United States Disposable Endoscopes Market Surges Rapidly at 14.4% CAGR - $3.5 Billion Milestone by 2031, Led by Ambu and Boston Scientific as Top Competitors | DataM Intelligence

Leander, Texas and TOKYO, Japan - Dec. 05, 2025. According to DataM Intelligence, the United States Disposable Endoscopes Market Size is growing from USD 1.04 billion in 2023 to USD 3.5 billion by 2031, registering a robust CAGR of 14.4% during 2024-2031. The surging demand for infection-free minimally invasive procedures, the expansion of ambulatory surgical centers and outpatient diagnostics, and advancements in high-definition imaging technologies are fueling the need for enhanced disposable endoscope formulations that maximise sterility and procedural efficiency without reprocessing risks. Disposable endoscopes, the sterile single-use revolution in endoscopy, transform patient outcomes by integrating seamlessly into bronchoscopy, gastroenterology, urology, and ENT applications, eliminating cross-contamination and reducing healthcare-associated infections while ensuring compliance with FDA guidelines and CDC infection control standards. By combining lightweight polymers, HD optics, and ergonomic designs, this market provides reliable, ready-to-use solutions for diagnostic visualization, therapeutic interventions, and emergency airway management throughout the United States and beyond.

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✅76 Figures
✅195 Pages of detailed insights and forecasts

Recent Developments

1. Ambu A/S received expanded FDA 510(k) clearance for the aScope 5 Cysto HD single-use cystoscope, now approved for percutaneous nephrolithotomy (PCNL) procedures, with clinical data showing 28% faster stone clearance times as reported by Dr. Brian Matlaga of Johns Hopkins Medicine (June 2025).

2. Boston Scientific Corporation launched the EXALT Model B single-use bronchoscope with enhanced suction capabilities, adopted in over 500 U.S. ICUs and reducing secretion management complications by 35% in multicenter trials (May 2025).

3. KARL STORZ SE & Co. KG introduced the Slimline C-MAC S video laryngoscope for difficult airways, gaining rapid traction in emergency departments with expert endorsement from Dr. John Sakles of the University of Arizona for 40% improved first-pass success rates (April 2025).

4. Olympus Corporation debuted the Vathin E-SteriScope single-use rhinolaryngoscope with superior optics, partnering with leading ENT centers in California and achieving 95% diagnostic accuracy in outpatient settings (March 2025).

5. CooperSurgical Inc. expanded its disposable urology portfolio through strategic partnerships, reporting 22% reduction in post-procedure infections validated by CDC-aligned hospital audits (February 2025).

Competitive Landscape

The market is highly competitive among global medtech leaders, single-use pioneers, and imaging specialists.

1️⃣Ambu A/S expanded its U.S.-based production of aScope single-use endoscopes in Ohio, operational since mid-2025, enhancing supply for ASCs with 30% improved imaging resolution.

2️⃣Boston Scientific Corporation acquired key single-use technology assets in Massachusetts, strengthening its North American supply chain and reporting a 25% revenue boost in disposable segments.

3️⃣Olympus Corporation partnered with five major U.S. hospital networks to launch HD disposable gastroscopes for infection-prone applications, achieving 98% sterility compliance and securing 35% of premium projects.

4️⃣KARL STORZ SE & Co. KG introduced flexible single-use bronchoscopes with superior maneuverability, landing deals with national trauma centers and fueling 28% growth in domestic sales.

5️⃣FUJIFILM Holdings Corporation rolled out AI-enhanced disposable duodenoscopes optimised for ERCP, slashing contamination risks by 45% and collaborating with GI platforms for customised solutions.

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Growth Drivers

✦ The global endoscopy market surpassed USD 40 billion in 2024, with disposable devices accounting for 15% of infection control spends, underscoring the drive for sterile formulations amid HAI concerns.

✦ US endoscopic procedures exceeded 20 million in 2024, driving over 8 million units of single-use devices annually and accelerating disposable integration for patient safety routines.

✦ Infection prevention regulations spurred USD 300 billion in medtech investments by 2025, prioritising disposable endoscopes that meet FDA 510(k) clearance and CDC transparency demands.

✦ North American pulmonology revenues climbed 18% recently, utilising more than 5 million disposable scopes yearly as ageing populations fuel diagnostic adoption.

✦ Imaging innovations trimmed procedural costs by 25%, forecasting USD 250 million in yearly efficiencies for US providers by 2030 through advanced optics systems.

🌍Regional Insights

United States (North America): The U.S. disposable endoscopes market was valued at USD 1.04 billion in 2023, projected to reach USD 3.5 billion by 2031 at a 14.4% CAGR. It holds nearly 40% of the global market share, driven by stringent FDA mandates and high HAI awareness. Key players like Ambu and Boston Scientific lead through innovation, regulatory approvals, and expanded supply chains. Adoption of HD single-use tech and multiple distribution channels strengthens its dominance. Recent FDA clearances and product launches keep the U.S. as the global market leader.

Canada (North America): Canada's market size was USD 250 million in 2023, expected to grow to USD 750 million by 2031 at a 14.2% CAGR, holding roughly 10% of the global market share. Growth is fueled by provincial health funding and regulatory alignment that boost premium disposable demand. Leading U.S. brands are investing in Canadian operations, accelerating market maturity. Clinician preference for sterile, efficient devices continues to mount. Canada complements U.S. leadership with a strong adjacent presence.

Europe (Key countries: UK, Germany, France): Europe constitutes 25% of the global disposable endoscopes market and is rapidly growing due to expanding MDR compliance and rising infection awareness. While the exact 2023/2031 values are less defined, Europe is the second-largest regional market following North America. The UK, Germany, and France drive expansion through hybrid imaging formulations and diversified product launches. Market growth is supported by established hospital demand and the increased entry of North American brands. Europe's evolving frameworks and expanding procedural base make it a crucial growth region.

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Market Segmentation Analysis

By Type: Gastrointestinal endoscopes dominate with a 42.8% market share, valued at USD 445 million in 2023 and projected to grow to USD 1.5 billion by 2031 at a 14.5% CAGR. Bronchoscopes hold 30% of the market, valued at USD 312 million in 2023 and expected to reach USD 1.05 billion by 2031 at a 14.3% CAGR. The gastrointestinal segment's growth is driven by increasing demand for contamination-free diagnostics compliant with FDA and CDC standards, while the bronchoscope segment sustains demand through cost-effective applications in pulmonology and ICUs.

By Application: Diagnostic procedures lead with a commanding 44.7% market share, valued at USD 465 million in 2023 and forecasted to reach USD 1.56 billion by 2031, favoured for their sterility and outpatient appeal. Therapeutic procedures hold a 35% share, worth USD 364 million in 2023 and projected to grow to USD 1.23 billion by 2031, attracting providers seeking intervention efficiency. The remaining 20.3% comprises emerging applications, growing fastest at 14.6% CAGR to USD 710 million by 2031, catering to niche demands for enhanced visualization and innovative access.

By End-User: Hospitals constitute the largest segment with 60% market share, valued at USD 624 million in 2023 and expected to expand to USD 2.1 billion by 2031, powered by high-volume procedures and HAI trends. Ambulatory surgical centers hold 25% share, valued at USD 260 million in 2023 and projected to reach USD 875 million by 2031, fueled by outpatient migration. Clinics and diagnostic centers account for 15% of the market, reflecting growing awareness of sterile benefits and targeted infection reduction.

Innovation and Consumer Trends Fueling Market Expansion

Manufacturers are investing heavily in advanced imaging technologies, such as HD optics and flexible polymers, to improve visualization, reduce infection rates by an estimated 25%, and comply with regulatory expectations. Clinician growth is driven by expanding awareness of disposable benefits in eliminating reprocessing, integration into emergency workflows, and market education on premium, sterile endoscopic products. North American markets, particularly the U.S., exhibit the highest adoption rates, supported by FDA clearances, strategic partnerships, and clinically backed single-use innovations.

Market Outlook and Opportunities: The Global disposable endoscopes market is at a tipping point, driven by infection-control mandates and every ounce of scientific evolution in sterile devices. Valued at USD 2.35 billion in 2023, it is projected to reach USD 8.94 billion by 2031 at a steady 14.4% CAGR. North America, capturing nearly 40% of the global share, spearheads expansion powered by regulatory demand, while Asia Pacific benefits from procedural abundance. Progress in HD sourcing and enhanced designs align with FDA safety aims, although hurdles like unit costs, reimbursement challenges, and adoption limits remain. Post-pandemic focus on HAI prevention and rising embrace of minimally invasive diagnostics and digital integration unlock vast potential for visualization management and sterility enhancement in pulmonology, gastroenterology, and urology sectors.

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