첨단 치료 의약품(ATMP) : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the advanced therapy medicinal products market size is projected to be USD 36.47 billion in 2025, USD 41.46 billion in 2026, and reach USD 86.76 billion by 2031, growing at a CAGR of 15.91% from 2026 to 2031.

This report is Segmented by Therapy Type (Cell Therapy, Gene Therapy, and More), Cell Source (Autologous, Allogeneic), Vector Type (Viral Vectors, and More), Application (Oncology, Rare Genetic Disorders, and More), End User (Hospitals & Transplant Centers, and More), Manufacturing Platform (In-Vivo Modified, and More), and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Global Advanced Therapy Medicinal Products Market Trends and Insights

Regulatory Fast-Track Designations and Approvals Surging Post-2024

Regulators are condensing review windows for high-need therapies, enabling first movers to secure orphan markets quickly. The EMA PRIME program accepted 11 advanced candidates in 2024, a 38% rise on 2023.Japan's Sakigake pathway similarly granted four allogeneic designations, allowing conditional approval on Phase II data. These mechanisms reduce the time-to-market to roughly six years, but new FDA guidance extends post-marketing surveillance for lentiviral products to 15 years, stretching the compliance budgets of smaller innovators.

Escalating VC and Big-Pharma Deal Values in ATMP Pipelines

Disclosed transaction value climbed to USD 12.3 billion in 2024, buoyed by Bristol-Myers Squibb's USD 4.8 billion Mirati buy-out and Gilead's USD 850 million Legend Biotech stake. Beam Therapeutics' USD 520 million Series D in 2025 exemplifies venture appetite for next-gen base-editing. Capital concentration in the United States and Europe accelerates multi-indication programs yet leaves many Asia-Pacific teams reliant on out-licensing.

High Cost and Reimbursement Uncertainty for Curative One-Off Therapies

List prices of USD 1.5 million-3 million per patient strain payer budgets, limiting access outside wealthy regions. Bluebird bio's Lyfgenia debuted at USD 3.1 million, and exa-cel lists at USD 2.2 million. U.S. private insurers often leave gene therapies off formularies, and middle-income economies lack subsidy frameworks, slowing adoption.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Prevalence of Orphan and Oncology Indications Addressable by ATMPs
2. Payer Shift Toward Outcome-Based Reimbursement Pilots for One-Time Cures
3. Complex Cold-Chain Logistics and Short Shelf-Life Challenges

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

Segment Analysis

The advanced therapy medicinal products market size for CAR-T constructs is forecast to advance at a 20.01% CAGR, narrowing the lead of gene therapy, which held 44.79% in 2025. Breyanzi's 2024 approval for second-line diffuse large B-cell lymphoma improved progression-free survival by 34% compared to chemotherapy. Cell therapy options, such as Temcell, posted USD 180 million in Japanese sales, while tissue-engineered products remain a niche market because payers still debate their cost-effectiveness. Combination ATMPs blending gene editing with hypoimmune cell engineering are entering first-in-human studies. Overall, rapidly expanding CAR-T pipelines recalibrate the therapeutic mix and are poised to capture a growing share of the advanced therapy medicinal products market.

Gene therapy remains critical for treating monogenic disorders, but it contends with vector supply limitations and immunogenicity hurdles. Demand centers in Europe leverage hospital-exemption options to accelerate adoption, whereas U.S. payers insist on long-term durability data. Academic-industry coalitions such as Penn-Novartis are refining CRISPR edits to improve engraftment, signaling iterative innovation inside the advanced therapy medicinal products market.

Allogeneic constructs are projected to outpace autologous workflows with a 17.53% CAGR through 2031, challenging the incumbent 61.73% autologous share. Century Therapeutics' iPSC-CAR-NK program showed zero graft-versus-host events across 24 patients, and Sana Biotechnology's SC291 posted 78% complete responses.

Global adoption hinges on inventory-based distribution, which reduces patient wait times to 48 hours and cuts manufacturing costs by 60%. Yet shorter persistence still drives some clinicians toward autologous regimens, sustaining segments of the advanced therapy medicinal products market size. Regulatory agencies now demand 10-year monitoring of gene-edited allogeneic constructs, adding clarity to risk management.

Geography Analysis

North America retained 39.22% of 2025 revenue thanks to FDA acceleration programs and a dense network of academic CAR-T hubs. Ten U.S. ATMP approvals in 2024, including exa-cel and BEAM-101, underline regulatory momentum. Canada's harmonized standards enabled simultaneous Lyfgenia launch, while Mexico's cost-effective trial infrastructure attracted Poseida's Phase II allogeneic study. Payer fragmentation remains a hurdle as 42% of U.S. private insurers exclude gene therapies, tempering near-term growth.

Asia-Pacific is projected to lead expansion with an 18.46% CAGR. China's NMPA cleared nine domestic CAR-T brands in 2024 and contributed most of Carvykti's USD 680 million sales. India earmarked USD 120 million for ATMP development in 2025, prioritizing hemoglobinopathies, while South Korea's Invossa secured USD 42 million sales under national insurance coverage. ASEAN regulatory divergence, however, still tacks 12-18 months onto regional launches, marginally delaying the advanced therapy medicinal products market ramp-up.

Europe continues to refine outcome-based reimbursement. Germany's pooled procurement initiative locked in a 22% gene-therapy discount in 2025, and France now spreads Zolgensma payments over five years. EMA's PRIME admissions accentuate the region's clinical depth. Middle East and Africa markets remain embryonic as cold-chain gaps and high out-of-pocket expenses limit diffusion. South America's first two CAR-T approvals in Brazil signal gradual emergence, yet reimbursement lags constrain immediate volume.

1. Adaptimmune Therapeutics plc
2. Beam Therapeutics Inc.
3. Bluebird Bio
4. Bristol-Myers Squibb
5. Century Therapeutics
6. CRISPR Therapeutics AG
7. Roche
8. Gilead Sciences
9. JCR Pharmaceuticals
10. Kolon TissueGene
11. Legend Biotech Corp.
12. MeiraGTx Holdings plc
13. Novartis
14. Orchard Therapeutics plc
15. Pharmicell
16. Poseida Therapeutics
17. Sana Biotechnology Inc.
18. Sarepta Therapeutics
19. Spark Therapeutics
20. uniQure N.V.
21. Vericel

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & 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 Regulatory Fast-Track Designations & Approvals Surging Post-2024
  • 4.2.2 Escalating VC & Big-Pharma Deal Values in ATMP Pipelines
  • 4.2.3 Rising Prevalence of Orphan & Oncology Indications Addressable by ATMPs
  • 4.2.4 Payer Shift Toward Outcome-Based Reimbursement Pilots for One-Time Cures
  • 4.2.5 Decentralized GMP Micro-Facilities Enabling Point-Of-Care Cell Manufacturing
  • 4.2.6 AI-Driven Vector Engineering Compressing Pre-Clinical Cycle Times
• 4.3 Market Restraints
  • 4.3.1 High Cost & Reimbursement Uncertainty for Curative One-Off Therapies
  • 4.3.2 Complex Cold-Chain Logistics & Short Shelf-Life Challenges
  • 4.3.3 Long-Term Insertional-Oncogenesis Monitoring Liability Deterring Insurers
  • 4.3.4 Shortage of GMP-Grade Plasmids & LNP Raw Materials
• 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 Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Therapy Type
  • 5.1.1 Cell Therapy
  • 5.1.2 Gene Therapy
  • 5.1.3 CAR-T Therapy
  • 5.1.4 Tissue-Engineered Product
  • 5.1.5 Combination ATMPs
• 5.2 By Cell Source
  • 5.2.1 Autologous
  • 5.2.2 Allogeneic
• 5.3 By Vector Type
  • 5.3.1 Viral Vectors
  • 5.3.2 Non-viral Vectors
  • 5.3.3 Gene-editing
• 5.4 By Application
  • 5.4.1 Oncology
  • 5.4.2 Rare Genetic Disorders
  • 5.4.3 Cardiovascular
  • 5.4.4 Musculoskeletal & Orthopedic
  • 5.4.5 Ophthalmology
  • 5.4.6 Neurological Disorders
  • 5.4.7 Others
• 5.5 By End User
  • 5.5.1 Hospitals & Transplant Centers
  • 5.5.2 Specialty Clinics
  • 5.5.3 Academic & Research Institutes
  • 5.5.4 Contract Manufacturing Organizations
• 5.6 By Manufacturing Platform
  • 5.6.1 In-vivo Modified
  • 5.6.2 Ex-vivo Modified
  • 5.6.3 Point-of-Care Facilities
  • 5.6.4 Centralised GMP Facilities
• 5.7 By Geography
  • 5.7.1 North America
    • 5.7.1.1 United States
    • 5.7.1.2 Canada
    • 5.7.1.3 Mexico
  • 5.7.2 Europe
    • 5.7.2.1 Germany
    • 5.7.2.2 France
    • 5.7.2.3 United Kingdom
    • 5.7.2.4 Italy
    • 5.7.2.5 Spain
    • 5.7.2.6 Rest of Europe
  • 5.7.3 Asia-Pacific
    • 5.7.3.1 China
    • 5.7.3.2 Japan
    • 5.7.3.3 India
    • 5.7.3.4 South Korea
    • 5.7.3.5 Australia
    • 5.7.3.6 Rest of Asia-Pacific
  • 5.7.4 Middle East & Africa
    • 5.7.4.1 GCC
    • 5.7.4.2 South Africa
    • 5.7.4.3 Rest of Middle East & Africa
  • 5.7.5 South America
    • 5.7.5.1 Brazil
    • 5.7.5.2 Argentina
    • 5.7.5.3 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 for key companies, Products and Services, and Recent Developments)
  • 6.3.1 Adaptimmune Therapeutics plc
  • 6.3.2 Beam Therapeutics Inc.
  • 6.3.3 Bluebird Bio Inc.
  • 6.3.4 Bristol-Myers Squibb Co.
  • 6.3.5 Century Therapeutics
  • 6.3.6 CRISPR Therapeutics AG
  • 6.3.7 F. Hoffmann-La Roche Ltd
  • 6.3.8 Gilead Sciences Inc.
  • 6.3.9 JCR Pharmaceuticals Co. Ltd
  • 6.3.10 Kolon TissueGene Inc.
  • 6.3.11 Legend Biotech Corp.
  • 6.3.12 MeiraGTx Holdings plc
  • 6.3.13 Novartis AG
  • 6.3.14 Orchard Therapeutics plc
  • 6.3.15 Pharmicell Co. Ltd
  • 6.3.16 Poseida Therapeutics
  • 6.3.17 Sana Biotechnology Inc.
  • 6.3.18 Sarepta Therapeutics
  • 6.3.19 Spark Therapeutics
  • 6.3.20 uniQure N.V.
  • 6.3.21 Vericel Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment