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市場調查報告書

商品編碼

1410034

病毒清除市場：2023 年至 2028 年預測

Viral Clearance Market - Forecasts from 2023 to 2028

出版日期: 2023年12月15日 | 出版商:

Knowledge Sourcing Intelligence | 英文 146 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

預計病毒清除市場在預測期內將以 6.75% 的複合年成長率成長。

病毒清除旨在透過有效去除樣本中的病毒（完全去除或使其無傳染性）來防止所需產品的污染。病毒清除應用涵蓋多個領域，包括血液製品、重組蛋白、細胞和基因治療產品、疫苗和其他相關領域。病毒清除產業的主要成長動力包括製藥和生物技術產業以及學術研究機構的出現和成長。

製藥業的崛起正在推動病毒清除市場的成長。

病毒清除用於製藥行業，以確保生物製藥的安全性和效率，並且隨著生技藥品需求的增加以及政府投資和積極舉措的增加，該行業顯著成長，病毒清除的需求變得更加明顯。例如，印度於2022年3月宣布了製藥業集約化（SPI）計劃，預計2021-22年至2025-26年財政支出為500億盧比。這些措施預計將為病毒清除的市場需求帶來積極的前景，並促進整體市場成長。

新的研究和開發正在推動病毒清除市場的擴大。

病毒清除用於研發 (R&D)，以確保生物製藥的安全性和效率。對創新生技藥品不斷成長的需求和生物技術的進步正在推動製藥業的研發活動。此外，研發投資的增加也增加了對病毒清除技術的需求，以滿足監管要求並降低病毒污染的風險。作為醫療保健領域的領導者，羅氏將其研發 (R&D) 投資大幅增加至 2022 年的 147 億美元，而前一年為 133 億美元。

技術進步正在推動病毒清除市場的成長。

病毒清除技術的不斷進步，如層析法、過濾和病毒去活化方法，顯著提高了病毒清除過程的效率和效果。因此，這些進展將有助於生物製藥公司透過更有效率、更可靠的病毒清除程序確保產品安全和純度，滿足嚴格的監管要求，並解決人們日益成長的病毒污染風險擔憂，在推動市場成長方面發揮著至關重要的作用。例如，2022 年 6 月，Bio-Rad Laboratories, Inc. 推出了 EconoFit 低壓預載色譜管柱包，以支援蛋白質精製工作流程開發和樹脂篩檢實驗。

預計北美將成為市場領導。

北美地區預計將佔據病毒清除市場的很大佔有率，因為以領先公司、廣泛的研發活動和先進的基礎設施為特徵的強大的製藥和生物技術行業將有助於全部區域。此外，由於對生技藥品的需求不斷成長、監管指南更加嚴格以及確保患者安全的需要，該地區正在對製藥和生物技術行業進行大量投資。例如，2022 年 9 月，美國衛生與公眾服務部宣布撥款 4000 萬美元，以擴大生物製造在活性藥物成分 (API)、抗生素和關鍵藥物成分生產中的作用，並加強美國應對大流行病的能力國。我們宣布將以美元進行投資。

高成本限制了病毒清除市場的成長

由於專業設備的高成本、對熟練人員的需求以及廣泛測試的需要，病毒清除行業面臨障礙。這些成本對財力有限的中小型企業造成了障礙，限制了他們投資清除病毒的能力。因此，市場成長可能會受到阻礙，因為中小企業可能難以滿足進行有效病毒清除的財務要求，從而限制市場進入。

企業產品

ClearancePlus： Charles River Laboratories 提供 ClearancePlus，這是一項綜合性病毒清除研究，其中包含基於風險的評估。該服務包括對與產品相關的所有樣品進行大容量電鍍的標準做法，這強化了對數減少值 (LRV) 聲明並有效確保病毒減少。這已經得到證實。這些技術徹底評估病毒清除的有效性，並為客戶提供有關其病毒減少策略有效性的可靠資料。
USP 病毒清除和調查方法： Nelson Labs 提供 USP 病毒清除和調查方法，旨在對生物製藥製造中使用的各種動物性材料和加工試劑進行品管測試。這些調查方法評估病毒污染物污染的可能性，並確保最終產品的安全性和完整性。透過採用 USP 建議的病毒清除方法，Nelson Labs 幫助維持高品質標準並降低製造過程中與病毒污染相關的風險。
MockV RVLP套件(M230)： MockV RVLP套件由 Cygnus 開發，使用 BSL-1 相容儲備液，其中含有源自 CHO 細胞培養物的非感染性類病毒顆粒(RVLP)。該解決方案可作為病毒清除測試的加標劑，確保測試過程的準確性和可靠性。套件包括 RVLP 庫存溶液、用於樣品分析的96孔盤孔板、RNA 萃取和 qPCR 試劑以及精心控制的 RNA 標準品等基本組件，以實現準確可靠的 RVLP 定量。

Viral clearance aims to prevent the contamination of the desired product by effectively eliminating viruses from the sample, either through complete removal or by rendering them non-infectious. The applications of viral clearance encompass various areas including blood products, recombinant proteins, cellular and gene therapy products, vaccines, as well as other relevant fields. The significant growth drivers for the viral clearance industry include the emergence and growth of the pharmaceutical and biotech industry, as well as academic research institutes.

Rising pharmaceuticals sector bolsters the viral clearance market growth.

Viral clearance is used in the pharmaceuticals industry to ensure the safety and efficiency of biopharmaceutical products and as the industry experiences significant growth due to the increasing demand for biologics coupled with the increased government investments and proactive initiatives the need for viral clearance becomes more prominent. For instance, in March 2022, in India, the Strengthening of Pharmaceutical Industry (SPI) Scheme unveiled a financial outlay of Rs. 500 crores for the duration of FY 2021-22 to FY 2025-26. Such initiatives are expected to provide a positive outlook to the market demand for viral clearance thereby augmenting the overall market growth.

Emerging research and development drive the viral clearance market expansion.

Viral clearance is used in research and development (R&D) to ensure the safety and efficiency of biopharmaceutical products. The growing demand for innovative biologics and advancements in biotechnology is promoting R&D activities in the pharmaceutical industry. Moreover, due to an increase in R&D investments, the need for viral clearance techniques to address regulatory requirements and mitigate viral contamination risks rises. Roche, a renowned healthcare leader, significantly increased its investment in research and development (R&D) to $14.7 billion in 2022, marking a notable rise from $13.3 billion in the previous year.

Technological advancements are driving viral clearance market growth.

The continuous progress in technological advancements of viral clearance techniques, including chromatography, filtration, and viral inactivation methods, has led to notable enhancements in the efficiency and effectiveness of viral clearance processes. As a result, these advancements play a pivotal role in driving the growth of the market, as they enable biopharmaceutical companies to ensure the safety and purity of their products through more efficient and reliable viral clearance procedures, meeting stringent regulatory requirements, and addressing growing concerns regarding viral contamination risks. For instance, in June 2022, Bio-Rad Laboratories, Inc., introduced EconoFit Low-Pressure Prepacked Chromatography Column Packs to aid protein purification workflow development and resin screening experiments.

North America is anticipated to be the market leader.

The North-American region will hold a significant share of the viral clearance market due to the region's robust pharmaceutical and biotech industry, characterized by major players, extensive research and development activities, and advanced infrastructure, which has contributed to the overall regional market growth. Furthermore, the region has witnessed substantial investments in the pharmaceutical and biotech industry propelled by the increasing demand for biologics, stringent regulatory guidelines, and the need for ensuring patient safety. For instance, in September 2022, the Department of Health and Human Services announced a $40 million investment to expand biomanufacturing's role in producing active pharmaceutical ingredients (APIs), antibiotics, and critical medication components, enhancing pandemic response capabilities in the United States.

High cost restrains the viral clearance market growth.

The viral clearance industry faces hindrances due to the high costs associated with specialized equipment, the need for skilled personnel, and the requirement for extensive testing. These expenses can create barriers for smaller companies with limited financial resources, impeding their ability to invest in viral clearance procedures. Consequently, market growth may be hindered as smaller companies struggle to meet the financial requirements for implementing effective viral clearance practices, limiting their participation in the market.

Key Developments

November 2022: Cygnus Technologies introduced the MockV RVLP Kit which empowers bioprocess scientists to accurately measure the elimination of Retrovirus-Like Particles (RVLPs) that are naturally generated by Chinese Hamster Ovary (CHO) cell lines throughout the biopharmaceutical manufacturing process.
March 2022: Thermo Fisher Scientific introduced the InhibiSURE Viral Inactivation Medium, a groundbreaking formulation that prioritizes safety by being non-hazardous, setting it apart from other inactivation media which often pose potential risks. Unlike traditional inactivation media, which often contain guanidine-based chemicals that can release toxic cyanide gas if mixed with bleach or strong acids, the InhibiSURE Viral Inactivation Medium ensures safety without compromising efficiency. Furthermore, the use of this medium eliminates the requirement for additional inactivation steps, streamlining laboratory workflows and enhancing overall throughput.

Company Products

ClearancePlus: Charles River Laboratories offers ClearancePlus, a comprehensive viral clearance study that incorporates risk-based assessments. This service includes a standard practice of utilizing large-volume plating for all product-relevant samples, thereby enhancing claims of log reduction value (LRV) and effectively demonstrating robust virus reduction. The inclusion of these practices ensures a thorough evaluation of viral clearance efficacy, providing clients with reliable data on the effectiveness of their viral reduction strategies.
USP Viral Clearance and Test Methodologies: Nelson Labs offers USP Viral Clearance and Test Methodologies, which are designed for conducting quality control testing on a range of animal-derived raw materials and processing reagents used in the manufacturing of biological products. These test methodologies serve to evaluate the potential for introducing viral contaminants, ensuring the safety and integrity of the final products. By employing USP-recommended viral clearance methods, Nelson Labs assists in maintaining high-quality standards and mitigating the risks associated with viral contamination during the production process.
MockV RVLP Kit (M230): The MockV RVLP Kit, developed by Cygnus, utilizes a BSL-1 compatible stock solution containing non-infectious Retrovirus-like Particles (RVLP) derived from CHO cell culture. This solution serves as a spiking agent for viral clearance testing, ensuring the accuracy and reliability of the testing process. The kit includes essential components such as RVLP stock solution, a 96-well plate for sample analysis, RNA extraction and qPCR reagents, and a meticulously controlled RNA standard, enabling precise and dependable quantification of RVLP.

Segmentation

By Method

Viral Removal Method
Viral Inactivation Method
Viral Detection Method

By Application

Blood and Blood Products
Recombinant Proteins
Cellular & Gene Therapy Products
Vaccines
Others

By End-Users

Pharmaceuticals and Biotech Industry
Academic Research Institutes
CROs
Others

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
United Kingdom
Germany
France
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Israel
Others
Asia Pacific
Japan
China
India
South Korea
Indonesia
Thailand
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

2.1. Research Data
2.2. Assumptions

3. EXECUTIVE SUMMARY

3.1. Research Highlights

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Force Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis

5. VIRAL CLEARANCE MARKET, BY METHOD

5.1. Introduction
5.2. Viral Removal Method
5.3. Viral Inactivation Method
5.4. Viral Detection Method

6. VIRAL CLEARANCE MARKET, BY APPLICATION

6.1. Introduction
6.2. Blood and Blood Products
6.3. Recombinant Proteins
6.4. Cellular & Gene Therapy Products
6.5. Vaccines
6.6. Others

7. VIRAL CLEARANCE MARKET, BY END-USERS

7.1. Introduction
7.2. Pharmaceutical and Biotech Industry
7.3. Academic Research Institutes
7.4. CROs
7.5. Others

8. VIRAL CLEARANCE MARKET, BY GEOGRAPHY

8.1. Introduction
8.2. North America
- 8.2.1. United States
- 8.2.2. Canada
- 8.2.3. Mexico
8.3. South America
- 8.3.1. Brazil
- 8.3.2. Argentina
- 8.3.3. Others
8.4. Europe
- 8.4.1. United Kingdom
- 8.4.2. Germany
- 8.4.3. France
- 8.4.4. Spain
- 8.4.5. Others
8.5. The Middle East and Africa
- 8.5.1. Saudi Arabia
- 8.5.2. UAE
- 8.5.3. Israel
- 8.5.4. Others
8.6. Asia Pacific
- 8.6.1. Japan
- 8.6.2. China
- 8.6.3. India
- 8.6.4. South Korea
- 8.6.5. Indonesia
- 8.6.6. Thailand
- 8.6.7. Others