pharmaceuticals

Global Host Cell Contaminant Testing Market

January 24, 2022
ID: SR/PH-03
Format:Pdf
Pages:220

Global Host Cell Contaminant Testing Market, By Product (Microbial, Mammalian, and Others), By Type (PCR-based Assays and ELISA-based Assays,), Application (Research & Development and Clinical Applications), By End-user (Biopharmaceutical Companies, Contract Research Organizations, Contract Manufacturing Organizations, and Academic & Research Institutes), and By Region (North America, Europe, Asia Pacific, South America, and the Middle East & Africa)-Global Forecast to 2028.

Description

The global Host Cell Contaminant Testing market size is forecasted to reach USD 4.9 billion with a CAGR of 4.5% over the forecast period, 2022-2028. The growing advancements in biopharmaceuticals, increasing demand for personalized medicine, rising incidences of chronic diseases such as cancer, and increasing R&D activities are the primary factors accelerating the growth of the global host cell contaminant testing market during the forecast period. Furthermore, the ongoing research & development activities associated with the testing and the rising number of regulatory approvals related to the testing equipment will further boost the growth of the global host cell contaminant testing market in the coming years.

What is Host Cell Contaminant Testing?

Host cell proteins generally refer to the heterogeneous group of proteins derived from host cells such as yeast, E-coli, and mammal, among others. Host cell proteins differ largely from each other in terms of properties, isoelectric point and molecular mass. They are the impurities found in biotechnological products that can cause immunogenicity, reduce the potency or stability of a drug, risk patient safety, resulting in an increased need for host cell contaminant testing. The acceptable level of HCPs in pharmaceutical drugs ranges from 1-100ppm (1–100 ng/mg product). These products require protein recovery processes to minimize their content in a final product. They are also often immunogenic and pose risks to the efficacy of a drug and patient safety.

Growth Driver

Rising advancements in the field of biopharmaceuticals

The growing demand for personalized medicine and advancements in biopharmaceuticals are the primary factors that are likely to stimulate the growth of the global host cell contaminant testing market in the coming years. Rising incidences of numerous chronic diseases such as cancer, an increasing number of ongoing research and rising investments in R&D activities are anticipated to create lucrative opportunities for the growth of the global host cell contaminant testing market in the future. Furthermore, host cell contaminant testing plays an essential role in the safety and effectiveness of a medicine. The manufacture of biopharmaceuticals involves using several protein groups, and each of these groups needs to be tested for contaminants. The host cell contaminant testing is conducted by several techniques, such as host cell protein assay (ELISA, Immunoligand Assay, SDS-PAGE, and Immunoblotting) and host cell DNA assay (Quantitative PCR and Dot-Blot Hybridization).

However, the high cost of testing, immunogenic reactions, and technical barriers associated with host cell proteins can hamper the growth of the global host cell contaminant testing market over the forecasted period. Furthermore, the growing presence of the pharmaceutical research and testing industry has played a vital role in driving the growth of the global market for host cell contaminant testing. In addition, several governments and healthcare regulatory bodies of various developed and developing countries are overtaking various cost-containment measures to overcome the healthcare burden across the globe.

Pre-Covid-19 impact on the global Host Cell Contaminant Testing market

The continuous growth in the clinical research studies to collect information related to the safety and effectiveness of medicines and drugs for various diseases and conditions, such as infectious disease, cancer, Alzheimer’s, allergies, and neurological disorders, has stimulated the growth of the global Host Cell Contaminant Testing market in the pre-COVID era. Furthermore, the growing need for understanding disease continues to fuel the development of new treatments for patients, resulting in a steadily increasing number of new Host Cell Contaminant Tests year-over-year for the last two decades.

Covid-19 impact on the global Host Cell Contaminant Testing market

The outbreak of the COVID-19 pandemic has partially impacted the growth of the global Host Cell Contaminant Testing market in 2021. The government and various health organizations, such as the World Health Organization (WHO) and US Food and Drug Administration (FDA), are highly focused on developing COVID-19 vaccines, which has disrupted many upcoming or ongoing clinical trials on other diseases around the globe.

Post Covid-19 impact on the global Host Cell Contaminant Testing market

The leading pharmaceutical companies of developed and developing countries need new, effective, and advanced therapeutic techniques and know that it is impossible to generate everything in-house. Thus, biopharmaceutical companies investing in host cell contaminant testing are entering partnership deals. Furthermore, the continuous improvements in medical research are expected to create opportunities for the global host cell contaminant market growth. The global host cell contaminant testing market is also anticipated to boost the need for rigorous quantitative analysis of contaminants within chemical research.

Type Segmental Analysis

Based on the Type, the global Host Cell Contaminant Testing market is categorized into PCR-based Assays and ELISA-based Assays. The ELISA-based Assays segment is accounted for the highest share in the global host cell contaminant testing market over the forecast period. This growth is attributable due to the increasing expenditure for R&D activities. ELISA-based Assays is the predominantly used process for detecting Host Cell Contamination, owing to its high sensitivity to proteins that detect the low level of HCPs produced in drugs, high level of reproducibility and compatibility with high-throughput screening.

Application Segmental Analysis

Based on the Application, the global Host Cell Contaminant Testing market is categorized into Research & Development and Clinical Applications. The Research & Development segment is expected to hold the highest share in the global host cell contaminant testing market in the coming years. This is attributable to the growing investments in Research & Development activities and improvements in medical research across the globe. Furthermore, the clinical applications are expected to witness significant growth in the global host cell contaminant testing market over the forecasted period.

End-User Segmental Analysis

Based on the End User, the global Host Cell Contaminant Testing market is segregated into Biopharmaceutical Companies, Contract Research Organizations, Contract Manufacturing Organizations, and Academic & Research Institutes. The Biopharmaceutical Companies segment dominates the global host cell contaminant testing in 2021 and is expected to continue this trend during the forecasted period, 2022-2028. Many pharmaceutical companies epitomize several prominent connections in the chain of pharmaceutical development, as they have the economic strength and drug manufacturing experience needed to introduce novel drugs into the market. Further, they have production capabilities and the necessary market infrastructure required for a product to reach the desired marketplace. Thus, several nascent biopharmaceutical companies depend on partnerships and agreements with large-scale pharmaceutical companies to finance, enhance their customer base, make expensive products, conduct clinical trials, and market their products.

Region Segmental Analysis

The Host Cell Contaminant Testing market is characterized by North America, Europe, Asia Pacific, South America, and Middle East & Africa. The North American region is expected to dominate the global host cell contaminant testing market in 2021 and is expected to continue this dominance during the forecast period, 2022-2028. This growth is attributable to the growing advancements in biopharmaceuticals, developed healthcare infrastructure, and increasing investments by leading players in the product market. Furthermore, the Asia Pacific region is expected to have significant growth in the global host cell contaminant testing market, followed by Europe in the coming years. The developing countries in the Asia Pacific region are witnessing significant improvement in medical infrastructure, the presence of a large target population suffering from life-threatening diseases like cancer, increased awareness and development of innovative and cost-effective solutions, and a rise in disposable income.

Competitor Analysis

Companies include BioGenes GmbH, GE Healthcare Life Sciences, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Cisbio Bioassays, Cygnus Technologies LLC, Enzo Life Sciences, Inc., ForteBio, Molecular Devices LLC., ProteinSimple, and other prominent players are the key players in the Host Cell Contaminant Testing market.

Key Stakeholders

Market research and consulting firms
Industry associations
Global Host Cell Contaminant Testing manufacturing firm
Local Governments
Regulatory bodies
Suppliers
Retailers

Recent Developments

In November 2019, Thermo Fisher Scientific launched ‘Torrent Genexus System,’ a product described as the first fully-integrated next-generation sequencing platform, which includes an automated specimen-to-report workflow capable of delivering efficient results in a single day.
In June 2019– Cygnus Technologies has announced that it has expanded its service offerings for host cell protein (HCP) impurities detection. The company claims that the product is also used for identification and quantification, which can impact the efficacy and stability of the therapeutic.

Scope of the Report

Report Attribute	Details
The revenue forecast in 2028	USD 4.9 Billion
Growth Rate	CAGR of 4.5% from 2022 to 2028.
Historical data	2018-2020
Forecast period	2022 – 2028
Region covered	America, Europe, Asia-Pacific, South America, and Middle East & Africa
Key companies Profiled	BioGenes GmbH, GE Healthcare Life Sciences, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Cisbio Bioassays, Cygnus Technologies LLC, Enzo Life Sciences, Inc., ForteBio, Molecular Devices LLC., ProteinSimple, and Other prominent players.

Market Modelling

By Product

Microbial
Mammalian
Others

By Type

PCR-based Assays
ELISA-based Assays

By Application

Research & Development
Clinical Applications

By End-User

Biopharmaceutical Companies
Contract Research Organizations
Contract Manufacturing Organizations
Academic & Research Institutes

By Region

North America
Europe
Asia Pacific
South America
Middle East & Africa

Table Of Contents

Methodology

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Frequently Asked Questions (FAQ):

What is Host Cell Contaminant Testing?

What is the growth rate of the Host Cell Contaminant Testing market?

The global Host Cell Contaminant Testing market size is forecasted to reach USD 4.9 billion with a CAGR of 4.5% during the forecast period, 2022-2028.

What are the driving factors for the global Host Cell Contaminant Testing market?

The growing advancements in biopharmaceuticals, increasing demand for personalized medicine, rising incidences of chronic diseases such as cancer, and increasing R&D activities are the primary factors accelerating the growth of the global host cell contaminant testing market during the forecast period.

What are the future growth opportunities for the global Host Cell Contaminant Testing market?

The global market for host cell contaminant testing endows multiple growth opportunities, and improvements in medical research have other accelerated market growth.

What are the key innovations in Host Cell Contaminant Testing market?

In November 2019, Thermo Fisher Scientific launched ‘Torrent Genexus System,’ a product described as the first fully-integrated next-generation sequencing platform, which includes an automated specimen-to-report workflow capable of delivering efficient results in a single day.

Which region is expected to have the largest share in global Host Cell Contaminant Testing?

The North American region is expected to dominate the global host cell contaminant testing market in 2021 and is expected to continue this dominance during the forecast period, 2022-2028, followed by the Asia Pacific and Europe.

Who are the major players in the global Host Cell Contaminant Testing?

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Global Host Cell Contaminant Testing Market

What is Host Cell Contaminant Testing?

Growth Driver

Rising advancements in the field of biopharmaceuticals

Pre-Covid-19 impact on the global Host Cell Contaminant Testing market

Covid-19 impact on the global Host Cell Contaminant Testing market

Post Covid-19 impact on the global Host Cell Contaminant Testing market

Type Segmental Analysis

Application Segmental Analysis

End-User Segmental Analysis

Region Segmental Analysis

Competitor Analysis

Recent Developments

Scope of the Report

Market Modelling

Report Content

Frequently Asked Questions (FAQ):

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