USD 1.48 Billion
Pharmaceutical Sterility Testing Market Size, Share, Growth Analysis, By Type(In-house, and Outsourcing), By Sample(Pharmaceuticals, Medical Devices, and Biopharmaceuticals), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35I2168 |
Region:
Global |
Published Date: April, 2024
Pages:
157
|Tables:
62
|Figures:
75
Pharmaceutical Sterility Testing Market Insights
Global Pharmaceutical Sterility Testing Market size was valued at USD 1.48 Billion in 2022 and is poised to grow from USD 1.66 Billion in 2023 to USD 4.10 Billion by 2031, at a CAGR of 12% during the forecast period (2024-2031).
The global pharmaceutical sterility testing market is driven by the increasing regulatory requirements for sterility testing, rising demand for quality pharmaceutical products, and the growing emphasis on drug safety and efficacy. The purpose of the pharmaceutical sterility testing market is to ensure the safety and efficacy of drugs and other pharmaceutical products by testing them for the absence of viable microorganisms. Sterility testing is required by regulatory agencies to ensure that drugs and other medical products are free of microbial contamination, which can cause serious adverse effects in patients. The major driving factors for the pharmaceutical sterility testing market include increasing regulatory requirements for sterility testing, the rising demand for quality pharmaceutical products, and the growing emphasis on drug safety and efficacy.
Regulatory agencies such as the US FDA and the European Medicines Agency (EMA) require that all drugs and medical products be tested for sterility to ensure their safety and efficacy. As a result, the demand for pharmaceutical sterility testing has increased significantly in recent years. The major restraining factor for the pharmaceutical sterility testing market is the high cost of testing products and services. Sterility testing is a complex and time-consuming process that requires specialized equipment and trained personnel. This can be a barrier to entry for some companies and may limit the growth of the market.
The major challenges facing the pharmaceutical sterility testing market is the increasing complexity of pharmaceutical products. New drug formulations and delivery methods can make it challenging to develop and validate effective sterility testing methods. In addition, the variability of microbial contamination can make it difficult to develop reliable and sensitive testing methods that can detect all potential contaminants. The key opportunities for the pharmaceutical sterility testing market is the increasing demand for outsourcing services. Many pharmaceutical companies are outsourcing their sterility testing to specialized contract testing organizations, which offer specialized expertise, equipment, and services. This trend is expected to continue, driven by the increasing regulatory requirements for sterility testing and the growing complexity of pharmaceutical products. The increasing demand for personalized medicine and biologics is expected to create new opportunities for the pharmaceutical sterility testing market.
US Pharmaceutical Sterility Testing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Outsourcing
Fastest Growth
In-house
Growth Rate
12% CAGR
Global Pharmaceutical Sterility Testing Market ($ Bn)
Country Share for Asia Pacific Region (%)
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Pharmaceutical Sterility Testing Market Segmental Analysis
The global pharmaceutical sterility testing market is segmented on the basis of type, application, and region. Based on type, the market is segmented into in-house, and outsourcing. In terms of sample, the market is grouped into pharmaceuticals, medical devices, and biopharmaceuticals. By region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Pharmaceutical Sterility Testing Market Analysis by Type
In 2022, the outsourcing segment held the majority market share of 55.0%. The market is divided into two segments, outsourcing and in-house. Outsourcing sterility testing is a popular option for small and medium-sized pharmaceutical and medical device companies who may not have the infrastructure to conduct quality sterility testing and prefer to outsource these services to meet FDA requirements. outsourcing can save time and cost for these companies as they don't have to invest in hiring and training employees or purchasing new equipment. Large pharmaceutical companies also prefer to outsource sterility testing to focus on their core competencies like research and development and marketing, thus contributing to the growth of the outsourcing segment.
The in-house segment is expected to grow at a CAGR of 12.3% during the forecast period. Quality and compliance issues associated with outsourcing pharmaceutical sterility testing are expected to promote the growth of the in-house segment. Small outsourcing firms may lack the necessary infrastructure, which can impact the quality of sterility testing. This factor is likely to increase demand for in-house pharmaceutical sterility testing in the market.
Pharmaceutical Sterility Testing Market Analysis by Sample
In 2022, the global pharmaceutical sterility testing market, pharmaceuticals held the largest market share of 38.7%. The market is segmented based on the sample, with pharmaceuticals, medical devices, and biopharmaceuticals being the categories. Pharmaceuticals include various dosage forms such as parenteral, aerosols, ointments, eye drops, and others, which are widely used globally. The increasing demand for these dosage forms is one of the primary factors driving the market's growth. Additionally, the growing number of recalls of these dosage forms due to the lack of sterility is further boosting the demand for sterility testing in the pharmaceutical industry. The biopharmaceutical segment is expected to grow at a CAGR of 12.7% during the forecast period. This growth is attributed to the rising demand for biologics and biosimilar drugs, which are highly effective in treating serious diseases such as cancer, neurological disorders, and infectious diseases.
Global Pharmaceutical Sterility Testing Market Size By Type
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Pharmaceutical Sterility Testing Market Regional Insights
In 2022, Asia Pacific dominated the global pharmaceutical sterility testing market. The market growth in the region is fueled by the increasing preference for alternative supplements and the adoption of modern lifestyles that demand the consumption of caffeinated drinks. As an example, in February 2021, Heineken Asia Pacific Beverages entered the energy drink market by using natural ingredients such as caffeine, which is attractive to health-conscious consumers. The consumption of energy drinks in the region is expected to increase as they claim to improve performance, endurance, and alertness, thus increasing their visibility among consumers.
Europe is expected to witness a CAGR of 7.6% during the forecast period. The trend of declaring the nutritional value of products on labels is likely to attract more consumers to Pharmaceutical Sterility Testing in the future. For instance, Prinova Europe launched a high-purity trehalose ingredient, enduro carb, for athletic endurance. The ingredient is slow-acting and double-sugar, designed to fuel muscles over extended periods. Additionally, the market growth in the region will be supported by the benefits of Pharmaceutical Sterility Testing such as increased cognitive performance, improved attention, and reaction speed, primarily due to caffeine.
Global Pharmaceutical Sterility Testing Market Size By Region
- Largest
- Fastest
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Pharmaceutical Sterility Testing Market Dynamics
Pharmaceutical Sterility Testing Market Drivers
Growing Demand for Biologics and Biosimilar Drugs
- The demand for biologics and biosimilar drugs has been increasing in recent years due to their effectiveness in treating serious diseases such as cancer, neurological disorders, and infectious diseases. This has led to a rise in demand for pharmaceutical sterility testing to ensure the safety and efficacy of these products. The approval of several biosimilar drugs in the past few years, such as Trastuzumab, Rituximab, and Adalimumab, has driven the growth of the pharmaceutical sterility testing market.
Increasing Regulatory Requirements for Pharmaceutical Sterility Testing
- Regulatory bodies such as the FDA and EMA require pharmaceutical companies to conduct sterility testing to ensure that their products are safe for use. This has led to a rise in demand for sterility testing services, which is expected to drive the growth of the market.
Pharmaceutical Sterility Testing Market Restraints
High Cost of Testing Services
- The high cost of pharmaceutical sterility testing services can be a significant barrier for many customers, especially in emerging markets or low-resource settings. Small and medium-sized pharmaceutical and medical device companies may lack the infrastructure to conduct quality sterility testing and therefore prefer to outsource these services to pass the FDA requirements.
Lack of Standardization of Testing Methods
- The lack of standardization of Mycoplasma testing methods can lead to variability and inconsistency in the results, making it challenging to compare and interpret data across different laboratories and applications. Differences in testing methods and equipment can lead to varying results in sterility testing, making it difficult for regulators and companies to make accurate comparisons between different products.
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Pharmaceutical Sterility Testing Market Competitive Landscape
The global pharmaceutical sterility testing market is highly fragmented, with several players operating in the market. Other companies are also investing in research and development activities to develop new and advanced testing methods to meet the increasing demand for sterility testing services. These initiatives are expected to drive the growth of the market and create opportunities for new entrants in the market. The company's microbiology testing services include microbial enumeration, bacterial endotoxin testing, microbial identification, sterility testing, and microbial limits testing.
Pharmaceutical Sterility Testing Market Top Player’s Company Profiles
- Charles River Laboratories International, Inc. (US)
- Eurofins Scientific (Luxembourg)
- Merck KGaA (Germany)
- Thermo Fisher Scientific Inc. (US)
- SGS SA (Switzerland)
- WuXi AppTec (China)
- bioMérieux SA (France)
- Nelson Laboratories, LLC (US)
- Pace Analytical Services, LLC (US)
- Toxikon Corporation (US)
- Sartorius AG (Germany)
- STERIS plc (US)
- Microbac Laboratories, Inc. (US)
- North American Science Associates, Inc. (US)
- Gibraltar Laboratories (US)
- Boston Analytical, Inc. (US)
- Analytical Lab Group (US)
- Becton, Dickinson and Company (US)
- Pacific Biolabs (US)
- Dynatec Labs (US)
Pharmaceutical Sterility Testing Market Recent Developments
- In March 2024, the Prange Group and its affiliate Adragos Pharma, one of Europe’s fastest growing CDMOs, completed the acquisition transaction of Fresenius Kabi production site in Halden, Norway - a leading sterile pharmaceutical manufacturing unit.
- In July 2023, ten23 health, the Basel-based partner to the pharmaceutical industry set up the new QC division to support release and stability testing of clinical and commercial sterile drug products according to international cGMP standards.
- In October 2022, Tema Sinergie launched four-glove pharmaceutical isolator for sampling sterile powders.
Pharmaceutical Sterility Testing Key Market Trends
- Increasing Adoption of Rapid Microbial Detection Technologies: Technologies for rapid microbial detection are becoming more and more common in the pharmaceutical sector as a result of their potential to speed up findings and shorten testing timeframes. In the upcoming years, it is predicted that this tendency will persist.
- Growing Demand for Outsourcing Sterility Testing Services: Many pharmaceutical and medical device companies are choosing to outsource their sterility testing services to specialized companies to save time and costs. This trend is expected to continue due to the increasing complexity of regulatory requirements and the need for specialized expertise in sterility testing.
Pharmaceutical Sterility Testing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our global pharmaceutical sterility testing market analyses, the market is expected to grow at a CAGR of 11.5% during the forecast period of 2023-2030. The market growth can be attributed to the increasing demand for quality sterility testing of pharmaceutical and medical devices, growing number of pharmaceutical and biopharmaceutical companies, and stringent regulatory requirements for sterility testing. The advantages of outsourcing such as saving time and cost for companies, and lack of infrastructure for small and medium-sized companies. The in-house segment is expected to grow with a CAGR of 12.3% during the forecast period due to quality issues and compliance issues associated with outsourcing. the growing demand for dosage forms such as parenteral, aerosols, ointments, and eye drops.
The global pharmaceutical sterility testing market is expected to witness significant growth during the forecast period due to the increasing demand for quality sterility testing and the presence of a large number of pharmaceutical and biopharmaceutical companies.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 1.48 Billion |
| Market size value in 2031 | USD 4.10 Billion |
| Growth Rate | 12% |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Pharmaceutical Sterility Testing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Pharmaceutical Sterility Testing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Pharmaceutical Sterility Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Pharmaceutical Sterility Testing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Pharmaceutical Sterility Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Pharmaceutical Sterility Testing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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