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Biosimilars in Emerging Markets

  • March 2013
  • -
  • Firstword Pharma
  • -
  • 226 pages

What are the implications for regulators, biosimilar companies and branded manufacturers?

There are few areas of the pharmaceutical market more hotly debated than biosimilars yet the pathway to developing a viable global product marketplace is not clear. Biosimilar interest is being driven by the potential offered by a range of high-value brands which will be subject to patent challenges in the next 5-10 years such as Roche’s Herceptin and Avastin.

The US market remains the big prize for biosimilars but is stalled with an untried regulatory process. Europe is more advanced but there are significant barriers to entry. It is no surprise, then, that biosimilar developers are turning to emerging markets as a preferred market entry point.

The fundamentals of biosimilars in emerging markets are sound: high unmet clinical need in large and expanding populations, growing GDP and health spending, increasing patient expectation and often amenable regulatory regimes all provide a fertile environment for biosimilar products. Many biosimilar companies in emerging markets are developing networks and alliances outside of the US and Europe which is providing valuable revenue and knowledge of international trade. Are we seeing a 2-speed biosimilars sector in which emerging markets and companies are taking a lead?

Understanding this complex market requires a detailed analysis of the trends which are shaping its development. Biosimilars in Emerging Markets is a 2-volume report which provides both a comprehensive overview of the biosimilars sector and highly-detailed expert analysis of the issues that are affecting developments on the ground in a range of emerging markets including Korea, India, China, Brazil, Russia and Turkey.

Report Overview

VOLUME 1: Putting emerging markets and companies into global context

This detailed volume succinctly reviews the biosimilars sector and will ensure you have a complete working brief of the current state of emerging markets in their international context. It provides a review of regulations covering biosimilars, identifies sales and patent expiry of leading biological brands and looks at market value and biosimilar pricing. There are country-by-country appraisals of leading emerging economies which examine the biosimilar operating environment along with company profiles of 23 local biosimilar developers with pipeline analysis for leading organisations.

VOLUME 2: Drilling down into emerging markets: local industry experts share their insights

What trends are driving biosimilars in emerging markets? Many countries have the need for biosimilars but do not have the development or manufacturing capacity to produce biosimilars for their own population. At the other end of the scale, a good deal of government interest and incentive for private companies has established the necessary framework for national/regional supply with long term ambitions for US/Europe. Even so, biosimilar companies may face challenges even with their own markets such as patient and clinical concerns over safety and quality. Volume 2 brings together highly-detailed market analysis with contributions from local industry experts whose clear insights provide a real world perspective of opportunities and challenges which must be overcome now and in the future.

The benefits of this 2 volume report...

Critically evaluate which emerging markets are best placed to exploit biosimilars
Evaluate the patent expiry profile of leading brands likely to be subject to biosimilar competition
Identify the position, products, pipelines and ambitions of leading companies from emerging markets
Gain valuable expert insights as to what the real situation is in emerging markets and their approach to biosimilars
Bring clarity to your understanding of the often confused regulatory pathways to be found worldwide
Knowledgeably define strategic responses to the opportunities and threats from biosimilar development in the emerging market world

Do you know...?

Which emerging market companies have got biosimilar versions of Roche’s Herceptin in development?
With which companies has Korean biosimilar company Celltrion struck alliances?
What role Korean electronics giants Samsung and LG are playing in the biosimilars area?
How Roche has responded to falling sales of MabThera as it comes under pressure from Dr Reddy’s Reditux biosimilar in India?
What the data requirements are for biosimilar applications in Latin America and how they vary between countries?
How the Brazilian government is incentivising biosimilar developers?
How Turkey can play an influential role in the markets for biosimilars in the Middle East?
Which Russian companies are building new bio-manufacturing plants?

Key quotes from Volume 2 of this report

From Brazil...
“The government’s goal is to build internal biotechnology and biomanufacturing capabilities, not provide foreign drug makers with unfettered access to the Brazilian pharmaceutical markets. The government’s bottom line is to reduce Brazil’s dependence on expensive, imported drugs.”
Kai Wolf
Genericpharma 2.0

From China...
“Most companies do not think beyond their local market. With 60 plus companies going after the same biosimilar portfolio, companies looking globally may have a strategic advantage and emerge as a winner,”
H Fai Poon
R&D Director
Hisun Pharma China

From India...
“In addition to our success in India, Biocon supplies 60% of the world’s biosimilar insulin to emerging markets like Mexico, Brazil, the Middle East, North Africa and many parts of Southeast Asia”.
Kiran Mazumdar Shaw
CEO and Chairman of Biocon
Biosimilar Manufacturer

From Russia...
“We don’t consider European or US markets as our priority in the long term. We are focused in the short term on markets of Russia with Southeast Asia and Latin America as mid-term goals.”
Roman Ivanov
VP of R&D Biocad
Biosimilar Manufacturer

On South Korea...
“The public and physician perception of biosimilars is critical for their acceptance in the Korean market. We believe that there needs to be huge investments in educational and marketing activities in both pre-and post-launch of these products.”
Paul Coleman
Hanwha Biologics

Table Of Contents

Biosimilars in Emerging Markets
1.Volume I: Understanding the market environment
1.1.The global biologics market
1.2.Patent expiries of leading biologics
1.3.Biosimilars in the global market
1.4.First generation biosimilars
1.5.Price comparison of biosimilars vs. reference product
1.6.Second generation biosimilars

2.Global Regulatory Picture
2.1.European Union
2.2.Other developed markets: Australia, Canada, Japan, Singapore
2.3.United States

3.Emerging markets
3.1.Demographic, economic background and pharmaceutical market size
3.2.Generics and biosimilars in emerging economies
3.3.Market characterisation, leading players and regulation in:
4. Latin America: Brazil and Mexico

5. Asia: India and South Korea

6. Middle East and Northern Africa: Saudi Arabia and Turkey

7.23 Company profiles including
7.2.Anhui Anke Biotech
7.4.Beijing SL Pharma
7.10.Dr Reddy's
7.11.Hanwha Biologics
7.12.Hikma Pharmaceuticals
7.13.Innovent Biologics
7.14.LG Life Sciences
7.15.Isu Abxis
7.17.Panacea Biotech
7.19.Reliance Life Sciences
7.20.Shanghai CP Guojian Pharmaceutical
7.21.Teva Pharmaceutical Industries
7.23.Zydus Cadila

8.Volume 2: Perspectives on market-shaping trends, challenges and opportunities

9.Comprehensive country analysis informed by industry experts
9.1.First Generation Biosimilars
9.2.Second Generation Biosimilars
9.3.Safety Concerns and Cost Savings
9.4.Key Players: Who's Who?
9.5.Not All Emerging Biosimilar Markets Are the Same

10.Individual Country/Regional Analysis

11.For each country covered in Volume 2 the following is provided:
11.1.Demographics and Market Size
11.2.Regulatory Overview
11.3.Market Characteristics and Key Players
11.4.Challenges and Hurdles

12.Countries/Regions covered
12.3.South Korea
12.4.Taiwan and other Asian Pacific Nations
12.11.Middle East
12.12.Northern Africa

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