The global bioprocess validation is expected to grow from USD 180 million in 2019 to USD 551 million by 2027, at a CAGR of 15.01% during the forecast period 2020-2027.
Validation is process of establishing documentary evidences that a procedure, process, or activity carried out in production or testing maintain desire level of compliance at all stages. It would be not feasible to use equipments without knowing whether it will produce the product we wanted or not. The pharmaceutical industry uses expensive material, sophisticated facilities and highly qualified personnel. The efficient use of these resources is necessary for the continued success of the industry. The cost of production failures, rejects, reworks, complaints are the significant part of the total production cost.
With the concept of the finished product, at the right time, and the right place becoming a buzzword of the biopharmaceutical industry, the market for bioprocess validation is anticipated to gain adhesion over the projection period. Furthermore, new drugs are being driven in the biopharmaceutical sector, and this will require bioprocess validation in the foreseeable future.
The suitability of operations & processes is a several of the difficulties faced by both the pharmaceutical and biopharmaceutical industries. Moreover, bioprocess validation aids in reducing the daunting process in these industries. In turn, is anticipated to steer the development of the bioprocess validation industry over the future.
The extractable/leachable testing services segment is expected to dominate the bioprocess validation market. The substantial share of this segment can be associated to the presence of regulatory orders and guidelines concerning the measurement of extractable and leachable. Growing outsourcing of testing services by biopharmaceutical manufacturers; the developing requirement for product safety, identity, purity, and quality; and the rising risk of product contamination. Based on end-users the market is segmented into biotechnology, pharmaceuticals & CDMO. The pharmaceutical companies are the major user of the bioprocess validation. The process component segment includes bioreactor and filter elements. Among the process component segment the bioreactor has the most significant market share of the market.
Geographically, global bioprocess validation market is segmented into Asia-pacific, North America, South America, Europe, and MEA & Africa. APAC is expected to exhibit the largest market share. the increasing number of biopharmaceutical manufacturing capabilities in Asian countries, increasing demand for outsourcing bioprocess validation market, improving life science research and growth specific by pharmaceutical and biotechnology companies is expected to drive market growth in APAC. North America has the most of the key players which carries the market.
Sartorius AG, Pall Corporation, Cobetter Filtration Equipments Co., Ltd., Toxikon Corporation, DOC S.r.l., Merck KGaA, SGS S.A., Eurofins Scientific MEISSNER Filtration Products, INC. and Thermo Fisher Scientific are the most efficient market players of the bioprocess validation market. These companies are mainly concentrated on the advancement of new technologies & devices; expand from their territories to grab the vital share of the global market.
The biggest pharma merger and acquisition deals of 2019: Initially announced in January 19, the deal got around 11 months unto Celgene became a fully controlled branch of BMS. The deal has increased the company’s pipelines in oncology, immunology, cardiovascular disease & haematology
The Study delivers comprehensive analysis of the segments as follows:
Global Bioprocess Validation Market Analysis And Forecast, By Type
Global Bioprocess Validation Market Analysis And Forecast, By Process Component
Global Bioprocess Validation Market Analysis And Forecast, By Route
Global Bioprocess Validation Market And Forecast, By Regional Analysis
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 Type
4.3.2. Market Attractiveness Analysis By Process Component
4.3.3. Market Attractiveness Analysis By Route
4.3.4. Market Attractiveness Analysis By Region
4.4. Industry Trends
5. Market Dynamics
5.1. Market Evaluation
5.2. Drivers
5.3. Restraints
5.4. Opportunities
5.5. Challenges
6. Global Bioprocess Validation Market Analysis and Forecast, By Type
6.1. Segment Overview
6.2. Integrity Testing
6.3. Microbiology Testing
6.4. Extractables and Leachable
7. Global Bioprocess Validation Market Analysis and Forecast, By Process Component
7.1. Segment Overview
7.2. Bioreactor
7.3. Filter Elements
8. Global Bioprocess Validation Market Analysis and Forecast, By Route
8.1. Segment Overview
8.2. Biotechnology
8.3. Pharmaceutical Companies
8.4. CDMO
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 Global 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. Sartorius AG
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. Pall Corporation
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. Cobetter Filtration Equipments Co., Ltd.
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. Toxikon Corporation
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. DOC S.r.l.
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. Merck KGaA
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. SGS S.A.
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. Eurofins Scientific MEISSNER Filtration Products, INC.
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
List of Table
1. Global Bioprocess Validation Market, By Type, 2017–2027(USD Million)
2. Global Integrity Testing In Bioprocess Validation Market, By Region, 2017–2027(USD Million)
3. Global Microbiology Testing In Bioprocess Validation Market, By Region, 2017–2027(USD Million)
4. Global Extractables and Leachable In Bioprocess Validation Market, By Region, 2017–2027(USD Million)
5. Global Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
6. Global Bioreactor Bioprocess Validation Market, By Region, 2017–2027(USD Million)
7. Global Filter Elements Bioprocess Validation Market, By Region, 2017–2027(USD Million)
8. Global Bioprocess Validation Market, By Route, 2017–2027(USD Million)
9. Global Biotechnology Bioprocess Validation Market, By Region, 2017–2027(USD Million)
10. Global Pharmaceutical Companies Bioprocess Validation Market, By Region, 2017–2027 (USD Million)
11. Global CDMO Bioprocess Validation Market, By Region, 2017–2027 (USD Million)
12. Global Bioprocess Validation Market, By Region, 2017–2027(USD Million)
13. Global Bioprocess Validation Market, By North America, 2017–2027(USD Million)
14. North America Bioprocess Validation Market, By Type, 2017–2027(USD Million)
15. North America Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
16. North America Bioprocess Validation Market, By Route, 2017–2027(USD Million)
17. U.S. Bioprocess Validation Market, By Type, 2017–2027(USD Million)
18. U.S. Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
19. U.S. Bioprocess Validation Market, By Route, 2017–2027(USD Million)
20. Canada Bioprocess Validation Market, By Type, 2017–2027(USD Million)
21. Canada Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
22. Canada Bioprocess Validation Market, By Route, 2017–2027(USD Million)
23. Mexico Bioprocess Validation Market, By Type, 2017–2027(USD Million)
24. Mexico Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
25. Mexico Bioprocess Validation Market, By Route, 2017–2027(USD Million)
26. Europe Bioprocess Validation Market, By Type, 2017–2027(USD Million)
27. Europe Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
28. Europe Bioprocess Validation Market, By Route, 2017–2027(USD Million)
29. Germany Bioprocess Validation Market, By Type, 2017–2027(USD Million)
30. Germany Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
31. Germany Bioprocess Validation Market, By Route, 2017–2027(USD Million)
32. France Bioprocess Validation Market, By Type, 2017–2027(USD Million)
33. France Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
34. France Bioprocess Validation Market, By Route, 2017–2027(USD Million)
35. U.K. Bioprocess Validation Market, By Type, 2017–2027(USD Million)
36. U.K. Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
37. U.K. Bioprocess Validation Market, By Route, 2017–2027(USD Million)
38. Italy Bioprocess Validation Market, By Type, 2017–2027(USD Million)
39. Italy Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
40. Italy Bioprocess Validation Market, By Route, 2017–2027(USD Million)
41. Spain Bioprocess Validation Market, By Type, 2017–2027(USD Million)
42. Spain Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
43. Spain Bioprocess Validation Market, By Route, 2017–2027(USD Million)
44. Asia Pacific Bioprocess Validation Market, By Type, 2017–2027(USD Million)
45. Asia Pacific Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
46. Asia Pacific Bioprocess Validation Market, By Route, 2017–2027(USD Million)
47. Japan Bioprocess Validation Market, By Type, 2017–2027(USD Million)
48. Japan Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
49. Japan Bioprocess Validation Market, By Route, 2017–2027(USD Million)
50. China Bioprocess Validation Market, By Type, 2017–2027(USD Million)
51. China Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
52. China Bioprocess Validation Market, By Route, 2017–2027(USD Million)
53. India Bioprocess Validation Market, By Type, 2017–2027(USD Million)
54. India Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
55. India Bioprocess Validation Market, By Route, 2017–2027(USD Million)
56. South America Bioprocess Validation Market, By Type, 2017–2027(USD Million)
57. South America Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
58. South America Bioprocess Validation Market, By Route, 2017–2027(USD Million)
59. Brazil Bioprocess Validation Market, By Type, 2017–2027(USD Million)
60. Brazil Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
61. Brazil Bioprocess Validation Market, By Route, 2017–2027(USD Million)
62. Middle East and Africa Bioprocess Validation Market, By Type, 2017–2027(USD Million)
63. Middle East and Africa Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
64. Middle East Bioprocess Validation Market, By Route, 2017–2027(USD Million)
65. UAE Bioprocess Validation Market, By Type, 2017–2027(USD Million)
66. UAE Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
67. UAE Bioprocess Validation Market, By Route, 2017–2027(USD Million)
68. South Africa Bioprocess Validation Market, By Type, 2017–2027(USD Million)
69. South Africa Bioprocess Validation Market, By Process Component, 2017–2027(USD Million)
70. South Africa Bioprocess Validation Market, By Route, 2017–2027(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 Type
9. Global Bioprocess Validation Market Attractiveness Analysis By Process Component
10. Global Bioprocess Validation Market Attractiveness Analysis By Route
11. Global Bioprocess Validation Market Attractiveness Analysis By Region
12. Global Bioprocess Validation Market: Dynamics
13. Global Bioprocess Validation Market Share By Type (2019 & 2027)
14. Global Bioprocess Validation Market Share By Process Component (2019 & 2027)
15. Global Bioprocess Validation Market Share By Route (2019 & 2027)
16. Global Bioprocess Validation Market Share by Regions (2019 & 2027)
17. Global Bioprocess Validation Market Share by Company (2019)
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