Radiotheranostics Market Size, Share & COVID-19 Impact Analysis, By Radioisotopes (Lutetium-177, Radium-223, Iodine-131, and Others), By Application (Neuroendocrine Tumors, Prostate Cancer, and Others), By End-user (Hospitals & Clinics, Diagnostic Centers, and Others), and Regional Forecast, 2023-2030

The global radiotheranostics market size was USD 1.80 billion in 2022 and is projected to grow from USD 2.01 billion in 2023 to USD 6.61 billion by 2030, exhibiting a CAGR of 18.5% during the forecast period.

Radiotheranostics is a combination of diagnostic and therapeutic radiopharmaceuticals that can be used to diagnose and treat diseases, especially cancer. It is emerging rapidly with the development of new radiopharmaceuticals, advancements in imaging techniques, and widespread application of existing products. In addition, rising approvals of novel radiotheranostic agents and increased public-private funding for R&D activities are further accelerating market growth.

• For instance, in March 2022, Novartis AG announced that the U.S. FDA (Food and Drug Administration) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of prostate cancer.

However, higher treatment costs and the short half-life of radioisotopes are factors likely to limit market growth. Nevertheless, pharmaceutical companies are focused on developing newer radiotheranostics with longer half-life and better treatment outcomes, which is likely to create growth opportunities for the market.

COVID-19 IMPACT

COVID-19 Pandemic Hampered Market Revenue Due to Decline in Imaging Procedures

The outbreak of COVID-19 had a negative impact on the global market. The issues, such as the risk of COVID-19 transmission, lack of workforce and staff, and the drop in diagnostic procedures such as PET-CT SPECT, hampered market expansion in 2020. Furthermore, the decline in the procedures was mainly attributed to the logistical challenges, disruptions of supply chains, and the adoption of safety precautions, which were not easy to maintain in the centers. Moreover, partial and complete lockdowns in most countries restricted the air transportation of radiopharmaceuticals, which were the key bottlenecks to the product distribution to hospitals. In addition, Bayer AG reported a decline in the sales of Xofigo in 2020, which was majorly impacted due to disruptions in the supply chain.

However, in 2021, the market recorded significant growth owing to the ease of regulations enforced by the governments of various countries. In 2022, the market witnessed a rapid growth in this revenue due to new product launches. For instance, in April 2022, Telix announced the launch of Illuccix, also known as 68Ga-PSMA-11 injection, in the U.S. to treat prostate cancer.

Radiotheranostics Market Trends

Increasing Collaborations Among Key Players to Enhance Patient Care in Theranostics

Major players in the market are focused on collaborations to establish best clinical practices in theranostics to enhance patient care.

• For instance, in September 2023, GE HealthCare and Mayo Foundation for Medical Education and Research (MFMER) entered a strategic collaboration to advance innovation in medical imaging and theranostics. The collaboration aimed to develop advanced practices of radiology and care for patients worldwide.


• In addition, in March 2023, Perspective Therapeutics and PharmaLogic announced a collaboration for the development and production of theranostics for cancer care.

Furthermore, the collaborations are mainly driven by the growing demand for theranostics infrastructure and best practices following the approval of new theranostics drugs and therapies by the U.S. Food and Drug Administration (FDA) and Health Canada. Moreover, collaborations enhance product development and bring innovations, ultimately accelerating the research & development activities toward patient care, offering more significant opportunities for improved patient care.

Radiotheranostics Market Growth Factors

Rising Prevalence of Cancers to Drive Market Growth

The exponential growth of the global radiotheranostics industry is driven by the increasing prevalence of cancer. The technology plays a significant role in the fight against cancer. It offers personalized medicine by using paired diagnostic and therapeutic radionuclide probes. These probes enable selective and targeted detection and the treatment of specific cells, especially cancer cells, specific to each patient's condition.

• For instance, according to the data published by the Centers for Disease Control and Prevention in June 2023, around 1,603,844 new cancer cases were reported in the U.S. in 2020. Furthermore, for every 100,000 people, 403 new cancer cases were reported.


• In addition, as per the data published by the European Commission in October 2023, around 2.74 million new cancer cases were reported in 2022 in Europe, which rose by 2.3% compared to 2020.

Increasing Number of Clinical Trials in Theranostics to Drive Market

The field of radiotheranostics has gained traction over the past years owing to its efficient disease management ability and positive patient outcomes. In addition, the introduction of a radiotheranostic approach has boosted the outcomes of radiotherapy, immunotherapy, and chemotherapy. Several pharmaceutical companies are focused on clinical trials to develop next-generation products that can improve treatment outcomes for children and adults with cancer.

• For instance, in August 2023, Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, announced the successful completion of cohort 2 and advancement to cohort 3 in the dose escalation phase of its Phase I/II theranostic trial, evaluating 64Cu/67Cu SAR-bisPSMA in patients with metastatic, castrate-resistant prostate cancer (mCRPC).

In addition, the ultimate aim is to improve patient outcomes by treating them with the right treatments at the right time. Theranostics have demonstrated success in prostate cancer and have potential applications in various clinical indications, which has been pivotal in increasing the demand for radiotheranostics.

RESTRAINING FACTORS

Short Half-Life of Radioisotopes to Restrain Market Expansion

Radiotheranostics contain radioactive isotopes that decay over time, resulting in a limited effective lifespan known as the half-life. The short half-life of radioisotopes necessitates efficient production, transportation, and distribution processes to ensure their availability when needed. It also poses logistics, inventory management, and patient scheduling challenges.

For instance, according to data published by the National Center for Biotechnology Information (NCBI), Lu-177 has a physical half-life of 6.647 days. Healthcare facilities and providers must have appropriate infrastructure and resources to handle radiopharmaceuticals with short half-lives.

These factors can increase operational complexities and costs, potentially limiting the market growth.

Radiotheranostics Market Segmentation Analysis

By Radioisotopes Analysis

Lutetium-177 Segment Accounted for the Highest Market Share Due to Longer Duration of Treatment and Potentially Better Outcomes for Patients

Based on radioisotopes, the market is segmented into Lutetium-177, Radium-223, Iodine-131, and others.

The Lutetium-177 segment accounted for the highest global radiotheranostics market share in 2022. The increasing prevalence of cancer, the growing number of clinical trials for Lutetium-177, and commercially available and FDA-approved products are the factors driving the segmental growth. In addition, manufacturers are focused on expanding their production capacity for Lu-177 in an effort to combat global shortages of cancer-fighting nuclear medicine, thereby influencing segmental growth.

• For instance, in June 2023, SHINE Technologies, LLC, a next-generation fusion technology company, announced that it had opened a production facility for Lutetium-177, a medical isotope used in targeted cancer therapies in North America. The company aims to expand its production of lutetium-177 to treat cancer.

By Application Analysis

Prostate Cancer Segment Accounted for the Highest Market Share Owing to its Growing Prevalence Worldwide

By application, the market is divided into neuroendocrine tumors, prostate cancer, and others.

The prostate cancer segment captured the highest market share in 2022. The growth is mainly credited to the high availability of prostate cancer radiotheranostics products in this marketspace. In addition, the surging demand for developing advanced therapeutics solutions and imaging tools, anticipated product launches, and recent product approvals are projected to boost the segment growth in the near future.

• For instance, in December 2022, Novartis AG announced the approval of Pluvicto from the European Commission (EC) to treat prostate cancer. The company is committed to delivering advanced therapies for patients.

The others segment is anticipated to grow at the fastest rate in the near future. This is owing to the growing investment in research of novel nuclear medicine for Hepatocellular Carcinoma and Metastatic Pheochromocytoma disorders.

By End-user Analysis

Hospitals & Clinics Segment to Expand with High Procedural Volume

By end-user, the market is subdivided into diagnostic centers, hospitals & clinics, and others.

The hospitals & clinics segment accounted for the highest revenue share in 2022. The high theranostic procedure volumes and the higher efficiency involved in the handling of these sensitive radioisotopes at clinics and hospitals are factors majorly responsible for its dominance.

The diagnostic centers segment registered the second-highest market share in 2022 and is anticipated to surge at the highest CAGR over the analysis period. The high growth rate of the segment is driven by the huge volumes of procedures performed in diagnostic centers and the escalating number of diagnostic institutions across North America and Europe.

REGIONAL INSIGHTS

By geography, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

The North America market for radiotheranostics stood at USD 1.03 billion in 2022. The region accounted for the major market share owing to the robust therapeutic radiopharmaceuticals demand and increasing inclination toward precision medicine in the region. In addition, the presence of prominent companies and various strategic initiatives deployed by them is further driving the market growth in the region.

• For instance, in May 2023, NUCLIDIUM announced a collaboration with PharmaLogic for the manufacturing and distribution of copper-based theranostics ⁶¹Cu in the U.S. ⁶¹Cu is a new diagnostic radioisotope that provides distinct properties for safe, cost-effective, and enhanced diagnostics to improve cancer staging and patient care.

Europe market for radiotheranostics accounted for the second-highest position in terms of value in the global market in 2022. The growth was mainly attributed to the deployment of advanced radiopharmaceuticals and the recent launch of numerous products by industry players. Moreover, collaborations, acquisitions, and mergers by key players are further influencing the market growth in European countries.

Asia Pacific is expected to grow at a lucrative CAGR from 2023-2030, owing to the growing prevalence of cancer and increasing investment in theranostics space. Moreover, a rise in procedural volumes for nuclear imaging is further augmenting these products’ adoption in the region.

On the other hand, the rest of the world segment comprises the Latin America and the Middle East & Africa markets, which are likely to witness considerable growth over the forecast period. This is owing to the rising awareness regarding efficient diagnostics and therapeutic methods for cancer and surging healthcare expenditures in these regions.

List of Key Radiotheranostics Market Companies

Bayer AG and Novartis AG Accounted for the Highest Market Share Owing to the Diversified and Robust Product Portfolio

Market players such as Bayer AG, Novartis AG, Lantheus Holdings, Inc., Telix Pharmaceuticals Limited, and others dominated the global market in 2022. Particularly, players such as Bayer AG and Novartis AG accounted for a significant market in 2022, owing to the presence of products such as Xofigo, Lutathera, and Pluvicto in their product portfolios. These players are focused on adopting strategies such as new product developments, mergers and acquisitions, and partnerships to increase their market share.

• For instance, in February 2021, Telix Pharmaceuticals Limited announced that it had reached a research cooperation agreement in Germany with Heidelberg University Hospital to develop next-generation theranostic radiopharmaceuticals for urologic oncology. This agreement would develop new conjugates and constructs for diagnostic and therapeutic use.

Other companies such as GE Healthcare (General Electric Company), Cardinal Health, ARICEUM THERAPEUTICS, Isotopia Molecular Imaging Ltd., and Radiopharm Theranostics are projected to bolster their market presence over the forecast period. The robust therapeutic radiopharmaceutical pipelines of these companies are anticipated to contribute to the industry expansion in the ensuing years.

LIST OF KEY COMPANIES PROFILED:

• Bayer AG (Germany)


• Novartis AG (Switzerland)


• Lantheus Holdings, Inc. (U.S.)


• Telix Pharmaceuticals Limited (Australia)


• GE Healthcare (General Electric Company) (U.S.)


• Cardinal Health (U.S.)


• ARICEUM THERAPEUTICS (Germany)


• Isotopia Molecular Imaging Ltd. (Israel)


• Radiopharm Theranostics (Australia)

KEY INDUSTRY DEVELOPMENTS:

• December 2023: ITM Isotope Technologies Munich SE (ITM), a Germany based radiopharmaceutical biotechnology company, announced that it had gained an exclusive license for radiolabeled folate derivatives to be used in therapeutic and diagnostic applications for malignant tumors.


• June 2023: ARICEUM THERAPEUTICS, a private biotech company manufacturing radiopharmaceutical products, announced the acquisition of Theragnostics Ltd. The latter is a U.K.-based private biopharmaceutical company involved in the development of radio-labeled PARP inhibitors for the diagnosis and treatment of cancers.


• March 2023: Radiopharm Theranostics, an Australian radiopharmaceuticals developer, announced that through its wholly-owned U.S. subsidiary, it acquired Pharma15 Corporation. Pharma15 is a private U.S.-based venture developing next-generation therapeutic radiopharmaceuticals for prostate cancer.


• November 2022: Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, announced the U.S. FDA approval of its IND (Investigational New Drug) application to evaluate its SAR-Bombesin product for metastatic castrate-resistant prostate cancer (mCRPC).


• August 2022: The University of Texas MD Anderson Cancer Center and Radiopharm Theranostics Limited announced the launch of Radiopharm Ventures, LLC, a joint venture company created to develop novel radiopharmaceutical therapeutic products for cancer.

REPORT COVERAGE

The market research report covers a detailed analysis and overview. It focuses on key aspects such as competitive landscape, radioisotopes, application, end-user, and region. Besides this, it offers insights into the market drivers, current market trends, market dynamics, COVID-19 impact on the market, and other key insights. In addition to the factors mentioned above, the market analysis encompasses several factors that have contributed to the growth of the market over recent years.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2030
Base Year	2022
Estimated Year	2023
Forecast Period	2023-2030
Historical Period	2019-2021
Growth Rate	CAGR of 18.5% from 2023 to 2030
Unit	Value (USD Billion)
Segmentation	By Radioisotopes Lutetium-177 Radium-223 Iodine-131 Others
By Application Neuroendocrine Tumors Prostate Cancer Others
By End-user Hospitals & Clinics Diagnostic Centers Others
By Region North America (By Radioisotopes, Application, End-user, and Country) U.S. Canada Europe (By Radioisotopes, Application, End-user, and Country) U.K. Germany France Italy Spain Rest of Europe Asia Pacific (By Radioisotopes, Application, End-user, and Country) China Japan India Australia Rest of Asia Pacific Rest of the World (By Radioisotopes, Application, and End-user)