Middle East, North Africa and Turkey (MENAT)

Pharmaceutical Market Size:

$35 billion (Turkey 17%)

Expected Annual Growth:

7%

Countries:

Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, Turkey, United Arab Emirates and Yemen

Region in short:
  • 17 individual countries with very heterogeneous healthcare systems.
  • Mix of low-, middle-, and high-income countries, almost all of which offer a socialized healthcare system.
  • Proportion of public spending compared to out-of-pocket spending can vary widely.
Rare diseases segment:
  • A growing segment in the MENAT region, driven by genetic rare diseases, which are many times higher than in the West due to consanguinity.
  • Funding for rare diseases and orphan medicines is generally stronger in the Gulf region, but North Africa, led by Algeria, and now Egypt with its SMA launch, form the next wave.
  • Oncology is small comparatively to the regions' size due to its young population, but is still a very well-funded segment.
  • Named Patient Programs, especially for rare and specialized products, exist primarily in the wealthier countries and are an attractive entry point on the path to full commercialization.

Russia and CIS

Pharmaceutical Market Size:

$22 billion

Expected Annual Growth:

11-14%

Countries:

Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine, Uzbekistan

Region in short:
  • The region consists of formerly constituent republics of the Soviet Union and includes 11 countries, not all of which are necessarily part of the official CIS.
  • Russia is the dominant market, worth over $16 billion in 2020. The remaining CIS markets, driven mainly by Kazakhstan, Belarus and Uzbekistan, are worth about $6 billion.
  • Most of the former Soviet republics retain the socialized healthcare form (healthcare is free for all). However, what falls under universal healthcare can vary drastically by market.
Rare diseases segment:
  • Rare diseases, orphan products and oncology are very well-funded in Russia and other leading markets of the CIS region.
  • Russia accounts for around 90% of total product sales.
  • With the launch of the Krug Dobra (Circle of Kindness) fund in Russia in 2021, rare disease funding is expected to exceed $2 billion in 2022.
  • Oncology funding has doubled over the last three years.
  • For rare and specialized products, there are Named Patient Programs, especially in Russia, which represent an attractive entry point on the path to full commercialisation, especially with the new Krug Dobra fund.

Central and Eastern Europe (CEE)

Pharmaceutical Market Size:

$21.8 billion

Countries:

Austria, Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Kosovo, Latvia, Lithuania, North Macedonia, Poland, Romania, Serbia, Slovakia, Slovenia

Region in short:
  • The CEE region covers Central Europe, the Baltics, Eastern Europe, and South Eastern Europe.
  • The focus is on nine countries: Bulgaria, Croatia, Czech Republic, Hungary, Lithuania, Poland, Romania, Slovakia, and Slovenia. These countries have some of the most developed healthcare systems in Europe.
  • Poland was by far the leading pharmaceutical market in CEE in 2019, with sales of over €7.2 billion ($8 billion). Romania ranked second with pharmaceutical market sales of €3.1 billion ($3.5 billion) this year. In addition, the Czech Republic was around €3 billion ($3.3 billion).
Rare diseases segment:
  • Reimbursement decisions are mostly made by the national health policy authorities.
  • Access to reimbursed orphan drugs varies widely.
  • The type of approval plays an important role in many CEE countries. In the Czech Republic, Lithuania and Slovakia, reimbursement status is significantly associated with the type of marketing authorization, whereas in Croatia, Estonia, Hungary and Lithuania, the type of disease is significantly associated with reimbursement status.
  • The proportion of orphan drugs reimbursed is not significantly associated with GDP or GDP per capita.
  • Croatia, Hungary, Lithuania, Romania and Slovakia have specific laws/policies for orphan drugs.

Switzerland

Pharmaceutical Market Size:

$6.6 billion

Expected Annual Growth:

1-2%

Country in short:
  • Switzerland is not a member of the EU and does not follow the EMA regulations. Drugs are registered through the national authority Swissmedic.
  • Switzerland is one of the highest GDP per capita markets in the world.
  • Healthcare system is hybrid and highly decentralized, with the cantons or federal states playing a key role. The system is financed by premiums paid by the insured, taxes (mostly cantonal), social insurance contributions and out-of-pocket payments.
  • Residents are required to purchase insurance from private insurers.
Rare diseases segment:
  • Due to its position outside the EU, Switzerland is often overlooked for rare and orphan products.
  • While Switzerland has a Named Patient System, it is still attractive to pursue approval for rare and orphan products due to high level of reimbursement from Swiss insurers and the resulting better access.

Latin America (LATAM)

Pharmaceutical Market Size:

$50 billion

Expected Annual Growth:

11-14%

Countries:

Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, Uruguay, Venezuela

Region in short:
  • A developing market, complicated and diverse in terms of regulatory, reimbursement, market, demographics and politics.
  • Struggling to align its public spending.
Rare diseases segment:
  • The region's health systems struggle to provide funds for complex, high-cost treatments.
  • Brazil has pioneered in the development of specific regulations for rare diseases and gene therapies. However, these advances have had unintended consequences for the other institutions involved in the incorporation process, such as the increase in requests for inclusion of therapies in the public system.
  • All Latin American countries have enshrined 'health for all' in their constitutions. This obliges private and public health services to procure prescribed treatment from abroad when it is not available locally.

Expertise

The aim of the alliance is to provide the best service and flexibility to our pharmaceutical partners with orphan portfolios in a broader territory.

Together we can achieve more.

With deep understanding of local healthcare systems, we can support our partners to expand their business throughout the complex WODA regions.

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