New Radiopharmaceuticals to Enter Market as R&D Activities Intensify

Over the past few decades, immunology, biology, and genetics have progressed at a considerable pace due to which the development of cardiological, oncological, and neurological therapies has received a much-needed push. In the past 20 years, multiple radionuclide-based targeted therapies have gradually emerged as one of the most efficient techniques for inflammatory lesions and cancer treatment. At present, an array of therapeutic radionuclides, particularly β− emitters, is increasingly being used across clinics or tested in ongoing clinical trials. At present, within the radiopharmaceutical market, several studies are investigating the potential of 188Re for a broad range of therapeutic applications.

Within the medical sector, the adoption of radiopharmaceuticals is at the nascent stage compared to that of other medicinal products and drugs. However, due to significant advancements and improvements in oncological and neurological therapies, the development of targeted radiopharmaceuticals has gained noteworthy momentum and are creating new growth avenues for stakeholders in the current market landscape. During the 1990s, the healthcare space across developed regions, including North America and Europe witnessed a major overhaul as new regulations and healthcare provisions were introduced. At present, manufacturers or drug developers in the radiopharmaceuticals market are required to comply with guidelines. The demand for radiopharmaceuticals is expected to witness considerable growth during the forecast period, due to their widening applications in oncology, cardiology, neurology, etc. Thus, the global radiopharmaceutical market is expected to reach a value of ~US$ 5.4 Bn by the end of 2027.

radiopharmaceutical market infographic

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Technetium – 99 Set to Retain Lead Due to Growing Adoption in Diagnostic Procedures

Nuclear medicine has gained significant traction in the past couple of decades. The growing popularity of nuclear medicine can be largely attributed to the availability of 99m Tc– an isotope that is deployed in ~80% diagnostic procedures. At present, nearly 25 million diagnostic procedures are carried out using 99m Tc radiopharmaceuticals and trends suggest that the number is expected to grow at a steady pace annually. One of the major factors that are driving the adoption of Technetium 99 is the availability of short-lived 99m Tc. At present, research and development activities are in full swing to improve the overall production capacity of 99 Mo, which in turn will positively impact the production of 99m Tc.

In the current scenario, 99m Tc is extensively used in multiple diagnostic procedures, including neuroendocrine tumor imaging and pertechnetate for thyroid uptake. The past few years have witnessed a significant rise in research activities that aim to discover new and improved 99m Tc radiopharmaceuticals. 99m Tc is expected to dominate the global radiopharmaceutical market as applications of 99m Tc for dynamic and morphological imaging of liver, renal, bone, etc., are likely to grow during the assessment period. In addition, several radiopharmaceuticals are set to gain acceptance due to their wide availability and economical costs.

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Stakeholders in Current Market Landscape Focus on Complying With Global FDA Guidelines

Stakeholders operating in the current radiopharmaceutical market are required to comply with the published FDA guidelines during the drug development phase. In August 2019, the U.S. FDA published the Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations. A large chunk of companies operating in the current radiopharmaceutical market has predominantly been active participants in the diagnostic sector, wherein fulfilling the stringent regulatory guidelines is the primary area of focus. At present, participants in the radiopharmaceutical market are likely to work in conjunction with companies active in the traditional pharmaceutical space to ensure that their commercialization and drug development strategies align with the FDA guidelines. Some of the major points included by the FDA focus on the evaluation of radiation toxicities, toxicities from the ligand, and data pertaining to product labeling, among others. Stakeholders in the radiopharmaceutical market will continue their pursuit of achieving approval from the FDA to stay relevant in the current market landscape.

Over the past five to six years, the FDA has approved around three advanced radiopharmaceutical therapies– LuDOTATATE for neuroendocrine carcinomas, Radium-223, and MIBG for paraganglioma and pheochromocytoma.

radiopharmaceutical market segmentation

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Analysts’ Viewpoint

The global radiopharmaceutical market is expected to grow at a CAGR of ~4% during the forecast period. The market growth can be primarily attributed to the increasing focus on the discovery of new radiopharmaceuticals and the soaring adoption rate of Technetium – 99 for diagnostic procedures. Stakeholders should align their product development activities and commercialization strategies in tune with regulatory guidelines laid down by the FDA. Moreover, attaining FDA approval will play an important role in the expansion of the radiopharmaceutical market in the coming years. On the regional front, developed regions including North America and Europe are expected to be at the forefront in terms of the development of new drugs, owing to high concentration of market players, rising investment toward research & development, and robust healthcare ecosystem in these regions.

Radiopharmaceutical Market: Overview

  • According to Transparency Market Research’s latest market report on the global radiopharmaceutical market for the historical period 2017–2018 and forecast period 2019–2027, factors such as increase in per-capita healthcare expenditure, rise in healthcare infrastructure such as cancer institute & hospitals, and rapid urbanization in developing countries in Asia is expected to increase the influx of emigrant population, which requires sufficient healthcare services to cater to the unmet medical needs, are anticipated to drive the global radiopharmaceutical market
  • According to the report, the global radiopharmaceutical market was valued at US$ 3.6 Bn in 2018 and is projected to expand at a CAGR of ~4% from 2019 to 2027

Increase in Purchasing Power of Hospitals and Technological Advancements: Key Drivers of Radiopharmaceutical Market

  • Rise in disposable income of people in emerging economies is expected to enable them to avail better healthcare facilities. Hence, availability of better imaging techniques are likely to prompt healthcare service providers to make significant investments in advanced medical automation technologies in order to meet patient needs, improve operational efficiency, and save both service costs and time. This is anticipated to drive the global radiopharmaceutical market.
  • Radionuclide medicine is primarily used in hospitals, owing to high usage of radiopharmaceutical in treatment. According to the World Nuclear Association, 95% of radioisotopes in the form of nuclear medicine are utilized by hospitals. The trend of development of radioisotopes has come into existence due to the introduction of SPECT and PET systems for cancer diagnosis and imaging techniques. Introduction of PET systems and increase in installation of cyclotrons regionally have driven the production of photon emitting radioisotopes (radiopharmaceutical), which fuels the global radiopharmaceutical market.

Major Shift from SPECT to PET/CT

  • The field of nuclear medicine is conquered by applications related to positron emission tomography (PET) and single-photon emission computerized tomography (SPECT). Increase in applications of the PET technology in oncology, cardiac, and neurological disorders is anticipated to drive the radiopharmaceutical market. Various PET procedures are performed in cardiology. Orthopedics, oncology, and infection imaging are developing areas that can also benefit these procedures which augment the growth of the radiopharmaceutical market.
  • Hybrid imaging modalities in the field of nuclear medicine is an emerging trend in the diagnostic imaging industry. Hybrid PET/CT machines have largely contributed toward better and early diagnosis and recurrence of cancer. This is anticipated to propel the global radiopharmaceutical market in the next few years.
  • Launch of such value-based PET/CT with high diagnostic accuracy, strong prognostic power, and low radiation dose has resulted in increase in adoption of PET/CT machines in hospitals and diagnostic centers. This is likely to fuel the global radiopharmaceutical market.

Stringent Regulatory Guidelines and Supply Shortage of Radioisotopes to Hamper Global Radiopharmaceutical Market

  • Production, storage, and usage of radioisotopes require proper precautions, as radioisotopes generate radiation, which can affect mass population and the environment. Approval from the Food and Drug Administration and Medicines and Healthcare Products Regulatory Agency is mandatory for any usage, storage, or production of radioisotopes.
  • According to the Nuclear Regulatory Commission, approximately 6,000 licenses are maintained for the use of radioactive materials; violation of agreement leads to enforcement actions, including loss of license
  • Supply of radioisotopes is unstable globally and is expected to reduce in the near future due to shut down of major reactors (Canada and the Netherlands), which is likely to hamper the global radiopharmaceutical market. Short half-life radioisotopes cannot be supplied to other regions where the production of raw materials is negligible, as these disintegrate rapidly. According to the Nuclear Energy Agency (NEA), supply of radioisotopes will deflate from 2016, not simply from reactors, but due to processing limitations such as transport, demand management, and communications, which is likely to hamper the global radiopharmaceutical market.

Radiopharmaceutical Market: Competitive Landscape

  • This report profiles major players in the global radiopharmaceutical market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments in radiopharmaceutical market
  • The global radiopharmaceutical market is highly consolidated, with presence of small number of players
  • Leading players in the global radiopharmaceutical market include
    • GE Healthcare
    • antheus Medical Imaging, Inc.
    • Mallinckrodt
    • Siemens Healthineers
    • Advanced Accelerator Application
    • Bayer AG, Eckert & Ziegler
    • IBA Radiopharma Solutions
    • Philips
    • Jubilant Life Sciences Limited

Radiopharmaceutical Market: Key Developments

  • Key players in the global radiopharmaceutical market are engaged in regulatory approvals, introduction of technologically advanced products, acquisitions, and collaborative agreements with other companies. Major developments by key players are likely to fuel the global radiopharmaceutical market. A few expansion strategies adopted by players operating in the radiopharmaceutical market are:
    • In October 2019, Nordion (Canada) Inc., and Societatea Nationala Nuclearelectrica SA (SNN) of Romania jointly signed an agreement to evaluate the potential commercial production of Cobalt-60 at the Cernavodă Nuclear Power Plant (CNPP)
    • In August 2019, Eckert & Ziegler AG formed a joint venture with Chinese TCL Healthcare Equipment (Shanghai) Co., Ltd. (TCL Healthcare) for the development, production, and distribution of advanced tumor irradiation devices highly effective against gynecological and other forms of cancer
    • In August 2019, Eckert & Ziegler AG signed a multi-year supply agreement with Alpha Tau Medical for the supply of thorium-228. The radioisotope is used for the production of Alpha DaRT, a new innovative therapy for the treatment of a variety of solid tumors.
    • In 2019, Ontario Power Generation (OPG) and Nordion (Canada) Inc. had signed an agreement to expand production of Cobalt-60 to the Darlington Nuclear Station
  • The report on the global radiopharmaceutical market discussed individual strategies, followed by company profiles of manufacturers of radiopharmaceutical products. The competitive landscape section has been included in the radiopharmaceutical market report to provide readers with a dashboard view and a company market share analysis of key players operating in the global radiopharmaceutical market.

Radiopharmaceutical Market - Scope of Report

TMR’s report on the global radiopharmaceutical market studies past as well as current growth trends and opportunities to gain valuable insights of the same indicators for the market during the forecast period from 2019 to 2027. The report provides revenue of the global radiopharmaceutical market for the period 2017–2027, considering 2018 as the base year and 2027 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the global radiopharmaceutical market during the forecast period.

The report has been prepared after an extensive primary and secondary research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with industry leaders and opinion makers. Extensive secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global radiopharmaceutical market.

Secondary research also includes Internet sources, statistical data from government agencies, websites, companies’ presentations, sales data, and trade associations. Analysts have employed a combination of top-down and bottom-up approaches to study various phenomenon in the global radiopharmaceutical market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Furthermore, the report sheds light on changing competitive dynamics in the global radiopharmaceutical market. These indices serve as valuable tools for existing market players as well as for entities interested in entering the global radiopharmaceutical market.

The report delves into the competitive landscape of the global radiopharmaceutical market. Key players operating in the global radiopharmaceutical market have been identified, and each one of these has been profiled for distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players in the global radiopharmaceutical market that have been profiled in this report.

Key Questions Answered in Radiopharmaceutical Market Report

  • What is the scope of growth of radioisotope in the radiopharmaceutical market?
  • What will be the Y-o-Y growth of the radiopharmaceutical market between 2019 and 2027?
  • What is the influence of changing trends in PET/CT on the global radiopharmaceutical market?
  • Will North America continue to remain the most profitable regional market for radiopharmaceutical providers?
  • Which factors are anticipated to impede the growth of the global radiopharmaceutical market during the forecast period?
  • Which are the leading companies in the global radiopharmaceutical market?

Research Methodology

A unique research methodology has been utilized by TMR to conduct comprehensive research on the growth of the global radiopharmaceutical market and arrive at conclusions on its growth prospects. This research methodology is a combination of primary and secondary research, which helps analysts warrant the accuracy and reliability of the drawn conclusions.

Secondary methods referred to by analysts during the production of the global radiopharmaceutical market report include statistics from company annual reports, SEC filings, company websites, investor presentations, regulatory databases, government publications, and industry white papers. Analysts have also interviewed senior managers, product portfolio managers, CEOs, VPs, and market intelligence managers, who contributed to the production of TMR’s study on the radiopharmaceutical market as primary methods.

These primary and secondary methods have provided exclusive information during interviews, which serves as a validation from the radiopharmaceutical market leaders. Access to an extensive internal repository and external proprietary databases enabled this report to address specific details and questions about the global radiopharmaceutical market with accuracy. The study also uses the top-down approach to assess the revenue for each segment and the bottom-up approach to counter-validate them. This has helped in reaching TMR’s estimates on future prospects of the global radiopharmaceutical market more reliably and accurately.

Radiopharmaceutical Market - Segmentation

Source

  • Nuclear Reactors
  • Cyclotrons

Radioisotope

  • Technetium-99
  • Gallium-67
  • Iodine-123
  • Iodine-125
  • 18F
  • Rubidium-82
  • Yttrium-90
  • Lutetium-177
  • Others

End User

  • Hospitals
  • Ambulatory Surgical Centers
  • Diagnostic Centers
  • Cancer Research Institutes
  • Others

Type

  • PET/CT
  • SPECT
  • Therapeutics

Application

  • Gastro-intestinal
  • Oncology
    • Brachytherapy
    • Others
  • Nephrology
  • Cardiology
  • Neurology
  • Inflammation
  • Others

Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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