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GMP Testing Service Market 2021 - Comprehensive Study Report & Recent Trends By 2027

GMP Testing Service Market Size By Service Type (Product Validation Testing, Bioanalytical Services, Packaging, And Shelf-Life Testing), By End-User (Pharmaceutical And Biopharmaceutical Companies, Medical Devices Company), By Region- Global Market Analysis And Forecast, 2021- 2027

  • Report ID : IMR-15848 |
  • Category : Healthcare  |
  • Published Date : September 2021 |
  • Format :   IMR Report Formats   IMR Report Formats   IMR Report Formats

Global GMP Testing Service Market Overview

The GMP Testing Service Market was valued at USD 1,097.23 Million in 2020, and it is expected to reach USD 1,625.60 Million by 2026, registering a CAGR of 6.97% from 2021 to 2026.

The growth of the GMP testing service market is majorly attributed to the rapidly growing pharmaceutical industry and the increasing trend in drug and device development. The growing burden of chronic diseases, the rising healthcare expenditure, and the upcoming patent expiration of blockbuster drugs are driving the trend of increasing drug and device development by biopharmaceutical companies, which, in turn, is expected to boost the growth of the market studied. Additionally, the increasing research and development activities by the drug manufacturers for the launch of innovative drugs with advanced features and strategic alliances are expected to drive the growth of the market studied. For instance, in March 2020, Existencia, an AI-based drug discovery company, entered a collaborative agreement with Diamond Light Source and Scripps Research for identifying COVID-19 antiviral therapies. Thus, these factors play a vital role in the growth of the GMP testing service market as GMP compliance is a major requirement for any drug and device development. Furthermore, with the increasing focus on the development of novel therapeutics to fight the COVID-19 pandemic by pharmaceutical development, there is an increasing demand for GMP testing services during the pandemic. Hence, all the aforementioned factors are expected to drive the growth of the studied market.

COVID-19 Impact on GMP Testing Service Market

At present, countries across the globe are facing a considerable threat from the COVID-19 pandemic. Many pharmaceutical and biotechnological companies are focusing their R&D activities on manufacturing novel therapeutics and vaccines to meet the increased demand for treating COVID-19 patients. Due to the situation, many pharmaceutical and biotechnological companies have been targeting their R&D departments on recognizing new molecules or leads for the treatment of this disease. Most of the economies have already accepted a vaccine for COVID-19. For instance, in December 2020, the World Health Organization (WHO) issued emergency use validation of the Pfizer/BioNTech COVID-19 mRNA vaccine globally. The increasing number of drugs, vaccines, diagnostics kits, and devices in various phases of development globally to combat the COVID-19 pandemic have resulted in surges in the demand for GMP testing services, which is very crucial at every step of the drug and device development and approval. However, the non-COVID-19 drug and devices development has seen a downward trend due to the postponement of clinical trials during the pandemic, which is expected to impact the market studied during the pandemic.

Market Dynamics And Factors

Drivers:

The Growing Pharmaceutical Industry

The pharmaceutical industries dedicate a large percentage of their budget for internal R&D processes, market expansion in developing countries, and technological advancements. The directly translates to increased expenditure on drug discovery. The production of Biopharmaceuticals has been growing not only by the introduction of novel therapeutics, but also by the introduction of generic Biopharmaceuticals or biosimilars. As many patents have been getting expired, there has been a significant focus on the production of generic pharmaceuticals. Pharma development involves the designing, building, and scaling-up of a process, to transform promising molecules synthesized in research labs into medicines for patient use. To test its purity and tenure, it consistently delivers safe and effective drug levels. The GMP testing service plays an important role; hence, the market is anticipated to grow promptly in the future years. Hence, owing to the growing investment in the pharmaceutical and medical device industry sector and research and development activities in both developed and developing countries, along with growing product approvals, the studied market is expected to propel over the forecast period.

Restraints:

GMP is a regulatory framework to ensure food, pharmaceutical, medical, and cosmetic products. They are consistently produced to provide quality standards, which are appropriate for their intended use and product specifications. These regulatory interventions can be circumvented only by proper research and manufacturing of the biological agents. Thereby, good manufacturing practices play a vital role in every aspect of product development and approvals. In this regard, a stringent regulatory framework has been imposed to prevent any further adverse events by the drugs or devices.

GMP practices are applied to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of pharmaceuticals, devices, dietary supplements, etc. Vaccines and other regulated products undergo a meticulous review of laboratory and clinical data to ensure the safety, efficacy, purity, and potency of these products.

Moreover, the high cost associated with GMP compliance, along with the additional cost of labour, facilities improvements, equipment, sanitation, record-keeping, and other procedures important to GMP compliance, is expected to hinder the market growth.

Opportunities:

The GMP testing service market is expected to witness healthy growth in the coming years, owing to the increasing need of the drug and device manufacturers to compliant the good manufacturing practices in their day-to-day research and development activities, for the smooth approval of the target products by the regulatory bodies. As there has been an increasing focus on the development of numerous therapeutics and medical devices aimed toward providing effective treatment for varied chronic diseases by major pharmaceutical and biopharmaceutical companies, the need for GMP testing services is expected to grow in the future.

Additionally, most of the pharmaceutical companies are involved in outsourcing the GMP service to overcome the financial burden imposed by the product call-backs due to non-compliance with the GMP guidelines. For instance, in March 2021, the US FDA issued a Warning Letter to a Chinese manufacturer, Foshan Biours Biosciences Co. Ltd, of over-the-counter (OTC) drug products due to significant violations of cGMP regulations for finished pharmaceuticals. As per the warning letter, the company failed to follow and establish written procedures for cleaning and maintenance of equipment and a written stability testing program for the respective active ingredient. Thus, owing to the increasing demand for GMP compliance and the strategic initiatives taken by the key players of the studied market, the GMP testing service market is expected to witness steady growth in the future.

Market Segmentation

By Service Type, GMP Testing Service has been segmented into:

  • Product Validation Testing
  • Bioanalytical Services
  • Packaging
  • And Shelf-Life Testing
  • And Other Service Types

By End-User, GMP Testing Service has been segmented into:

  • Pharmaceutical And Biopharmaceutical Companies
  • Medical Devices Company

Regions and Countries Level Analysis:

  • North America (U.S., Canada, Mexico)
  • Europe (Germany, U.K., France, Italy, Russia, Spain etc.)
  • Asia-Pacific (China, India, Japan, Southeast Asia etc.)
  • South America (Brazil, Argentina etc.)
  • Middle East & Africa (Saudi Arabia, South Africa etc.)

Segmentation Insights

Based on Service Type, the product validation testing segment dominated the studied market share with a revenue of USD 497.10 million in 2020 and is expected to register a CAGR over the forecast period. The increasing need for validation and verification of medical devices is leading to increased demand for product validation testing. Pharmaceutical products and medical devices need to follow a set of standards for the assurance of quality. Hence, from the aforementioned factors, the product validation testing segment is estimated to witness high growth over the forecast period. Thus, the bioanalytical testing segment is expected to grow significantly during the forecast period due to the aforementioned factors.

Based on End-Users, the pharmaceutical and biopharmaceutical companies segment dominated the studied market's share with a revenue of USD 844.85 million in 2020 and is expected to register a high CAGR over the forecast period. The novel drug development in the pharmaceutical and biopharmaceutical industry is expected to drive the segment's market growth over the forecast period. With growing research and development activities, there has been an increasing need for GMP testing in the pharmaceutical industry. The medical device manufacturers are creating a high demand for GMP testing services. The COVID-19 pandemic has also increased the demand for medical device GMP testing services as these services are vital in protecting consumers from poor quality, unsafe medical device products.

Regional Insights

The North American region of the market studied dominated with a revenue of USD 465.73 million in 2020, and it is expected to register the highest CAGR over the forecast period. The United States is expected to dominate the global GMP testing service market, throughout the forecast period, due to an increasing number of clinical studies, the presence of key market players, the growing pharmaceutical industry, and increasing drug and devices development.

Countries in the European region also have advanced healthcare and biopharmaceutical infrastructure, which helps set up operations for many companies. Thus, the aforementioned factors are expected to drive the regional market growth in upcoming years.

Some of the major factors driving the market growth in China include growing the pharmaceutical and medical industries and the increasing drug and devices development. The main factors attributing to the growth of the market are the growing biotech, pharmaceutical, and medical device industries in the APAC region. The increasing research and development activities are also expected to boost market growth.

Key Industry Developments

  • In May 2021, PPD Inc. started a multipurpose clinical research laboratory in Suzhou, China. The new laboratory will help to provide services to Western and China-based pharmaceuticals and biotech companies controlling China research studies.

Players Covered in GMP Testing Service market are :


Frequently Asked Questions :

  • The forecast period in the GMP Testing Service market research report is 2021-2027.

  • The key players mentioned are Eurofins Scientific, PPD Inc., Microchem Laboratory, Sartorius AG, North American Science Associates Inc., Laboratory Corporation of America Holdings (Covance Inc.), Sotera Health (Nelson Laboratories LLC), Almac Group, Pace Analytical, Wuxi AppTec, Intertek Group PLC, Charles River Laboratories.

  • The GMP Testing Service market is segmented into End-User type, product type and region. By End-User , the market is categorized into Pharmaceutical And Biopharmaceutical Companies, Medical Devices Company. By product type, it is classified into Product Validation Testing, Bioanalytical Services, Packaging, And Shelf-Life Testing, And Other Service Types and others. By region, it is analysed across North America (U.S.; Canada; Mexico), Europe (Germany; U.K.; France; Italy; Russia; Spain etc.), Asia-Pacific (China; India; Japan; Southeast Asia etc.), South America (Brazil; Argentina etc.), Middle East & Africa (Saudi Arabia; South Africa etc.).

  • The growth of the GMP testing service market is majorly attributed to the rapidly growing pharmaceutical industry and the increasing trend in drug and device development. The growing burden of chronic diseases, the rising healthcare expenditure, and the upcoming patent expiration of blockbuster drugs are driving the trend of increasing drug and device development by biopharmaceutical companies, which, in turn, is expected to boost the growth of the market studied.

  • The GMP Testing Service Market was valued at USD 1,097.23 Million in 2020, and it is expected to reach USD 1,625.60 Million by 2026, registering a CAGR of 6.97% from 2021 to 2026.

1. Market Overview of GMP Testing Service
	1.1 GMP Testing Service Market Overview
		1.1.1 GMP Testing Service Product Scope
		1.1.2 Market Status and Outlook
	1.2 GMP Testing Service Market Size by Regions: 2015 VS 2021 VS 2026
	1.3 GMP Testing Service Historic Market Size by Regions (2015-2020)
	1.4 GMP Testing Service Forecasted Market Size by Regions (2021-2026)
	1.5 Covid-19 Impact on Key Regions, Keyword Market Size YoY Growth (2015-2026)
		1.5.1 North America
		1.5.2 Europe
		1.5.3 Asia Pacific
		1.5.4 Middle East & Africa
		1.5.5 South America
		1.5.6 Rest of the World
	1.6 Coronavirus Disease 2019 (Covid-19) Impact Will Have a Severe Impact on Global Growth
		1.6.1 Covid-19 Impact: Global GDP Growth, 2019, 2020 and 2021 Projections
		1.6.2 Covid-19 Impact: Commodity Prices Indices
		1.6.3 Covid-19 Impact: Global Major Government Policy
2. Covid-19 Impact GMP Testing Service Sales Market by Type (2015-2026)
	2.1 Global GMP Testing Service Historic Market Size by Type (2015-2020)
	2.2 Global GMP Testing Service Forecasted Market Size by Type (2021-2026)
	2.3 Product Validation Testing
	2.4 Bioanalytical Services
	2.5 Packaging
	2.6 And Shelf-Life Testing
	2.7 And Other Service Types
3. Covid-19 Impact GMP Testing Service Sales Market by Application (2015-2026)
	3.1 Global GMP Testing Service Historic Market Size by Application (2015-2020)
	3.2 Global GMP Testing Service Forecasted Market Size by Application (2021-2026)
	3.3 Pharmaceutical And Biopharmaceutical Companies
	3.4 Medical Devices Company
4. Covid-19 Impact Market Competition by Manufacturers
	4.1 Global GMP Testing Service Production Capacity Market Share by Manufacturers (2015-2020)
	4.2 Global GMP Testing Service Revenue Market Share by Manufacturers (2015-2020)
	4.3 Global GMP Testing Service Average Price by Manufacturers (2015-2020)
5. Company Profiles and Key Figures in GMP Testing Service Business
	5.1 Eurofins Scientific
		5.1.1 Eurofins Scientific Company Profile
		5.1.2 Eurofins Scientific GMP Testing Service Product Specification
		5.1.3 Eurofins Scientific GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.2 PPD Inc.
		5.2.1 PPD Inc. Company Profile
		5.2.2 PPD Inc. GMP Testing Service Product Specification
		5.2.3 PPD Inc. GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.3 Microchem Laboratory
		5.3.1 Microchem Laboratory Company Profile
		5.3.2 Microchem Laboratory GMP Testing Service Product Specification
		5.3.3 Microchem Laboratory GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.4 Sartorius AG
		5.4.1 Sartorius AG Company Profile
		5.4.2 Sartorius AG GMP Testing Service Product Specification
		5.4.3 Sartorius AG GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.5 North American Science Associates Inc.
		5.5.1 North American Science Associates Inc. Company Profile
		5.5.2 North American Science Associates Inc. GMP Testing Service Product Specification
		5.5.3 North American Science Associates Inc. GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.6 Laboratory Corporation of America Holdings (Covance Inc.)
		5.6.1 Laboratory Corporation of America Holdings (Covance Inc.) Company Profile
		5.6.2 Laboratory Corporation of America Holdings (Covance Inc.) GMP Testing Service Product Specification
		5.6.3 Laboratory Corporation of America Holdings (Covance Inc.) GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.7 Sotera Health (Nelson Laboratories LLC)
		5.7.1 Sotera Health (Nelson Laboratories LLC) Company Profile
		5.7.2 Sotera Health (Nelson Laboratories LLC) GMP Testing Service Product Specification
		5.7.3 Sotera Health (Nelson Laboratories LLC) GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.8 Almac Group
		5.8.1 Almac Group Company Profile
		5.8.2 Almac Group GMP Testing Service Product Specification
		5.8.3 Almac Group GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.9 Pace Analytical
		5.9.1 Pace Analytical Company Profile
		5.9.2 Pace Analytical GMP Testing Service Product Specification
		5.9.3 Pace Analytical GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.10 Wuxi AppTec
		5.10.1 Wuxi AppTec Company Profile
		5.10.2 Wuxi AppTec GMP Testing Service Product Specification
		5.10.3 Wuxi AppTec GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.11 Intertek Group PLC
		5.11.1 Intertek Group PLC Company Profile
		5.11.2 Intertek Group PLC GMP Testing Service Product Specification
		5.11.3 Intertek Group PLC GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
	5.12 Charles River Laboratories
		5.12.1 Charles River Laboratories Company Profile
		5.12.2 Charles River Laboratories GMP Testing Service Product Specification
		5.12.3 Charles River Laboratories GMP Testing Service Production Capacity, Revenue, Price and Gross Margin (2015-2020)
6. North America
	6.1 North America GMP Testing Service Market Size (2015-2026)
	6.2 North America GMP Testing Service Key Players (2015-2020)
	6.3 North America GMP Testing Service Market Size by Type (2015-2020)
	6.4 North America GMP Testing Service Market Size by Application (2015-2020)
7. Europe
	7.1 Europe GMP Testing Service Market Size (2015-2026)
	7.2 Europe GMP Testing Service Key Players (2015-2020)
	7.3 Europe GMP Testing Service Market Size by Type (2015-2020)
	7.4 Europe GMP Testing Service Market Size by Application (2015-2020)
8. Asia Pacific
	8.1 Asia Pacific GMP Testing Service Market Size (2015-2026)
	8.2 Asia Pacific GMP Testing Service Key Players (2015-2020)
	8.3 Asia Pacific GMP Testing Service Market Size by Type (2015-2020)
	8.4 Asia Pacific GMP Testing Service Market Size by Application (2015-2020)
9. Middle East & Africa
	9.1 Middle East & Africa GMP Testing Service Market Size (2015-2026)
	9.2 Middle East & Africa GMP Testing Service Key Players (2015-2020)
	9.3 Middle East & Africa GMP Testing Service Market Size by Type (2015-2020)
	9.4 Middle East & Africa GMP Testing Service Market Size by Application (2015-2020)
10. South America
	10.1 South America GMP Testing Service Market Size (2015-2026)
	10.2 South America GMP Testing Service Key Players (2015-2020)
	10.3 South America GMP Testing Service Market Size by Type (2015-2020)
	10.4 South America GMP Testing Service Market Size by Application (2015-2020)
11. Rest of the World
	11.1 Rest of the World GMP Testing Service Market Size (2015-2026)
	11.2 Rest of the World GMP Testing Service Key Players (2015-2020)
	11.3 Rest of the World GMP Testing Service Market Size by Type (2015-2020)
	11.4 Rest of the World GMP Testing Service Market Size by Application (2015-2020)
16 GMP Testing Service Market Dynamics
	16.1 Covid-19 Impact Market Top Trends
	16.2 Covid-19 Impact Market Drivers
	16.3 Covid-19 Impact Market Challenges
	16.4 Porter’s Five Forces Analysis
18 Regulatory Information
17 Analyst's Viewpoints/Conclusions
18 Appendix
	18.1 Research Methodology
		18.1.1 Methodology/Research Approach
		18.1.2 Data Source
	18.2 Disclaimer
Tables and figures
Table Main Market Activities by Regions
Table Market Revenue (M USD) and Growth Rate 2015-2020
Table Major Players
Table Market Revenue (M USD) and Growth Rate 2015-2020
Table Major Players
Table Market Revenue (M USD) and Growth Rate 2015-2020
Table Major Players
Table Market Revenue (M USD) and Growth Rate 2015-2020
Table Major Players
Table Market Revenue (M USD) and Growth Rate 2015-2020
Table Major Players
Table Major Production Market share by Players 2019
Table Major Revenue (M USD) Market share by Players 2019
Table Production Market share by Major Regions in 2015-2020
Table Production Market share by Major Regions in 2021-2026
Table Revenue (M USD) Market share by Regions in 2015-2020
Table Revenue (M USD) Market share by Regions in 2021-2026
Table Industry Supply chain Analysis
Table Raw material Prices Analysis 2015-2020
Table Raw material Suppliers Market Analysis
Table Manufacturing Equipment Suppliers Analysis
Figure Production Process Analysis
Figure Production Cost Structure
Table major End Users by Regions
Table Eurofins Scientific Information List
Figure GMP Testing Service Picture, Specifications and Applications of Eurofins Scientific
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  PPD Inc. Information List
Figure GMP Testing Service Picture, Specifications and Applications of  PPD Inc.
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Microchem Laboratory Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Microchem Laboratory
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Sartorius AG Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Sartorius AG
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  North American Science Associates Inc. Information List
Figure GMP Testing Service Picture, Specifications and Applications of  North American Science Associates Inc.
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Laboratory Corporation of America Holdings (Covance Inc.) Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Laboratory Corporation of America Holdings (Covance Inc.)
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Sotera Health (Nelson Laboratories LLC) Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Sotera Health (Nelson Laboratories LLC)
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Almac Group Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Almac Group
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Pace Analytical Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Pace Analytical
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Wuxi AppTec Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Wuxi AppTec
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Intertek Group PLC Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Intertek Group PLC
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table  Charles River Laboratories Information List
Figure GMP Testing Service Picture, Specifications and Applications of  Charles River Laboratories
Table GMP Testing Service Sales Volume, Price, Operating Cost, Operating Profits, Revenue (M USD) and Profits
Table Business Locations
Figure Supply channels
Figure marketing strategy
Table Major Distributors and contact information by Regions
Table Major Customers and contact information by Regions
Table USA Supply, Import, Export, Consumption and Consumption Value (M USD)
Table Germany Supply, Import, Export, Consumption and Consumption Value (M USD)
Table China Supply, Import, Export, Consumption and Consumption Value (M USD)
Table Japan Supply, Import, Export, Consumption and Consumption Value (M USD)
Table India Supply, Import, Export, Consumption and Consumption Value (M USD)
Table World Demand by Regions Forecast Analysis of Animal Feed Additives (2021-2026)
Table World Price by Regions Forecast Analysis of Animal Feed Additives (2021-2026)
Table World Price by Types Forecast Analysis of Animal Feed Additives (2021-2026)
Table World Price by Applications Forecast Analysis of Animal Feed Additives (2021-2026)
Table World Revenue (M USD) by Regions Forecast Analysis of Animal Feed Additives (2021-2026)
Table World Revenue (M USD) by Types Forecast Analysis of Animal Feed Additives (2021-2026)
Table World Revenue (M USD) by Applications Forecast Analysis of Animal Feed Additives (2021-2026)
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