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The Pharmaceutical Market
                  in Latin America in 2020
                              NextLevel Pharma:
                    Pharmaceutical Market & Patient Access in
                                 Latin America
                               February 7, 2011
                                                          James A. Cercone
                                                                    President
                                                     Sanigest Internacional


                                                w w w . s a n i g e s t . c o m




© Sanigest 2005                      Original                                     Página 1
Today‟s Discussion

     • Latin America pharmaceutical market
     size and characteristics

     • Factors affecting pharmaceutical
     supply and demand

     • Market access models: Limitations
     and Potential for growth

© Sanigest 2005         Original             Página 2
As of 2009, the
            pharmaceutical market in
         Latin America was worth over
         40 billion USD and is expected
          to increase to 63 billion USD
                     by 2012

  Source: Business Wire 2011

© Sanigest 2005                Original   Página 3
Where are we now? Market size in 2009 (USD)

                                                            Colombia
                                                             2.24bil.    Venezuela
                                      Mexico                               3.5bil.
                                      13.0bil.

        Central America
       (excluding Mexico)                                                           Brazil
                                                  Peru                              16.9bil.
       accounted for over
                                                 1.25bil.
           2 bil. USD

               Other Latin
                American                                                Argentina
                                                     Chile               3.37bil.
                countries
                                                    1.04bil.
              accounted for
               nearly 1 bil.
Source: BMI country reports Q4 2010
© Sanigest 2005                                      Original                              Página 4
Market Share, 2009

         LA market is highly consolidated. Five countries = 90% of market size.


                                         Market size (bil. USD)          Cumulative % of market
                                    18                                                            100%




                                                                                                         Cumulative % of market
                                    16                                                            90%
           Market size (bil. USD)




                                    14                                                            80%
                                    12                                                            70%
                                                                                                  60%
                                    10
                                                                                                  50%
                                     8
                                                                                                  40%
                                     6                                                            30%
                                     4                                                            20%
                                     2                                                            10%
                                     0                                                            0%




Source: World Bank and BMI country reports Q4 2010
© Sanigest 2005                                                   Original                                                        Página 5
Market Share by Country, 2009

                                 2%                                          Argentina
                                          5%         8%                      Brazil
                                                                             Mexico
                             8%
                   2%                                                        Colombia
                  3%                                                         Peru
                                                                             Chile
                                                                             Venezuela
                   5%
                                                                             Other
                                                                     38%     Central America

                                                                           Brazil, Mexico and
                                                                           Venezuela account
                            29%                                              for the largest
                                                                           proportions of the
                                                                             Latin American
                                                                            pharmaceutical
Source: World Bank and BMI country reports Q4 2010                               market
© Sanigest 2005                                           Original                             Página 6
Expected market size (bil. USD), 2009 - 2019
         Market size should more than double in the next ten years…In high scenario,
         market would reach US$90 billion in 2019.


                                                                              40
                       30




                                                                   Billions
            Billions




                                                                              35
                       25
                                                                              30
                       20
                                                                              25
                       15                                                     20
                                                         2009                      2009
                       10                                                     15
                                                         2014                      2014
                                                                              10
                       5                                 2019                      2019
                                                                              5
                       0
                                                                              0




Source: World Bank, BMI country reports Q4 2010 and Sanigest Projections
© Sanigest 2005                                             Original                   Página 7
Per capita drug expenditure vs. income level
  GDP, 2009
         Rising incomes per capita will contribute to faster growth…




                                                                             Drug
                                                                       expenditure is
                                                                         expected to
                                                                         increase as
                                                                        income level
                                                                          increases
Source: BMI country reports Q4 2010
© Sanigest 2005                                Original                         Página 8
Per capita drug expenditure, 2009-2019 (USD)
                                     $250
                                                                                  Argentina
 Drug expenditure per capita (USD)




                                                                                  Brazil
                                     $200                                         Mexico
                                                                                  Colombia
                                                                                  Venezuela
                                     $150
                                                                                  Chile
                                                                                  Peru

                                     $100




                                      $50
                                                                            Increasing per capita
                                                                            drug expenditure
                                                                            through 2019 – notably:
                                       $0                                   Brazil ($228),
                                            2009   2014              2019   •Mexico ($211)
                                                                            •Argentina ($210)
Source: BMI country reports Q4 2010
© Sanigest 2005                                           Original                             Página 9
On average, per capita drug
                   expenditure is expected to
                  increase from $77 pp in 2009
                       to $129 pp in 2019

Source: BMI country reports Q4 2010
© Sanigest 2005                       Original   Página 10
Pharmaceutical Market by Sub-Sector
                                         • By value, represents
                                           largest pharmaceutical
                       Patented            sub-sector
                                         • Decreasing market
                                           share forecasted
                                           through 2019



                                              • Marked increase in
                                                market share forecasted
                           Generic              through 2019
                                              • Subject to price ceilings
                                                in most of Latin America



                                         • Growing sub-sector
                                         • Opportunities depend
                                           on ‘’switching
                        OTC                procedures’’
                                         • Generally under free
                                           pricing
© Sanigest 2005               Original                                      Página 11
Pharmaceutical market size (USD) by sub-
  sector, in billions, 2009
                              16
                                                      OTC         Generic      Patented
                              14

                              12
     Market size (bil. USD)




                              10

                              8

                              6

                              4

                              2

                              0
                                   Brazil   Mexico   Argentina Venezuela Colombia   Chile   Peru
Source: BMI country reports Q4 2010
© Sanigest 2005                                                 Original                           Página 12
Example: Composition of Mexico‟s pharmaceutical
  market by drug type and product origin
                  Type                       Percentage of market                                Unit price
                                            Value                        Volume              Non-patented =
                                                                                                  100
        Patented                                      20.4                           4.4                         5.5
        innovative (from
        one source)
        Non-patented                                  79.6                         95.6                          1.0
        (from multiple
        sources)
        • Non-branded                                  11.4                        34.4                          0.4
        generics*
        • Branded                                     17.9                         19.6                          1.1
        generics
        • Branded**                                   50.3                         41.7                          1.5
    *This includes medicines known as ‘interchangeable generics’
    **This includes innovated non-patented products, non-patentable products and copy products which were introduced in
    the market prior to the original product’s patent expiring.
    Source: IMS Health 2009
© Sanigest 2005                                               Original                                                    Página 13
Today‟s Discussion

     • Pharmaceutical market size: Where
     are we now?

     • Factors affecting pharmaceutical
     supply and demand

     • Market access models: Limitations
     and Potential for growth

© Sanigest 2005         Original           Página 14
Undermining the pharmaceutical market…




                                                  One survey showed that
        An estimated 7-22% of
                                                  50% of Latin Americans
        drugs on the market in
                                                   use under-the-counter
          Latin America are
                                                 (UTC) drugs on a regular
              counterfeit
                                                          basis




Source: BMI country reports Q4 2010
© Sanigest 2005                       Original                              Página 15
Distribution Channels
        •         Public health insurance vs. pharmacies
                   – Patented medicines not always stocked by public sector
                     pharmacies
                   – Consolidation of pharmacy chains: Retail sector controlled by
                     few main pharmacies – vulnerable to collusion

        •         Penetration of private pharmacies into new markets
                   – Increasingly rapidly (11% increase in 2009 in Argentina alone)
                   – Dominated by high price branded medicines
                   – Introduction of private pharmacies could spur pricing wars
                   – Possible shift to private pharmacy dispensing for public systems
                     could drive sales.

        •         Possibility of regional purchasing for Central America would
                  create regional purchasing pool putting pressures on margins.
© Sanigest 2005                                 Original                             Página 16
Factors affecting pharmaceutical supply and demand


     Final determination of market size depends on
     interaction of demand and supply with the health
     system

                                             Demand




                                    Supply


                                                        Health
                                                        System




© Sanigest 2005                              Original                  Página 17
Factors affecting pharmaceutical supply and demand


        Market access strategies and estimates of demand
        should be based on realistic assessment of interaction
        of health systems factors for each product…
                                            Financing




                               Access
                                          Market        Regulation
                                          Access



                                             Staff

© Sanigest 2005                             Original                   Página 18
Trend: Data Driven Approach


                  Market access strategies
                   should look carefully at
                  population segmentation,
                  insurance coverage and
                  expansion of access and
                        technology.

© Sanigest 2005               Original        Página 19
Looking Ahead

    Three factors affecting pharmaceutical demand:


         1 Epidemiological and demographic
         shifts

         2 Global economic climate
         3 Expanding national health insurance
© Sanigest 2005               Original               Página 20
Age standardized DALYs (per 100,000 pop.) by
  cause
          Countries are moving from a high communicable
          disease burden to a high chronic disease burden


                               Chronic disease care will require
                                 long-term and/or high tech
                                  pharmaceutical solutions




                                                                   High Income Country
                                                                         Disease Profile


© Sanigest 2005                       Original                                             Página 21
Demographic Shift: increased overall demand and demand
                           for specialized care (geriatric, chronic disease, etc.)
         Population over 40 will increase from177,881,896 in 2009 to 293,140,656 in 2030
                                      Population Boom                                                                                  Demographic Aging
                       Population 2025                             % increase (2010-2025)                                               0-14   15-64   65+
                               250                                                                        25
                                                                                                                            100
                    Millions




                                                                                                                             90
                               200                                                                        20                 80
 Total population




                                                                                                                             70

                                                                                                               % increase
                               150                                                                        15                 60
                                                                                                                             50
                                                                                                                             40
                               100                                                                        10
                                                                                                                             30
                                                                                                                             20
                                50                                                                        5
                                                                                                                             10
                                                                                                                              0
                                 0                                                                        0
                                                                                   Colombia
                                                                    Chile
                                                                            Peru
                                                       Argentina
                                     Brazil




                                                                                              Venezuela
                                              Mexico




Source: Population Reference Bureau, CIA World Fact book, US Census Bureau
© Sanigest 2005                                                                                                             Original                         Página 22
Demographic Shift
                   Population 2010                                                        Population 2030
           100+                                                               100+
          95-99                                              Female          95-99
          90-94                                                              90-94
                                                             Male                                             Female
          85-89                                                              85-89
          80-84                                                              80-84                            Male
          75-79                                                              75-79
          70-74                                                              70-74
          65-69                                                              65-69
          60-64                                                              60-64
          55-59                                                              55-59
          50-54                                                              50-54
          45-49
                                                                             45-49
          40-44
                                                                             40-44
          35-39
                                                                             35-39
          30-34
                                                                             30-34
          25-29
                                                                             25-29
          20-24
                                                                             20-24
          15-19
                                                                             15-19
          10-14
                                                                             10-14
            5-9
                                                                               5-9
            0-4
                                                                               0-4
                  40   20       0            20          40
                                                                                     40     20   0    20          40
                                                  Millions
                                                                                                           Millions

                                                      Over 70 age group has most drug users, so as
  Source: US Census Bureau Int’l Database
  and Norwegian Institute of Public Health
                                                     countries age, drug consumption is expected to
                                                                        increase
© Sanigest 2005                                                       Original                                         Página 23
Looking Ahead

    Three factors affecting pharmaceutical demand:


         1 Epidemiological and demographic
         shifts

         2 Global economic climate
         3 Expanding national health insurance
© Sanigest 2005               Original               Página 24
Global Economic Climate

              • Increased cost for energy and importing raw
                goods for production
    Inflation • Rising consumer prices lowers demand


           • Cost-pressure on government spending
           • High unemployment depresses consumer
  Spending   spending


            • Weakening Latin American currencies vs.
              USD
   Currency • Affect of shifting exchange rates on imports


© Sanigest 2005                 Original                      Página 25
Looking Ahead

    Three factors affecting pharmaceutical demand:


         1 Epidemiological and demographic
         shifts

         2 Global economic climate
         3 Expanding national health insurance
© Sanigest 2005               Original               Página 26
As a general trend, Latin American governments are investing more in
healthcare


     Healthcare expenditure (USD) as a % of GDP, 2005-2019
                                          12
                                                                                      Argentina
     Healthcare expenditure as % of GDP




                                          10                                          Colombia
                                                                                      Mexico
                                                                                      Peru
                                           8
                                                                                      Venezuela
                                                                                      Brazil
                                           6                                          Chile
                                                                                      Other
                                           4

                                                                               Increased healthcare
                                           2                                   spending in:
                                                                               Colombia
                                                                               •Mexico
                                           0
                                                                               •Peru
                                               2009   2014              2019
                                                                               •Brazil
Source: BMI country reports Q4 2010
© Sanigest 2005                                              Original                             Página 27
Market Trends
                                                            Colombia is
                                                             expecting
                     Mexico is                             universal and    Venezuela is
                   implementing                            unified health    negotiating
                     universal                             coverage by       drug price
                      health                                    2014          increases
                     coverage

                                              Peru is
                                          increasing per
              These 7                       capita drug
                                                                            Argentina is
                                            expenditure
             countries                                                      planning to
            represent a                                                      increase
                                                                              pharma
           market of 468                             Chile is
                                                                              access
                                                  increasing
          million people                           insurance
          and GDP of 2.7                            coverage

            trillion USD
Source: Business Wire and BMI country reports Q4 2010
© Sanigest 2005                                           Original                         Página 28
Health insurance coverage

                                    100%
                                            Mexico and Costa
                                    90%    Rica have the highest                                                                                                      0.2%          2.8%
                                                                                                                                                                                              19.6%


                                    80%
                                              levels of public
                                              coverage (87%)                                                                                                 17.6%

                                    70%
                                                                                                                                    2.0%
              Population coverage




                                    60%
                                                                                                                     7.9%                       42.0%
                                    50%
                                                                                           1.8%
                                                                                                                                                                      86.8%         87.0%
                                    40%                                                                                                                                                       80.4%

                                                                                   10.0%              30.0%                         67.1%                    68.3%
                                    30%
                                                                                                                    51.2%
                                                                                           45.0%
                                    20%                                5.0%
                                                        3.3%                                                                                    34.4%
                                                                                   28.1%
                                    10%    4.0%                        18.0%                          18.3%
                                                        15.1%
                                           7.7%
                                     0%
                                                                                            Uruguay




                                                                                                                                                              Chile
                                                                        Honduras




                                                                                                                        Argentina
                                                                                                        Guatemala
                                            Nicaragua




                                                                                    Peru




                                                                                                                                                 Venezuela




                                                                                                                                                                                               Brazil
                                                                                                                                                                                     Mexico
                                                                                                                                     Colombia
                                                         El Salvador




                                                                                                                                                                       Costa Rica
                                                                                                      Public        Private

© Sanigest 2005                                                                                              Original                                                                                   Página 29
Effects of Health Insurance Coverage on
  Pharmaceutical Markets
        • Expanding health insurance coverage
          – Increased drug consumption as more people
            are covered and reduces ‘co-pay’

        • Potential for group purchasing of branded
          drugs – expands access but pressure on unit
          prices

        • Pharmacoeconomics as an influence on
          pharmaceutical supply
           – Using Health Technology Assessment (HTA)
             to evaluate cost-effectiveness of treatment
             options
© Sanigest 2005                Original                    Página 30
Looking Ahead

    Three factors affecting pharmaceutical supply:


      1. Pricing and reimbursement


      2. Global economic climate


      3. Technology: mHealth


© Sanigest 2005                Original              Página 31
Pricing and Reimbursement


           2011 emphasis on procurement and un-regulated private pricing should
           shift to more regulated P&R schemes with reference pricing, discounting
           and more aggressive pharmacist distribution.

           Increasing interest in LA to use HTA, or pharmacoeconomics for
           formulary and pricing decisions.
                            Price                             Prior
                                          Discounts
                           Freezes                        authorization

     Pharmacist
     substitution                                                             Positive &
                                P&R measures in Latin America
                                                                              Negative
         OTC
      Substitution
                          Reference       Patient co-       Rebate &
                           Pricing           pay             taxes


© Sanigest 2005                                Original                               Página 32
Pricing and Reimbursement

         Large
                                                                 Increase Private
                                          Increase in formal     Insurance Market
                                          labor market 
                                          social insurance
                   Growth of Middle                              • Private insurance
                   Class                                          greater pressure
                                          • Increase access to    reimbursement
Market                                     social insurance       control, more
Size               • Middle-of-Pyramid     reduces OOP and        interest in branded
                     driving               shifts purchasing      to differentiate.
                     consumption
                   • Increased access
                     to private
                     pharmacy
         Small
                   Low                                                      High
                                         Pressure on P&R

 © Sanigest 2005                              Original                                  Página 33
What‟s on the horizon for pharmaceutical
  pricing?
        • Expanding use of “procurement auctions” to
          obtain value for money in social security
          purchases: example Mexico IMSS and Chile
        • Increasing use of reference pricing for public
          and private sectors
        • Tightening of private distribution of
          prescription drugs
        • Increasing consolidation of public coverage
          of the population  reduction in out-of-
          pocket private spending.
        • Introduction of Pay-For-Performance scheme
          for expanding use of innovators
© Sanigest 2005                Original                Página 34
Looking Ahead

    Three factors affecting pharmaceutical supply:




      1. Pricing and reimbursement


      3. Technology: mHealth




© Sanigest 2005                Original              Página 35
Looking Ahead

    Three factors affecting pharmaceutical supply:




      1. Pricing and reimbursement


      3. Technology: mHealth




© Sanigest 2005                Original              Página 36
Trend: Mhealth


       Mhealth has the potential to be
        a disruptive technology for
            pharma industry…

                  …Early innovators may
                  capture market share

© Sanigest 2005             Original      Página 37
mHealth Pharmaceuticals

      Incidence of mhealth on pharma industry

                                               Controlling
                                               Counterfeit

                                     Chronic
                                                             Compliance
                                      care




                                     Supply
                                                             Payments
                                     Chain

                                               Adherence
Source: Healthcare on Mobiles 2010
© Sanigest 2005                                  Original                 Página 38
mHealth: Adherence and Chronic Care
        Offers unique opportunity for communication with
          patient


        Improved patient adherence
        •         Studies show improved TB, HIV drug adherence
        •         Improved adherence to glucose control and weight loss
                  programs

                                                              Evidence suggests
        Improved patient outcomes                               that successful
                                                                 trials and pilot
        •         Link patient biomarkers to dosing           programs could be
        •         Improved glucose control                     easily adapted to
        •         Better/faster diagnostic testing            the Latin American
                                                                     context

© Sanigest 2005                              Original                          Página 39
Evidence for mHealth
                           Study                                                         Impact

  Mobile Phone-Based Remote Patient Monitoring System        Average 24-h BP fell by 11 /5 (+/- 13/7 SD) mmHg a difference of
  for Management of Hypertension in Diabetic Patients         35% from baseline
  (Logan et al. 2007)                                        Overall, BP improved significantly


  “Comparison of an SMS text messaging and phone             Subjects who received a text message reminder were 60% more
  reminder to                                                 like than controls to attend their health appointment
  improve attendance at a health promotion center:
  A randomized controlled trial “ (Chen et al. 2008)

  “A randomized control trial of Sweet Talk, a text          Patients with Sweet Talk and intensive therapy had a decrease of
  messaging system to support young people with               9.2% (+/- 2.2%) in their blood glucose. Other groups had no
  diabetes” (Franklin et al. 2006)                            significant change
                                                             No impact on knowledge score

  “A randomized trial of a proactive cellular telephone      Those receiving the mobile intervention were 3.6 times as likely to
  intervention for smokers living with HIV/AIDS “             quit smoking at 3 months than controls
  (Vidrine et al. 2006)


  “Using internet and mobile technology to deliver an        The intervention group lost significantly more body fat and had
  automated physical activity program: randomized             significantly more physical activity than the control group
  controlled trial” (Hurling et al. 2007 )


  SIMpill                                                    Treatment success 94% with SIMpill (compared to 71% nationally
                                                              with standard DOTS)


© Sanigest 2005                                               Original                                                         Página 40
More cost-benefit
                  research is needed to
                  guide development of
                    scalable business
                  models for pharma in
                         mhealth
© Sanigest 2005            Original       Página 41
Future Forces




© Sanigest 2005   Original   Página 42
Conclusions
        •         Epidemiological and demographic shifts will increase overall
                  demand for pharmaceuticals

        •         Increased government investment in healthcare and
                  expenditure on pharmaceuticals through 2019

        •         Trends like mHealth could increase pharmaceutical sales
                  through:
                   – Increased patient compliance and preference for branded drugs
                     tied to mHealth technology

        •         Likely shift to reference pricing

        •         Increased insurance coverage
                   - Pharmacoeconomics influence on drug supply
                   - Potential for group purchasing

© Sanigest 2005                                 Original                         Página 43
Thank you for your Attention
                         Contact Information

                           James A. Cercone
                        jcercone@sanigest.com




© Sanigest 2005                  Original        Página 44
Works Cited
        1.        Argentina Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. 10 Jul. 2010.
        2.        Brazil Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010.
        3.        Chile Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010.
        4.        CIA World Factbook. Available online at http://www.cia.gov. Accessed 23 Jan. 2011.
        5.        Colombia Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Aug. 2010.
        6.        „Drug Consumption in Norway – A Fact Sheet.‟‟ Norwegian Institute of Public Health. 5 Jul. 2010.
        7.        Global Infobase. WHO. Available online at http:///Infobase.who.int. Accessed 21 Jan. 2011.
        8.        Image of Latin America available online at http://www.worldatlas.com. Accessed 24 Jan. 2011.
        9.        „Kaiser Permanente Teams With mobileStorm for SMS Reminders, Sees 30% Cost Savings.‟ Mobile Marketing
                  Watch. 30 Dec. 2009. Available online at http:///www.mobilemarketingwatch.com. Accessed 30 Jan 2011.
        10.       Mexico Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Jul. 2010.
        11.       Peru Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010.
        12.       “Population mid-2025 (projected).‟‟ Population Reference Bureau. PRB 2010 World Population Data Sheet.
        13.       „The Pharmaceutical Markets in Latin America USD41 Billion – and Growing Fast.‟‟ Business Wire. 18 Jan. 2011.
        14.       „The World Bank, Pharmaceutical Policies and Health Reforms in Latin America.‟ International Journal of Health
                  Services. Vol. 35, No. 4, 2005: 691-717.
        15.       US Census Bureau International Database. Available online at http://www.census.gov/ipc/www/idb. Accessed 31
                  Jan 2011.
        16.       Venezuela Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010.




© Sanigest 2005                                                      Original                                                      Página 45

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The Pharmacuetical Market In Latam In 2020

  • 1. The Pharmaceutical Market in Latin America in 2020 NextLevel Pharma: Pharmaceutical Market & Patient Access in Latin America February 7, 2011 James A. Cercone President Sanigest Internacional w w w . s a n i g e s t . c o m © Sanigest 2005 Original Página 1
  • 2. Today‟s Discussion • Latin America pharmaceutical market size and characteristics • Factors affecting pharmaceutical supply and demand • Market access models: Limitations and Potential for growth © Sanigest 2005 Original Página 2
  • 3. As of 2009, the pharmaceutical market in Latin America was worth over 40 billion USD and is expected to increase to 63 billion USD by 2012 Source: Business Wire 2011 © Sanigest 2005 Original Página 3
  • 4. Where are we now? Market size in 2009 (USD) Colombia 2.24bil. Venezuela Mexico 3.5bil. 13.0bil. Central America (excluding Mexico) Brazil Peru 16.9bil. accounted for over 1.25bil. 2 bil. USD Other Latin American Argentina Chile 3.37bil. countries 1.04bil. accounted for nearly 1 bil. Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 4
  • 5. Market Share, 2009 LA market is highly consolidated. Five countries = 90% of market size. Market size (bil. USD) Cumulative % of market 18 100% Cumulative % of market 16 90% Market size (bil. USD) 14 80% 12 70% 60% 10 50% 8 40% 6 30% 4 20% 2 10% 0 0% Source: World Bank and BMI country reports Q4 2010 © Sanigest 2005 Original Página 5
  • 6. Market Share by Country, 2009 2% Argentina 5% 8% Brazil Mexico 8% 2% Colombia 3% Peru Chile Venezuela 5% Other 38% Central America Brazil, Mexico and Venezuela account 29% for the largest proportions of the Latin American pharmaceutical Source: World Bank and BMI country reports Q4 2010 market © Sanigest 2005 Original Página 6
  • 7. Expected market size (bil. USD), 2009 - 2019 Market size should more than double in the next ten years…In high scenario, market would reach US$90 billion in 2019. 40 30 Billions Billions 35 25 30 20 25 15 20 2009 2009 10 15 2014 2014 10 5 2019 2019 5 0 0 Source: World Bank, BMI country reports Q4 2010 and Sanigest Projections © Sanigest 2005 Original Página 7
  • 8. Per capita drug expenditure vs. income level GDP, 2009 Rising incomes per capita will contribute to faster growth… Drug expenditure is expected to increase as income level increases Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 8
  • 9. Per capita drug expenditure, 2009-2019 (USD) $250 Argentina Drug expenditure per capita (USD) Brazil $200 Mexico Colombia Venezuela $150 Chile Peru $100 $50 Increasing per capita drug expenditure through 2019 – notably: $0 Brazil ($228), 2009 2014 2019 •Mexico ($211) •Argentina ($210) Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 9
  • 10. On average, per capita drug expenditure is expected to increase from $77 pp in 2009 to $129 pp in 2019 Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 10
  • 11. Pharmaceutical Market by Sub-Sector • By value, represents largest pharmaceutical Patented sub-sector • Decreasing market share forecasted through 2019 • Marked increase in market share forecasted Generic through 2019 • Subject to price ceilings in most of Latin America • Growing sub-sector • Opportunities depend on ‘’switching OTC procedures’’ • Generally under free pricing © Sanigest 2005 Original Página 11
  • 12. Pharmaceutical market size (USD) by sub- sector, in billions, 2009 16 OTC Generic Patented 14 12 Market size (bil. USD) 10 8 6 4 2 0 Brazil Mexico Argentina Venezuela Colombia Chile Peru Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 12
  • 13. Example: Composition of Mexico‟s pharmaceutical market by drug type and product origin Type Percentage of market Unit price Value Volume Non-patented = 100 Patented 20.4 4.4 5.5 innovative (from one source) Non-patented 79.6 95.6 1.0 (from multiple sources) • Non-branded 11.4 34.4 0.4 generics* • Branded 17.9 19.6 1.1 generics • Branded** 50.3 41.7 1.5 *This includes medicines known as ‘interchangeable generics’ **This includes innovated non-patented products, non-patentable products and copy products which were introduced in the market prior to the original product’s patent expiring. Source: IMS Health 2009 © Sanigest 2005 Original Página 13
  • 14. Today‟s Discussion • Pharmaceutical market size: Where are we now? • Factors affecting pharmaceutical supply and demand • Market access models: Limitations and Potential for growth © Sanigest 2005 Original Página 14
  • 15. Undermining the pharmaceutical market… One survey showed that An estimated 7-22% of 50% of Latin Americans drugs on the market in use under-the-counter Latin America are (UTC) drugs on a regular counterfeit basis Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 15
  • 16. Distribution Channels • Public health insurance vs. pharmacies – Patented medicines not always stocked by public sector pharmacies – Consolidation of pharmacy chains: Retail sector controlled by few main pharmacies – vulnerable to collusion • Penetration of private pharmacies into new markets – Increasingly rapidly (11% increase in 2009 in Argentina alone) – Dominated by high price branded medicines – Introduction of private pharmacies could spur pricing wars – Possible shift to private pharmacy dispensing for public systems could drive sales. • Possibility of regional purchasing for Central America would create regional purchasing pool putting pressures on margins. © Sanigest 2005 Original Página 16
  • 17. Factors affecting pharmaceutical supply and demand Final determination of market size depends on interaction of demand and supply with the health system Demand Supply Health System © Sanigest 2005 Original Página 17
  • 18. Factors affecting pharmaceutical supply and demand Market access strategies and estimates of demand should be based on realistic assessment of interaction of health systems factors for each product… Financing Access Market Regulation Access Staff © Sanigest 2005 Original Página 18
  • 19. Trend: Data Driven Approach Market access strategies should look carefully at population segmentation, insurance coverage and expansion of access and technology. © Sanigest 2005 Original Página 19
  • 20. Looking Ahead Three factors affecting pharmaceutical demand: 1 Epidemiological and demographic shifts 2 Global economic climate 3 Expanding national health insurance © Sanigest 2005 Original Página 20
  • 21. Age standardized DALYs (per 100,000 pop.) by cause Countries are moving from a high communicable disease burden to a high chronic disease burden Chronic disease care will require long-term and/or high tech pharmaceutical solutions High Income Country Disease Profile © Sanigest 2005 Original Página 21
  • 22. Demographic Shift: increased overall demand and demand for specialized care (geriatric, chronic disease, etc.) Population over 40 will increase from177,881,896 in 2009 to 293,140,656 in 2030 Population Boom Demographic Aging Population 2025 % increase (2010-2025) 0-14 15-64 65+ 250 25 100 Millions 90 200 20 80 Total population 70 % increase 150 15 60 50 40 100 10 30 20 50 5 10 0 0 0 Colombia Chile Peru Argentina Brazil Venezuela Mexico Source: Population Reference Bureau, CIA World Fact book, US Census Bureau © Sanigest 2005 Original Página 22
  • 23. Demographic Shift Population 2010 Population 2030 100+ 100+ 95-99 Female 95-99 90-94 90-94 Male Female 85-89 85-89 80-84 80-84 Male 75-79 75-79 70-74 70-74 65-69 65-69 60-64 60-64 55-59 55-59 50-54 50-54 45-49 45-49 40-44 40-44 35-39 35-39 30-34 30-34 25-29 25-29 20-24 20-24 15-19 15-19 10-14 10-14 5-9 5-9 0-4 0-4 40 20 0 20 40 40 20 0 20 40 Millions Millions Over 70 age group has most drug users, so as Source: US Census Bureau Int’l Database and Norwegian Institute of Public Health countries age, drug consumption is expected to increase © Sanigest 2005 Original Página 23
  • 24. Looking Ahead Three factors affecting pharmaceutical demand: 1 Epidemiological and demographic shifts 2 Global economic climate 3 Expanding national health insurance © Sanigest 2005 Original Página 24
  • 25. Global Economic Climate • Increased cost for energy and importing raw goods for production Inflation • Rising consumer prices lowers demand • Cost-pressure on government spending • High unemployment depresses consumer Spending spending • Weakening Latin American currencies vs. USD Currency • Affect of shifting exchange rates on imports © Sanigest 2005 Original Página 25
  • 26. Looking Ahead Three factors affecting pharmaceutical demand: 1 Epidemiological and demographic shifts 2 Global economic climate 3 Expanding national health insurance © Sanigest 2005 Original Página 26
  • 27. As a general trend, Latin American governments are investing more in healthcare Healthcare expenditure (USD) as a % of GDP, 2005-2019 12 Argentina Healthcare expenditure as % of GDP 10 Colombia Mexico Peru 8 Venezuela Brazil 6 Chile Other 4 Increased healthcare 2 spending in: Colombia •Mexico 0 •Peru 2009 2014 2019 •Brazil Source: BMI country reports Q4 2010 © Sanigest 2005 Original Página 27
  • 28. Market Trends Colombia is expecting Mexico is universal and Venezuela is implementing unified health negotiating universal coverage by drug price health 2014 increases coverage Peru is increasing per These 7 capita drug Argentina is expenditure countries planning to represent a increase pharma market of 468 Chile is access increasing million people insurance and GDP of 2.7 coverage trillion USD Source: Business Wire and BMI country reports Q4 2010 © Sanigest 2005 Original Página 28
  • 29. Health insurance coverage 100% Mexico and Costa 90% Rica have the highest 0.2% 2.8% 19.6% 80% levels of public coverage (87%) 17.6% 70% 2.0% Population coverage 60% 7.9% 42.0% 50% 1.8% 86.8% 87.0% 40% 80.4% 10.0% 30.0% 67.1% 68.3% 30% 51.2% 45.0% 20% 5.0% 3.3% 34.4% 28.1% 10% 4.0% 18.0% 18.3% 15.1% 7.7% 0% Uruguay Chile Honduras Argentina Guatemala Nicaragua Peru Venezuela Brazil Mexico Colombia El Salvador Costa Rica Public Private © Sanigest 2005 Original Página 29
  • 30. Effects of Health Insurance Coverage on Pharmaceutical Markets • Expanding health insurance coverage – Increased drug consumption as more people are covered and reduces ‘co-pay’ • Potential for group purchasing of branded drugs – expands access but pressure on unit prices • Pharmacoeconomics as an influence on pharmaceutical supply – Using Health Technology Assessment (HTA) to evaluate cost-effectiveness of treatment options © Sanigest 2005 Original Página 30
  • 31. Looking Ahead Three factors affecting pharmaceutical supply: 1. Pricing and reimbursement 2. Global economic climate 3. Technology: mHealth © Sanigest 2005 Original Página 31
  • 32. Pricing and Reimbursement 2011 emphasis on procurement and un-regulated private pricing should shift to more regulated P&R schemes with reference pricing, discounting and more aggressive pharmacist distribution. Increasing interest in LA to use HTA, or pharmacoeconomics for formulary and pricing decisions. Price Prior Discounts Freezes authorization Pharmacist substitution Positive & P&R measures in Latin America Negative OTC Substitution Reference Patient co- Rebate & Pricing pay taxes © Sanigest 2005 Original Página 32
  • 33. Pricing and Reimbursement Large Increase Private Increase in formal Insurance Market labor market  social insurance Growth of Middle • Private insurance Class greater pressure • Increase access to reimbursement Market social insurance control, more Size • Middle-of-Pyramid reduces OOP and interest in branded driving shifts purchasing to differentiate. consumption • Increased access to private pharmacy Small Low High Pressure on P&R © Sanigest 2005 Original Página 33
  • 34. What‟s on the horizon for pharmaceutical pricing? • Expanding use of “procurement auctions” to obtain value for money in social security purchases: example Mexico IMSS and Chile • Increasing use of reference pricing for public and private sectors • Tightening of private distribution of prescription drugs • Increasing consolidation of public coverage of the population  reduction in out-of- pocket private spending. • Introduction of Pay-For-Performance scheme for expanding use of innovators © Sanigest 2005 Original Página 34
  • 35. Looking Ahead Three factors affecting pharmaceutical supply: 1. Pricing and reimbursement 3. Technology: mHealth © Sanigest 2005 Original Página 35
  • 36. Looking Ahead Three factors affecting pharmaceutical supply: 1. Pricing and reimbursement 3. Technology: mHealth © Sanigest 2005 Original Página 36
  • 37. Trend: Mhealth Mhealth has the potential to be a disruptive technology for pharma industry… …Early innovators may capture market share © Sanigest 2005 Original Página 37
  • 38. mHealth Pharmaceuticals Incidence of mhealth on pharma industry Controlling Counterfeit Chronic Compliance care Supply Payments Chain Adherence Source: Healthcare on Mobiles 2010 © Sanigest 2005 Original Página 38
  • 39. mHealth: Adherence and Chronic Care Offers unique opportunity for communication with patient Improved patient adherence • Studies show improved TB, HIV drug adherence • Improved adherence to glucose control and weight loss programs Evidence suggests Improved patient outcomes that successful trials and pilot • Link patient biomarkers to dosing programs could be • Improved glucose control easily adapted to • Better/faster diagnostic testing the Latin American context © Sanigest 2005 Original Página 39
  • 40. Evidence for mHealth Study Impact Mobile Phone-Based Remote Patient Monitoring System  Average 24-h BP fell by 11 /5 (+/- 13/7 SD) mmHg a difference of for Management of Hypertension in Diabetic Patients 35% from baseline (Logan et al. 2007)  Overall, BP improved significantly “Comparison of an SMS text messaging and phone  Subjects who received a text message reminder were 60% more reminder to like than controls to attend their health appointment improve attendance at a health promotion center: A randomized controlled trial “ (Chen et al. 2008) “A randomized control trial of Sweet Talk, a text  Patients with Sweet Talk and intensive therapy had a decrease of messaging system to support young people with 9.2% (+/- 2.2%) in their blood glucose. Other groups had no diabetes” (Franklin et al. 2006) significant change  No impact on knowledge score “A randomized trial of a proactive cellular telephone  Those receiving the mobile intervention were 3.6 times as likely to intervention for smokers living with HIV/AIDS “ quit smoking at 3 months than controls (Vidrine et al. 2006) “Using internet and mobile technology to deliver an  The intervention group lost significantly more body fat and had automated physical activity program: randomized significantly more physical activity than the control group controlled trial” (Hurling et al. 2007 ) SIMpill  Treatment success 94% with SIMpill (compared to 71% nationally with standard DOTS) © Sanigest 2005 Original Página 40
  • 41. More cost-benefit research is needed to guide development of scalable business models for pharma in mhealth © Sanigest 2005 Original Página 41
  • 42. Future Forces © Sanigest 2005 Original Página 42
  • 43. Conclusions • Epidemiological and demographic shifts will increase overall demand for pharmaceuticals • Increased government investment in healthcare and expenditure on pharmaceuticals through 2019 • Trends like mHealth could increase pharmaceutical sales through: – Increased patient compliance and preference for branded drugs tied to mHealth technology • Likely shift to reference pricing • Increased insurance coverage - Pharmacoeconomics influence on drug supply - Potential for group purchasing © Sanigest 2005 Original Página 43
  • 44. Thank you for your Attention Contact Information James A. Cercone jcercone@sanigest.com © Sanigest 2005 Original Página 44
  • 45. Works Cited 1. Argentina Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. 10 Jul. 2010. 2. Brazil Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010. 3. Chile Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010. 4. CIA World Factbook. Available online at http://www.cia.gov. Accessed 23 Jan. 2011. 5. Colombia Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Aug. 2010. 6. „Drug Consumption in Norway – A Fact Sheet.‟‟ Norwegian Institute of Public Health. 5 Jul. 2010. 7. Global Infobase. WHO. Available online at http:///Infobase.who.int. Accessed 21 Jan. 2011. 8. Image of Latin America available online at http://www.worldatlas.com. Accessed 24 Jan. 2011. 9. „Kaiser Permanente Teams With mobileStorm for SMS Reminders, Sees 30% Cost Savings.‟ Mobile Marketing Watch. 30 Dec. 2009. Available online at http:///www.mobilemarketingwatch.com. Accessed 30 Jan 2011. 10. Mexico Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Jul. 2010. 11. Peru Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010. 12. “Population mid-2025 (projected).‟‟ Population Reference Bureau. PRB 2010 World Population Data Sheet. 13. „The Pharmaceutical Markets in Latin America USD41 Billion – and Growing Fast.‟‟ Business Wire. 18 Jan. 2011. 14. „The World Bank, Pharmaceutical Policies and Health Reforms in Latin America.‟ International Journal of Health Services. Vol. 35, No. 4, 2005: 691-717. 15. US Census Bureau International Database. Available online at http://www.census.gov/ipc/www/idb. Accessed 31 Jan 2011. 16. Venezuela Pharmaceuticals & Healthcare Report Q4 2010. Business Monitor International. Sept. 2010. © Sanigest 2005 Original Página 45