Host Cell Protein Testing Market Projected To Reach USD 4.34 Billion By 2032, With 8.14% CAGR – SNS Insider

Austin, Oct. 22, 2024 (GLOBE NEWSWIRE) -- According to SNS Insider, The Host Cell Protein Testing Market Size was valued at USD 2.15 billion in 2023 and is expected to reach USD 4.34 billion by 2032, growing at a CAGR of 8.14% over the forecast period from 2024 to 2032. In turn, the growth of this market is primarily due to the rising demand for biologics and biosimilars as well as the requirement for strict regulatory compliance in the biopharmaceutical sector. With the new biologics growing rapidly, host cell protein testing takes on greater importance to ascertain product safety and effectiveness.

Host Cell Protein Testing Market Overview

The Host Cell Protein Testing Market is one of the most crucial markets in the biopharmaceutical industry as host cell proteins are generally used for quality control. Demand for HCP testing is arising from the rapid development of biologics and the increasing complexity of biologic products. The regulatory pressure on companies also increases, when they need to prove product safety. Hence, an advanced level of testing protocols will be required. On the supply side, advances in technologies, such as ELISA and mass spectrometry-based assays, are gaining popularity with higher sensitivity and specificity. The market landscape is competitive, and the largest market share is of biopharmaceutical companies which occupy 60% market share. The trend thus represents a growing demand for superior testing methodologies to maintain compliance with international standards.

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Key Host Cell Protein Testing Market Players:

• Enzo Life Sciences Inc
• Abcam plc
• Thermo Fisher Scientific Inc
• Cytiva
• Bio-Rad Laboratories Inc
• Biogenes GmbH
• Cisbio Bioassays
• Cygnus Technologies LLC
• Rockland Immunochemicals Inc
• Agilent Technologies Inc
• Other Players

Host Cell Protein Testing Market Report Scope:

Host Cell Protein Testing Market Segment Insights

By Type

In 2023, ELISA-based assays accounted for more than 45% of the market share. The criteria for such methods should provide proven reliability in determining the level of host cell proteins within biopharmaceuticals. Such methods give high sensitivity along with specificity and can be carried out economically, hence having preference among most of the companies involved in this industry.

Where on the other hand, the mass spectrometry-based assays market is poised to witness the fastest growth and hold its top position in this segment, with a base of 12% above during the forecasted period. This market's rapid growth requirement is because of the need for detailed quantitative data and the possible identification of multiple HCPs in a single analysis. The high sensitivity and reduced test time provided by LC-MS and MS/MS technologies are forcing biopharmaceutical companies to switch over from traditional methods to these advanced testing solutions.

By End User

In 2023, biopharmaceutical companies remained the largest category of end-users, accounting for almost 60% market share. This tremendous percentage reflects the extent of attention given to biologics regarding safety and efficacy and the strict regulations put in place during the development process of biologics. Because these companies are expanding their pipelines, testing requirements for HCPs for those candidates have increased significantly to ensure they meet these regulatory standards.
Contract Research Organizations (CROs) will also be on the growth fast track with an expected growth rate of 11% CAGR over the period. The primary reason for this increase is the growing need for outsourcing R&D and testing functions among small and medium-sized biopharmaceutical firms. CROs offer specialized expertise and cost-effective solutions with which companies can then concentrate on core activities and ensure high-quality HCP testing.

Market Segmentation

By Type

• PCR-Based Assays
• ELISA-based Assays
• Mass Spectrometry-Based Assays
  • Liquid Chromatography–Mass Spectrometry (LC-MS)
  • Tandem Mass Spectrometry (MS/MS)
  • Others
• Others

By End User

• Contract Research Organizations
• Biopharmaceutical Companies
• Others

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Regional Analysis

North America

North America dominated the global market for Host Cell Protein Testing in 2023. The region has a well-established biopharma industry and is home to most players. Not only is there significant investment in R&D, but biologics innovation is also heavily emphasized. Companies like Pfizer and Amgen use state-of-the-art testing technologies to meet regulatory standards. The high adoption of advanced testing methods has further solidified the fact that North America is the leading market in the HCP testing market. The new biologics and biosimilars, which enter the market are highly demanded in the region with thorough HCP testing solutions.

Europe

The Host Cell Protein Testing Market in the European region is growing at a significant rate. This development comes from increased investment in biopharmaceutical research and the increasing number of market entries of biosimilars. For instance, stringent regulations on the testing process by the European Medicines Agency compel the firms to strengthen the testing capabilities of HCP. Leading the Europe pack are Germany and Switzerland; companies like Novartis and Roche are readily entering this innovative cycle of biologics. Moreover, partnerships and collaborations between biopharmaceutical companies and CROs are on the increase in Europe, thereby increasing the HCP testing capacity and adherence to regulatory standards.

Recent Events

• Agilent Technologies released a new LC-MS solution targeted to host cell protein testing in September 2024. It has increased sensitivity and throughput.
• In August 2024, the company developed a simplified version of an ELISA kit that is supposed to detect host cell proteins; the assay time is reduced by 30%.
• In April 2024 Charles River Laboratories launched a new portfolio of contract testing services tailored exclusively for HCP analysis within biopharmaceuticals.
• In March 2024 Lonza Group introduced an advanced assay platform that brings the combination of ELISA and mass spectrometry for superior host cell protein testing in biologics.

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Table of Contents – Major Key Points

1. Introduction

2. Executive Summary

3. Research Methodology

4. Market Dynamics Impact Analysis

5. Statistical Insights and Trends Reporting

• Incidence and Prevalence (2023)
• Prescription Trends, (2023), by Region
• Healthcare Spending: Expenditure data by government, insurers, and out-of-pocket by patients.

6. Competitive Landscape

7. Host Cell Protein Testing Market Segmentation, by Service

8. Host Cell Protein Testing Market Segmentation, by Delivery Model

9. Regional Analysis

10. Company Profiles

11. Use Cases and Best Practices

12. Conclusion

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