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The growing production of biopharmaceuticals has a big effect on how the HCP testing market works. As the market for biologics grows thanks to progress in bioengineering, so does the need for accurate and sensitive HCP testing methods.
Regulatory agencies have strict rules for the biotech business, which means that products have to go through a lot of HCP testing before they can be approved. Following these rules changes the way the market works, leading to new testing methods and affecting the business plans of companies that work in this area.
More and more new technologies have a big impact on the HCP testing market. Better sample sensitivity, high-throughput screening methods, and the use of new analysis tools all make testing more efficient and reliable, which meets the changing needs of the business.
The HCP testing market is dominated by big businesses that offer laboratory services and drug testing. Because these players are in such fierce competition with each other, testing methods are always getting better and more complete testing solutions are being made.
Because biological goods are so different, they need specific HCP testing methods. Companies that offer flexible testing services have an advantage over their competitors because they can give customers solutions that work with the unique properties of their biologics.
Risk reduction is a big deal in the HCP testing business, especially during the bioproduction process. Biopharmaceutical companies use strong testing methods to find and fix any problems that might be connected to host cell proteins. This protects the quality of the products they make and the safety of patients.
Automation is being used more and more in HCP testing to make the process more efficient and cut down on mistakes made by people. Automated systems help with more work getting done, faster response times, and better repeatability, which meets the need for testing processes that are simplified and reliable.
Data handling and reporting that work well are very important parts of HCP testing. Companies that can do strong data analysis and reporting are better able to meet the growing need for detailed paperwork, which helps them stay in line with regulations and keep clients happy.
Host Cell Protein Testing Market Highlights:
Global Host Cell Protein Testing Market Overview
Host Cell Protein Testing Market size was valued at USD 1.31 billion in 2023. The host cell protein testing market industry is projected to grow from USD 1.38 Billion in 2024 to USD 2.17 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.77% during the forecast period (2023 - 2032). The growing R&D activities and developments in the biopharmaceutical industry are driving market growth.
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
Host Cell Protein Testing Market Trends
- The Growing R&D Activities boost market growth.
The emergence of chronic and viral diseases around the world has increased expenditure on R&D initiatives. The drug development process is being accelerated by technological advancement and innovation in biomedical sciences. This advancement has accelerated the development of drugs and reduced the drug lifecycle period by 500 days. Additionally, educational institutions and research organizations are investing in the production of fused and functional proteins. The rising investments in pharmaceutical stability have increased the demand for better host cell protein methods. Moreover, Scientists are researching strategies to keep antibodies and proteins stable in biological environments.
Furthermore, the growing demand for protein-based vaccines to treat viral, bacterial, and other microbe-based diseases has fueled global research efforts. The rising prevalence of diseases such as paroxysmal nocturnal hemoglobinuria and factor VII and VIII deficiency has boosted research into enhanced medicinal and commercial protein manufacturing. Thus, during the forecast period, such opportunities are projected to drive the host cell protein testing market.
Host Cell Protein Testing Market Segment Insights
Host Cell Protein Testing Type Insights
The Host Cell Protein Testing Market segmentation, based on type, includes PCR-based assays, ELISA-based assays, mass spectrometry-based assays, and others. Mass spectrometry-based assays are further segmented into Liquid Chromatography–Mass Spectrometry (LC-MS), Tandem Mass Spectrometry (MS/MS), and others. The ELISA-based Assays segment held the majority share in 2022 in the Host Cell Protein Testing Market revenue. This is due to the increasing incidence of infectious diseases and the rising number of clinical trials of antibodies-based vaccines.
June 2023: Biogenes GmbH (Germany) launched the HEK293 HCP ELISA kit. The HEK 293 HCP ELISA Kit, can be used as a process development tool to monitor the best removal of host cell contaminants as well as in routine final product release testing.
Figure 2: HOST CELL PROTEIN TESTING MARKET SIZE, BY TYPE, 2023 & 2032 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
Host Cell Protein Testing End User Insights
The Host Cell Protein Testing Market segmentation is based on end user that include contract research organizations, biopharmaceutical companies, and others. The biopharmaceutical companies segment has dominated the market in 2022 and is projected to be the fastest-growing segment during the forecast period, 2024-2032. This is due to the growing biopharmaceutical industry, rising investment in research and development, and rapid technological advancements in biopharmaceutical firms.
June 2019: Cygnus Technologies (US) launched mass spectrometry services for host cell protein impurity characterization. This new product launch will be helpful to identify and quantify impurities, which can impact the efficacy and stability of the therapy.
Host Cell Protein Testing Regional Insights
By Region, the study segments the market into North America, Europe, Asia-Pacific, and the Rest of the World. The North America host cell protein testing market accounted for the largest market share in 2022. This is due to the increasing number of clinical trials, rising demand for innovative medicine for chronic diseases, and increasing research for gene and cell therapy products in the North American region. Companies such as Enzo Life Sciences, Inc. (US), Bio-Rad Laboratories, Inc. (US), Abcam plc (UK), and Thermo Fisher Scientific Inc (US) are actively working on improving host cell protein testing and fulfilling the demands of customers. Thermo Fisher Scientific Inc (US) offers comprehensive research and Host Cell Protein Testing products, and in several research studies, the company has provided lucrative growth opportunities. Thus, the presence of key market players in the region fuels the growth of the host cell protein testing market in the region.
Further, the major countries studied are the U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3: HOST CELL PROTEIN TESTING MARKET SIZE, BY REGION 2023 & 2032 (USD Billion
Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review
Europe host cell protein testing market accounts for the second-largest market share due to an increasing number of clinical trials in countries such as Germany, and France, highly adopted technologically advanced products in biopharmaceutical industries, and contract research organizations. further, Germany host cell protein testing market was attributed to hold the largest market share, and the France host cell protein testing market is expected to fastest-growing market in the European region.
The Asia-Pacific host cell protein testing market is expected to grow at a significant share from 2024 to 2032. This is due to the rising number of clinical trials with high intensity, increasing biopharmaceutical industries, and increasing investment in R&D in the Asia-Pacific region. Moreover, China host cell protein testing market is expected to hold the largest market share, and India host cell protein testing market is expected fastest-growing market in the Asia-Pacific region.
The Rest of the World is segmented into the Middle East, Africa, and Latin America. The host cell protein testing market in the above-mentioned regions is likely to witness growth due to rising number of contract research organizations, high demand for monoclonal antibodies for infectious diseases, and increasing number of clinical trials in Brazil and Argentina. Moreover, lack of resources for host cell protein testing and dearth of skilled professionals to run tests are affecting the market's growth to some extent in these regions.
Host Cell Protein Testing Key Market Players & Competitive Insights
The Host Cell Protein Testing Market is characterized by the presence of many global, regional, and local vendors. Developments in the healthcare industry and growing research and development 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 market comprises tier-1, tier-2, and local players. The tier-1 and tier-2 players have reach across the globe with diverse product portfolios. Companies such as Enzo Life Sciences, Inc (US) Bio-Rad Laboratories, Inc (US) Biogenes GmbH (Germany) Cisbio Bioassays (France) dominate the Host Cell Protein Testing Market due to product differentiation, financial stability, strategic developments, and diversified regional presence. The players are focused on investing in research and development. Furthermore, they adopt strategic growth initiatives, such as expansion, product launches, joint ventures, and partnerships, to strengthen their market position and capture a large customer base.
One of the primary business strategies adopted by manufacturers in the global host cell protein testing industry to benefit clients and expand the host cell protein testing market sector is to manufacture locally to reduce operating costs.
Bio-Rad Laboratories, Inc. (US) provides the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process, and medical diagnostic labs obtain faster and better results. It provides instruments, software, consumables, reagents, and content in the areas of cell biology, gene expression, protein purification, and protein quantitation. The company also offers products for drug discovery & manufacture, food safety and environmental quality testing, and science education. Its products & solutions are based on technologies to separate, purify, identify, analyze, and amplify biological materials such as antibodies, proteins, nucleic acids, cells, and bacteria. The company operates through three business segments, namely, clinical diagnostics, life science, and others. The firm has a strong presence across North America, Europe, and Asia-Pacific. For instance, in March 2020, Bio-Rad Laboratories, Inc. (US) partnered with Assurance Scientific Laboratories, Birmingham, Alabama, (US) for the detection of COVID-19 samples using Bio-Rad’s CFX384 Touch Real-Time PCR Detection System. In addition, the company also partnered with other testing labs worldwide to support COVID-19 testing.
Also, Enzo Life Sciences, Inc (US) operates as a life sciences and biotechnology company. Enzo Life Sciences, Inc. is a wholly-owned subsidiary of Enzo Biochem, Inc. (US). It is engaging in the development, production, marketing, and sales of innovative life science research reagents across the globe. It offers a wide range of products, including proteins, antibodies, peptides, small molecules, labeling probes, dyes, and kits. The company offers its products for a wide range of applications for pharmaceutical industries, such as gene expression analysis, nucleic acid detection, protein biochemistry and detection, and cellular analysis. It has a strong distribution network across the globe. It has a strong presence number of countries, namely, France, Finland, Greece, Germany, Hungary, India, Indonesia, Iraq, Japan, Kuwait, Mexico, and New Zealand among others.
Key Companies in the Host Cell Protein Testing Market include
- Enzo Life Sciences, Inc (US)
- Abcam plc (UK)
- Thermo Fisher Scientific Inc (US)
- Cytiva (US)
- Bio-Rad Laboratories, Inc (US)
- Biogenes GmbH (Germany)
- Cisbio Bioassays (France)
- Cygnus Technologies, LLC (US)
- Rockland Immunochemicals, Inc (US)
- Agilent Technologies, Inc (US)
Host Cell Protein Testing Industry Developments
June 2021: Bio-Rad Laboratories, Inc (US) partnered with Seegene (South Korea) for the clinical development and commercialization of infectious disease molecular diagnostic products.
April 2020: Cytiva (US) collaborated with Avacta (UK) to develop and manufacture an Affimer-based point-of-care diagnostic test for detecting COVID-19 infection in large populations. The diagnostic assay will be transferred to Cytiva's unique point-of-care test strip platform and will work together to complete analytical and clinical validation of the test "as rapidly as possible.
August 2019: Cygnus Technologies, LLC (US) partnered with Bio-Techne Corporation (US) to develop a 3G Chinese hamster ovary host cell protein (CHO-HCP) assay. This partnership has introduced the co-developed third-generation CHO-HCP assay in the proprietary Simple Plex immunoassay cartridge for customers in North America and Europe.
Host Cell Protein Testing Market Segmentation
Host Cell Protein Testing Type Outlook
-
PCR-Based Assays- ELISA-based Assays
- Mass Spectrometry-Based Assays
- Liquid Chromatography–Mass Spectrometry (LC–MS)
- Tandem Mass Spectrometry (MS/MS)
- Others
- Others
Host Cell Protein Testing End User Outlook
- Contract Research Organizations
- Biopharmaceutical Companies
- Others
Host Cell Protein Testing Regional 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
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