디지털 알약 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the digital pills market size is expected to grow from USD 5.52 billion in 2025 to USD 6.20 billion in 2026 and is forecast to reach USD 11.16 billion by 2031 at 12.45% CAGR over 2026-2031.

Global Digital Pills Market Trends and Insights

Expansion of Objective Medication-Adherence Measurement Drives Core Demand

The Digital pills market addresses a key clinical challenge, as providers often cannot confirm medication intake outside of directly observed settings. A 2026 randomized trial of the PrEPSteps intervention found 14% higher PrEP adherence over three months among participants using a digital pill system than among controls. The findings showed that providers could combine ingestion records with interventions rather than use them only for recordkeeping. This also strengthened discussions with payers on treatment outcomes. The evidence also supported chronic therapies, where missed doses can affect treatment effectiveness. Digital adherence systems enabled care teams to identify missed-dose patterns earlier than periodic self-reporting. The Digital pills market may benefit when providers integrate this information into established patient-support processes. However, technology alone does not address access, trust, or treatment barriers.

Growth of Decentralized and Hybrid Clinical Trials Creates Sustained Pharma Demand

Drug developers need reliable records of when participants take study medication, particularly when trial visits occur less frequently. A 2026 review assessed 1,021 interventional trials registered from 2001 through 2025 that used wearable-derived data and identified broader use of device-based endpoints in drug development. Ingestible sensors provided time-stamped medication records that complemented other remote data sources. These systems reduced reliance on patient recall and pill counts in decentralized and hybrid trial designs. The FDA posted cooperative agreement RFA-FD-26-012 in July 2026 for digital health technologies in drug and biologic clinical investigations. The opportunity provided USD 1.1 million in funding, anticipated two awards, and covered digital health endpoints and pediatric patient monitoring.

High Total Cost of Sensor-Enabled Therapy Limits Broad Adoption

Sensor-enabled therapy involves more than the sensor itself. It may require co-encapsulation, device provision, software services, regulatory compliance, and operational support. An analysis of prescription digital therapeutics identified policy and reimbursement approaches as critical to improving patient access. These additional components can increase treatment costs beyond those of the base medication. Consequently, initial adoption is more practical in use cases where adherence clearly affects outcomes or where reimbursement is already available. The Digital Pills Market has stronger near-term opportunities in applications with defined payment pathways.

Cost also influences competition between diagnostic capsules and adherence systems. Capsule endoscopy benefits from established gastrointestinal procedures across many care settings. In contrast, adherence platforms often require separate payer discussions because their service models include the device, software, and follow-up care. This difference may direct investment toward diagnostic applications with clearer revenue models. It may also slow the adoption of ingestion monitoring in therapies that could otherwise benefit from it. Lower-cost hardware and more efficient care processes could improve access, provided they maintain clinical reliability.

Other drivers and restraints analyzed in the detailed report include:

1. Regulatory Precedent for Ingestible Event Markers Reduces Market-Entry Risk
2. Rising Demand for Remote Monitoring in Chronic Therapy Diversifies End-User Applications
3. Limited Reimbursement and Unproven Outcomes at Scale Remain Structural Barriers

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Capsules accounted for 61.40% of 2025 revenue, giving them the largest digital pills market share by product type. Their design allows sensors to be added to existing drug formulations without altering the active ingredient, reducing redevelopment requirements. Capsule endoscopy maintained an established role in gastrointestinal imaging, supported by reimbursement, with Fujifilm, Olympus, CapsoVision, AnX Robotica, and several Asian manufacturers participating in this segment. Microchip delivery devices remained an early-stage sub-segment, with commercial adoption for sustained-release and targeted gastrointestinal delivery expected beyond 2028.

The digital pills market size for tablets is projected to grow at a CAGR of 13.65% through 2031. Tablet-based ingestible event marker systems integrate sensors into conventional oral drug forms, as demonstrated by Abilify MyCite with aripiprazole. A 2026 study reported a Pearson correlation of 0.75 between system-detected ingestions and pill counts for a tablet-based digital pill system with a wristband receiver. Compatibility with blister-pack and strip-dispensing channels supports pharmacy-led adherence programs, although growth depends on demonstrating value for patients, pharmacies, and care teams.

Medication adherence accounted for 34.55% of 2025 revenue and represented the leading application share. The segment addresses the need to verify whether patients take prescribed therapies, particularly where treatment outcomes depend on consistent dosing. A 2025 clinical study examined a real-time digital intervention supporting oral HIV pre-exposure prophylaxis adherence. Drug delivery, disease management, and other applications accounted for the remaining use cases, while adoption depended on reimbursement and care-team integration.

The digital pills market size for patient monitoring is projected to expand at a CAGR of 14.51% through 2031. Ingestible systems can capture gastrointestinal pH, transit, and temperature data in addition to ingestion events. AnX Robotica's MotiliCap received FDA 510(k) clearance in May 2025 to assess gastric emptying, small bowel transit, and colonic motility. The system supports therapy management and gastrointestinal diagnostics, although providers require clear workflows to translate findings into clinical actions.

Complete Report Scope:

• By Product Type
  • Tablet
  • Capsule
  • Microchip Delivery Device
• By Indication
  • Medication Adherence
  • Drug Delivery
  • Patient Monitoring
  • Disease Management
  • Other Indications
• By Disease
  • Cardiovascular Diseases
  • Mental Disorders
  • Infectious Diseases
  • Diabetes
  • Cancer
  • Other Diseases
• By End User
  • Hospitals
  • Clinics
  • Home Care Settings
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 42.45% of revenue in 2025, making it the largest regional market for digital pills. The region combines established FDA pathways, a developed capsule endoscopy base, and increasing focus on reimbursement for digital medicine. The American Medical Association's Digital Medicine Payment Advisory Group supports coding and reimbursement considerations, while the United States remains central through ID-Cap clinical research programs involving VA hospitals, transplant clinics, and behavioral health centers. Canada contributes hospital-based demand for capsule endoscopy, while Mexico remains a smaller market with potential driven by the digitalization of chronic disease management.

Europe was the second-largest regional market in 2025. Germany, the United Kingdom, and France supported the clinical use of capsule endoscopy for gastrointestinal disorders, supported by established diagnostic practices. However, adherence systems faced varying market access requirements, while national approval processes extended commercialization timelines for new devices. GDPR requirements made consent, data management, and clear communication of privacy protections critical to implementation.

Asia-Pacific is projected to grow at a CAGR of 15.20% through 2031, the highest among all regions. Regulatory modernization, expanding diagnostic capacity, and the high burden of tuberculosis and hepatitis support regional growth. South Korea enacted the Digital Medical Device Act in January 2025, and by mid-2026, the CONNECT DTx platform had reached 42% of tertiary hospitals in the Seoul metropolitan area and recorded more than 3,300 cumulative prescriptions. China is developing channels for digital therapeutic products, while the Middle East and Africa and South America offer longer-term opportunities through healthcare modernization in the GCC and regulatory interest in Brazil.

1. AccuHealth Technologies
2. AnX Robotica Corp.
3. Bio-Images Research Ltd.
4. CapsoVision, Inc.
5. Check-Cap Ltd.
6. Chongqing Jinshan Pharmaceutical Co., Ltd.
7. Cosmo Pharmaceuticals
8. etectRx, Inc.
9. FUJIFILM
10. Given Imaging Ltd.
11. IntroMedic Co., Ltd.
12. Jinshan Science and Technology (Group) Co., Ltd.
13. Medispec Ltd.
14. Medtronic
15. Olympus
16. Otsuka
17. Pentax Medical
18. Proteus Digital Health, Inc.
19. RF Co., Ltd.
20. Wision A.I.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expansion of Objective Medication-Adherence Measurement
  • 4.2.2 Growth of Decentralized and Hybrid Clinical Trials
  • 4.2.3 Regulatory Precedent for Ingestible Event Markers
  • 4.2.4 Rising Demand for Remote Monitoring in Chronic Therapy
  • 4.2.5 Pharmacy and Care-Team Integration of Dose-Level Data
  • 4.2.6 Reusable Reader and Wearable-Form-Factor Innovation
• 4.3 Market Restraints
  • 4.3.1 High Total Cost of Sensor-Enabled Therapy
  • 4.3.2 Limited Reimbursement and Unproven Outcomes
  • 4.3.3 Dose-Detection Failure and Data-Latency Risk
  • 4.3.4 Patient Consent, Privacy and Workflow Friction
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 Tablet
  • 5.1.2 Capsule
  • 5.1.3 Microchip Delivery Device
• 5.2 By Indication
  • 5.2.1 Medication Adherence
  • 5.2.2 Drug Delivery
  • 5.2.3 Patient Monitoring
  • 5.2.4 Disease Management
  • 5.2.5 Other Indications
• 5.3 By Disease
  • 5.3.1 Cardiovascular Diseases
  • 5.3.2 Mental Disorders
  • 5.3.3 Infectious Diseases
  • 5.3.4 Diabetes
  • 5.3.5 Cancer
  • 5.3.6 Other Diseases
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Clinics
  • 5.4.3 Home Care Settings
  • 5.4.4 Other End Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Strategic Moves
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 AccuHealth Technologies
  • 6.3.2 AnX Robotica Corp.
  • 6.3.3 Bio-Images Research Ltd.
  • 6.3.4 CapsoVision, Inc.
  • 6.3.5 Check-Cap Ltd.
  • 6.3.6 Chongqing Jinshan Pharmaceutical Co., Ltd.
  • 6.3.7 Cosmo Pharmaceuticals N.V.
  • 6.3.8 etectRx, Inc.
  • 6.3.9 Fujifilm Corporation
  • 6.3.10 Given Imaging Ltd.
  • 6.3.11 IntroMedic Co., Ltd.
  • 6.3.12 Jinshan Science and Technology (Group) Co., Ltd.
  • 6.3.13 Medispec Ltd.
  • 6.3.14 Medtronic plc
  • 6.3.15 Olympus Corporation
  • 6.3.16 Otsuka Pharmaceutical Co., Ltd.
  • 6.3.17 PENTAX Medical
  • 6.3.18 Proteus Digital Health, Inc.
  • 6.3.19 RF Co., Ltd.
  • 6.3.20 Wision A.I.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment