방사성 의약품 CDMO 및 CMO 서비스 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the radiopharmaceutical cDMO/CMO services market size is expected to grow from USD 3.48 billion in 2025 to USD 3.75 billion in 2026 and is forecast to reach USD 5.82 billion by 2031 at 9.19% CAGR over 2026-2031.

This report is Segmented by Service (Isotope Production & Supply, Process Development & Radiolabeling/Conjugation, and More), Modality (Diagnostic, Therapeutic), Radioisotope (F-18, Ga-68, Tc-99m, and More), Scale of Operation (Preclinical, Clinical, Commercial), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Radiopharmaceutical CDMO/CMO Services Market Trends and Insights

RLT Approvals and Scaling Raise Outsourced GMP Demand

Commercial-stage lutetium-177 therapies have moved batch volumes from grams to kilograms, tightening GMP slots at dual-licensed plants. Sponsors now reserve capacity two years ahead, as shown by Eckert & Ziegler's March 2025 deal with Actinium Pharmaceuticals for actinium-225 supply . Alpha-emitter containment adds extra hot-cell construction and radioprotection layers, driving earlier outsourcing of process development. The shift from PET imaging tracers to therapeutic payloads means CDMOs must re-validate purification, stability, and QC methods under cGMP before scale-up. Limited radiochemistry talent compounds the squeeze, reinforcing premium pricing for integrated offerings.

Regionalization (NA Leadership, APAC Build-Out) Increases Outsourcing

North America commands mature regulatory pathways and proximate isotope suppliers, yet the Asia-Pacific is building cyclotrons that lower delivered isotope cost. GE HealthCare's 100% acquisition of Nihon Medi-Physics in April 2025 turns Japan into a theranostics hub that can serve the wider region from 13 plants. China's domestic F-18 and Ga-68 output trims import reliance and attracts cost-sensitive clinical trials. India and Australia stand out as secondary nodes, leveraging pharmaceutical scale-up know-how and access to ANSTO's reactor-based lutetium-177. Local plants cut transport time for short-lived isotopes and reduce decay-driven yield losses.

Scarcity and Price Volatility of Key Isotopes (Lu-177, Ac-225, Ga-68)

Clinical-grade actinium-225 still depends on limited thorium-229 generators. Actinium Pharmaceuticals claims its cyclotron method will deliver 10-20 times cheaper isotope at 99.8% purity, yet commercial scale is pending. Reactor outages spike lutetium-177 prices, while Ga-68 generator bottlenecks restrict PSMA PET imaging. APAC shortages are sharper because cyclotron density trails Western levels. CDMOs respond with multi-year offtake contracts that secure volumes but hamper flexibility for ad-hoc studies.

Other drivers and restraints analyzed in the detailed report include:

1. Lu-177 and Emerging Ac-225 Supply Investments Unlock New Programs
2. Specialist CDMOs Expand Capacity and Sites
3. Dual GMP and Nuclear Transport/Licensing Burden Slows Tech Transfer

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

Segment Analysis

Process Development & Radiolabeling/Conjugation services are rising at a 10.40% CAGR to 2031 as sponsors front-load chemistry risk mitigation. ABX's six development hot cells highlight the depth of capability needed to perfect labeling and purification across isotopes . Meanwhile, GMP Drug Substance & Drug Product Manufacturing still captured 47.24% of 2025 revenue, reflecting mature diagnostic output and commercial lutetium-177 runs. The Radiopharmaceutical CDMO/CMO Services Market size for isotope production continues to expand as companies like Cardinal Health shift from commodity sales to long-term actinium-225 partnerships. Other bundled services, such as regulatory CMC and cold-chain logistics, remain niche but gain value as developers seek one-stop solutions.

Sponsors gravitate to CDMOs that can bridge preclinical and GMP chemistry without re-validation. Perceptive has supported more than 80 IND packages by integrating precursor synthesis, analytical methods, and documentation. High-volume F-18 FDG batches carry lower margins, so CDMOs use these runs to feed cash flow while investing profits in therapeutic infrastructure. Those without development expertise risk relegation to price-driven commodity roles within the Radiopharmaceutical CDMO/CMO Services Market.

Diagnostic agents retained 58.36% of 2025 revenue, yet therapeutic pipelines are advancing at a 9.76% CAGR to 2031. Therapeutic batches command premium pricing due to isotope scarcity and stringent containment. Eckert & Ziegler's deal with Actinium Pharmaceuticals underpins pivotal alpha-emitter trials, exemplifying how CDMOs leverage isotope access for differentiation. Diagnostic F-18 FDG margins compress as cyclotron capacity spreads across APAC, eroding Western suppliers' pricing power.

Therapeutics carry longer timelines but promise blockbuster revenue on approval, attracting big-ticket mergers like GE HealthCare's full purchase of Nihon Medi-Physics. Modality divergence is driving geographic specialization: North America and Europe focus on alpha- and beta-therapeutic expertise, while APAC scales high-volume diagnostic plants to serve burgeoning PET demand.

Geography Analysis

North America commanded 47.35% of 2025 revenue due to FDA clarity and proximity to isotope suppliers such as NorthStar and Cardinal Health. The Radiopharmaceutical CDMO/CMO Services Market size in Asia-Pacific is catching up, expanding at a 9.60% CAGR through 2031 on the back of China's cyclotron rollout and Japan's theranostics pivot after GE HealthCare's buyout of Nihon Medi-Physics. India leverages low-cost manufacturing and English-language filings, though isotope access remains a hurdle. Australia benefits from ANSTO's reactor-based lutetium-177 supply, drawing South-East Asian clinical trials that need predictable isotope deliveries.

Europe's strong nuclear research base, exemplified by SCK CEN in Belgium, supports capacity ramps such as SpectronRx's actinium-225 plant operationalized in Q1 2025 . EMA harmonization eases pan-EU distribution, yet transport logistics remain complex for high-specific-activity isotopes. Middle East & Africa and South America are small today but may grow as GCC healthcare investments and Brazil's pharma sector push for local PET and therapy supply to cut import costs.

The Radiopharmaceutical CDMO/CMO Services Market therefore operates on a hub-and-spoke model: process development concentrates in North America and Europe, while GMP manufacturing spreads to regional nodes that minimize decay loss during transport.

1. ABX advanced biochemical compounds
2. AtomVie Global Radiopharma
3. Cardinal Health Nuclear & Precision Health Solutions
4. Curium Pharma
5. Cyclotek
6. Eckert & Ziegler Radiopharma
7. Evergreen Theragnostics
8. Isotopia Molecular Imaging
9. ITM Isotope Technologies Munich
10. Jubilant Radiopharma
11. Minerva Imaging
12. Monrol
13. Nihon Medi-Physics
14. NorthStar Medical Radioisotopes
15. Nucleus RadioPharma
16. PharmaLogic
17. Siemens Healthineers PETNET Solutions
18. SOFIE
19. SpectronRx

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 RLT Approvals and Scaling Raise Outsourced GMP Demand
  • 4.2.2 Regionalization (NA Leadership, APAC Build-Out) Increases Outsourcing
  • 4.2.3 Lu-177 And Emerging Ac-225 Supply Investments Unlock New Programs
  • 4.2.4 Specialist CDMOS Expand Capacity and Sites
  • 4.2.5 Decentralized Multi-Site Networks to Beat Half-Life Logistics
  • 4.2.6 Alpha-Emitters CDMO Playbooks (Containment/Generator Partnerships)
• 4.3 Market Restraints
  • 4.3.1 Scarcity And Price Volatility of Key Isotopes (Lu-177, Ac-225, Ga-68)
  • 4.3.2 Dual GMP And Nuclear Transport/Licensing Burden Slows Tech Transfer
  • 4.3.3 Talent Gaps in Radiochemistry, HP, And QA/QP
  • 4.3.4 Radioactive Waste Handling and Site Licensing Bottlenecks
• 4.4 Value Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 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 & Growth Forecasts (Value, USD)

• 5.1 By Service
  • 5.1.1 Isotope Production & Supply
  • 5.1.2 Process Development & Radiolabeling/Conjugation
  • 5.1.3 GMP Drug Substance & Drug Product Manufacturing
  • 5.1.4 Others
• 5.2 By Modality
  • 5.2.1 Diagnostic
  • 5.2.2 Therapeutic
• 5.3 By Radioisotope
  • 5.3.1 F-18
  • 5.3.2 Ga-68
  • 5.3.3 Tc-99m
  • 5.3.4 Zr-89
  • 5.3.5 I-131
  • 5.3.6 Lu-177
  • 5.3.7 Others
• 5.4 By Scale of Operation
  • 5.4.1 Preclinical
  • 5.4.2 Clinica
  • 5.4.3 Commercial
• 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 Strategic Moves
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.4.1 ABX advanced biochemical compounds
  • 6.4.2 AtomVie Global Radiopharma
  • 6.4.3 Cardinal Health Nuclear & Precision Health Solutions
  • 6.4.4 Curium
  • 6.4.5 Cyclotek
  • 6.4.6 Eckert & Ziegler Radiopharma
  • 6.4.7 Evergreen Theragnostics
  • 6.4.8 Isotopia Molecular Imaging
  • 6.4.9 ITM Isotope Technologies Munich
  • 6.4.10 Jubilant Radiopharma
  • 6.4.11 Minerva Imaging
  • 6.4.12 Monrol
  • 6.4.13 Nihon Medi-Physics
  • 6.4.14 NorthStar Medical Radioisotopes
  • 6.4.15 Nucleus RadioPharma
  • 6.4.16 PharmaLogic
  • 6.4.17 Siemens Healthineers PETNET Solutions
  • 6.4.18 SOFIE
  • 6.4.19 SpectronRx

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment