Bioprocess Validation Market By Type (Integrity Testing, Microbiology Testing and Extractables and Leachable), Process Component (Bioreactors, Filter Elements), End Users (Biotechnology, Pharmaceutical Companies and CDMO) Regions And Global Forecast 2020-2027

  • Publish Date: Jun, 2020
  • Report ID: 418373
  • Category: Pharmaceutical
  • Pages: 238
$4700

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

  • Integrity Testing
  • Microbiology Testing
  • Extractables and Leachable

Global Bioprocess Validation Market Analysis And Forecast, By Process Component

  • Bioreactor
  • Filter Elements

Global Bioprocess Validation Market Analysis And Forecast, By Route

  • Biotechnology
  • Pharmaceutical Companies
  • CDMO

Global Bioprocess Validation Market And Forecast, By Regional Analysis

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • Sweden
    • Netherland
    • U.K.
    • Italy
    • Spain
    • Turkey
    • Switzerland
    • Belgium
    • Rest Of Europe
  • Asia-Pacific
    • Japan
    • China
    • India
    • South Korea
    • Australia
    • Singapore
    • Malaysia
    • Thailand
    • Indonesia
    • Philippines
    • Rest Of APAC
  • South America
    • Brazil
    • Argentina
    • Peru
    • Colombia
    • Rest Of South America
  • Middle East And Africa
    • UAE
    •  Saudi Arabia
    •  Egypt
    •  Nigeria
    • South Africa
    • Rest of MEA

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)

Research Methodology

Market research is a method of gathering, assessing and deducing data & information about a particular market. Market research is very crucial in these days. The techniques analyze about how a product/service can be offered to the market to its end-customers, observe the impact of that product/service based on the past customer experiences, and cater their needs and demands. Owing to the successful business ventures, accurate, relevant and thorough information is the base for all the organizations because market research report/study offers specific market related data & information about the industry growth prospects, perspective of the existing customers, and the overall market scenario prevailed in past, ongoing present and developing future. It allows the stakeholders and investors to determine the probability of a business before committing substantial resources to the venture. Market research helps in solving the marketing issues challenges that a business will most likely face.

Market research is valuable because of the following reasons:

  • Market research helps businesses strengthen a company’s position
  • Market research helps in minimizing the investment risks associated with the businesses in any industry vertical
  • Market research helps in identifying the potential threats and opportunities associated with the business industry
  • Market research aids in spotting the emerging trends and facilitates strategic planning in order to stay ahead in the competition

Our research report features both the aspects; qualitative and quantitative. Qualitative part provides insights about the market driving forces, potential opportunities, customer’s demands and requirement which in turn help the companies to come up with new strategies in order to survive in the long run competition. The quantitative segment offers the most credible information related to the industry. Based on the data gathering, we use to derive the market size and estimate their future growth prospects on the basis of global, region and country.

Our market research process involves with the four specific stages.

  • Data Collection
  • Data Synthesis
  • Market Deduction & Formulation
  • Data Screening & Validation

Data Collection: This stage of the market research process involves with the gathering and collecting of the market/industry related data from the sources. There are basically two types of research methods:

  • Primary Research: By conducting primary research, it involves with the two types of data gathering; exploratory and specific. Exploratory data is open-ended and helps us to define a particular problem involving surveys, and pilot study to the specific consumer group, knowing their needs and wants catering to the industry related product/service offering. Explanatory data gathering follows with the bit of unstructured way. Our analyst group leads the study by focusing on the key crowd, in this manner picking up bits of knowledge from them. In light of the points of view of the clients, this data is used to plan advertise techniques. In addition, showcase overviews causes us to comprehend the current scenario of the business. Specific data gathering on the hand, involves with the more structured and formal way. The primary research usually includes in telephonic conversations, E-mail collaborations and up close and personal meetings/interviews with the raw material suppliers, industrial wholesalers, and independent consultants/specialists. The interviews that we conduct offers important information on showcase size and industry development patterns. Our company likewise conducts interviews with the different business specialists so as to increase generally bits of knowledge of the business/showcase.
  • Secondary Research: The secondary research incorporates with the data gathering from the non-profit associations and organizations, for example, World bank, WHO, investor relations and their presentations, statistical databases, yearly(annual reports) reports, national government records, factual databases, websites, articles, white papers, press releases, blogs and others. From the annual report, we deduce an organization's income/revenue generation to comprehend the key product segment related to the market. We examine the organization sites and implement product mapping strategy which is significant for determining the segment revenue. In the product mapping technique, we choose and categorize the products offered by the companies catering to the industry specific market, derive the segment revenue for each of the organizations to get the market estimation. We also gather data & Information based on the supply and demand side of the value chain involved with the domain specific market. The supply side denotes the distributors, wholesalers, suppliers and the demand side denotes the end-consumers/customers of the value chain. The supply side of the market is analyzed by examining the product growth across industry in each of the region followed by its pricing analysis. The demand side is analyzed by the evaluating the penetration level and adoption rates of the product by referring to the historical/past data, examine the present usage and forecasting the future trends. 
  • Purchased Database: Our purchased data provides insights about the key market players/companies along with their financial analysis. Additionally, our data base also includes market related information. 
    • We also have the agreements with various reputed data providers, consultants and third party vendors who provide information which are not limited to:
      • Export & Import Data
      • Business Information related to trade and its statistics
      • Penetration level of a particular product/service based on geography mainly focusing on the unmet prerequisites of the customers.
  • In-house Library: Apart from these third-party sources, we have our in-house library of quantitative and qualitative data & information. Our in-house database includes market data for various industry and domains. These data are updated on regular basis as per the changing market scenario. Our library includes, internal audit reports, historic databases, archives and journal publications. Sometimes there are instances where there is no metadata or raw data available for any domain specific market. For those particular cases, we utilize our expertise to forecast and estimate the market size in order to generate comprehensive data sets. Our analyst team adopts a robust research technique in order to deduce the market size and its estimates:
  • Examining demographic along with psychographic segmentation for market evaluation
  • Analyzing the macro and micro-economic indicators for each demography
  • Evaluating the current industry trends popular in the market.

Data Synthesis: This stage includes the evaluation and assessment of all the data acquired from the primary and secondary research. It likewise includes in evaluating the information for any disparity watched while information gathering identified with the market. The data & information is gathered with consideration to the heterogeneity of sources. Scientific and statistical methods are implemented for synthesizing dissimilar information sets and provide the relevant data which is fundamental for formulating strategies. Our organization has broad involvement with information amalgamation where the information goes through different stages:

  • Information Screening: Information screening is the way toward examining information/data gathered from the sources for errors/mistakes and amending it before data integration process. The screening includes in looking at raw information, identifying and distinguishing mistakes and managing missing information. The reason for the information screening is to ensure information is effectively entered or not. Our organization utilizes objective and precise information screening grades through repetitive quality checks.
  • Data Integration: The data integration method involves with the incorporation of numerous information streams. The data streams is important so as to deliver investigate examines that give overall market scenario to the investors. These information streams originate from different research contemplates and our in house database. After the screening of the information, our analysts conduct efficient integration of the data streams, optimizing connections between integrated surveys and syndicated data sources. There are two research approaches that we follow so as to coordinate our information; top down methodology and bottom up methodology. 
    • Top-down analysis generally refers to using broad factors as a basis for decision making. The top-down approach helps in identifying the overall market scenario along with the external and internal factors effecting the market growth.
    • The bottom-up approach takes a completely different approach. Generally, the bottom-up approach focuses its analysis on micro attributes and specific characteristics of the domain specific market.

Market Formulation & Deduction: The last stage includes assigning the data & information in a suitable way in order to derive market size. Analyst reviews and domain based opinions based on holistic approach of market estimation combined with industry investigation additionally features a crucial role in this stage.

This stage includes with the finalization of the market size and numbers that we have gathered from primary and secondary research. With the data & information addition, we ensure that there is no gap in the market information. Market trend analysis is finished by our analysts by utilizing data extrapolation procedures, which give the most ideal figures to the market.

Data Validation: Validation is the most crucial step in the process. Validation & re-validation through scientifically designed technique and process that helps us finalize data-points to be used for final calculations. This stage also involves with the data triangulation process. Data triangulation generally implicates the cross validation and matching the data which has been collected from primary and secondary research methods.

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