GMP Testing Service Market Share, Size | Global Trends 2028

GMP Testing Service Market Forecast to 2028 – COVID-19 Impact and Global Analysis – by Service Type (Product Validation Testing, Bioanalytical Services, Packaging & Shelf-Life Testing, and Other Services Type) and End User (Pharmaceutical and Biopharmaceutical Companies, and Medical Device Companies)

Publication Month : Sep 2022

  • Report Code : TIPRE00029684
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 166
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The GMP testing service market is valued US$ 1,830.57 million in 2021; it is estimated to grow at a CAGR of 6.7% from 2022 to 2028.

The market growth is attributed to the continuous proliferation of the pharmaceutical and medical industries.

The GMP testing service market comprises major competitive players adopting strategies such as product launches, geographic expansion, and technological advancements. A few recent developments in the market are listed below:

  • In February 2022, Eurofins Clinical Testing Lux Sarl, a subsidiary of Eurofins Scientific, acquired Genetic Testing Service JSC (Gentis), a pioneer in genetic testing in Vietnam. Through this acquisition, Eurofins intends to expand its presence in Asia, which would complement its global network of clinical diagnostics laboratories focused on specialized and advanced genetic testing.
  • In December 2021, oncology researchers at the University of Arkansas for Medical Sciences (US) and Queen’s University Belfast (UK) used a unique software-driven solution for gene expression data analysis—claraT—offered by Almac Diagnostic Services, a member of the Almac Group, in the study of brain and breast cancers. The study was recently published in the MDPI Cancer Journal and the British Journal of Cancer, have the potential to lead to better therapeutic outcomes for patients. 
  • In December 2021, WuXi AppTec acquired OXGENE. This acquisition enables WuXi AppTec to offer its customers end-to-end support in the creation and development of cutting-edge cell and gene therapies.

Such product innovations and developments by major market players, along with regulatory approvals, are fueling the growth of the GMP testing service market.

The regulatory compliance criteria for GMP testing services depend on the location of pharmaceutical and biotechnology companies, and the geographic reach of their distribution channels. In North America, FDA regulates the GMP testing services market, whereas, in Europe, European Medicines Agency (EMA) regulates the GMP testing services market. The Association of South-East Asian Nations (ASEAN) and the Pharmaceutical Inspection Convention are among the other agencies that regulate GMP testing services. These regulatory agencies need to ensure appropriate compliance depending on where the product is manufactured, distributed, and marketed by the pharmaceutical companies. The regulatory agencies evaluate all sites involved in the manufacturing of a drug. This evaluation includes all the steps ranging from the initial steps of the raw materials/API manufacturing to the final packaging facilities. Moreover, regulations may change depending on the steps involved in a particular manufacturing process. If a company fail to comply with the specifications of a regulatory body in a particular country or region, its products are considered adulterated under the law, and the FDA advises patients not to take such medications, which could have serious consequences on their health. Thus, stringent regulatory frameworks for GMP testing services in different regions are hampering the growth of the GMP testing services market.

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GMP Testing Service Market: Strategic Insights

Market Size Value inUS$ 1,830.57 Million in 2021
Market Size Value byUS$ 2,863.42 Million by 2028
Growth rateCAGR of 6.7% from 2022 to 2028
Forecast Period2022-2028
Base Year2021
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Regional Overview

Asia Pacific is expected to register the highest CAGR in the GMP testing service market during the forecast period. Regulation and rising awareness boost the demand for GMP testing services. The GMP testing services market in China is expected to flourish during the forecast period owing to the increase in the number of pharmaceutical companies and their R&D activities, and the ongoing development projects of medical devices, biosimilars, and combination products, which need GMP testing at both clinical and preclinical drug development stages.

The regulatory bodies keep on making amendments to their existing regulations or introducing new regulations for GMP testing. In April 2020, the National Medical Products Administration (NMPA) announced its newly implemented random inspection regimens for manufacturing, distribution, and management of medical devices marketed in China. Under the new regulation, the NMPA and its regional branches would conduct random inspections in the first quarter of each year. The heavily targeted medical devices are considered high-risk and of questionable quality. Foreign medical device manufacturers must designate a local representative based in China to cooperate with the health authorities for random inspections of their products.

The GMP testing market players are adopting inorganic and organic growth strategies for business development in China.

  • In April 2020, WuXi Biologics (Suzhou) Co., Ltd. passed its first GMP inspection conducted by the EMA without any critical findings.
  • In June 2020, the Suzhou facility of WuXi Biologics received the EMA GMP certificate, following that it also received certification from China Inspection Body and Laboratory Mandatory Approval (CMA) and China National Accreditation Service for Conformity Assessment (CNAS). This enables the company to be one of the few third-party biosafety testing providers certified by EMA GMP standards in China and Asia Pacific.
  • In May 2020, Porton Pharma Solutions Ltd. opened integrated cGMP Laboratories at its Chongqing Process Technology Center in China.

Japan's quality control and quality assurance requirements are often more stringent than those in the West, and many Japanese quality standards and regulations have different names and content from equivalent Western regulations. In July 2021, the Government of Japan announced they would start conducting surprise inspections at drug, pharmaceutical, and medical device manufacturing facilities. The Pharmaceuticals and Medical Devices Agency (PMDA) started its surprise inspections in August 2021. In Japan, GMP for drugs is referred to as Japanese GMP, or J-GMP. Further, the Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP) are a few more Japan-specific pharmaceutical/drug quality standards.

Lucrative Regions for GMP Testing Service Market

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Service Type Insights

Based on service type, the GMP testing service market is segmented into product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. The product validation testing segment held the largest market share in 2021. Moreover, this segment is expected to register the highest CAGR of 7.3% during the forecast period.

Product validation testing is documented evidence that ascertains the quality of manufactured pharmaceutical and medical products. The validation follows a set of guidelines to ensure that the manufactured products meet all the needs and requirements the product was intended to serve. Rising healthcare expenditure in various developed countries encourages new drug discoveries and the evaluation of various medical products for potential medical treatments. In addition to the continuous growth of the pharmaceuticals and biopharmaceuticals industries, the rising number of development and commercialization of pharmaceutical and biopharmaceutical products due to government support in countries such as the US, Germany, the UK, and Japan propels the need for product validation testing, thereby fueling the GMP testing service market.

GMP Testing Service Market, by Service Type – 2021 and 2028

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Companies operating in the GMP testing service market primarily focus on the product innovation strategy to meet the evolving customer demands worldwide, which also allows them to maintain their brand name in the market.

GMP Testing Service Market – Segmentation

The GMP testing service market is analyzed on the basis of service type, end user, and geography. Based on service type, the market is segmented into product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. Based on end user, the GMP testing service market is segmented into pharmaceutical and biopharmaceutical companies, and medical devices companies. On the basis of geography, the GMP testing service market is segmented into North America (US, Canada, and Mexico), Europe (UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (UAE, Saudi Arabia, Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

Company Profiles

  • Eurofins Scientific
  • North American Sciences Associates, LLC
  • Almac Group
  • PPD, Inc
  • Intertek Group Plc
  • Nelson Laboratories
  • Wuxi Apptec
  • Sartorius AG
  • Boston Analyticals
  • Pace Analyticals
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Service Type, and End User

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions

What is GMP testing service?

Good Manufacturing Practices (GMP) are designed to give manufacturers of regulated products with a system for consistently producing high-quality and safe items. Subsequently, manufacturers are needed to ensure their suppliers (testing laboratories, raw material providers, etc.) are also following GMP standards. GMP Laboratory services support manufacturers in their mission to comply with GMP specifications not just because it is required, but because it is the right thing to do. The GMP testing services are an essential obligation for medical device manufacturers to reduce product recall from the market. GMP testing services include services like product development testing, bioanalytical testing, shelf-life testing, and sterility testing.

What are the factors impacting for the GMP testing service market?

Several factors are believed to affect GMP testing service market in the coming years. Factors such as continuous proliferation of pharmaceuticals industry, flourishment of medical device industry are driving the market growth. However, lack of uniform regulatory framework related to GMP testing services are likely to hamper the growth of the market.

Who are the major players in the GMP testing service market?

The GMP testing service market majorly consists of the players such as Eurofins Scientific; North American Sciences Associates, LLC; Almac Group; PPD, Inc; Intertek Group Plc; Nelson Laboratories; Wuxi Apptec; Sartorius AG; Boston Analyticals; Pace Analyticals and others.

What is the market value of GMP testing service market based on region?

The global GMP testing service market is segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. The North American area holds the largest market for GMP testing service. The United States held the most significant GMP testing service market and is expected to grow due to factors such as the increasing need for developing novel drugs and medical devices and increasing developments in the pharmaceutical industry boosting the growth rate in US.
The Asia Pacific region is expected to account for the fastest growth in the GMP testing service market. In Japan, India and South Korea, the market is expected to grow owing to the rising government health expenditure.

Which is the most influencing segment growing in the GMP testing service market report?

The global GMP testing service market based on service type is segmented into product validation testing, bioanalytical services, packaging and shelf-life testing, and other service types. In 2021, the product validation testing segment held the largest share of the market, by service type while the same segment is expected to witness fastest CAGR during 2021 to 2028, due to increasing production of drugs and vaccines and rising regulatory bodies.

The List of Companies - GMP Testing Service Market

  1. Eurofins Scientific
  2. North American Sciences Associates, LLC
  3. Almac Group
  4. PPD, Inc.
  5. Intertek Group Plc
  6. Nelson Laboratories
  7. Wuxi Apptec
  8. Sartorius AG
  9. Boston Analyticals
  10. Pace Analyticals

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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