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Sterility Testing Market Size, Share & Industry Trends Analysis Report By Product, By Test Type (Membrane Filtration, Direct Inoculation and Others), By Application, By End User, By Regional Outlook and Forecast, 2023-2029

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    Report

  • 241 Pages
  • April 2023
  • Region: Global
  • Marqual IT Solutions Pvt. Ltd (KBV Research)
  • ID: 5806208
The Global Sterility Testing Market size is expected to reach $2 billion by 2029, rising at a market growth of 10.2% CAGR during the forecast period.

Pharmaceutical, biotechnology, and medical device companies use sterility testing to evaluate the quality of the raw materials, process control, and the result. Through sterility testing, the existence or absence of living bacteria that are capable of procreating and multiplying under optimum conditions is identified.



Additionally, sterility testing is done on raw materials, cell banks, and pharmaceuticals in bulk and final form. The rising demand for sterilized goods will likely lead to growth in the sterility testing market in the near future. However, the growth media must also be properly produced and tested to guarantee the most effective microbiological growth during sterility testing.

The market is expanding due to rising life sciences research and development, increased drug launches, and rising sterilized product demand. During the forecast period, it is also anticipated that the market will be driven by the rising demand for sterilized products around the world as well as a few potential safety concerns related to the products, which typically arise from manufacturing processes that involve the complicated biological or structural characteristics of the products.

Infectious disease detection is a diagnostic method that uses various diagnostic tools and is carried out by trained technicians or medical professionals to identify the presence of foreign antigens or organisms. The sample of mucus, urine, blood, or other body fluids is examined using various diagnostic techniques and tools to reveal details about the pathogenic organism.

COVID-19 Impact Analysis

While pharmaceutical and biotech companies get to find a cure for the COVID-19 coronavirus, speedy testing is essential to guarantee that the vaccine is secure, efficient, and approved by regulatory bodies. A final product sterility test must be performed on each vaccine and injection before they may be given to patients. Because of the existing procedure that many vaccine producers utilize, each lot of vaccine must wait two weeks before it is made available to the general public. Before a COVID-19 vaccine is approved by the regulatory body, manufacturers and governments must seek quick solutions to meet the need for mass production and the market. Therefore, during the pandemic periods, the sterility testing market continued to witness growth, which will remain the same after the pandemic.

Market Growth Factors

Growing production capacities of pharmaceutical & biopharmaceutical companies

Sterility testing is carried out at all stages of manufacture in the pharmaceutical and biopharmaceutical sectors to reduce the possibility of product contamination. Therefore, expanding this end-use business in the upcoming years will significantly increase the usage of sterility testing. The need for sterility testing goods and services will increase as the production capacity of pharmaceuticals & biopharmaceuticals increases globally. Pharmaceutical and biopharmaceutical products must undergo sterility testing at every stage of production. As a result, more kits, reagents, and equipment for sterility testing will be used due to increasing production capacity in the pharmaceutical and biopharmaceutical industries.

Emergence of advanced technology in pharmaceutical testing

Traditional microbiological testing techniques for detection, enumeration, sterilization, and identification frequently relied heavily on culture procedures and were time- and labor-intensive. The limitation of such processes regarding practical concerns frequently restricts how frequently microbiological tests are used for both microbiological quality assurance and formulation development. Numerous more cutting-edge and forthcoming techniques exist, like the Merk Millipore MF sterility test device, which aseptically filters liquid samples for sterility testing and may have broad applications in the pharmaceutical industry. This is anticipated to be one of the key drivers of the sterility testing market's expansion.

Market Restraining Factors

Rising acceptance of single use technology

Single-use technology replaces the stainless-steel & hard-piped configurations utilized in sterile production or aseptic processing. Single-use technology employs gamma-irradiated pre-assembled process systems. This technique is utilized for both upstream and downstream processing in addition to the aseptic filling. The fundamental advantage of single-use technology is that no time or money is spent on labor-intensive cleaning, costly sterilization validation tests, or their ongoing revalidation. It also eliminates the need for system sterilization and cleaning in between batches. The need for sterility testing for both products and services will be hampered by the adoption of such technology.

Product Outlook

By product & service, the sterility testing market is divided into kits & reagents, services, and instruments. The services segment garnered a significant revenue share in the sterility testing market in 2022. To create new drugs & medical equipment, the pharmaceutical & biotech companies are significantly funding R&D. To assure the security and effectiveness of these products, this has boosted the need for sterility testing.



Test Type Outlook

Based on test type, the sterility testing market is segmented into membrane filtration, direct inoculation and other tests. In 2022, the membrane filtration segment registered the maximum revenue share in the sterility testing market. Test samples are passed over a conventional membrane that captures and holds bacteria during membrane filtration sterility testing. Membrane filtration is often utilized for all purposes, including vaccines and samples with adjuvant gel. When utilizing membrane filtration, microorganisms are held in place by a 0.45 m pore-size filter, and all interfering substances are removed using the proper rinsing solution. This testing is most popular in the pharmaceutical industry.

Application Outlook

On the basis of application, the sterility testing market is bifurcated into pharmaceuticals & biologicals, medical devices, and other applications. The medical devices segment acquired a substantial revenue share in the sterility testing market in 2022. For assessing the sterility of medical devices, direct transfer sterility is advised. Throughout the incubation period, when any microorganisms in or on the device will develop and propagate, the test device is in direct contact with the test media. For items with hollow tubes, including transfusion & infusion assemblies, product flush sterility testing is suggested when the fluid channel is indicated as sterile.

End-user Outlook

By end-user, the sterility testing market is categorized into pharmaceutical companies, biotechnical companies and others. In 2022, the pharmaceutical companies segment witnessed the largest revenue share in the sterility testing market. Since most of these medicines are consumed by patients, pharmaceutical companies must undergo sterility testing to guarantee product safety, particularly for oral dosage forms. The requisite sterility tests that must be carried out for a particular drug are specified in detail in each nation's pharmacopeia according to predefined regulations.

Regional Outlook

Region wise, the sterility testing market is analyzed across North America, Europe, Asia Pacific and LAMEA. In 2022, the North America region led the sterility testing market by generating the highest revenue share. Expanding the pharmaceutical businesses in the United States and Canada may be responsible for this. A significant expansion in the market is anticipated as a result of the huge number of prominent market players present in this region. The expansion is further supported by the region's strict regulatory requirements for the sterility testing of pharmaceuticals & medical equipment.

The market research report covers the analysis of key stakeholders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Charles River Laboratories International, Inc., SGS S.A., Merck KGaA, BioMérieux S.A., WuXi AppTec Co., Ltd., Sartorius AG, Samsung Biologics Co., Ltd. (Samsung Group), Nelson Laboratories, LLC (Sotera Health Company) and Pacific Biolabs, Inc.

Scope of the Study

By Product

  • Kits & Reagents
  • Instruments
  • Services

By Test Type

  • Membrane Filtration
  • Direct Inoculation
  • Others

By Application

  • Pharmaceuticals & Biologicals
  • Medical Devices
  • Others

By End-user

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Others

By Geography

  • North America
  • US
  • Canada
  • Mexico
  • Rest of North America
  • Europe
  • Germany
  • UK
  • France
  • Russia
  • Spain
  • Italy
  • Rest of Europe
  • Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Singapore
  • Malaysia
  • Rest of Asia Pacific
  • LAMEA
  • Brazil
  • Argentina
  • UAE
  • Saudi Arabia
  • South Africa
  • Nigeria
  • Rest of LAMEA

Key Market Players

List of Companies Profiled in the Report:

  • Thermo Fisher Scientific, Inc.
  • Charles River Laboratories International, Inc.
  • SGS S.A.
  • Merck KGaA
  • BioMérieux S.A.
  • WuXi AppTec Co., Ltd.
  • Sartorius AG
  • Samsung Biologics Co., Ltd. (Samsung Group)
  • Nelson Laboratories, LLC (Sotera Health Company)
  • Pacific Biolabs, Inc.

Unique Offerings

  • Exhaustive coverage
  • The highest number of Market tables and figures
  • Subscription-based model available
  • Guaranteed best price
  • Assured post sales research support with 10% customization free

Table of Contents

Chapter 1. Market Scope & Methodology
1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 Global Sterility Testing Market, by Product
1.4.2 Global Sterility Testing Market, by Test Type
1.4.3 Global Sterility Testing Market, by Application
1.4.4 Global Sterility Testing Market, by End User
1.4.5 Global Sterility Testing Market, by Geography
1.5 Methodology for the research
Chapter 2. Market Overview
2.1 Introduction
2.1.1 Overview
2.1.1.1 Market Composition & Scenario
2.2 Key Factors Impacting the Market
2.2.1 Market Drivers
2.2.2 Market Restraints
Chapter 3. Global Sterility Testing Market by Product
3.1 Global Kits & Reagents Market by Region
3.2 Global Instruments Market by Region
3.3 Global Services Market by Region
Chapter 4. Global Sterility Testing Market by Test Type
4.1 Global Membrane Filtration Market by Region
4.2 Global Direct Inoculation Market by Region
4.3 Global Others Market by Region
Chapter 5. Global Sterility Testing Market by Application
5.1 Global Pharmaceuticals & Biologicals Market by Region
5.2 Global Medical Devices Market by Region
5.3 Global Others Market by Region
Chapter 6. Global Sterility Testing Market by End User
6.1 Global Pharmaceutical Companies Market by Region
6.2 Global Biotechnology Companies Market by Region
6.3 Global Others Market by Region
Chapter 7. Global Sterility Testing Market by Region
7.1 North America Sterility Testing Market
7.1.1 North America Sterility Testing Market by Product
7.1.1.1 North America Kits & Reagents Market by Country
7.1.1.2 North America Instruments Market by Country
7.1.1.3 North America Services Market by Country
7.1.2 North America Sterility Testing Market by Test Type
7.1.2.1 North America Membrane Filtration Market by Country
7.1.2.2 North America Direct Inoculation Market by Country
7.1.2.3 North America Others Market by Country
7.1.3 North America Sterility Testing Market by Application
7.1.3.1 North America Pharmaceuticals & Biologicals Market by Country
7.1.3.2 North America Medical Devices Market by Country
7.1.3.3 North America Others Market by Country
7.1.4 North America Sterility Testing Market by End User
7.1.4.1 North America Pharmaceutical Companies Market by Country
7.1.4.2 North America Biotechnology Companies Market by Country
7.1.4.3 North America Others Market by Country
7.1.5 North America Sterility Testing Market by Country
7.1.5.1 US Sterility Testing Market
7.1.5.1.1 US Sterility Testing Market by Product
7.1.5.1.2 US Sterility Testing Market by Test Type
7.1.5.1.3 US Sterility Testing Market by Application
7.1.5.1.4 US Sterility Testing Market by End User
7.1.5.2 Canada Sterility Testing Market
7.1.5.2.1 Canada Sterility Testing Market by Product
7.1.5.2.2 Canada Sterility Testing Market by Test Type
7.1.5.2.3 Canada Sterility Testing Market by Application
7.1.5.2.4 Canada Sterility Testing Market by End User
7.1.5.3 Mexico Sterility Testing Market
7.1.5.3.1 Mexico Sterility Testing Market by Product
7.1.5.3.2 Mexico Sterility Testing Market by Test Type
7.1.5.3.3 Mexico Sterility Testing Market by Application
7.1.5.3.4 Mexico Sterility Testing Market by End User
7.1.5.4 Rest of North America Sterility Testing Market
7.1.5.4.1 Rest of North America Sterility Testing Market by Product
7.1.5.4.2 Rest of North America Sterility Testing Market by Test Type
7.1.5.4.3 Rest of North America Sterility Testing Market by Application
7.1.5.4.4 Rest of North America Sterility Testing Market by End User
7.2 Europe Sterility Testing Market
7.2.1 Europe Sterility Testing Market by Product
7.2.1.1 Europe Kits & Reagents Market by Country
7.2.1.2 Europe Instruments Market by Country
7.2.1.3 Europe Services Market by Country
7.2.2 Europe Sterility Testing Market by Test Type
7.2.2.1 Europe Membrane Filtration Market by Country
7.2.2.2 Europe Direct Inoculation Market by Country
7.2.2.3 Europe Others Market by Country
7.2.3 Europe Sterility Testing Market by Application
7.2.3.1 Europe Pharmaceuticals & Biologicals Market by Country
7.2.3.2 Europe Medical Devices Market by Country
7.2.3.3 Europe Others Market by Country
7.2.4 Europe Sterility Testing Market by End User
7.2.4.1 Europe Pharmaceutical Companies Market by Country
7.2.4.2 Europe Biotechnology Companies Market by Country
7.2.4.3 Europe Others Market by Country
7.2.5 Europe Sterility Testing Market by Country
7.2.5.1 Germany Sterility Testing Market
7.2.5.1.1 Germany Sterility Testing Market by Product
7.2.5.1.2 Germany Sterility Testing Market by Test Type
7.2.5.1.3 Germany Sterility Testing Market by Application
7.2.5.1.4 Germany Sterility Testing Market by End User
7.2.5.2 UK Sterility Testing Market
7.2.5.2.1 UK Sterility Testing Market by Product
7.2.5.2.2 UK Sterility Testing Market by Test Type
7.2.5.2.3 UK Sterility Testing Market by Application
7.2.5.2.4 UK Sterility Testing Market by End User
7.2.5.3 France Sterility Testing Market
7.2.5.3.1 France Sterility Testing Market by Product
7.2.5.3.2 France Sterility Testing Market by Test Type
7.2.5.3.3 France Sterility Testing Market by Application
7.2.5.3.4 France Sterility Testing Market by End User
7.2.5.4 Russia Sterility Testing Market
7.2.5.4.1 Russia Sterility Testing Market by Product
7.2.5.4.2 Russia Sterility Testing Market by Test Type
7.2.5.4.3 Russia Sterility Testing Market by Application
7.2.5.4.4 Russia Sterility Testing Market by End User
7.2.5.5 Spain Sterility Testing Market
7.2.5.5.1 Spain Sterility Testing Market by Product
7.2.5.5.2 Spain Sterility Testing Market by Test Type
7.2.5.5.3 Spain Sterility Testing Market by Application
7.2.5.5.4 Spain Sterility Testing Market by End User
7.2.5.6 Italy Sterility Testing Market
7.2.5.6.1 Italy Sterility Testing Market by Product
7.2.5.6.2 Italy Sterility Testing Market by Test Type
7.2.5.6.3 Italy Sterility Testing Market by Application
7.2.5.6.4 Italy Sterility Testing Market by End User
7.2.5.7 Rest of Europe Sterility Testing Market
7.2.5.7.1 Rest of Europe Sterility Testing Market by Product
7.2.5.7.2 Rest of Europe Sterility Testing Market by Test Type
7.2.5.7.3 Rest of Europe Sterility Testing Market by Application
7.2.5.7.4 Rest of Europe Sterility Testing Market by End User
7.3 Asia Pacific Sterility Testing Market
7.3.1 Asia Pacific Sterility Testing Market by Product
7.3.1.1 Asia Pacific Kits & Reagents Market by Country
7.3.1.2 Asia Pacific Instruments Market by Country
7.3.1.3 Asia Pacific Services Market by Country
7.3.2 Asia Pacific Sterility Testing Market by Test Type
7.3.2.1 Asia Pacific Membrane Filtration Market by Country
7.3.2.2 Asia Pacific Direct Inoculation Market by Country
7.3.2.3 Asia Pacific Others Market by Country
7.3.3 Asia Pacific Sterility Testing Market by Application
7.3.3.1 Asia Pacific Pharmaceuticals & Biologicals Market by Country
7.3.3.2 Asia Pacific Medical Devices Market by Country
7.3.3.3 Asia Pacific Others Market by Country
7.3.4 Asia Pacific Sterility Testing Market by End User
7.3.4.1 Asia Pacific Pharmaceutical Companies Market by Country
7.3.4.2 Asia Pacific Biotechnology Companies Market by Country
7.3.4.3 Asia Pacific Others Market by Country
7.3.5 Asia Pacific Sterility Testing Market by Country
7.3.5.1 China Sterility Testing Market
7.3.5.1.1 China Sterility Testing Market by Product
7.3.5.1.2 China Sterility Testing Market by Test Type
7.3.5.1.3 China Sterility Testing Market by Application
7.3.5.1.4 China Sterility Testing Market by End User
7.3.5.2 Japan Sterility Testing Market
7.3.5.2.1 Japan Sterility Testing Market by Product
7.3.5.2.2 Japan Sterility Testing Market by Test Type
7.3.5.2.3 Japan Sterility Testing Market by Application
7.3.5.2.4 Japan Sterility Testing Market by End User
7.3.5.3 India Sterility Testing Market
7.3.5.3.1 India Sterility Testing Market by Product
7.3.5.3.2 India Sterility Testing Market by Test Type
7.3.5.3.3 India Sterility Testing Market by Application
7.3.5.3.4 India Sterility Testing Market by End User
7.3.5.4 South Korea Sterility Testing Market
7.3.5.4.1 South Korea Sterility Testing Market by Product
7.3.5.4.2 South Korea Sterility Testing Market by Test Type
7.3.5.4.3 South Korea Sterility Testing Market by Application
7.3.5.4.4 South Korea Sterility Testing Market by End User
7.3.5.5 Singapore Sterility Testing Market
7.3.5.5.1 Singapore Sterility Testing Market by Product
7.3.5.5.2 Singapore Sterility Testing Market by Test Type
7.3.5.5.3 Singapore Sterility Testing Market by Application
7.3.5.5.4 Singapore Sterility Testing Market by End User
7.3.5.6 Malaysia Sterility Testing Market
7.3.5.6.1 Malaysia Sterility Testing Market by Product
7.3.5.6.2 Malaysia Sterility Testing Market by Test Type
7.3.5.6.3 Malaysia Sterility Testing Market by Application
7.3.5.6.4 Malaysia Sterility Testing Market by End User
7.3.5.7 Rest of Asia Pacific Sterility Testing Market
7.3.5.7.1 Rest of Asia Pacific Sterility Testing Market by Product
7.3.5.7.2 Rest of Asia Pacific Sterility Testing Market by Test Type
7.3.5.7.3 Rest of Asia Pacific Sterility Testing Market by Application
7.3.5.7.4 Rest of Asia Pacific Sterility Testing Market by End User
7.4 LAMEA Sterility Testing Market
7.4.1 LAMEA Sterility Testing Market by Product
7.4.1.1 LAMEA Kits & Reagents Market by Country
7.4.1.2 LAMEA Instruments Market by Country
7.4.1.3 LAMEA Services Market by Country
7.4.2 LAMEA Sterility Testing Market by Test Type
7.4.2.1 LAMEA Membrane Filtration Market by Country
7.4.2.2 LAMEA Direct Inoculation Market by Country
7.4.2.3 LAMEA Others Market by Country
7.4.3 LAMEA Sterility Testing Market by Application
7.4.3.1 LAMEA Pharmaceuticals & Biologicals Market by Country
7.4.3.2 LAMEA Medical Devices Market by Country
7.4.3.3 LAMEA Others Market by Country
7.4.4 LAMEA Sterility Testing Market by End User
7.4.4.1 LAMEA Pharmaceutical Companies Market by Country
7.4.4.2 LAMEA Biotechnology Companies Market by Country
7.4.4.3 LAMEA Others Market by Country
7.4.5 LAMEA Sterility Testing Market by Country
7.4.5.1 Brazil Sterility Testing Market
7.4.5.1.1 Brazil Sterility Testing Market by Product
7.4.5.1.2 Brazil Sterility Testing Market by Test Type
7.4.5.1.3 Brazil Sterility Testing Market by Application
7.4.5.1.4 Brazil Sterility Testing Market by End User
7.4.5.2 Argentina Sterility Testing Market
7.4.5.2.1 Argentina Sterility Testing Market by Product
7.4.5.2.2 Argentina Sterility Testing Market by Test Type
7.4.5.2.3 Argentina Sterility Testing Market by Application
7.4.5.2.4 Argentina Sterility Testing Market by End User
7.4.5.3 UAE Sterility Testing Market
7.4.5.3.1 UAE Sterility Testing Market by Product
7.4.5.3.2 UAE Sterility Testing Market by Test Type
7.4.5.3.3 UAE Sterility Testing Market by Application
7.4.5.3.4 UAE Sterility Testing Market by End User
7.4.5.4 Saudi Arabia Sterility Testing Market
7.4.5.4.1 Saudi Arabia Sterility Testing Market by Product
7.4.5.4.2 Saudi Arabia Sterility Testing Market by Test Type
7.4.5.4.3 Saudi Arabia Sterility Testing Market by Application
7.4.5.4.4 Saudi Arabia Sterility Testing Market by End User
7.4.5.5 South Africa Sterility Testing Market
7.4.5.5.1 South Africa Sterility Testing Market by Product
7.4.5.5.2 South Africa Sterility Testing Market by Test Type
7.4.5.5.3 South Africa Sterility Testing Market by Application
7.4.5.5.4 South Africa Sterility Testing Market by End User
7.4.5.6 Nigeria Sterility Testing Market
7.4.5.6.1 Nigeria Sterility Testing Market by Product
7.4.5.6.2 Nigeria Sterility Testing Market by Test Type
7.4.5.6.3 Nigeria Sterility Testing Market by Application
7.4.5.6.4 Nigeria Sterility Testing Market by End User
7.4.5.7 Rest of LAMEA Sterility Testing Market
7.4.5.7.1 Rest of LAMEA Sterility Testing Market by Product
7.4.5.7.2 Rest of LAMEA Sterility Testing Market by Test Type
7.4.5.7.3 Rest of LAMEA Sterility Testing Market by Application
7.4.5.7.4 Rest of LAMEA Sterility Testing Market by End User
Chapter 8. Company Profiles
8.1 Thermo Fisher Scientific, Inc.
8.1.1 Company Overview
8.1.2 Financial Analysis
8.1.3 Segmental and Regional Analysis
8.1.4 Research & Development Expenses
8.1.5 Recent strategies and developments:
8.1.5.1 Product Launches and Product Expansions:
8.1.5.2 Geographical Expansions:
8.2 Charles River Laboratories International, Inc.
8.2.1 Company Overview
8.2.2 Financial Analysis
8.2.3 Segmental and Regional Analysis
8.2.4 Recent strategies and developments:
8.2.4.1 Product Launches and Product Expansions:
8.3 SGS S.A.
8.3.1 Company Overview
8.3.2 Financial Analysis
8.3.3 Segmental and Regional Analysis
8.3.4 Research & Development Expenses
8.4 Merck KGaA
8.4.1 Company Overview
8.4.2 Financial Analysis
8.4.3 Segmental and Regional Analysis
8.4.4 Research & Development Expense
8.5 BioMérieux S.A.
8.5.1 Company Overview
8.5.2 Financial Analysis
8.5.3 Segmental and Regional Analysis
8.5.4 Research & Development Expenses
8.5.5 Recent strategies and developments:
8.5.5.1 Partnerships, Collaborations, and Agreements:
8.5.5.2 Acquisition and Mergers:
8.6 WuXi AppTec Co., Ltd.
8.6.1 Company Overview
8.6.2 Financial Analysis
8.6.3 Segmental Analysis
8.6.4 Research & Development Expenses
8.6.5 Recent strategies and developments:
8.6.5.1 Geographical Expansions:
8.7 Sartorius AG
8.7.1 Company Overview
8.7.2 Financial Analysis
8.7.3 Segmental and Regional Analysis
8.7.4 Research & Development Expenses
8.8 Samsung Biologics Co., Ltd. (Samsung Group)
8.8.1 Company Overview
8.8.2 Financial Analysis
8.8.3 Regional Analysis
8.8.4 Research & Development Expenses
8.9 Nelson Laboratories, LLC (Sotera Health Company)
8.9.1 Company Overview
8.9.2 Financial Analysis
8.9.3 Segmental and Regional Analysis
8.10. Pacific Biolabs, Inc.
8.10.1 Company Overview

Companies Mentioned

  • Thermo Fisher Scientific, Inc.
  • Charles River Laboratories International, Inc.
  • SGS S.A.
  • Merck KGaA
  • BioMérieux S.A.
  • WuXi AppTec Co., Ltd.
  • Sartorius AG
  • Samsung Biologics Co., Ltd. (Samsung Group)
  • Nelson Laboratories, LLC (Sotera Health Company)
  • Pacific Biolabs, Inc.

Methodology

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