Smart Pills Market

Market Definition

The market encompasses a range of digital and ingestible devices integrated with sensors, cameras, and data transmitters designed for diagnostic and monitoring applications within the gastrointestinal tract and beyond.

This market includes products and services offered by healthcare technology companies, pharmaceutical firms, and diagnostics providers, supporting functions such as patient compliance monitoring, internal imaging, and real-time data transmission to healthcare professionals.

The report outlines the primary drivers of market growth, along with an in-depth analysis of emerging trends and evolving regulatory frameworks shaping the market trajectory.

Smart Pills Market Overview

The global smart pills market size was valued at USD 672.9 million in 2023 and is projected to grow from USD 746.0 million in 2024 to USD 1,574.5 million by 2031, exhibiting a CAGR of 11.26% during the forecast period.

The market is registering significant growth driven by the rising demand for minimally invasive diagnostic procedures, advancements in wireless health monitoring technologies, and increasing adoption of digital health solutions. Growing focus on personalized medicine, coupled with the rising prevalence of gastrointestinal disorders and chronic diseases, is fueling the market.

Major companies operating in the smart pills industry are CapsoVision, Inc., Check-Cap, IntroMedic, JINSHAN Science & Technology, Medtronic, Olympus Corporation, AnX Robotics, Otsuka Holdings Co., Ltd., BodyCAP, Lonza, Atmo Biosciences, Biora Therapeutics, Inc., AARDEX Group, Hoya Corporation, and Microchip Technology Inc.

Furthermore, the market is benefiting from increasing healthcare expenditures and the global shift toward value-based care, which emphasizes early diagnosis and efficient disease management.

The aging population and the rising incidence of lifestyle-related conditions are also contributing to the uptake of smart pill technologies, particularly for monitoring and managing long-term health conditions.

Key Highlights

1. The smart pills industry size was valued at USD 672.9 million in 2023.
2. The market is projected to grow at a CAGR of 11.26% from 2024 to 2031.
3. North America held a market share of 35.95% in 2023, with a valuation of USD 241.9 million.
4. The capsule endoscopy segment garnered USD 283.7 million in revenue in 2023.
5. The esophagus segment is expected to reach USD 582.8 million by 2031.
6. The occult GI bleeding segment is expected to reach USD 471.4 million by 2031.
7. The hospitals segment is expected to reach USD 559.8 million by 2031.
8. The market in Asia Pacific is anticipated to grow at a CAGR of 12.16% during the forecast period.

Market Driver

"Advancements in Research and Technology"

The smart pills market is being driven by ongoing research and technological advancements that are pushing the boundaries of what smart pill technologies can achieve.

Innovations in materials science, miniaturization, and sensor technology demonstrate that smart pills are becoming capable of monitoring a wider range of health conditions with greater precision.

These advancements are not only improving the functionality and effectiveness of smart pills but also expanding their potential applications across various therapeutic areas, including chronic disease management and disease prevention.

As research explores new ways to integrate biosensors, wireless communication, and data analytics, the market is registering an increase in the development of next-generation smart pills that can provide real-time health insights, enhance patient outcomes, and improve medication adherence.

• In June 2024, researchers at the USC Viterbi School of Engineering developed ingestible smart pills equipped with sensors and AI for real-time 3D tracking and gas detection in the gastrointestinal tract. The capsules use a wearable magnetic coil system and an optical sensing membrane to identify gasses like ammonia associated with conditions such as gastritis and gastric cancers.

Market Challenge

"High Development and Production Costs"

One of the major challenges faced by the smart pills market is the high development and production costs associated with these technologies. The integration of sensors, electronics, and other advanced materials into ingestible pills requires significant investment in research and development, manufacturing capabilities, and regulatory compliance.

These costs can be prohibitive, especially for smaller companies trying to bring innovative smart pill products to the market. Additionally, the complexity of scaling up production while maintaining quality and precision adds to the financial burden.

Companies can focus on optimizing the manufacturing process by leveraging advanced technologies such as 3D printing and miniaturization to reduce costs. Partnering with contract manufacturers or utilizing existing production infrastructure can also help alleviate the financial strain.

Market Trend

"Digital Integration and Real-time Monitoring"

The smart pills market is registering significant growth, due to the increasing integration of smart pill technologies with digital health platforms. This market trend focuses on enabling real-time monitoring, data collection, and medication adherence, which are essential in today’s personalized healthcare landscape.

The demand for data-driven solutions in healthcare is growing, with an emphasis on improving patient outcomes by providing continuous, remote monitoring capabilities.

Smart pills are transforming how patients and healthcare providers approach treatment by integrating advanced analytics and Machine Learning (ML) into medication management. This aids in enhancing adherence, reducing errors, and optimizing healthcare efficiency.

The shift highlights the industry's movement toward a more interconnected, personalized, and efficient healthcare ecosystem, where patients receive continuous, real-time assistance in managing their health.

• In November 2024, Custom Health and PatchRx partnered to integrate PatchRx’s smart pill bottle caps into Custom Health’s medication adherence platform to create a data-driven medication intelligence solution for health plans, providers, and pharmacies.

Smart Pills Market Report Snapshot

Segmentation	Details
By Application	Capsule Endoscopy, Drug Delivery, Vital Sign Monitoring
By Target	Esophagus, Small Intestine, Large Intestine, Stomach
By Disease Indication	Occult GI Bleeding, Crohn’s Disease, Small Bowel Tumors, Celiac Disease, Neurological Disorders, Others
By End Use	Hospitals, Diagnostic Centers, Research Institute, Others
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation

• By Application (Capsule Endoscopy, Drug Delivery, and Vital Sign Monitoring): The capsule endoscopy segment earned USD 283.7 million in 2023, due to its widespread use in non-invasive gastrointestinal diagnostics and increasing patient preference for minimally invasive procedures.
• By Target (Esophagus, Small Intestine, Large Intestine, and Stomach): The esophagus segment held 37.37% of the market in 2023, due to the rising incidence of esophageal disorders and growing demand for early detection of upper GI tract conditions.
• By Disease Indication (Occult GI Bleeding, Crohn’s Disease, Small Bowel Tumors, Celiac Disease, Neurological Disorders, Others): The occult GI bleeding segment is projected to reach USD 471.4 million by 2031, owing to the increasing prevalence of undiagnosed gastrointestinal bleeding and the effectiveness of smart pills in pinpointing bleeding sources.
• By End Use (Hospitals, Diagnostic Centers, Research Institute, and Others): The hospitals segment is projected to reach USD 559.8 million by 2031, owing to the high adoption of advanced diagnostic tools, growing patient inflow, and availability of skilled healthcare professionals.

Smart Pills Market Regional Analysis

Based on region, the market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America smart pills market share stood at around 35.95% in 2023, with a valuation of USD 241.9 million. This dominance is primarily attributed to the high prevalence of gastrointestinal and chronic disorders in the U.S., along with the region's well-established healthcare infrastructure and strong emphasis on early diagnostic technologies.

The presence of key industry players and the rapid adoption of digital health innovations by leading healthcare systems have significantly contributed to market expansion.

Furthermore, high healthcare spending and the integration of smart diagnostic tools into clinical workflows across major hospitals and outpatient centers have driven the demand for smart pills in North America.

The smart pills industry in Asia Pacific is expected to register the fastest growth, with a projected CAGR of 12.16% over the forecast period. This growth is largely driven by increasing investments in healthcare infrastructure across emerging economies like China and India, where there is a rising burden of digestive and metabolic disorders.

In addition, the region is registering the growing awareness of non-invasive diagnostic alternatives, particularly in urban medical centers and specialty clinics. Technological advancements and increasing collaboration between regional healthcare providers and international medtech companies are accelerating the adoption of smart pill solutions.

The region’s expanding middle-class population, coupled with rising disposable income and increasing access to advanced medical diagnostics in countries such as South Korea, Japan, and Singapore, further supports the market growth.

Regulatory Frameworks

• In the U.S., smart pills are regulated by the Food and Drug Administration (FDA) as combination products. Smart pills are considered drug-device combinations, and their approval is overseen by the Office of Combination Products (OCP).
• In Europe, the European Medicines Agency (EMA) is the primary regulatory authority responsible for overseeing the safety, quality, and effectiveness of medicines, including smart pills. The EMA works with national competent authorities in EU member states to ensure that medicines are evaluated and approved appropriately.
• In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is the primary regulatory authority for pharmaceuticals, medical devices, and other related products, including smart pills. The PMDA works with the Ministry of Health, Labour, and Welfare (MHLW) to ensure the safety, efficacy, and quality of these products.
• In India, smart pills are directly regulated by the Central Drugs Standard Control Organization (CDSCO). The CDSCO is responsible for ensuring the safety, efficacy, and quality of all medical products, including smart pills that are manufactured, imported, and distributed in India.

Competitive Landscape

The smart pills industry is characterized by rapid technological innovation and strategic collaborations among key players. Companies are heavily investing in research and development to enhance the functionality and accuracy of smart pill technologies, particularly in areas such as real-time data transmission, wireless communication, and miniaturization of sensors.

Several players are pursuing partnerships with digital health firms and academic institutions to co-develop integrated diagnostic and therapeutic solutions to strengthen their market position.

Mergers and acquisitions are also common strategies aimed at expanding product portfolios and gaining access to proprietary technologies. Additionally, many market participants are focusing on clinical validation and large-scale trials to improve product credibility and accelerate commercialization.

Firms are also scaling their operations by building dedicated manufacturing and innovation hubs in key markets, while adopting AI-enabled platforms to refine data analytics and enhance user interfaces for healthcare providers.

List of Key Companies in Smart Pills Market:

• CapsoVision, Inc.
• Check-Cap
• IntroMedic
• JINSHAN Science & Technology
• Medtronic
• Olympus Corporation
• AnX Robotics
• Otsuka Holdings Co., Ltd.
• BodyCAP
• Lonza
• Atmo Biosciences
• Biora Therapeutics, Inc.
• AARDEX Group
• Hoya Corporation
• Microchip Technology Inc.

Recent Developments (M&A/Partnerships/Agreements/Product Launches)

• In January 2025, CapsoVision, Inc.'s CapsoCam Plus capsule endoscopy system received FDA clearance for remote ingestion, allowing patients to ingest the capsule from home under virtual medical supervision, enhancing accessibility and comfort in diagnostic procedures for small bowel visualization.
• In December 2024, Lonza launched a tailored offering for companies developing smart capsules, focusing on bespoke drug delivery solutions and customized capsule designs for oral biologic drugs, utilizing bi-layer manufacturing technology.