GMP Testing Service Market: global industry analysis and forecast (2024-2030)

GMP Testing Service Market Overview

The good manufacturing practice (GMP) system ensures that products are manufactured consistently and under quality standards. The goal is to minimize the risks related to pharmaceutical manufacturing that cannot be eliminated by evaluating the final product. Throughout the projection period, growth is expected in the pharmaceutical and biopharmaceutical firms area. The process of making sure that goods are regularly produced and regulated following quality standards is known as good manufacturing practice, or GMP. It is intended to reduce the dangers associated with producing pharmaceuticals that cannot be removed by testing the finished product.

 

Its primary goal is to guarantee the safety, quality, and purity of manufactured goods. The most extensively utilized form of GMP rules is promoted by the World Health Organization (WHO) and is enforced by the Food and Drug Administration (FDA) in the United States. It includes every facet of production, from the initial supplies, buildings, and machinery to the personnel's cleanliness and training. The World Health Organization's (WHO) list of good manufacturing practices is the foundation upon which many nations have built their criteria.

 

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GMP Testing Service Market Dynamics

The pharmaceutical and biopharmaceutical companies grabbed the highest market share.

The pharmaceutical industry allocates a significant portion of its budget to technical developments, market growth in emerging nations, and internal research and development operations. This translates into more money being spent on medication development. The emergence of biosimilars or generic biopharmaceuticals, in addition to new therapies, has led to an increase in the manufacturing of biopharmaceuticals. Generic drug manufacturing has received a lot of attention as a result of the numerous patents that are expiring. To turn promising compounds created in research labs into medications for use by patients, pharma development entails developing, constructing, and scaling up a process.

 

It continuously provides medication levels that are both safe and effective, allowing for the testing of its purity and longevity. The market is expected to increase quickly in the future years thanks to the significant role that GMP testing services play. Consequently, the researched market is expected to increase over the projected period to rising investment in the pharmaceutical and medical device industrial sector, research and development efforts in both developed and developing nations, coupled with growing product approvals.

 

Restraints In the GMP Testing Service Market

Growing labor, equipment, and facility improvement costs are a barrier to market growth caused by high compliance costs.

GMP is a set of regulations designed to guarantee items used in food, medicine, and cosmetics. They are constantly made following product requirements and quality standards suitable for the purposes for which they are designed. The only way to get around these regulatory interventions is to properly manufacture and conduct biological agent research. Good manufacturing processes are therefore essential to all facets of product development and approvals. Strict regulations have been put in place in this regard to stop the medications or technologies from causing any further negative side effects.

 

GMP procedures are used to comply with the standards advised by the regulatory bodies that oversee the granting of licenses and permits for the production and distribution of medical devices, medicines, nutritional supplements, and other items. To guarantee the safety, effectiveness, purity, and potency of vaccines and other regulated goods, laboratory and clinical data are carefully examined. The high cost of GMP compliance also impedes market increase, by resolving the increased expenses for labor, equipment, facility upgrades, sanitation, record-keeping, and other GMP-related activities.

 

Opportunities In The GMP Testing Service Market

The growing requirement for drug and device manufacturers to adhere to good manufacturing practices in their daily research and development activities is expected to drive the market used for GMP testing services to healthy growth in the impending years. This is necessary to ensure the regulatory bodies approve the target products promptly. Future demand for GMP testing services is expected to increase thanks to the growing focus of major pharmaceutical and biopharmaceutical firms on developing a variety of therapies and medical devices intended to provide effective treatment for a wide range of chronic conditions. In addition, the majority of pharmaceutical businesses outsource their GMP services to avoid having to pay for product callbacks that result from non-compliance with GMP regulations.

 

• For example, in March 2021, the us FDA sent a warning letter to Foshan Biores Biosciences Co. Ltd, a Chinese producer of over-the-counter (otc) drug items, citing serious infractions of the cGMP rules for pharmaceutical finished goods

 

GMP Testing Service Market Segment Analysis

By service type, analysing bioanalytical services to determine the concentration of medications, metabolites, or biomarkers in biological matrices is the process of providing bioanalytical services. These services are essential for pharmacokinetic and pharmacodynamic research, which guarantee the security and effectiveness of pharmaceuticals. Our scientists are globally connected and are able to assist you with complicated challenges through a network of bioanalytical professionals. We offer services for bioanalysis from the clinic to research. They also provide quick lead times and assist you in choosing the most dependable analytical methodology with high-quality standard operating procedures (sops) so that you meet important deadlines.

 

• The bioanalytical testing services market is divided into research & academic institutes, contract research organizations, pharmaceutical & biotechnology firms, and other end-users based on end-use. In 2023, the market share of the pharmaceutical and biotechnology firm’s category was 45.9%.

Packaging and shelf-life testing is a real-time assessment of the systems and materials used for packaging by the user (e.g. Hospitals). Throughout the test, test packets are ready, sanitized, and kept in circumstances that simulate aging in real-time. Both pack rotation and environmental monitoring are done once a week. The packets are stored before being moved to our sterility suite, where the contents are subjected to a sterility test. To determine the sterilization cycle parameters, shelf-life tests should be carried out once sterilization validations and penetration investigations are finished. We follow guidelines while doing our packaging shelf-life testing.

 

GMP Testing Service Market Regional Analysis

North America’s presence of major players in the market and access to cutting-edge technology is expected to contribute to its considerable market share throughout the forecast period. Additionally, strong medical demand and a supportive regulatory environment are expected to support regional market growth. The FDA constantly monitors medication manufacturers' adherence to its current good manufacturing practice (cGMP) requirements to ensure the quality of their products. Minimum standards for the facilities, procedures, and controls utilized in the production, processing, and packaging of pharmaceutical products are included in the cGMP rules. The rules guarantee that a product is secure and has the components and potency it specifies. Additionally, it is expected that the rising prevalence of chronic illnesses is boost the need for innovative medications, probably resulting in a rise in drug production and market increase.

 

• For example, according to CDC statistics from 2022, almost six out of ten Americans have a chronic illness, which is the main cause of the country's yearly healthcare expenses, which come to nearly USD 4.1 trillion. The rising rate of illness is estimated to drive up demand for premium medications, which in turn drives up manufacturing activity that has to undergo GMP testing and accelerates market growth.

 

• North America holds a sizable share of the global market because key biopharmaceutical and pharmaceutical businesses are headquartered in the us and other North American countries. The emergence of major pharmaceutical businesses and their R&D Endeavours in the region is another factor driving the necessity for GMP testing.

 

GMP testing service market competitive landscape

Testing technologies are advancing at a quick pace, offering more accurate and efficient ways for quality control, which is driving considerable expansion in the global market. Also, there is a growing requirement for GMP testing services to the growing tendency to outsource manufacturing to outside manufacturers, which increases the need for global quality standards. Additionally, businesses that merge with or buy other businesses take on new systems and procedures, which calls for GMP testing services to guarantee that integrated systems adhere to all legal requirements. In light of this, the market is being positively impacted. In addition, today's customers want items that are made ethically and sustainably. Important players microchem laboratory and Icon plc.

 

• Only a few labs in the US, including Microchem Laboratory in 2024, offer specialized aerobiological testing services for antimicrobial compounds and technology.
• In this article from PharmaTimes on March 29, 2024, ICON plc company explains how to deal with the difficulties and complexities of the changing digital landscape of healthcare data.

GMP testing service market scope
Market size in 2023	USD 1.5 bn.
Market size in 2030	USD 2.49 bn.
CAGR (2024-2030)	6.5%
Historic data	2018-2022
Base year	2023
Forecast period	2024-2030
Segment scope	By service type        bioanalytical services Packaging and shelf-life testing Product validation testing
	By end user          pharmaceutical and biopharmaceutical companies      medical device companies
Regional scope	North America- United States, Canada, And Mexico Europe – UK, France, Germany, Italy, Spain, Sweden, Austria, And Rest of Europe Asia Pacific – China, India, Japan, South Korea, Australia, Asean, Rest of APAC Middle East and Africa - South Africa, GCC, Egypt, Nigeria, Rest of The Middle East And Africa South America – Brazil, Argentina, Rest Of South America

 

Key player in the GMP testing service market

1. microchem laboratory
2. icon plc
3. sartorius
4. Wuxi app tec
5. Nelson labs
6. Eurofins scientific
7. Merck kgaa
8. Ul solution
9. Intertek group plc
10. Charles river laboratory
11. Almac group
12.  namsa.
13. Jaguar holding.
14. Sigma-aldrich.
15. Pace analytical.
16. Ppd inc
17. Labcorp grug development
18. Sgs
19. R d laboratories
20. Atz speciality chemical