Pharmaceutical Sterility Testing Market: by Sample (Sterile Drugs, Medical Devices, and Biologics), by Product Type (Instruments, Kits & Reagents, and Services), by Type (In-house and Outsourcing), by Test Type (Sterility Testing, Bioburden Testing, and Bacterial Endotoxin Testing), by End User (Compounding Pharmacies, Medical Devices Companies, Pharmaceutical Companies, and Others), and by Region (North America, Europe, Asia-Pacific, and Rest of the World)—Forecast to 2030

Pharmaceutical Sterility Testing Market Overview

The pharmaceutical sterility testing market is expected to cross USD 900 Million by 2030 at a CAGR of 6.10%. Sterility is the non-appearance of viable microorganisms, dust, fibers, foreign particles, and other biological agents. Pharmaceutical sterility testing is a major aspect of good manufacturing practice (GMP) microbiology and is crucial for tissue materials, pharmaceutical preparations, and medical devices, all of which must be sterile due to their intended use. Moreover, it is also used for cell banks, raw materials, and pharmacological finished goods. According to the laws of the European Pharmacopoeia and United States Pharmacopoeia, pharmaceutical preparations and substances must be made sterile. For instance, all parenteral biological formulations intended for human use must be sterile; hence sterility testing is required. The major factors driving the pharmaceutical sterility testing market include an increasing number of drug launches, expansion of the biotechnology & pharmaceutical industry, and increasing R&D in life science research. Moreover, new technological development and improving focus on quality control in accordance with regulatory requirements further contribute to the market growth. However, time-consuming and stringent regulatory policies are the factors that may hamper market growth.

COVID-19 Analysis

The global pharmaceutical sterility testing market emerged from the COVID-19 shut down due to the pharmaceutical and biotech companies' race to discover a vaccine for the COVID-19. Speedy testing is essential to verify that a vaccine is safe, effective, and approved by regulatory agencies. Every vaccine and injection given to patients must pass final product sterility testing to be considered safe. This will drive the pharmaceutical sterility testing market and is expected to grow at a rapid pace during the pandemic period. However, many vaccine manufacturers currently utilize a 14-day sterility test, which means each lot of vaccine must wait two weeks before being released to the public. Due to this time-consuming factor, market growth may be hampered.

Market Dynamics

• Increasing number of new drug launches and expansion of the biotechnology & pharmaceutical industry

• 
  
  
  
  • The number of new drug approvals and drug launches has increased over the years. In 2020, The US Food and Drug Administration (USFDA) Center for Drug Evaluation and Research has approved around 53 novel drugs as new molecular entities under the New Drug Applications (NDAs). Similarly, according to the Pharma and Annual Review 2021 report, 1,324 new drugs were launched in the global market in 2020. These new product launches are boosting the adoption of pharmaceutical sterility testing, and the global market for pharmaceutical sterility testing is expected to grow during the forecast period.  Furthermore, pharmaceutical sterility testing is performed at all levels of manufacturing in the pharmaceutical and biopharmaceutical sectors to reduce the possibility of product contamination. As a result, the expansion of this biotechnology & pharmaceutical industry will significantly increase the overall usage of pharmaceutical sterility testing in the future years.
  
  
  
  


• New technological developments 
  
  
  
  • The technological advances in pharmaceutical sterility testing methods resulted in a decrease in procedural time and human interaction, increasing the test's efficiency and accuracy, thereby driving the market. For instance, in October 2019, Alcami Corporation (US) launched a new rapid sterility offering, Milliflex Rapid System, that uses cutting-edge microbiological testing technology to provide consumers with much faster testing results. It uses adenosine triphosphate (ATP) bioluminescence for the detection of microorganisms after five days. More advanced computer-generated findings are also included in the technology, which eliminates observer bias.
  
  
  
  


• Rising investment in R&D activities in life science researc

• Time-consuming and stringent regulatory policies
  
  
  
  • The process of establishing the quality of pharmaceutical medications begins with sterility testing. However, strict regulatory policies, regulations, and time-consuming processes in many countries may hamper the growth of the pharmaceutical sterility testing market to some extent.
  
  
  
  


• Shortage of skilled professionals

Growing government initiatives towards the biotechnology sector

• An increasing number of patients are suffering from cardiovascular diseases such as heart failure, heart attack, stroke, arrhythmias, high blood pressure, and cancer-related diseases. As a result, pharmaceutical sterility testing is projected to gain more importance. The pharmaceutical sterility testing market is predicted to grow in the next years, and it will be useful in determining the quality of pharmaceutical drugs. Moreover, market development is mostly determined by technical advancements and their application during the process.

• Sterile Drugs: Sterile drugs should be free from all types of microorganisms and should be isotonic.Sterile dosage forms include parenteral preparations and ophthalmic preparations. Parenteral preparations include injections, transfusions fluids, sterile suspensions, sterile solids, sterile solutions or emulsions, and ophthalmic preparations include eye drops, eye lotions, eye ointments, eye gels, eye suspensions, and contact lens solutions.


• Medical Devices: Medical equipment manufacturers strive to provide safe and effective goods, and sterility assurance is an important part of that process. Soybean-casein digest medium is used to assess the sterility of medical devices.


• Biologics: Biologics are a type of potent medicine that reduces the harmful effects of inflammation. It includes biosimilars and vaccines.

• Instruments: The instruments segment encompasses a wide variety of equipment and machinery. Each instrument plays a vital role in the success of each step in the manufacturing process. The instruments required in the pharmaceutical sterility testing industry are high-temperature sterilization instruments, low-temperature sterilization instruments, ionizing radiation instruments, non-ionizing radiation instruments, and filtration sterilization instruments.


• Kits & Reagents: Kits & reagents consist of sterile fluid thioglycollate medium and sterile soybean casein digest medium. It is cost-efficient, easy to use, and known as a rapid pharmaceutical sterility testing method. The repeated purchasing of these products by end users all over the world is a crucial factor contributing to the growth of the kits & reagent segment.


• Services: Services are designed to address problems at different stages during the sterility test. Companies in the pharmaceutical sterility testing market are establishing new sterility testing services to augment their product portfolio and expand their market presence. The corporates have launched well-equipped services to exploit the growth potential of the pharmaceutical sterility testing market. For instance, in 2019, Reading Scientific Services Ltd (UK) established a sterility testing solution for pharmaceutical and medical device firms that is fast, responsive, and adaptable. This service reduces the risks of particulate contamination, as well as endotoxin to analyze potential pyrogen contamination.

• In-house For pharmaceuticals, biopharmaceuticals, and medical devices companies, in-house sterility testing is an important aspect of quality assurance and Good Manufacturing Practices (GMP). Each batch must pass sterility testing before being released, allowing the segment to expand.


• Outsourcing Pharmaceutical sterility testing can be outsourced because some pharmaceutical and medical device companies lack the necessary infrastructure to perform high-quality sterility testing. They prefer to outsource these services. Moreover, many organizations outsource sterility testing to save money.

• Sterility Testing: Sterility testing is one of the most significant components of the healthcare industry, which verifies the purity and safety of a product or substance. There are several types of sterility tests available such as membrane filtration sterility testing, direct transfer sterility testing, and fluid path sterility testing. A membrane filtration sterility testing is one of the most popular sterility testings for filterable pharmaceuticals.


• Bioburden Testing: Bioburden testing is the measure of microbial contamination levels on a product that has not been sterilized. Bioburden testing is conducted on medical devices, pharmaceuticals, raw materials, packaging, human tissue, and animal tissue to determine the total viable microorganism count prior to the sterilization process. Bioburden testing, sterility testing, and sterilization process validation are crucial aspects of GMP for assuring the safety of the end products.


• Bacterial Endotoxin Testing: Bacterial endotoxin testing is an in-vitro assay that detects and quantifies bacterial endotoxins, part of gram-negative bacteria's cell wall. Endotoxins can reduce a medicinal product's effectiveness and induce side effects such as fever, hypotension, pulmonary edema, and widespread coagulation events in humans and animals. Thus, bacterial endotoxin testing is widely used for pharmaceutical manufacturing, medical device manufacturing, raw materials production, and packaging manufacture. For Instance, in May 2020, Suez S.A. launched the Sievers Eclipse Bacterial Endotoxin Testing platform, which saves pipetting processes, lowers operator-to-operator variability, and boosts laboratory productivity.

• Compounding Pharmacies: The Drug Quality and Security Act provides the FDA authority to monitor and regulate the compounding of drugs, thereby increasing the adoption of sterility testing procedures by the compounding pharmacies. Moreover, the regulatory framework for sterile products in pharmacies is increasingly becoming stringent to avoid any adverse events. For instance, in August 2019, the US Food and Drug Administration (USFDA) has warned patients and health care providers not to use Pacifico National Inc.'s sterile drug products due to significant quality and sterility concerns.


• Medical Devices Companies: Medical devices companies provide several medical devices such as instruments, apparatus, machines, and implants are supplied to the final user as sterile products. The government support for medical device companies and advancement in sterilization technologies drives the demand for pharmaceutical sterility testing for the medical device companies.


• Pharmaceutical Companies: Pharmaceutical companies carried out sterility testing to determine the quality of raw materials and process control and end-product validation. The "pharmacopeia" methods and good manufacturing practices (GMP) guidelines are usually used by pharmaceutical companies for testing medicinal products. The increasing number of drug launches across the globe and the rising number of pharmaceutical companies drive the market's growth. For instance, the US Food and Drug Administration (USFDA) has approved 31 novel drugs in 2021 till July.


• Others: Other end users include academic research institutes and centers and cell banks. Moreover, an increase in the number of cell banks is likely to fuel market growth.

• North America
  
  
  
  • The North American market accounted for the largest market share in 2020 due to the presence of a large number of international and domestic players in the region and innovative technologies. Furthermore, the advanced healthcare infrastructure and rising R&D investment are expected to influence the growth of the pharmaceutical sterility testing market over the forecast period. For instance, according to the Congressional Budget Office's April 2021 report on "Research and Development in the Pharmaceutical Industry," the pharmaceutical industry spent USD 83 billion on R&D in 2019.
  
  
  
  


• Europe
  
  
  
  • The European pharmaceutical sterility testing market is driven by increasing government initiatives and the extensive availability of research grants. The European market is rich with developed, well-equipped outsourcing companies for pharmaceutical sterility testing due to the rising biopharmaceutical product development and technological advancements in the region. For instance, the New Sterisart Universal Pump has the special software of the high-end version that guides the user by individual menu prompts. These technological advancements save time and money and help ensure reliable sterility test results. Moreover, countries such as the Netherlands, which has a rich tradition of public-private cooperation and has been further stimulated by multiple government-initiated programs, are expected to increase the market growth in this region.
  
  
  
  


• Asia-Pacific:
  
  
  
  • The pharmaceutical sterility testing market is projected to be the fastest-growing regional market due to the increasing harmonization of the regulatory standards with the International Council for Harmonisation (ICH) standards in developing nations. Moreover, technological advances and rising disposable income levels in developing countries such as China and India. Moreover, several growing economies in the region are taking steps to improve the domestic pharmaceutical market and are encouraging global corporations to set up operations in the region, driving the growth of the pharmaceutical sterility testing market in the Asia-Pacific region.
  
  
  
  


• Rest of the World:
  
  
  
  • The Rest of the World is segmented into the Middle East, Africa, and Latin America. The pharmaceutical sterility testing market in the region is driven by technological development and developing healthcare infrastructure.
  
  
  
  

• The global pharmaceutical sterility testing market is characterized by the presence of many global, regional, and local players. The high prevalence rate of patients with cardiovascular diseases and cancer, an increasing number of drug approvals & new drug launches, and technological developments make the pharmaceutical sterility testing market lucrative. To expand their reach and optimize their operational costs, the major players focus on mergers & acquisitions, regional expansion, product launches, contractual agreements, and joint ventures to gain a substantial market share. For instance, in August 2020, Pace Analytical Services, LLC acquired Emerson Resources Inc. (US), a contract production and manufacturing organization (CDMO). The acquisition will enable the company to service pharmaceutical and biopharmaceutical industries from early-stage product development to phase II clinical trial material manufacturing.

• Merck KGaA (Germany)


• Rapid Micro Biosystems (US)


• Sartorius AG (Germany)


• Solvias AG (Switzerland)


• SGS SA (Switzerland)


• Boston Analytical (US)


• BioMérieux, Inc. (France)


• Charles River Laboratories International, Inc. (US)


• Thermo Fisher Scientific, Inc. (US)


• Pace Analytical Services, LLC (US)


• Toxikon, Inc. (US)


• Sotera Health (US)


• Pacific Biolabs Inc. (US)


• STRERIS Corporation (US)


• WuXi AppTec (China)

• In August 2020, Pace Analytical Services, LLC acquired Emerson Resources Inc. (US), a contract production and manufacturing organization (CDMO). The acquisition will enable the company to service pharmaceutical and biopharmaceutical industries from early-stage product development to phase II clinical trial material manufacturing.


• In May 2020, Suez S.A. launched the Sievers Eclipse Bacterial Endotoxin Testing platform, which saves pipetting processes, lowers operator-to-operator variability, and boosts laboratory productivity.


• In October 2019, Alcami Corporation launched a new rapid sterility offering, a service that uses cutting-edge microbiological testing technology to provide consumers with much faster testing results.


• In August 2018, Sotera Health acquired Gibraltar Laboratories (US). The acquisition is expected to expand the business of analytical testing capabilities of Sotera Health's Nelson Labs.

• The study covers the existing short-term and long-term market effects, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID on the market

• Sterile Drugs


• Medical Devices


• Biologics

• Instruments


• Kits & Reagents


• Services

• In-house


• Outsourcing

• Sterility Testing


• Bioburden Testing


• Bacterial Endotoxin Testing

• Compounding Pharmacies


• Medical Devices Companies


• Pharmaceutical Companies


• Others