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Global Radiopharmaceuticals Market Insight

February 2014 | 450 pages | ID: GFD7FF4CD7FEN
Kuick Research

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Radioisotopes are radioactive isotopes having an unstable balance of atomic nucleus. Radioisotopes are produced either by using nuclear research reactor or by using cyclotron. These isotopes emit energy in the form of alpha, beta or gamma when changed to a stable nature. The gamma rays, thus emitted are used in Nuclear medicine, specifically in medical diagnostics. In this field, the radiation is used to provide diagnostic information about a human body’s functioning. Radiotherapy is also used to treat some life-threatening diseases like cancer. Also, it has been observed that the increasing use of radioisotopes is one of the major reasons for a fall in deaths caused by cancer across the globe. It is because of this feature that the demand for radioisotopes or otherwise called radiopharmaceuticals is increasing significantly.

A major part of the radiopharmaceuticals market is dominated by diagnostic radiopharmaceuticals, where, SPECT and PET isotopes are most common. The new innovations in nuclear medicine to target coronary heart disease, Alzheimer’s disease, breast cancer, and bone metastasis would be the major drivers of the diagnostic radiopharmaceuticals market in the future. The other segment of the market is the therapeutic segment, which accounts for the remaining 10%. This segment is mainly dominated by isotopes like I-131, Sm-153, Re-186, Y-90, and Lu-177. It is expected that over the next 5-6 years horizon, this market would witness a steep increase owing to the introduction of many new products for treating lymphoma, colon cancer, lung cancer, prostate cancer, bone cancer and other persistent cancers.

The increasing popularity and use of SPECT and PET scans, new and efficient technological equipment, increased awareness about radiopharmaceuticals among physicians and most importantly, the easy availability of radiopharmaceutical from cyclotrons are some of the major factors driving the global radiopharmaceutical market.

Inspite of the market for radiopharmaceuticals growing rapidly, there are many challenges, like high cost of devices using radioisotopes, short half-life, lack of good manufacturing practices, and stringent regulatory approvals. Additionally, there are also some obstacles with regards to the manufacturing of radioisotopes, which need to be addressed to tap the opportunities.

The global market for radiopharmaceuticals was estimated to be valued at approximately USD 5.3 billion in 2013. Owing to factors like the increasing adoption rates of PET and SPECT scanners, alpha radioimmunotherapy based targeted cancer treatment, and ready availability of radiopharmaceutical from cyclotrons, coupled with significant developments in research and technology, this market is expected to record a CAGR of close to 15% to reach approximately USD 10.6 billion by 2018.

“Global Radiopharmaceuticals Market Insight” Report Highlights
  • Global Radio Pharmaceuticals Market Overview by Region
  • arget Patient Base by Region
  • Radiopharmaceuticals Market Regulation for US, Europe & Canada
  • Radioisotopes Used in Radiopharmaceuticals
  • Radiopharmaceutical Clinical Pipeline Insight
  • Profile of 87 Radiopharmaceuticals Drugs in Clinical Phase

1. GLOBAL RADIOPHARMACEUTICALS MARKET OUTLOOK

1.1 Market Overview
1.2 Diagnostic & Therapeutic Radiopharmaceuticals
1.3 Market Dynamics
1.4 Radioisotopes Used in Radiopharmaceuticals
1.5 Radiopharmaceuticals in Clinical Development Phase

2. EUROPE GUIDELINES FOR RADIOPHARMACEUTICALS

2.1 Physico-Chemical, Biological or Microbiological Tests of Medicinal Products
2.2 Toxicological & Pharmacological Tests
2.3 Clinical Documentation
2.4 Radiation Dosimetry
2.5 Labelling & Packaging

3. US GUIDELINES FOR RADIOPHARMACEUTICALS

3.1 Clinical Indication
3.2 General Considerations for Safety Assessments
3.3 Clinical Evaluation of Medical Imaging Agents

4. CANADA GUIDELINES FOR RADIOPHARMACEUTICALS

4.1 Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research
4.2 Use of Positron Emitting Radiopharmaceuticals in Basic Research involving Humans
4.3 Stability Testing of Existing Drug Substances and Products
4.4 Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)

5. RADIOPHARMACEUTICALS CLINICAL TRIAL INSIGHT BY INDICATION, COUNTRY & PHASE

5.1 Phase Unknown
5.2 Research
5.3 Preclinical
5.4 Clinical
5.5 Phase
5.6 Phase I
5.7 Phase I/II
5.8 Phase II
5.9 Phase III
5.10 Preregistration
5.11 Registered

6. MARKETED RADIOPHARMACEUTICALS BY INDICATION & COUNTRY

7. DISCONTINUED & SUSPENDED RADIOPHARMACEUTICALS DRUG PROFILES BY INDICATION, COUNTRY & PHASE

7.1 Discontinued Clinical Trials for Radiopharmaceuticals
7.2 Suspended Clinical Trials for Radiopharmaceuticals
7.3 No Development Reported

8. COMPETITIVE LANDSCAPE

8.1 Avid Radiopharmaceuticals
8.2 Actinium Pharmaceuticals
8.3 AREVA Med
8.4 Bayer HealthCare Pharmaceuticals
8.5 Cardinal Health
8.6 Immunomedics
8.7 Lantheus Medical Imaging
8.8 Merck & Co
8.9 Navidea
8.10 Nordion
8.11 Lantheus Medical Imaging
8.12 GE Healthcare
8.13 Ion Beam Applications
8.14 PETNET Solutions (Siemens Healthcare Global)

LIST OF FIGURES

Figure 1-1: Global Radiopharmaceuticals Market (US$ Billion), 2013-2018
Figure 1-2: Global Radiopharmaceuticals Market by Region (%), 2013 & 2018
Figure 1-3: Global Radiopharmaceuticals Market by Region (US$ Billion), 2013 - 2018
Figure 1-4: Target Patient Base for Radiopharmaceuticals (Million), 2013-2018
Figure 1-5: Target Patient Base for Radiopharmaceuticals by Region (%), 2013 & 2018
Figure 1-6: Target Patient Base for Radiopharmaceuticals by Region (Million), 2013 - 2018
Figure 1-7: Radiopharmaceuticals Development by Clinical Phase (%), 2014
Figure 1-8: Radiopharmaceuticals Development by Clinical Phase (Number of Drugs), 2014
Figure 1-9: Suspended & Discontinued Radiopharmaceuticals in Clinical Phase (Number of Drugs), 2014
Figure 8-1: Lantheus Medical Imaging Product Pipeline

Radioisotopes are radioactive isotopes having an unstable balance of atomic nucleus. 

Radioisotopes  are  produced  either  by  using  nuclear  research  reactor  or  by  using cyclotron.  These  isotopes  emit  energy  in  the  form  of  alpha,  beta  or  gamma  when changed  to  a  stable  nature.  The  gamma  rays,  thus  emitted  are  used  in  Nuclear medicine,  specifically  in  medical  diagnostics.  In this field, the radiation is used to provide diagnostic information about a human body’s functioning.  Radiotherapy is also used to treat some life-threatening diseases like cancer.  Also, it has been pbserved that the increasing use of radioisotopes is one of the major reasons for a fall in deaths caused by cancer across the globe. It is because of this feature that the demand for radioisotopes or otherwise called radiopharmaceuticals is increasing significantly. 

Across  the  globe  more  than  10,000  hospitals  have  included  radioisotopes  in  their medicines and close to xx% procedures are for diagnosis. In recent years, amongst the radioisotopes  being  used,  technetium-99  is  one  of  the  most  common  one  used  with close  to  40  million  procedures  annually  which  occupies  80%  of  the  total  nuclear procedures used. 

A  major  part  of  the  radiopharmaceuticals  market  is  dominated  by  diagnostic radiopharmaceuticals,  where,  SPECT  and  PET  isotopes  are  most  common.  The  new innovations in nuclear medicine to target coronary heart disease, Alzheimer’s disease, breast  cancer,  and  bone  metastasis  would  be  the  major  drivers  of  the  diagnostic radiopharmaceuticals  market  in  the  future.  The  other  segment  of  the  market  is  the therapeutic  segment,  which  accounts  for  the  remaining  10%.  This  segment  is  mainly dominated  by  isotopes  like  I-131,  Sm-153,  Re-186,  Y-90,  and  Lu-177.  It  is  expected that over the next 5-6 years horizon, this market would witness a steep increase owing to the introduction of many new products for treating lymphoma, colon cancer, lung cancer, prostate cancer, bone cancer and other persistent cancers. 

The  increasing  popularity  and  use  of  SPECT  and  PET  scans,  new  and  efficient technological  equipment,  increased  awareness  about  radiopharmaceuticals  among physicians  and  most  importantly,  the  easy  availability  of  radiopharmaceutical  from cyclotrons  are  some  of  the  major  factors  driving  the  global  radiopharmaceutical  market. 

 Inspite  of  the  market  for  radiopharmaceuticals  growing  rapidly,  there  are  many  challenges, like high cost of devices using radioisotopes, short half-life, lack of good manufacturing  practices,  and  stringent  regulatory  approvals.  Additionally,  there  are also some obstacles with regards to the manufacturing of radioisotopes, which need to be addressed to tap the opportunities. SPECT techniques are currently replacing the PET techniques. The static planar scans currently can be quantified with the changing tissue  concentration  of  radiotracers.  Thus,  the  radio-immunodetection  technology, which  uses  the  monoclonal  antibodies,  is  expected  to  become  extremely  popular  in future years. The most common diagnostic isotope, 99mTc is expected to be the most dominant radionuclide in the applications. Additionally, imaging for “hot-spot” would be the most significant application with immense future potential. 

The   global   market   for   radiopharmaceuticals   was   estimated   to   be   valued   at approximately  USD  xx  billion  in  2013.  Owing  to  factors  like  the  increasing  adoption rates  of  PET  and  SPECT  scanners,  alpha  radioimmunotherapy  based  targeted  cancer treatment,  and  ready  availability  of  radiopharmaceutical  from  cyclotrons,  coupled with significant developments in research and technology, this market is expected to record a CAGR of close to xx% to reach approximately USD xx billion by 2018.

Global Radiopharmaceuticals Market by Region (US$ Billion), 2013 – 2018
Global Radiopharmaceuticals Market by Region (US$ Billion), 2013 – 2018 



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