Bowie Dick Test Pack Market Size, Share & COVID-19 Impact Analysis, By Application (Pharmaceutical & Medical Device Companies, Healthcare Facilities, and Others), and Regional Forecast, 2021-2028

The global bowie dick test pack market size was USD 169.8 million in 2020 and is projected to grow from USD 178.7 million in 2021 to USD 254.6 million in 2028, exhibiting a CAGR of 5.2% in the 2021-2028 period. Based on our analysis, the market will exhibit a stellar growth of 15.2% in 2020 as compared to the average year-on-year growth during 2017-2019. The global impact of COVID-19 has been unprecedented and staggering, with the bowie dick test pack witnessing a positive demand shock across all regions amid the pandemic. The sudden fall in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Bowie dick test packs are chemical indicators used on a day-to-day basis to evaluate the performance of air removal systems such as autoclaves. These air removal bowie dick type test packs are used in hospitals, laboratories, and pharmaceutical & medical device companies to verify the pre-vacuum sterilizer effectively before loading the goods or packs in the sterilization machine. There are both types of preassembled, single-use test packs, and reusable test packs designed to assess the overall performance of the air removal system, especially of a pre-vacuum-equipped sterilizer.

The key factors contributing to the market growth are the rise in the number of pharmaceutical and medical device companies, increasing focus on sterilization in healthcare, and rising demand for higher value-added products. Also, the growing demand for sterilization monitoring products to control hospital-acquired infections (HAIs) caused during hospital stays or during invasive surgeries is likely to fuel the global market during the forecast period. For instance, according to the World Health Organization (WHO), and the European Centre for Disease Prevention and Control (ECDC) datasheet, the prevalence of HAIs is 7.1% in European countries expected to surge the demand for sterilization monitoring products.

Furthermore, the strong technological advancements, growth in healthcare manufacturing facilities, and surging penetration by key companies are driving the bowie dick test pack market growth. The growing competition for advanced product launches by key players is anticipated to boost the global market growth during the forecast period.

Global Market is Projected to Witness a Positive Impact due to the COVID-19 Pandemic

The emergence of COVID-19 has accelerated the demand for sterilization and disinfectant products across pharmaceutical, biotech, and medical device companies. The manufacturing facilities follow the protocols while engaging in the manufacturing process. Due to the COVID pandemic, the healthcare manufacturing facilities are emphasizing more on sterilization monitoring steps which have positively increased the demand for this product.

Additionally, the pandemic has exposed the need for sterilization monitoring in hospitals, dental clinics, and other healthcare facilities before using the medical instruments for any surgical process. The pandemic has highlighted the importance of sterile and infection-free medical instruments during dental practice and invasive surgical procedures to avoid viral or bacterial hospital-acquired infection (HAIs). In the long term, the COVID-19 pandemic will positively impact the global market as it has increased awareness about the need for sterilization and disinfectant in the healthcare system.

LATEST TRENDS

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Launch of Technological Advancements in Sterilization Monitoring Products

The global market is growing at a significant level due to the rising technological developments, product launches, lab technicians training, etc., which is expected to drive the growth of the market further. There is continuous technological development in the Bowie-Dick test products. The traditional standard packs were made from paper, but there are new electronic devices. These new systems use temperature and pressure data to provide an electronic pass or fail result rather than a chemical indicator sheet.

For instance, in May 2019, Ellab, a Denmark-based company, announced the launch of SteriSense, the latest innovative electronic BowieDick test system, which offers quick and accurate test results. It is user-friendly and economically efficient and also provides ease in comparing and tracing data. This automatic electronic Bowie-Dick test device can substitute for the traditional disposable Bowie Dick chemical test strips, which will save money and time for the same process. Thus, the increasing research and development (R&D) initiatives and the introduction of advanced Bowie Dick test products are some of the biggest trends for market growth.

DRIVING FACTORS

Increasing Surgical Procedure Boosts the Demand for Equipment Sterilization Products

There is an increase in the number of invasive surgical procedures for the treatment of various health conditions. During these procedures, the surgical instrument comes in contact with the tissue, increasing the risk of infection. To ensure patient safety, the surgical instruments, medical devices, and equipment must be adequately sterilized. According to the Association for the Advancement of Medical Instrumentation (AAMI) guidelines, it is compulsory to perform a Bowie Dick test for the steam penetration before starting loading.

The growing incidence of surgical-site infections (SSIs) and hospital-acquired infections supports the demand for these test packs to standardize or decontaminate the medical devices used in the surgical process. According to Massachusetts Health & Hospital Association, Inc., SSIs account for 22% of HAIs infection, which increases the scope for Bowie-Dick test pack in the hospital and clinics to reduce contamination.

Additionally, the increasing prevalence of cardiac diseases, orthodontic procedures, and other surgical procedures require sterilized products to conduct procedures, which ultimately drives the demand for steam sterilizers and their validating products. According to the Organization for Economic Co-operation and Development (OECD), in Germany, the number of cataract surgical procedures increased from 140,340 to 870,018 between 2004 and 2018. The increasing number of surgical procedures supports the demand for equipment sterilization products which supports the growth of the global market.

Stringent Government Regulations to Prevent Contamination Supports the Market Growth

It is mandatory to meet regulatory guidelines for the biotechnology, pharmaceutical, and medical device companies regarding the usage of air removal tests in pre-vacuum autoclave sterilizers. The U.S. Food and Drug Administration (FDA), and Association for the Advancement of Medical Instrumentation (AAMI), along with the International Organization for Standardization (ISO), British Standards Institution (BSI), and the European Committee for Standards (CEN), has set up guidelines for the use of air removal test.

The healthcare manufacturing companies have to follow the guidelines and meet the benchmark standards set by these regulatory bodies. The mandatory air removal tests daily are likely to increase the demand for this product.

Similarly, the hospitals, clinics, and ambulatory centers also follow the regulatory bodies’ sterilization protocol before undergoing any surgical procedure to minimize the risk of infection and provide a safe environment. For instance, the National Accreditation Board for Hospitals & Healthcare Providers (NABH) and National Accreditation Board for Testing and Calibration Laboratories (NABL) are constituent boards of India's quality council that monitors the quality and safety in the health organizations.

These organizations emphasize on following all the sterilization steps to reduce the chances for infection. The guidelines and recommendations set by these regulatory bodies increase the demand for these products worldwide and create an opportunity for the market to grow faster.

RESTRAINING FACTORS

Noncompliance to Sterilization Standards and Low Adoption Bowie Dick Test Pack Due to Lack of Awareness May Restrain the Market Growth

Some limiting factors that are expected to restrain the global market growth during the forecast period are the lack of awareness and not following the sterilization standards by the hospitals, clinics, nursing homes, laboratories, and local healthcare manufactures as a cost-cutting practice. Despite the sterilization monitoring guidelines, the hospitals and clinics are not aware of the application and importance of the Bowie-Dick test in equipment standardization.

The lack of awareness or ignorance about the standardization steps by such healthcare facilities reduces the demand for these products and also hampers patient’s quality of life. For instance, according to the International Journal of Antisepsis Disinfection Sterilization 2016 article, in Oklahoma in March 2013 it was reported that 7,000 patients were screened for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV), because dental instruments used during the procedure were not sterilized. Such practices by the end users are attributed to the limited adoption of sterilization monitoring products.

SEGMENTATION

By Application Analysis

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Healthcare Facilities Segment to Grow at Faster Pace during 2021-2028

Based on application, the global market can be segmented into healthcare facilities, pharmaceutical & medical device companies, and others. The healthcare facilities segment held the dominant share of the global market in 2020. The healthcare facilities in developed countries focus on providing safe, effective, and infection free high-quality treatment and services by following all the safety standards set for hospitals and clinics, which fuels the segment's growth during the forecast period.

Furthermore, the increasing number of hospitals across the globe enhances the demand for this product. For instance, the number of hospitals in various countries like Russia is (5,300), France (3,082), the U.K. (1,932), Germany (1,925), and Italy (1,034) creates demand for sterilization monitoring products.

Additionally, according to India's Government, India in 2018, there were an estimated 19,810 rural government hospitals and 3,772 urban government hospitals. The other Asian countries such as China, Japan, and South Korea will have 34,000, 8,334, and 4,133 hospital facilities in 2020. The presence of a large number of hospitals will boost the demand for sterilization monitoring products.

The pharmaceutical & medical device companies are anticipated to be the second-largest segment during the forecast period, with some of the critical factors contributing to the adoption of bowie dick test packs, including recommended guidelines by the U.S. FDA for the pharmaceutical manufacturers regulating the use of bowie-dick test packs before loading goods.

Additionally, according to the Association for the Advancement of Medical Instrumentation (AAMI) guidelines, it is compulsory to perform air removal tests before loading. The others segment includes nursing centers, research academies which accounts for almost negligible market share.

REGIONAL INSIGHTS

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Based on region, the global market can be segmented into North America, Europe, Asia Pacific, and the Rest of the World. The market in North America was valued at USD 60.1 million in 2020 and is anticipated to continue to dominate the global market during the forecast period. Some of the critical factors contributing to the region’s dominance include the increasing prevalence of healthcare-acquired infections (HAIs) and stringent safety norms to control infection during hospital stay drives the market growth in this region. For instance, the Centers for Disease Control (CDC) estimated that HAIs infects an estimated 1.7 million patients, and 99,000 die each year. To control this condition, the hospitals are recommended to follow sterilization monitoring guidelines, increasing the demand for this product.

Europe is estimated to be the second-most dominant region in terms of market share by 2028 due to the presence of many pharmaceutical and medical device manufacturing facilities in this region. These manufacturing facilities are mandatory to perform air removal tests using standardized Bowie Dick test sheets. The International Organization for Standardization (ISO), the European Committee for Standards (EN), the Association for the Advancement of Medical Instrumentation (AAMI), along with British Standards Institution (BSI), guide the use of air removal tests as a routine process.

The market in Asia Pacific is estimated to grow at the highest CAGR. The key factors boosting the market growth include the presence of medical device and pharmaceutical manufacturing plants and hospital facilities, which are the end users for a bowie-dick test pack. The other factor that surges the market is the healthcare disinfection guidelines. For instance, in February 2017 the Asia Pacific Society of Infection Control (APSIC) launched its revised guidelines for disinfection and sterilization of instruments in health care facilities. The document defines the guidelines and recommendations for the reprocessing of devices in healthcare settings.

The emerging markets of Latin America and the Middle East & Africa are projected to account for lower market shares during the forecast period due to the limited healthcare infrastructure and no such stringent regulations. However, the establishment of new manufacturing plants in Latin America, and the Middle East & Africa is expected to lead to future growth prospects.

KEY INDUSTRY PLAYERS

Steris’s Sales Performance to Enable the Company to Market Dominance

The competitive landscape for the global bowie dick test pack market has some of the dominant key players such as 3M, STERIS, Medline Industries, Inc., Crosstex AirView, and Getinge AB that cover the majority of the market share. Other prominent players in the global market include Konkore Packaging, PMS, Propper Manufacturing Co., Inc., Thermal Compliances, Terragene, Mesa Labs, Inc.

The increasing research and development (R&D) by these companies are expected to strengthen their market share. For instance, Crosstex AirView, one of the leading companies, provides Lantor Cube, a reusable bowie dick test pack at 134°C for 3.5 minutes. This device contains 25 test sheets per pack and can be used 25 times before disposal. Additionally, Ellab A/S offers SteriSense, an electronic Bowie Dick pack that is cost-effective compared to traditional products. These product offerings will provide support for the increase of their market revenue share in the forecast period.

LIST OF KEY COMPANIES PROFILED:

• 3M (Minnesota, U.S.)


• STERIS (Mentor, Ohio, U.S.)


• Medline Industries, Inc. (Northfield, Illinois, USA)


• Crosstex AirView (Hauppauge, NY, USA)


• EDM3 HealthLink (Florida, USA)


• Getinge AB (Gothenburg, Sweden)

KEY INDUSTRY DEVELOPMENTS:

• May 2019– Ellab, a Denmark-based company, announced the launch of SteriSense, the latest innovative electronic Bowie-Dick test system, which offers quick and accurate test results. It is user friendly and economically efficient and also provides ease in comparing and trace data.

REPORT COVERAGE

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The global bowie dick test pack market report provides a detailed analysis of the market and focuses on key aspects such as market drivers, restraints, and opportunities. Moreover, the report also includes information on key industry developments, which covers mergers, acquisitions, product launch, expansion and partnerships, sales channels analysis, porter's five forces analysis, key industry developments - mergers, partnerships, & acquisitions, impact of COVID-19 on the global market. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation