The global bioprocess validation market is expected to grow from USD 350 million in 2022 to USD 828.57 million by 2032, at a CAGR of 9% during the forecast period 2023-2032. The increasing research and expenditure by pharmaceutical companies will drive the global bioprocess validation market.
The natural world of flora and fauna has the potential to solve world problems. The technological advancements in the past century have enabled the scientific community to harness this potential and use it for the betterment of society. Scientific breakthroughs, discoveries, and innovations have allowed the use of living cells and its component to produce drugs, vaccines, therapeutics, and other products. The processing of living cells or their components to make certain products is known as bioprocessing. Bioprocessing finds application in the pharmaceutical, biotechnology, healthcare, food processing, beverages, and agricultural sectors. These processes are experimental, and desired results are achieved after several trials. However, each experiment requires extensive resources, considerable time, and effort. Each experiment is approved only after carefully considering all aspects, including the viability, feasibility, and success ratio. This avoids the waste of resources. The trials and experiments are recorded for future reference and assessment. The equipment, devices, samples, processes, and results are well documented in bioprocess validation. The successful bioprocessing trials are also noted, and their accuracy is established in a defined structural format. This bioprocess validation is mandated by government institutions and followed by market players to achieve quality products and cost reduction. Bioprocess validation involves several stages, with multiple parameters tested at each stage. Bioprocess validation ensures that good quality products are delivered consistently to optimize company resources.
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January 2023 - Cell Metric X, a high-contrast imager that allows automatic same-day identification of clonally generated cells, was released by Advanced Instruments, a global producer of scientific and analytical instruments. Cell Metric X, a revolutionary new addition to Solentim's market-leading Cell Metric, delivers automatic picture analysis to speed up cell line generation procedures. Scientists can swiftly recognize clonally generated cells given the Automatic Evidence of Clonality (AEC) powered by artificial intelligence. This lowers the time and effort spent on picture analysis needed to certify successful seeding. As a result, the FDA (Food and Drug Administration) received the image-based proof required for the IND (Investigational New Drug) submission weeks sooner than expected.
The increasing government scrutiny of pharmaceuticals and healthcare produce – Pharmaceuticals and healthcare are a public-private sector, with a significant market share held by each of the two players. However, the critical nature of pharmaceuticals and healthcare necessitates their regulation, control, and monitoring by federal government institutions. These sectors have the potential to directly harm the public, and therefore it is the responsibility of the government to ensure the development, production, and distribution of quality products. The death of children in African countries due to acute kidney failure caused by the consumption of India-manufactured cough syrups is a case in point. The inability to apply bioprocess validation to ensure consistent viability, feasibility, reliability, and quality of pharma products damages the consumer, producer, company brand, and country's global position. Therefore, there is a renewed push towards constructing robust and comprehensive regulatory infrastructure to ensure high-quality pharma products. Given the rising acute and chronic healthcare conditions, the growing need for medicines, therapies, and treatments has increased research and development in pharmaceuticals and biotechnology, which will be under the government's regulatory network to ensure accountability. The increasing government scrutiny of pharmaceuticals, biotechnology, and other bioprocessing applications to provide high-quality products will drive the market's growth.
Bioprocess validation is not full-proof – The testing methods and stages of validation processes are not without errors. The errors can be intrinsic or caused by personnel performing the validation process. The samples can show false positives or negatives, which could alter the results. These minute errors can sometimes cause significant losses for the company and potentially limit the market's growth.
The rising research and development – The pandemic caught the world by surprise and led to devastating losses to global social, economic, and personal lives. The millions of deaths in the early months of the pandemic were worrying and led to the fast-track development of vaccines followed by their emergency approvals. The vaccine coverage increased with time, and there were fewer deaths in the last year of the pandemic. The importance of robust research and development infrastructure to develop vaccines, medicines, and treatments was highlighted due to covid-19. The advancements in the pharmaceutical sector result from increased research and development expenditure and renewed supportive push from the governments, and federal funding is anticipated to grow in the future. The rising research and development also mandate a similar rise in regulatory oversight, internal checks, accountability measures, and quality assurances like that of bioprocess validation. Therefore, the rising research and development will propel the market’s growth and offer lucrative market opportunities for the industry players. The growth in public-private or private-private collaborations will also augment the market’s growth.
Regulatory institutions fail to ensure accountability from market players – Despite the stringent, well-defined guidelines and regulations backed by legal provisions aimed at ensuring quality checks and controls, the pharma giants continue to violate these rules. The lack of political will to implement these regulations is a major obstacle while implementing these accountability measures. The insufficient funding offered to regulatory institutions and understaffed offices is other prominent factors responsible for the failure of these bodies. The prevalent and ever-lasting corruption in the system enables the big-pocket pharma companies to exploit the loopholes in regulations and surpass these quality checks to save money. Therefore, the failure of regulatory institutions to ensure accountability from market players will challenge the market's growth.
The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. The North American region emerged as the largest global bioprocess validation market, with a 42% market revenue share in 2022. The North American region is home to some key pharmaceutical and biotechnology companies. The region's significant population is witnessing a rise in several acute and chronic health conditions offering lucrative market opportunities for the pharma companies to exploit by introducing new drugs and medicines. The region also has a well-established healthcare sector along with extensive pharmacist retail networks like Walgreens and CVS, contributing to the regional market's growth. The robust regulatory framework governing the implementation of quality controls, checks, and approvals, like the US FDA (Food and Drug Administration), favors the region's market development. The increasing research and development expenditure by pharmaceuticals, biotechnology, and research institutes with partial funding from the government aids the market's growth. Collaboration, mergers, partnerships, acquisitions among key players, and the growing presence of outsourcing pharma validation service providers augment the market's growth.
North America Region Bioprocess Validation Market Share in 2022 - 42%
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The testing type segment is divided into extractables and leachables testing, integrity testing, bioprocess residuals testing, filtration and fermentation, viral clearance testing, systems testing, compatibility testing, microbiological testing, physiochemical testing, bacterial retention testing, adsorption testing, and others. The extractables and leachables testing segment dominated the market with a revenue share of around 37% in 2022. The extractables and leachables testing is used to identify potentially harmful chemicals that may be transferred to the patient with the drug or medicine. The harmful chemical is not present in the drug but is transferred from the packaging or storage of these medicines. They are identified through laboratory testing to avoid undesirable consequences. Extractables and leachables testing consider a broader view of the validation process to ensure that the drug is stored or packed in the right material. They are highly effective testing procedures and vital to ensuring the quality of the drug. The quality of the drug is compromised if harmful chemicals transfer from its packaging, causing harm to the patient and the good-quality drugs and its brand reputation. Therefore, market players invested sufficiently in extractables and leachables testing services.
The process component segment is divided into filter elements, freezing and thawing process bags, bioreactors, connectors, samplers, media containers, and bags, mixing systems, transfer systems, and others. The filter elements segment dominated the market with a market share of around 38% in 2022. The filter elements form the basis of bioprocess validation as they are the vital step towards ensuring the integrity of the products. They remove all the unwanted particles, including undesirable microorganisms, to deliver quality products. Their extensive use and ease of application are responsible for their dominance in the market.
The end-user segment is divided into pharmaceutical companies, contract development and manufacturing organizations, biotechnology companies, research laboratories and institutions, and others. The pharmaceutical companies segment dominated the market with a market share of around 43% in 2022. Pharmaceutical companies research, develop, manufacture, and distribute drugs, vaccines, and tests to consumers to treat diseases/ailments or prevent and test them. The companies have the capital to invest in extensive research and development of new drugs if they find a potential market. They apply bioprocess validation to safeguard their brand reputation, retain their consumer base, attract new market share and comply with government guidelines. Biopharmaceuticals are the top players in drug development and therefore dominate the global bioprocess validation market.
Report Description:
Attribute | Description |
---|---|
Market Size | Revenue (USD Million) |
Market size value in 2022 | USD 350 Million |
Market size value in 2032 | USD 828.57 Million |
CAGR (2023 to 2032) | 9% |
Historical data | 2019-2021 |
Base Year | 2022 |
Forecast | 2023-2032 |
Regional Segments | The regions examined for the market are Europe, Asia Pacific, North America, South America, and Middle East & Africa. |
Segments | The research segment is based on testing type, process component, and end-user. |
As per The Brainy Insights, the size of the bioprocess validation market was valued at USD 350 million in 2022 to USD 828.57 million by 2032.
Global bioprocess validation market is growing at a CAGR of 9% during the forecast period 2023-2032.
The market's growth will be influenced by the increasing government scrutiny of pharmaceuticals and healthcare produce.
Bioprocess validation is not full-proof and that could hamper the market growth.
1. Introduction
1.1. Objectives of the Study
1.2. Market Definition
1.3. Research Scope
1.4. Currency
1.5. Key Target Audience
2. Research Methodology and Assumptions
3. Executive Summary
4. Premium Insights
4.1. Porter’s Five Forces Analysis
4.2. Value Chain Analysis
4.3. Top Investment Pockets
4.3.1. Market Attractiveness Analysis by Testing Type
4.3.2. Market Attractiveness Analysis by Process Component
4.3.3. Market Attractiveness Analysis by End User
4.3.4. Market Attractiveness Analysis by Region
4.4. Industry Trends
5. Market Dynamics
5.1. Market Evaluation
5.2. Drivers
5.2.1. The increasing government scrutiny of pharmaceuticals and healthcare produce
5.3. Restraints
5.3.1. Bioprocess validation is not full-proof
5.4. Opportunities
5.4.1. The rising research and development
5.5. Challenges
5.5.1. Failure of regulatory institutions in ensuring accountability from market players
6. Global Bioprocess Validation Market Analysis and Forecast, By Testing Type
6.1. Segment Overview
6.2. Extractables and Leachables Testing
6.3. Integrity Testing
6.4. Bioprocess Residuals Testing
6.5. Filtration and Fermentation
6.6. Viral Clearance Testing
6.7. Systems Testing
6.8. Compatibility Testing
6.9. Microbiological Testing
6.10. Physiochemical Testing
6.11. Bacterial Retention Testing
6.12. Adsorption Testing and Others
7. Global Bioprocess Validation Market Analysis and Forecast, By Process Component
7.1. Segment Overview
7.2. Filter Elements
7.3. Freezing and Thawing Process Bags
7.4. Bioreactors
7.5. Connectors
7.6. Samplers
7.7. Media Containers and Bags
7.8. Mixing Systems
7.9. Transfer Systems
7.10. Others
8. Global Bioprocess Validation Market Analysis and Forecast, By End User
8.1. Segment Overview
8.2. Pharmaceutical Companies
8.3. Contract Development and Manufacturing Organizations
8.4. Biotechnology Companies
8.5. Research Laboratories and Institutions
8.6. Others
9. Global Bioprocess Validation Market Analysis and Forecast, By Regional Analysis
9.1. Segment Overview
9.2. North America
9.2.1. U.S.
9.2.2. Canada
9.2.3. Mexico
9.3. Europe
9.3.1. Germany
9.3.2. France
9.3.3. U.K.
9.3.4. Italy
9.3.5. Spain
9.4. Asia-Pacific
9.4.1. Japan
9.4.2. China
9.4.3. India
9.5. South America
9.5.1. Brazil
9.6. Middle East and Africa
9.6.1. UAE
9.6.2. South Africa
10. Global Bioprocess Validation Market-Competitive Landscape
10.1. Overview
10.2. Market Share of Key Players in the Bioprocess Validation Market
10.2.1. Global Company Market Share
10.2.2. North America Company Market Share
10.2.3. Europe Company Market Share
10.2.4. APAC Company Market Share
10.3. Competitive Situations and Trends
10.3.1. Product Launches and Developments
10.3.2. Partnerships, Collaborations, and Agreements
10.3.3. Mergers & Acquisitions
10.3.4. Expansions
11. Company Profiles
11.1. Almac Group
11.1.1. Business Overview
11.1.2. Company Snapshot
11.1.3. Company Market Share Analysis
11.1.4. Company Product Portfolio
11.1.5. Recent Developments
11.1.6. SWOT Analysis
11.2. Cobetter Filtration Equipment Co. Ltd.
11.2.1. Business Overview
11.2.2. Company Snapshot
11.2.3. Company Market Share Analysis
11.2.4. Company Product Portfolio
11.2.5. Recent Developments
11.2.6. SWOT Analysis
11.3. Danaher Corporation
11.3.1. Business Overview
11.3.2. Company Snapshot
11.3.3. Company Market Share Analysis
11.3.4. Company Product Portfolio
11.3.5. Recent Developments
11.3.6. SWOT Analysis
11.4. Eurofins Scientific Inc.
11.4.1. Business Overview
11.4.2. Company Snapshot
11.4.3. Company Market Share Analysis
11.4.4. Company Product Portfolio
11.4.5. Recent Developments
11.4.6. SWOT Analysis
11.5. Merck KGaA
11.5.1. Business Overview
11.5.2. Company Snapshot
11.5.3. Company Market Share Analysis
11.5.4. Company Product Portfolio
11.5.5. Recent Developments
11.5.6. SWOT Analysis
11.6. Pall Corporation
11.6.1. Business Overview
11.6.2. Company Snapshot
11.6.3. Company Market Share Analysis
11.6.4. Company Product Portfolio
11.6.5. Recent Developments
11.6.6. SWOT Analysis
11.7. Sartorius AG
11.7.1. Business Overview
11.7.2. Company Snapshot
11.7.3. Company Market Share Analysis
11.7.4. Company Product Portfolio
11.7.5. Recent Developments
11.7.6. SWOT Analysis
11.8. SGS SA
11.8.1. Business Overview
11.8.2. Company Snapshot
11.8.3. Company Market Share Analysis
11.8.4. Company Product Portfolio
11.8.5. Recent Developments
11.8.6. SWOT Analysis
11.9. Thermo Fisher Scientific
11.9.1. Business Overview
11.9.2. Company Snapshot
11.9.3. Company Market Share Analysis
11.9.4. Company Product Portfolio
11.9.5. Recent Developments
11.9.6. SWOT Analysis
11.10. Toxikon Corporation
11.10.1. Business Overview
11.10.2. Company Snapshot
11.10.3. Company Market Share Analysis
11.10.4. Company Product Portfolio
11.10.5. Recent Developments
11.10.6. SWOT Analysis
List of Table
1. Global Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
2. Global Extractables and Leachables Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
3. Global Integrity Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
4. Global Bioprocess Residuals Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
5. Global Filtration and Fermentation Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
6. Global Viral Clearance Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
7. Global Systems Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
8. Global Compatibility Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
9. Global Microbiological Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
10. Global Physiochemical Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
11. Global Bacterial Retention Testing Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
12. Global Adsorption Testing and Others Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
13. Global Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
14. Global Filter Elements Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
15. Global Freezing and Thawing Process Bags Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
16. Global Bioreactors Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
17. Global Connectors Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
18. Global Samplers Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
19. Global Media Containers and Bags Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
20. Global Mixing Systems Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
21. Global Transfer Systems Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
22. Global Others Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
23. Global Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
24. Global Pharmaceutical Companies Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
25. Global Contract Development and Manufacturing Organizations Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
26. Global Biotechnology Companies Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
27. Global Research Laboratories and Institutions Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
28. Global Others Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
29. Global Bioprocess Validation Market, By Region, 2019-2032 (USD Million)
30. North America Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
31. North America Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
32. North America Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
33. U.S. Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
34. U.S. Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
35. U.S. Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
36. Canada Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
37. Canada Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
38. Canada Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
39. Mexico Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
40. Mexico Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
41. Mexico Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
42. Europe Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
43. Europe Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
44. Europe Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
45. Germany Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
46. Germany Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
47. Germany Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
48. France Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
49. France Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
50. France Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
51. U.K. Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
52. U.K. Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
53. U.K. Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
54. Italy Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
55. Italy Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
56. Italy Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
57. Spain Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
58. Spain Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
59. Spain Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
60. Asia Pacific Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
61. Asia Pacific Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
62. Asia Pacific Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
63. Japan Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
64. Japan Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
65. Japan Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
66. China Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
67. China Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
68. China Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
69. India Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
70. India Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
71. India Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
72. South America Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
73. South America Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
74. South America Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
75. Brazil Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
76. Brazil Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
77. Brazil Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
78. Middle East and Africa Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
79. Middle East and Africa Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
80. Middle East and Africa Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
81. UAE Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
82. UAE Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
83. UAE Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
84. South Africa Bioprocess Validation Market, By Testing Type, 2019-2032 (USD Million)
85. South Africa Bioprocess Validation Market, By Process Component, 2019-2032 (USD Million)
86. South Africa Bioprocess Validation Market, By End User, 2019-2032 (USD Million)
List of Figures
1. Global Bioprocess Validation Market Segmentation
2. Bioprocess Validation Market: Research Methodology
3. Market Size Estimation Methodology: Bottom-Up Approach
4. Market Size Estimation Methodology: Top-Down Approach
5. Data Triangulation
6. Porter’s Five Forces Analysis
7. Value Chain Analysis
8. Global Bioprocess Validation Market Attractiveness Analysis by Testing Type
9. Global Bioprocess Validation Market Attractiveness Analysis by Process Component
10. Global Bioprocess Validation Market Attractiveness Analysis by End User
11. Global Bioprocess Validation Market Attractiveness Analysis by Region
12. Global Bioprocess Validation Market: Dynamics
13. Global Bioprocess Validation Market Share by Testing Type (2022 & 2032)
14. Global Bioprocess Validation Market Share by Process Component (2022 & 2032)
15. Global Bioprocess Validation Market Share by End User (2022 & 2032)
16. Global Bioprocess Validation Market Share by Regions (2022 & 2032)
17. Global Bioprocess Validation Market Share by Company (2021)
This study forecasts revenue at global, regional, and country levels from 2019 to 2032. The Brainy Insights has segmented the bioprocess validation market based on below mentioned segments:
Bioprocess Validation Market by Testing Type:
Bioprocess Validation Market by Process Component:
Bioprocess Validation Market by End User:
Bioprocess Validation Market by Region:
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