“The Global Voice of Probiotics” “The Global Voice of Probiotics” International Probiotics Association – Anvisa Probiotic Workshop Conclusion George Paraskevakos, MBA Executive Director, IPA November 2015
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
International Probiotics Association –Anvisa Probiotic Workshop Conclusion
George Paraskevakos, MBA
Executive Director, IPA November 2015
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
Our journey for this workshop�A two year work in process since Athens world congress
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
�Fast forward to this week
�And my detour through Rio
Our journey for this workshop
“The Global Voice of Probiotics”
Probiotics: The fasting growing supplements globally
*Euromonitor International
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
• Foods that contain live microbes are not necessarily probiotic• These foods may be healthy, but that does not make them probiotic
What qualifies a micro organism as a probiotic?
“The Global Voice of Probiotics”
Probiotics; alone or together?
� Mono-strain probiotics
� Multi-strain probiotics
� Multi-species probiotics (is also multi-strain)
“The Global Voice of Probiotics”
Single vs. Multiple strain
� What meta-analyses compare:
� Single strain (A) vs. Multiple strain (B + C)
� vs.
� What should be compared:
� Single strains (A, B) vs. their combination (A + B)
� vs. vs.
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
The science around the world is the same
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
Quick overview of the current regulatory FRAMEWORKfor probiotics supplements in global regions
• No positive lists • No FDA oversight
except for NDI or SF Claims (truthful)
• Intended use=food, supplement or drug
• QPS list • Notification (quick
market access)• No claim (except
Italy & Switzerland)
New framework • Generic claim
• Claims• Positive listsOnly limited by
pharma-like for sites
New framework• Claims possible • Quick market access(Evidence based notification)
• Positive list• Registration
(long)• Claims
• Positive list (monograph)
• Registration• Claims
No claims But market accessible
Existing
many regions
Existing category with specificities but easily achievable in many regions
issues in some areas
ROW achievable although limited by cultural trends/financial issues in some areas
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
Vitamins and Dietary Supplement
US$88.3 billion
Probiotic supplements
US$3.8 billion
Fortified Functional Packaged Foods
US$166.6 billion
Total Probiotic Yoghurt
US$30.8 billion
Probiotics: The fasting growing category globally
“The Global Voice of Probiotics”
*Euromonitor International
GERMANYGR 0%
$0.87 per capita spend
FRANCEGR 2%
$1.53 per capita spend
ITALYGR 8 to 10%
$8.30 per capita spend
BELGIUMGR 0%
$1.81 per capita spend
W.Europe Probiotics supplements Growth rate and Per capita spending
Coincidence or Regulatory environment
Stagnating GrowthRussia -1%Poland 4%Ukraine -3%Finland 2%Norway -7%Sweden 1%
Mature market and probiotic guidelines for Italy
“The Global Voice of Probiotics”
Y-on-y %
Growth
2008-
2009
2009-
2010
2010-
2011
2011-
2012
2012-
2013
2013-
2014
2014-
2015
Average in EU 20 4.5 3.4 -0.8 -2.0 -2.6 -1.3 -1.2
Probiotic yoghurt, Retail value year on year growth
Does the regulatory environment make a difference?
*Euromonitor International
Probiotic regulations and claims ban
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
Outcomes from today�More dialogue is needed
�Cooperation – Anvisa, Industry, IPA, Abifisa
�Share and discuss findings
�Should a review of the regulations be considered after today’s discussions
�…and hopefully to have a positive response to our invitation for the IPA world congress
“The Global Voice of Probiotics”“The Global Voice of Probiotics”
�Contact:
�George Paraskevakos
+514.612.0472
+514.571.5949
Questions and Information