Product Code: PH 7264
"The bioprocess validation market is estimated to grow at a CAGR of 14.6%"
The global bioprocess validation market is exceeded USD 180 million in 2019 and is projected to be valued over USD 360 million by 2024, at a CAGR of 14.6% during the forecast period. The growth of the bioprocess validation services market is driven primarily by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries. This has also stimulated the demand for the outsourcing of bioprocess validation services. The rising R&D spending in the life science industry has contributed to this demand significantly, while the growing demand for bioprocess validation in emerging countries and patent expiries have ensured steady market growth. However, the issues related to extractable and leachable testing affect market growth to a certain extent during the forecast period.
"Extractables/leachables testing services segment to witness the highest growth during the forecast period"
The combination systems segment is estimated to grow at the highest CAGR during the forecast period. This can primarily be attributed to increasing outsourcing of testing services by biopharmaceutical manufacturers; the presence of regulatory mandates and guidelines regarding the testing of extractables & leachables; and growing product safety, identity, purity, and quality; and the increasing risk of product adulteration related requirement.
"Filter elements segment to grow at the highest CAGR in the bioprocess validation market, by process component"
The major factors driving the demand for filter elements in bioprocess validation are stringent regulations and industry standards for biopharmaceutical products; increasing usage of a variety of filters in bioprocessing; and the high demand for the evaluation of specific filter elements and their impact on the final drug product owing to the factors such as safety and efficacy of biopharmaceutical products.
"APAC market to witness the highest growth during the forecast period"
The Asia Pacific is estimated to be the fastest-growing regional market for bioprocess validation during the forecast period. The growing biopharmaceutical manufacturing capabilities in Asian countries, increasing demand for outsourcing bioprocess validation, growing life science research specific to biologics, increasing investments by pharmaceutical & biotechnology companies, rising awareness about the advantages of biopharmaceutical drugs, increasing number of CROs & CDMOs, and the favorable government initiatives to promote the growth of the pharmaceutical & biotechnology industries in several APAC countries are some of the major factors driving the growth of this market.
A breakdown of the primary participants in this report is provided below:
- By Company Type: Tier 1-46%, Tier 2-33%, and Tier 3-21%
- By Designation: C-level-43%, Director Level-35%, and Others-22%
- By Region: North America-34%, Europe-26%, Asia Pacific-19%, Latin America-11%, and the Middle East & Africa-10%
The prominent players operating in the global bioprocess validation market are: Merck KGaA (Germany), SGS S.A. (Switzerland), Eurofins Scientific (Luxembourg), Sartorius Stedim Biotech (France), Pall Corporation (US), Cobetter Filtration Equipments Co., Ltd. (China), Toxikon Corporation (US), DOC S.r.l. (Italy), MEISSNER FILTRATION PRODUCTS, INC. (US), and Thermo Fisher Scientific (US).
Research Coverage:
This report analyzes the market for various bioprocess validation and their adoption patterns. It aims at estimating the size and future growth potential of the global bioprocess validation market as well as its segments (by test type, process component, end-user, and region). The report also includes an in-depth competitive analysis of key market players along with their company profiles, service offerings, and recent developments.
Reasons to Buy the Report:
This report will enrich established firms as well as new entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them garner a greater share. Firms purchasing the report could use one, or any combination of the below mentioned five strategies for strengthening their market presence.
- Market Penetration: Comprehensive information on the service portfolios offered by the top players in the global bioprocess validation market
- Service Development/Innovation: Detailed insights on the upcoming trends, R&D activities, and service launches in the global bioprocess validation market
- Market Development: Comprehensive information on the lucrative emerging regions
- Market Diversification: Exhaustive information about new services, growing geographies, and recent developments in the global bioprocess validation market
- Competitive Assessment: In-depth assessment of services offered, market shares, growth strategies, and revenue analysis of leading players in the global bioprocess validation market
TABLE OF CONTENTS
1 INTRODUCTION
- 1.1 OBJECTIVES OF THE STUDY
- 1.2 MARKET DEFINITION
- 1.3 MARKET SCOPE
- 1.3.1 MARKETS COVERED
- 1.3.2 YEARS CONSIDERED FOR THE STUDY
- 1.4 CURRENCY
- 1.5 LIMITATIONS
- 1.6 STAKEHOLDERS
2 RESEARCH METHODOLOGY
- 2.1 RESEARCH DATA
- 2.1.1 SECONDARY DATA
- 2.1.1.1 Key data from secondary sources
- 2.1.2 PRIMARY DATA
- 2.1.2.1 Key data from primary sources
- 2.1.2.2 Key industry insights
- 2.2 MARKET SIZE ESTIMATION
- 2.3 MARKET BREAKDOWN AND DATA TRIANGULATION
- 2.4 ASSUMPTIONS FOR THE STUDY
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
- 4.1 BIOPROCESS VALIDATION SERVICES: MARKET OVERVIEW
- 4.2 ASIA PACIFIC: BIOPROCESS VALIDATION SERVICES MARKET, BY END USER (2018)
- 4.3 GEOGRAPHICAL SNAPSHOT OF THE BIOPROCESS VALIDATION SERVICES MARKET
- 4.4 REGIONAL MIX: BIOPROCESS VALIDATION SERVICES MARKET
- 4.5 BIOPROCESS VALIDATION SERVICES MARKET: DEVELOPING VS. DEVELOPED COUNTRIES
5 MARKET OVERVIEW
- 5.1 INTRODUCTION
- 5.2 MARKET DYNAMICS: IMPACT ANALYSIS
- 5.2.1 DRIVERS
- 5.2.1.1 Stringent safety and quality regulations
- 5.2.1.2 Increasing demand for biopharmaceuticals
- 5.2.1.3 Increasing demand for outsourcing bioprocess validation
- 5.2.1.4 Rising life science R&D expenditure
- 5.2.2 RESTRAINTS
- 5.2.2.1 Issues related to extractables & leachables
- 5.2.3 OPPORTUNITIES
- 5.2.3.1 Growth opportunities in Asia Pacific and Latin American countries
- 5.2.3.2 Patent expiry
- 5.2.4 CHALLENGES
- 5.2.4.1 Waste disposal
- 5.2.4.2 Development of new validation methods for next generation bioproducts
6 INDUSTRY INSIGHTS
- 6.1 INDUSTRY TRENDS
- 6.1.1 AUTOMATION IN BIOPROCESS VALIDATION SERVICES
- 6.1.2 GEOGRAPHIC EXPANSIONS BY MARKET PLAYERS
- 6.2 REGULATORY GUIDELINES FOR BIOPROCESS VALIDATION
7 BIOPROCESS VALIDATION SERVICES MARKET, BY TEST TYPE
- 7.1 INTRODUCTION
- 7.2 EXTRACTABLES/LEACHABLES TESTING SERVICES
- 7.2.1 SPECIFICATIONS AND GUIDELINES FOR EXTRACTABLES/ LEACHABLES TESTING HAVE ENSURED THE CONTINUED DEMAND FOR THESE SERVICES
- 7.3 MICROBIOLOGICAL TESTING SERVICES
- 7.3.1 LARGE-SCALE EUKARYOTIC CELL CULTURE TESTING SERVICES
- 7.3.1.1 North America shows the highest demand for large-scale eukaryotic cell culture testing services
- 7.3.2 VIRUS PRODUCTION & PURIFICATION TESTING SERVICES
- 7.3.2.1 Increased concerns of viral contaminant presence in raw materials are driving the adoption of testing services
- 7.3.3 ELECTRON MICROSCOPY TESTING SERVICES
- 7.3.3.1 Electron microscopy provides high-resolution images of specimens present in bioprocesses
- 7.4 PHYSIOCHEMICAL TESTING SERVICES
- 7.4.1 NEED FOR DETECTION AND CHARACTERIZATION OF IMPURITIES IN THE FINAL PRODUCT IS DRIVING MARKET GROWTH
- 7.5 INTEGRITY TESTING SERVICES
- 7.5.1 INTEGRITY TESTING IS VITAL TO DETECT WEAR AND TEAR AND PRESSURE-CAUSED DAMAGE
- 7.6 COMPATIBILITY TESTING SERVICES
- 7.6.1 DEMAND FOR EVALUATING PROCESS COMPONENT-FORMULATION INTERACTION HAS NECESSITATED COMPATIBILITY TESTING
- 7.7 OTHER TESTING SERVICES
8 BIOPROCESS VALIDATION SERVICES MARKET, BY PROCESS COMPONENT
- 8.1 INTRODUCTION
- 8.2 FILTER ELEMENTS
- 8.2.1 STRINGENT REGULATIONS FOR BIOPHARMACEUTICAL PRODUCTS ARE DRIVING THE GROWTH OF THIS SEGMENT
- 8.3 MEDIA CONTAINERS AND BAGS
- 8.3.1 VALIDATION AND QUALIFICATION OF MEDIA CONTAINERS AND BAGS IS NECESSARY TO MAINTAIN THE SAFETY OF THE FINAL BIOPHARMACEUTICAL PRODUCT
- 8.4 FREEZING AND THAWING PROCESS BAGS
- 8.4.1 THE HIGH RISK OF SEAL LEAKS IN THE PRE-FREEZING AND THAWING STAGE IS DRIVING MARKET GROWTH
- 8.5 MIXING SYSTEMS
- 8.5.1 GROWING NEED TO MEET FDA AND OTHER REGULATORY GUIDELINES DURING THE MIXING OF INGREDIENTS TO MAINTAIN PRODUCT QUALITY IS A KEY DRIVER
- 8.6 BIOREACTORS
- 8.6.1 BIOPHARMACEUTICAL COMPANIES ARE INCREASINGLY ADOPTING BIOPROCESS VALIDATION SERVICES FOR BIOREACTORS TO LOWER THE RISK OF CROSS-CONTAMINATION
- 8.7 TRANSFER SYSTEMS
- 8.7.1 THE NECESSITY TO MAINTAIN STERILE CONDITIONS DURING TRANSFER IS DRIVING THE MARKET
- 8.8 OTHER PROCESS COMPONENT
9 BIOPROCESS VALIDATION SERVICES MARKET, BY END USER
- 9.1 INTRODUCTION
- 9.2 PHARMACEUTICAL COMPANIES
- 9.2.1 INCREASING PRODUCTION VOLUME HAS ENABLED PHARMA COMPANIES TO DOMINATE THE END-USER MARKET
- 9.3 CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATIONS
- 9.3.1 EMERGING COUNTRIES HAVE BECOME KEY HUBS FOR THE OUTSOURCING OF PRODUCTION AND VALIDATION PROCESSES
- 9.4 BIOTECHNOLOGY COMPANIES
- 9.4.1 NEED FOR REGULATORY COMPLIANCE HAS DRIVEN THE DEMAND FOR BIOPROCESS VALIDATION IN BIOTECH COMPANIES
- 9.5 OTHER END USERS
10 BIOPROCESS VALIDATION SERVICES MARKET, BY REGION
- 10.1 INTRODUCTION
- 10.2 NORTH AMERICA
- 10.2.1 US
- 10.2.1.1 US dominated the North American bioprocess validation services market in 2018
- 10.2.2 CANADA
- 10.2.2.1 Growing investments in the Canadian biopharmaceuticals sector to support market growth during the forecast period
- 10.3 EUROPE
- 10.3.1 GERMANY
- 10.3.1.1 Germany accounted for the largest share of the European bioprocess validation services market in 2018
- 10.3.2 FRANCE
- 10.3.2.1 High demand for biologics and implementation of favorable government initiatives to drive the demand for bioprocess validation services in France
- 10.3.3 UK
- 10.3.3.1 Growing demand for outsourcing compliance-related testing services in biopharmaceutical production to support market growth in the UK
- 10.3.4 ITALY
- 10.3.4.1 Growing biopharmaceutical manufacturing to drive the adoption of bioprocess validation services in Italy
- 10.3.5 SPAIN
- 10.3.5.1 High consumption of biologics to support the growth of the bioprocess validation services market in Spain
- 10.3.6 REST OF EUROPE
- 10.4 ASIA PACIFIC
- 10.4.1 CHINA
- 10.4.1.1 China is one of the most-preferred destinations for leading biopharmaceutical companies for biologics production
- 10.4.2 JAPAN
- 10.4.2.1 Japan is one of the largest and most established markets for pharmaceutical products in the Asia Pacific
- 10.4.3 INDIA
- 10.4.3.1 Rising volume of biopharmaceutical production to drive market growth in India
- 10.4.4 REST OF ASIA PACIFIC
- 10.5 LATIN AMERICA
- 10.5.1 BRAZIL
- 10.5.1.1 Growing investments in biopharmaceutical research to drive market growth in Brazil
- 10.5.2 MEXICO
- 10.5.2.1 Strong presence of global pharmaceutical companies in the country to support market growth
- 10.5.3 REST OF LATIN AMERICA
- 10.6 MIDDLE EAST & AFRICA
11 COMPETITIVE LANDSCAPE
- 11.1 OVERVIEW
- 11.2 MARKET SHARE ANALYSIS
- 11.3 COMPETITIVE LEADERSHIP MAPPING, 2018
- 11.4 VENDOR INCLUSION CRITERIA
- 11.5 VENDOR DIVE
- 11.5.1 VISIONARY LEADERS
- 11.5.2 INNOVATORS
- 11.5.3 EMERGING COMPANIES
- 11.5.4 DYNAMIC DIFFERENTIATORS
- 11.6 COMPETITIVE SITUATIONS AND TRENDS
- 11.6.1 ACQUISITIONS
- 11.6.2 COLLABORATIONS, PARTNERSHIPS, AND AGREEMENTS
- 11.6.3 SERVICE LAUNCHES
- 11.7 SERVICE PORTFOLIO ANALYSIS
- 11.7.1 SERVICE PORTFOLIO ANALYSIS
12 COMPANY PROFILES
(Business overview, Services offered, Recent developments, MNM view, SWOT analysis)*
- 12.1 MERCK KGAA
- 12.2 PALL CORPORATION (A PART OF DANAHER CORPORATION)
- 12.3 SARTORIUS STEDIM BIOTECH S.A.
- 12.4 SGS S.A.
- 12.5 EUROFINS SCIENTIFIC
- 12.6 COBETTER FILTRATION EQUIPMENT CO., LTD.
- 12.7 TOXIKON CORPORATION
- 12.8 DOC S.R.L.
- 12.9 MEISSNER FILTRATION PRODUCTS, INC.
- 12.10 THERMO FISHER SCIENTIFIC, INC.
- 12.11 ADDITIONAL COMPANY PROFILES
- 12.11.1 PORVAIR PLC
- 12.11.2 BIOZEEN
- 12.11.3 TIANSHAN (TS FILTER) PRECISION FILTER MATERIAL CO., LTD.
- 12.11.4 HANGZHOU ANOW MICROFILTRATION CO., LTD.
- 12.11.5 ALMAC GROUP
Business overview, Services offered, Recent developments, MNM view, SWOT analysis might not be captured in case of unlisted companies.
13 APPENDIX
- 13.1 INSIGHTS OF INDUSTRY EXPERTS
- 13.2 DISCUSSION GUIDE
- 13.3 KNOWLEDGE STORE: MARKETSANDMARKETS' SUBSCRIPTION PORTAL
- 13.4 AVAILABLE CUSTOMIZATIONS
- 13.5 RELATED REPORTS
- 13.6 AUTHOR DETAILS
