Pharma & OTC: Entering the most prosperous Emerging ... · PDF filefor non MNC CPHI worldwide...

Chameleon Pharma Consulting

Chameleon-pharma.comMr. Reiner [email protected]

Pharma & OTC: Entering the most prosperous Emerging Markets

for non MNC

CPHI worldwide Frankfurt 2017


1• About CPC

2• Potential in the EM

3• Mexico OTC & Pharma Insights + case study

4• Russia and Vietnam OTC & Pharma Insights

5• Systematic approach to Internationalisation

6• Executive Summary

Agenda


About CPC


Who We Are…

• CPC was established in 2010, has is headquarters in Berlin, Germany with

Partner Office in Latin America, CIS and Asia

• We have 22 Experts & Project Managers in Asia, CEE/CIS, Latin America,

Europe and Middle East

• Our CPC experts have 15y.+ experience in Rx., OTC, MD, Derma & FS


CPC - House of Competence

Establishing

International

Business

Licensing

and

M&A

International

Strategy

Systematic

Partner

Identification

Segment focus: Rx., OTC, Medical Devices, Hospital, Pharmacy Chains

Focus: Emerging Markets (Asia, CIS/CEE, LATIN America, Middle E.) + Europe

Chameleon Pharma ConsultingThe Expert in the Emerging Markets

Executive Search

Regulatory

Check/

Registration

Expert Market

Reports + Analysis


Bricks of Competence

Individual portfolio identification

Highlighting GAPS

International Partner Identification

International Strategy

& Market Entry

Identification of best fitting CMO

Preparation of production transfer

Checking required local regulations

Localization

e.g. Russia

Registration strategy check

Fast track registration options

Guidance through registration and

marketing authorization procedures

Registration &

Regulatory GAP

Analysis

Identification of the best fitting local partner

for your company and products

Unique and tailored approach

approx. 200 partner identifications

Systematic Partner

Search


Detailed check of your potential in Country XYZ

Highlighting GAPS

Advise on how to enter new

Potential Analysis

Conduction of due diligence and M&A processes

e.g. Sales & Marketing, Regulatory, Mid-Long Term

Plan

On all global markets

Licensing and M&A

Preparation and advice on GMP/ GOST Audit

pre-production plant audit by our experts

Guidance throughout and after the audit

GMP Audit/ GOST Audit

In depth analysis of pharma markets

Expert report writing

Valuable insights for our clients

Expert Market Reports

and Analysis

Bricks of Competence


The WEM-News Magazine is published with a focus on the

developments, news and changes in the Emerging Markets around

the world.

Different issues focusing on:

Latin America

CEE & CIS

Asia

Europe

Numerous expert reports, studies and

articles on:

Consumer health

Rx. Products

Medical Devices

Derma & Food Supplements

Retail & Wholesale

CPC Publications & Market Reports

Real insights Market reports

eg. on Russia:

- Pharmacy chains,

- OTC & Rx.,

- Wholesale,

- Medical Devices


Importance of The Emerging Markets in a Global Context

20062011

20162020

2030

86% 80% 70% 64%58%

14%20%

30%36%

42%

Emerging Markets

Rest of the world

Development of Pharma/OTC Market by Region

Economic growth in mature markets e.g. Europe is likely to stay at 1-3% only.

However, the Emerging Markets are predicted to have rapidly increasing

growth rates of around 9-12% each year and therefore outweigh the mature

markets. In 2030, they will reach the impressive size of more than 40%


Top Pharmaceutical Markets, 2010 and Forecasted 2030

Forecast Rank 20301. US

2. China

3. Japan

4. Germany

5. Brazil

6. India

7. Italy

8. UK

9. Russia

10. Mexico

11. France

12. Spain

13. Canada

14. South Korea

15. Australia

16. Colombia

17. Saudi Arabia

18. Indonesia

19. Turkey

20. Poland

Top Markets in 2010

Top 10 are the most

developed countries

Some EM in the lower

end of the Top 30

Source: Various sources incl. public data, DSM Group, Insight Health, IMS etc.

2030

outlookRussia &

Mexico

in Top 10



• Mexico has the second largest pharmaceutical market in Latin

America and one of the strongest economies in Latin America

• Mexico has more than 128 Mio. inhabitants

• Market access is not too difficult, but you will need a good network

• >14bil. US$ market size and high pharmacy prices and government

payments in a number of segments

• Mexico is an interesting doctor driven market, meaning that the

specialists play an important role in recommendation & prescription

of products

• Moreover also the OTX/OTC market is very interesting and shows

very high pharmacy prices in a number of market segments

Mexico Pharma Market Facts


A new Market Entry in Mexico or Latin America can be as complex as the Tokyo subway system

You will mostly find a complex, confusing and non-harmonized

regulatory landscape


Registration process for innovative products

Submit registration dossier and pre-approval

Conduct clinical trials according to

the recommendations of the Committee

Register drug as generic

Is it a new molecule?

Innovative product

Prepare Registration Dossier with full information: legal & administrative, quality, pre-clinical and clinical

Is your product registered in USA, Canada, Australia, Switzerland or EMA?

Your product may qualify for

an equivalency review1

process.

Submit Documentation / Registration Dossier

Fast Track process

COFEPRIS reviews request

Yes

No

Certificate issued by COFEPRIS and

registration approval is posted on the COFEPRIS website

You may now begin marketing your

product.

Request meeting with Committee for New Molecules

Committee determines if your product is a new molecule

and issues an opinion regarding safety, efficacy and quality of your new molecule

Yes

No

Pre-approval is issued

Is documentation complete?NoYes

Source: Chamaleon Pharma Regulatory Guide - Mexico


MEX Registration Process

20182017 2019

Source: Chamaleon Pharma Regulatory Guide - Mexico

Bioequivalence

Dossier

PreparationCOFEPRIS

Translation

Fast

Track

Generic products:

CNM

Dossier

PreparationCOFEPRIS

Bioequivalence / Clinical Studies

Fast Track

Translation

Innovative / New molecules:

Dossier

PreparationCOFEPRIS

Translation

Fast

Track

Phytomedicines

OTC & Phyto products

can be done in 6 month

with dossier available

COFEPRIS is currently

changing the process for

the CMN. Things might be

even faster for non-NCE

drugs in the future.


International Case study:

Which is one of the best accessible,

underdeveloped and growing

Cough & Cold markets for Phyto OTC

drugs in the Emerging Markets.


Product &

Country Matrix-Analy.

Systematic

local

Partner

Selection Process

Country

Selection

International

Portfolio

Selection-> which product

can go

international ?

A. B. C. E.

Regulatory

D.

KPI`s Nr. 2 KPI`s Nr. 3

Systematic Approach to Entering the EM

KPI`s Nr. 1


$0

$50.000.000

$100.000.000

$150.000.000

$200.000.000

$250.000.000

VALORES 2009 VALORES 2010 VALORES 2011 VALORES 2012 VALORES 2013

Val

ores

in M

ex. P

eso

Cough & Cold Products which are promoted via doctors

in value

PANOTO-S

BISOLVON

SENSIBIT XP

MUCOSOLVAN

MUCOFLUX

Products

• Well known brands in the market

• All lose market share

• All use similar Marketing Mix

Mexico Cough and Cold Market Players

Mexico


$0

$50.000.000

$100.000.000

$150.000.000

$200.000.000

$250.000.000

VALORES 2009 VALORES 2010 VALORES 2011 VALORES 2012 VALORES 2013

Val

ores

in M

ex. P

eso

Cough & Cold Products which are promoted via doctors

in value

PANOTO-S

BISOLVON

SENSIBIT XP

MUCOSOLVAN

MUCOFLUX

• Insight Analysis: Consumers are tired of chemical actives

• Phyto / Homeopathic = natural product! - seen as safe for the

whole family

• Panatos-S= the only liquid Phyto product on the Mexican market

• Panatos-S= a brand from Europe

• Sales 12-19 US$ per pack;

• Approx. 20 Mio. US$ at WS Prices;

• +20% growth p.a., clearly differentiated

brand marketing mix approach

Mexico



Russia OTC & Pharma Insights


Russian OTC & Pharma market structure

64% 72% 77% 72%

36%12%

23%28%

16%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Prescription Status Distribution Channel Country of Origin Financing Source

RX Retail

Hospital

DomesticState

DLO

OTC

Import Out of

pocket

• Russian Market is strongly depending on imports, close to 75%

• The OTC market is very big compared to other Emerging markets

• The Out-of-pocket market remains the biggest segment of the market

Source: DSM Group, Various sources


• 9% overall growth and 12% growth in OOP segment, outperforms EU markets

• OOP expenditure and price increase have been the main growth drivers

Source: IMS Russia, DSM Group, Various sources

Russian OTC & Pharma market structure


0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

3,000,000

3,500,000

2016 2017 2020 2025 2030

Total Pharma Market in Bil. RUB

2016

2017

2020

2025

2030

2.737 Bil. RUB in US$ in 2030Rub Exchange rate:

35,00 = 78,2 Mrd. US$57,00= 48,0 Mrd. US$

• The RU market is growing, despite the strong influence of the oil price / currency

• See RU market size calculated with two different exchange rates

• We do expect that double digit growth rates will return in the near future

Source: IMS Russia, DSM Group, Various sources

Russian OTC & Pharma Outlook


The Russian Pharma Market + Outlook

• Total population of Russia is 147 million people, this is great potential for

pharmaceutical companies

• In 2016 the Russian pharma market reached 806 Bil rubles (+9,3% vs. 2015)

• In spite of crisis and sharp decrease in ruble value, the market showed

9,0% growth in many segments in value

• Moreover the local market development

is 5-6 times above the EU level

• Around 80% of Pharma / OTC products

in value have been imported

• Important local changes e.g. RU Pharma

Strategy 2020 and EUEA Region changes

need to be taken into considerations

• CPC is the leading Expert in Russia & CIS Region with experts having +20years experience in Commercial & Regulatory topics



• Vietnam with more than 93 Mio.

inhabitancies

• The OTC & Pharma Market in

Vietnam will increase in value to

$3.8 billion in 2018 and to an

estimated US$10.6 billion by 2030.

• Strong double digit +18% growth

in 2016

• Approx. 65% of OTC & Pharma

products, are currently imported.

• Hospitals in Vietnam mostly

purchase pharmaceuticals through

bidding, which is subject to a price

ceiling per drug (also for OTC drugs, but not for FS)

• FS have become very popular in VN


Systematic International Product & Country Analysis for non-MNC


Can you name the

Top-5 best potential Countries to go for, that

fit your individual TOP-5

focus products best?


Which product, which country, which consumer, why?

Many influencing

factors!

COGs and

margin

structure

Market

Size and

stage of

developmentRegulatory

Documents

available

Galenic forms

Differences LatAm

to CEE, CIS, Asia

Price

Level

Positioning /

International

Marketing

Strategy Cost of

internationalisation

Level of

international

Competition

Distribution

channel &

Trade channel

Future

Market

growth

Production

topics (GMP, FDA)

Product

USPs

Time to

Market


Getting the overview in the EM!


Here is our suggested

Systematic Strategy Market

Entry Model…


Product &Country Matrix-Analy.

Systematic local

Partner

Selection Process

CountrySelection

International

Portfolio

Selection-> which product

can go

international ?

A. B. C. E.

Regulatory

D.

KPI`s Nr. 2 KPI`s Nr. 3

Systematic Approach to entering the EM

KPI`s Nr. 1


Regulatory /

time + cost

/ Other

Consumer / Sales /

Growth Potential /

Marketing Mix

Country / Market /

Competition /

Sales Channel

Strategy ProcessA.

Can you name the

Top-5 best

potential Countriesto go for, that fit

your individual

focus products best?

Product Analysis: KPI setting is very crucial for the Strategy Process. We suggest

working with about 7-9 KPIs beyond market data!


Country SelectionB.

KPI Analysis – Countries 1. KPI - Market growth in % per country 2017 -> 2025

2. KPI - Regulatory time + cost 3. KPI - OTC market size in 2025

4. KPI - Market Entry cost & time + complexity analysis in detail5. KPI - Healthcare expenditure per capita in US$

6. XYZ …

7. XYZ …

KPIs will be

adjusted to

local needs,

current

market and

segment

situation

Approx. 10-12 CountriesTop-7-8

Countries

TOP performing 3-4 Countries / Fitting 2-3 Product / Segments

?


Product & Country Matrix-AnalysisC.

0

5

10

Mature

Markets

Emerging

Markets

Company + Pharma Market Growth in %

2010

2015

2025

Best fitting Product-Country-Matrix:

• TOP product portfolio (Step 1)

• for internationalization analysed

by TOP country (Step 2) selection

• KPIs weighted according to

company focus

• Result: about 12-15 KPIs ranked

by best Product-Country-Mix


Local RegistrationD.

QC &

GMP Audi

t

Time to

approval

Time

Regulatory (BE study, Stability

data, complexity,

Quality of dossier) Cost

Regulatory Solutions:

• Setting right KPIs on product

segment analysis

• Strong partnerships with

ministry experts, e.g. COFEPRIS

• Knowledge on future

regulations

• Don´t try to do this on your

own

International Regulatory Barriers:


Systematic Local Market Entry ModelE.

Tool kit for Internationalization

depending on your market entry execution model:

- Local / Regional Partner

- Local / Regional JV

- Acquisition

- Green Field

- Other

More than >80% of the local country success

depends on your local partner

There should be a dependence on the

products e.g. >5% of the local partner sales

is made with your products


How your Analysis results

may look like…


Low hanging fruits & Quick Wins

Results of systematic international product-portfolio-country-analysis

• We have identified a number of low hanging fruits & Quick Wins

• Some require more focus on implementation than other

• Have in mind that e.g. Vietnam is very different from Colombia

Recommendations

and findings based on:

– Systematic analysis

– Market data research

– Hard data, experience

and local expert

knowledge

Must Haves

Money Pits

Quick Wins

Low-Hanging

fruits

Ease of implementation

Imp

ac

t

Low

Hard Easy

High


America`s best fitting Markets to your portfolio

Best fitting countries for your portfolio

CEE, CIS, Middle East, Europe's best fitting Markets to your portfolio

Asia`s best fitting Markets to your portfolio

Top 10 relevant Key Parameters for your product portfolio are shown on a

“one-page-overview” per country


World Region 1 – Pharma Market Growth Potential

• C-2 is the market with the highest long-term growth potential, however the regulatory and government payments are difficult to overcome

• C-1has the highest short-term CAGR

• C-3 will only grow marginally in the short and long term

C-2

C-3

-5%

5%

15%

25%

-5% 5% 15% 25%

Sh

ort

-te

rm C

AG

R 2

01

5 -

20

17

Long-term CAGR 2018 - 2025

C-1

C-5

C-4

Confidential


0 10 20

Total Score

Sales & Margin

Market & Marketing

Competition

Regulatory

Scoring KPI

Regulatory:

• …

• …

Product X scoring in Country Y

CPC – Optimum Range Analysis

Conclusion: • Xxxxxxx

• Xxxxxxx

• Xxxxxxx

• Xxxxxxx

Max.Min.

Competition:

• …

• …

Market & Marketing:

• …

• …

Sales & Margin:

• …

• …

Comment on KPI

optimum range

optimum range

optimum range

optimum range


Example Product Factsheet – Product A

Current international footprint – Product A

0

20

40

60

Future priority countries – Product A

Top Countries for Product A

Kasachstan

Mexico

Vietnam

Peru

Columbia

Indonesia

Romania


Transparent view on your possible Strategy Options in the

Emerging Markets and how to identify + enter the best markets


Executive Summary


Executive Summary

• Beside all the analysis on where to go, with what products, when

Passion is good fuel to succeed in the EM!

• Many EM do show double digit growth and Europe is flat, but still

Europe does offers among the highest reimbursement budget and

good niches for Special Generics, MD and OTCs

• All EM should be analysed individually, because regulations,

requirements and segments e.g. Mexico, Russia, Vietnam, Poland

Chile, Philippines vary widely!

• Don´t try to enter all EM, but analyse which TOP-5

EM fit your individual TOP-5 products with clear set

of KPI`s beyond IMS data


Chameleon-pharma.com

Mr. Reiner Christensen

[email protected]

Thank you!

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