize complex proteins with human-like post-translational modifications. According to industry sources, more than 70% of recombinant protein treatments are produced in mammalian cells, increasing the necessity for mammalian host cell contaminant testing.

The rapidly expanding biologics and biosimilars sector, which mostly uses mammalian expression systems, drives the demand for mammalian host cell contaminant testing. The global biologics market is estimated to reach USD 529.46 Billion by 2031, with a sizable percentage produced in mammalian cells, necessitating stringent contaminant testing procedures.

Furthermore, mammalian-derived biopharmaceuticals are subject to strict regulatory regulations due to their complexity and potential immunogenicity hazards. The FDA and EMA guidelines emphasize comprehensive host cell protein and DNA testing for mammalian-derived goods, which is fueling the expansion of this testing segment to ensure compliance and product safety.

How Do PCR Tests Support the Growing Demand of the Market?

The polymerase chain reaction (PCR) segment is estimated to dominate the host cell contaminant testing market during the forecast period. PCR can detect trace amounts of host cell DNA or proteins with remarkable accuracy. This makes it perfect for assuring product purity in biopharmaceutical manufacturing, where even minor impurities might impair medicine safety and efficacy. The technique’s ability to amplify and detect precise genomic sequences is unique.

PCR can be tailored to identify a wide range of host cell contaminants from a variety of expression systems (such as CHO cells and E. coli). This adaptability enables businesses to employ a single platform for different goods and cell lines, expediting testing procedures and lowering total costs. The approach can also be simply modified as rules change.

Furthermore, modern PCR systems feature automated procedures and high-throughput testing, allowing for rapid and efficient examination of many samples. This enhanced speed and capacity are critical in biopharmaceutical production, where quick results are required to maintain production schedules and meet regulatory standards. Automation also lowers human error and increases reproducibility.

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Country/Region-wise Acumens

How Does the Robust Biopharmaceutical Industry in North America Propel the Growth of the Market?

According to analyst, North America is estimated to dominate the host cell contaminant testing market during the forecast period. North America, particularly the United States, has a flourishing biopharmaceutical industry that requires stringent host cell contaminant testing. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), the US biopharmaceutical industry invested an estimated $102.3 billion in research and development in 2021. This large expenditure necessitates advanced testing methods to ensure product safety and quality.

The FDA’s stringent guidelines for biopharmaceutical goods require extensive host cell contaminant testing. The FDA’s Center for Biologics Evaluation and Research (CBER) authorized 17 biological license applications (BLAs) in 2021, each of which required comprehensive purity testing. This regulatory landscape drives the demand for sophisticated testing solutions in the North American market.

Furthermore, North America’s high healthcare spending helps to drive the growth of the host cell contaminant testing market. According to the Centers for Medicare and Medicaid Services (CMS), U.S. healthcare spending reached USD 4.3 Trillion in 2021, or $12,914 per person. This significant investment in healthcare includes financing for sophisticated biopharmaceutical development and testing techniques, which will fuel the market for host cell contaminant testing.

What are the Main Drivers Propelling the Market in the Asia Pacific Region?

The Asia Pacific region is estimated to exhibit the highest growth within the host cell contaminant testing market during the forecast period. The region is experiencing a spike in biopharmaceutical manufacturing, which is increasing demand for host cell contaminant testing. According to an Asia Pacific Economic Cooperation (APEC) report, the APEC region’s biopharmaceutical market is predicted to develop at a 9.7% CAGR between 2020 and 2025, reaching $233 billion by 2025. This expansion needs additional quality control methods, such as host cell contaminant testing.

Regulatory organizations in the Asia Pacific are enforcing stronger requirements for biopharmaceutical production, emphasizing the importance of thorough contaminant testing. For example, China’s National Medical Products Administration (NMPA) updated its criteria in 2021 to require more complete host cell protein profiling for biological products. This has resulted in a 30% increase in demand for advanced testing procedures in China alone, according to a 2022 report by the China Pharmaceutical Industry Association.

Furthermore, countries in the Asia Pacific are significantly raising their investments in biotechnology research and development. For example, the Indian Department of Biotechnology predicts that India’s biotech industry will reach USD 150 Billion by 2025, rising at a CAGR of 16.4%. This rapid expansion necessitates advanced host cell contaminant testing to ensure product safety and quality.

Competitive Landscape

The host cell contaminant testing market is competitive, with both established and rising competitors. Key competitors are focusing on finding new and cost-effective solutions to fulfill the growing demand for biologics.

Some of the prominent players operating in the host cell contaminant testing market include

• Bio-Rad Laboratories, Inc.
• Merck KGaA
• Thermo Fisher Scientific, Inc.
• Danaher Corporation
• Sartorius AG
• Charles River Laboratories International, Inc.
• Promega Corporation
• Lonza Group Ltd
• Cygnus Technologies LLC
• Enzo Life Sciences, Inc.
• ForteBio (Pall Corporation)
• GE Healthcare Life Sciences

Latest Developments

• In June 2021, Bio-Rad Laboratories Inc. partnered with Seegene Inc., a global leader in multiplex molecular diagnostics, to develop and commercialize infectious disease diagnostic solutions.
• In February 2021, Thermo Fisher Scientific Inc. acquired Mesa Biotech, Inc., a privately held molecular diagnostics company.

Report Scope

Host Cell Contaminant Testing Market, By Category

Type

• Microbial
• Mammalian
• Others

Test

• PCR
• Immunoassay
• Others

End-User

• Pharmaceutical & Biotechnology Industries
• Academic & Research Institutes
• Diagnostic Centers
• Others

Region

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

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