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Orphan Drug Commercialisation and Market Access in Emerging Markets

1 Executive summary
2.Research Strategy
3.Glossary
3.1.SWOT Analysis: Market Access for Orphan Drugs in Emerging Markets
4.Introduction
5.Market shaping for orphan medicines in emerging markets
5.1.Access to orphan drugs in emerging markets is inconsistent
5.2.On paper, access is better than might be expected
5.3.In emerging markets, market shaping has a broader definition
5.4.Disease guidelines can give local experts a voice
5.5.Emerging-market physicians and patients are eager to engage
6.Market access and pricing for orphan medicines in emerging markets
6.1.Registries, not risk shares, can address payer uncertainty
6.2.Conditional Coverage Has Limited Scope in Emerging Markets
6.3.Named Patient Programmes are a Time-Limited Solution
6.4.Orphan Drugs’ High-Price, Low-Budget Impact Business Model is Problematic
6.4.Market Segmentation is a Critical Success Factor
7.Middle East & Africa
7.1.SWOT Analysis: Middle East & Africa
7.2.Some Middle Eastern populations have unique rare disease characteristics
7.3.Wealthy populations and first-class infrastructure, but pricing is a challenge
7.4.Pricing and reimbursement barriers in the Middle East & Africa
7.4.Market access is highly specific to the local context
8.Latin America
8.1.SWOT Analysis: Latin America
8.2.Niche reimbursement, and court injunctions, drive the opportunity in Latin America
8.3.Some Latin American payers cannot meet their policy commitments
9.Eastern Europe & Central Asia
9.1.SWOT Analysis: Central & Eastern European Emerging Markets
9.2.Russia is the largest market, but is challenging for foreign companies
9.3.European Union and Periphery: Transitioning from Price Markets to HTA markets
10.Asia and the Pacific Rim
10.1.SWOT Analysis: Asia and the Pacific Rim
10.2.Rare Diseases Struggle to Gain Acceptance in China and India
10.3.Mid-Sized Asian Markets Offer Small Opportunities for Orphan Drugs
11.Conclusions
12.About the author

Orphan Drug Commercialisation and Market Access in Emerging Markets

Introduction

Market access for orphan drugs: Can your company break through in emerging markets?
Find out which emerging markets offer the best investment prospects for orphan drug manufacturers.
Based on interviews with eight senior executives and two specialist market access consultants, the report explores more than 35 emerging markets, and gives you a ranked list of the 15 most promising targets.
You'll understand emerging markets’ unique dynamics, hear about local stakeholders who help shape the market, and learn how to build the critical mass your product needs to win broad reimbursement at a fair price.

Reasons to Purchase

Actionable information for orphan drug manufacturers

  • Understand emerging markets: Breakdowns of the strengths, weaknesses, opportunities, and threats (SWOT analysis) paint a clear picture of the market access climate four major regions.
  • Learn the facts on the ground: Charts and tables show you at-a-glance the unique market access barriers and opportunities you’re likely to encounter in 35 emerging markets.
  • Pinpoint the best opportunities: A ranked list of the 15 most promising emerging markets shows you which countries offer the pricing and reimbursement climates for manufacturers.
  • Get expert insight: Benefit from the verbatim comments of orphan-drugs experts, including top industry executives and experienced advisors with hands-on experience in emerging markets.
  • Find out what works: Get in-depth analysis of successful real-world strategies, including special access pathways for orphan drugs (pre-registration coverage, named patient programmes, etc.).
Answering Key Questions
  • Unfamiliar territory: The systems and standards that determine access for orphan drugs in advanced markets don’t apply in emerging markets. So what exactly are the ground rules?
  • Learn the local laws: Every emerging market has a different legal framework for orphan drugs. Find out how to navigate this ever-changing environment successfully.
  • Take a hands-on approach: In emerging markets, market-shaping may extend to helping locals close gaps in the health system. What kind of support should you be prepared to offer?
  • Don’t overstep: How do you ensure that your market-shaping activities align with local regulations, compliance protocols, and resource constraints?
  • Education is key: How does helping patients, payers and physicians understand rare disease treatment influence the conversation around market access?
  • Know who your friends are: Most emerging markets have friendly non-payer stakeholders with an interest in helping you broaden access to orphan drugs. Who are your most likely allies?
Expert contributors

The report is based on structured interviews with 10 subject matter experts: eight senior market access executives from leading orphan drug manufacturers, and two specialist market access consultants.
  • Sam Pearce, VP & General Manager EMEA Emerging Markets, Celgene
  • Ad Rietveld, Partner, RJW & Partners
  • Charles Rowlands, Managing Director, Parioforma Consulting
  • Helen Stoop, Regional Market Access Lead - Central Eastern Europe, Middle East and Africa (CEEMEA), Shire Pharmaceuticals.
  • Brazil Market Access Director, Rare Diseases-Focused Biopharmaceutical Company
  • Colombia Director, Top 10 Biopharmaceutical Company
  • Latin America Market Access Director, Leading Orphan Drug Company
  • International Marketing Director, Europe-based orphan drug manufacturer
  • Market Access Director, Rare Cancers-focused Biopharmaceutical Company
  • Orphan Disease Area Lead, Top 10 global pharmaceutical company
All respondents are responsible for their respective regions, or have special expertise in the countries surveyed, having led value dossier submissions and/or payer negotiations.

Interviews were conducted in April and May of 2016.
About FirstWord

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