Bioprocess Integrity Testing Systems Market Snapshot (2022-2032)

[300 Pages Report] Global Bioprocess Integrity Testing systems market demand is anticipated to be valued at US$ 74.2 Million in 2022, forecast to grow at a CAGR of 5.7% to be valued at US$ 136.6 Million from 2022 to 2032. Growth is attributed to increasing the availability of fully automated integrity test systems. From 2016-2021 a CAGR of 5.0% was registered for the biscuit mixes market.

Report Attribute Details
Projected Growth Rate (2022 to 2032) 5.7% CAGR
Expected Market Value (2022) US$ 74.2 Million
Anticipated Forecast Value (2032) US$ 136.6 Million

Many multi-national companies are focusing on new product innovations and are required to follow the GMP guidelines which is the most critical factor in bioprocess Integrity Testing systems These factors contribute to the bioprocess Integrity Testing systems market.

In the manufacturing of sterile drug products, it is critical to access filter Bioprocess Integrity Testing as regulated by regulatory bodies. The filter in the bioprocess is subjected to wear owing to particle load, fluctuations in pressure and temperature, changes in pH, and other factors. The performance of filter elements is crucial in any bioprocess.

Pressure hold testing, bubble point testing, and diffusive flow testing are some of the examples of filter integrity tests. Out of these, the bubble point test is considered simple, economical, and comes with easy applicability.

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What are Some Prominent Drivers Spearheading Bioprocess Integrity Testing Systems Market Growth?

Increasing awareness about the benefits of using the Bioprocess Integrity Testing systems market among healthcare professionals and consumers fuelling the demand for the Bioprocess Integrity Testing systems market. Technological advancements in filter design and manufacturing improve performance, and the increasing availability of fully automated integrity test systems will boost the growth of the market in the forecasting period.

Due to the reliability of the systems, portability, and ease of implementation Bioprocess Integrity Testing is adopted by leading biopharmaceutical players and biotechnology companies. The market for bioprocess Integrity Testing systems would be accelerated due to the accelerated testing capabilities of the systems.

What are the Challenges Faced by the Bioprocess Integrity Testing System Industry?

Although the Bioprocess Integrity Testing system market has numerous end-uses, there are numerous obstacles that likely pose a challenge to market growth. Lack of technical expertise and lack of awareness in the developing and underdeveloped economies may impede the growth of the Bioprocess Integrity Testing system market. The High cost associated with testing may also hider the growth of the Bioprocess Integrity Testing system market.

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Why is North America Emerging as an Opportunistic Bioprocess Integrity Testing System Market?

North America was the largest market for the Bioprocess Integrity Testing system market and the trend is expected to continue into the forecast period owing to the increasing government support and increasing R&D activities. The technological advancement in the healthcare sector in the region is expected to augment the Bioprocess Integrity Testing system market. The region is forecast to have a 33.0% total share of the Bioprocess Integrity Testing system market.

North America is expected to be the next dominant region witnessing high adoption rates for the Bioprocess Integrity Testing system market during the forecast period due to the increasing demand for biopharmaceuticals and the implementation of drug safety guidelines by the FDA.

How is Europe Contributing to the Growth of the Bioprocess Integrity Testing System Market?

According to Future Market Insights Europe accounts for a total 30.0% share in the global Bioprocess Integrity Testing system market. Increasing healthcare investments and the presence of prominent market vendors and providers also benefit Europe’s market.

The global Bioprocess Integrity Testing system market is gaining traction in the region due to increasing research facilities and the developing biopharmaceutical industry and the growth in the biologics market. Also, stringent government guidelines for purity requirements in pharmaceutical and biotechnology manufacturing boost the growth of the market.

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Startup Scenario

Bugworks Research, Medgenome, BitBio, uFraction, Tasi Group and vertex-scientific-lab-instruments-co-company are some start-up companies operating in the Bioprocess Integrity Testing system market.

Market Competition

Some of the key participants present in the global Bioprocess Integrity Testing system market include Merck Millipore, Eurofins Scientific, Pall Corporation, Sartorius Group, and Viet Anh Scientific Co., Ltd. among others.

Attributed to the presence of such a high number of participants, the market is highly competitive. While global players such as Merck Millipore, Eurofins Scientific, Pall Corporation account for considerable market size, several regional level players are also operating across key growth regions, particularly in the Asia Pacific.

  • In June 2022 – Merck, announced that it has entered a collaboration with Agilent Technologies to advance Process Analytical Technologies (PAT). PAT, which is strongly encouraged by global regulatory authorities, is a key enabler for real-time release and Bioprocessing 4.0.

Report Scope

Report Attribute Details
Growth Rate CAGR of 5.7% from 2022 to 2032
Expected Market Value (2022) US$ 74.2 Million
Anticipated Forecast Value (2032) US$ 136.6 Million
Base Year for Estimation 2021
Historical Data 2016 to 2021
Forecast Period 2022 to 2032
Quantitative Units Revenue in US$ Million and CAGR from 2022-2032
Report Coverage Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends and Pricing Analysis
Segments Covered
  • Product Type
  • Process Type
  • End User
  • Region
Regions Covered
  • North America 
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East and Africa
Key Countries Profiled
  • USA
  • Canada
  • Brazil
  • Mexico
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • China
  • Japan
  • South Korea
  • Malaysia
  • Singapore
  • Australia
  • GCC
  • South Africa
  • Israel
Key Companies Profiled
  • Merck Millipore
  • Eurofins Scientific
  • Pall Corporation
  • Sartorius Group
  • Viet Anh Scientific Co. Ltd.
Customization Available Upon Request

Key Segments Profiled in the Bioprocess Integrity Testing System Industry Survey

Bioprocess Integrity Testing System Market by Product Type:

  • Bioprocess Integrity Destructive Testing System
  • Bioprocess Integrity Non-Destructive Testing System
  • Bioprocess Integrity Bubble Point Testing System
  • Bioprocess Integrity Diffusion Testing System
  • Bioprocess Integrity Pressure Hold Testing System

Bioprocess Integrity Testing System Market by Process Type:

  • Particle-based Bioprocess Integrity Testing System
  • Liquid Property Based Bioprocess Integrity Testing System

Bioprocess Integrity Testing System Market by End User:

  • Bioprocess Integrity Testing System for Biopharmaceutical Industry
  • Bioprocess Integrity Testing System for Biotechnology Industry
  • Bioprocess Integrity Testing System for Other End Users

Bioprocess Integrity Testing System Market by Region:

  • North America Bioprocess Integrity Testing System Market
  • Latin America Bioprocess Integrity Testing System Market
  • Europe Bioprocess Integrity Testing System Market
  • Asia Pacific Bioprocess Integrity Testing System Market
  • Middle East and Africa Bioprocess Integrity Testing System Market

Frequently Asked Questions

What is the anticipated growth of the Bioprocess Integrity Testing system market until 2032?

FMI projects the global Bioprocess Integrity Testing system market to expand at a 5.7% value CAGR by 2032.

Which region is forecast to be the most lucrative for Bioprocess Integrity Testing system market growth?

North America is expected to be the most opportunistic with a 33.0% share of the total Bioprocess Integrity Testing system market.

Which are some prominent Bioprocess Integrity Testing system market manufacturers?

Merck Millipore, Eurofins Scientific, Pall Corporation are some prominent Bioprocess Integrity Testing system market manufacturers.

Table of Content

1. Executive Summary

    1.1. Global Market Outlook

    1.2. Demand-side Trends

    1.3. Supply-side Trends

    1.4. Technology Roadmap Analysis

    1.5. Analysis and Recommendations

2. Market Overview

    2.1. Market Coverage / Taxonomy

    2.2. Market Definition / Scope / Limitations

3. Market Background

    3.1. Market Dynamics

        3.1.1. Drivers

        3.1.2. Restraints

        3.1.3. Opportunity

        3.1.4. Trends

    3.2. Scenario Forecast

        3.2.1. Demand in Optimistic Scenario

        3.2.2. Demand in Likely Scenario

        3.2.3. Demand in Conservative Scenario

    3.3. Opportunity Map Analysis

    3.4. Investment Feasibility Matrix

    3.5. PESTLE and Porter’s Analysis

    3.6. Regulatory Landscape

        3.6.1. By Key Regions

        3.6.2. By Key Countries

    3.7. Regional Parent Market Outlook

4. Global Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast, 2022-2032

    4.1. Historical Market Size Value (US$ Mn) Analysis, 2017-2021

    4.2. Current and Future Market Size Value (US$ Mn) Projections, 2022-2032

        4.2.1. Y-o-Y Growth Trend Analysis

        4.2.2. Absolute $ Opportunity Analysis

5. Global Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Product Types

    5.1. Introduction / Key Findings

    5.2. Historical Market Size Value (US$ Mn) Analysis By Product Types, 2017-2021

    5.3. Current and Future Market Size Value (US$ Mn) Analysis and Forecast By Product Types, 2022-2032

        5.3.1. Destructive Testing

        5.3.2. Non-Destructive Testing

        5.3.3. Bubble Point Testing

        5.3.4. Diffusion Testing

        5.3.5. Pressure Hold Testing

    5.4. Y-o-Y Growth Trend Analysis By Product Types, 2017-2021

    5.5. Absolute $ Opportunity Analysis By Product Types, 2022-2032

6. Global Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Process Types

    6.1. Introduction / Key Findings

    6.2. Historical Market Size Value (US$ Mn) Analysis By Process Types, 2017-2021

    6.3. Current and Future Market Size Value (US$ Mn) Analysis and Forecast By Process Types, 2022-2032

        6.3.1. Particle-Based

        6.3.2. Liquid Property Based

    6.4. Y-o-Y Growth Trend Analysis By Process Types, 2017-2021

    6.5. Absolute $ Opportunity Analysis By Process Types, 2022-2032

7. Global Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By End Users

    7.1. Introduction / Key Findings

    7.2. Historical Market Size Value (US$ Mn) Analysis By End Users, 2017-2021

    7.3. Current and Future Market Size Value (US$ Mn) Analysis and Forecast By End Users, 2022-2032

        7.3.1. Biopharmaceutical Industry

        7.3.2. Biotechnology Industry

    7.4. Y-o-Y Growth Trend Analysis By End Users, 2017-2021

    7.5. Absolute $ Opportunity Analysis By End Users, 2022-2032

8. Global Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Region

    8.1. Introduction

    8.2. Historical Market Size Value (US$ Mn) Analysis By Region, 2017-2021

    8.3. Current Market Size Value (US$ Mn) Analysis and Forecast By Region, 2022-2032

        8.3.1. North America

        8.3.2. Latin America

        8.3.3. Europe

        8.3.4. Asia Pacific

        8.3.5. MEA

    8.4. Market Attractiveness Analysis By Region

9. North America Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Country

    9.1. Historical Market Size Value (US$ Mn) Trend Analysis By Market Taxonomy, 2017-2021

    9.2. Market Size Value (US$ Mn) Forecast By Market Taxonomy, 2022-2032

        9.2.1. By Country

            9.2.1.1. U.S.

            9.2.1.2. Canada

        9.2.2. By Product Types

        9.2.3. By Process Types

        9.2.4. By End Users

    9.3. Market Attractiveness Analysis

        9.3.1. By Country

        9.3.2. By Product Types

        9.3.3. By Process Types

        9.3.4. By End Users

    9.4. Key Takeaways

10. Latin America Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Country

    10.1. Historical Market Size Value (US$ Mn) Trend Analysis By Market Taxonomy, 2017-2021

    10.2. Market Size Value (US$ Mn) Forecast By Market Taxonomy, 2022-2032

        10.2.1. By Country

            10.2.1.1. Brazil

            10.2.1.2. Mexico

            10.2.1.3. Rest of Latin America

        10.2.2. By Product Types

        10.2.3. By Process Types

        10.2.4. By End Users

    10.3. Market Attractiveness Analysis

        10.3.1. By Country

        10.3.2. By Product Types

        10.3.3. By Process Types

        10.3.4. By End Users

    10.4. Key Takeaways

11. Europe Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Country

    11.1. Historical Market Size Value (US$ Mn) Trend Analysis By Market Taxonomy, 2017-2021

    11.2. Market Size Value (US$ Mn) Forecast By Market Taxonomy, 2022-2032

        11.2.1. By Country

            11.2.1.1. Germany

            11.2.1.2. U.K.

            11.2.1.3. France

            11.2.1.4. Spain

            11.2.1.5. Italy

            11.2.1.6. Rest of Europe

        11.2.2. By Product Types

        11.2.3. By Process Types

        11.2.4. By End Users

    11.3. Market Attractiveness Analysis

        11.3.1. By Country

        11.3.2. By Product Types

        11.3.3. By Process Types

        11.3.4. By End Users

    11.4. Key Takeaways

12. Asia Pacific Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Country

    12.1. Historical Market Size Value (US$ Mn) Trend Analysis By Market Taxonomy, 2017-2021

    12.2. Market Size Value (US$ Mn) Forecast By Market Taxonomy, 2022-2032

        12.2.1. By Country

            12.2.1.1. China

            12.2.1.2. Japan

            12.2.1.3. South Korea

            12.2.1.4. Malaysia

            12.2.1.5. Singapore

            12.2.1.6. Australia

            12.2.1.7. Rest of Asia Pacific

        12.2.2. By Product Types

        12.2.3. By Process Types

        12.2.4. By End Users

    12.3. Market Attractiveness Analysis

        12.3.1. By Country

        12.3.2. By Product Types

        12.3.3. By Process Types

        12.3.4. By End Users

    12.4. Key Takeaways

13. MEA Bioprocess Integrity Testing Systems Market Analysis 2017-2021 and Forecast 2022-2032, By Country

    13.1. Historical Market Size Value (US$ Mn) Trend Analysis By Market Taxonomy, 2017-2021

    13.2. Market Size Value (US$ Mn) Forecast By Market Taxonomy, 2022-2032

        13.2.1. By Country

            13.2.1.1. GCC Countries

            13.2.1.2. South Africa

            13.2.1.3. Israel

            13.2.1.4. Rest of MEA

        13.2.2. By Product Types

        13.2.3. By Process Types

        13.2.4. By End Users

    13.3. Market Attractiveness Analysis

        13.3.1. By Country

        13.3.2. By Product Types

        13.3.3. By Process Types

        13.3.4. By End Users

    13.4. Key Takeaways

14. Key Countries Bioprocess Integrity Testing Systems Market Analysis

    14.1. U.K.

        14.1.1. Pricing Analysis

        14.1.2. Market Share Analysis, 2021

            14.1.2.1. By Product Types

            14.1.2.2. By Process Types

            14.1.2.3. By End Users

    14.2. Canada

        14.2.1. Pricing Analysis

        14.2.2. Market Share Analysis, 2021

            14.2.2.1. By Product Types

            14.2.2.2. By Process Types

            14.2.2.3. By End Users

    14.3. Brazil

        14.3.1. Pricing Analysis

        14.3.2. Market Share Analysis, 2021

            14.3.2.1. By Product Types

            14.3.2.2. By Process Types

            14.3.2.3. By End Users

    14.4. Mexico

        14.4.1. Pricing Analysis

        14.4.2. Market Share Analysis, 2021

            14.4.2.1. By Product Types

            14.4.2.2. By Process Types

            14.4.2.3. By End Users

    14.5. Rest of Latin America

        14.5.1. Pricing Analysis

        14.5.2. Market Share Analysis, 2021

            14.5.2.1. By Product Types

            14.5.2.2. By Process Types

            14.5.2.3. By End Users

    14.6. Germany

        14.6.1. Pricing Analysis

        14.6.2. Market Share Analysis, 2021

            14.6.2.1. By Product Types

            14.6.2.2. By Process Types

            14.6.2.3. By End Users

    14.7. U.K.

        14.7.1. Pricing Analysis

        14.7.2. Market Share Analysis, 2021

            14.7.2.1. By Product Types

            14.7.2.2. By Process Types

            14.7.2.3. By End Users

    14.8. France

        14.8.1. Pricing Analysis

        14.8.2. Market Share Analysis, 2021

            14.8.2.1. By Product Types

            14.8.2.2. By Process Types

            14.8.2.3. By End Users

    14.9. Spain

        14.9.1. Pricing Analysis

        14.9.2. Market Share Analysis, 2021

            14.9.2.1. By Product Types

            14.9.2.2. By Process Types

            14.9.2.3. By End Users

    14.10. Italy

        14.10.1. Pricing Analysis

        14.10.2. Market Share Analysis, 2021

            14.10.2.1. By Product Types

            14.10.2.2. By Process Types

            14.10.2.3. By End Users

    14.11. Rest of Europe

        14.11.1. Pricing Analysis

        14.11.2. Market Share Analysis, 2021

            14.11.2.1. By Product Types

            14.11.2.2. By Process Types

            14.11.2.3. By End Users

    14.12. China

        14.12.1. Pricing Analysis

        14.12.2. Market Share Analysis, 2021

            14.12.2.1. By Product Types

            14.12.2.2. By Process Types

            14.12.2.3. By End Users

    14.13. Japan

        14.13.1. Pricing Analysis

        14.13.2. Market Share Analysis, 2021

            14.13.2.1. By Product Types

            14.13.2.2. By Process Types

            14.13.2.3. By End Users

    14.14. South Korea

        14.14.1. Pricing Analysis

        14.14.2. Market Share Analysis, 2021

            14.14.2.1. By Product Types

            14.14.2.2. By Process Types

            14.14.2.3. By End Users

    14.15. Malaysia

        14.15.1. Pricing Analysis

        14.15.2. Market Share Analysis, 2021

            14.15.2.1. By Product Types

            14.15.2.2. By Process Types

            14.15.2.3. By End Users

    14.16. Singapore

        14.16.1. Pricing Analysis

        14.16.2. Market Share Analysis, 2021

            14.16.2.1. By Product Types

            14.16.2.2. By Process Types

            14.16.2.3. By End Users

    14.17. Australia

        14.17.1. Pricing Analysis

        14.17.2. Market Share Analysis, 2021

            14.17.2.1. By Product Types

            14.17.2.2. By Process Types

            14.17.2.3. By End Users

    14.18. Rest of Asia Pacific

        14.18.1. Pricing Analysis

        14.18.2. Market Share Analysis, 2021

            14.18.2.1. By Product Types

            14.18.2.2. By Process Types

            14.18.2.3. By End Users

    14.19. GCC Countries

        14.19.1. Pricing Analysis

        14.19.2. Market Share Analysis, 2021

            14.19.2.1. By Product Types

            14.19.2.2. By Process Types

            14.19.2.3. By End Users

    14.20. South Africa

        14.20.1. Pricing Analysis

        14.20.2. Market Share Analysis, 2021

            14.20.2.1. By Product Types

            14.20.2.2. By Process Types

            14.20.2.3. By End Users

    14.21. Israel

        14.21.1. Pricing Analysis

        14.21.2. Market Share Analysis, 2021

            14.21.2.1. By Product Types

            14.21.2.2. By Process Types

            14.21.2.3. By End Users

    14.22. Rest of MEA

        14.22.1. Pricing Analysis

        14.22.2. Market Share Analysis, 2021

            14.22.2.1. By Product Types

            14.22.2.2. By Process Types

            14.22.2.3. By End Users

15. Market Structure Analysis

    15.1. Competition Dashboard

    15.2. Competition Benchmarking

    15.3. Market Share Analysis of Top Players

        15.3.1. By Regional

        15.3.2. By Product Types

        15.3.3. By Process Types

        15.3.4. By End Users

16. Competition Analysis

    16.1. Competition Deep Dive

        16.1.1. Merck Millipore

            16.1.1.1. Overview

            16.1.1.2. Product Portfolio

            16.1.1.3. Profitability by Market Segments

            16.1.1.4. Sales Footprint

            16.1.1.5. Strategy Overview

                16.1.1.5.1. Marketing Strategy

        16.1.2. Eurofins Scientific

            16.1.2.1. Overview

            16.1.2.2. Product Portfolio

            16.1.2.3. Profitability by Market Segments

            16.1.2.4. Sales Footprint

            16.1.2.5. Strategy Overview

                16.1.2.5.1. Marketing Strategy

        16.1.3. Pall Corporation

            16.1.3.1. Overview

            16.1.3.2. Product Portfolio

            16.1.3.3. Profitability by Market Segments

            16.1.3.4. Sales Footprint

            16.1.3.5. Strategy Overview

                16.1.3.5.1. Marketing Strategy

        16.1.4. Sartorius Group

            16.1.4.1. Overview

            16.1.4.2. Product Portfolio

            16.1.4.3. Profitability by Market Segments

            16.1.4.4. Sales Footprint

            16.1.4.5. Strategy Overview

                16.1.4.5.1. Marketing Strategy

        16.1.5. Viet Anh Scientific Co., Ltd.

            16.1.5.1. Overview

            16.1.5.2. Product Portfolio

            16.1.5.3. Profitability by Market Segments

            16.1.5.4. Sales Footprint

            16.1.5.5. Strategy Overview

                16.1.5.5.1. Marketing Strategy

17. Assumptions & Acronyms Used

18. Research Methodology

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