GMP Testing Service Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The GMP testing service market is segmented by Service Type (Product Validation Testing, Bioanalytical Services, Packaging and Shelf-Life Testing, and Other Service Types), End User (Pharmaceutical and Biopharmaceutical Companies and Medical Devices Company), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

gmp testing service market analysis
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: North America
Largest Market: Asia Pacific
CAGR: 6.97 %

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Market Overview

The GMP testing service market is expected to register a CAGR of 6.97% during the forecast period (2022 - 2027).

Lockdowns were implemented following the COVID-19 outbreak in order to stop the virus's spread. Both demand-side and supply-side effects on the industrial sector have been seen as a result of these lockdowns. People are learning to live with the virus, though, and new regulations and limits have been implemented across all industries. Compared to 2019, the market expanded more rapidly in 2021. According to Eurostat 2021 from the European Commission, industrial production in Europe climbed by 1.4 percent in July 2021, and the overall level of production was 1% higher than in February 2020. The production of pharmaceutical goods and products increased by more than 30% between July 2020 and July 2021, according to Eurostat 2021. However, businesses have started to provide GMP-compliant coronavirus vaccine testing solutions. By providing testing services for new viral threats/pandemics using quick and sophisticated testing platforms, such as Next Generation Sequencing (NGS) technologies and more than 400 validated rapid PCR tests for potentially dangerous viruses in vaccine manufacturing processes, SGS' Center of Excellence for Biosafety opened in February 2020 to help the fight against coronavirus. Thus, the market is expected to grow in the future.

The factors such as growing pharmaceutical industry and increasing drug and devices development are expected to increase the market growth. The European Federation of Pharmaceutical Industries and Associations predicted that the worldwide pharmaceutical market will generate USD 1,077,856 million in sales in 2020. In the United States and South Korea, some 40 drugs are recalled each year, according to a study that was published in the International Journal of Environmental Research and Public Health. As a result, the requirement to test the goods and the manufacturing process is increased. Companies might lower their capital investments by outsourcing these services. In order to increase its facility's capacity and add new capabilities for the development and manufacturing of Active Pharmaceutical Ingredients, Piramal Pharma Limited's Pharma Solutions business, a prominent Contract Development and Manufacturing Organization (CDMO), invested USD 32 million in December 2020. Additionally, Indian Immunologicals Ltd (IIL) announced in November 2020 that it would invest INR 75 crore in the construction of a new viral antigen manufacturing facility in Phase III of Genome Valley, Telangana, India, in order to expand its capacity to produce more high-quality and secure vaccines. There are other researchers working on innovative therapies as well. Three peptides were accepted as Active Pharmaceutical Ingredients (APIs) by the FDA, according to a research article that appeared in Pharmaceuticals in February 2020. In 2019, 48 medicines were approved, 38 of which were new chemical entities (NCEs) made up of peptides and oligonucleotides, 10 of which were biologics. Additionally, Roche Holding AG, one of the most profitable pharmaceutical companies in Europe, planned to increase its research spending in February 2021 and streamline other areas of its operations after investing an additional CHF800 million in R&D in 2020 to advance 20 late-stage experimental drugs and early-stage gene therapy. Another element influencing market expansion is recent company advancements. For instance, in August 2020, Eurofins Scientific and Noritsu Koki Co., Ltd. reached a deal to buy GeneTech Inc., a major leader in genetic analysis in Japan, in order to broaden Eurofins' testing capabilities there. Similarly, in September 2020, SunDream Environmental Technical Co. Ltd., Blue Formosa Environmental Technical Co. Ltd., and Universe Environmental Technology Co. Ltd. were all bought by Eurofins Scientific. Thus, future market growth is anticipated to be accelerated by such advancements.

While the above factors are expected to play a significant role in the GMP testing services market growth, the regulatory framework's precise requirement concerning GMP outsourced activities may hinder the market growth in the studied forecast period.

Scope of the Report

Good manufacturing practices (GMP) are procedures that ensure the product is following the quality standards. GMP testing services provide an examination from the initial phase of the product until the finished products. The GMP testing service market is segmented by Service Type (Product Validation Testing, Bioanalytical Services, Packaging and Shelf-Life Testing, and Other Service Types), End User (Pharmaceutical and Biopharmaceutical Companies and Medical Devices Company), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Service Type
Product Validation Testing
Bioanalytical Services
Packaging and Shelf-Life Testing
Other Service Types
By End User
Pharmaceutical and Biopharmaceutical Companies
Medical Devices Company
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Rest of the World

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Key Market Trends

Pharmaceutical and Biopharmaceutical Companies Segment Expected to Hold Major Market Share in the GMP Testing Service Market

The pharmaceutical and biopharmaceutical companies segment is expected to grow during the forecast period.

The pharmaceutical and biopharmaceutical industries' innovative drug development is anticipated to fuel market expansion in this sector. Nearly 300 biopharmaceuticals have been patented in the past three decades, according to an article titled "Current perspectives on biosimilars" that was published in the Journal of Industrial Microbiology & Biotechnology in July 2019. About 382 vaccine candidates were under development as of February 2021, according to the International Federation of Pharmaceutical Manufacturers and Associations' "Facts & Figures Report 2021," of which 24 were in Phase I, 34 were in Phase II, and 23 were in Phase III trials. The same report states that as of March 2021, the European Medicines Agency (EMA) had given Pfizer-BioNTech, Janssen, Moderna, and AstraZeneca's COVID-19 vaccines a conditional marketing authorization. The United States Food and Drug Administration (FDA) had also approved COVID-19 vaccines from PfizerBioNTech, Janssen, and Moderna. The biopharmaceutical sector is taking extraordinary, quick steps to get vaccinations to patients. In order to address the pressing needs of the pandemic, the biopharmaceutical industry has opened up new perspectives and partnerships. As medication development processes have increased as a result of the COVID-19 pandemic, there is also a demand for product validation testing services; these services must be used to ensure that medicinal products are of high quality, efficacious, and safe standards. With the onset of the COVID-19 pandemic in December 2020, Eurofins BioPharma Product Testing Italy increased its virucidal testing capacity. Similarly, in April 2021, PPD Inc., a leading global contract research organization, announced its plans to expand Good Manufacturing Practice (GMP) lab in Ireland to enhance its biopharmaceutical testing capabilities. As a result, the category of pharmaceutical and biopharmaceutical businesses is driving market expansion and is anticipated to favourably affect the growth of the GMP testing services market during the course of the projected year.

Cumulative Trending cGMP FDA Inspectional Observations (2016-2020), Drug (by Number of Citations)

North America is Expected to Hold Significant Share in the Forecast Period

North America is expected to be a dominant region in the GMP testing services market due to the emerging need for developing new drugs and devices. More than 34.2 million Americans have diabetes, and more than 868,000 people die from heart disease each year, according to data from the Centers for Disease Control and Prevention that was examined on January 10th, 2022. The number of medication production facilities is expanding as a result of rising death rates and the rise in chronic diseases. The GMP testing services market is anticipated to grow due to the aforementioned causes. Furthermore, in November 2020, there were 13,010 domestic FDA-registered facilities for the production of medical devices, 3,568 facilities for the production of human drugs, and 5,112 facilities for the production of biologics, according to a factsheet released by the US Food and Drug Administration (FDA). The market for GMP testing services is anticipated to expand as a result of the rising number of pharmaceutical manufacturing facilities. About 4,676 medication manufacturing facilities are located in the United States, according to the Food and Drug Administration (FDA). The National Institute of Health has also increased financing for the biotechnology sector and adjacent industries (NIH). In the United States, biotechnology received USD 7,655 million in funding in 2020. Additionally, the National Institutes of Health (NIH) has expanded funding over the past few years for a number of illnesses like diabetes and cancer that need cutting-edge testing equipment. The financing for diabetes in the United States in 2020 was USD 1,179 million. The majority of the major firms who test gadgets for accuracy are anticipated to be drawn by the rising financing for research, which will fuel the industry under study's rapid expansion.The market for GMP testing services is expected to rise as a result of the rising demand for creating new pharmaceuticals and medications.

gmp testing service market growth

Competitive Landscape

The GMP testing service market consists of several major players. A few major players are currently dominating the market in terms of market share. The companies are taking initiatives to meet the higher demand for medicines and devices. Some of the companies currently dominating the market include Eurofins Scientific, PPD Inc., Microchem Laboratory, Sartorius AG, North American Science Associates Inc., Covance Inc., Nelson Laboratories LLC, Almac Group, Pace Analytical, Wuxi AppTec., Intertek Group PLC, and Charles River Laboratories.

Recent Developments

  • In February 2022, The analytical testing services laboratories of the Center for Breakthrough Medicines (CBM) were established to provide the most complete testing capabilities in the sector. These essential service provisions address expanding capacity requirements in the cell & gene therapy business, which is highly supply-constrained.
  • In December 2021, Eurofins announced the BioPharma product testing network of laboratories expanded its footprint of GMP testing laboratories with the recent acquisition of Astellas Analytical Science Laboratories, Inc. (ASL). With this acquisition, ASL established Eurofins’ first Good Manufacturing Practice (GMP) testing facility in Japan.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Growing Pharmaceutical Industry

      2. 4.2.2 Increasing Drug and Devices Development

    3. 4.3 Market Restraints

      1. 4.3.1 Stringent Regulatory Framework

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Service Type

      1. 5.1.1 Product Validation Testing

      2. 5.1.2 Bioanalytical Services

      3. 5.1.3 Packaging and Shelf-Life Testing

      4. 5.1.4 Other Service Types

    2. 5.2 By End User

      1. 5.2.1 Pharmaceutical and Biopharmaceutical Companies

      2. 5.2.2 Medical Devices Company

    3. 5.3 Geography

      1. 5.3.1 North America

        1. 5.3.1.1 United States

        2. 5.3.1.2 Canada

        3. 5.3.1.3 Mexico

      2. 5.3.2 Europe

        1. 5.3.2.1 Germany

        2. 5.3.2.2 United Kingdom

        3. 5.3.2.3 France

        4. 5.3.2.4 Italy

        5. 5.3.2.5 Spain

        6. 5.3.2.6 Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. 5.3.3.1 China

        2. 5.3.3.2 Japan

        3. 5.3.3.3 India

        4. 5.3.3.4 Australia

        5. 5.3.3.5 South Korea

        6. 5.3.3.6 Rest of Asia-Pacific

      4. 5.3.4 Rest of the World

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Eurofins Scientific

      2. 6.1.2 PPD Inc.

      3. 6.1.3 Microchem Laboratory

      4. 6.1.4 Sartorius AG

      5. 6.1.5 North American Science Associates Inc.

      6. 6.1.6 Laboratory Corporation of America Holdings (Covance Inc.)

      7. 6.1.7 Sotera Health (Nelson Laboratories LLC)

      8. 6.1.8 Almac Group

      9. 6.1.9 Pace Analytical

      10. 6.1.10 Wuxi AppTec

      11. 6.1.11 Intertek Group PLC

      12. 6.1.12 Charles River Laboratories

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies, and Recent Developments

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Frequently Asked Questions

The Global GMP Testing Service Market market is studied from 2019 - 2027.

The Global GMP Testing Service Market is growing at a CAGR of 6.97% over the next 5 years.

North America is growing at the highest CAGR over 2021- 2026.

Asia Pacific holds highest share in 2021.

Eurofins Scientific, PPD, Inc. , Microchem Laboratories, Sartorius AG , NORTH AMERICAN SCIENCE ASSOCIATES INC. are the major companies operating in Global GMP Testing Service Market.

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