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Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type (In-house, Outsourcing), By Product Type, By Test Type, By End-use, By Sample, By Region, And Segment Forecasts, 2022 - 2030

October 2022 | 100 pages | ID: P8365291BE5EN
Grand View Research, Inc.

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Pharmaceutical Sterility Testing Market Growth & Trends

The global pharmaceutical sterility testing market size is expected to reach USD 3,389.3 million by 2030, registering a CAGR of 11.5% during the forecast period, according to a new report by Grand View Research, Inc. Actively growing investment in pharmaceutical R&D, increasing demand for the new therapies, and a rise in the number of drug and medical device approvals in recent years are some of the major factors driving the market's growth.

During the initial period of COVID-19, the majority of the clinical research conducted was related to COVID-19 therapeutics with an aim to eradicate the issue at hand. However, this trend has witnessed a transition post-2021. For instance, Pharma R&D Review January 2022 stated that the majority of therapeutics pertaining to the oncology area was in the late-stage clinical pipeline, which indicates a rise in demand for the sterility testing of these anti-cancer drugs, thus supporting the market’s growth.

There is a growing focus to improve the quality and sterility of drugs. Stringent regulations regarding the quality and sterility of the products are improving the demand for sterility testing of pharmaceutical and medical devices. Moreover, in recent years, a significant number of recalls have been witnessed on the FDA and EMA websites due to the lack of drug sterility. For instance, in July 2021, Innoveix Pharmaceuticals, Inc. voluntarily recalled their injectable AOD-9604 3mg due to lack of sterility.

Recalls not only cause heavy losses but also affect the brand image of the company. Contracting organizations have seized this opportunity to help gain more clientele, which in turn has increased the revenue for sterility testing of the pharmaceuticals and medical devices in the market.

The governments are actively trying to improve R&D by providing tax deductions. For instance, the Indian government in January 2022, stated that it is providing a weighted average tax deduction upto 200% in R&DSuch initiatives are expected to improve the R&D activities on drugs and thus showcase the growing investment within the sector.

Global expenditure on medicines is also on the rise. According to the data provided in a report published by IQVIA, one can conclude that global spending on medicines is expected to increase in the next 4-5 years. The report states that global payments on medicine accounted for USD 955.0 billion in 2019 and will reach USD 1,115.0–1,145.0 billion by 2024. The rise in pharmaceutical spending is expected to increase the development of the medication, which in turn grows demand for pharmaceutical sterility testing in the post-pandemic period.

Pharmaceutical Sterility Testing Market Report Highlights
  • Outsourcing segment emerged as the largest segment in 2021, as pharmaceutical and medical device companies are trying to focus on their core competencies such as research and marketing, owing to which they outsource sterility testing service
  • The bacterial endotoxin testing segment is expected to account for the largest share with 39.4% in 2021. The growing demand for implants and sterile medicines is supporting the growth of the segment market
  • The biologics and therapeutics segment by the sample is expected to grow at the fastest rate of 11.7% CAGR throughout the forecast period as we anticipate rising clinical trials for the biologics and biosimilar, globally, for the treatment of cancer, autoimmune diseases, infectious diseases, and others
  • Based on end use, the pharmaceutical companies accounted for the largest share of 42.9% in 2021; owing to the current high spending on medicines, globally
  • In Asia Pacific, the market is expected to encounter the highest CAGR during the forecast period, owing to the significant number of initiatives taken by the public organization in the region to boost pharmaceutical manufacturing and R&D.This contributes to the demand for sterility testing of the pharmaceuticals in Asia Pacific
CHAPTER 1. METHODOLOGY AND SCOPE

1.1. Market Segmentation & Scope
  1.1.1. Type
  1.1.2. Product Type
  1.1.3. Test Type
  1.1.4. Sample
  1.1.5. End-use
  1.1.6. Regional scope
  1.1.7. Estimates and forecast timeline
1.2. Research Methodology
1.3. Information Procurement
  1.3.1. Purchased database
  1.3.2. GVR’s internal database
  1.3.3. Secondary sources
  1.3.4. Primary research
  1.3.5. Details of primary research
1.4. Information or Data Analysis
  1.4.1. Data analysis models
1.5. Market Formulation & Validation
1.6. Model Details
  1.6.1. Commodity flow analysis (Model 1)
    1.6.1.1. Approach 1: Commodity flow approach
  1.6.2. Volume price analysis (Model 2)
    1.6.2.1. Approach 2: Volume price analysis
1.7. List of Secondary Sources
1.8. List of Primary Sources
1.9. Objectives
  1.9.1. Objective
  1.9.2. Objective

CHAPTER 2. EXECUTIVE SUMMARY

2.1. Market Outlook

CHAPTER 3. PHARMACEUTICAL STERILITY TESTING MARKET VARIABLES, TRENDS & SCOPE

3.1. Market Lineage Outlook
  3.1.1. Parent market outlook
  3.1.2. Related/ancillary market outlook
3.2. Penetration & Growth Prospect Mapping
3.3. Market Dynamics
  3.3.1. Market driver analysis
    3.3.1.1. Supportive government investment in the healthcare industry
    3.3.1.2. Increasing R&D activities
    3.3.1.3. Increasing number of drug launches
    3.3.1.4. Increasing focus on quality and sterility
  3.3.2. Market restraint analysis
    3.3.2.1. Third party performance
3.4. Pharmaceutical Sterility Testing Market Analysis Tools
  3.4.1. Porter’s Five Forces Analysis
  3.4.2. PESTLE Analysis
  3.4.3. Major Deals & Strategic Alliances Analysis
    3.4.3.1. Mergers and Acquisition
    3.4.3.2. Expansions
    3.4.3.3. Agreements and Collaborations
    3.4.3.4. Product and Service Launches
3.5. COVID-19 Impact and Reformation Strategy

CHAPTER 4. PHARMACEUTICAL STERILITY TESTING MARKET: TYPE ESTIMATES & TREND ANALYSIS

4.1. Definitions and Scope
4.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  4.2.1. In- house pharmaceutical sterility testing
    4.2.1.1. In- house pharmaceutical sterility testing market estimates and forecast, 2018 to 2030 (USD Million)
  4.2.2. Outsourcing pharmaceutical sterility testing
    4.2.2.1. Outsourcing pharmaceutical sterility testing market estimates and forecast, 2018 to 2030 (USD Million)

CHAPTER 5. PHARMACEUTICAL STERILITY TESTING MARKET: PRODUCT TYPE ESTIMATES & TREND ANALYSIS

5.1. Definitions and Scope
5.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  5.2.1. Kits and Reagents
    5.2.1.1. Kits and Reagents market estimates and forecast, 2018 to 2030 (USD Million)
  5.2.2. Instruments
    5.2.2.1. Instruments market estimates and forecast, 2018 to 2030 (USD Million)
  5.2.3. Service
    5.2.3.1. Service market estimates and forecast, 2018 to 2030 (USD Million)

CHAPTER 6. PHARMACEUTICAL STERILITY TESTING MARKET: TEST TYPE ESTIMATES & TREND ANALYSIS

6.1. Definitions and Scope
6.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  6.2.1. Sterility testing
    6.2.1.1. Sterility testing market estimates and forecast, 2018 to 2030 (USD Million)
    6.2.1.2. Membrane Filtration
      6.2.1.2.1. Membrane Filtration market estimates and forecast, 2018 to 2030 (USD Million)
    6.2.1.3. Direct Inoculation
      6.2.1.3.1. Direct Inoculation market estimates and forecast, 2018 to 2030 (USD Million)
  6.2.2. Bioburden testing
    6.2.2.1. Bioburden testing market estimates and forecast, 2018 to 2030 (USD Million)
  6.2.3. Bacterial endotoxin testing
    6.2.3.1. Bacterial endotoxin testing market estimates and forecast, 2018 to 2030 (USD Million)
  6.2.4. Container closure integrity testing
    6.2.4.1. Container closure integrity testing market estimates and forecast, 2018 to 2030 (USD Million)
  6.2.5. Antimicrobial effectiveness testing
    6.2.5.1. Antimicrobial effectiveness testing market estimates and forecast, 2018 to 2030 (USD Million)
  6.2.6. Rapid Micro Test
    6.2.6.1. Rapid Micro Test market estimates and forecast, 2018 to 2030 (USD Million)
    6.2.6.2. ATP bioluminescence
      6.2.6.2.1. ATP bioluminescence market estimates and forecast, 2018 to 2030 (USD Million)
    6.2.6.3. Fluorescent labeling
      6.2.6.3.1. Fluorescent labeling market estimates and forecast, 2018 to 2030 (USD Million)
    6.2.6.4. Electrical resistance
      6.2.6.4.1. Electrical resistance market estimates and forecast, 2018 to 2030 (USD Million)
  6.2.7. Others
    6.2.7.1. Others market estimates and forecast, 2018 to 2030 (USD Million)

CHAPTER 7. PHARMACEUTICAL STERILITY TESTING MARKET: SAMPLE ESTIMATES & TREND ANALYSIS

7.1. Definitions and Scope
7.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  7.2.1. Pharmaceuticals
    7.2.1.1. Pharmaceuticals market estimates and forecast, 2018 to 2030 (USD Million)
  7.2.2. Medical devices
    7.2.2.1. Medical devices market estimates and forecast, 2018 to 2030 (USD Million)
  7.2.3. Biopharmaceuticals
    7.2.3.1. Biopharmaceuticals market estimates and forecast, 2018 to 2030 (USD Million)

CHAPTER 8. PHARMACEUTICAL STERILITY TESTING MARKET: END-USE ESTIMATES & TREND ANALYSIS

8.1. Definitions and Scope
8.2. Pharmaceutical Sterility Testing Market Share, 2021 & 2030
  8.2.1. Compounding Pharmacies
    8.2.1.1. Compounding Pharmacies market estimates and forecast, 2018 to 2030 (USD Million)
  8.2.2. Medical devices Companies
    8.2.2.1. Medical devices Companies market estimates and forecast, 2018 to 2030 (USD Million)
  8.2.3. Pharmaceutical Companies
    8.2.3.1. Pharmaceutical Companies market estimates and forecast, 2018 to 2030 (USD Million)
  8.2.4. Others
    8.2.4.1. Other market estimates and forecast, 2018 to 2030 (USD Million)

CHAPTER 9. PHARMACEUTICAL STERILITY TESTING MARKET: REGIONAL ESTIMATES & TREND ANALYSIS

9.1. Regional market share analysis, 2021& 2030
9.2. North America
  9.2.1. U.S.
    9.2.1.1. U.S. Market estimates and forecast, 2018 - 2030
  9.2.2. Canada
    9.2.2.1. Canada Market estimates and forecast, 2018 - 2030
9.3. Europe
  9.3.1. UK
    9.3.1.1. UK Market estimates and forecast, 2018 - 2030
  9.3.2. Germany
    9.3.2.1. Germany Market estimates and forecast, 2018 - 2030
  9.3.3. France
    9.3.3.1. France Market estimates and forecast, 2018 - 2030
  9.3.4. Italy
    9.3.4.1. Italy Market estimates and forecast, 2018 - 2030
  9.3.5. Spain
    9.3.5.1. Spain Market estimates and forecast, 2018 - 2030
  9.3.6. Netherlands
    9.3.6.1. Netherlands Market estimates and forecast, 2018 - 2030
  9.3.7. Sweden
    9.3.7.1. Sweden Market estimates and forecast, 2018 - 2030
  9.3.8. Switzerland
    9.3.8.1. Switzerland Market estimates and forecast, 2018 - 2030
  9.3.9. Russia
    9.3.9.1. Russia Market estimates and forecast, 2018 - 2030
  9.3.10. Belgium
    9.3.10.1. Belgium Market estimates and forecast, 2018 - 2030
9.4. Asia Pacific
  9.4.1. Japan
    9.4.1.1. Japan Market estimates and forecast, 2018 - 2030
  9.4.2. China
    9.4.2.1. China Market estimates and forecast, 2018 - 2030
  9.4.3. India
    9.4.3.1. India Market estimates and forecast, 2018 - 2030
  9.4.4. Australia
    9.4.4.1. Australia Market estimates and forecast, 2018 - 2030
  9.4.5. South Korea
    9.4.5.1. South Korea Market estimates and forecast, 2018 - 2030
  9.4.6. Thailand
    9.4.6.1. Thailand Market estimates and forecast, 2018 - 2030
  9.4.7. Malaysia
    9.4.7.1. Malaysia Market estimates and forecast, 2018 - 2030
  9.4.8. New Zealand
    9.4.8.1. New Zealand Market estimates and forecast, 2018 - 2030
  9.4.9. Philippines
    9.4.9.1. Philippines Market estimates and forecast, 2018 - 2030
  9.4.10. Singapore
    9.4.10.1. Singapore Market estimates and forecast, 2018 - 2030
9.5. Latin America
  9.5.1. Brazil
    9.5.1.1. Brazil Market estimates and forecast, 2018 - 2030
  9.5.2. Mexico
    9.5.2.1. Mexico Market estimates and forecast, 2018 - 2030
  9.5.3. Argentina
    9.5.3.1. Argentina Market estimates and forecast, 2018 - 2030
  9.5.4. Colombia;
    9.5.4.1. Colombia Market estimates and forecast, 2018 - 2030
  9.5.5. Chile
    9.5.5.1. Chile Market estimates and forecast, 2018 - 2030
9.6. MEA
  9.6.1. South Africa
    9.6.1.1. South Africa Market estimates and forecast, 2018 - 2030
  9.6.2. Saudi Arabia
    9.6.2.1. Saudi Arabia Market estimates and forecast, 2018 - 2030
  9.6.3. UAE
    9.6.3.1. UAE Market estimates and forecast, 2018 - 2030
  9.6.4. Israel
    9.6.4.1. Israel Market estimates and forecast, 2018 - 2030
  9.6.5. Egypt
    9.6.5.1. Egypt Market estimates and forecast, 2018 - 2030

CHAPTER 10. CHAPTER 8 COMPETITIVE ANALYSIS

10.1. Recent Developments & Impact Analysis, By Key Market Participant
10.2. Company/Competition Categorization (Key Innovators, Market Leaders, Emerging Players)
10.3. Participant Categorization
  10.3.1. Innovators
    10.3.1.1. STERIS
    10.3.1.2. Boston Analytical
    10.3.1.3. Charles River Laboratories
    10.3.1.4. SGS SA
10.4. Vendor Landscape
  10.4.1. List of Key Service Providers
  10.4.2. Market Differentiators
  10.4.3. Pharmaceutical Sterility Testing Market Share Analysis

CHAPTER 11. COMPETITIVE LANDSCAPE

11.1. Company Profiles
  11.1.1. Pacific Bio labs
    11.1.1.1. Company overview
    11.1.1.2. Product benchmarking
    11.1.1.3. Strategic initiatives
  11.1.2. STERIS
    11.1.2.1. Company overview
    11.1.2.2. Financial performance
    11.1.2.3. Product benchmarking
    11.1.2.4. Strategic initiatives
  11.1.3. Boston Analytical
    11.1.3.1. Company overview
    11.1.3.2. Financial performance
    11.1.3.3. Product benchmarking
    11.1.3.4. Strategic initiatives
  11.1.4. Nelson Laboratories, LLC
    11.1.4.1. Company overview
    11.1.4.2. Financial performance
    11.1.4.3. Product benchmarking
    11.1.4.4. Strategic initiatives
  11.1.5. Sartorius AG
    11.1.5.1. Company overview
    11.1.5.2. Financial performance
    11.1.5.3. Product benchmarking
    11.1.5.4. Strategic initiatives
  11.1.6. SOLVIAS AG
    11.1.6.1. Company overview
    11.1.6.2. Financial performance
    11.1.6.3. Product benchmarking
    11.1.6.4. Strategic initiatives
  11.1.7. SGS SA
    11.1.7.1. Company overview
    11.1.7.2. Financial performance
    11.1.7.3. Product benchmarking
    11.1.7.4. Strategic initiatives
  11.1.8. Laboratory Corporation of America Holding
    11.1.8.1. Company overview
    11.1.8.2. Financial performance
    11.1.8.3. Product benchmarking
    11.1.8.4. Strategic initiatives
  11.1.9. Pace Analytical
    11.1.9.1. Company overview
    11.1.9.2. Financial performance
    11.1.9.3. Product benchmarking
    11.1.9.4. Strategic initiatives
  11.1.10. Charles River Laboratories
    11.1.10.1. Company overview
    11.1.10.2. Financial performance
    11.1.10.3. Product benchmarking
    11.1.10.4. Strategic initiatives
  11.1.11. Thermo Fisher Scientific, Inc.
    11.1.11.1. Company overview
    11.1.11.2. Financial performance
    11.1.11.3. Product benchmarking
    11.1.11.4. Strategic initiatives
  11.1.12. Rapid Micro Bio systems, Inc.
    11.1.12.1. Company overview
    11.1.12.2. Financial performance
    11.1.12.3. Product benchmarking
    11.1.12.4. Strategic initiatives
LIST OF TABLES

Table 1 List of secondary sources
Table 2 List of Abbreviations
LIST OF FIGURES

Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Primary research pattern
Fig. 4 Market research approaches
Fig. 5 Value-chain-based sizing & forecasting
Fig. 6 QFD modeling for market share assessment
Fig. 7 Market formulation & validation
Fig. 8 Commodity flow analysis
Fig. 9 Volume Price Analysis
Fig. 10 Pharmaceutical Sterility Testing market snapshot (2021)
Fig. 11 Pharmaceutical Sterility Testing market segmentation
Fig. 12 Market driver relevance analysis (Current & future impact)
Fig. 13 Market restraint relevance analysis (Current & future impact)
Fig. 14 Penetration & growth prospect mapping
Fig. 15 Porter’s five forces analysis
Fig. 16 SWOT analysis, by factor (political & legal, economic and technological)
Fig. 17 Pharmaceutical Sterility Testing market type outlook: Segment dashboard
Fig. 18 Pharmaceutical Sterility Testing market: Type movement analysis
Fig. 19 In- house pharmaceutical sterility testing market, 2018 - 2030 (USD Billion)
Fig. 20 Outsourcing pharmaceutical sterility testing market, 2018 - 2030 (USD Billion)
Fig. 21 Pharmaceutical Sterility Testing market product type outlook: Segment dashboard
Fig. 22 Pharmaceutical Sterility Testing market: Product type movement analysis
Fig. 23 Kits and Reagents market, 2018 - 2030 (USD Billion)
Fig. 24 Instruments market, 2018 - 2030 (USD Billion)
Fig. 25 Service testing market, 2018 - 2030 (USD Billion)
Fig. 26 Pharmaceutical Sterility Testing market test type outlook: Segment dashboard
Fig. 27 Pharmaceutical Sterility Testing market: Test type movement analysis
Fig. 28 Sterility testing market, 2018 - 2030 (USD Billion)
Fig. 29 Membrane Filtration market, 2018 - 2030 (USD Billion)
Fig. 30 Direct Inoculation market, 2018 - 2030 (USD Billion)
Fig. 31 Bioburden testing market, 2018 - 2030 (USD Billion)
Fig. 32 Bacterial endotoxin testing market, 2018 - 2030 (USD Billion)
Fig. 33 Container closure integrity testing market, 2018 - 2030 (USD Billion)
Fig. 34 Rapid micro test market, 2018 - 2030 (USD Billion)
Fig. 35 ATP bioluminescence market, 2018 - 2030 (USD Billion)
Fig. 36 Fluorescent labeling market, 2018 - 2030 (USD Billion)
Fig. 37 Electrical resistance market, 2018 - 2030 (USD Billion)
Fig. 38 Others market, 2018 - 2030 (USD Billion)
Fig. 39 Antimicrobial effectiveness testing market, 2018 - 2030 (USD Billion)
Fig. 40 Pharmaceutical Sterility Testing market sample outlook: Segment dashboard
Fig. 41 Pharmaceutical Sterility Testing market: Sample movement analysis
Fig. 42 Pharmaceuticals market, 2018 - 2030 (USD Billion)
Fig. 43 Medical devices market, 2018 - 2030 (USD Billion)
Fig. 44 Biopharmaceuticals market, 2018 - 2030 (USD Billion)
Fig. 45 Pharmaceutical Sterility Testing market: Sample movement analysis
Fig. 46 Pharmaceutical sterility testing market end-use outlook: Segment dashboard
Fig. 47 Pharmaceutical Sterility Testing market: End-use movement analysis
Fig. 48 Compounding Pharmacies market, 2018 - 2030 (USD Billion)
Fig. 49 Medical devices companies market, 2018 - 2030 (USD Billion)
Fig. 50 Pharmaceutical companies market, 2018 - 2030 (USD Billion)
Fig. 51 Others market, 2018 - 2030 (USD Billion)
Fig. 52 Regional market: Key takeaways
Fig 53 Regional outlook, 2021 & 2030
Fig. 54 North America market, 2018 - 2030 (USD Billion)
Fig. 55 U.S. market, 2018 - 2030 (USD Billion)
Fig. 56 Canada market, 2018 - 2030 (USD Billion)
Fig. 57 Europe market, 2018 - 2030 (USD Billion)
Fig 58 UK market, 2018 - 2030 (USD Billion)
Fig. 59 Germany market, 2018 - 2030 (USD Billion)
Fig. 60 France market, 2018 - 2030 (USD Billion)
Fig. 61 Italy market, 2018 - 2030 (USD Billion)
Fig. 62 Spain market, 2018 - 2030 (USD Billion)
Fig. 63 Netherlands market, 2018 - 2030 (USD Billion)
Fig. 64 Belgium market, 2018 - 2030 (USD Billion)
Fig. 65 Sweden market, 2018 - 2030 (USD Billion)
Fig. 66 Switzerland market, 2018 - 2030 (USD Billion)
Fig. 67 Russia market, 2018 - 2030 (USD Billion)
Fig. 68 Asia Pacific market, 2018 - 2030 (USD Billion)
Fig. 69 China market, 2018 - 2030 (USD Billion)
Fig. 70 India market, 2018 - 2030 (USD Billion)
Fig. 71 Japan market, 2018 - 2030 (USD Billion)
Fig. 72 Australia market, 2018 - 2030 (USD Billion)
Fig. 73 South Korea market, 2018 - 2030 (USD Billion)
Fig. 74 Malaysia market, 2018 - 2030 (USD Billion)
Fig. 75 New Zealand market, 2018 - 2030 (USD Billion)
Fig. 76 Philippines market, 2018 - 2030 (USD Billion)
Fig. 77 Thailand market, 2018 - 2030 (USD Billion)
Fig. 78 Singapore market, 2018 - 2030 (USD Billion)
Fig. 79 Latin America market, 2018 - 2030 (USD Billion)
Fig. 80 Brazil market, 2018 - 2030 (USD Billion)
Fig. 81 Mexico market, 2018 - 2030 (USD Billion)
Fig. 82 Argentina market, 2018 - 2030 (USD Billion)
Fig. 83 Colombia market, 2018 - 2030 (USD Billion)
Fig. 84 Chile market, 2018 - 2030 (USD Billion)
Fig. 85 MEA market, 2018 - 2030 (USD Billion)
Fig. 86 South Africa market, 2018 - 2030 (USD Billion)
Fig. 87 Saudi Arabia market, 2018 - 2030 (USD Billion)
Fig. 88 Israel market, 2018 - 2030 (USD Billion)
Fig. 89 Egypt market, 2018 - 2030 (USD Billion)
Fig. 90 UAE market, 2018 - 2030 (USD Billion)


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