GMP Testing Service Market By Service Type (Product Validation Testing, Bioanalytical Services, Packaging and Shelf-Life Testing, Others), By End User (Pharmaceutical and Biopharmaceutical Companies, Medical Device Companies): Global Opportunity Analysis

GMP Testing Service Market By Service Type (Product Validation Testing, Bioanalytical Services, Packaging and Shelf-Life Testing, Others), By End User (Pharmaceutical and Biopharmaceutical Companies, Medical Device Companies): Global Opportunity Analysis and Industry Forecast, 2021-2031

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

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

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