바이러스 클리어런스 시장 예측(-2030년) : 방법별, 용도별, 최종사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Viral Clearance Market is accounted for $764.64 million in 2023 and is expected to reach $1938.15 million by 2030 growing at a CAGR of 14.21% during the forecast period. The development of recombinant proteins, glycoproteins, tissue- and blood-derived products, medical devices, and monoclonal antibodies all depend on the viral clearance process. Animal or human cells can become infected by viruses, which have the capacity to multiply on their own. Additionally, they have the power to multiply and spread within the host cell of bacteria, causing damage and infection. An important component of the viral clearance method is the evaluation of the capacity to produce a product without risk and guarantee the product's safety for human use. Raw materials, downstream processing, and cell culture processes are all impacted by viral infections. This would contribute to the development of viral safety practices and the implementation of the virus clearance process.

According to BioSpace, in 2018, 386 drugs were registered for clinical development, observing a significant growth from 2008, when the number of drugs was only 178. The increase in the number of drugs in the development process has increased viral clearing services' demand.

Market Dynamics:

Driver:

Increasing prevalence of chronic diseases

Some of the factors propelling the growth of the viral inactivation market include the rising prevalence of chronic viral infections and diseases and the rising demand for effective treatment methods. Additionally, the market is expected to grow as a result of rising investment in the life sciences industry, the introduction of more new drugs, and increased R&D innovation.

Restraint:

High costs incurred by cutting-edge technologies

The market expansion is being hampered by high development costs for goods and technology. Additionally, the lengthy drug development process and some issues related to virus clearance, such as protein crosslinking, protein denaturation, and protein degradation, are restricting the market's expansion.

Opportunity:

Increasing viral safety regulations

The evaluation of viral safety is an important step in ensuring the safety of products. Regulatory agencies place a lot of emphasis on viral safety and demand high-caliber data to support it, particularly for IND and BLA approvals. For effective strategic planning, it is crucial to be knowledgeable about the regulatory requirements, the process, and the key areas of the process. These viral safety regulations during the development of pharmaceutical products have increased the demand for services to conduct studies more successfully.

Threat:

Scarcity of qualified specialists

Virus removal service providers face challenges in attracting and retaining highly skilled professionals as they compete for qualified and experienced scientists with pharmaceutical companies, biotechnology companies, medical device companies, and research and academic institutions. Companies have to offer higher compensation and other incentives to compete, which affects the finances and performance of players, especially smaller analytics test providers. This scarcity of skilled professionals may hinder the adoption of new technologies and processes, limiting the growth of the market in the coming years.

COVID-19 Impact:

The market was negatively impacted by the COVID-19 pandemic. The market was challenged by a lack of workers and staff, a risk of infection spread, and a slowdown in manufacturing in the biopharmaceutical and biotech sectors. However, the market witnessed a sharp acceleration in growth in 2021. This growth was attributed to an increase in clinical trials. To develop vaccines and medications against the SARS-CoV-2 virus, many pharmaceutical and biopharmaceutical companies increased their R&D and manufacturing processes. Additionally, following the COVID-19 outbreak, there have been numerous new global partnerships and collaborations with pharmaceutical companies and academic institutions for the development of COVID-19 vaccines.

The recombinant proteins segment is expected to be the largest during the forecast period:

During the forecast period, the recombinant proteins segment is anticipated to hold the largest market share. One of the main factors influencing the segment's growth is the rising demand for biopharmaceuticals for managing inflammatory diseases like psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases. The production and development of biotherapeutics have been completely transformed by the introduction of recombinant proteins. As numerous biologics and vaccines made of recombinant proteins are currently in the pipeline and are anticipated to receive FDA approval, it is anticipated that the number of recombinant drugs will increase. The market is therefore anticipated to grow in light of all the aforementioned factors.

The contract research organizations segment is expected to have the highest CAGR during the forecast period:

Due to growing investments by major market players in various research organizations to improve their products, the contract research organizations segment is anticipated to experience strong market growth in the upcoming years. The ability of contract research organizations to make significant investments in drug discovery infrastructure and an increase in the outsourcing of drug discovery services to CROs by organizations like start-ups, academic institutions, pharmaceutical companies, and small biotechnology companies are the main factors behind their extraordinary growth in the global viral clearance market.

Region with largest share:

Throughout the forecast period, North America is anticipated to dominate the viral clearance market. The presence of important players and their use of cutting-edge medical technologies to advance are primarily responsible for the largest share. The primary driver of market expansion is the rise in the production of recombinant proteins and vaccines, as well as the requirement to keep them virus- and risk-free. Additionally, the population is becoming more aware of the benefits of using biopharmaceuticals, which is driving up demand for services related to viral clearance. Furthermore, the market is expanding as a result of increased funding for pharmaceuticals across the United States.

Region with highest CAGR:

Due to rising government investments in medical research and rising healthcare costs, Asia Pacific is expected to grow significantly during the forecast period, which will increase the risk of cell culture contamination and the presence of CROs in nations like China, Japan, and India. According to statistics from the WHO, more than 15 million people between the ages of 35 and 69 die from chronic diseases, and both developed and developing nations account for 85% of premature deaths. Additionally, a large number of clinical research services, particularly in China, are anticipated to fuel market expansion in the upcoming years.

Key players in the market

Some of the key players profiled in the Viral Clearance Market include Avance Biosciences Inc., BioReliance Corporation, Bioscience Laboratories, BSL Bioservice Scientific Laboratories GmbH, Charles River Laboratories, Inc., Clean Cells Inc., Cytovance Biologics Inc., Eurofins Scientific, F. Hoffmann-La Roche Ltd., GE Healthcare Life Sciences, Kedrion Biopharma Inc., Labor Dr. Merk & Kollegen GmbH, Lonza Group AG, Merck KGaA, Nelson Laboratories LLC, Novartis AG, Sartorius AG, Sigma-Aldrich Corporation, Syngene International Limited, Texcell, Inc., Vironova AB, ViruSure GmbH and WuXi AppTec.

Key Developments:

In September 2022, Merck opened a viral clearance (VC) laboratory as part of the first building phase of its new EUR 29 million China Biologics Testing Center.

In April 2022, Abzena, a partner research organization (PRO), announced the opening of a biologics testing laboratory situated near the company's biologics process development and manufacturing hub in San Diego, California. The facility will give partners access to cell-based and PCR safety assays; and viral clearance studies to support their IND, IMPD, BLA, and MAA applications.

In April 2022, WuXi Biologics awarded the bioprocessing excellence in viral clearance and safety accolade for the second time at the Asia Pacific Bioprocessing Excellence Awards (ABEA) event.

Methods Covered:

• Viral Removal
• Viral Inactivation
• Viral Detection Method

Application Covered:

• Recombinant Proteins
• Blood and Blood Products
• Cellular and Gene Therapy Products
• Vaccines
• Other Applications

End Users Covered:

• Pharmaceutical and Biotechnology Companies
• Academic Research Institutes
• Contract Research Organizations
• Other End Users

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026 and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 Application Analysis
• 3.7 End User Analysis
• 3.8 Emerging Markets
• 3.9 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Viral Clearance Market, By Method

• 5.1 Introduction
• 5.2 Viral Removal
  • 5.2.1 Chromatography
  • 5.2.2 Nanofiltration
  • 5.2.3 Precipitation
• 5.3 Viral Inactivation
  • 5.3.1 Low pH
  • 5.3.2 Solvent Detergent Method
  • 5.3.3 Heat Pasteurization
  • 5.3.4 Other Viral Inactivation Methods
• 5.4 Viral Detection Method

6 Global Viral Clearance Market, By Application

• 6.1 Introduction
• 6.2 Recombinant Proteins
• 6.3 Blood and Blood Products
• 6.4 Cellular and Gene Therapy Products
• 6.5 Vaccines
• 6.6 Other Applications

7 Global Viral Clearance Market, By End User

• 7.1 Introduction
• 7.2 Pharmaceutical and Biotechnology Companies
• 7.3 Academic Research Institutes
• 7.4 Contract Research Organizations
• 7.5 Other End Users

8 Global Viral Clearance Market, By Geography

• 8.1 Introduction
• 8.2 North America
  • 8.2.1 US
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 Italy
  • 8.3.4 France
  • 8.3.5 Spain
  • 8.3.6 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 Japan
  • 8.4.2 China
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 New Zealand
  • 8.4.6 South Korea
  • 8.4.7 Rest of Asia Pacific
• 8.5 South America
  • 8.5.1 Argentina
  • 8.5.2 Brazil
  • 8.5.3 Chile
  • 8.5.4 Rest of South America
• 8.6 Middle East & Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 UAE
  • 8.6.3 Qatar
  • 8.6.4 South Africa
  • 8.6.5 Rest of Middle East & Africa

9 Key Developments

• 9.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 9.2 Acquisitions & Mergers
• 9.3 New Product Launch
• 9.4 Expansions
• 9.5 Other Key Strategies

10 Company Profiling

• 10.1 Avance Biosciences Inc.
• 10.2 BioReliance Corporation
• 10.3 Bioscience Laboratories
• 10.4 BSL Bioservice Scientific Laboratories GmbH
• 10.5 Charles River Laboratories, Inc.
• 10.6 Clean Cells Inc.
• 10.7 Cytovance Biologics Inc.
• 10.8 Eurofins Scientific
• 10.9 F. Hoffmann-La Roche Ltd.
• 10.10 GE Healthcare Life Sciences
• 10.11 Kedrion Biopharma Inc.
• 10.12 Labor Dr. Merk & Kollegen GmbH
• 10.13 Lonza Group AG
• 10.14 Merck KGaA
• 10.15 Nelson Laboratories LLC
• 10.16 Novartis AG
• 10.17 Sartorius AG
• 10.18 Sigma-Aldrich Corporation
• 10.19 Syngene International Limited
• 10.20 Texcell, Inc.
• 10.21 Vironova AB
• 10.22 ViruSure GmbH
• 10.23 WuXi AppTec