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India: Manufacturing and R&D Hub for Bio-Pharmaceuticals. Himanshu DAVE Senior Vice President Corporate Business Strategy & Development Avesthagen Limited [email protected]. 1. Next decade Biosimilars would fuel the growth. - PowerPoint PPT Presentation
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India: Manufacturing and R&D Hub for Bio-Pharmaceuticals
Himanshu DAVESenior Vice President Corporate Business Strategy & DevelopmentAvesthagen [email protected]
• The global biopharmaceutical market is expected to grow to over $320 billion by 2020 (GBI Research)
• More than 30 branded biologics, with combined estimated annual sales of $51 billion,will lose patent between 2011 and 2015.
• Global sales of biosimilars reached $243 million in 2010 and are projected to grow to $3.7 billion in 2015 (Datamonitor)
• Estimates $100bn worth of biopharmaceuticals will have lost patent protection by 2020. (Frost & Sullivan)
• The global biopharmaceutical market is expected to grow to over $320 billion by 2020 (GBI Research)
• More than 30 branded biologics, with combined estimated annual sales of $51 billion,will lose patent between 2011 and 2015.
• Global sales of biosimilars reached $243 million in 2010 and are projected to grow to $3.7 billion in 2015 (Datamonitor)
• Estimates $100bn worth of biopharmaceuticals will have lost patent protection by 2020. (Frost & Sullivan)
Next decade Biosimilars would fuel the growthNext decade Biosimilars would fuel the growth
Three major clusters for biosimilars
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Can India can aspire to become Biopharmaceutical R&D & Manufacturing hub?Can India can aspire to become Biopharmaceutical R&D & Manufacturing hub?
But why India?But why India?
• Largest number of USFDA-compliant manufacturing facilities outside the US.
• India holds 8% (8.5% for China) of the global concentration of capacity and employment [source: Top 1000 Global Biopharmaceutical Manufacturing Index, BioPlan]
• Indian companies ahead of the Chinese companies in meeting US-FDA’s cGMP standards
• India's low-cost-high-value proposition offers an edge amidst global shortage of biomanufacturing capacity
• The Indian biopharmaceuticals market is currently worth nearly $2 billion a year and growing rapidly.
• 20 biopharma companies are already producing biosimilars
• Largest number of USFDA-compliant manufacturing facilities outside the US.
• India holds 8% (8.5% for China) of the global concentration of capacity and employment [source: Top 1000 Global Biopharmaceutical Manufacturing Index, BioPlan]
• Indian companies ahead of the Chinese companies in meeting US-FDA’s cGMP standards
• India's low-cost-high-value proposition offers an edge amidst global shortage of biomanufacturing capacity
• The Indian biopharmaceuticals market is currently worth nearly $2 billion a year and growing rapidly.
• 20 biopharma companies are already producing biosimilars
India’s main national competitors in the biopharmaceutical space include China, Israel, South Korea, Singapore and Taiwan.
These countries have initiated a number of infrastructure support and policy initiatives that provide an environment conducive to the growth of strong domestic industries
India’s main national competitors in the biopharmaceutical space include China, Israel, South Korea, Singapore and Taiwan.
These countries have initiated a number of infrastructure support and policy initiatives that provide an environment conducive to the growth of strong domestic industries
Competitive AnalysisCompetitive Analysis
Projected 2013Projected 2013
Manufacturing Capacity would Create Competitive EdgeManufacturing Capacity would Create Competitive Edge
India Scores over China in Manufacturing FOBIndia Scores over China in Manufacturing FOB
Current State of Indian Biopharma Current State of Indian Biopharma
R&D spend structure in India in 2010
REF: 12th 5 year plan
Indian Companies need to spend more on R&D
Academia - Industry
Need for Academy – Industry linkageRef: FICCI report
Trend in Growth of R&D Centers and talent poolsRef: http://yourstory.in
Increase in talent poolsIncrease in talent pools
Various funding options offered by Ministry ofScience & Technology
Ref: FICCI report
Govt has become supportiveGovt has become supportive
Ref: birapdbt.nic.in
Govt has become supportiveGovt has become supportive
• BIRAC (Biotechnology Industry Research Assistance Council) has initiated Biotechnology Ignition Grant (BIG) scheme.
• This scheme is designed to stimulate commercialization of research discoveries by providing very early stage grants for the development and maturation of those discoveries into marketable product or intellectual property (IP), in particular to help bridge the gap between discovery and invention.
• BIRAC (Biotechnology Industry Research Assistance Council) has initiated Biotechnology Ignition Grant (BIG) scheme.
• This scheme is designed to stimulate commercialization of research discoveries by providing very early stage grants for the development and maturation of those discoveries into marketable product or intellectual property (IP), in particular to help bridge the gap between discovery and invention.
Govt has become supportiveGovt has become supportive
• A significant R&D tax incentive in India is a 200% accelerated deduction on scientific research expenditure incurred by an in-house R&D facility within bio-technology or on the manufacture or production of an article or thing. This incentive has a sunset clause of March 31, 2012, but may get extended in Budget 2012 with the delayed introduction of the Direct Taxes Code (DTC).
• Other R&D-related tax benefits include 100% deduction of revenue and capital expenditure (other than land costs) in scientific research related to the business, and 125-175% deductions for contributions made to a scientific research association, university, college or other institution towards scientific research.
• A significant R&D tax incentive in India is a 200% accelerated deduction on scientific research expenditure incurred by an in-house R&D facility within bio-technology or on the manufacture or production of an article or thing. This incentive has a sunset clause of March 31, 2012, but may get extended in Budget 2012 with the delayed introduction of the Direct Taxes Code (DTC).
• Other R&D-related tax benefits include 100% deduction of revenue and capital expenditure (other than land costs) in scientific research related to the business, and 125-175% deductions for contributions made to a scientific research association, university, college or other institution towards scientific research.
Budget 2012, the first Budget of the Twelfth Five Year Plan, is likely to address short-term measures to support R&D, pending the introduction of future legislative reforms.
Budget 2012, the first Budget of the Twelfth Five Year Plan, is likely to address short-term measures to support R&D, pending the introduction of future legislative reforms.
Foster Research & DevelopmentFoster Research & Development
• Build Protein Characterization Laboratories and GLP-Certified Animal Study Facilities
• Create a National Animal Breeding Facility• Expand Viral Testing Facilities• Provide Financial Assistance for Ensuring Compliance with
Global Standards• Promote the Development of Pre-clinical Service Providers• Provide Practical Support for Clinical Trials• Simplify the Procedures for Importing and Exporting Biologics
• Build Protein Characterization Laboratories and GLP-Certified Animal Study Facilities
• Create a National Animal Breeding Facility• Expand Viral Testing Facilities• Provide Financial Assistance for Ensuring Compliance with
Global Standards• Promote the Development of Pre-clinical Service Providers• Provide Practical Support for Clinical Trials• Simplify the Procedures for Importing and Exporting Biologics
Improve Manufacturing & CommercializationImprove Manufacturing & Commercialization
• Create a Single-Window System for Approvals and Clearances
• Introduce Flexible Pollution Controls• Invest in Better Transport Links and Cold-Chain
Facilities• Provide Fiscal Incentives
• Create a Single-Window System for Approvals and Clearances
• Introduce Flexible Pollution Controls• Invest in Better Transport Links and Cold-Chain
Facilities• Provide Fiscal Incentives
Strengthening Human CapitalStrengthening Human Capital
• Expand India’s Capability in Toxicity Studies• Foster a Trilateral Relationship between Industry,
Academia and Government • Improve and Expand the Workforce Development
Pipeline• Establish Exchange Programmes, Finishing Schools
and Scholarships• Increase Public Awareness about Career
Opportunities in the Industry• Provide More Training for Existing Employees
• Expand India’s Capability in Toxicity Studies• Foster a Trilateral Relationship between Industry,
Academia and Government • Improve and Expand the Workforce Development
Pipeline• Establish Exchange Programmes, Finishing Schools
and Scholarships• Increase Public Awareness about Career
Opportunities in the Industry• Provide More Training for Existing Employees
Simplify Regulatory FrameworkSimplify Regulatory Framework
• Simplify the Procedure for Approving Biologics• Create an Independent Inspection Facility• Modify the Regulations on Process Validation
• Simplify the Procedure for Approving Biologics• Create an Independent Inspection Facility• Modify the Regulations on Process Validation
Incentivising InnovationIncentivising Innovation
• Provide Seed Funding for Innovation• Construct Biotechnology Clusters• Promote Translational Research• Provide Financial Support in Specific Areas of
Innovation
• Provide Seed Funding for Innovation• Construct Biotechnology Clusters• Promote Translational Research• Provide Financial Support in Specific Areas of
Innovation
Longterm GoalLongterm Goal
India will not only need to build a robust biopharmaceutical infrastructure, it will also need to become a source of innovation. There are at least five initiatives the GOI could implement to help the domestic BioPharma industry leverage its unique advantages.
• Create a framework for Intelligent Regulation• Invoke Market Pull• Seek Opportunities for Growth through Acquisitions• Encourage Highly Skilled Expats to Come Home• Leverage India’s Expertise in Holistic & Traditional Medicines
India will not only need to build a robust biopharmaceutical infrastructure, it will also need to become a source of innovation. There are at least five initiatives the GOI could implement to help the domestic BioPharma industry leverage its unique advantages.
• Create a framework for Intelligent Regulation• Invoke Market Pull• Seek Opportunities for Growth through Acquisitions• Encourage Highly Skilled Expats to Come Home• Leverage India’s Expertise in Holistic & Traditional Medicines
AVESTHAGEN LIMITED
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India’s leading and only integratedsystems biology platform company
focus
Convergence of Food, Pharma & Population Genetics Predictive approach leading to Preventive & Personalized Healthcare
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Business Model – Theranostic approach
AVESTHAGEN LIMITED
Predictive Diagnostics
Prevention Therapy
Personalization
Products:- Medical Foods- Dietary Supplements
Conditions:- Bone health- Cardiovascular health- Metabolic syndrome (diabetes, weight)- General wellness
Products:- Biosimilars- NBEs
Conditions:- Cancer- Autoimmune disorders- Anemia- Cardiovascular
Nutrigenonomics Pharmacogenomics
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