Host Cell Protein Testing Market Size, Share and Segmentation by End User (CROs, Biopharmaceutical Companies), by Type (PCR-based Assays, ELISA-based Assays), by Region, and Global Forecast 2023-2030

Report Scope & Overview:

The Host Cell Protein Testing Market Size was valued at USD 1.26 billion in 2022 and is expected to reach USD 1.99 billion by 2030, and grow at a CAGR of  5.81% over the forecast period 2022-2030.

Host Cell Proteins are low-level protein impurities identified in therapeutic products obtained from the host organism during bio therapeutic production (HCPs). Many endogenous proteins can be produced by host cell systems during the production of a re combinant protein medication. Re combinant proteins, particularly monoclonal antibodies, offer potentially novel therapy approaches for previously incurable diseases. As a result, their importance in the pharmaceutical sector is rapidly growing. To create re combinant proteins for therapeutics, insect cells, yeast, and bacteria are used as expression hosts.

HCPs, the most frequent type of process-related impurity, are undesirable in pure protein products because they may endanger human safety. HCPs may be biologically active in the human body, or they may destroy the therapeutic protein or product-stabilizing chemicals, affecting product stability.

MARKET DYNAMICS:

KEY DRIVERS:

• 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.

• Biopharmaceutical advancements with expanding R&D activity

RESTRAINTS:

• Concerns Regarding Immunogenesis

• PROBLEMS WITH THE EFFICIENCY AND ACCURACY OF THE TEST KITS

OPPORTUNITY:

• Automated mass spectrometry is being used to detect host cell proteins.

• The industry is investing in technologies that will allow the detection of host cell protein in commercially generated antibodies to be automated.

IMPACT OF COVID-19:

The global spread of the fatal corona virus has hampered the movement of commodities across continents and regions. The virus outbreak impacted the entire supply chain, from raw material delivery to finished goods transit. The providers have formed a special team to assess the complete supply chain of raw materials and finished goods. During the pandemic era, the special team is responsible for assessing cross-border problems and trade restrictions. Furthermore, in order to meet the criteria, the manufacturers have improved their transportation facilities and upgraded their packaging infrastructure.

Assays based on polymerase chain reaction (PCR) are used to detect genetic material from a specific organism, such as a virus. These assays are generally used for the rapid and precise diagnosis of infectious disorders caused by viruses or bacteria. It is also utilised to identify on-cultivable or slow-growing microorganisms from tissue culture assays and animal models, such as anaerobic bacteria, mycobacteria, or viruses. It enables the detection of small numbers of disease organisms in convenient samples, whether dead or alive. Standard single PCR, allele-specific PCR, multiplex PCR, and real-time PCR are all examples of PCR-based assays.

The ELISA-based assay is a plate-based assay technique for detecting and quantifying soluble molecules such proteins, peptides, hormones, and antibodies. Direct ELISA, indirect ELISA, sandwich ELISA, and competitive ELISA are the four types of ELISA. An antigen-coated multi-well plate is detected by an antibody that has been directly coupled to an enzyme in the direct ELISA experiment. It is a fast detection method that eliminates secondary antibody cross-reactivity. Sandwich ELISA is a form of enzyme-linked immunosorbent test that employs two antibodies, one for detection and one for capture. It offers several benefits, including high specificity, adaptability for complicated samples, versatility, and sensitivity. A surface/plate-based test, competitive ELISA coats the plate with capture antibodies reactive to the chemical of interest. A competitive ELISA assay requires no sample preparation and can employ crude or impure samples.

A mass spectrometry-based test has evolved as an effective analytical technique for identifying, characterising, and quantifying different macromolecules in biological materials. In recent years, quantitative bioanalysis of proteins has gained increasing attention and interest. It has several advantages, including the capacity to assess numerous analytes in a single analytical run, the ease with which new assays may be developed, minimal volume requirements, and inexpensive reagent costs. In medication development, there is an increasing demand for quantitative bioanalysis of protein therapies.

Contract research groups want to evaluate host cell proteins. A contract research organisation (CRO) is a corporation that provides outsourced pharmaceutical research services to pharmaceutical and biotechnology companies. In 2021, there will be 4,087 contract research organisations enterprises in the United States, according to IBIS World. Contract research organisations employ host cell protein testing for researching novel treatments and pharmaceuticals. It aids in the development of biological assays, preclinical research, and the administration of clinical trials. It aids in the progression of new pharmaceuticals from conception to FDA/EMA marketing approval.

Biopharmaceutical businesses use host cell protein testing. Biopharmaceutical medications are used to treat a wide range of disorders, including cardiovascular disease, diabetes, and cancer. Mammalian cell lines, microbial cells, and plant cell cultures can all be used to make it. Biopharmaceuticals such as recombinant proteins and therapeutic antibodies are created in host cells that have been genetically modified. To assure product safety, host cell protein testing effectively removes host cell contaminants from production cell lines.

MARKET PLAYER

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.

MARKET SEGMENTS:

by End User

• CROs

• Biopharmaceutical Companies

by Type

• PCR-based Assays

• ELISA-based Assays

REGIONAL ANALYSIS:

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 programme 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.

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

Frequently Asked Questions (FAQ) :