Radiopharmaceutical CDMO Market Explained

Radiopharmaceuticals, a class of drugs that contain radioactive isotopes, are revolutionising the landscape of nuclear medicine, offering unprecedented opportunities for both diagnostic imaging and therapeutic applications.

These sophisticated compounds are at the forefront of medical innovation, providing clinicians with powerful tools to visualise, diagnose, and treat a wide array of medical conditions with remarkable precision.

The radiopharmaceutical contract manufacturing market is poised for substantial growth, reflecting the increasing demand for these cutting-edge medical solutions. According to the latest research by InsightAce Analytic, the market is projected to reach $5.44 Billion USD by 2031, growing from USD 2.75 billion in 2023 (source). This represents a robust compound annual growth rate (CAGR) of 9.0% during the forecast period of 2024-2031, underscoring the sector’s significant potential and the growing recognition of radiopharmaceuticals’ value in modern healthcare.

Notable CDMOs specialising in radiopharmaceuticals include:

• Almac
• Cardinal Health
• Eckert & Ziegler
• Evergreen Theragnostics, Inc.
• GBI Biomanufacturing
• Global Medical Solutions
• IONETIX Corporation
• ITM Isotope Technologies Munich SE
• Medi-Radiopharma
• Minerva Imaging
• Monrol
• NorthStar Medical Radioisotopes
• Nucleus RadioPharma
• PharmaLogic
• RadioMedix
• Seibersdorf Labor GmbH
• SOFIE
• SpectronRx
• DuChemBio

Download the hi-resolution Radiopharma CDMO Landscape infographic here:

Key factors driving the impressive growth of radiopharmaceuticals manufacturing include:

Growing Demand for Targeted Therapies: The shift towards personalised medicine has heightened interest in targeted therapies, where radiopharmaceuticals excel. In a similar way to ADCs, radiopharmaceuticals can deliver localised treatment with minimal systemic effects makes them particularly attractive for complex conditions like metastatic cancers.

Rising Prevalence of Chronic Diseases The global increase in chronic ailments, particularly cancer, cardiovascular disorders, and neurological conditions, has intensified the need for advanced diagnostic and therapeutic options. Radiopharmaceuticals offer unique capabilities in these areas, fuelling demand for their development and production.

Technological Advancements: Continuous innovations in radioisotope production, drug delivery systems, and imaging technologies are expanding the applications of radiopharmaceuticals and improving their efficacy. These advancements are opening new avenues for treatment and diagnosis, further stimulating market growth.

Expanding Research and Development: Increased investment in R&D by pharmaceutical companies and research institutions is the field is accelerating the development of novel radiopharmaceuticals, broadening the pipeline of potential products and applications.

The intricate nature of radiopharmaceutical manufacturing, coupled with stringent regulatory requirements, has led to a surge in demand for specialised contract development and manufacturing organisations (CDMOs). These entities play a crucial role in the radiopharmaceutical value chain, offering expertise in producing active pharmaceutical ingredients (APIs), ensuring regulatory compliance, and providing comprehensive services from drug development to commercial-scale production.

“Personalized healthcare is a major trend in modern medicine, and nuclear medicine is crucial to this advancement.” says Kathy Spencer-Pike, Chief Commercial Officer, Nucleus RadioPharma.

” Radiopharmaceuticals like 177Lu-PSMA-617 have shown considerable promise in treating advanced prostate cancer. Ongoing research and development are expanding the potential for personalized treatments for various diseases, including breast cancer and neurological disorders. This progress is driving growth in the radiopharmaceutical market, with projections indicating substantial increases as biotech and pharma continue to invest in innovative treatments.

The future of nuclear medicine and molecular imaging is full of promise. Continued advancements in radiopharmaceuticals, such as research into promising radionuclides like actinium-225 and lead-212, are set to transform cancer treatment and broaden the scope of conditions that can be effectively treated.

Unlike traditional pharmaceuticals, radiopharmaceutical therapies must contend with the same stringent quality standards coupled with accelerated timelines, lack of inventory, complex logistics, and capacity constraints. For those companies seeking a CDMO partner, it’s critical that they choose a partner that is committed to and can demonstrate the highest of quality and safety standards, deep expertise in radiopharmaceuticals, strong supply agreements and of course, a logistics platform that is ensures patients get the right doses at the right time.”

Radiopharmaceuticals definition 

Radiopharmaceuticals are a unique class of pharmaceutical drugs that contain radioactive isotopes, also known as radionuclides. These sophisticated compounds are designed to harness the power of radioactivity for medical purposes, primarily in the fields of nuclear medicine and molecular imaging. The fundamental principle behind radiopharmaceuticals lies in their ability to emit detectable radiation, which can be leveraged for both diagnostic and therapeutic applications.

At their core, radiopharmaceuticals consist of two main components:

1. Radioactive isotope: This is the radio nuclidethat emits radiation.
2. A targeting molecule: This is typically a biologically active carrier molecule that determines where the radiopharmaceutical will localise in the body.

When linked, these components allows radiopharmaceuticals to target specific organs, tissues, or cellular processes with remarkable precision.

How Radiopharmaceuticals Work

The functioning of radiopharmaceuticals relies on the physical properties of radioactive decay and the biological behaviour of the carrier molecule:

For diagnostic purposes: Radiopharmaceuticals emit gamma rays or positrons that can be detected by specialised imaging equipment such as gamma cameras, SPECT (Single Photon Emission Computed Tomography), or PET (Positron Emission Tomography) scanners. As the radiopharmaceutical accumulates in specific areas of the body, it provides detailed images of organ function, blood flow, or metabolic processes.

For therapeutic applications: Radiopharmaceuticals leveraging beta or alpha emitters deliver localised radiation therapy to targeted cells or tissues. The radiation energy destroys or damages the target cells, making this approach particularly effective for treating cancers.

Applications in Nuclear Medicine

Radiopharmaceuticals have found a wide array of applications in modern medicine, revolutionising both diagnostic and therapeutic approaches:

1. Diagnostic Applications:
   • Oncology: Detection and staging of various cancers
   • Cardiology: Assessment of heart function and blood flow
   • Neurology: Evaluation of brain function and detection of neurological disorders
   • Endocrinology: Imaging of thyroid and other endocrine glands
   • Infection and inflammation: Localisation of infection sites
2. Therapeutic Applications:
   • Cancer treatment: Targeted radiation therapy for various types of cancer, including thyroid cancer, neuroendocrine tumours, and metastatic prostate cancer
   • Pain management: Palliation of bone pain in metastatic cancer
   • Theranostics: Combined diagnostic imaging and therapy, allowing for personalised treatment planning and monitoring

Recent Developments

The field of radiopharmaceuticals has seen significant advancements in recent years, with several notable products making their mark in the market:

1. Key Products:
   • Lutathera (lutetium-177 oxodotreotide): Approved by the FDA in 2018 for neuroendocrine tumours
   • Pluvicto (lutetium-177 vipivotide tetraxetan): Approved in 2022 for metastatic prostate cancer
   • Xofigo (radium-223 dichloride): Used for treating bone metastases in prostate cancer
2. Recent Launches and Pipeline Drugs:
   • Actinium-225 based therapies: Several companies, including RayzeBio and Fusion Pharma, are developing therapies using this alpha-emitting radioisotope
   • Copper-64 and Copper-67 agents: Clarity Pharmaceuticals is advancing therapies for prostate cancer, breast cancer, and neuroblastoma using these isotopes
3. Significant M&A Activities and Deals:
   • Bristol Myers Squibb’s acquisition of RayzeBio for $4.1 billion in December 2023, gaining access to RayzeBio’s Actinium-225 based radiopharmaceutical platform
   • Eli Lilly’s $1.4 billion acquisition of Point Biopharma in December 2023, strengthening its position in the radiopharmaceutical market
   • Novartis’s strategic moves, including the acquisitions of Advanced Accelerator Applications and Endocyte, cementing its leadership in the radiopharmaceutical space

As research continues and new technologies emerge, the landscape of radiopharmaceuticals is expected to evolve rapidly.

Radiopharmaceuticals Manufacturing Challenges

Despite the positive growth outlook, the radiopharmaceutical contract manufacturing market faces several significant challenges to be navigated. These include:

Capacity Limitations 

The production of radiopharmaceuticals requires specialised facilities and equipment, which are currently in limited supply. This shortage of manufacturing capacity can lead to production bottlenecks and supply chain issues.

Regulatory Hurdles 

The radiopharmaceutical industry is subject to stringent regulations due to the use of radioactive materials. Navigating the complex regulatory landscape across different regions can be challenging and time-consuming for manufacturers.

Skilled Workforce Shortage 

The production of radiopharmaceuticals requires highly specialised expertise. There is a global shortage of skilled professionals with the necessary training in radiochemistry, nuclear pharmacy, and related fields.

Supply Chain Complexities

The short half-life of many radiopharmaceuticals necessitates rapid production and distribution, creating logistical challenges. Ensuring a reliable supply chain while maintaining product quality is a significant challenge for the industry.

High Costs 

The development and production of radiopharmaceuticals involve substantial costs, from specialised infrastructure to expensive raw materials. This can limit market access and adoption, particularly in developing economies.

Guide to Selecting the Right Radiopharmaceutical CDMO

Choosing the right Contract Development and Manufacturing partner is crucial for success. Here are some areas to consider when evaluating potential CDMOs:

Manufacturing Capability and Facility Design

Assess their understanding of the radiopharmaceutical market and their track record in successfully manufacturing and launching new products.

Review the list of drugs they currently manufacture to ensure they have experience with products similar to yours. Evaluate the quality of their technology transfer group, which is responsible for translating your drug innovations into actionable production activities. 

It’s crucial that this transfer occurs at the facility where your drug will be manufactured. Additionally, consider whether the CDMO can help design manufacturing facilities with distribution in mind, incorporating best practices learned from other operations.

Distribution Network and Shipping Expertise

A robust distribution network is essential for radiopharmaceuticals due to their short half-life. Look for a CDMO with a nationwide nuclear pharmacy network that has a strong local presence. This can help ensure efficient delivery and reduce transportation costs. 

Assess the CDMO’s shipping expertise, particularly their compliance with regulations such asInternational Air Transport Association (IATA) for handling hazardous materials. A CDMO with extensive shipping experience can significantly improve your product’s distribution efficiency.

Product Utilisation and Supply Chain Management

Efficient product utilisation is critical in radiopharmaceutical manufacturing to minimise waste due to decay. Evaluate the CDMO’s strategy for optimising product use, including their approach to centralised versus local nuclear pharmacies. Consider their ability to handle cancellations and returns efficiently. Look for CDMOs with “track and trace” capabilities that provide visibility throughout the supply chain, from manufacturing to the point of care. This level of oversight can help in identifying and resolving issues quickly.

Regulatory Expertise and Quality Systems

A CDMO with strong regulatory expertise can be invaluable in navigating the complex landscape of radiopharmaceutical regulations. Assess their experience with regulatory affairs and their relationships with bodies like the Nuclear Regulatory Commission (NRC), FDA, and state boards of pharmacy. Consider their ability to assist with regulatory strategy, filings, and post-marketing commitments. Additionally, evaluate their quality systems and their ability to integrate with or help develop your own quality processes. Ensure they can operate in both clinical and commercial modes under tailored systems.

Reporting Capabilities and Communication

Effective reporting and communication are essential for maintaining oversight of your product’s manufacturing and distribution. Determine if the CDMO can provide both standard and customized reports that meet your specific needs. Look for a CDMO that offers a single point of contact for various aspects such as billing, training, and operational queries. Assess the accessibility and openness of their communication channels, as this will be crucial for maintaining visibility across the entire supply chain and quickly resolving any issues that arise.

Consulting Resources and Commercialization Support

A valuable CDMO should offer more than just manufacturing services. Look for a partner that can provide support from clinical trials through to commercialization. This might include health physics consultants to ensure customer readiness, assistance with designing hot labs for handling radiopharmaceuticals at customer sites, and expertise in market dynamics. Evaluate their ability to uncover clinician insights and create compelling messaging to differentiate your product in the marketplace.

Clinical Trial Support and Scale-up Capabilities

Consider the CDMO’s ability to support your product from early-stage clinical trials through to commercial production. Look for a partner that thinks about commercialization from day one, optimizing technology and processes to meet potential commercial demand. Evaluate their experience in scaling up production while maintaining quality and consistency. A CDMO with this forward-thinking approach can help streamline your path to market.

Additional Services and Flexibility

Finally, consider any additional services the CDMO offers that could add value to your operation. This might include support for ordering and billing capabilities, assistance with educating healthcare providers about your product, or flexibility in adapting to changing market demands.

 A CDMO that can offer a comprehensive suite of services beyond just manufacturing can be a true strategic partner for the long-term success of your radiopharmaceutical products.