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2022

GMP Testing Service Market

GMP Testing Service Market Size, Share, Competitive Landscape and Trend Analysis Report by Service Type, by End User : Global Opportunity Analysis and Industry Forecast, 2021-2031

LS : Healthcare

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Author's: Prachi Sanjay Rakshe | Roshan Deshmukh
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GMP Testing Service Market Research, 2031

The global gmp testing service market size was valued at $1.3 billion in 2021, and is projected 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 used 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. Its main purpose is to ensure the purity, quality and safety of manufactured products. Enforced by the U.S. Food and Drug Administration (FDA), the World Health Organization (WHO) promotes the most widely leveraged version of GMP regulations. It covers all the aspects of production, from the starting materials, premises and equipment to the training and personal hygiene of staff. Many countries have formulated their requirements for good manufacturing practice based on World Health Organization (WHO) good manufacturing practices. Others have harmonized their requirements, for example in the Association of South-East Asian Nations (ASEAN), in the European Union and through the Pharmaceutical Inspection Convention.

GMP Testing Service Market

GMP testing service market growth is driven by the development of biosimilars, combination products, and other innovative medicines that 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 and generic & 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 market growth. However, the precise requirement of the regulatory framework concerning GMP outsourced activities are 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.

Coronavirus (COVID-19) was discovered in late December in Hubei province of Wuhan city in China. The situation of COVID-19 has varied outcome when related to vaccinations. There is an emerging gap in the economic recovery between high-income and low and middle income countries. Trade contributes to speeding up economic recovery from the pandemic by providing sustained foreign demand for exports and ensuring the availability of imported intermediate products and services. 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 growth of the GMP testing service market is expected to augment considerably during the forecast period with many pharmaceutical and biopharmaceutical companies focusing on new drug development to combat the pandemic.

Segment Review

The gmp testing service market is segmented into Service Type and End User. By 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 GMP testing industry 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.

By Service Type

GMP Testing Service Market by Service Type

By service type, the product validation testing segment dominated the global market in 2021 and is anticipated to continue this trend during the forecast period. This is attributed to rise in demand for more 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 that is the vital factor that drives the growth of the market.

By End User

GMP Testing Service Market by End User

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. Moreover, the pharmaceutical and biopharmaceutical companies segment is expected to exhibit fastest market growth during the forecast period, owing to the biopharmaceutical companies preference to outsource manufacturing in markets where they have limited expertise in various stages of value chain, especially toward the end where CDMOs presence in a particular region that gives them access to a vast distribution network as well as knowledge of existing regulatory guidelines.

By Region

GMP Testing Service Market 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. However, Asia-Pacific is projected to exhibit fastest growth rate of 9.0% during the GMP testing service market forecast. This is mainly attributed to increase in the import and sale of medicines by large number of key players that have been manufactured according to internationally recognized GMP standards. Moreover, the biopharmaceutical sector has opened new approaches and collaborations in the industry to respond to the urgent needs of the pandemic which is projected to boost the market growth.

Key Benefits For Stakeholders

  • This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the gmp testing service market analysis from 2021 to 2031 to identify the prevailing gmp testing service market opportunity.
  • The market research is offered along with information related to key drivers, restraints, and opportunities.
  • Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
  • In-depth analysis of the gmp testing service market segmentation assists to determine the prevailing market opportunities.
  • Major countries in each region are mapped according to their revenue contribution to the global market.
  • Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
  • The report includes the analysis of the regional as well as global gmp testing service market trends, key players, market segments, application areas, and market growth strategies.

GMP Testing Service Market Report Highlights

Aspects Details
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By Service Type
  • Packaging and Shelf-Life Testing
  • Others
  • Product Validation Testing
  • Bioanalytical Services
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By End User
  • Pharmaceutical and Biopharmaceutical Companies
  • Medical Device Companies
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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)
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Key Market Players

Wuxi App Tec, Microchem Laboratory, Charles River Laboratory, Intertek Group PLC, almac group, Merck KgaA, Nelson Laboratories, Eurofins Scientific, Sartorius AG, ICON INC.

Analyst Review

According to the CXOs, GMP testing service is a system that consists of processes, procedures and documentation that ensures manufacturing service such as pharmaceutical service that is consistently produced and controlled according to set quality standards. Also, the biopharmaceutical industry is undertaking rapid and exceptional measures to bring vaccines to patients and the biopharmaceutical sector has opened new approaches in the industry to respond to quality and safety management of service, which is expected to foster the growth of the GMP testing service market.

The CXOs further added that product validation testing segment is expected to remain dominant during the forecast period, owing to presence of large number of key players in the market. Moreover, North America is expected to offer lucrative opportunities to the market during the forecast period, due to emerging need for developing novel drugs and devices. However, Asia-Pacific is expected to register the fastest growth rate during the forecast period, owing to the development in healthcare infrastructure, rise in disposable incomes, and well-established presence of domestic companies in the region

Author Name(s) : Prachi Sanjay Rakshe | Roshan Deshmukh
Frequently Asked Questions?

Increase in development of medical devices, biosimilars, and combination products, higher demand of GMP testing at both clinical and preclinical stages, along with constant focus of manufacturing companies to fulfill requirements of regulatory bodies concerning GMP are some of the driving factors of the market

Among service type, the product validation testing segment dominated the global market in 2021

North America is the largest regional market for GMP Testing Service Market

The estimated industry size of GMP Testing Service Market was $2.5 billion in 2021

Eurofins Scientific SE, Charles River Laboratories and Wuxi App Tec are some of the leading companies in GMP Testing Service Market

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GMP Testing Service Market

Global Opportunity Analysis and Industry Forecast, 2021-2031