Host Cell Protein Testing Market Research Report: Information by Type (PCR-based Assays, ELISA-based Assays), by EndUser (CROs, Biopharmaceutical Companies), by and Region (North America, Europe, Asia-Pacific, and Rest of the World) - Forecast till 2027

Host Cell Protein Testing Market Forecast

The host cell protein testing market is projected to grow at a CAGR of ~5.7% during the forecast period of 2021 to 2027

Market Overview:

Low-level, process-related protein contaminants in therapeutic products obtained from the host organism during biotherapeutic production are known as Host Cell Proteins (HCPs). Many endogenous proteins can be expressed by host cell systems during the synthesis of a recombinant protein medication. During the product purification stages, these HCPs are removed as the presence of these HCPs, even in low residual levels, might negatively impact the safety and efficacy of the recombinant product. The market is driven by factors like developments in the biopharmaceutical field and growing R&D activities. However, the lack of skilled professionals could hamper the growth of the market.

COVID-19 Analysis

The present COVID-19 pandemic has impacted people all over the world and forced the closure of operational facilities across the world. According to the World Bank, in June 2020, the world economy has suffered substantially, with global GDP shrinking by an estimated 5.2%. During the lockdown, the healthcare business faced extraordinary challenges such as supply chain disruptions, resulting in an increase in warehouse inventories of manufactured goods.This COVID-19 pandemic is also creating opportunities for the players in the host cell protein testing industry.This is due to the increased R&D efforts made by companies to produce treatments for COVID-19, such as monoclonal antibody therapies where HCP testing is a must. For instance, in May 2021, the FDA approved Sotrovimab, a monoclonal antibody therapy for emergency use in mild-to-moderate COVID-19 cases. Furthermore, Biological E (India) has made a recombinant protein vaccine called the Corbevax vaccine for COVID-19. These therapeutic products require HCP testing to ensure efficacy and gain approval for the products,therefore, impacting the market positively.

Market Dynamics

Drivers

• Developments in the biopharmaceutical field
  
  
  
  • The growth of the host cell protein testing market will be fueled by developments in the biopharmaceutical field, including ongoing R&D activities as well as an increase in the number of regulatory approvals for testing equipment. Other considerations include the rising prevalence of chronic diseases such as cancer, which necessitate the development of advanced innovative biopharmaceutical products, and the growing demandfor personalized medications.
  
  
  • In 2018, according to the International Agency for Research on Cancer, the cancer burden had risento 18.1 million in 2018. Cancer was the leading cause of death worldwide in 2020, accounting for around 20 million deaths. The increased funding for such chronic diseases will also lead to more R&D activities where HCP testing will be required. For example, in 2020,the National Institutes of Health (NIH) received a total funding of USD 41.46 billion for research, and a USD 6.9 billion increase in funding for National Cancer Institute (US).
  
  
  
  

Market Opportunities

• Technological advancements in therapeutics
  
  
  
  • Novel methods for HCP testing will lead to more market growth opportunities in the future. The current gold standard for HCP testing is the use of ELISA. However, there are downsides of this method, like it detects only immunologically active host cell proteins. Therefore, in recent times, the introduction of methods like liquid chromatography (LC) and mass spectrometry (MS) for detecting and quantifying HCPs have led to technological advancements in the field.
  
  
  • In May 2021, the FDA approved the Investigational New Drug Application (IND) for a drug with only LC-MS data and no ELISA data, which showed the entry and acceptance of newer technologies in the HCP testing field. Furthermore, newer technologies such as gene therapies where host cells are used as expression systems will also require efficient HCP testing methods, supplementing the growth of the HCP testing market in the future.
  
  
  
  

Market Restraints

• Dearth of skilled professionals
  
  
  
  • The HCP testing is an essential part of drug development and approval for the majority of the drugs that use a host cell expression system in their development phase. Therefore, this method needs to be carried out with high precision and expertise, as the HCP levels present in the final drug component directly affect the product efficacy and approval rates.
  
  
  • HCP testing methodologies, especially mass spectroscopy and liquid chromatography techniques,are not only expensive but also require a lot of expertise for proper execution and interpretation of the data. Therefore, the lack of skilled professionals might hamper the growth of the market
  
  
  
  

Regulatory Implications

• A proper regulatory framework for therapeutic products involving host cells is extremely important. The transmission of oncogenes, which could potentially lead to tumor growth in the patient receiving the therapy, is an issue connected with leftover host-cell DNA. Immunogenicity is a potential hazard for host-cell proteins, as antibodies may be formed against the therapeutic product itself or against endogenous proteins homologous to the host cell protein.


• Regulatory bodies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have mandated the documentation of HCP quantity in the final drug and set a maximum level allowed for approval. These HCP and host cell DNA levels are also evaluated during the development and validation of processes, which help producers choose the optimal ways for reducing contaminants.For instance, after purification, the FDA mandates host cell DNA levels of 100 pg or less and 100 ng/mg in therapeutic protein or less for host cell protein as the allowed limit in drugs approved by the FDA. Therefore, HCP testing is essential for drug development and approval, increasing the demand for HCP testing methodologies.

Segment Overview

By Type

PCR-based Assays

• Polymerase Chain Reaction (PCR) is a laboratory method that is used to amplify DNA sequences. Short DNA sequences called primersare used in this method to specify the region of the DNA to be amplified. With the help of temperature regulation which is repeatedly increased and decreased for the DNA replication enzymes to function properly, around a billion copies of the target DNA sequence can be created in just a few hours. These capabilities of PCR are used to quantify the residual host cell DNA in therapeutic protein products. Host cell DNA quantification is most important as the presenceof only a very small amount is permitted in drug substances for approval. PCR is also used for the detection and quantification of HCPs. For example, qPCR is coupled with immunoassays which gives superior results than existing techniques such as ELISA for HCP quantification.The ProteinSEQ Protein Quantitation System by Thermo Fisher Scientific (US) is one such example. 

ELISA-based Assays

• Enzyme-Linked Immunosorbent Assay (ELISA)works on the principle of antibody affinity and selectivity towards antigens, which are HCPs in this case.ELISAs for HCP detection are mostly of the sandwich mode type, in which the antigen is between two layers of antibodies, called capture and detection antibodies. ELISA is the most commonly used method for HCP screening and testing as it is highly sensitive and reproduciblecapable of high throughput screening of HCPs.Furthermore, the availability of different ELISA kits for HCP detection in different expression systems like CHO, E. coli, Protein A, and Pichia further improve the usability of ELISA. New product launches also drive this segment. For instance, in September 2019, Amsbio LLC(UK) launched new HCP detection ELISA kits that can be used at any stage of product development.

Others

• Other methods such as mass spectroscopy, 2D electrophoresis, and western blotting are also used for HCP quantification as HCPs are of a wide variety, and not all the HCPs can be detected by immunoassays because not all HCPs are immunoreactive in nature.


• By End User

Contract Research Organizations

• Contract Research Organizations (CROs) are expected to hold a significant share in the host cell protein testing market as CROs are responsible for carrying out drug development and clinical trial phases andmonitor the HCP levels. HCP assays are carried out in the process development stage, in early clinical phases,andduring phase III clinical trials for product validation.  Therefore, there is a significant demand for HCP testing from CROs driving the market growth for this segment.

Biopharmaceutical Companies

• Biopharmaceutical companies hold the major share in the end user segment due to factors like increasing R&D activities, especially in the recombinant protein and antibody field, rising investments in newer technologies, and product launches.For instance, Thermo Fisher Scientific, Inc. (US) cooperated with Northeastern University's Biopharmaceutical Analysis Training Laboratory (BATL) in 2019to expand analytical capabilities and foster innovation across the biopharmaceutical industry, especially in areas like monoclonal antibodies and gene and cell therapy, where HCP testing and purification is extremely important.

Others

• The other end users for the host cell protein testing market include hospitals, research institutes,and contract manufacturing organizations,where HCP testing is utilized for various purposes.

Regional Analysis

North America

• Increasing number of research activities and rising healthcare budget are driving the growth of the North American host cell protein testing market.

North Americaheldthe largest share in the host cell protein testing market in 2020. Several major players, such as Thermo Fisher Scientific (US), Charles River (US), and Bio-Rad Laboratories (US), are driving the market growth with product innovations and new launches. Additionally, the healthcare infrastructure in the region is highly developed, enabling extensive R&D in the field.Increasing research funding also supplements the growth of the market in the region. For instance, in 2020,the National Institutes of Health (NIH) had total funding of USD 41.7 billion for cancer research.

Europe

• Government initiatives and increased research funding arefueling the Europeanhost cell protein testing Market.

The Europeanhost cell protein testing market accounted for a significant market share in 2020. Europe also houses several key players, such as BioGenes GmbH (Germany) and Cisbio Bioassays (France). The region also possesses a well-developedhealthcareinfrastructure, and increasing healthcare expenditurefurther drives the market in the region. Government initiatives and research funding are also fueling the growth of this market. For instance,The Oxford Protein Production Facility-UK (OPPF-UK) in the UKhad received a USD 3 million funding from the Laboratory of Molecular Biology (MRC) in 2019for high throughput expression, purification, and crystallization of recombinant proteins advancements where HCP testing plays a critical part.

Asia-Pacific

• Presence of emerging economies and the high prevalence of chronic diseases like cancer in the region to create more opportunities for market growth in the forecast period.

The developing healthcare infrastructures of the emerging countries and the high prevalence of chronic disorders such as cancer in countries within this region are driving extensive R&D of drugs. This, in turn, is positively impacting the HCP testing market in the region. For instance, according to World Cancer Research Fund (WCRF), in 2018, Australia had the highest prevalence of cancer in the world for both sexes at 468.0 per 100,000 individuals. Furthermore, increasing R&D funding is boosting the market growth. For instance, according to the National Bureau of Statistics, China's R&D spending increased by 10.3% compared to 2019, to USD 378 billion in 2020, which was the highest investment done by the country in R&D up till 2020.

Rest of the World

• Increasing government initiatives areexpected to drive market growth in the region in the forecast period.

The Rest of the World region is projected to register a slower growth rate due to comparatively lesser R&D happening in the region. The majority of the growth comes from the Gulf countries. Supportive government regulations and increasing investments for the domestic production of pharmaceutical productsare driving the growth of the market in the region.

Competitive Landscape

• The industry players are adopting several business strategies to increase their market presence. They are significantly investing in R&D activities to expand their product portfolio, further driving the host cell protein testing market. In addition, the market players are adopting several strategic initiatives such as new product launches,contractual agreements,mergers and acquisitions, increasing investments, and partnering with other players to expand their global footprint.


• One of the key players is Cygnus Technologies Inc. (US). The company was founded in 1997 and specializes in HCP and other process-related impurity detection. The company provides tools and solutions to enhance the process development process and obtain faster regulatory approvals. Cygnus possesses a wide product portfolio for different types of HCP detection. For e.g., mammalian hcp ELISA kits, yeast HCPELISA kits, transgenics HCPELISA kits, bacterial HCPELISA kits, and insect cell HCPELISA kits.

List of companies with HQ

• Enzo Life Sciences, Inc. (US)


• Cygnus Technologies Inc. (US)


• BioGenes GmbH (Germany)


• Cytiva (US)


• Cisbio Bioassays (France)


• Molecular Devices (US)


• Thermo Fisher Scientific (US)


• Charles River (US)


• Bio-Rad Laboratories (US)


• ForteBio (Pall) (US)


• Others

Recent Developments

• In November 2020, Thermo Fisher Scientific (US) had collaborated with Northeastern University, US, to enhance its analytical capabilities and innovate in areas like monoclonal antibodies, gene and cell therapies, etc., where HCP testing is required.


• In September 2019, Amsbio LLC (UK) launched new HCP detection kits,which are specialized in detecting HCP at any stage of the drug development process.


• In August 2019, Cygnus Technologies (US) announced a strategic partnership with Bio-Techne for the quantification of chinese hamster ovary host cell proteins (CHO-HCP) on the ProteinSimple Ella immunoassay platform.


• In June 2019, Cygnus Technologies(US) broadened its service offerings for HCP analysis with its Mass Spec Services, which will allow the detection and quantification of HCPs.

Report Overview

• The study covers the existing short-term and long-term market effects. It helps decision-makers to draught short-term and long-term business plans 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.

Market Segmentation:

Global Host Cell Protein Testing Market,By Type

• PCR-based Assays


• ELISA-based Assays


• Others

Global Host Cell Protein Testing Market, By End User

• Research Institutes


• Biopharmaceutical Companies


• Others

Global Host Cell Protein Testing Market, By Region

• 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
  
  
  
  

Report Scope:

Report Attribute/Metric	Details
Market Size	2027:~USD Million
CAGR	5.7%
Base Year	2020
Forecast Period	2021-2027
Historical Data	2018 & 2019
Forecast Units	Value (USD Million)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered	Type,and End User
Geographies Covered	North America, Europe, Asia-Pacific, and Rest of the World
Key Vendors	Enzo Life Sciences, Inc. (US), Cygnus Technologies Inc. (US), BioGenes GmbH (Germany), Cytiva (US), Cisbio Bioassays (France), Molecular Devices (US), Thermo Fisher Scientific (US), Charles River (US), Bio-Rad Laboratories (US), ForteBio (Pall) (US) and others
Key Market Opportunities	• Technological advancements in therapeutics
Key Market Drivers	• Developments in the biopharmaceutical field • Rise in R&D activities