장시간 지속형 주사제 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the Long-Acting injectables market size was valued at USD 19.22 billion in 2025 and is estimated to grow from USD 21.59 billion in 2026 to reach USD 38.63 billion by 2031, at a CAGR of 12.34% during the forecast period (2026-2031).

Global Long Acting Injectables Market Trends and Insights

Improved Adherence and Relapse Prevention in Chronic Disease Management

Oral antipsychotic nonadherence affected nearly half of individuals with schizophrenia spectrum disorders and contributed significantly to inpatient psychiatric spending. The American Psychiatric Association recommended considering long-acting injectables (LAIs) earlier after a confirmed diagnosis, expanding the eligible patient population beyond those with documented oral treatment failure. A 2026 mirror-image study of 149 patients in Turkey associated LAI initiation with an 80% reduction in hospitalization hazard and an 83% reduction in relapse hazard compared with prior oral treatment periods. A 2025 EULAST trial analysis found that LAIs reduced the risk of all-cause discontinuation by 36% versus oral antipsychotics among individuals with early-phase schizophrenia and comorbid substance use disorder.

Expansion of Long-Acting HIV Treatment and Pre-Exposure Prophylaxis

Long-acting HIV therapies evolved from specialized adherence solutions into established clinical options. The FDA approved Gilead's twice-yearly Yeztugo (lenacapavir) for pre-exposure prophylaxis (PrEP) in June 2025, following the PURPOSE 1 and PURPOSE 2 trials, in which at least 99.9% of participants remained HIV-negative. ViiV Healthcare's LATITUDE Phase III trial found that Cabenuva reduced the cumulative risk of regimen failure to 22.8%, compared with 41.2% for daily oral therapy among individuals with adherence challenges. The CDC's 2025 clinical recommendation and ViiV Healthcare's expanded Medicines Patent Pool license covering 133 countries supported access and clinical capacity development in Sub-Saharan Africa and South Asia.

High Acquisition Cost and Reimbursement Complexity

New LAIs may experience slow uptake despite strong clinical evidence, as regulatory approval does not ensure routine coverage. Yeztugo had a U.S. annual list price of USD 28,218, increasing focus on formulary decisions and patient access. CVS Caremark initially excluded Yeztugo from its commercial and ACA formularies during negotiations, delaying treatment initiation. The Medicare Part D benefit redesign under the Inflation Reduction Act changed plan incentives for high-cost LAI antipsychotics and may have increased the use of prior authorization or step therapy. The olanzapine pamoate REMS required 3-hour post-injection monitoring at a certified facility, increasing delivery costs, which TEV-749 aimed to avoid through its REMS-free design.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Need for Extended-Release Therapies in Opioid Use Disorder
2. Formulation Platforms Enabling Monthly-to-Six-Month Dosing Intervals
3. Manufacturing Scale-Up Risk for Sterile Suspensions and Complex Depots

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

Segment Analysis

CNS disorders accounted for 45.23% of the long-acting injectables market in 2025, supported by the established use of antipsychotic LAIs for schizophrenia, schizoaffective disorder, and bipolar I disorder. Paliperidone palmitate is available in PP1M, PP3M, and PP6M formulations, supporting 1-, 3-, and 6-month treatment intervals. Otsuka's and Alkermes' aripiprazole LAI portfolios also serve the established psychiatric treatment population. These products support patient management from stabilization through long-term maintenance.

Infectious diseases are forecast to grow at a CAGR of 14.53% between 2026 and 2031, driven by HIV treatment and prevention. As of April 2026, the FDA had approved Cabenuva for administration every 1 to 2 months, Sunlenca every 6 months, and Yeztugo as a twice-yearly PrEP option. These dosing intervals expand patient and clinician options and extend LAI use beyond psychiatric treatment. Metabolic and endocrine disorders remain a stable therapeutic area, supported by LHRH agonist depots for hormone management in prostate and breast cancer. Camurus launched monthly subcutaneous octreotide, CAM2029, in Germany in late 2025 for acromegaly.

Small molecules accounted for 78.55% of the long-acting injectables market in 2025. Their leadership reflects the maturity of antipsychotics, antiretrovirals, and LHRH agonists in controlled-release formulation development. PLGA microspheres and nanocrystal suspensions are well established for many active ingredients, while regulatory precedents remain more developed for small-molecule LAIs than for newer biologic depots.

Biologics are forecast to grow at a CAGR of 14.67% from 2026 to 2031. HIV broadly neutralizing antibody programs and emerging autoimmune LAI programs support this outlook. ViiV Healthcare's Phase IIb EMBRACE study found that lotivibart, combined with monthly intramuscular cabotegravir, maintained viral suppression in 94% of intravenous recipients and 82% of subcutaneous recipients. These findings indicate that biologic delivery can support durable pharmacokinetic activity across multiple administration routes.

Complete Report Scope:

• By Therapeutic Area
  • Central Nervous System Disorders
  • Infectious Diseases
  • Metabolic and Endocrine Disorders
  • Oncology and Supportive Care
  • Substance Use Disorders
  • Autoimmune and Inflammatory Diseases
  • Reproductive Health and Contraception
  • Other Therapeutic Areas
• By Molecule Type
  • Small Molecules
  • Biologics
• By Technology
  • Polymer-Based Depot Systems
  • Microsphere-Based Formulations
  • In-Situ-Forming Depots
  • Nanoformulations and Nanocrystal Suspensions
  • Liposomal Systems
  • Others
• By Route of Administration
  • Intramuscular
  • Subcutaneous
  • Intradermal and Other Routes
• By End User
  • Hospitals
  • Specialty Clinics and Community Mental-Health Centers
  • Ambulatory Care and Physician Offices
  • Homecare Settings
  • Others
• 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 accounted for 41.67% of the long-acting injectables market share in 2025. The region benefited from established specialty pharmacy infrastructure, buy-and-bill reimbursement under Medicare Part B, and a supportive regulatory environment. The FDA approved Yeztugo for twice-yearly HIV pre-exposure prophylaxis (PrEP) in June 2025 and accepted the new drug application for TEV-749, a long-acting injectable olanzapine formulation, in February 2026. Canada approved ABILIFY ASIMTUFII in January 2025, introducing a bimonthly aripiprazole option for schizophrenia and bipolar I disorder.

Europe was the second-largest geography, with Germany, the United Kingdom, France, Italy, and Spain serving as key commercial markets. The European Commission authorized Yeytuo for HIV prevention, extending access across European Union member states, Norway, Iceland, and Liechtenstein. Camurus launched Oczyesa, CAM2029, a monthly subcutaneous octreotide treatment, in Germany in November 2025, while the EMA accepted the marketing authorization application for TEV-749 in May 2026. Prior authorization delays, the Part D redesign, and payer requirements for demonstrated administration or safety benefits remained relevant across developed markets.

Asia-Pacific is forecast to grow at a CAGR of 14.22% from 2026 to 2031. China expanded healthcare infrastructure and domestic manufacturing capabilities, supported by biosimilar and innovative LAI development, while Japan's aging population and outpatient psychiatric care focus supported longer treatment intervals. A 2026 study reported PP3M continuation rates consistent with clinical trial findings, and Australia approved Yeytuo for HIV PrEP in January 2026. South Korea may support regional LAI production, while the Middle East and Africa and South America offer incremental opportunities through access programs, hormonal LAIs, and generic antipsychotic depot formulations.

1. Alkermes plc
2. Amneal Pharmaceuticals
3. Aurobindo Pharma
4. Camurus AB
5. Dr. Reddy's Laboratories
6. H. Lundbeck
7. Indivior
8. Johnson & Johnson
9. Lupin
10. Luye Pharma Group Ltd.
11. Mapi Pharma Ltd.
12. MedinCell S.A.
13. Novartis
14. Otsuka
15. Pharmathen S.A.
16. Sun Pharmaceuticals Industries
17. Teva Pharmaceutical Industries
18. Tolmar, Inc.
19. Viatris
20. ViiV Healthcare Limited
21. Zydus Lifesciences Limited

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 Improved Adherence and Relapse Prevention in Chronic Disease
  • 4.2.2 Expansion of Long-Acting HIV Treatment and Pre-Exposure Prophylaxis
  • 4.2.3 Rising Need for Extended-Release Therapies in Opioid Use Disorder
  • 4.2.4 Increasing Evidence for Lower Dosing Burden and Reduced Hospitalization
  • 4.2.5 Formulation Platforms Enabling Monthly-to-Six-Month Dosing
  • 4.2.6 Provider Workflow and Injection-Visit Infrastructure as a Commercial Adoption Lever
• 4.3 Market Restraints
  • 4.3.1 High Acquisition Cost and Reimbursement Complexity
  • 4.3.2 Injection-Site Reactions, Administration Burden, and Limited Reversibility
  • 4.3.3 Manufacturing Scale-Up Risk for Sterile Suspensions and Complex Depots
  • 4.3.4 Missed-Dose, Bridging, and Pharmacokinetic Tail-Management Complexity
• 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 Therapeutic Area
  • 5.1.1 Central Nervous System Disorders
  • 5.1.2 Infectious Diseases
  • 5.1.3 Metabolic and Endocrine Disorders
  • 5.1.4 Oncology and Supportive Care
  • 5.1.5 Substance Use Disorders
  • 5.1.6 Autoimmune and Inflammatory Diseases
  • 5.1.7 Reproductive Health and Contraception
  • 5.1.8 Other Therapeutic Areas
• 5.2 By Molecule Type
  • 5.2.1 Small Molecules
  • 5.2.2 Biologics
• 5.3 By Technology
  • 5.3.1 Polymer-Based Depot Systems
  • 5.3.2 Microsphere-Based Formulations
  • 5.3.3 In-Situ-Forming Depots
  • 5.3.4 Nanoformulations and Nanocrystal Suspensions
  • 5.3.5 Liposomal Systems
  • 5.3.6 Others
• 5.4 By Route of Administration
  • 5.4.1 Intramuscular
  • 5.4.2 Subcutaneous
  • 5.4.3 Intradermal and Other Routes
• 5.5 By End User
  • 5.5.1 Hospitals
  • 5.5.2 Specialty Clinics and Community Mental-Health Centers
  • 5.5.3 Ambulatory Care and Physician Offices
  • 5.5.4 Homecare Settings
  • 5.5.5 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 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 Alkermes plc
  • 6.3.2 Amneal Pharmaceuticals, Inc.
  • 6.3.3 Aurobindo Pharma Limited
  • 6.3.4 Camurus AB
  • 6.3.5 Dr. Reddy's Laboratories Limited
  • 6.3.6 H. Lundbeck A/S
  • 6.3.7 Indivior PLC
  • 6.3.8 Johnson & Johnson
  • 6.3.9 Lupin Limited
  • 6.3.10 Luye Pharma Group Ltd.
  • 6.3.11 Mapi Pharma Ltd.
  • 6.3.12 MedinCell S.A.
  • 6.3.13 Novartis AG
  • 6.3.14 Otsuka Pharmaceutical Co., Ltd.
  • 6.3.15 Pharmathen S.A.
  • 6.3.16 Sun Pharmaceutical Industries Limited
  • 6.3.17 Teva Pharmaceutical Industries Ltd.
  • 6.3.18 Tolmar, Inc.
  • 6.3.19 Viatris Inc.
  • 6.3.20 ViiV Healthcare Limited
  • 6.3.21 Zydus Lifesciences Limited

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment