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GMP Testing Service Market Segmentation By Type - Product Validation Testing | Bioanalytical Services | Packaging & Shelf-Life Testing
The global GMP Testing Service market was valued at US$ 1900 Million in 2022 and is expected to expand at a CAGR of 5.4% from 2022 to 2032. Factors such as the expanding pharmaceutical sector and increased medication and device development are projected to drive market expansion.
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Report Attributes |
Details |
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GMP Testing Service Market Size (2022) |
US$ 1,900 Million |
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Projected Market Value (2032) |
US$ 3,200 Million |
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Global Market Growth Rate (2022-2032) |
5.4% CAGR |
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The worldwide market for GMP testing services is expected to increase significantly due to the increasing requirement for process validation, effective documentation standards, and the ability to generate high-quality goods. GMP testing services offer a wide range of services according on the needs of the end customer.
Innovative speciality pharmaceuticals must be made with extreme care in order to achieve the quality standards that may be certified by the use of GMP testing services. GMP testing services are a vital need for medical device makers in order to decrease product recalls from the market. Bioanalytical testing, product development testing, sterility testing, and shelf-life testing are all examples of GMP testing services. Hence, the market for GMP testing services is anticipated to grow at a CAGR of 5.4% during the forecast period.
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Get a Customized VersionRising Demand for Medical Devices anticipated driving the Global Market
The medical device sector is a key facilitator of the development of medical technologies that aid in the diagnosis and treatment of a variety of disorders. This business manufactures anything from ordinary items like surgical masks to high-tech imaging equipment. Insulin delivery systems, glucose monitors, oxygen concentrators, and nebulizers are among the medical equipment that are increasingly being utilised at home for the diagnosis and treatment of a few medical problems. These gadgets are linked to the patient's EMR, wearables, telephones, and telemedicine platforms to deliver essential data for better clinical and operational decisions. According to PRODSMART statistics, the medical device manufacturing business was valued at $4.2 billion in 2020.
The rise in the frequency of chronic illnesses, as well as the growing elderly population, is the primary variables projected to affect the medical device industry's advancement in the approaching years. Smart gadgets, smart sensors, and other lightweight communication devices are used in the integration of medical equipment with Internet of Medical Things (IoMT) systems. These advances help healthcare professionals improve patient outcomes while cutting costs and enhancing efficiency.
GMPs are extremely essential in medical device production since they maintain a degree of quality, safety, purity, and strength in any items that are distributed to the public. Adhering to these procedures assists producers in avoiding negative consequences, product recalls, and faults, which may result in costly liability litigation in the future. Because quality control and uniform testing settings are critical for a successful production cycle, the emphasis on GMPs is growing in order to minimise product contamination, failure, and quality variation.
Lack of a Unified Regulatory Framework restraining Market Growth
The lack of a unified regulatory framework for GMP testing services impedes the overall growth of the GMP testing service industry. The regulatory compliance standards for GMP testing services are determined by the geographical reach of pharmaceutical and biotechnology businesses' distribution networks.
The FDA supervises the GMP testing services industry in North America, whereas the European Medicines Agency (EMA) oversees the GMP testing services market in Europe. Other organisations that govern GMP testing services include the Association of South-East Asian Nations (ASEAN) and the Pharmaceutical Inspection Convention. These regulatory authorities must assure adequate compliance based on where pharmaceutical businesses produce, distribute, and advertise their products.
All locations involved in the manufacture of a medicine are evaluated by regulatory organisations. This evaluation comprises all phases, from raw material/API manufacture through final packaging facilities. Furthermore, rules may differ based on the processes involved in a certain manufacturing process. If a corporation fails to meet the standards of a regulatory body in a certain nation or area, its goods are considered adulterated under the law and the FDA urges patients not to use such drugs, which might have major health implications. As a result, tight regulatory frameworks for GMP testing services in many areas are impeding the market's growth.
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Established Infrastructure and Compliance Acceptance Driving Market for GMP Testing Service
The WHO version of GMP is widely utilised in underdeveloped nations, however each country can have its own minimum GMP criteria. The GMP testing services market is divided into seven geographical regions: South Asia, East Asia, Europe, Latin America, North America, Oceania, and the Middle East and Africa.
North America is likely to be the largest revenue stakeholder due to its established infrastructure and compliance acceptance. Europe, which has a big number of healthcare product manufacturing facilities, is expected to follow North America.
Why are Suppliers of GMP Testing Service investing in the U.S.?
Growing Demand for Creating Innovative Pharmaceuticals and Technologies to Drive Market Growth
Because of the growing demand for creating innovative pharmaceuticals and technologies, North America is likely to be a dominating location in the GMP testing services market. According to data from the Centers for Disease Control and Prevention, more than 34.2 million Americans have diabetes, and more than 868,000 individuals die from heart disease each year, as of January 10th, 2022.
As a result of increased death rates and chronic disease prevalence, the number of medicine manufacturing plants is growing. The market for GMP testing services is expected to increase as a result of the aforementioned factors. Moreover, in November 2020, there were 13,010 domestic FDA-registered facilities for the manufacture of medical devices, 3,568 facilities for the manufacture of human medications, and 5,112 facilities for the manufacture of pharmaceuticals.
The market for GMP testing services is expected to grow as the number of pharmaceutical manufacturing facilities increases. According to the Food and Drug Administration, there are about 4,676 drug production facilities in the United States (FDA). The National Institutes of Health has also expanded funding for biotechnology and related companies (NIH). Biotechnology got USD 7,655 million in funding in the United States in 2020.
Furthermore, the National Institutes of Health (NIH) has increased funding in recent years for a variety of disorders such as diabetes and cancer that require cutting-edge testing equipment. Diabetes funding in the United States in 2020 was USD 1,179 Million. TShe bulk of the large businesses that test devices for accuracy are expected to be pulled by increased research funding, which will fuel the industry's rapid growth. The market for GMP testing services is predicted to grow as the need for novel drugs and therapies rises.
How Will the Chinese GMP Testing Service Market Evolve?
Growing Number of Contract Manufacturing Units to boost the Regional Market Growth
The growing number of contract manufacturing units in China is likely to increase demand for GMP testing services. GMP testing services are necessary to ensure that the originating unit and the manufacturing unit where production is outsourced are in accordance with the compliances and requirements.
By Service Type, which Segment is Driving Market Growth?
The Product Validation Testing Segment type is expected to grow at a significant rate
The GMP testing service market is divided into several service types, including product validation testing, bioanalytical services, packaging and shelf-life testing, and others. In 2021, the product validation testing category was the market leader. During the projection period, this segment's market is predicted to develop at a CAGR of 5%.
Which End User Shows Higher Implementation in GMP Testing Service Market?
Demand from the Pharmaceutical and Biopharmaceutical Companies Segment to Gain Traction
During the projection period, the pharmaceutical and biopharmaceutical companies segment is predicted to increase. Innovative medication discovery in the pharmaceutical and biopharmaceutical sectors is expected to drive market expansion in this area.
The biopharmaceutical industry is moving at breakneck speed to provide vaccines to patients. To answer the pandemic's urgent demands, the biopharmaceutical sector has opened up new avenues and alliances. As a result of the COVID-19 pandemic, there is an increasing demand for product validation testing services; these services must be employed to guarantee that pharmaceutical items are of high quality, effective, and safe standards.
Eurofins BioPharma Product Testing Italy enhanced its virucidal testing capability when the COVID-19 pandemic began in December 2020. Similarly, PPD Inc., a renowned worldwide contract research firm, announced intentions in April 2021 to expand its Good Manufacturing Practice (GMP) facility in Ireland in order to improve its biopharmaceutical testing capabilities. As a consequence, the pharmaceutical and biopharmaceutical companies are driving market expansion and are expected to positively impact the expansion of the GMP testing services market during the forecast year.
There are numerous key companies in the GMP testing service industry. In terms of market share, a few significant firms now dominate the industry. Companies are taking steps to fulfil the increased demand for medications and medical gadgets.
Companies that are presently dominating the market include Eurofins Scientific, North American Science Associates Inc., Almac Group, PPD Inc., Intertek Group PLC, Nelson Laboratories LLC, Wuxi AppTec., Sartorius AG, Boston Analyticals and Pace Analyticals.
Recent Developments
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Attributes |
Details |
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Forecast Period |
2022-2032 |
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Historical Data Available For |
2017-2021 |
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Market Analysis |
US$ Bn for Value |
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Key Countries Covered |
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By Market Segments |
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Key Companies Profiled |
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Pricing |
Available Upon Request |
By Type
By End User
By Region
The global GMP Testing Service market accounts for a revenue of US$ 1,900 Million in 2022.
The global market for GMP Testing Service is expected to reach US$ 3,200 Million by 2032.
Demand for GMP Testing Service from 2022 to 2032 is projected to expand at a stellar CAGR of 5.4%.
By 2032, the pharmaceutical and biopharmaceutical companies segment is projected to hold a maximum share of the market.
Key suppliers of GMP Testing Service are Eurofins Scientific, North American Science Associates Inc., Almac Group, PPD Inc., Intertek Group PLC, Nelson Laboratories LLC, Wuxi AppTec., Sartorius AG, Boston Analyticals and Pace Analyticals.
