Opportunity Analysis for Biosimilars – Korea
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Transcript of Opportunity Analysis for Biosimilars – Korea
Opportunity Analysis for Biosimilars – KoreaOpportunity Analysis for Biosimilars – Korea
Yamunah Kandasamy, Research AnalystHealthcare
18 May 2012
© 2012 Frost & Sullivan. All rights reserved. This document contains highly confidential information and is the sole property of Frost & Sullivan. No part of it may be circulated, quoted, copied or otherwise reproduced without the written approval of Frost & Sullivan.
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Today’s Presenter
Apart from market opportunity analysis, Yamunah has knowledge and experience base covering following range of sectors, with exposure to end users’ perspective on medical investments such as stem cell harvesting.
Medical devicesBiotechnologyMedical imagingLife Sciences and IT
Yamunah Kandasamy, Research Analyst
Frost & Sullivan
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Focus Points
• South Korea Biosimilars Market Overview• Challenges, Drivers and Restraints of Biosimilars Market• Competitors’ Profile• Last Word - Conclusion
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South Korea Biosimilars Market Overview
• A new engine of Korea’s economic growth
• Biosimilars are generics for biologics or biotechnology drugs
• Requires upfront investment and infrastructure for the development, much lesser than
biologics but much more than the development of generic drugs
• Doctors may be reluctant to prescribe biosimilars, as the developers capabilities, expertise
and credentials may not be known to them as much as the innovator drug manufacturing
companies
• The U.S. market will be tough for Korean firms to penetrate
• South Korea has a long history in manufacturing biologicals and a regulatory pathway for
biosimilars was introduced in 2009
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Market Segmentation
• Biosimilars, the imitation of biological products follow the same segmentation. They can be broadly divided into therapeutic proteins whose basis are large blocks of amino acids while the other category includes antibody-based therapeutics.
• The geographical scope of this research is South Korea, an emerging market with immense potential to become a strong player in the biosimilars market.
• Vaccines are not covered in this research.
Market Segmentation
• Biosimilars, the imitation of biological products follow the same segmentation. They can be broadly divided into therapeutic proteins whose basis are large blocks of amino acids while the other category includes antibody-based therapeutics.
• The geographical scope of this research is South Korea, an emerging market with immense potential to become a strong player in the biosimilars market.
• Vaccines are not covered in this research.
Total Biosimilars MarketTotal Biosimilars Market
Biosimilars Market: Market Segmentation (Korea), 2011
Human growth hormones
Human growth hormones
ErythropoietinErythropoietin G-CSFG-CSF
Source: Frost & Sullivan
Market Overview—Segmentation
Monoclonal AntibodiesMonoclonal Antibodies
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Revenue Forecasts
Years
61.063.6
75.1
89.7
82.1
71.167.262.3
Biosimilars Market: Revenue forecasts (Korea), 2010
Source: Frost & Sullivan analysis
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Biosimilars Market Challenges in Emerging Markets
EMERGING MARKETS
Source : Frost and Sullivan
Quality consciousness among doctors/physicians
Doctors/physicians are loyal to innovator molecules and can be very fussy in switching prescriptions. However, when price is concerned, a lower prices presents an attractive proposal if the similarity is established.
Lack of or low reimbursement for high priced biologics
Emerging countries typically have poor insurance coverage.
Huge patient potential in ROW
Breast cancer, non-Hodgkin's lymphoma (NHL), autoimmune deficiencies are out of control and most of the time, do not afford biologics.
Lack of patent protection for high growth products (G-CSF and MAbs)
Lack of patent rights in majority of the emerging countries for biologics like enbrel, TNF- alpha inhibitors creates a huge market.
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Biosimilars Challenges in South Korea
• Acceptance by doctors/ physicians to switch prescriptions
• Immunogenicity and complexity in establishing similarity with the originator molecule
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Drivers 1–2 Years 3–4 Years 5–7 Years
Strategic partnerships between Korean biosimilar
companies and other company to drive growthL M H
Access to patients in comparison to cost containment will compensate for lower prices of biosimilars
H M M
Impact Ratings: H = High, M = Medium, L = Low
Drivers—Impact and Duration
Source: Frost & Sullivan analysis
Market Drivers – Biosimilars Market, South Korea, 2011
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Drivers—Explanation
• Strategic partnerships between Korean biosimilar companies and other company to drive
growth
Samsung Electronics Co., Ltd., the world’s largest electronics company, and its affiliated companies
have entered into a strategic partnership with Quintiles, the world’s leading pharmaceutical
services company, to support Samsung’s entry into the biopharmaceuticals market.
• Access to patients in comparison to cost containment will compensate for lower prices
of biosimilars
Only a proportion of patients currently have access to expensive life-saving drugs, the availability of
lower cost biosimilars will allow more patients to be treated. Also, as access to patients
increases, cost containment such as price cuts will compensate for lower prices of biosimilars.
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Restraints 1–2 Years 3–4 Years 5–7 Years
Biosimilar clinical trials require large capacity for approvals from FDA/EMEA/PMDA to cater to export markets
H H M
Cost of development and marketing necessitates deep pockets which in turn requires partnerships with big pharmas/regional partners
H H M
Impact Ratings: H = High, M = Medium, L = Low
Restraints—Impact and Duration
Source: Frost & Sullivan analysis
Market Restraints– Biosimilars Market, South Korea, 2011
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Restraints—Explanation
• Biosimilar clinical trials require large capacity for approvals from FDA/EMEA/PMDA to
cater to export markets
Before biosimilars drugs can be marketed globally, clinical trials need to be done and approved by
FDA/EMEA/PMDA. Biosimilar clinical trials are generally needed in large quantities because the
comparability test and samplings need to be done repetitively to ensure consistent results.
• Cost of development and marketing necessitates deep pockets which in turn requires
partnerships with big pharmas/regional partners
Development and marketing cost of biosimilars are high, this creates a necessity for companies
to make strategic partnerships with big pharmas/regional partners to have more cash flow.
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Competitive Landscape
Company Core Portfolio Corporate Strategies
Samsung Electronics Consumer Electronics/IT Industry Entering biosimilars business (2009)
ISU Abxis Antibody therapeutics Biologics/Biosimilars
AprogenMonoclonal Antibodies
(NCEs/Biosimilars)Biosimilars
Teva PharmaceuticalsNCES (CNS therapeutics)
Generics/Biosimilars
LG Life Sciences-LG Subsidiary NCEs/Biologics/Biosimilars NCEs/Biosimilars
Source: Frost & Sullivan analysis
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Company Core Portfolio Corporate Strategies
CelltrionTherapeutic monoclonal antibodies,
Recombinant proteinsGenerics/Biosimilars
Dong-A PharmaceuticalNCEs (antibiotics)/
Biologics/Biosimilars NCEs/Biologics/Biosimilars
Competitive Landscape (Cont’d)
Source: Frost & Sullivan analysis
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The Last Word — Conclusion: Key Take-Aways
22With companies like Samsung making a foray into biosimilars, the market will witness newer entrants and changing business models. However, the success will largely depend on their ability to overcome the threat from big pharma’s strong expertise in marketing
With companies like Samsung making a foray into biosimilars, the market will witness newer entrants and changing business models. However, the success will largely depend on their ability to overcome the threat from big pharma’s strong expertise in marketing
33 The Korean market is expected to be largely export driven . Exports are expected to contribute as much as 50% of the total revenues. The Korean market is expected to be largely export driven . Exports are expected to contribute as much as 50% of the total revenues.
11By 2020, the familiar crisis of dwindling pipeline will hit the biosimilars as newer and more complex originator molecules need to be identified as target markets
By 2020, the familiar crisis of dwindling pipeline will hit the biosimilars as newer and more complex originator molecules need to be identified as target markets
Source: Frost & Sullivan analysis
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For Additional Information
Donna JeremiahCorporate CommunicationsAsia Pacific+61 (0) 8247 8927 [email protected]
Carrie LowCorporate CommunicationsAsia Pacific+603 6204 [email protected]
Miok LeeCorporate CommunicationsKorea+ 82 2 6710 [email protected]