Global Radiopharmaceutical CDMO/CMO Services Market Report 2026-2031 | Therapeutic Approvals are Driving Outsourced GMP, Radiolabeling and Isotope Supply
Dublin, Aug. 20, 2026 (GLOBE NEWSWIRE) -- The "Radiopharmaceutical CDMO/CMO Services - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.
The global radiopharmaceutical CDMO/CMO services market is projected to grow from USD 3.48 billion in 2025 to USD 3.75 billion in 2026 before reaching USD 5.82 billion by 2031. The market is forecast to expand at a compound annual growth rate of 9.19% from 2026 to 2031, supported by rising demand for radioligand therapies, increased isotope production investments and the expansion of regional manufacturing capacity.
Radioligand Therapy Approvals Drive Outsourced GMP Manufacturing
Commercial approvals of lutetium-177 therapies are increasing demand for outsourced Good Manufacturing Practice production. Higher batch volumes are tightening available capacity at facilities licensed to manage both pharmaceutical manufacturing and radioactive materials. As a result, sponsors are reserving production slots further in advance and entering long-term isotope supply agreements.
Eckert & Ziegler's March 2025 agreement with Actinium Pharmaceuticals for actinium-225 supply reflects the growing importance of reliable isotope access. Alpha-emitter manufacturing requires specialized containment, hot-cell infrastructure and radioprotection systems, prompting developers to outsource process development earlier. The transition from PET imaging tracers to therapeutic radiopharmaceuticals also requires CDMOs to validate purification, stability and quality-control methods before commercial scale-up.
A limited pool of experienced radiochemistry professionals is adding to capacity constraints. This shortage is strengthening demand for integrated radiopharmaceutical CDMO services that combine isotope sourcing, process development, radiolabeling, analytical testing, regulatory support and commercial manufacturing.
Isotope Availability Remains a Critical Market Constraint
Supply limitations and price volatility for lutetium-177, actinium-225 and gallium-68 continue to affect radiopharmaceutical development. Clinical-grade actinium-225 remains dependent on a limited number of thorium-229 generators, while reactor outages can disrupt lutetium-177 availability and increase prices. Gallium-68 generator bottlenecks may also restrict access to prostate-specific membrane antigen PET imaging.
CDMOs and isotope suppliers are responding through capacity investments, alternative production methods and multi-year offtake agreements. These arrangements improve supply security for clinical and commercial programs, although they can reduce flexibility for short-notice studies. Continued investment in lutetium-177 and actinium-225 production is expected to unlock additional therapeutic pipelines during the forecast period.
Process Development and Therapeutic Services Outpace the Broader Market
Process development and radiolabeling or conjugation services are forecast to expand at a 10.40% CAGR through 2031 as sponsors address chemistry and manufacturing risks earlier in development. Specialized facilities, including ABX's six development hot cells, demonstrate the technical infrastructure required to optimize labeling and purification processes across multiple radioisotopes.
GMP drug substance and drug product manufacturing accounted for 47.24% of market revenue in 2025, supported by established diagnostic production and commercial lutetium-177 programs. Demand is also increasing for bundled regulatory chemistry, manufacturing and controls support, precursor synthesis, analytical method development and cold-chain logistics.
Diagnostic radiopharmaceuticals retained 58.36% of market revenue in 2025. However, therapeutic applications are projected to grow at a 9.76% CAGR through 2031. Therapeutic batches attract premium pricing because of isotope scarcity, complex containment requirements and stringent manufacturing controls. By comparison, margins for high-volume F-18 FDG production are facing pressure as cyclotron capacity expands, particularly across Asia-Pacific.
North America Leads as Asia-Pacific Expands Regional Capacity
North America generated 47.35% of global radiopharmaceutical CDMO/CMO services market revenue in 2025. The region benefits from established regulatory pathways, advanced therapeutic development capabilities and proximity to isotope suppliers such as NorthStar Medical Radioisotopes and Cardinal Health.
Asia-Pacific is forecast to record a 9.60% CAGR through 2031, driven by China's cyclotron expansion and Japan's growing theranostics capabilities. GE HealthCare's acquisition of Nihon Medi-Physics in April 2025 strengthened Japan's position as a regional radiopharmaceutical manufacturing hub with a network of 13 plants. China's increasing domestic production of F-18 and Ga-68 is also reducing import dependence and supporting cost-sensitive clinical trials.
India is leveraging its pharmaceutical manufacturing expertise, while Australia benefits from access to reactor-produced lutetium-177 through ANSTO. Europe remains an important center for nuclear research and advanced radioisotope production, supported by organizations such as Belgium's SCK CEN and new actinium-225 capacity, including SpectronRx's facility launched in the first quarter of 2025.
The radiopharmaceutical CDMO/CMO services market is increasingly adopting a regional hub-and-spoke manufacturing model. Process development remains concentrated in North America and Europe, while GMP production is expanding closer to patients and clinical sites. This regionalization reduces transportation times, limits radioactive decay losses and improves the reliability of diagnostic and therapeutic radiopharmaceutical supply chains.
Key Topics Covered
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
For more information about this report visit https://www.researchandmarkets.com/r/uke8dt
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