Key Trends in BRICMIST Market Access
Key Trends in BRICMIST Market Access
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Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.
Publisher: Datamonitor Healthcare
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Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets. Rising incomes and broader access to subsidized provision have been the main drivers of demand for medicines in these eight markets, but the booming economies which fueled these trends are running out of steam. Where public healthcare spending has increased, budgets are now under growing pressure, prompting the imposition of tougher cost-containment policies and, in some countries, threatening future healthcare reform plans.
Pharmaceutical expenditure is a favored cost-containment target, and while patient demand for broader access to new drugs is rising, policymakers are being forced to weigh a desire to respond to those calls against the need to limit the impact of such products on healthcare budgets. As a result, while efforts are being made to ease the development and registration of innovative medicines, more restrictive rules governing their procurement, pricing, reimbursement, prescription, and promotion are being implemented. These developments are driving rapid changes in the market access climate, which manufacturers must manage effectively if they are to build on their existing business in the BRIC/MIST countries.
Table of Contents
7 EXECUTIVE SUMMARY
7 Emerging markets are attractive targets that present unique challenges
7 Intellectual property protection is improving, but remains problematic
7 Regulatory reforms solve some problems – but create others
8 Cost-containment is driving pricing and reimbursement policy
8 Distribution chain dynamics are changing
8 Prescribing and promotion are subject to growing scrutiny
10 THE BRIC/MIST MARKETS
10 BRIC/MIST markets share several common characteristics
21 The BRIC/MIST pharma markets
27 Accessing the BRIC/MIST pharma markets
30 Bibliography
33 INTELLECTUAL PROPERTY PROTECTION
34 International obligations versus local stakeholder interests
35 Patent enforcement, linkage, and data protection are key targets for improvement
36 Compulsory licensing remains a threat in some countries
37 Key national developments
44 Bibliography
47 CLINICAL TRIAL REGULATIONS
47 Clinical trial activity in the BRIC/MIST markets
48 Key national developments
53 Bibliography
55 DRUG REGISTRATION
55 Registration is a significant barrier to market access
55 Efforts to expedite drug registration are under way
56 Key national developments
65 Bibliography
69 PRICING
69 Pricing controls are a growing feature of the BRIC/MIST landscape
70 Manufacturers are refining pricing strategies
71 Pricing policy trends
72 Key national developments
81 Bibliography
84 REIMBURSEMENT AND FORMULARY ACCESS
84 Major reimbursement issues
87 Key national developments
101 Bibliography
106 PUBLIC SECTOR PROCUREMENT
106 Procurement strategies as a cost-containment tool
108 Key national developments
113 Bibliography
115 DISTRIBUTION
115 Barriers to market access for imported drugs
117 Key national developments
122 Bibliography
126 PRESCRIBING
126 Shortages of medical specialists
127 Regulatory controls on prescribers
127 Enforcing the prescription status of antibiotics
128 Affordability as a barrier to prescribing
128 Key national developments
136 Bibliography
139 PROMOTION AND MARKETING
139 Promotion as a market access tool
140 Regulatory controls on promotion and marketing are being stepped up
141 Key national developments
146 Bibliography
149 MARKET ACCESS OUTLOOK IN THE BRIC/MIST MARKETS
149 Key trends
151 Brazil
155 Russia
158 India
161 China
164 Mexico
167 Indonesia
170 South Korea
173 Turkey
176 Bibliography
182 APPENDIX
182 About the author
182 Scope
182 Methodology
15 Figure 1: Population aging in the BRIC/MIST markets, by country, 2015–30
List of figures and tables
15 Figure 1: Population aging in the BRIC/MIST markets, by country, 2015–30
18 Figure 2: National healthcare spending as a percentage of gross domestic product in the
BRIC/MIST markets, by country, 2000–14
18 Figure 3: Per capita health spend in the BRIC/MIST markets, by country, 2013
20 Figure 4: Out-of-pocket contributions to national health spending in the BRIC/MIST markets,
by country
23 Figure 5: Shares of the BRIC/MIST market countries, 2015
26 Figure 6: BRIC/MIST pharmaceutical market growth forecasts, by currency (%), 2016
34 Figure 7: BRIC/MIST intellectual property protection regimes, by country
35 Figure 8: Key originator intellectual property protection concerns in BRIC/MIST markets, by
country
48 Figure 9: New Phase II/Phase III industry-funded trials in the BRIC/MIST markets, by country, 2011–15
62 Figure 10: New allopathic drug approvals in Mexico, 2010–15
78 Figure 11: Comparison of patented drug prices in South Korea and other Asian markets
88 Figure 12: Outcomes of completed CONITEC reviews, by source of submission, between 2011
and July 2015
100 Figure 13: Public sector drug spending as a proportion of gross domestic product in Turkey,
2002–14
131 Figure 14: Contributions to public hospital revenues in China
11 Table 1: Key constraints and drivers of market access in BRIC/MIST markets
13 Table 2: BRIC/MIST populations, current growth rates and 2025 forecasts
16 Table 3: Proportion of mortality attributable to non-communicable diseases in the BRIC/MIST markets (%)
21 Table 4: Pharmaceutical market rankings of BRIC/MIST countries in the global top 20,
2003–18
23 Table 5: BRIC/MIST pharmaceutical market values, 2015
25 Table 6: Impact of currency movements on the value of BRIC/MIST markets, by country,
2015–16
33 Table 7: Global competitiveness rankings for BRIC/MIST intellectual property protection
frameworks
37 Table 8: Compulsory licenses issued by Indonesia in 2012
57 Table 9: Lag times between FDA and ANVISA approvals of new oncology drugs
88 Table 10: Outcomes of completed CONITEC reviews, by source of submission, between 2011
and July 2015
89 Table 11: Q1 federal funding for CEAF catastrophic drug coverage, 2013–16
92 Table 12: Additions to the VZN reimbursement schedule, 2015
97 Table 13: Significant omissions from the Mexican Social Security Institute’s 2016 formulary
98 Table 14: Low reimbursement listing rates for orphan and oncology drugs in South Korea
between 2007 and July 2014
135 Table 15: Impacts of cost-effective prescribing initiatives in South Korea, 2002–13
153 Table 16: Market access outlook in Brazil
156 Table 17: Market access outlook in Russia
159 Table 18: Market access outlook in India
162 Table 19: Market access outlook in China
165 Table 20: Market access outlook in Mexico
168 Table 21: Market access outlook in Indonesia
171 Table 22: Market access outlook in South Korea
174 Table 23: Market access outlook in Turkey
Table 1: Key constraints and drivers of market access in BRIC/MIST markets
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