The global Good Manufacturing Practices (GMP) testing service market was valued at $1,314.6 million in 2021 and is projected to reach $2.514.37 million by 2031 registering a CAGR of 6.7% from 2022 to 2031.
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practices cover all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors. This protects the consumers from purchasing a service which is not effective or even dangerous. GMP regulations address issues which include record keeping, personal qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
The main driving factors that foster the growth of the GMP testing service market are rise in applications of GMP testing service in various fields such as pharmaceutical industries, chemical industry, food industry, environmental testing laboratories, and forensic science. In addition, the rise in number of players globally in the pharmaceutical and biopharmaceutical sector is one of the basic drivers of the GMP testing service. The need to disclose quality assurance parameters is anticipated to be one of the primary surging factor for GMP testing products. Moreover, the need of aseptic and sterile production machineries and spaces is expected to boost the growth of GMP testing service. The demand for GMP testing service is expected to increase with rise in need for innovator drugs and unique medical devices.
In addition, according to U.S Food & Drug Administration in 2019, there were approximately 4,676 manufacturing sites for drugs. There is an increase in the demand for developing new drugs and pharmaceuticals. This boosts the growth of the GMP testing service market. Moreover, for instance, in April 2021, PPD Inc., a leading global contract research organization, announced its plans to expand Good Manufacturing Practice lab in Ireland to enhance its biopharmaceutical testing capabilities. These factors foster the growth of the market.
The development of biosimilars, combination products, and other innovative medicines has increased the demand for specific testing procedures. Furthermore, several biopharmaceutical companies are using bioanalytical testing outsourcing service for drug development and validation of assays at both clinical and preclinical stages, thus supporting the growth of the market. Moreover, generic and branded drug compounds are mostly small molecules. Generic manufacturers have to conduct and submit bioanalytical testing results due to increase in patent expiration. This in turn, drives the adoption of bioanalytical testing for small molecules, which boosts the market growth. Furthermore, rise in number of contract manufacturing units, and increase in need for developing novel devices and drugs propel the growth of the market. For instance, according to an article entitled 'Current perspectives on biosimilars' published in the Journal of Industrial Microbiology & Biotechnology in July 2019, almost 300 biopharmaceuticals have been patented in the last three decades. Also, in February 2021, according to the International Federation of Pharmaceutical Manufacturers and Associations, approximately 382 vaccine candidates were in phase III trial. Thus, these aforementioned factors have increased the growth of the market.
For instance, according to Congressional Budget Office 2021, the pharmaceutical business invested &83 billion in research and development. This results in rise the market growth. In addition, academic institutions are also partnering with biopharmaceutical companies to monitor the innovation and acquire expertise in drug discovery and development. The biopharmaceutical companies prefer to outsource manufacturing in markets where they have limited expertise in various stages of value chain, especially towards the end where CDMO’s presence in a particular region gives them access to a vast distribution network as well as knowledge of existing regulatory guidelines. This factor drives the growth of GMP testing service market. Moreover, the Merck’s BioReliance testing service is the leading GMP testing service provider for the development of therapeutics. In biopharmaceutical manufacturing, every product produced for preclinical and clinical studies, as well as for the global pharmaceutical markets, requires testing to demonstrate regulatory guideline compliance. Thus, availability of numerous testing service and surge in usage of testing service due to increase in pharmaceutical production contributes toward the market growth. However, the precise requirement of the regulatory framework concerning GMP outsourced activities is projected to hinder the market growth. In contrast, adoption of GMP testing service in R&D are some of the factors expected to offer lucrative growth opportunities for players in the GMP testing service market.
The GMP testing service market is segmented on the basis of service type, end user and region. On the basis of service type, the market is divided into product validation testing, bioanalytical service, packaging and shelf life testing, and others. By end user, it is categorized into pharmaceutical & bio-pharmaceutical company and medical device company. By region, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. The key players mentioned in the report are Almac Group, Charles River Laboratories, Intertek Group Plc, Icon Inc., Eurofins Scientific SE, Microchem Laboratory, Merck KgaA, Nelson Laboratories, Sartorious AG, and Wuxi App Tec
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practices cover all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors. This protects the consumers from purchasing a service which is not effective or even dangerous. GMP regulations address issues which include record keeping, personal qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
The main driving factors that foster the growth of the GMP testing service market are rise in applications of GMP testing service in various fields such as pharmaceutical industries, chemical industry, food industry, environmental testing laboratories, and forensic science. In addition, the rise in number of players globally in the pharmaceutical and biopharmaceutical sector is one of the basic drivers of the GMP testing service. The need to disclose quality assurance parameters is anticipated to be one of the primary surging factor for GMP testing products. Moreover, the need of aseptic and sterile production machineries and spaces is expected to boost the growth of GMP testing service. The demand for GMP testing service is expected to increase with rise in need for innovator drugs and unique medical devices.
In addition, according to U.S Food & Drug Administration in 2019, there were approximately 4,676 manufacturing sites for drugs. There is an increase in the demand for developing new drugs and pharmaceuticals. This boosts the growth of the GMP testing service market. Moreover, for instance, in April 2021, PPD Inc., a leading global contract research organization, announced its plans to expand Good Manufacturing Practice lab in Ireland to enhance its biopharmaceutical testing capabilities. These factors foster the growth of the market.
The development of biosimilars, combination products, and other innovative medicines has increased the demand for specific testing procedures. Furthermore, several biopharmaceutical companies are using bioanalytical testing outsourcing service for drug development and validation of assays at both clinical and preclinical stages, thus supporting the growth of the market. Moreover, generic and branded drug compounds are mostly small molecules. Generic manufacturers have to conduct and submit bioanalytical testing results due to increase in patent expiration. This in turn, drives the adoption of bioanalytical testing for small molecules, which boosts the market growth. Furthermore, rise in number of contract manufacturing units, and increase in need for developing novel devices and drugs propel the growth of the market. For instance, according to an article entitled 'Current perspectives on biosimilars' published in the Journal of Industrial Microbiology & Biotechnology in July 2019, almost 300 biopharmaceuticals have been patented in the last three decades. Also, in February 2021, according to the International Federation of Pharmaceutical Manufacturers and Associations, approximately 382 vaccine candidates were in phase III trial. Thus, these aforementioned factors have increased the growth of the market.
For instance, according to Congressional Budget Office 2021, the pharmaceutical business invested &83 billion in research and development. This results in rise the market growth. In addition, academic institutions are also partnering with biopharmaceutical companies to monitor the innovation and acquire expertise in drug discovery and development. The biopharmaceutical companies prefer to outsource manufacturing in markets where they have limited expertise in various stages of value chain, especially towards the end where CDMO’s presence in a particular region gives them access to a vast distribution network as well as knowledge of existing regulatory guidelines. This factor drives the growth of GMP testing service market. Moreover, the Merck’s BioReliance testing service is the leading GMP testing service provider for the development of therapeutics. In biopharmaceutical manufacturing, every product produced for preclinical and clinical studies, as well as for the global pharmaceutical markets, requires testing to demonstrate regulatory guideline compliance. Thus, availability of numerous testing service and surge in usage of testing service due to increase in pharmaceutical production contributes toward the market growth. However, the precise requirement of the regulatory framework concerning GMP outsourced activities is projected to hinder the market growth. In contrast, adoption of GMP testing service in R&D are some of the factors expected to offer lucrative growth opportunities for players in the GMP testing service market.
The GMP testing service market is segmented on the basis of service type, end user and region. On the basis of service type, the market is divided into product validation testing, bioanalytical service, packaging and shelf life testing, and others. By end user, it is categorized into pharmaceutical & bio-pharmaceutical company and medical device company. By region, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. The key players mentioned in the report are Almac Group, Charles River Laboratories, Intertek Group Plc, Icon Inc., Eurofins Scientific SE, Microchem Laboratory, Merck KgaA, Nelson Laboratories, Sartorious AG, and Wuxi App Tec
KEY BENEFITS FOR STAKEHOLDERS
- This report provides an extensive analysis of the current and emerging market trends and dynamics in the global GMP testing services market to identify the prevailing opportunities.
- This study presents the competitive landscape of the global market to predict the competitive environment across geographies.
- Comprehensive analysis of factors that drive and restrict the market growth is provided.
- Region- & country-wise analysis is provided to understand the market trends and dynamics.
Key Market Segments
By Service Type
- Packaging and Shelf-Life Testing
- Others
- Product Validation Testing
- Bioanalytical Services
By End User
- Pharmaceutical and Biopharmaceutical Companies
- Medical Device Companies
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Spain
- Rest of Europe
- Germany
- France
- U.K.
- Italy
- Asia-Pacific
- Japan
- China
- Australia
- India
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- almac group
- Charles River Laboratory
- Intertek Group PLC
- Merck KgaA
- Eurofins Scientific
- Nelson Laboratories
- Wuxi App Tec
- Sartorius AG
- ICON INC.
- Microchem Laboratory
Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: GMP TESTING SERVICE MARKET, BY SERVICE TYPE
CHAPTER 5: GMP TESTING SERVICE MARKET, BY END USER
CHAPTER 6: GMP TESTING SERVICE MARKET, BY REGION
CHAPTER 7: COMPANY LANDSCAPE
CHAPTER 8: COMPANY PROFILES
List of Tables
List of Figures
Executive Summary
According to the report, titled, “GMP Testing Service Market," the gmp testing service market size was valued at $1.3 billion in 2021, and is estimated to reach $2.5 billion by 2031, growing at a CAGR of 6.7% from 2022 to 2031.Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP constitutes the license to operate in pharmaceutical manufacturing and is a core condition worldwide. However, rules and interpretations differ from country to country and change frequently. GMP guidelines are not prescriptive instructions on how to manufacture product. There are series of general principles that must be applied during manufacturing.
Increase in the import and sale of medicines by large number of key players that have been manufactured to internationally recognized GMP standards, propel the growth of the GMP testing service market. In addition, the biopharmaceutical sector has opened new approaches and collaborations in the industry to respond to the urgent needs of the pandemic. For instance, according to the Center for Disease Control and Prevention data reviewed on 10 January 2022, more than 868,000 Americans die of heart diseases, almost 600,000 die from cancer every year and more than 34.2 from diabetes. Thus, there is an increase in the number of drug manufacturing plants across both developed and emerging countries owing to rise in incidences of deaths, and increase in number of chronic diseases. Hence, these factors are expected to drive the growth of the GMP testing service market.
According to the International Journal of Environmental Research and Public Health published study, in the U.S. and South Korea around 40 medications are recalled per year. This enhances the need for testing the medicines and the manufacturing process, which is further expected to drive GMP testing service market growth. In addition, according to U.S Food and Drug Administration in 2019, there were approximately 4,676 manufacturing sites for drugs and many others are in standby. These factors surge the demand for developing new drugs and pharmaceuticals which is propel the growth of the GMP testing service market. However, high cost of GMP testing service equipment and shortage of skilled professionals to operate GMP testing service instruments are some key challenges that hinder the growth of the market. On the contrary increase in number of pharmaceutical drugs and medical devices manufacturing plants surges the demand for GMP testing service and creates an opportunity for the manufacturers to tap and capitalize in the market.
Outbreak of COVID-19 has positively impacted on GMP testing service market. The lockdowns have shown both demand-side and supply-side impacts on the manufacturing sector. However, people are learning to live with the virus, and all industries have opened with new guidelines and new restrictions. The market witnessed better growth in 2021 than in 2019. According to European Commission, Eurostat 2021, industrial Production in Europe increased by 1.4% in July 2021, and the total Production level was 1.0% in February 2020. Thus, rise in production of new drugs in pharmaceutical industry propel the growth of the market.
The GMP testing industry is segmented on the basis of service type, end user, and region. By service type, the market is segmented into product validation testing, bioanalytical service, packaging and shelf life testing, and others.
By service type, the product validation testing segment dominated the global market in 2021 and is anticipated to remain dominant during the forecast period. This is attributed to, rise in demand for quality and safe management of service. In addition, the bioanalytical service segment is expected to hold higher market share during the forecast period owing to rise in focus on development of bioanalytical testing service. .
By end user, the pharmaceutical and biopharmaceutical companies acquired the largest share in 2021, and is expected to remain dominant throughout the forecast period. This is attributed to the increase in innovation and new service development boost the market growth.
By region, North America accounted for the largest GMP testing service market share in 2021, and is expected to remain dominant throughout the forecast period. This was attributed to the presence of giant biopharmaceutical and pharmaceutical firms in the countries such as the U.S. In addition, increase in frequency of major pharmaceutical companies and their R&D activities drive the demand for GMP testing in the region during the forecast period.
Key Findings of the Study
- This report provides a detailed quantitative analysis of the current GMP testing service market trends and forecast estimations from 2022 to 2031, which assists to identify the prevailing market opportunities.
- On the basis of service type, the product validation testing segment was the highest contributor to the market in 2021.
- On the basis of end user, the pharmaceutical and biopharmaceutical companies segment was the highest contributor to the market in 2021.
- On the basis of region, North America garnered the largest revenue share in 2021, whereas Asia-Pacific is anticipated to grow at the highest 9.0% CAGR during the forecast period.
Companies Mentioned
- Almac Group
- Charles River Laboratory
- Intertek Group plc
- Merck Kgaa
- Eurofins Scientific
- Nelson Laboratories
- Wuxi App Tec
- Sartorius AG
- Icon Inc.
- Microchem Laboratory
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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