The pharmaceutical sterility testing market is anticipated to be generated global sales revenue of USD 1,250.7 million in 2023. Demand is expected to develop at a CAGR of 11.8% to reach a valuation of USD 3,815.6 million by 2033.
Sterility testing applications are endless in the pharmaceutical, biotech, and medical device industries. The need for sterility testing in pharmaceuticals is greatly increasing since it covers the important stage of investigating the quality of raw materials, as well as process control and validation of finished products.
The pharmaceutical and biopharmaceutical production business experienced increasing demand for sterility testing. This is due to the severity and high infection rate of diseases, as well as the growing number of medications and vaccines. As a result, there is now a huge requirement for rigorous sterility of the items.
Rising drug launches and life sciences research and development prove to be driving factors for the industry. The demand for pharmaceutical sterility testing is also predicted to increase due to the rising need for sterilized goods internationally, as well as a few potential product safety concerns.
| Attributes | Details |
|---|---|
| Expected Market CAGR (2023 to 2033) | 11.8% |
| Expected Market Size (2023) | USD 1,250.7 million |
| Expected Market Size (2033) | USD 3,815.6 million |
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The background of the market is quite promising, and numbers are likely to increase during the research period. A number of developing nations have sped up the launch of new medicines in order to meet the world's rising need for healthcare. By doing this, the scope for CAGR increases from 9.8% (2018 to 2022) to 11.8% by 2033. As a result of the rising prevalence of chronic and infectious diseases, there is an increasing demand for pharmaceuticals on a global scale. For instance,
Future illness load is anticipated to increase demand for pharmaceuticals, supporting the need for pharmaceutical sterility testing. Due to this, the global market had the potential to thrive. In 2018, the market was valued at USD 773.7 million, and by 2022, it reached USD 1,124.7 million.
The regulatory changes have significantly improved the likelihood of widespread adoption. Drugs like Elagolix and Lanadelumab, whose debut is considerably assisting the market's growth, are biopharmaceutical products that require special sterility testing. Given all of these influences, the market is probably anticipating a 1.1x growth between 2022 and 2023.
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In 2022, it is anticipated that North America accounted for 39% of the global pharmaceutical sterility testing market. The existence of numerous international and domestic competitors in the area is responsible for the region's rise.
During the forecast period, a huge amount of money is likely to be spent on research and development to support the growth of North America market. The biopharmaceutical business has a substantial total economic impact on the economy of America.
The United States held a dominant market share of 41.5% in 2022. This is due to the factors such as:
For instance, PreHevbrio was introduced by VBI Vaccines Inc. in March 2022 for the treatment of persons aged 18 years old. It is for those who are at risk of contracting any of the recognized subtypes of the hepatitis B virus (HBV). In November 2021, the FDA authorized this vaccine as the exclusive adult 3-antigen HBV vaccine. Consequently, Canada spent USD 23,400 million internally on pharmaceutical research and development in 2021, and it reached USD 23,800 million in 2022, a 1.7% increase.
By 2033, China is anticipated to hold a significant rank in the pharmaceutical sterility testing sector, with a CAGR of 12.1%. This is a result of emerging countries increasingly harmonizing their regulatory norms with ICH standards. Additionally, the region's emerging economies are taking a variety of steps to expand their domestic pharmaceutical market and are enticing multinational corporations to establish operations there.
Contract research organizations (CROs) are anticipated to expand significantly over the next few years. Sterile testing services are significantly being outsourced to CROs because of the benefits they provide including flexibility, cost-effectiveness, and access to specialist knowledge. The primary end-users of sterility testing services in the nation are anticipated to be the biopharmaceutical industry and CROs.
India is prepared to manufacture medical devices and conduct extensive sterility testing due to substantial pharmaceutical investment. By 2033, India is projected to have a 12.8% CAGR.
According to the Union Budget for the years 2021 to 2022, the Indian Ministry of Science and Technology allocated USD 430 million, a 25% increase from the budget for the years 2020 to 2021, for the DBT (Department of Biotechnology). This is primarily for biotechnology research and development, as well as industrial and entrepreneurship development in the nation. This budget sets new goals for India pharmaceutical sterility testing market. In accordance with the analysis, the Indian biotechnology market was estimated to be worth USD 70,200 million in 2020; by 2025, it is anticipated to be worth USD 150,000 million.
In Germany, automated methods rule the market. The market was initially growing, with a share of 6.2% in 2022, and by 2033, it is projected to have a wide scope. Automated systems that contribute effectively to the global industry include the BacT/ALERT system. These techniques are made to be highly sensitive and specific in identifying the presence of microorganisms in pharmaceutical items.
Germany has a stringent regulatory framework that is overseen by the European Pharmacopoeia (Ph. Eur.) and the German Medicines Act (AMG). All pharmaceutical products that are intended for infusion, implantation, or injection into the human body must pass sterility testing. This testing is essential to make sure the product is devoid of living microorganisms like bacteria, viruses, and fungi that possibly infect people or create other adverse effects.
| Category | Product Type |
|---|---|
| Top-segment | Kits & Reagents |
| Market Share (2022) | 39.7% |
| Category | Services |
|---|---|
| Top-segment | Outsourced |
| Market Share (2022) | 54.1% |
| Category | Test type |
|---|---|
| Top-segment | Bacterial endotoxin testing |
| Market Share (2022) | 38.4% |
Through 2033, the kits and reagents market is predicted to experience significant growth. The availability of a variety of items that aid in reducing the danger of false negative and false positive results is credited with this increase. These also consist of sterility testing pumps, which are easily integrated into any testing environment, streamline workflow, and help to maximize safety.
Over the anticipated period, segmental growth is expected to be boosted by the rising demand for comparable products.
In 2022, the segment for bacterial endotoxin testing held the leading market share with 38.4%. These tests are used to evaluate medical equipment like implants. The market for this category is expanding as a result of rising parenteral medication and implant demand. Along with an increase in the number of drug and medical device launches, there is a growing emphasis on product quality.
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How do Pharmaceutical Sterility Testing Manufacturers Expand in the Market?
The demand for pharmaceutical sterility testing is projected to increase along with medical improvements, and producers can profit from these technological developments.
The growth of the biotechnology sector offers businesses a lot of room for future advancements.
Concerns like the safety of biological pharmaceuticals are surging. New technological advancements in the area of sterility testing have improved the procedure's efficiency, allowing manufacturers to introduce new products in the market.
The market is highly fragmented due to the presence of multiple local and MNC contract service providers and research facilities. The main strategies employed by the bulk of these organizations include regional growth and digitalization of service delivery for sterility testing. Companies in the sector are subject to intense regulatory scrutiny and must abide by rules relating to the security of pharmaceutical products. As a result, specialized consulting companies have emerged. These companies offer services related to pharmaceutical sterility testing that are related to regulatory compliance and quality assurance.
Recent Developments:
The market is valued at USD 1,250.7 million in 2023.
SGS SA, Toxikon, Inc., and Pace Analytical Services are key market players.
India, Japan, and China dominate the Asian market.
The market is estimated to reach USD 3,815.6 million by 2033.
Asia-Pacific is projected to emerge as a lucrative market.
1. Executive Summary 2. Market Overview 3. Market Background 4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033 5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product 5.1. Kits and Reagents 5.2. Instruments 5.3. Services 6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Application 6.1. Sterile Drugs 6.2. Medical Devices 6.3. Biologics 6.4. Therapeutics 7. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Test Type 7.1. Sterility Testing 7.1.1. Membrane Filtration 7.1.2. Direct Inoculation 7.2. Bioburden Testing 7.3. Bacterial Endotoxin Testing 7.4. Container Closure Integrity Testing 7.5. Rapid Micro Test 7.5.1. ATP Bioluminescence 7.5.2. Fluorescent Labeling 7.5.3. Electrical Resistance 7.6. Others 8. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Manufacturing 8.1. In-House 8.2. Outsourced 9. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By End Use 9.1. Compounding Pharmacies 9.2. Medical Devices Companies 9.3. Pharmaceutical Companies 10. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region 10.1. North America 10.2. Latin America 10.3. Europe 10.4. Asia Pacific 10.5. MEA 11. North America Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 12. Latin America Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 13. Europe Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 14. Asia Pacific Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 15. MEA Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country 16. Key Countries Global Market Analysis 17. Market Structure Analysis 18. Competition Analysis 18.1. Pacific Bio labs 18.2. STERIS 18.3. Boston Analytical 18.4. Nelson Laboratories, LLC 18.5. Sartorius AG 18.6. SOLVIAS AG 18.7. SGS SA 18.8. Laboratory Corporation of America Holding 18.9. Pace Analytical 18.10. Charles River Laboratories 18.11. Thermo Fisher Scientific, Inc. 19. Assumptions & Acronyms Used 20. Research Methodology
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Pharmaceutical Sterility Testing Market
