Nuclear medicine , once considered a "niche" field, is now rapidly entering the fast lane of pharmaceutical innovation.

Novartis' Pluvicto surpassed $1 billion in sales in just three years, not only demonstrating the enormous commercial potential of radiopharmaceuticals but also igniting the R&D enthusiasm of pharmaceutical companies worldwide. In China, driven by both favorable policies and technological innovation, the radiopharmaceutical market is transitioning from a period of stagnation to full-scale explosive growth.

However, behind this seemingly prosperous track lie multiple challenges, such as target homogenization, tight supply of nuclides, and high technological barriers.

01
The rise of a multi-billion dollar industry

Amidst the global wave of pharmaceutical innovation, radiopharmaceuticals are emerging at an astonishing pace, becoming a "new blue ocean" for capital and pharmaceutical companies. In 2023, the global radiopharmaceutical market reached $10.7 billion, and is projected to climb to $22.8 billion by 2030, representing a compound annual growth rate (CAGR) of 9.1%. In China, this market is also showing robust growth, projected to increase from 5 billion yuan in 2023 to 26 billion yuan in 2030, with a CAGR of 24.8%. So, what forces are driving this explosive growth in the radiopharmaceutical market? The answer lies in the combined forces of policy, technology, and capital .

Since the beginning of the 14th Five-Year Plan period, China has introduced a series of policies to support radiopharmaceutical development, focusing on two core areas: accelerated review and approval and industry-academia-research collaboration. These policies aim to remove bottlenecks and strengthen safeguards for the industry's development. At the review and approval level, the policies establish a "clinical value-oriented" principle, prioritizing the review of urgently needed radiopharmaceuticals and establishing a long-term mechanism for research and review collaboration, significantly shortening the review cycle and accelerating the market launch of new drugs. Regarding industry-academia-research collaboration, the policies encourage universities and enterprises to jointly conduct radiopharmaceutical research and development and talent training, accelerating the transformation of scientific and technological achievements.

Technological breakthroughs are one of the core driving forces behind the development of the radiopharmaceutical market. Among numerous technological innovations, radionuclide conjugates (RDCs) are undoubtedly the most imaginative direction. RDCs consist of four main components: the radionuclide, the targeting ligand, the chelating agent, and the linker. The synergistic innovation of these components enhances the efficacy and safety of the drug, bringing revolutionary changes to radiopharmaceutical therapy. Radionuclide selection must match the treatment scenario: β-radioactive substances (such as 177Lu) are technologically mature, possess both diagnostic and therapeutic functions, and are widely used clinically; α-radioactive substances (such as 225Ac) and Auger electron radionuclides (such as 161Tb), with their advantages of "short range and high lethality," have significant potential in clearing small lesions and overcoming drug resistance, becoming research hotspots. The diversification of targeting ligands is a highlight of RDC innovation. Compared to large molecule antibodies (slow pharmacokinetics, poor penetration) and small molecule fragments (low stability), peptide drugs have fast pharmacokinetics, precise targeting, and low radiation exposure, making them a popular research area. Chelating agents and linkers are the core bridges of RDC, ensuring stable binding and precise delivery of radionuclides: the stability of chelating agents determines the safety and efficacy of drugs (e.g., DOTA is a core chelating agent for therapeutic radiopharmaceuticals), and linkers can optimize pharmacokinetic characteristics (e.g., polyethylene glycol linkers reduce renal uptake and prolong circulation time).

As the potential of the radiopharmaceutical market continues to be unleashed, capital is pouring in, injecting strong momentum into the development of the radiopharmaceutical industry. From multinational pharmaceutical companies to domestic biotech companies, all are increasing their financing and pipeline development in the radiopharmaceutical field, demonstrating strong confidence in this sector. Several representative transactions in 2025 further confirm this trend and reveal the clear strategic intentions behind capital deployment:

Pursuing Next-Generation Targets : In June 2025, BMS subsidiary RayzeBio acquired the global rights to OncoACP3, a novel radiopharmaceutical target for prostate cancer, for a total consideration of $1.35 billion. This largest radiopharmaceutical business development deal of the year highlights the determination of tech giants to invest heavily in new targets in the "post-PSMA era" to build future competitiveness.

Securing the lifeline of the supply chain : In July 2025, Grand Pharmaceutical Group acquired the exclusive distribution rights in China for the world's leading germanium-68/gallium-68 generators. This deal directly targets the stable supply of key diagnostic radionuclides, reflecting that ensuring the security of the upstream supply chain has become a core strategy for enterprises amidst the R&D boom.

Cross-industry integration and synergy : The strategic cooperation between Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd. and GE Healthcare (November 2025), and the R&D alliance between Harbour BioMed and Lannacheng (December 2025), respectively embody the integration logic of "pharmaceutical-device synergy" and "complementary technology platforms." Capital is driving the nuclear medicine industry from single drug development to the construction of an ecosystem covering imaging diagnostics, technology platforms, and even global commercialization.

These intensive trading activities clearly outline the current investment logic of capital in the radiopharmaceutical field: its focus has shifted from simple pipeline investment to strategic positioning around "next-generation technologies, key supply chains and industrial ecosystems".

On the one hand, giants are willing to bet billions of dollars on new targets such as ACP3 in order to seize future treatment standards; on the other hand, the competition for technology platforms such as gallium-68 generators, as well as the promotion of cross-border integration between pharmaceutical, imaging and R&D platforms, all indicate that building a sustainable and self-controllable industrial ecosystem is becoming a more important competitive dimension than chasing a single hot target.

02
Target Battle

In the field of radiopharmaceutical development, target selection and development are undoubtedly key competitive focuses. Currently, global research and development of therapeutic radiopharmaceuticals is highly concentrated, with prostate-specific membrane antigen (PSMA) dominating the field of prostate cancer treatment. PSMA is overexpressed in almost all prostate cancer cells, making it a highly attractive target. Novartis' Pluvicto is a successful example of a PSMA-targeted drug; since its approval in 2022, its sales have soared, exceeding $1 billion in 2023, demonstrating the enormous potential of the PSMA target in prostate cancer treatment.

However, an overemphasis on PSMA targets has also exposed the risk of "involution" within the industry. As more and more companies enter this field, competition intensifies, and the problem of R&D homogenization becomes increasingly prominent. Once the market becomes saturated, companies will face immense competitive pressure, and the commercialization prospects of their products will be affected. Therefore, expanding into new targets and indications has become crucial to overcoming this "involution" in the field of radiopharmaceutical R&D.

In the journey of expanding targets and indications, vertical extension of mature targets is one of the important strategies. Novartis' Lutathera, for example, targets somatostatin receptor 2 (SSTR2) and was initially approved for the treatment of progressive somatostatin receptor-positive gastrointestinal pancreatic neuroendocrine tumors (GEP-NETs). Thanks to its excellent efficacy, Lutathera has achieved remarkable success in the market, with sales reaching $605 million in 2023.

To further explore the potential of the SSTR2 target, Novartis is actively conducting clinical trials to explore the application of Lutathera in other indications. Currently, a Phase II clinical trial for pheochromocytoma/paraganglioma is underway, which is expected to expand the indication from GEP-NETs to other SSTR-positive tumors.

In addition to vertical expansion of mature targets, horizontal exploration of emerging targets is also an important direction for radiopharmaceutical research and development. Some emerging targets, such as fibroblast activating protein (FAP), gastrin-releasing peptide receptor (GRPR), and Delta-like ligand 3 (DLL3), have become new hot spots for companies to focus on due to their high expression characteristics in various solid tumors.

FAP is highly overexpressed in tumor-associated fibroblasts of epithelial tumors (such as lung cancer, breast cancer, and pancreatic cancer), exhibiting strong specificity. Novartis' lutetium [177Lu]-FAP-2286 has made rapid progress in development and has shown positive clinical results in indications such as gastrointestinal tumors and advanced lung cancer. In a clinical trial for patients with gastrointestinal tumors, the proportion of patients treated with lutetium [177Lu]-FAP-2286 significantly increased, with good safety, bringing new hope to the treatment of gastrointestinal tumors.

DLL3 has a positive rate of 60%-80% in small cell lung cancer, and its radiopharmaceutical development is showing diversified technological approaches. For example, ETN029 uses a humanized monoclonal antibody conjugated with In, combining high affinity with highly efficient alpha particle killing; MP0712 is developed based on the DARPins platform, labeled with 212Pb, with a small molecular weight and strong tissue penetration. Exploring these different technological approaches provides more possibilities for the development of DLL3-targeted radiopharmaceuticals, helping to find the most suitable treatment regimen.

Amid the global surge in radiopharmaceutical R&D, Chinese companies have demonstrated strong capabilities and unique strategic deployments. Data shows that as of November 15, 2025, China will account for nearly half of all new RDC pipeline additions globally , demonstrating the active participation and strong competitiveness of Chinese companies in the field of radiopharmaceutical R&D.

03
Nuclide Dilemma and Supply Chain Autonomy

As a core element of radiopharmaceuticals, the stable supply and technological innovation of radionuclides are crucial for the development of the radiopharmaceutical industry. However, China's radiopharmaceutical industry currently faces numerous challenges in radionuclide supply, such as tight production capacity of 177Lu and reliance on imports for emerging radionuclides like 225Ac and 212Pb , which severely restrict the industry's development. Breaking through this radionuclide predicament and achieving supply chain self-sufficiency has become a critical issue that urgently needs to be addressed by China's radiopharmaceutical industry.

While the mainstream therapeutic radionuclide 177Lu is technologically mature, its production capacity is tightening due to market expansion. Its reactor-dependent production process is complex and yields are limited. Supply stability is insufficient, constrained by equipment operation and production planning, which has already affected the production and market launch schedule of related radiopharmaceuticals. Emerging radionuclides such as 225Ac and 212Pb are attracting research attention due to their therapeutic advantages, but domestic supply is almost entirely dependent on imports.

In radiopharmaceutical therapy, different types of radionuclides, such as beta-nuclides, alpha-nuclides, and Auger electron-emitting radionuclides, exhibit their respective advantages in treating large tumors and micrometastases due to their different radiation characteristics and mechanisms of action, leading to competition and selection of technical approaches. Beta-nuclides (such as 177Lu) have moderate range, mature technology, stable supply, and diagnostic and therapeutic functions, making them the mainstream radionuclides in clinical practice. They are suitable for treating large tumors, but their efficacy against micrometastases is limited, and they are prone to damaging surrounding normal tissues. Alpha-nuclides (such as 225Ac) and Auger electron-emitting radionuclides (such as 161Tb) have the advantages of "short range and high lethality," precisely eliminating micro-lesions and showing significant effects in overcoming drug resistance. However, their production is difficult and their supply is unstable, limiting their widespread clinical application.

Therefore, when selecting a radionuclide technology approach, it is necessary to comprehensively consider factors such as tumor type, size, metastasis, and the stability and safety of the radionuclide supply to achieve the best therapeutic effect. For large tumors, β-radicals can be given priority; for micrometastases, α-radicals or Auger electron radicals can be selected. Some studies are also exploring the combined application of different radionuclides to leverage their respective advantages and improve therapeutic efficacy.

To break the radionuclide impasse and achieve supply chain self-sufficiency, domestic enterprises and research institutions are making efforts across the entire chain, from radioactive isotope production to drug preparation, and are enhancing their core competitiveness through three major paths: cooperation, independent research and development, and international competition and cooperation.

On the isotope production side, enterprises are collaborating with research institutions to tackle key challenges: the China Academy of Engineering Physics (CAEP) has partnered with enterprises to break through 177Lu production technology and increase production capacity; Hangzhou Yao Accelerator is focusing on electron accelerator technology to promote the large-scale preparation of radionuclides such as Ac-225, alleviating supply bottlenecks. On the drug development side, enterprises are increasing their investment in independent research and development. Leading company Dongcheng Pharmaceutical has seen its R&D investment increase by more than 25% annually over the past three years, building platforms for single-domain antibodies and radionuclide conjugation, with multiple 177Lu/RDC pipelines entering late-stage clinical trials, facilitating the commercialization of innovative products. In terms of international competition and cooperation, domestic enterprises are expanding their development paths and enhancing their international influence through collaborative development of radiopharmaceuticals, the introduction of advanced technologies, and participation in international exchanges to showcase their achievements.

04
Conclusion

The meteoric rise of radiopharmaceuticals is no accident, but rather an inevitable evolution in pharmaceutical innovation from molecular targeting to precision radiotherapy. China, with nearly half of the world's new RDC pipeline additions, demonstrates remarkable R&D vitality, but still faces severe challenges in radionuclide supply, target originality, and clinical translation efficiency. In the future, only by adhering to a three-dimensional breakthrough of "target innovation + radionuclide self-sufficiency + in-depth clinical practice" can China truly transform from a follower to a rule-maker in this global radiopharmaceutical race. The story of radiopharmaceuticals has only just begun.

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