Spirometer Calibration Syringe

Part
01
of seven
Part
01

Spirometer Calibration Syringe: Market Size

We could not find or triangulate the U.S. market size for either spirometer calibration syringes or calibration syringes overall. An explanation of how and where we looked for that information, though we were ultimately unable to find it, is provided in the Research Strategy section below. The few, indirectly related data points we found pertaining to the U.S. or North American (included due to lack of U.S.-specific data) syringe markets are provided below, which we included in an effort to provide as much information as we could despite the unavailability of the specific data requested.

U.S. & North American Market Size Statistics

  • In 2019, the North American market size for prefilled syringes totaled $1.52 billion. That equates to a current (2020) market size of slightly over $1.6 billion ($1.52 billion x 0.0551 (representing the compound annual growth rate (CAGR) of 5.51%) = $83,752,000; Then $1.52 billion + $83,752,000).
  • In 2018, the size of the global "disposable syringes market" was $7.1 billion and North America's share of the market that year was 47.1%, which equates to a North American market size of slightly over $3.34 billion ($7.1 billion x 0.471 (representing the 47.1% market share)). That equates to a current (2020) market size for North America of slightly over $3.7 billion. We calculated that current market size in North America as follows: 2019 ($3,344,100,000 (2018 market size) x 0.056 (representing the 5.6% CAGR) =$187,269,600; Then $3,344,100,000 + $187,269,600 = $3,531,369,600); 2020 ($3,531,369,600 (previously calculated 2019 market size) x 0.056 = $197,756,697.6; Then $3,531,369,600 + $197,756,697.6 = $3,729,125,697.6).

Research Strategy

We looked thoroughly for, but ultimately could not find any information whatsoever about the U.S. market size for spirometer calibration syringes or the overall calibration syringe market. We could not even find the size of either of those markets globally. We looked for information about those market sizes through three research approaches. First, we thoroughly reviewed available market research reports from sources such as IBIS World and Allied Market Research, though not a single one of those reports was specifically about the spirometer calibration syringes market or the calibration syringes market as a whole. Furthermore, most of the market research reports we found about those related markets (such as syringes in general) were global in scope and didn’t provide a breakdown by country (nor did any other source), so we could not triangulate market size. Second, we checked the Statista database to see if we could find any data about the U.S. market size for spirometer calibration syringes or calibration syringes. The only indirectly related data we found through Statista was the size of the U.S. "syringes and needles market", which we mentioned above. As a third research approach, we also conducted wide-ranging searches for any articles that might have mentioned information about the size of either market in the U.S. However, we didn't find a single article during our research that included that information. Throughout our research, we also looked for any data that we might have been able to use to triangulate the U.S. market size for spirometer calibration syringes or calibration syringes in general, but we didn't find any such information that was sufficient for us to do so.
Part
02
of seven
Part
02

Spirometer Calibration Syringe: Market Forecast

The US growth rate for spirometer calibration syringes and calibration syringes in general was publicly unavailable. It was also impossible to accurately triangulate the growth rate using the information gathered. In the Research Strategy below, we have explained how and where we searched for the information. Although we did not find the required growth rate, we have included related information on spirometer accessories, globally, which includes spirometer calibration syringe, considering that it is used to test and determine the accuracy of spirometers. Paywalled reports that possibly contain the market size and growth rate of spirometer calibration syringes are also listed below.

Spirometer and Spirometer Accessories Market

  • According to Globe Newswire, the global spirometer market is expected to reach $1,234.4 million by 2025 at a CAGR of 8.15%.
  • The consumables and accessories (including spirometer calibration syringes) segment is the largest segment of the spirometer market. In both 2017 and 2018, this segment held the largest market shares with $248.01 million in 2017 alone, representing 39.05% of the total spirometry market size. The growth in this segment has been attributed to the "rising incidence of chronic respiratory diseases and technological advancements related to consumer devices."
  • Hill-Rom, a US company, has been reported as the largest key player in the spirometry market. North America is tagged as the largest spirometry market, however, it is not the fastest-growing.
  • The following reports contain a breakdown of the spirometer market and its accessories (including spirometer calibration syringes) by region (including the US):

1. Spirometer Market by Product (Device, Consumables, Accessories, Software), Mechanism (Flow Sensor, Peak Flow Meters), Application (COPD, Asthma), End User (Hospital, Clinical Laboratories, Home care, Industrial Settings) - Global Forecast to 2023 by Markets and Markets.

2. Global Spirometer Market by Product (Consumables & Accessories, Devices, Software), Mechanism (Flow-Sensing Spirometers, Peak Flow Meters), Disposable Components, Application, End Use, Region, Global Industry Analysis, Market Size, Share, Growth, Trends, and Forecast 2018 to 2025 by Fior Markets.

3. Spirometer Market — Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017–2025 by Transparency Market Research.

Research Strategy

We began our research by exhaustively scouring market research and report sources such as Market Research, Markets and Markets, and IBIS World for the growth rate of spirometer calibration syringes and calibration syringes overall. This search proved abortive as there were no reports regarding such information.
Our next attempt was to use the market size of the product from two different years to calculate its growth rate. At this point, we decided to expand the search and make it global with the intention that if a global figure was discovered, it will be possible to triangulate the CAGR for the US. Unfortunately, this was not successful as there was no available information regarding the market size of spirometer calibration syringe and calibration syringes generally either in the US alone or globally.
During our research, we determined that Spirometer calibration syringes are "accessories" of Spirometers since they are used in testing and calibrating Spirometers. Therefore, we decided to try a new approach and divert our research to focus on market reports on Spirometers. We found several paid reports, some of which include data on Spirometer accessories. We are convinced that these paywalled reports will contain the needed breakdown on Spirometer Calibration Syringes. We also extracted some information we deemed helpful from the report summaries and included them in this research.
Part
03
of seven
Part
03

Spirometer Calibration Syringe: Top Competitors, Part 1

In the spirometer market, which includes spirometer accessories like spirometer calibration syringes, Hill-Rom and Vyaire Medical are the two most competitive companies and comprise a significant portion of sales in the spirometer market in the U.S. and globally. An overview of each company, as well as its competitive advantages in the spirometer calibration syringe market, are provided in the attached spreadsheet.

Top Competitors in Spirometer Calibration Syringe Industry

Hill-Rom
  • Based in the U.S., Hill-Rom is a large company that owns several subsidiaries, operates globally, and primarily focuses on specialty bed systems, patient management software, and operating room equipment, among other medical technologies.
  • As the leading company in the spirometer market in terms of revenue, Hill-Rom not only produces spirometer devices but also manufactures consumables, accessories, and software used to operate them.
  • Hill-Rom's leadership in the spirometer market is due to its acquisition of medical device company Welch Allyn.
  • Hill-Rom's subsidiary company Welch Allyn reported $1.96 billion in U.S. revenue in 2018.
Vyaire Medical
  • Created by parent company Apax Partners after its acquisition of the respiratory solutions division of Becton Dickinson, Vyaire Medical operates dozens of respiratory medical technology brands that create products for diagnosing, monitoring and treating respiratory conditions.
  • Vyaire Medical is the second-leading company in terms of revenue in the spirometer market based on market reports.
  • The company uniquely focuses exclusively on respiratory medical technologies, which has allowed it to establish its dominance in the spirometer market.
  • In 2018, Vyaire Medical reported $800 million in annual sales.

Research Strategy

Direct data about the market size and top competitors in the spirometer calibration syringe industry was not available, however we triangulated which companies would be most competitive in this industry by focusing on companies that are competitive in the spirometer market, within which spirometer accessory sales are included. Often, these companies will produce the 3L spirometer calibration needles to either be sold with or in addition to spirometers as healthcare practitioners are expected to perform frequent calibrations of their spirometers. Specific figures regarding sales and revenue of spirometer calibration syringes for both overall market and for individual companies could not be found as they were only available in paid market reports. However, we were able to identify the top two competitors in the spirometer market, Hill-Rom and Vyaire Medical, as well as relevant data on each company's overall annual domestic revenue and sales, respectively.
Additionally, we learned that the global spirometer market is estimated to reach a valuation of $1.23 billion by 2025, and the consumables & accessories segment represents the largest portion of that revenue, 39.05% as of 2017. Using those figures, the estimated global market share of consumables & accessories by 2025 could be calculated as $480 million (0.3905 x $1,230,000,000,000.00). The North American revenue of the spirometer market in 2018 was $241.6 million, which translates to $94.3 million (0.3905 x $241,600,000.00) for the spirometer consumables & accessories segment. If the U.S. spirometer market revenue of both Hill-Rom and Vyaire Medical, similar calculations can be done to estimate each company's spirometer consumables & accessories revenue in the U.S. Additionally, if the portion of spirometer calibration syringe revenue relative to spirometer consumables & accessories revenue is found, the specific market for spirometer calibration syringes in the U.S., as well as for both Hill-Rom and Vyaire can be calculated.

Part
04
of seven
Part
04

Spirometer Calibration Syringe: Top Competitors, Part 2

Two additional top competitors in the spirometer calibration syringe industry are Midmark and nSpire Health. An overview of each company and its competitive advantages are provided in columns E-F of the attached spreadsheet.

Midmark

nSpire Health

  • nSpire Health specializes in software and medical devices related to respiratory system evaluation such as diagnostic spirometry, pulmonary function testing, and respiratory monitoring.
  • The company is headquartered in Longmont, Colorado and generates an estimated annual revenue of $22-24.7 million.
  • nSpire Health has claimed that its KoKo® line of spirometers to be “the number one choice for both discerning specialists and clinical research studies”.
  • The company has developed a syringe that enables calibration of various volume settings in addition to the standard 3-liter volume. It also holds a patent for the technology to maintain different, specific flow rates for the calibration.

Research Strategy

We've learned that the North American spirometer consumables & accessories segment is estimated to be valued at $94.3 million by 2025. As sales figures specific to spirometer calibration syringes are not publicly available, we’ve aligned with the approach of previous research by focusing on companies competitive in the overall spirometer industry and identified top competitors based on total annual revenue.
We started by screening through all US companies mentioned in previously referenced market reports and verified that other companies such as MGC Diagnostics, Benson, and GE Healthcare do not sell spirometer calibration syringes such as the ones in the given examples. This could be due to the automated/ calibration-free feature of their spirometers.
To find the second top competitor in the industry, we searched for additional US manufacturers that are not mentioned in the reports. We’ve used a similar approach as above and compared annual revenues for spirometer calibration syringe providers including Bionet America, A-M Systems, Jones Medical, Futuremed, Spirometric, and nSpire Health. In the end, we've selected nSpire Health as the second top competitor for the research as it is the only company that has an estimated annual revenue above $20 million.
Part
05
of seven
Part
05

Spirometer Calibration Syringe: Trends, Part 1

In order to ensure results are accurate with a spirometer, verification with a calibration syringe is routinely recommended. Proper use of a spirometer includes performing calibration to help make an accurate diagnosis for respiratory disorders including asthma and COPD. Trends surrounding the use of calibration syringes for spirometer calibration include more stringent standards and an increased use of calibration.

More stringent standards

  • The American Thoracic Society (ATS)/European Respiratory Society (ERS) recommend that the calibration of spirometers should be verified on a daily basis with a 3-L syringe and the recorded value should be 3 L ±2.5%.
  • A study of 7,497 calibration verifications of spirometers showed a need for more stringent standards.
  • According to a recent ERS journal article, experts believe that the performance of modern spirometers allow for tighter calibration ranges, including the use of mean ±2SD. These experts are recommending the use of more stringent calibration standards such as requiring a mean calibration value of 3 L ±1.5% for better accuracy.

Increased frequency of calibration

  • While most portable spirometers are calibrated by the manufacturer on an annual basis, calibration checks should be done on a daily basis. According to recent guidelines from the CDC, calibration checks should be performed daily or more frequently in cases of temperature or environmental changes.
  • Even with spirometers that don’t require calibration, such as the EasyOne spirometer, regular calibration with a calibration syringe may be recommended. One recent study found systematic differences between the EasyOne spirometer and the Masterscreen pneumotachograph that may be attributed to differences in calibration methods.
  • In response to the 2019 Spirometry Update from ATS/ERS, experts are urging manufacturers to include syringes as part of the spirometer purchase. Oftentimes, calibration syringes are sold as a separate accessory.


Research Strategy

Data on calibration syringe trends was retrieved through reviewing current spirometry guidelines among other journals and expert-reviewed sources. In-depth research was implemented to obtain the most up-to-date standards and trends for using spirometer calibration syringes. We also searched for any further information regarding specific manufacturers and their role in these trends. Many manufacturers did not provide the sought-after details to indicate how they were driving these trends. However, this may be due to the most trends and guidelines being relatively new. Manufacturers may look to these new standards to devise new products or update current ones.

Part
06
of seven
Part
06

Spirometer Calibration Syringe: Trends, Part 2

Two additional trends currently happening in the spirometer calibration syringes market of the US are the increasing demand due to growth in COPD cases and pollution, and the adoption of new technologies like mobile synchronization.

1. Increasing Demand due to Asthma, COPD cases, and Pollution

  • During 2018 and 2025, it is expected that the demand in the market of spirometer calibration syringes will increase in the US and the rest of the world.
  • Driving the trend is the growing number of people needing diagnosis for respiratory diseases, asthma, and chronic obstructive diseases caused by the high levels of air pollution and environmental conditions.
  • The large spread of diseases, like the Coronavirus (COVID-19), are also increasing the demand for spirometer calibration syringes in the US and global market since they are used to diagnose air presence in the patients' lungs, and being requested in hospitals, home care settings, and clinical laboratories.
  • The U.S. Department of Health and Human Services (HHS) indicated that in the past decade, the number of Americans diagnosed with chronic obtrusive pulmonary diseases (COPD) increased by 27%, as well as the asthma cases.
  • Team Med is an example of the companies recognizing the high demand for spirometer calibration syringes to control respiratory diseases.

2. Adoption of Mobile-Based Data Analysis

  • Spirometer calibration syringes, as well as other consumables and accessories in the spirometer market, are adapting to newer technologies like mobile-data analysis and embracing new methods of connectivity.
  • Driving this trend are the numerous technological improvements available in healthcare and digital technology, which are pushing the industry to evolve and create monitoring solutions that collect data in mobile devices and computers.
  • Henry Schein and Midmark have released more advanced models of spirometer calibration syringes, the Digital IQSpiro and the Digital Spirometer 3-liter calibration syringe, that allow synchronization through mobile apps and a computer.
  • In 2017, technological advances and a rise in COPD cases increased the market size of the consumables and accessories segment of the spirometer market to $248.01 million.
Part
07
of seven
Part
07

Spirometer Calibration Syringe: Customer Perceptions

Medical professionals who use spirometer calibration syringes require highly accurate devices. Therefore, manufacturers are expected to provide detailed information regarding proper handling and validation of these syringes. The fact that the syringes are sold separately from the spirometers is a concern for some customers.

Key Findings

  • According to the American Thoracic Society, syringes that only require a monthly leak test are preferred. This is because these syringes should be used daily according to the standards established by the Society. Therefore, daily leak tests would be time-consuming and impractical for practitioners.
  • Spirometer Calibration Syringes that offer extended warranties might be preferred. Any damage to the syringe requires re-calibration. One of the most common sources of damage to this equipment comes from it being dropped to the floor.
  • Some manufacturers offering lifetime warranties are Jones Medical and nSpire Health. In addition, nSpire Health offers a re-calibration service, which could make the process easier for medical practitioners.
  • The expected accuracy of a spirometer calibration syringe is ±0.015 L or ±0.5% of the full scale. Similarly, the American Thoracic Society expects manufacturers to provide information regarding recommended intervals to verify the accuracy of the syringe. The most common interval according to the Society is one year.
  • An identified pain point for customers is the fact that spirometer calibration syringes are sold separately from spirometers. This might lead some professionals to forego the use of these syringes, believing they are not necessary.
  • Considering spirometers are bought with the intent of long-term use, not having the spirometer calibration syringe included requires an extra effort for the practitioners as well as an additional expense.
  • Companies like Medikro offer universal adapters for its calibration syringes; however, other manufacturers such as MidMark offer syringes that are compatible only with the spirometer of the same brand.
  • Due to the aforementioned pain points, medical professionals have urged manufacturers to sell the spirometer and the spirometer calibration syringes together. This would make the purchasing process easier for customers.
  • Timely delivery and good customer service from providers are features appreciated by buyers of spirometer calibration syringes.

Research Strategy

Customer reviews and evaluations regarding spirometer calibration syringes were not readily available. Therefore, we looked for information provided by national medical associations that use this instrument. Furthermore, we performed in-depth research about customers of nationwide providers of this equipment. While only one of the sellers of spirometer calibration syringes in the United States had reviews regarding this specific product, information about the general expectations from customers was found in recent medical journals.
Sources
Sources

From Part 03
Quotes
  • "Calibration verifications must be undertaken daily, or more frequently if specified by the manufacturer. Precalibrated spirometers cannot be recalibrated by the operator but must still undergo a calibration verification. Manufacturers must specify the action to be taken if a precalibrated device fails the calibration verification."
Quotes
  • "Hill-Rom is the largest player in the spirometers market. The company focuses on the development of devices, consumables, accessories, and software required to perform spirometer tests."
  • "Vyaire Medical is a pioneer in the spirometers market. As a result, it has a strong foothold in the spirometers devices market."
Quotes
  • "Vyaire Medical brings in approximately $800 million in annual sales, according to Apax Partners, and is currently active in manufacturing and distributing respiratory and anesthesia and surgical consumables as well as capital equipment for respiratory diagnostics and ventilation."
Quotes
  • "The global spirometer market is expected to grow from USD 635.11 million in 2017 to USD 1,234.44 million by 2025 at a CAGR of 8.15% during the forecast period 2018-2025, according to the new report published by Fior Markets."
  • "Key players operating in the global spirometer market are Hill-Rom, Vyaire Medical, Fukuda Sangyo, Chest M.I., Schiller AG, MGC Diagnostics, Medical International Research, NDD Medizintechnik AG, Vitalograph, Midmark Corporation, Benson Medical Instruments, Bionet America, Inc., COSMED srl, Advanced Medical Engineering, Medikro Oy, and among others. The Hill-Rom, Vyaire Medical, Fukuda Sangyo, Chest M.I., Schiller AG, and MGC Diagnostics are the top leading players of the market."
  • "Product segment is divided into consumables & accessories, devices, and software. The devices segment further includes pc-based spirometers, portable spirometers, and table-top spirometers. Consumables & accessories segment dominated the global spirometer market and held largest market share of 39.05% in 2017 due to rising incidence of chronic respiratory diseases and technological advancements related to consumer devices."
  • "North America region dominated the global spirometer market with USD 241.60 million in 2017."
From Part 04