GMP Testing Service Market Report by Service Type (Packaging and Shelf-life Testing, Product Validation Testing, Bioanalytical Services, and Others), End User (Pharmaceutical and Biopharmaceutical Companies, Medical Device Companies), and Region 2024-2032

GMP Testing Service Market Report by Service Type (Packaging and Shelf-life Testing, Product Validation Testing, Bioanalytical Services, and Others), End User (Pharmaceutical and Biopharmaceutical Companies, Medical Device Companies), and Region 2024-2032

Report Format: PDF+Excel | Report ID: SR112024A7440
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GMP Testing Service Market Size:

The global GMP testing service market size reached US$ 1.5 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 2.5 Billion by 2032, exhibiting a growth rate (CAGR) of 5.34% during 2024-2032. The market is experiencing steady growth driven by the increasing level of regulatory scrutiny across various industries, the stringent regulatory environment compelling businesses to invest in GMP testing services, and the rise in contract manufacturing and outsourcing.

Report Attribute
Key Statistics
Base Year
2023
Forecast Years
2024-2032
Historical Years
2018-2023
Market Size in 2023
US$ 1.5 Billion
Market Forecast in 2032
US$ 2.5 Billion
Market Growth Rate 2024-2032 5.34%

GMP Testing Service Market Analysis:

  • Market Growth and Size: The global market is experiencing robust growth, driven by the increasing emphasis on quality assurance and regulatory compliance in the manufacturing and healthcare sectors. The market is expanding as companies across industries recognize the importance of adhering to GMP standards to ensure the safety and efficacy of their products.
  • Major Market Drivers: Key drivers include the stringent regulatory requirements for product quality and safety, the rising demand for pharmaceutical and healthcare products, and the growing awareness among manufacturers about the significance of GMP compliance.
  • Technological Advancements: Technological advancements, such as the integration of automated testing processes, advanced analytical techniques, and real-time monitoring systems, are shaping the GMP testing service market. Automation and digitization are streamlining testing procedures, improving accuracy, and reducing testing time, contributing to overall efficiency in GMP compliance.
  • Industry Applications: The service finds applications across various industries, including pharmaceuticals, biotechnology, medical devices, food and beverages, and cosmetics. GMP testing services are essential in ensuring the quality, safety, and consistency of products throughout the manufacturing process, from raw materials to the final product.
  • Key Market Trends: Key trends include the increasing demand for outsourced GMP testing services, the integration of advanced analytical technologies such as mass spectrometry and chromatography, and the rising focus on comprehensive testing solutions that cover a wide range of quality parameters.
  • Geographical Trends: Geographically, the market exhibits variations based on regional regulatory frameworks and industry concentration. Regions with a strong pharmaceutical and biotechnology presence often experience higher demand for GMP testing services. Additionally, emerging markets are witnessing a growing awareness of GMP compliance, driving increased adoption of testing services.
  • Competitive Landscape: The competitive landscape is characterized by the presence of global testing service providers, specialized laboratories, and regulatory compliance consulting firms. Key players in the market focus on expanding their service portfolios, acquiring accreditations, and establishing partnerships to strengthen their position.
  • Challenges and Opportunities: Challenges include the complexity of evolving regulatory requirements, the need for continuous investment in advanced testing equipment, and the potential impact of global supply chain disruptions. Opportunities lie in providing specialized GMP testing services, offering comprehensive compliance solutions, and leveraging technological advancements to enhance testing capabilities.
  • Future Outlook: The future outlook for the market remains positive, with sustained growth expected. The increasing focus on quality and safety standards, coupled with the continuous evolution of regulatory landscapes, will drive the demand for GMP testing services. As technology continues to advance and industries become more interconnected globally, the market is poised for further expansion and innovation to meet the dynamic needs of manufacturers across diverse sectors.
     

Global GMP Testing Service Market

GMP testing service refers to good manufacturing practice testing, a crucial element in ensuring the quality and safety of various products including pharmaceuticals, food, and medical devices. The service is aimed at confirming that manufacturers adhere to established quality standards throughout the production process. By performing systematic tests, GMP testing services evaluate the efficacy, safety, and quality of products. This often involves assessing the cleanliness of the manufacturing environment, validation of manufacturing processes, and stringent quality control tests for the final products. The objective is to minimize the risks associated with cross-contamination, errors, and inconsistencies, thereby safeguarding consumer well-being. Utilizing GMP testing services is not only a regulatory requirement in many jurisdictions but also a mark of integrity and quality assurance for manufacturers. This service is instrumental in helping companies gain consumer trust and meet legal compliance, ultimately ensuring that only high-quality, safe, and effective products reach the market.

One of the most significant market drivers for good manufacturing practice (GMP) testing services is the increasing level of regulatory scrutiny across various industries, especially in the pharmaceutical, food, and medical device sectors. Therefore, the stringent regulatory environment compels businesses to invest in GMP testing services as a preventative measure against non-compliance, thereby driving demand for these services. Along with this, the rise in contract manufacturing and outsourcing is an additional factor propelling the growth of the GMP testing services market. Companies are increasingly turning to third-party manufacturers to produce their goods, which involves multiple stages of quality control to ensure that the products meet regulatory and customer expectations. This trend elevates the need for trustworthy GMP testing services that can assess the quality of products made by various manufacturers at different locations. In addition, transparency about sourcing, production methods, and environmental impact is increasingly being seen as a competitive advantage for businesses. To meet this demand, companies are scrutinizing their supply chains and production methods closely, further raising the demand for GMP testing services.

GMP Testing Service Market Trends:

Rising Consumer Awareness and Expectations

Consumer behavior has evolved significantly with the advent of digital technologies that facilitate easy access to information. Along with this, consumers are informed about the products they use, from their ingredients to the ethical considerations surrounding their production. This increased awareness has set high expectations for product quality, safety, and efficacy, especially in sectors like healthcare and food production. In addition, consumers are now willing to pay a premium for products that guarantee these attributes, which puts additional pressure on manufacturers to comply with quality standards. In such a market context, GMP testing services serve as a verifiable way for companies to showcase their commitment to quality and safety. Third-party GMP certification acts as a mark of trust and can be a significant factor in purchasing decisions. Therefore, the rise in consumer awareness and expectations serves as a critical driver for the growth of the GMP testing service market.

Continuous Technological Advancements

The rapid technological advancements in analytical methods and equipment are another major driver in the market. In addition, the introduction of cutting-edge technologies such as High-Performance Liquid Chromatography (HPLC), Mass Spectrometry, and Next-Generation Sequencing allows for more accurate, efficient, and comprehensive testing procedures. These technologies provide a more in-depth understanding of product composition and potential contaminants, which is essential for ensuring quality and safety. Along with this, the utilization of these advanced technologies enables GMP testing services to offer more precise and timely results. This efficiency speeds up the time-to-market for products and helps manufacturers quickly identify and address any quality issues, thereby reducing the risks associated with product recalls or legal action. Moreover, companies are increasingly relying on GMP testing services equipped with the latest technologies to meet the ever-rising quality standards.

Globalization of Supply Chains

In today's interconnected world, supply chains have become increasingly globalized. Ingredients and components often come from multiple countries, each with its own set of regulations and quality standards. This complexity introduces several challenges in ensuring consistent quality and safety across all products. Furthermore, global supply chains are susceptible to various risks such as contamination, adulteration, and fraudulent practices, all of which can compromise product quality. In confluence with this, GMP testing services play a pivotal role in ensuring that products meet the quality and safety criteria irrespective of their origin. These services can audit and test products at various stages of the supply chain, ensuring compliance with international standards. This is particularly crucial for companies that export products, as they need to meet the regulatory requirements of both the country of origin and the destination markets. Therefore, the globalization of supply chains significantly contributes to the growing demand for comprehensive GMP testing services.

GMP Testing Service Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on service type and end user.

Breakup By Service Type:

GMP Testing Service Market

  • Packaging and Shelf-life Testing
  • Product Validation Testing
  • Bioanalytical Services
  • Others
     

Product validation testing dominates the market

The report has provided a detailed breakup and analysis of the market based on the service type. This includes packaging and shelf-life testing, product validation testing, bioanalytical services, and others. According to the report, product validation testing represented the largest segment.

Product validation testing within the GMP testing service industry is experiencing significant market growth, driven by the stringent regulatory requirements across sectors, such as pharmaceuticals, food, and medical devices necessitating rigorous validation testing to ensure products meet established safety and efficacy benchmarks. Failure to pass these validation tests can result in costly recalls, legal consequences, and reputational damage, making companies increasingly proactive in employing these services. Additionally, as technological advancements continue to introduce complex formulations and components, the need for sophisticated validation testing grows correspondingly to ensure that these new elements adhere to quality standards. Along with this, consumer awareness about product quality is at an all-time high, largely due to easy access to information. Consumers now demand transparency and evidence of product safety, making validation testing a significant market differentiator. Moreover, the globalization of supply chains makes validation testing indispensable for ensuring consistency in product quality, irrespective of the origin of components or the manufacturing location.

Breakup By End User:

  • Pharmaceutical and Biopharmaceutical Companies
  • Medical Device Companies
     

Pharmaceutical and biopharmaceutical companies hold the largest share in the market

A detailed breakup and analysis of the market based on the end user has also been provided in the report. These include pharmaceutical and biopharmaceutical companies and medical device companies. According to the report, pharmaceutical and biopharmaceutical companies accounted for the largest market share.

The growing demand for GMP testing services among pharmaceutical and biopharmaceutical companies is fueled by stringent guidelines laid out by authorities such as the FDA and EMA necessitate comprehensive GMP testing to ensure product safety and efficacy. Along with this, the increasing complexity of pharmaceuticals, especially with the rise of biologics and gene therapies, calls for advanced GMP testing to validate quality and performance. As companies continue to expand globally, the harmonization of quality standards becomes critical, making GMP testing essential for ensuring consistent quality across diverse markets. Another driving force is the accelerating pace of drug development and commercialization, especially evident during events like the rapid development of COVID-19 vaccines. This fast-tracking intensifies the need for reliable GMP testing services that can keep up with the accelerated timelines without compromising on quality control. Lastly, public and stakeholder scrutiny is higher than ever in the healthcare sector. Issues related to drug safety and effectiveness have far-reaching consequences, making it imperative for companies to invest in top-notch GMP testing services as a risk-mitigation strategy.

Breakup by Region:

GMP Testing Service Market

  • North America
    • United States
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa
     

North America exhibits a clear dominance, accounting for the largest GMP testing service market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America exhibited the largest segment.

The market for GMP testing services in North America is experiencing robust growth, driven by the growing awareness and demand for high-quality and safe products. The North American market is characterized by well-informed consumers who seek transparency and assurance that the products they consume meet the highest safety and efficacy standards. Technological innovation is another critical factor. The availability of advanced testing technologies and methods enables more accurate and efficient quality control processes, thereby bolstering the GMP testing market.

Additionally, the prevalence of global supply chains in North America industries increases the complexity of ensuring consistent product quality, further fueling the need for comprehensive GMP testing. Furthermore, the region has a growing biotechnology sector, where rapid innovation and product development amplify the importance of reliable GMP testing services. These drivers collectively contribute to the strong demand for GMP testing services in North America.

Competitive Landscape:

The global market is experiencing significant growth due to the rapid advancements in testing technologies that provide more efficient and accurate methods for quality control. Along with this, the emerging trend of outsourcing production to third-party manufacturers amplifies the need for universal quality standards, driving demand for GMP testing services. In addition, companies merging with or acquiring others inherit new systems and processes, necessitating GMP testing services to ensure that integrated systems meet all regulatory standards. Thus, this is positively influencing the market. Apart from this, modern consumers demand ethically produced and environmentally friendly products. GMP testing services can help companies verify that their products meet these sustainability standards, in addition to ensuring quality and safety. In confluence with this, brands expanding into new product lines require adaptable GMP testing services that can validate a variety of products against multiple sets of regulations, significantly supporting the market. Furthermore, the escalating demand for GMP testing services that offer rapid validation without compromising on quality is contributing to the market.

The market report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

  • Almac Group
  • Charles River Laboratories International Inc.
  • Eurofins Scientific SE
  • ICON plc
  • Intertek Group plc
  • Merck KgaA
  • Nelson Laboratories LLC (Sotera Health Company)
  • North American Science Associates LLC
  • Pace Analytical Services LLC
  • PPD Inc. (Thermo Fisher Scientific Inc.)
  • Sartorius AG
  • Wuxi Apptec Co. Ltd.

Recent Developments:

  • In August 2023, Charles River Laboratories International Inc. formed a partnership with Fondazione Telethon to manufacture High Quality (HQ) plasmids.
  • In September 2020, Almac Group added biologics testing solutions to the range of analytical services it offers. In order to assist customers' drug substance and drug product programmes for both innovative biologics and biosimilars, the business stated its services would now also comprise, in part, GMP lot release and stability services.
  • In October 2022, the life science division of Merck KGaA, Darmstadt, Germany's MilliporeSigma, announced the opening of a commercial facility for its brand-new Millipore CTDMO Services product at its Martillac, France, location.

GMP Testing Service Market Report Scope:

Report Features Details
Base Year of the Analysis 2023
Historical Period 2018-2023
Forecast Period 2024-2032
Units US$ Billion
Scope of the Report Exploration of Historical Trends and Market Outlook, Industry Catalysts and Challenges, Segment-Wise Historical and Predictive Market Assessment:
  • Service Type
  • End User
  • Region
Service Types Covered Packaging and Shelf-life Testing, Product Validation Testing, Bioanalytical Services, Others
End Users Covered Pharmaceutical and Biopharmaceutical Companies, Medical Device Companies
Regions Covered Asia Pacific, Europe, North America, Latin America, Middle East and Africa
Countries Covered United States, Canada, Germany, France, United Kingdom, Italy, Spain, China, Japan, India, South Korea, Australia, Indonesia, Brazil, Mexico
Companies Covered Almac Group, Charles River Laboratories International Inc., Eurofins Scientific SE, ICON plc, Intertek Group plc, Merck KgaA, Nelson Laboratories LLC (Sotera Health Company), North American Science Associates LLC, Pace Analytical Services LLC, PPD Inc. (Thermo Fisher Scientific Inc.), Sartorius AG, Wuxi Apptec Co. Ltd., etc.

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
Customization Scope 10% Free Customization
Report Price and Purchase Option Single User License: US$ 3899
Five User License: US$ 4899
Corporate License: US$ 5899
Post-Sale Analyst Support 10-12 Weeks
Delivery Format PDF and Excel through Email (We can also provide the editable version of the report in PPT/Word format on special request)

Key Benefits for Stakeholders:

  • IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the GMP testing service market from 2018-2032.
  • The research report provides the latest information on the market drivers, challenges, and opportunities in the global GMP testing service market.
  • The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
  • Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the GMP testing service industry and its attractiveness.
  • Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.

Key Questions Answered in This Report

The global GMP testing service market was valued at US$ 1.5 Billion in 2023.

We expect the global GMP testing service market to exhibit a CAGR of 5.34% during 2024-2032.

The rising prevalence of chronic diseases caused by the aging population, sedentary lifestyles, unhealthy dietary habits, etc., along with the introduction of biosimilars, combination drugs, and other innovative medicines, is primarily driving the global GMP testing service market.

The sudden outbreak of the COVID-19 pandemic has led to the growing demand for GMP testing services in the drug development process, ensuring that products are safe, effective, and of high quality, which in turn, allows to combat the spread of the coronavirus infection.

Based on the service type, the global GMP testing service market has been segmented into packaging and shelf-life testing, product validation testing, bioanalytical services, and others. Among these, product validation testing holds the majority of the total market share.

Based on the end user, the global GMP testing service market can be bifurcated into pharmaceutical and biopharmaceutical companies, and medical device companies. Currently, pharmaceutical and biopharmaceutical companies exhibit a clear dominance in the market.

On a regional level, the market has been classified into North America, Asia Pacific, Europe, Latin America, and Middle East and Africa, where North America currently dominates the global market.

Some of the major players in the global GMP testing service market include Almac Group, Charles River Laboratories International Inc., Eurofins Scientific SE, ICON plc, Intertek Group plc, Merck KgaA, Nelson Laboratories LLC (Sotera Health Company), North American Science Associates LLC, Pace Analytical Services LLC, PPD Inc. (Thermo Fisher Scientific Inc.), Sartorius AG, Wuxi Apptec Co. Ltd., etc.

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GMP Testing Service Market Report by Service Type (Packaging and Shelf-life Testing, Product Validation Testing, Bioanalytical Services, and Others), End User (Pharmaceutical and Biopharmaceutical Companies, Medical Device Companies), and Region 2024-2032
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