Korea entry strategy (biocon)


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  • Biocon, India's largest biotech company is focused on delivering affordable innovation.
  • As a fully integrated biopharma company it delivers innovative biopharmaceutical solution ranging from discovery to development and commercilizatnE.g. Mylan and biocon
  • Biocon’s key innovation include world’s first pichia based recombinant human insulin “INSUGEN” and first indigeneously monoclonal antibody “BIOMAB”
  • Oral insulin and itolizumab
  • Chaebol (from chae: wealth or property + pol: faction or clan)[1] refers to a South Korean form of business conglomerate. They are typically globalmultinationals owning numerous international enterprises,[1] controlled by a chairman who has power over all the operations.[1][2] The term is often used in a context similar to that of the English word "conglomerate". The term was first used in 1984.[1] There are several dozen large Korean family-controlled corporate groups which fall under this definition.The chaebol has also played a significant role in South Korean politics. In 1988 a member of a chaebol family, Chung Mong-jun, president of Hyundai Heavy Industries, successfully ran for the National Assembly of South Korea. Other business leaders also were chosen to be members of the National Assembly through proportional representation. Since 2000, Hyundai has played a role in the thawing of North Korean and South Korean relationsin South Korea, it's apparently a different story. Samsung alone is responsible for 20 percent of the country's $1.1 trillion economy. For reference, government spen$237 billion in sales last year. Samsung Electronics is the crown jewel, and the country's biggest individual company.ding there also makes up about 20 percent of GDP.It plays such an outsized role in the nation's economic life that, according toBloombergBusinessweek, South Korea is referred to in some circles as "The Republic of Samsung.“It's closest rival is the Hyundai Motor Group, owner of the namesake car company and Kia Motors (and here you thought they were rivals). 
  • Uptake of biosimilars varies between different countries when therapy areas are considered according to drug class [1]. For example, the market for somatropin is differentiated due to a complex stakeholder landscape influenced by physicians, the competition is based on multiple marketing levers. This results in uptake of biosimilarsomatropin being significantly lower than in commodity markets where access is mostly controlled by payers, e.g. tender, step-wise algorithms; and price competition, e.g. G-CSF, epoietins. Differentiated biosimilars are most likely when they are indicated for chronic treatment and/or long therapeutic cycles, where patients prefer to stick to a ‘known’ product. On the other hand, commodity biosimilars are most likely those indicated for acute treatment and/or frequent cycling among therapies.
  • Korea entry strategy (biocon)

    1. 1. Market entry strategy for Mihir Pandit [PC-09] Jigar Raval [PA-08] Vipul Patil [PA-20] Bhakti Shethia [PC-20] Sneha Agarwal [QA-17]
    2. 2. OUTLINE  Biocon-Snapshot  Country Choice-Why South Korea?  External Challenges :Drivers and Restraints  Forecast trends  Entry Mode Strategy  Target market and Positioning  Strategic Implementation  Controls
    3. 3. BIOCON SNAPSHOT VISION Biocon is an emerging, global Bio-pharmaceutical enterprise that is focused on developing affordable products and services for patients, partners and healthcare system across the world. Biocon is committed to: • Reducing therapy costs of chronic diseases. • Research and marketing partnership that provide global access. • Leveraging the India cost advantage to deliver high value, licensable R & D assets. Source: http://www.biocon.com/docs/Biocon_H1FY1_MediaPrstn.pdf
    4. 4. COMPANY PROFILE Source: http://www.biocon.com/docs/Biocon_H1FY1_MediaPrstn.pdf
    5. 5. COMPANY PROFILE Source: http://www.biocon.com/docs/Biocon_H1FY1_MediaPrstn.pdf
    6. 6. PRODUCT PORTFOLIO Source: http://www.biocon.com/docs/Biocon_H1FY1_MediaPrstn.pdf
    7. 7. PRODUCT PIPELINE 2 New drugs in late stage clinical trials Source: http://www.biocon.com/docs/Biocon_H1FY1_MediaPrstn.pdf
    8. 8. CEO PERSPECTIVE: WHY SOUTH KOREA? Focus on high growth product classes Continuous monitoring of Biobetters globally. Scalable production facilities Parallel product registration in developed markets products launch quickly and gain advantage. Partnerships with CROs will help speed up the drug development and registration process.
    9. 9. COUNTRY CHOICE Why choose South Korea Biosimilar market? •Long history in manufacturing biologicals •A regulatory pathway for biosimilars Requires upfront investment and infrastructure for the development, much lesser than biologics Source: Frost & Sullivan analysis Exports are expected to contribute as much as 50% of the total revenues. •Government’s policy to promote the biosimilars industry •Korean Food and Drug Administration (KFDA) •BLA (biologics license application) By 2030, its total number of retirees is forecast to be approaching 40% of the population. http://www.icis.com/blogs/asian-chemical-connections/2012/11/south-koreas-demographicchall/#sthash.2x5UWyfc.dpuf •Universal coverage of population through social health insurance (SHI) since 1989 •High out-of-pocket payment, amounting to 35-40% of total health expenditure •Social insurance for long-term care, introduced in July 2008
    10. 10. COUNTRY CHOICE Rank Disease Deaths % 1 Stroke 38497 17.19 2 CHD 20496 9.15 3 Lung Cancer 16437 7.34 4 Diabetes Melitus 13766 6.15 5 Stomach cancer 12794 5.71 6 Liver cancer 11797 5.27 7 Suicide 11408 5.10 8 Road traffic accident 7570 3.38 9 Colon cancer 7562 3.38 10 Liver disease 7406 3.31 Biocon’s Product portfolio is very suitable to penetrate market Source : WHO health statistics
    11. 11. 20 20.4 20.8 21.8 22.9 24.1 26.0 28.1 30 30.6 31.2 33.1 35.1 37.2 40.9 45.0 5 5.1 5.2 5.4 5.6 5.9 6.2 6.6 6 6.2 6.4 6.9 7.4 8.0 9.0 10.1 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 90.0 2010 2011 2012 2013 2014 2015 2016 2017 Human Growth Hormone Erythropoietin Monoclonal Antibodies GCSF COUNTRY CHOICE Biosimilars Market: Revenue forecasts (Korea), 2010 Years Revenues($million) Source: Frost & Sullivan analysis Biosimilar market is growing very rapidly and South korea in particular, with plan to become a leading biosimilars player.
    12. 12. ENVIORNMENT 1. 35% R&D biosimilar Investment in 2012 while in chemical drug development accounted for just 12 %. 2. Tailored consulting programme by KFDA 3. “Columbus” Project in 2011 4. Out of 36 biosimilars 47% are Mab included in korean pipeline. 5. Global leader with 17 mAb portfolio by 9 korean co. 6. Paradigm shift away from imitation towards innovation by focus on biobetters. Regulatory enviornment Operating environment 1. New pricing system 2. Pharma industry competitive enhancement plan: 3 criteria: Four benefits from govt: 1. Drug price benefit 2. Tax system support 3. Financial support 4. R&D support
    13. 13. • Chalebols: Business conglomerate like Samsung and LG • Samsung to invest 389 million in biosimilar devlopment. • Extreme pressure on local generics.(limited resources) • EU-FTA: July 2011 • US-FTA March 2012 • Tariff abolition • Strengthen IPR protection • Current negotiation with ASEAN countries and other countries. • Korean govt planning to invest 1 trillion won. • Democratic union party if elected-renegotiate . Local Industry and FTA’S ENVIORNMENT
    15. 15. DRIVERS: 1. Strong experience + Active government support 2. Accessibility +Cost 3. Focus on high growth G-CSF &Mab 4. Early mover advantage 5. Strategic partnership: Korean Biosimilars co. +foreign co. 6. Exmple: Samsung+ Quintiles RESTRAINTS: 1. Large capacities for approval (FDA/EMEA/PMDA) 2. Deep pockets. 3. Cost Effectiveness Major threats in Asia 4. Ambiguity in nomenclature. 5. Reluctance by physicians EXTERNAL CHALLENGES:
    16. 16. Forecast assumption 1. Market volume 2. Biosimilars penetration 3. Biosimilars market share 4. Economy indicators Revenue forecast discussion Among four segments 1.Erythropoitins : Example: Espogen by LG life science 2.Human growth hormone: Example: Euotropin FORECAST TRENDS
    17. 17. ENTRY MODE STRATEGY Source: http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf
    18. 18. ENTRY MODE STRATEGY Current Scenario: Innovation is not an easy game and my business model proves it can be done through partnering. One problem with India has been that we are not good at innovation. My model has been about partnering for innovation. - Kiran Mazumdar Shaw New Proposition : Strategic alliance with LG life science ltd as an entry mode strategy. Vision : To become a "top-tier life sciences company with world-class new drugs"
    19. 19. Main aim: Risk sharing & Increasing competitive strengths • To enter the South Korean market • Health profile of South Korea • Extensive sales & marketing network • R& D resources & know-how • Emerging as a global top brand in the diagnostic field • To add to the existing product portfolio RATIONALE FOR SELECTION
    20. 20. ENTRY MODE STRATEGY COMPETITIVE ADVANTAGE OF ALLIANCE HURDLES  Fast entry into the foreign market  Minimum risks  Better understanding of the host country  Access to new technology  More efficient production & innovation  Price – plays a key role  Competition with local Biosimilars  Huge promotional investment  Changing regulatory policies  Conflicts of control
    21. 21. TARGET MARKET Aging korean population demanding affordable therapy for diabetes, cancer & Cardiovascular diseases  Large pool of patients  Prevalence of diabetes- 8%, Incidence of disease – 0.4% per year  Insulin therapy  Huge demand for affordable products  Non-small Cell Lung Cancer drug market  Majority of patients in stage III or IV at the time of diagnosis
    22. 22. POSITIONING Commodity Differentiated BIOSIMILARS • Payer driven • Acute treatment • Price driven • Lower risk of immunogenic reaction • Fully understood mode of action • Chronic treatment • Limited competition • Higher risk of immunogenic reaction • Mode of action not clear • Influenced by multiple stake holders
    23. 23. PLACEPROMOTION STRATEGIC IMPLEMENTATION PRODUCT PRICE • Tailor go-to-market approach • To local dynamics, both in terms of sales force model and marketing offering • Target Therapy areas • Build trust and network development • Human Insulin • Insulin Lispro • Monoclonal Antibodies • Oncology products • Specialty and primary care products • lower cost biosimilar drugs •Value based pricing •Payer Strategy • South Korea • Export drugs to Asia and developed countries (EU, USA) through LG’s distribution network
    24. 24. CORRECTIVE ACTIONCOMPARE ACTUAL Vs PLANNED PERF. CONTROLS SETTING STANDARDS MEASURING ACTUAL PERFORMANCE • Build lasting, collaborative relationships with our customers • To check the above, consumer satisfaction and feedback website • Doing what’s right – for patients, customers and employees •Transaction strategy to balance and grow portfolios • Identification and evaluation of investment opportunities • Financial Report • This is the point of decision making • A thorough understanding of highly complex and dynamic healthcare systems • To be done quarterly initially and take proactive actions •In case of failure ,send a specialized team to assess the situation(risks and benefits of continuation). • Quality system design and optimization • GCP, GLP, GMP and cGMP compliance and risk mitigation
    25. 25. PUBLIC OPINION India- Global leader in Biosimilars