Smart Pills Market Size & Outlook, 2026-2034

Smart Pills Market Overview

The global smart pills market size is estimated at USD 2.57 billion in 2025 and is projected to reach USD 6.76 billion by 2034, growing at a CAGR of 11.38% during the forecast period. Strong growth of the market is due to the advancements in capsule endoscopy, which allows doctors to check the digestive system without surgery.

Key Market Trends & Insights

• North America held a dominant share of the global market, accounting for 40.52% share in 2025.
• The Asia Pacific region is growing at the fastest pace, with a CAGR of 12.52%.
• Based on Indication, the celiac disease segment dominated the market in 2025 with a revenue share of 33.18%.
• Based on the Application, the drug delivery segment is expected to register the fastest CAGR growth of 12.96%.
• Based on End User, the diagnostic centers segment dominated the market in 2025.
• The U.S. dominates the global market, valued at USD 850.00 million in 2024 and reaching USD 940.00 million in 2025.

Graph: U.S. Market Revenue Forecast (2022 – 2034)

Source: Straits Research

Market Size & Forecast

• 2025 Market Size: USD 2.57 billion
• 2034 Projected Market Size: USD 6.76 billion
• CAGR (2025 to 2034): 11.38%
• Dominating Region: North America
• Fastest Growing Region: Asia Pacific

The global smart pills market encompasses a broad range of technologies designed to enable non-invasive diagnostics, targeted drug delivery, and real-time monitoring of gastrointestinal and systemic conditions, thereby improving patient outcomes and clinical efficiency. By indication, the market includes celiac disease, small bowel diseases, colon cancer, and others, with small bowel diseases leading the segment due to the increasing adoption of capsule endoscopy for early diagnosis and monitoring. By application, the market is classified into capsule endoscopy, drug delivery, and vital sign monitoring, where capsule endoscopy holds a high share owing to its ability to provide minimally invasive visualization of the gastrointestinal tract. By end user, smart pills are utilized in hospitals and clinics, as well as diagnostic centers, with hospitals and clinics accounting for the major share, as they serve as the primary point for administering smart pill technologies and integrating them into patient care workflows.

Latest Market Trends

AI-Powered Smart Pills for Personalized Medication Management

A major trend in the smart pills market is the use of artificial intelligence (AI) to improve medication adherence and personalized healthcare. As per the data published by Cornell University, smart pill systems use RFID and NFC technology for dose tracking, combined with mobile apps that provide alerts, suggestions, and dosage guidance. Advanced techniques, such as federated learning (AI/ML models) supported in personalizing medication management while keeping patient data secure.

Such a trend highlighted the shift towards digital health, patient-centric solutions, and data-driven personalized medicine, which further enhanced growth in the global market.

Development of Advanced Smart Capsules for Real-Time, Non-Invasive Gastrointestinal (GI) Tract Monitoring

A key trend in the global market is the development of smart capsules that provide real-time, noninvasive monitoring of the gastrointestinal tract. According to the California Institute of Technology, Caltech introduced PillTrek, a smart capsule designed to continuously monitor the gut, which further improved diagnostic efficiency and enhanced patient comfort during gastrointestinal assessments.

Such innovation highlighted the trend of integrating smart pill technology into clinical practice by offering continuous gut monitoring without invasive procedures.

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Smart Pills Market Drivers

Integration of Smart Pills with Vital Sign Monitoring for Real-Time Health Surveillance

A major driver in the smart pills market is the combination of smart pills with vital sign monitoring, as this supports doctors to monitor patients continuously, detect health problems early, and provide timely treatment. For example, in December 2023, Celero Systems launched an ingestible smart pill that monitored vital signs directly from inside the stomach. The pill sends real time data to mobile apps and healthcare providers to support in detecting conditions, such as sleep apnea.

Hence, this integration made healthcare more proactive and improved patient safety and treatment outcomes, which further enhanced the market growth.

Market Restraint

Limitations of Capsule Endoscopy (CE) Technology

A key restraint in the smart pill market is the limitations of capsule endoscopy technology. CE faces challenges such as high rates of missed findings, time-consuming image interpretation, and the lack of therapeutic capabilities, which limit its wider adoption in the smart pills market. These limitations reduced physician confidence and slowed adoption, highlighting the demand for technological advancements to enhance accuracy, efficiency, and overall clinical utility.

Market Opportunity

Smart Pills in Remote Patient Monitoring

An opportunity for the smart pill market is the integration of ingestible sensors into remote patient monitoring systems. For example, in April 2024, Tenovi announced the launch of its FDA-listed cellular-connected smart pillbox. This device automatically tracked medication adherence without requiring patients to use apps, WiFi, charging, or syncing.

Such integration into patients’ routines allowed healthcare providers to monitor patients remotely and intervene before complications arise.

Regional Analysis

The North America region dominated the market with a revenue share of 40.52% in 2025. The growth is attributed to factors such as improved reimbursement rates, which facilitate the adoption of smart pill technologies in clinical settings, and a high consumer base with increasing openness to adopt advanced medical technologies.

The smart pills market in the U.S. is widely driven by the establishment of the Digital Health Center of Excellence by the U.S. FDA in January 2025. This initiative streamlines regulatory processes for digital health innovations, including smart pills, by offering tailored guidance and support. By facilitating faster approvals and clearer pathways, the center accelerates market entry for new smart pill technologies, thereby expanding the market size and fostering sustained market growth.

Asia Pacific Market Insights

The Asia Pacific region is the fastest-growing region with a CAGR of 12.52% during the forecast timeframe, owing to factors such as national colorectal and GI screening programs, rapid telehealth adoption, and expanding private diagnostics.

India continues to position itself in the smart pills market, due to the rising use of capsule endoscopy for diagnosing small bowel bleeding. Clinical studies have reported exceptionally high detection rates, ranging from 43% to 90%, for gastrointestinal lesions in over 2,300 patients using capsule endoscopy in India. This advancement is driving more hospitals to adopt capsule endoscopy technology, thereby expanding the market size and fueling global market growth.

Pie Chart: Regional Market Share, 2025

Source: Straits Research

Europe Market Insights

A growing trend in the European market is the integration of smart pills with wearable sensors and remote monitoring platforms, which allows continuous tracking of a patient’s gastrointestinal activity and vital parameters. This integration provides physicians with real-time, comprehensive data, improving the accuracy of diagnoses and enabling earlier detection of conditions such as Crohn’s disease, small bowel tumors, and colon cancer.

The smart pills market in the UK is propelling due to the NHS-approved research that has evaluated a Digital Medicine System that pairs an ingestible sensor-enabled medication, a wearable patch, and a mobile app to track ingestion and clinical status in psychiatric care. This smart pill approach links dosing data to outcomes, supporting adoption and market growth.

Middle East and Africa Market Insights

The market is growing due to the focus on medical tourism for advanced gastrointestinal diagnostics, which drives demand in countries like the UAE and South Africa. Hospitals are increasingly integrating smart pills with telemedicine platforms and remote monitoring systems, enabling physicians to track patient progress in real time without prolonged hospital stays.

Smart pills market growth in South Africa is increasing due to the supporting cost-efficient outpatient diagnostics by reducing the requirement for prolonged hospital stays and invasive procedures, which aligns with the country’s healthcare focus on outpatient and ambulatory care, particularly in managing gastrointestinal disorders.

Latin America Market Insights

In Latin America, the smart pills market is being driven by the growing adoption of telemedicine and remote patient monitoring, which allows healthcare providers to track gastrointestinal health and treatment outcomes in real time, particularly in underserved or remote regions, thereby improving access to advanced diagnostics and reducing the burden on centralized hospital facilities.

The Argentine smart pills market is witnessing steady expansion driven by the country’s growing focus on advanced diagnostic technologies and minimally invasive healthcare solutions. Several leading hospitals in Buenos Aires, such as the Hospital Italiano de Buenos Aires, have started adopting capsule endoscopy systems for early detection of gastrointestinal disorders, allowing physicians to visualize the digestive tract without invasive procedures. This shift toward non-invasive diagnostics reflects Argentina’s broader healthcare modernization efforts and growing acceptance of smart medical devices.

Indication Insights

The celiac disease segment dominated the market in 2025 with a revenue share of 33.18%. The growth is attributed to the rising gluten-related disorders, growing public awareness and screening programs for celiac disease, as well as increasing healthcare investments.

The small bowel diseases are anticipated to register the fastest CAGR of 12.12% during the forecast period, owing to the increasing adoption of capsule endoscopy for diagnosing conditions such as Crohn’s disease, obscure gastrointestinal bleeding, and small bowel tumors. These conditions often present challenges for traditional diagnostic methods, making capsule endoscopy a valuable tool in clinical practice.

Source: Straits Research

Application Insights

The drug delivery segment is anticipated to grow at a CAGR of 12.96% from 2026-2034. This growth is attributed to advancements in smart drug delivery systems, integration of AI in smart pill devices, and a favourable regulatory framework, which further accelerates the adoption of advanced smart pill technologies.

The capsule endoscopy dominated the market with a revenue share of 53.3%, due to its non-invasive nature and the ability to provide detailed imaging of the gastrointestinal tract, particularly the small intestine, which is challenging to visualize using traditional endoscopic methods.

End User Insights

The diagnostic centers dominated the market in 2025. The growth is attributed to their ability to offer cost-efficient and quick diagnostic services, the rising number of outpatient visits for gastrointestinal evaluations, and the adoption of smart pill technologies for early disease detection and monitoring, which reduces the requirement for hospitalization.

The hospital and clinics segment is anticipated to register the fastest CAGR of 12.58% during the forecast period, owing to the increasing adoption of smart pills for non-invasive diagnostics, growing patient volume in gastrointestinal and related disorders, and the availability of advanced clinical infrastructure that facilitates seamless integration of these technologies into routine care.

Competitive Landscape

The global smart pills market is moderately fragmented, with the major players driving capsule endoscopy adoption while numerous emerging companies contributing to innovative digital pill and sensor-based solutions.

PENTAX Medical: An emerging market player

PENTAX Medical is an emerging player in the global market, specializing in advanced endoscopic imaging and capsule endoscopy technologies to enhance gastrointestinal diagnostics.

• In January 2024, PENTAX Medical launched an innovative Digital Capture Module 9380 to transform medical recording competencies in ENT and speech language pathology settings, reflecting its commitment to digital innovation and precision imaging, the same expertise that drives its capsule endoscopy (smart pill) solutions for advanced gastrointestinal diagnostics.

List of key players in Smart Pills Market

1. Medtronic
2. Otsuko America Pharmaceutical, Inc.
3. Olympus America
4. CapsoVision, Inc
5. Pentax Medical
6. BDD Ltd
7. JINSHAN Science & Technology 
8. etectRx
9. INTROMEDIC 
10. BodyCAP
11. Check-Cap Ltd.
12. Abbott
13. GE HealthCare
14. Bio-Images & Medimetrics
15. RF Co., Ltd.
16. Tenovi
17. Koninklijke Philips N.V.,
18. Proteus Digital Health, Inc.
19. JINSHAN Science & Technology
20. Novartis AG
21. Others

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Strategic Initiatives

• June 2025: CapsoVision, Inc. received FDA clearance for CapsoCam Plus for patients aged two years and older.
• January 2025: CapsoVision received FDA clearance that allowed patients to ingest the CapsoCam Plus capsule at home under virtual medical supervision, eliminating the requirement for in-clinic administration and enhancing accessibility for remote or mobility-limited patients.
• January 2024: AnX Robotics received FDA approval for expanded indications of its NaviCam Small Bowel Video Capsule Endoscopy for both adults and children of age 2 years and older.