Incontinence products that are designed for one-time use comprise urine bags, urinary catheters, and protective garments. The protective garments are used to manage bladder leakage while preventing odor and creating a barrier that keeps moisture away from the skin. Various types of protective garments are available, including cloth and disposable adult diapers, belted and beltless undergarments, disposable underpads or sheets, and disposable pads and liners.
The global market for disposable incontinence products is predicted to experience growth in the projected period due to the rising incidence of chronic bladder-related ailments. As an example, the International Continence Society reported that about 63 million individuals across the globe experienced urgency urinary incontinence in 2018.
Furthermore, the market is anticipated to benefit from a rise in the number of elderly individuals. As an example, the U.S. Census Bureau has projected that the elderly population in the United States will increase to 77 mn by the year 2035.
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The utilization of disposable goods generates waste that is not reusable and harms the environment, thereby potentially impeding the market’s progress.
Additionally, the market’s growth is projected to be restrained by the unwillingness of adults to buy products for managing incontinence. Despite experiencing an increase in the frequency of urination, many adults still exhibit hesitation towards using such products.
Various campaigns and advertisements can be utilized by industry participants to raise awareness and eliminate social stigma related to incontinence.
Players in the market are poised to benefit from the rising incidence of bladder cancer, which presents promising opportunities for growth. As per the American Cancer Society, the US is projected to record approximately 80,470 fresh cases of bladder carcinoma in 2019 (with around 61,700 cases in males and 18,770 cases in females), along with 17,670 fatalities from bladder cancer (with approximately 12,870 deaths in males and 4,800 deaths in females).
During the projected period, the segment for Protective Incontinence Garments within the worldwide market for disposable incontinence products is estimated to grow at a CAGR of 4.4%, reaching a value of US$ 11,528.4 million by 2027, up from US$ 7,739.4 million in 2018.
The primary objective of leading market participants is to enhance their product portfolios through M&A tactics. As an illustration, in March 2020, Daio Paper Corporation, a Japanese company that specializes in producing paper, pulp, and paperboard, revealed its intentions to acquire Özen Ki?isel Bak?m Ürünleri Üretim A.?., which is a manufacturer of hygiene products, as well as Santher – Fábrica de Papel Santa Therezinha S.A., a company that produces personal care items, like adult disposable diapers.
Market leaders are prioritizing the introduction of innovative urinary catheters that prioritize patient safety. An example of this is Safe Medical Design, Inc., which received approval from the US Food and Drug Administration (USFDA) in February 2019 to sell its signal catheter in the United States.
Regulations governing both conventional and antimicrobial Foley catheters
The FDA regulations in 21 CFR 876.5130(a), Urological Catheter and Accessories, define both conventional and antimicrobial Foley catheters as a flexible tube-like apparatus that is inserted via the urethra and utilized to transfer fluids to or from the urinary tract.
As per 21 CFR 876.5130(b), these devices fall under the category of Class II classification, and their corresponding product codes are 78 EZL, which refers to catheters with a balloon for retention, and 78 MJC, which refers to urological catheters with antimicrobial properties and related accessories.
The ASTM F 623-89 standard includes a description of a Foley catheter, which is a type of indwelling catheter that medical professionals use to drain the bladder via the urethra using a balloon retention mechanism.
The catheter is designed to be used only once and is meant for short-term use, typically lasting less than 30 days. It remains in the bladder by a balloon that is filled with sterile liquid, with sterile water being the preferred option.
If a catheter falls outside the boundaries of the ASTM F 623-89 standard, both the manufacturer and FDA may need to give it extra consideration.
The ASTM standard does not apply to catheters with 3 lumens, balloons that have a volume of 30 cm3 or more, or shaft sizes that are less than 12 Fr or greater than 26 Fr.
Catheters used for pediatric purposes and nonurethral catheterizations like ureterostomies, nephrostomies, enemas, suprapubic cystostomies, gastrostomies, etc. are not included.
The catheter’s features that fall beyond the standard specifications may allow it to be utilized for purposes that demand further evidence to establish both its effectiveness and safety, such as clinical data.
This standard does not apply to catheters that have been coated with antimicrobial and hydrophilic materials, and therefore, no additional data is required for such catheters.
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Regulations for urine bags
The items listed, such as the paste-on device for incontinence, corrugated rubber sheath, leg bag for external use, pediatric urine collector, and urosheath-type incontinence device, and are a set of urine collection tools and accessories that are not designed to be linked with an indwelling catheter.
A urine collector and its accessories designed to connect to an indwelling catheter are categorized under Class II and require special controls.
Subject to 876.9, the device is not required to undergo premarket notification procedures as outlined in subpart E of part 807 of this chapter.
If a urine collector & its accessories are not designed to be linked to an indwelling catheter, they belong to Class I (general controls) and are not required to undergo premarket notification procedures as stated in subpart E of Part 807 of this chapter. However, this exemption is subject to the restrictions outlined in Section 876.9.
The current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter do not apply to a device that is not marked or indicated as sterile. However, there are two exceptions to this exemption: 820.180, which pertains to general record-keeping requirements, and 820.198, which concerns complaint files.
Prominent players, including Mega Soft (Fujian) Hygiene Products Co., Ltd., Medtronic PLC, Paul Hartmann AG, B. Braun Melsungen AG, Unicharm Corporation, Ontex International N.V., ConvaTec Inc., C. R. Bard, Inc. (Becton, Dickinson, and Company), Medline Industries, Theos Medical Systems, Inc., Fujian Yifa Healthcare Products Co., Ltd., SCA Hygiene Products AB, Kimberly-Clark Corporation, Fujian Hengan Group Ltd., and Abena Group, are operating in the global disposable incontinence products market.
The market’s leading figures have set their sights on obtaining approval for reimbursement of their products. An example of this is Bactiguard’s indwelling urinary catheters (Foleys), which were granted reimbursement approval in the Netherlands in September 2019.
Major stakeholders in the industry are emphasizing on obtaining approval and releasing novel items to broaden their range of products. As an illustration, Hollister Incorporated was granted a 2019 Innovative Technology Recognition by Vizient, Inc. in July 2019 for their VaPro No Touch Intermittent Catheter, which is a urinary catheter.
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Table of Content
Chapter 1 Industry Overview
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 Disposable Incontinence Products Market Size Analysis from 2023 to 2030
11.6 COVID-19 Outbreak: Disposable Incontinence Products Industry Impact
Chapter 2 Global Disposable Incontinence Products Competition by Types, Applications, and Top Regions and Countries
2.1 Global Disposable Incontinence Products (Volume and Value) by Type
2.3 Global Disposable Incontinence Products (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 Global Disposable Incontinence Products Sales, Consumption, Export, Import by Regions (2017-2023)
Chapter 5 North America Disposable Incontinence Products Market Analysis
Chapter 6 East Asia Disposable Incontinence Products Market Analysis
Chapter 7 Europe Disposable Incontinence Products Market Analysis
Chapter 8 South Asia Disposable Incontinence Products Market Analysis
Chapter 9 Southeast Asia Disposable Incontinence Products Market Analysis
Chapter 10 Middle East Disposable Incontinence Products Market Analysis
Chapter 11 Africa Disposable Incontinence Products Market Analysis
Chapter 12 Oceania Disposable Incontinence Products Market Analysis
Chapter 13 South America Disposable Incontinence Products Market Analysis
Chapter 14 Company Profiles and Key Figures in Disposable Incontinence Products Business
Chapter 15 Global Disposable Incontinence Products Market Forecast (2023-2030)
Chapter 16 Conclusions
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