The Host Cell Protein Testing Market Size was valued at USD 1.32 billion in 2023 and is expected to reach USD 2.06 billion by 2031 and grow at a CAGR of 5.76% over the forecast period 2024-2031.
The Host Cell Protein (HCP) Testing Market is involved in testing biopharmaceutical drugs to ensure the absence of residual proteins from the host cells used in their production. Host cells are typically mammalian cells, such as Chinese Hamster Ovary (CHO) cells, used to manufacture biologic drugs like vaccines, monoclonal antibodies, and insulin.
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increasing demand for biologics and biosimilars where biologics are a rapidly growing class of drugs that are derived from living organisms driving the market growth. Biosimilars are similar versions of already approved biological drugs. The development and manufacturing of these drugs require rigorous. The rising incidence of chronic diseases such as cancer, autoimmune disorders, and diabetes is fueling the demand for novel therapeutic drugs, including biologics driving the growth of the HCP testing market. With the advancements in HCP testing technologies, are improving the sensitivity and accuracy of HCP detection. This is enabling the detection of even low levels of HCPs in biopharmaceutical products which could propels the growth of the Host Cell Protein (HCP) Testing Market in coming year.
The growing demand for medications to treat various types of cancer and inflammatory disorders has compelled market participants to upgrade biopharmaceutical research and production facilities.
Rising needs for cancer and inflammation treatments are driving a surge in demand for new drugs. This is pushing biopharmaceutical companies to invest in revamping their research labs and production facilities to keep pace with innovation and efficiently manufacture these critical medications.
Concerns Regarding Immunogenesis
Immunogenicity is a major hurdle in developing biopharmaceuticals. It occurs when a patient's immune system mistakes the therapeutic drug for a foreign invader and attacks it. This can render the drug ineffective or even trigger adverse effects. Stringent testing and production practices are crucial to minimize this risk.
Problems With The Efficiency And Accuracy Of The Test Kits
Automated mass spectrometry is being used to detect host cell proteins.
Automated mass spectrometry is a powerful tool for identifying trace amounts of host cell proteins (HCPs) left behind in biopharmaceuticals. It analyzes the sample's unique molecular fingerprint, allowing researchers to sensitively detect even low levels of HCPs that might be missed by other methods. This improved detection helps ensure the safety and efficacy of biopharmaceutical drugs.
The industry is investing in technologies that will allow the detection of host cell protein in commercially generated antibodies to be automated.
Low Abundance, High Impact
HCPs are often present in very low quantities compared to the therapeutic protein itself. Yet, even these low levels can trigger an immune response in patients. Detecting these trace amounts accurately remains a challenge.
Current HCP testing methods, particularly those involving antibody development, can be expensive and time-consuming. This can slow down drug development timelines and increase costs.
The Russia Ukraine casts a shadow of uncertainty on the Host Cell Protein Testing Market. The conflict disrupts global supply chains, potentially causing shortages and price increases for materials and equipment crucial for HCP testing. Furthermore, the biopharmaceutical industry might shift its focus towards treatments relevant to the war zone, potentially leading to a temporary slowdown in investment for other drug development areas and impacting the demand for HCP testing services. Additionally, the war could displace skilled scientific personnel from both Russia and Ukraine, further straining the talent pool available for this specialized field.
However, the war might also have some unforeseen positive consequences for the market. An increased need for biologics like vaccines and treatments for war-related injuries and illnesses could drive the demand for HCP testing to ensure the safety and efficacy of these drugs. The war might also heighten global concerns about biosecurity, potentially leading to increased investment in biopharmaceutical research and development could translate to stricter regulations and more rigorous testing requirements, creating a long-term growth opportunity for the Host Cell Protein Testing Market.
An economic slowdown could put a damper on the host cell protein testing (HCP) market and Contract Research Organizations (CROs) that provide these services. Biopharmaceutical companies, facing lesser budgets, might delay new drug development projects or prioritize later-stage drugs requiring less HCP testing. This could lead to slower growth in the HCP testing market and increased competition among CROs. However, the critical role of HCP testing in drug safety offers some protection. Economic downturns might even encourage outsourcing of R&D activities, potentially benefiting CROs with HCP expertise. Additionally, the development of faster and more affordable HCP testing methods could be spurred by the need for efficiency. The slowdown's impact might also vary depending on the targeted therapeutic area, with unmet medical needs offering some buffer. Finally, government funding for research programs could help mitigate the negative effects. While a temporary setback is possible, the essential nature of HCP testing suggests the industry's long-term strength.
CROs
Biopharmaceutical Companies
Others
The main players are biopharmaceutical companies, followed by contract research organizations (CROs) and others. Biopharmaceutical companies are the current leaders in this market share and are expected to keep growing the fastest. This is fueled by the overall expansion of the biopharmaceutical industry, with companies investing heavily in R&D and adopting new technologies to create better drugs.
PCR-based Assays
ELISA-based Assays
Mass Spectrometry-Based Assay
Liquid Chromatography–Mass Spectrometry (LC–MS)
Tandem Mass Spectrometry (MS/MS)
Others
Others
North America dominated the global host cell protein testing market due to a variety of factors, including advancements in the biopharmaceutical sectors, increased investment in R&D activities, and the region's well-established healthcare infrastructure. North America is separated into two countries: the United States and Canada. The United States is the world leader in biopharmaceutical R&D and the largest biopharmaceutical market, increasing demand for host cell protein testing solutions in the region. For more than 30 years, the biopharmaceutical industry in the United States has been the global leader in the development of novel medications. Furthermore, market leaders' collaboration and alliances are projected to result in highly innovative, industry-leading solutions, fuelling demand for host cell protein testing across the region. Canada also boasts a large number of biotechnology firms.
Europe has also emerged as a significant market for host cell protein testing, with well-established R&D facilities throughout the area, the availability of supportive regulatory regimes, and companies developing new and cost-effective host cell protein testing solutions. The United Kingdom boasts a one-of-a-kind global health and life sciences ecosystem, as well as a solid track record of scientific discoveries with next-generation technology and services. The government provides an R&D platform for market enterprises. Government initiatives and research funding are also propelling this business forward.
Because of the presence of a large target population suffering from chronic diseases such as cancer, increased government investment in healthcare infrastructure, and increased awareness about chronic diseases, Asia Pacific presents lucrative opportunities for players operating in the host cell protein testing market. Cancer cases in India could rise by 12% in the next five years, according to the Indian Council of Medical Research (ICMR) and the National Centre for Disease Informatics and Research (NCDIR). The governments are conducting numerous programmes to raise public awareness.
In India, the Pradhan Mantri Swasthya Suraksha Yojana (PMSSY) was introduced with the goals of eliminating regional inequalities in the availability of affordable/reliable tertiary healthcare services and expanding facilities for quality medical education.
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REGIONAL COVERAGE:
North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
south Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin America
Major players are Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Cygnus Technologies, Llc, Biogenes Gmbh, Cisbio Bioassays, Charles River Laboratories International, Inc., Rockland Immunochemicals, Inc. and Abcam Plc, Cytiva, Enzo Life Sciences, Inc. and other players.
In June 2023, Biogenes GmbH, a German company, introduced a new tool for the biopharmaceutical industry: the HEK293 HCP ELISA kit. This kit helps manufacturers track the effectiveness of their processes in removing unwanted HEK293 host cell proteins from their drugs. It can be used throughout the development process and even for final quality control testing before a drug is released.
In June 2021, Bio-Rad, a US leader in life science research and diagnostics, joined forces with Seegene, a South Korean company known for multiplex molecular diagnostics. This partnership aimed to develop and bring to market new diagnostic tests for infectious diseases.
| Report Attributes | Details |
|---|---|
| Market Size in 2023 | US$ 1.32 Billion |
| Market Size by 2031 | US$ 2.06 Billion |
| CAGR | CAGR of 5.76% From 2024 to 2031 |
| Base Year | 2023 |
| Forecast Period | 2024-2031 |
| Historical Data | 2020-2022 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments |
|
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Cygnus Technologies, Llc, Biogenes Gmbh, Cisbio Bioassays, Charles River Laboratories International, Inc., Rockland Immunochemicals, Inc. and Abcam Plc, Cytiva, Enzo Life Sciences, Inc. |
| Key Drivers |
|
| RESTRAINTS |
|
Ans: The Host Cell Protein Testing Market Expected to reach USD 2.06 billion by 2031.
Ans: The host Cell Protein Testing Market grow at a CAGR of 5.76% over the forecast period 2024-2031.
Ans: Host Cell Proteins are low-level protein impurities identified in therapeutic products obtained from the host organism during biotherapeutic production (HCPs).
Ans: The major players are Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Cygnus Technologies, Llc, Biogenes Gmbh, Cisbio Bioassays, Charles River Laboratories International, Inc., Rockland Immunochemical, Inc. and Abcam Plc, Cytiva, Enzo Life Sciences, Inc., and others in final report.
Ans: The growing demand for medications to treat various types of cancer and inflammatory disorders has compelled market participants to upgrade biopharmaceutical research and production facilities and Biopharmaceutical advancements with expanding R&D activity.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Industry Flowchart
3. Research Methodology
4. Market Dynamics
4.1 Drivers
4.2 Restraints
4.3 Opportunities
4.4 Challenges
5. Impact Analysis
5.1 Impact Of Russia Ukraine Crisis
5.2 Impact of Economic Slowdown on Major Countries
5.2.1 Introduction
5.2.2 United States
5.2.3 Canada
5.2.4 Germany
5.2.5 France
5.2.6 UK
5.2.7 China
5.2.8 Japan
5.2.9 South Korea
5.2.10 India
6. Value Chain Analysis
7. Porter’s 5 Forces Model
8. Pest Analysis
9. Host Cell Protein Testing Market Segmentation, By End user
9.1 Introduction
9.2 Trend Analysis
9.3 CROs
9.4 Biopharmaceutical Companies
9.5 Others
10. Host Cell Protein Testing Market Segmentation, By Type
10.1 Introduction
10.2 Trend Analysis
10.3 PCR-based Assays
10.4 ELISA-based Assays
10.5 Mass Spectrometry-Based Assays
10.5.1 Liquid Chromatography–Mass Spectrometry (LC–MS)
10.5.2 Tandem Mass Spectrometry (MS/MS)
10.5.3 Others
10.6 Others
11. Regional Analysis
11.1 Introduction
11.2 North America
11.2.1 Trend Analysis
11.2.2 North America Host Cell Protein Testing Market by Country
11.2.3 North America Host Cell Protein Testing Market By End user
11.2.4 North America Host Cell Protein Testing Market By Type
11.2.5 USA
11.2.5.1 USA Host Cell Protein Testing Market By End user
11.2.5.2 USA Host Cell Protein Testing Market By Type
11.2.6 Canada
11.2.6.1 Canada Host Cell Protein Testing Market By End user
11.2.6.2 Canada Host Cell Protein Testing Market By Type
11.2.7 Mexico
11.2.7.1 Mexico Host Cell Protein Testing Market By End user
11.2.7.2 Mexico Host Cell Protein Testing Market By Type
11.3 Europe
11.3.1 Trend Analysis
11.3.2 Eastern Europe
11.3.2.1 Eastern Europe Host Cell Protein Testing Market by Country
11.3.2.2 Eastern Europe Host Cell Protein Testing Market By End user
11.3.2.3 Eastern Europe Host Cell Protein Testing Market By Type
11.3.2.4 Poland
11.3.2.4.1 Poland Host Cell Protein Testing Market By End user
11.3.2.4.2 Poland Host Cell Protein Testing Market By Type
11.3.2.5 Romania
11.3.2.5.1 Romania Host Cell Protein Testing Market By End user
11.3.2.5.2 Romania Host Cell Protein Testing Market By Type
11.3.2.6 Hungary
11.3.2.6.1 Hungary Host Cell Protein Testing Market By End user
11.3.2.6.2 Hungary Host Cell Protein Testing Market By Type
11.3.2.7 Turkey
11.3.2.7.1 Turkey Host Cell Protein Testing Market By End user
11.3.2.7.2 Turkey Host Cell Protein Testing Market By Type
11.3.2.8 Rest of Eastern Europe
11.3.2.8.1 Rest of Eastern Europe Host Cell Protein Testing Market By End user
11.3.2.8.2 Rest of Eastern Europe Host Cell Protein Testing Market By Type
11.3.3 Western Europe
11.3.3.1 Western Europe Host Cell Protein Testing Market by Country
11.3.3.2 Western Europe Host Cell Protein Testing Market By End user
11.3.3.3 Western Europe Host Cell Protein Testing Market By Type
11.3.3.4 Germany
11.3.3.4.1 Germany Host Cell Protein Testing Market By End user
11.3.3.4.2 Germany Host Cell Protein Testing Market By Type
11.3.3.5 France
11.3.3.5.1 France Host Cell Protein Testing Market By End user
11.3.3.5.2 France Host Cell Protein Testing Market By Type
11.3.3.6 UK
11.3.3.6.1 UK Host Cell Protein Testing Market By End user
11.3.3.6.2 UK Host Cell Protein Testing Market By Type
11.3.3.7 Italy
11.3.3.7.1 Italy Host Cell Protein Testing Market By End user
11.3.3.7.2 Italy Host Cell Protein Testing Market By Type
11.3.3.8 Spain
11.3.3.8.1 Spain Host Cell Protein Testing Market By End user
11.3.3.8.2 Spain Host Cell Protein Testing Market By Type
11.3.3.9 Netherlands
11.3.3.9.1 Netherlands Host Cell Protein Testing Market By End user
11.3.3.9.2 Netherlands Host Cell Protein Testing Market By Type
11.3.3.10 Switzerland
11.3.3.10.1 Switzerland Host Cell Protein Testing Market By End user
11.3.3.10.2 Switzerland Host Cell Protein Testing Market By Type
11.3.3.11 Austria
11.3.3.11.1 Austria Host Cell Protein Testing Market By End user
11.3.3.11.2 Austria Host Cell Protein Testing Market By Type
11.3.3.12 Rest of Western Europe
11.3.3.12.1 Rest of Western Europe Host Cell Protein Testing Market By End user
11.3.2.12.2 Rest of Western Europe Host Cell Protein Testing Market By Type
11.4 Asia-Pacific
11.4.1 Trend Analysis
11.4.2 Asia Pacific Host Cell Protein Testing Market by Country
11.4.3 Asia Pacific Host Cell Protein Testing Market By End user
11.4.4 Asia Pacific Host Cell Protein Testing Market By Type
11.4.5 China
11.4.5.1 China Host Cell Protein Testing Market By End user
11.4.5.2 China Host Cell Protein Testing Market By Type
11.4.6 India
11.4.6.1 India Host Cell Protein Testing Market By End user
11.4.6.2 India Host Cell Protein Testing Market By Type
11.4.7 Japan
11.4.7.1 Japan Host Cell Protein Testing Market By End user
11.4.7.2 Japan Host Cell Protein Testing Market By Type
11.4.8 South Korea
11.4.8.1 South Korea Host Cell Protein Testing Market By End user
11.4.8.2 South Korea Host Cell Protein Testing Market By Type
11.4.9 Vietnam
11.4.9.1 Vietnam Host Cell Protein Testing Market By End user
11.4.9.2 Vietnam Host Cell Protein Testing Market By Type
11.4.10 Singapore
11.4.10.1 Singapore Host Cell Protein Testing Market By End user
11.4.10.2 Singapore Host Cell Protein Testing Market By Type
11.4.11 Australia
11.4.11.1 Australia Host Cell Protein Testing Market By End user
11.4.11.2 Australia Host Cell Protein Testing Market By Type
11.4.12 Rest of Asia-Pacific
11.4.12.1 Rest of Asia-Pacific Host Cell Protein Testing Market By End user
11.4.12.2 Rest of Asia-Pacific Host Cell Protein Testing Market By Type
11.5 Middle East & Africa
11.5.1 Trend Analysis
11.5.2 Middle East
11.5.2.1 Middle East Host Cell Protein Testing Market by Country
11.5.2.2 Middle East Host Cell Protein Testing Market By End user
11.5.2.3 Middle East Host Cell Protein Testing Market By Type
11.5.2.4 UAE
11.5.2.4.1 UAE Host Cell Protein Testing Market By End user
11.5.2.4.2 UAE Host Cell Protein Testing Market By Type
11.5.2.5 Egypt
11.5.2.5.1 Egypt Host Cell Protein Testing Market By End user
11.5.2.5.2 Egypt Host Cell Protein Testing Market By Type
11.5.2.5 South Africa
11.5.2.5.1 South Africa Host Cell Protein Testing Market By End user
11.5.2.5.2 South Africa Host Cell Protein Testing Market By Type
11.5.2.6 Rest of Africa
11.5.2.6.1 Rest of Africa Host Cell Protein Testing Market By End user
11.5.2.6.2 Rest of Africa Host Cell Protein Testing Market By Type
11.5.2.6 Saudi Arabia
11.5.2.6.1 Saudi Arabia Host Cell Protein Testing Market By End user
11.5.2.6.2 Saudi Arabia Host Cell Protein Testing Market By Type
11.5.2.7 Qatar
11.5.2.7.1 Qatar Host Cell Protein Testing Market By End user
11.5.2.7.2 Qatar Host Cell Protein Testing Market By Type
11.5.2.8 Rest of Middle East
11.5.2.8.1 Rest of Middle East Host Cell Protein Testing Market By End user
11.5.2.8.2 Rest of Middle East Host Cell Protein Testing Market By Type
11.5.3 Africa
11.5.3.1 Africa Host Cell Protein Testing Market by Country
11.5.3.2 Africa Host Cell Protein Testing Market By End user
11.5.3.3 Africa Host Cell Protein Testing Market By Type
11.6 Latin America
11.6.1 Trend Analysis
11.6.2 Latin America Host Cell Protein Testing Market by Country
11.6.3 Latin America Host Cell Protein Testing Market By End user
11.6.4 Latin America Host Cell Protein Testing Market By Type
11.6.5 Brazil
11.6.5.1 Brazil Host Cell Protein Testing Market By End user
11.6.5.2 Brazil Host Cell Protein Testing Market By Type
11.6.6 Argentina
11.6.6.1 Argentina Host Cell Protein Testing Market By End user
11.6.6.2 Argentina Host Cell Protein Testing Market By Type
11.6.7 Colombia
11.6.7.1 Colombia Host Cell Protein Testing Market By End user
11.6.7.2 Colombia Host Cell Protein Testing Market By Type
11.6.8 Rest of Latin America
11.6.8.1 Rest of Latin America Host Cell Protein Testing Market By End user
11.6.8.2 Rest of Latin America Host Cell Protein Testing Market By Type
12. Company Profiles
12.1 Thermo Fisher Scientific Inc.
12.1.1 Company Overview
12.1.2 Financial
12.1.3 Products/ Services Offered
12.1.4 SWOT Analysis
12.1.5 The SNS View
12.2 Bio-Rad Laboratories, Inc.
12.2.1 Company Overview
12.2.2 Financial
12.2.3 Products/ Services Offered
12.2.4 SWOT Analysis
12.2.5 The SNS View
12.3 Cygnus Technologies, Llc
12.3.1 Company Overview
12.3.2 Financial
12.3.3 Products/ Services Offered
12.3.4 SWOT Analysis
12.3.5 The SNS View
12.4 Biogenes Gmbh
12.4.1 Company Overview
12.4.2 Financial
12.4.3 Products/ Services Offered
12.4.4 SWOT Analysis
12.4.5 The SNS View
12.5 Cisbio Bioassays
12.5.1 Company Overview
12.5.2 Financial
12.5.3 Products/ Services Offered
12.5.4 SWOT Analysis
12.5.5 The SNS View
12.6 Charles River Laboratories International, Inc.
12.6.1 Company Overview
12.6.2 Financial
12.6.3 Products/ Services Offered
12.6.4 SWOT Analysis
12.6.5 The SNS View
12.7 Rockland Immunochemicals, Inc. and Abcam Plc
12.7.1 Company Overview
12.7.2 Financial
12.7.3 Products/ Services Offered
12.7.4 SWOT Analysis
12.7.5 The SNS View
13. Competitive Landscape
13.1 Competitive Benchmarking
13.2 Market Share Analysis
13.3 Recent Developments
13.3.1 Industry News
13.3.2 Company News
13.3.3 Mergers & Acquisitions
14. USE Cases And Best Practices
15. Conclusion
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