Advances in Molecular Imaging Market in Coming age

Since 2010, the market has seen stronger growth, helped by demand in under-penetrated markets, the adoption of newer-generation hybrid imaging technologies such as PET/CT and a move towards the use of PET from SPECT, necessitating the purchase of new PET systems.

The short-lived positron-emitting isotopes used in PET imaging are generally produced in a cyclotron and then synthesised on-site before patient administration. Although not requiring the use of a nuclear reactor, this limits the use of PET imaging to centres with access to a cyclotron and synthesis equipment. Therefore, a major development is the recent availability of smaller and cheaper cyclotrons which are designed to produce C-11 and F-18 isotopes economically and on-demand, without the need for radiochemistry or PET accelerator expertise.

The drive towards PET has been additionally boosted by advancement in the diagnosis of Alzheimer’s disease and the approval of Avid Radiopharmaceuticals’ Amyvid (florbetapir F-18 injection). Avid (owned by Eli Lilly) is the first company to achieve approval for a diagnostic PET tracer which estimates beta amyloid neuritic plaque density in adults with cognitive impairment. This is likely to become a busy marketplace with GE, Piramel and Navidea developing late-stage products whilst the focus of new research is targeting the tau proteins.

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With this report you will:

- Know the state of the molecular imaging market and recent advances in Alzheimer’s diagnosis
- Establish the future market growth with 5-year value forecasts
- Know the clinical and regulatory challenges facing the sector
- Assess the companies that are developing hybrid technologies
- Review the challenges facing producers of radiopharmaceuticals and the research which is seeking alternative paths
- Know why PET is outpacing SPECT and the advantages it brings
- Appreciate the regulatory hurdles affecting radiopharmaceutical producers in the US
- Understand the changing competitive landscape and market positioning of new entrants
- The MI market fundamentals remain solid and there are strong opportunities for growth within the industry. These are being driven by continued innovation and new product development, beneficial demographics, an ageing installed base of imaging equipment in the developed markets of the US and Europe, and the increasing adoption of MI technologies in emerging markets.

- In particular, the increasing incidence of cancer, cardiovascular and neurological diseases means that demand for faster and more accurate diagnosis, as well as drug development and pre-clinical study efforts, will continue to accelerate in coming years. In addition, MI technologies will become more widely adopted as clinical evidence is established as to their benefits, and new technological innovations continue to be brought to market, particularly related to the MI of cancer and neurological diseases such as Alzheimer’s and Parkinson’s.

- In addition, the current lack of penetration for nuclear and molecular imaging in emerging economies is driving demand, where new facilities are being set up and lower-cost systems are in demand.

Challenges to overcome
The short and mid-term prospects for MI are to a large extent dependant on the pace of economic recovery, which will affect the ability of smaller companies to obtain financing and future healthcare budgets, particularly in Europe. In addition, uncertainties currently exist surrounding Mo-99 supply, the impact of the US medical device excise tax, new regulatory hurdles for radiopharmaceuticals in the US and whether beta amyloid PET imaging (and related technologies) will be sufficiently reimbursed to facilitate their widespread use.

A changing competitive landscape
Currently, the key players in the MI market include medical diagnostic imaging equipment manufacturers such as Philips, Siemens and GE; radiopharmaceutical and imaging agent companies such as GE, Bracco, Covidien, IBA Molecular and Lantheus Medical Imaging; and companies that operate radiopharmacies such as Cardinal Health, Triad Isotopes and Siemens. The landscape is shifting and, despite pharmaceutical companies such as BMS and Bayer leaving the MI market, others have been keen to enter.

Piramal Group has gained a strong position in MI. The company now owns the intellectual property and development, marketing and distribution rights for Bayer’s lead compound, florbetaben, which is seen as a promised imaging agent for AD. Through the Bayer transaction, Piramal now also owns other clinical and pre-clinical agents that are in development for cardiology and oncology imaging.
Progenics Pharmaceuticals is focusing on developing therapeutic radiopharmaceuticals and targeted MI agents for oncology, through its acquisition of Molecular Insight Pharmaceuticals.

And it is not just Pharma companies:

PerkinElmer has acquired VisEn Medical and Caliper Lifesciences, who’s in vivo and in vitro diagnostics are used in pre-clinical drug development work.
Samsung has strengthened its medical imaging business with the acquisition, in January 2013, of NeuroLogica. Although mainly focused on portable CT scanners, NeuroLogica also offers the inSPira HD portable SPECT system.

The report covers companies active in the major MI sectors

Nuclear Imaging
Near infrared or optical imaging
Ultrasound
MRI
MRI/PET
MRI/SPECT
Tracers and Radiopharmaceuticals

This report answers key business questions…

What alternatives are being considered to mitigate the ongoing supply issues with the Molybdenum-99 isotope?
In which therapy sectors are MI technologies playing a key diagnostic role and with what success?
What collaborative role are academic institutions playing in MI development?
Which companies are most advanced in introducing hybrid imaging systems?
For which tracing agent did Navidea receive FDA approval in March 2013?
Which 2 Spanish companies did Advanced Accelerator Applications acquire in January 2013?
What development in 2012 strengthened Bruker’s position in the pre-clinical imaging sector?
What developments are helping GE maintain its leading position in the molecular imaging sector?

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Table of Content

Executive Summary      1
Introduction      1
Applications of MI.2
Neurological Disease    2
Oncology   2
Cardiovascular Disease3
MI for use in LifeSciences and the Pharmaceutical Industry    3
MI Modalities   4
Hybrid MRI/PET Imaging    5
Hybrid MRI/SPECT Imaging    7
Tracers and Radiopharmaceuticals    7

Competitive Landscape    8
New Market Entrants9
Market Consolidation 10
Collaborative Development Efforts  11
Barriers to Market Entry and Challenges for Smaller Companies    12

Current Market Dynamics      13
Nuclear Imaging Adoption    13
Market Insight       13
Fig.1: Diagnostic Imaging Systems Market by Modality, 2012      14
Fig.2: Medical Imaging Market, 2005-2012 (US$ billion)*      15
Fig.3: Nuclear Imaging Equipment Market, 2007-2012 (US$ billion)*      16
Fig.4: Molecular Imaging Market by End-Use Product Type, 201016
Molybdenum-99 Isotope Supply Issues16
Recent Developments in the PET Market   21
Alzheimer’s Disease PET Imaging   22
Lymphoseek Lymph Node Imaging 26
PET Regulatory Approval Issues 26
Improved Optical Imaging Techniques 27

Market Outlook  8
Molecular Imaging: Market Drivers, Restraints & Future Opportunities 28
Fig.5: Nuclear Imaging Equipment Market, 2012-2017E (US$ million)*   29
Fig.6: Pre-Clinical Imaging Systems Market, 2012-2017E (US$ million)   29
Fig.7: Radiopharmaceuticals Market, 2012-2017E (US$ million)    30
Fig.8: Molecular Imaging End-Use Products Market, 2012-2017E (US$ million)*       30

Molecular Imaging Companies   31
ABT Molecular Imaging31

“Dose on Demand” Biomarker Generator31
ABX       33

Advanced Accelerator Applications    34
Recent Events.34
Mergers and Acquisitions    35
Products.35
Research & Development: Annexin V-128.36
Current Alliances36

UWRC Spółka Z Ograniczoną Odpowiedzialnością, University Of Warsaw  36
GE Healthcare   37
Institut Curie      37
IASON GmbH   37
European Molecular Imaging Manufacturers Association   37
Bracco   37
Financial Performance      37

Advanced Cyclotron Systems       38
Recent Events38
Products.38
TR 24 Cyclotrons   38
TR 30 Cyclotrons   39
TR PET Cyclotrons39
CycloTec R&D Programme    39
Current Alliances 40
TRIUMF    40
GE Healthcare   41

Advanced Medical Isotope    42
Products in Development      42
US Production of Molybdenum-99 43
Alliance with GSG International  44
Financial Performance    44
AMIC - Operating Results, 2007-2011 (US$ thousand)      45
Fig.9: AMIC - Revenue by Type, 2011.45
Latest Results   45

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