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Nuclear Medicine and Radiopharmaceuticals Manufacturing Market, 2020-2030

Nuclear Medicine and Radiopharmaceuticals Manufacturing Market, 2020-2030

  • July 2020
  • 323 pages
  • ID: 5976266
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Since the discovery of the means to artificially synthesize radioisotopes (early 1930s), they were almost immediately adopted for healthcare applications, by the mid-1940s. Presently, a variety of diagnostic and therapeutic techniques are based on the use of such substances, commonly referred to as radiopharmaceuticals. Despite their inherent toxicity, nuclear medicine is considered an important part of modern healthcare, with applications spanning across a number of therapeutic areas, including infectious diseases, immunological disorders, gastroenteric disease, cardiological disorders, oncological disorders, neurological disorders, and even certain psychiatric conditions. According to an article published by World Nuclear Association in May 2020, more than 10,000 hospitals worldwide claim to be using radioisotopes for various medical procedures; interestingly, of the aforementioned applications, 90% were reported to be related to disease diagnosis. Typically, diagnostic tests, involving radiopharmaceuticals, are performed using highly specialized imaging solutions, such as single photon emission computed tomography (SPECT) and positron emission tomography (PET). It is worth highlighting that around 40 million diagnostic procedures, involving the use of the radioisotope Tc-99m alone, are conducted worldwide annually. Further, the introduction of the concept of theranostics, which involves the use of a single active ingredient for both diagnostic and therapeutic purposes, has opened up a new dimension of applications for nuclear medicine.

Over the years, medical research teams across the world have gradually tapped into the vast potential of radiopharmaceuticals and nuclear medicines. In fact, the technology that is now used in this field is reported to have witnessed significant evolution, in terms of technological sophistication. As a result, the demand for such specialized chemicals has grown at an exponential rate. However, the development and production of radiopharmaceuticals is inherently complex, and requires specialized facilities and operational expertise. Therefore, acquiring the necessary technical acumen and infrastructure to support such operations is not a feasible option for pharmaceutical companies, owing to a number of associated clauses and concerns (such as need for high capital investments, unique operating licenses and compliance to special regulatory requirements). Currently, stakeholders in the pharmaceutical industry primarily rely on suppliers and contract manufacturers to fulfill their radiopharmaceutical procurement needs. Moreover, there are a number of specialty service providers that claim to be engaged in this field, offering a variety of radioisotopes and affiliated services for healthcare applications. As more applications are discovered, the demand for nuclear material suppliers and service providers is likely to increase. This, coupled to the anticipated advances in the field of radiopharmaceuticals, affiliated technologies and products, is expected to offer lucrative opportunities to the contract service providers that are engaged in this domain.

SCOPE OF THE REPORT
The ‘Nuclear Medicine and Radiopharmaceuticals Manufacturing Market, 2020-2030’ report provides a detailed study on the current market landscape and future potential of the companies having the capabilities to manufacture radiopharmaceuticals. In addition, the study features an in-depth analysis, highlighting the capabilities of a diverse set of industry stakeholders. Amongst other elements, the report features the following:
- A detailed assessment of the current market landscape with respect to the players (industry and non-industry) involved in manufacturing radiopharmaceuticals. It features information on the year of establishment, company size, purpose of production (fulfilling in-house requirements / for contract services), location of headquarters, location of manufacturing facilities, scale of production, applications of radiopharmaceuticals (in diagnosis, therapeutics and theranostics), type of diagnostic radiopharmaceuticals (PET and SPECT), type of therapeutic radiopharmaceuticals (alpha emitters, beta emitters and others), target therapeutic area (cardiology, oncology, neurology, thyroid and others) and services offered.
- An insightful four-dimensional comparison of the radiopharmaceutical manufacturers, based on supplier power (year of establishment), product portfolio (number of isotopes being manufactured for various applications targeting different therapeutic areas) of the manufacturer, scale at which they manufacture their respective products and company size.
- Tabulated profiles of key industry players based in North America, Europe and Asia-Pacific (shortlisted based on the company size of the players), featuring a brief overview of the company, a list of products and manufacturing facilities, recent developments and an informed future outlook.
- An analysis of recent partnerships and collaborations inked in this domain since 2017, based on several parameters, such as the type of partnership, year of partnership, type of radioisotope involved, therapeutic area mentioned in the agreement, application of the radioisotope mentioned in the agreement, and a schematic representation showcasing the players that have forged the maximum number of alliances. Furthermore, we have provided a world map representation of the deals inked in this field, highlighting those that have been established within and across different continents.
- A detailed discussion on the supply chain model of medical isotope Mo-99 (Tc-99m), highlighting the main steps of the supply chain, from irradiation of uranium targets in nuclear research reactors to the administration of Tc-99m to patients. Along with this, it describes the structure of the industry and product market at each step.

One of the key objectives of this report was to evaluate the current market size and the future opportunity associated with the radiopharmaceutical manufacturing market, over the coming decade. Based on various parameters, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] target therapeutic area (cardiology, neurology, oncology, thyroid and others), [B] application area (diagnostic and therapeutic) and [C] type of diagnostic radiopharmaceuticals (PET and SPECT), [D] type of therapeutic radiopharmaceuticals (alpha emitters, beta emitters and others), [E] purpose of production (in-house / outsourcing) and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (arranged in the order of participant’s designation):
- James Davis (Vice President Quality / R&D, Shertech Laboratories)
- Andreas Fotopoulos (Professor of Nuclear Medicine, University of Ioannina Medical School)
- Jan Pruim (Professor of Medical Imaging / Nuclear Medicine Physician, University Medical Center of Groningen)
- Michael van Dam (Professor, Crump Institute for Molecular Imaging, Molecular & Medical Pharmacology)
- Anonymous (ITM Isotopen Technologien München)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts’ views

While the focus has been on forecasting the market over the next decade, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED
- Who are the leading industry and non-industry players engaged in the nuclear medicine and radiopharmaceutical manufacturing market?
- For which application and disease indications are the radiopharmaceuticals being manufactured?
- What are the various type of radionuclides being manufactured for the formulation of radiopharmaceuticals?
- What is the relative competitiveness of manufacturers involved in the nuclear medicine and radiopharmaceutical manufacturing?
- Which partnership models are commonly adopted by the radiopharmaceutical manufacturers in this industry?
- What is the supply chain process for medical isotope Mo-99 / Tc-99m?
- What are the key factors that are likely to influence the evolution of the nuclear medicine and radiopharmaceutical manufacturing market?
- How is the current and future market opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of nuclear medicine and radiopharmaceutical manufacturing market, in the short to mid and long term.

Chapter 3 provides a general introduction and a brief historical background of nuclear medicines and radiopharmaceuticals. It includes details on the applications of radiopharmaceuticals in the medical field, as well as various methods adopted by manufacturers for the production of radiopharmaceuticals. It also highlights the guidelines laid down by regulatory authorities for the production, packaging, labelling and storage, of radiopharmaceuticals. In addition, it features a discussion on the need for outsourcing in this field. Further, it presents the key requisites for the selection of a CMO partner and key future perspectives related to the use of radiopharmaceuticals within the nuclear medicine industry.

Chapter 4 provides a detailed overview of around 60 companies, featuring both contract service providers and in-house manufacturers that are actively involved in the production of radiopharmaceuticals. The chapter provides details on the year of establishment, company size, purpose of production (fulfilling in-house requirements / for contract services), location of headquarters, location of manufacturing facilities, scale of production, applications of radiopharmaceuticals (in diagnosis, therapeutics and theranostics), type of diagnostic radiopharmaceuticals (PET and SPECT), type of therapeutic radiopharmaceuticals (alpha emitters, beta emitters and others), target therapeutic area (cardiology, oncology, neurology, thyroid and others) and services offered.

Chapter 5 provides an overview of around 70 non-industry players (academia and research institutes) that are actively involved in the production of radiopharmaceuticals. The chapter provides details on the year of establishment, purpose of production (fulfilling in-house requirements / for contract services), location of manufacturing facilities, scale of production, applications of radiopharmaceuticals (in diagnosis, therapeutics and theranostics), type of diagnostic radiopharmaceuticals (PET and SPECT) and type of therapeutic radiopharmaceuticals (alpha emitters, beta emitters and others).

Chapter 6 features tabulated profiles of the mid-large sized US based contract service providers / in-house manufacturers that possess the capabilities for the production of radiopharmaceuticals. Each profile presents a brief overview of the company, list of products and manufacturing facilities, recent developments and an informed future outlook..

Chapter 7 features tabulated profiles of the large EU based contract service providers / in-house manufacturers that possess the capabilities for the production of radiopharmaceuticals. Each profile presents a brief overview of the company, list of products and manufacturing facilities, recent developments and an informed future outlook.

Chapter 8 features tabulated profiles of the mid-large sized contract service providers / in-house manufacturers based in Asia-Pacific and rest of the world, that possess the capabilities for the production of radiopharmaceuticals. Each profile presents a brief overview of the company, list of products and manufacturing facilities, recent developments and an informed future outlook.

Chapter 9 features a four-dimensional comparison of the radiopharmaceutical manufacturers, based on supplier power (year of establishment), product portfolio (number of isotopes being manufactured for various applications targeting different therapeutic areas) of the manufacturer, the scale at which they manufacture their respective products and company size.

Chapter 10 features an analysis of recent partnerships and collaborations inked in this domain, since 2017. It includes a brief description of the partnership models (including manufacturing / supply agreement, acquisition / merger, product development agreement and commercialization agreement, R&D agreement, licensing agreement, asset acquisition, distribution agreement, clinical trial agreement, process development agreement and others) that have been adopted by the stakeholders in this domain. It also includes the analysis based on various parameters such as year of partnership, type of radioisotope involved, therapeutic area mentioned in the agreement and application of the radioisotope mentioned in the agreement. It consists of a schematic representation showcasing the players that have forged the maximum number of alliances. Furthermore, we have provided a world map representation of the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 11 presents a detailed discussion on the supply chain model of medical isotope Mo-99 / Tc-99m, highlighting the main steps of the supply chain, from irradiation of uranium targets in nuclear research reactors to the administration of Tc-99m to patients. Along with this, it describes the structure of the industry and product market at each step.

Chapter 12 presents an informed estimate of the current and future opportunity in the nuclear medicine and radiopharmaceutical manufacturing market, highlighting the likely growth of the market till the year 2030. The chapter presents a detailed market segmentation on the basis of target therapeutic area (cardiology, nephrology, oncology, thyroid and others), application area (diagnostic and therapeutic), type of diagnostic radiopharmaceuticals (PET and SPECT), type of therapeutic radiopharmaceuticals (alpha emitters, beta emitters and others), purpose of production (in-house / outsourcing) and key geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 13 is a summary of the overall report. In this chapter, we have provided a list of the key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 14 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with (arranged in the order of participant’s designation) James Davis (Vice President Quality / R&D, Shertech Laboratories), Andreas Fotopoulos (Professor of Nuclear Medicine, University of Ioannina Medical School), Jan Pruim (Professor of Medical Imaging / Nuclear Medicine Physician, University Medical Center of Groningen), Michael van Dam (Professor, Crump Institute for Molecular Imaging, Molecular & Medical Pharmacology) and Anonymous (ITM Isotopen Technologien München).

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which provides the list of companies and organizations mentioned in the report.

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