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

According to Mordor Intelligence, the adenoid cystic carcinoma market size is projected to be USD 182.30 million in 2025, USD 182.30 million in 2026, and reach USD 268.56 million by 2031, growing at a CAGR of 6.67% from 2026 to 2031.

This report is Segmented by Treatment (Chemotherapy, Targeted Therapy, and More), by Drug Class (Cytotoxic Drugs, Tyrosine Kinase Inhibitors, and More), by Route of Administration (Oral, Intravenous, and More), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and More), and by Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Adenoid Cystic Carcinoma Market Trends and Insights

Rising Unmet Need in Advanced and Recurrent Disease

The Adenoid cystic carcinoma market continues to draw support from the large treatment gap in advanced and recurrent disease. Clinical documentation for the ZANACC Phase 2 program notes that 50% of ACC patients who undergo surgery and adjuvant radiotherapy eventually develop recurrent or metastatic disease. Yet, no regulatory body has approved a systemic treatment for that population. That gap sustains demand across targeted therapy, chemotherapy, and supportive care at the same time, rather than shifting revenue from one treatment type to another. MYB overactivation in more than 90% of tumors has remained difficult to address because transcription factors lacked conventional binding pockets, but RNA-targeting small molecules are now creating a more direct clinical route for this disease biology. Recurrent disease is also prolonged by the natural history of ACC, which often advances slowly and keeps patients within treatment pathways for years. Perineural invasion further extends demand because it frequently leaves positive margins even after technically complete resection, which returns patients to repeat local treatment and later systemic management.

Increasing Use of Molecular Profiling for Patient Stratification

The Adenoid cystic carcinoma market is also benefiting from a clearer molecular taxonomy that is changing how patients are classified and monitored. A 2024 study on sinonasal ACC described at least 3 therapeutically distinct molecular groups, which included MYB-fusion-positive, MYBL1-fusion-positive, and non-canonical-fusion disease, each with different target relevance and clinical behavior. A retrospective 2025 cohort analysis of 182 ACC specimens found that MYB and NOTCH co-mutations were linked to higher recurrence risk, and NOTCH1 activation was associated with solid-pattern histology in 50.5% of cases. That shift from histopathology alone toward subtype-based molecular selection expands demand for testing and creates a companion diagnostics layer that has been limited in ACC so far. Regulatory signals are reinforcing this shift because emiltatug ledadotin received Breakthrough Therapy Designation in ACC-1, while REM-422 and RGT-61159 received orphan or expedited development support based on subtype-focused clinical evidence. Better stratification is also likely to improve surveillance intensity and clinical trial matching in specialist centers.

No Approved Systemic Standard of Care

The Adenoid cystic carcinoma market still lacks the basic commercial anchor that most oncology categories use to build pricing, coverage, and prescribing patterns. No FDA or EMA-approved systemic treatment exists for ACC, so revenue still comes from off-label prescribing, supportive care, and clinical trial channels rather than an established commercial product base. That creates a difficult environment for payers and formulary committees because there is no approved comparator for pricing and no formal standard to anchor reimbursement reviews. Published evidence also underscores this weak foundation, as conventional chemotherapy, immune checkpoint inhibitors, and most TKIs have generally shown response rates that rarely exceeded 20% across larger ACC series, with no durable population-level remissions documented. Orphan drug incentives can improve development economics, but they do not remove the need for convincing comparative evidence when companies enter pricing and health technology assessment discussions. The practical effect is a slower commercial scale-up even when promising Phase 1 or Phase 2 data emerge.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Biomarker-Driven Pipeline Activity
2. Adoption of Decentralized and Tissue-Sparing Diagnostics
3. Limited Eligible Patient Pool for Commercialization

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

Segment Analysis

Targeted therapy held 45.18% of the Adenoid cystic carcinoma market share in 2025, which made it the largest treatment segment in the period. Its lead came from growing off-label use of investigational kinase inhibitors, especially multi-target anti-angiogenic agents such as lenvatinib and cabozantinib, in advanced or recurrent disease. The segment is also set to record the fastest 8.59% CAGR through 2031, which reflects pipeline momentum more than approved product penetration. The Adenoid cystic carcinoma market is therefore leaning toward targeted care even before a formal label expansion has taken place.

Chemotherapy still plays a role for rapidly progressing disease, especially through platinum-based regimens, but its function remains largely palliative. Published clinical series noted that objective response rates for chemotherapy rarely exceeded 20%, and no standard backbone produced durable control across the population. Supportive and palliative care remains stable because ACC often progresses slowly and requires long periods of symptom management. The Adenoid cystic carcinoma industry also continues to generate treatment spending before approvals because Phase 2 combinations such as lenvatinib with pembrolizumab in recurrent or metastatic salivary gland cancer are building off-label use around ACC cohorts. As oral MYB-targeting agents move closer to potential approval, targeted therapy is likely to extend its lead further within the forecast period.

TKIs held 41.38% of drug class revenue in 2025, which placed them at the top of the class mix even though the strongest future momentum lies elsewhere. Monoclonal antibodies, including ADCs, are projected to deliver the fastest 8.26% CAGR through 2031 as B7-H4 and c-Kit directed constructs move through expansion cohorts. The Adenoid cystic carcinoma market has relied on TKIs because they were the most accessible off-label systemic option, even without biomarker-selected label guidance. That base remains meaningful, but the field is increasingly measuring value through deeper biological selection rather than physician habit alone.

Emiltatug ledadotin gave the clearest example of this shift when 55.6% of ACC-1 patients experienced tumor shrinkage in Phase 1 dose-expansion cohorts, a result that helped support FDA Breakthrough Therapy Designation for the asset. Cytotoxic drugs still occupy an entrenched but declining place because they are generally used after other options have been exhausted. The remaining category also includes GSK-3B inhibitors, with elraglusib reporting a 6.4-month median progression-free survival in recurrent or metastatic salivary gland cancers that included ACC. The Adenoid cystic carcinoma market is likely to see ADCs challenge the TKI revenue lead as Phase 2 readouts arrive later in the forecast window. That transition would also push the class mix toward more subtype-defined treatment use.

Complete Report Scope:

• By Treatment
  • Chemotherapy
  • Targeted Therapy
  • Supportive/Palliative Care
• By Drug Class
  • Cytotoxic Drugs
  • Tyrosine Kinase Inhibitors
  • Monoclonal Antibodies
  • Other Drug Classes
• By Route of Administration
  • Oral
  • Intravenous
  • Other Injectable Routes
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Specialty Pharmacies
  • Online Pharmacies
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • 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 43.18% of the Adenoid cystic carcinoma market size in 2025, which made it the largest regional contributor. The region benefits from the concentration of National Cancer Institute designated cancer centers, dedicated salivary gland tumor programs, and early use of NGS-based profiling in rare cancers. The FDA also remains central to development momentum, with orphan and expedited designations supporting assets such as RGT-61159 and REM-422. Canada adds support through publicly funded rare disease pathways, although reimbursement review timing can delay uptake versus the United States. Mexico still contributes at a lower level because specialist oncology infrastructure remains concentrated in major cities.

Europe stands as the second largest regional market because Germany, the United Kingdom, France, Italy, and Spain host dense networks of academic hospitals that manage a large share of the continent's rare salivary gland cancer burden. The EMA orphan framework supports this position by offering 10 years of exclusivity, fee reductions, and protocol assistance for qualifying therapies. Reimbursement remains the main gating issue because agencies such as NICE and IQWiG depend on comparative clinical evidence that is difficult to generate in a rare and slow-recruiting disease setting. France and Italy are also helping expand the evidence base through participation in multicenter ADC studies, including the emiltatug ledadotin program.

Asia-Pacific is projected to record the fastest 8.03% CAGR through 2031, and the Adenoid cystic carcinoma market size in the region is being supported by better diagnostics, stronger rare disease policy frameworks, and greater clinical trial capacity. Japan is leading that shift, and in March 2026 the country approved darolutamide with goserelin for androgen receptor positive salivary gland cancer based on the DISCOVARY Phase 2 trial, which reported a 45.2% objective response rate and a 13.1-month median progression-free survival. China is also increasing its role through rare disease policy updates and larger ACC-specific studies such as the Phase 2 HG146 trial that began in December 2024 and planned to enroll 140 patients. The Adenoid cystic carcinoma market remains smaller in the Middle East and Africa and in South America because biomarker testing and patient identification are still limited outside select centers in South Africa, Brazil, and GCC countries. Those regions are more likely to see gradual expansion as sponsors use new trial sites to speed rare cancer recruitment and as rare disease access policies become more established.

1. Actuate Therapeutics, Inc.
2. Amgen
3. AstraZeneca
4. Ayala Pharmaceuticals
5. Bristol-Myers Squibb
6. Celgene
7. Eisai
8. Elevar Therapeutics
9. Eli Lilly and Company
10. Merck Sharp and Dohme Corp.
11. Mersana Therapeutics, Inc.
12. Novartis
13. OncoC4
14. OncoMed Pharmaceuticals, Inc.
15. Pfizer
16. Prelude Therapeutics Incorporated
17. Remix Therapeutics
18. Rgenta Therapeutics
19. Roche
20. VM Oncology

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 Rising Unmet Need in Advanced and Recurrent Disease
  • 4.2.2 Increasing Use of Molecular Profiling for Patient Stratification
  • 4.2.3 Expansion of Biomarker-Driven Pipeline Activity
  • 4.2.4 Durable Demand for Surgery and Radiation in Localized Disease
  • 4.2.5 Adoption of Decentralized and Tissue-Sparing Diagnostics
• 4.3 Market Restraints
  • 4.3.1 No Approved Systemic Standard of Care
  • 4.3.2 Limited Eligible Patient Pool for Commercialization
  • 4.3.3 Low Biomarker Testing Penetration Outside Major Centers
  • 4.3.4 High Cost and Access Friction for Novel Targeted Therapies
• 4.4 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 Industry Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Treatment
  • 5.1.1 Chemotherapy
  • 5.1.2 Targeted Therapy
  • 5.1.3 Supportive/Palliative Care
• 5.2 By Drug Class
  • 5.2.1 Cytotoxic Drugs
  • 5.2.2 Tyrosine Kinase Inhibitors
  • 5.2.3 Monoclonal Antibodies
  • 5.2.4 Other Drug Classes
• 5.3 By Route of Administration
  • 5.3.1 Oral
  • 5.3.2 Intravenous
  • 5.3.3 Other Injectable Routes
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Specialty Pharmacies
  • 5.4.4 Online Pharmacies
• 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 Japan
    • 5.5.3.3 India
    • 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 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 Actuate Therapeutics, Inc.
  • 6.3.2 Amgen Inc.
  • 6.3.3 AstraZeneca plc
  • 6.3.4 Ayala Pharmaceuticals
  • 6.3.5 Bristol-Myers Squibb Company
  • 6.3.6 Celgene Corporation
  • 6.3.7 Eisai Co., Ltd.
  • 6.3.8 Elevar Therapeutics
  • 6.3.9 Eli Lilly and Company
  • 6.3.10 Merck Sharp and Dohme Corp.
  • 6.3.11 Mersana Therapeutics, Inc.
  • 6.3.12 Novartis AG
  • 6.3.13 OncoC4
  • 6.3.14 OncoMed Pharmaceuticals, Inc.
  • 6.3.15 Pfizer Inc.
  • 6.3.16 Prelude Therapeutics Incorporated
  • 6.3.17 Remix Therapeutics
  • 6.3.18 Rgenta Therapeutics
  • 6.3.19 Roche Holding AG
  • 6.3.20 VM Oncology

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment