The document discusses emerging trends in the biosimilars industry in India. It notes that the global biosimilars market is expected to grow to $10 billion by 2015 due to $79 billion worth of biologics going off-patent. The Indian biosimilars industry is estimated to be worth $338 million and growing at 30% annually, with around 25 Indian companies marketing about 50 products domestically and abroad. Key challenges for the industry include strict regulations in major markets and a lack of formal regulatory approval processes in India, though partnerships between Indian and large pharmaceutical companies are helping address some of these challenges.
This document provides an overview of the Indian pharmaceutical industry, Biocon India Group, and a case study they are considering. It discusses the political, economic, demographic, and technological factors shaping the Indian pharmaceutical industry. It also summarizes India's patent regime and how it has evolved over time. The document then provides background on Biocon Group, including their culture and business units. It outlines the broad questions Biocon is considering regarding their growth strategy and whether to expand their Clinigene clinical trials segment. Potential short and long-term strategies for expansion are discussed.
Biocon is an integrated biopharmaceutical company based in India with four business divisions: small molecules and enzymes, branded formulations, research services, and novel molecules. The document discusses Biocon's business overview, growth opportunities in key therapeutic areas like diabetes and oncology, strong partnerships with large pharmaceutical companies, and promising pipeline of novel drug candidates. Biocon has a diversified business model and revenues, and is well-positioned to benefit from the large and growing biopharma industry globally.
This document provides information about Roni Bhowmik's master's program project on Beximco Pharmaceuticals Ltd (BPL). Specifically, it includes:
1) Roni Bhowmik is completing a master's program and chose BPL as the topic of their assignment.
2) The objectives of the assignment are to understand BPL's market research process and use of e-marketing, as well as get practical experience in a business setting.
3) Information was collected from sources like the internet, textbooks, BPL's annual reports, and information provided by BPL's Market Research & Statistical Cell department.
This document discusses the development of the biopharmaceuticals industry in India. It provides an overview of the characteristics and growth of the Indian biopharma market, which is valued at over $4 billion and growing 20-25% annually. It also outlines India's advantages for global R&D, including a skilled workforce, lower costs, and efficient clinical trials. The upcoming biosimilars opportunity from patent expiries is highlighted as a major driver. Challenges include financing difficulties and developing human resources excellence. Overall, the biopharma sector is one of India's fastest growing industries.
This document provides an overview of biopharmaceutical investment opportunities in Korea. It discusses the size and growth of Korea's pharmaceutical and biotech industries. The pharmaceutical market was KRW 19.29 trillion in 2013, up 0.3% year-over-year, while the biotech industry was KRW 7.52 trillion in 2013, up 5.3% year-over-year. The number of biotech companies and people employed in these industries has also increased in recent years. The global pharmaceutical and biotech markets have steadily expanded due to aging populations and increased health awareness worldwide. Future industry development is expected to be led by technology convergence in areas like ubiquitous healthcare.
Bio-pharmaceuticals Industry in India (2018-2023) - Snippets of the Market Re...Research On Global Markets
Bio-pharmaceutical products are manufactured in the form of complex macromolecules developed through genetic manipulation of living organisms using gene cloning, recombination of DNA and cell fusion. India caters to nearly 50% of the global demand for pharmaceutical products, most of which are based on the usage of biotechnological applications.
The document provides an overview of the Indian biotechnology market. It discusses [1] the growth and size of the market, with the biopharmaceutical sector being the largest, [2] the key players in the market like Serum Institute of India and Biocon, and [3] the opportunities in the market like biotech clusters in major cities. The biotechnology sector in India has been growing significantly and holds potential to further expand.
This document provides an overview of the Indian pharmaceutical industry, Biocon India Group, and a case study they are considering. It discusses the political, economic, demographic, and technological factors shaping the Indian pharmaceutical industry. It also summarizes India's patent regime and how it has evolved over time. The document then provides background on Biocon Group, including their culture and business units. It outlines the broad questions Biocon is considering regarding their growth strategy and whether to expand their Clinigene clinical trials segment. Potential short and long-term strategies for expansion are discussed.
Biocon is an integrated biopharmaceutical company based in India with four business divisions: small molecules and enzymes, branded formulations, research services, and novel molecules. The document discusses Biocon's business overview, growth opportunities in key therapeutic areas like diabetes and oncology, strong partnerships with large pharmaceutical companies, and promising pipeline of novel drug candidates. Biocon has a diversified business model and revenues, and is well-positioned to benefit from the large and growing biopharma industry globally.
This document provides information about Roni Bhowmik's master's program project on Beximco Pharmaceuticals Ltd (BPL). Specifically, it includes:
1) Roni Bhowmik is completing a master's program and chose BPL as the topic of their assignment.
2) The objectives of the assignment are to understand BPL's market research process and use of e-marketing, as well as get practical experience in a business setting.
3) Information was collected from sources like the internet, textbooks, BPL's annual reports, and information provided by BPL's Market Research & Statistical Cell department.
This document discusses the development of the biopharmaceuticals industry in India. It provides an overview of the characteristics and growth of the Indian biopharma market, which is valued at over $4 billion and growing 20-25% annually. It also outlines India's advantages for global R&D, including a skilled workforce, lower costs, and efficient clinical trials. The upcoming biosimilars opportunity from patent expiries is highlighted as a major driver. Challenges include financing difficulties and developing human resources excellence. Overall, the biopharma sector is one of India's fastest growing industries.
This document provides an overview of biopharmaceutical investment opportunities in Korea. It discusses the size and growth of Korea's pharmaceutical and biotech industries. The pharmaceutical market was KRW 19.29 trillion in 2013, up 0.3% year-over-year, while the biotech industry was KRW 7.52 trillion in 2013, up 5.3% year-over-year. The number of biotech companies and people employed in these industries has also increased in recent years. The global pharmaceutical and biotech markets have steadily expanded due to aging populations and increased health awareness worldwide. Future industry development is expected to be led by technology convergence in areas like ubiquitous healthcare.
Bio-pharmaceuticals Industry in India (2018-2023) - Snippets of the Market Re...Research On Global Markets
Bio-pharmaceutical products are manufactured in the form of complex macromolecules developed through genetic manipulation of living organisms using gene cloning, recombination of DNA and cell fusion. India caters to nearly 50% of the global demand for pharmaceutical products, most of which are based on the usage of biotechnological applications.
The document provides an overview of the Indian biotechnology market. It discusses [1] the growth and size of the market, with the biopharmaceutical sector being the largest, [2] the key players in the market like Serum Institute of India and Biocon, and [3] the opportunities in the market like biotech clusters in major cities. The biotechnology sector in India has been growing significantly and holds potential to further expand.
Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory ...ReportsnReports
This report analyzes biopharmaceutical manufacturing and the contract manufacturing industry in India, China, and South Korea. It provides an overview of regulatory frameworks, infrastructure support, and funding that have created an environment conducive to industry growth. The report details market sizes and forecasts through 2016, as well as trends such as outsourcing and partnerships between pharmaceutical companies and contract manufacturers in these regions. It also profiles major players and assesses factors like operating costs, skills, and government initiatives that affect industry competitiveness in each country.
Incepta Pharmaceuticals is a Bangladeshi pharmaceutical company with the second largest market share and growth rate in the country. It produces quality generic medicines that are acceptable in global markets. However, it faces some weaknesses such as dependency on imported raw materials and a lack of international standard quality control laboratories and bioequivalence testing facilities. PESTEL and Porter's Five Forces analyses indicate opportunities for market expansion but also threats from increasing competition and price fluctuations of raw materials.
Implications for indian_pharmaceuticalsAkshay Bawa
Global pharmaceutical companies are facing a major "patent cliff" between 2010-2015 as drugs worth $100 billion lose patent protection. This provides opportunities for Indian generic drug firms to gain market share. Indian companies have evolved into globally competitive generic producers through regulatory changes and low-cost manufacturing advantages. However, to succeed long-term, firms will need to focus on niche areas, new drug delivery systems, and backward integration in production. Other Indian industries like contract research and manufacturing are also well positioned to benefit from the patent cliff through outsourcing from major pharmaceutical companies.
The document discusses opportunities for medical device companies in emerging markets. It notes that emerging markets currently make up 15% of the global medical device market but are growing 2-5x faster than developed markets. Key points discussed include:
- Emerging markets are becoming new frontiers for growth as their populations and numbers of elderly expand dramatically.
- Major medical device companies have made acquisitions in China and other emerging Asian markets but M&A activity is expected to pick up further, especially in India following regulatory changes.
- To succeed in emerging markets, companies need to develop products tailored for local needs and costs, leverage low-cost manufacturing and partnerships for market access, and establish research and business operations locally.
The document provides an overview of biosimilars and non-innovator biotherapeutics in India. It discusses that India has a large population with limited access to expensive biologic drugs. This has led Indian companies to develop "copy" or non-innovator versions of biologics through an abbreviated approval process. Over 50 such products are now approved or in development. The regulatory process in India differs from WHO and EMA guidelines by not requiring comparative clinical trials or testing against reference products. Non-clinical and Phase III clinical trials are required. The biologics industry in India is an important supplier of more affordable versions of biologics to address healthcare needs.
The biotechnology industry in India is expected to grow significantly by 2017 due to factors such as growing demand from India's large population, increasing government support and investments, and a favorable policy environment. The government has steadily increased funding for biotechnology over the years through various five-year plans and aims to spend $3.7 billion in the current 12th five-year plan compared to $1.1 billion in the previous plan. Various segments within the biotechnology industry such as bio-pharmaceuticals, bio-services, and bio-agriculture have also experienced high growth rates in recent years. The biotechnology sector represents a major opportunity for India given the country's strengths in areas like generics, vaccines, and contract research
Strategic Analysis of the Indian Pharmaceutical Contract Manufacturing Market...Aiswariya Chidambaram
The Indian Pharmaceutical CMO market has been analyzed and assessed with respect to APIs and finished dose formulations (solids, liquids and injectables). Strategic recommendations for the success of market participants have been provided.
The document discusses Becton, Dickinson & Co.'s (BD) acquisition of CareFusion Corporation and how it will increase BD's position in the medication management industry. The acquisition will boost BD's revenues through increased presence in emerging markets and the US healthcare sector. The implementation of the Affordable Care Act and an aging population will increase demand for healthcare products. BD focuses on developing current products and new products planned through 2017 to ensure growth across all business segments.
Job opportunity for Chemistry GraduatesDr. Amsavel A
The document discusses the Indian chemical and pharmaceutical industries. It provides an overview of the industries, noting that the chemical industry contributes 7% to India's GDP and the pharmaceutical industry is the 3rd largest by volume globally. The pharmaceutical industry is growing at 15-20% annually and is expected to reach $100 billion by 2025. The document outlines the major categories and companies in the industries. It also discusses opportunities in the industries such as clinical research outsourcing, exports, and research and development. Finally, it describes various career opportunities and skills required for different roles.
Indian Pharmaceutical Export Market - Top Export Destinations for Indian Phar...Irish Pereira
By Mr. Irish Pereira. The report present snapshot of Indian Pharmaceutical industry in both domestic as well as export market. It is collation of facts pertaining to Indian pharma exports and explore key emerging trends pertaining to pharma export market. It describes key players of Indian pharma market and their export orientation as in their target export destinations, their focus therapies etc.
Fact sheet:
1) Indian Pharma Market size 2015
2) Indian pharmaceutical market segments by value
3)Patented (Innovator) Vs Generics Scenario
4)Growth drivers of Indian pharmaceutical industry
5) Indian Pharmaceutical sector – SWOT Analysis
6)PHARMEXCIL – Facilitating agency for Indian Pharma Exports
7) Indian Pharmaceutical Exports (USD bn)
8)Formulations share in Total Pharma Exports (2014-15)
9) Top 25 destination countries of India’s pharmaceutical exports during 2013-14 (INR mn)
10) Major Indian Pharma Companies (By Revenue-USD mn)
11) Pharma players and their export destinations
Sun Pharma,Dr. Reddy’s Lab,
CIPLA, Lupin, Aurobindo, Cadila Healthcare, Torrent Pharma, Wockhardt,
12) Emerging trends in Indian Pharma Market
Process guidelines for foreign companies exporting infant formula to china(f...Rong Liu
After years of dedicating to Chinese dairy and infant formula market, we have summarized the opportunities& challenges for foreign infant formula companies to enter and stay in China market.
After tracking the related regulations, standards, notices, we also provide you a process guideline as well as regulation mapping regarding Chinese dairy industry especially for infant formula.
We are confident that this document can help foreign manufactures, international traders master the whole and clear picture about Chinese infant formula market from regulatory perspective.
Global Biopharmaceutical Contract Manufacturing Market - Qualitative and Quan...Aiswariya Chidambaram
This presentation which highlights the key market and technology trends in the global biopharmaceutical contract manufacturing market was delivered as a lecture at the In-Focus Seminar session at CPhI Worldwide 2013 held at Frankfurt, Germany.
FoodMate “Compliance Excellence” to reduce your losses due non-compliance wit...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
The document discusses India's pharmaceutical industry, including its current size and growth rate. It notes that formulations make up 79% of the industry while bulk drugs account for 21%. The background section outlines how India's Patents Act of 1970 only recognized process patents and led to increased domestic production. It also discusses how India transitioned to a product patent regime in 2005 to comply with TRIPS and how this has impacted multinational companies investing in India.
The Indian pharmaceutical industry has grown significantly over the past few decades from a market dominated by foreign companies to becoming a major exporter and the 4th largest producer by volume globally. It meets 95% of domestic medical needs through companies manufacturing generic drugs and drug intermediates. The industry is projected to grow at 8% annually to $34 billion by 2012, higher than global growth, driven by factors like rising incomes, health awareness, and increasing treatment of medical conditions. The government provides various incentives and export promotion initiatives to support the industry's continued growth and ability to capture opportunities in outsourcing and the global market.
Cipla Ltd is an Indian pharmaceutical company founded in 1935 that specializes in manufacturing generic drugs. It is a leading manufacturer of anti-infectives and anti-asthmatics. The document discusses Cipla's history, products, market share, SWOT analysis, and CSR policy. It notes that Cipla has developed a positive image by providing low-cost drugs for cancer patients and is working on treatments for malaria and breast cancer screening. The CSR policy outlines Cipla's commitment to provide healthcare at reasonable costs and its governance around CSR activities and expenditures.
Losses due non-compliance with China food regulation and how to overcome Chi...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
- The document outlines the agenda and speaker details for the 5th Biosimilars Congregation 2014 conference taking place on September 10th, 2014 in Mumbai, India.
- The conference will bring together leaders in the pharmaceutical, biotechnology, and regulatory fields to discuss challenges in biosimilar development and the evolving regulatory landscape.
- Key topics to be covered include assessing biosimilar similarity, strategic choices for biobetters and biosimilars, safety evaluation, regulatory updates, and emerging market opportunities for biosimilars in countries like India.
Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory ...ReportsnReports
This report analyzes biopharmaceutical manufacturing and the contract manufacturing industry in India, China, and South Korea. It provides an overview of regulatory frameworks, infrastructure support, and funding that have created an environment conducive to industry growth. The report details market sizes and forecasts through 2016, as well as trends such as outsourcing and partnerships between pharmaceutical companies and contract manufacturers in these regions. It also profiles major players and assesses factors like operating costs, skills, and government initiatives that affect industry competitiveness in each country.
Incepta Pharmaceuticals is a Bangladeshi pharmaceutical company with the second largest market share and growth rate in the country. It produces quality generic medicines that are acceptable in global markets. However, it faces some weaknesses such as dependency on imported raw materials and a lack of international standard quality control laboratories and bioequivalence testing facilities. PESTEL and Porter's Five Forces analyses indicate opportunities for market expansion but also threats from increasing competition and price fluctuations of raw materials.
Implications for indian_pharmaceuticalsAkshay Bawa
Global pharmaceutical companies are facing a major "patent cliff" between 2010-2015 as drugs worth $100 billion lose patent protection. This provides opportunities for Indian generic drug firms to gain market share. Indian companies have evolved into globally competitive generic producers through regulatory changes and low-cost manufacturing advantages. However, to succeed long-term, firms will need to focus on niche areas, new drug delivery systems, and backward integration in production. Other Indian industries like contract research and manufacturing are also well positioned to benefit from the patent cliff through outsourcing from major pharmaceutical companies.
The document discusses opportunities for medical device companies in emerging markets. It notes that emerging markets currently make up 15% of the global medical device market but are growing 2-5x faster than developed markets. Key points discussed include:
- Emerging markets are becoming new frontiers for growth as their populations and numbers of elderly expand dramatically.
- Major medical device companies have made acquisitions in China and other emerging Asian markets but M&A activity is expected to pick up further, especially in India following regulatory changes.
- To succeed in emerging markets, companies need to develop products tailored for local needs and costs, leverage low-cost manufacturing and partnerships for market access, and establish research and business operations locally.
The document provides an overview of biosimilars and non-innovator biotherapeutics in India. It discusses that India has a large population with limited access to expensive biologic drugs. This has led Indian companies to develop "copy" or non-innovator versions of biologics through an abbreviated approval process. Over 50 such products are now approved or in development. The regulatory process in India differs from WHO and EMA guidelines by not requiring comparative clinical trials or testing against reference products. Non-clinical and Phase III clinical trials are required. The biologics industry in India is an important supplier of more affordable versions of biologics to address healthcare needs.
The biotechnology industry in India is expected to grow significantly by 2017 due to factors such as growing demand from India's large population, increasing government support and investments, and a favorable policy environment. The government has steadily increased funding for biotechnology over the years through various five-year plans and aims to spend $3.7 billion in the current 12th five-year plan compared to $1.1 billion in the previous plan. Various segments within the biotechnology industry such as bio-pharmaceuticals, bio-services, and bio-agriculture have also experienced high growth rates in recent years. The biotechnology sector represents a major opportunity for India given the country's strengths in areas like generics, vaccines, and contract research
Strategic Analysis of the Indian Pharmaceutical Contract Manufacturing Market...Aiswariya Chidambaram
The Indian Pharmaceutical CMO market has been analyzed and assessed with respect to APIs and finished dose formulations (solids, liquids and injectables). Strategic recommendations for the success of market participants have been provided.
The document discusses Becton, Dickinson & Co.'s (BD) acquisition of CareFusion Corporation and how it will increase BD's position in the medication management industry. The acquisition will boost BD's revenues through increased presence in emerging markets and the US healthcare sector. The implementation of the Affordable Care Act and an aging population will increase demand for healthcare products. BD focuses on developing current products and new products planned through 2017 to ensure growth across all business segments.
Job opportunity for Chemistry GraduatesDr. Amsavel A
The document discusses the Indian chemical and pharmaceutical industries. It provides an overview of the industries, noting that the chemical industry contributes 7% to India's GDP and the pharmaceutical industry is the 3rd largest by volume globally. The pharmaceutical industry is growing at 15-20% annually and is expected to reach $100 billion by 2025. The document outlines the major categories and companies in the industries. It also discusses opportunities in the industries such as clinical research outsourcing, exports, and research and development. Finally, it describes various career opportunities and skills required for different roles.
Indian Pharmaceutical Export Market - Top Export Destinations for Indian Phar...Irish Pereira
By Mr. Irish Pereira. The report present snapshot of Indian Pharmaceutical industry in both domestic as well as export market. It is collation of facts pertaining to Indian pharma exports and explore key emerging trends pertaining to pharma export market. It describes key players of Indian pharma market and their export orientation as in their target export destinations, their focus therapies etc.
Fact sheet:
1) Indian Pharma Market size 2015
2) Indian pharmaceutical market segments by value
3)Patented (Innovator) Vs Generics Scenario
4)Growth drivers of Indian pharmaceutical industry
5) Indian Pharmaceutical sector – SWOT Analysis
6)PHARMEXCIL – Facilitating agency for Indian Pharma Exports
7) Indian Pharmaceutical Exports (USD bn)
8)Formulations share in Total Pharma Exports (2014-15)
9) Top 25 destination countries of India’s pharmaceutical exports during 2013-14 (INR mn)
10) Major Indian Pharma Companies (By Revenue-USD mn)
11) Pharma players and their export destinations
Sun Pharma,Dr. Reddy’s Lab,
CIPLA, Lupin, Aurobindo, Cadila Healthcare, Torrent Pharma, Wockhardt,
12) Emerging trends in Indian Pharma Market
Process guidelines for foreign companies exporting infant formula to china(f...Rong Liu
After years of dedicating to Chinese dairy and infant formula market, we have summarized the opportunities& challenges for foreign infant formula companies to enter and stay in China market.
After tracking the related regulations, standards, notices, we also provide you a process guideline as well as regulation mapping regarding Chinese dairy industry especially for infant formula.
We are confident that this document can help foreign manufactures, international traders master the whole and clear picture about Chinese infant formula market from regulatory perspective.
Global Biopharmaceutical Contract Manufacturing Market - Qualitative and Quan...Aiswariya Chidambaram
This presentation which highlights the key market and technology trends in the global biopharmaceutical contract manufacturing market was delivered as a lecture at the In-Focus Seminar session at CPhI Worldwide 2013 held at Frankfurt, Germany.
FoodMate “Compliance Excellence” to reduce your losses due non-compliance wit...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
The document discusses India's pharmaceutical industry, including its current size and growth rate. It notes that formulations make up 79% of the industry while bulk drugs account for 21%. The background section outlines how India's Patents Act of 1970 only recognized process patents and led to increased domestic production. It also discusses how India transitioned to a product patent regime in 2005 to comply with TRIPS and how this has impacted multinational companies investing in India.
The Indian pharmaceutical industry has grown significantly over the past few decades from a market dominated by foreign companies to becoming a major exporter and the 4th largest producer by volume globally. It meets 95% of domestic medical needs through companies manufacturing generic drugs and drug intermediates. The industry is projected to grow at 8% annually to $34 billion by 2012, higher than global growth, driven by factors like rising incomes, health awareness, and increasing treatment of medical conditions. The government provides various incentives and export promotion initiatives to support the industry's continued growth and ability to capture opportunities in outsourcing and the global market.
Cipla Ltd is an Indian pharmaceutical company founded in 1935 that specializes in manufacturing generic drugs. It is a leading manufacturer of anti-infectives and anti-asthmatics. The document discusses Cipla's history, products, market share, SWOT analysis, and CSR policy. It notes that Cipla has developed a positive image by providing low-cost drugs for cancer patients and is working on treatments for malaria and breast cancer screening. The CSR policy outlines Cipla's commitment to provide healthcare at reasonable costs and its governance around CSR activities and expenditures.
Losses due non-compliance with China food regulation and how to overcome Chi...Rong Liu
As the world’s largest imported food market, China imported totally 38 billion US dollars food products from187 countries in 2016.
The growing China market has attracted a lot of interest from different countries over the world. Meanwhile China government has, over the last years, developed a tougher and tougher food regulation regime to regulate the market and ensure food safety.
Due to various challenges (languages, resources, information accessibility etc.), foreign SMEs learned a lot lessons and experienced big losses due to non-compliance with Chinese regulations.
Actually majority of these losses due non-compliance can be easily prevented if SMEs have reliable regulatory information in hand.
As a leading Chinese food regulation consulting company, FoodMate developed “Compliance Excellence” information service product for foreign SMEs with target to minimize your losses due regulatory non-compliance by assessing reliable and tailor made regulatory information.
- The document outlines the agenda and speaker details for the 5th Biosimilars Congregation 2014 conference taking place on September 10th, 2014 in Mumbai, India.
- The conference will bring together leaders in the pharmaceutical, biotechnology, and regulatory fields to discuss challenges in biosimilar development and the evolving regulatory landscape.
- Key topics to be covered include assessing biosimilar similarity, strategic choices for biobetters and biosimilars, safety evaluation, regulatory updates, and emerging market opportunities for biosimilars in countries like India.
The document provides details about the 5th Biosimilars Congregation 2014 conference organized by Virtue Insight. It lists the key speakers from various pharmaceutical companies that will be speaking at the conference. The conference will discuss various topics related to biosimilars like clinical trials challenges, regulatory landscape, analytical strategies for biosimilarity, emerging market opportunities etc. It provides the agenda with session details, speaker bios and profiles. The document aims to invite attendees from pharmaceutical, biotech and regulatory organizations to attend and gain insights on biosimilars development and commercialization.
The document discusses opportunities in the Indian pharmaceutical and biotechnology sectors. It outlines 8 subsectors: pharmaceuticals, biopharma, contract research organizations, industrial enzymes, agribiotech, bioinformatics, diagnostics, and lab supplies. The core pharmaceutical industry focuses on small molecule drugs and generics. The biotech industry includes bio-pharma, agriculture, bioinformatics and is growing at 30% annually. The Indian pharma/biotech market was estimated at $18 billion in 2008-2009 and is projected to continue strong growth across subsectors.
This document discusses the biosimilar drug market and opportunities for biosimilar drug developers. It notes that as biologic drug patents expire, biosimilar drugs that are comparable in efficacy and safety to reference biologics at a lower cost represent a major market opportunity. However, biosimilar market uptake faces challenges from regulatory uncertainty, physician concerns about switching patients, and efforts by innovator companies to defend their biologic drugs. The document estimates that biosimilars may not achieve critical mass adoption until 2023-2025.
Biosimilars are highly similar versions of biologic drugs produced from living organisms. The development and validation of biosimilars against reference biologics plays an important role in their commercialization. Factors driving the biosimilars market include lower prices, easier development and quicker approval compared to biologics. Favorable regulations and intellectual property protections also boost market growth. However, issues around production efficiency and lack of guidelines in some regions are hindering growth. The global biosimilars market is expected to grow from $2.5 billion in 2014 to over $26 billion in 2020.
Biocon provides an investor presentation summarizing its business operations and financial performance. It discusses its focus on developing biosimilars and biologics through research and development efforts. However, it notes that forward-looking statements in the presentation are subject to risks and uncertainties. The presentation provides an overview of Biocon's business segments and product portfolio, and highlights its financial results for the first quarter of the 2014 fiscal year which showed growth across key metrics.
Biocon India Group should expand its operations through Clinigene, its clinical research subsidiary, to capture opportunities in the growing clinical trials market in India. The summary is:
1) Clinigene should expand from bioequivalence and bioavailability studies into clinical trials over 2 years by developing expertise, recruiting qualified staff, and securing clinical trial projects.
2) Factors to consider include maintaining Biocon's public image on ethical issues, protecting its organizational culture, and avoiding expertise divergence from other Biocon operations.
3) A phased expansion over 2 years allows Clinigene to establish itself while Biocon drafts an expansion plan and scouts required resources, minimizing risks to its reputation and operations.
Biocon is India's largest biopharmaceutical company, established in 1978. It has grown from an enzyme manufacturing unit to a fully integrated biopharmaceutical enterprise. Biocon has shown strong financial performance over the years, with increasing profits and revenues. However, it has also faced some ethical criticisms over unapproved clinical trials that led to deaths and not following proper procedures. While Biocon's work in biotechnology is innovative, it must focus on conducting all activities ethically to ensure patient safety and trust in its products.
The document discusses biosimilars and the regulatory pathway for biosimilar approval in India. It provides background on biosimilars and how they differ from generics in terms of manufacturing complexity and clinical development requirements. It summarizes India's draft biosimilar guidelines, including that phase III trials with 100+ patients are required for approval but phase I-II may be waived. The guidelines aim to streamline the process while aligning with global standards from the EMA and WHO. Over 20 biosimilars have been approved in India across several therapeutic classes.
This document discusses biosimilars in India and the opportunities and challenges in the biosimilars industry in India. It defines biosimilars and provides an overview of the global and Indian biosimilars market and regulatory landscape. The key opportunities for India include providing affordable treatment options and commercial benefits from lower cost manufacturing. However, challenges include regulatory hurdles, concerns around quality and safety, high development costs, and physician reluctance to prescribe biosimilars.
Bio similar- An opportunities or challenge for Indian Company Debashish Kar
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
Q1FY14: Biocon Delivers a Healthy Growth of 22% driven by strong traction in ...Biocon
Biocon delivered 22% revenue growth in Q1 FY14 driven by strong performance in its biopharma business. Revenues were ₹723 crores with EBITDA of ₹175 crores and PAT of ₹94 crores. The company's insulin business continues to grow due to an increased geographic footprint in emerging markets. Research services also grew at 26% due to increased demand for integrated services. Biocon plans to launch its second novel biologic, Alzumab, for the treatment of psoriasis in India in the current fiscal year.
Diem Nguyen, regional president of North America for Global Established Pharmaceuticals at Goldman Sachs, presented at a biosimilars conference on April 2, 2015. The presentation discussed the attractive growth opportunity for biosimilars, with the market expected to reach $20 billion by 2020. It noted biosimilars have the potential to expand access to important medicines while providing savings to healthcare systems. However, biosimilars are complex to produce and require significant expertise in manufacturing. Pfizer believes policies should be based on science and physicians should have the ability to choose the treatment that is best for their patients. Pfizer is well positioned in the biosimilars space due to its capabilities and experience developing
This is a basic report of BEXIMCO pharma industry. Only basic tools and topics of management were used to prepare this report. This report might help the students who are doing MGT 210 COURSE in North South University of BANGLADESH.
Pharmaceutical Offshoring Landscape A Syndicated Reportshekhar619
- The pharmaceutical industry is increasingly offshoring R&D activities to countries like India and China to take advantage of lower costs. India captured $125 million in offshored R&D spending in 2008 and China captured $375 million.
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2. ........................................................................................................................
CONTENTS
1. GLOBAL BIOSIMILARS INDUSTRY ......................................................................................... 1
1.1 Market Overview..................................................................................................................... 1
2. GLOBAL BIOSIMILARS INDUSTRY: COMPETITIVE ANALYSIS AND SOLUTIONS........... 2
2.1 SWOT Analysis ...................................................................................................................... 2
2.2 Market Attractiveness Scoring and Solutions .................................................................... 4
2.3 A Complex Global Industry ................................................................................................... 5
3. GOVERNMENT REGULATION AND POLICIES ...................................................................... 6
4. BIOSIMILARS INDUSTRY IN INDIA ....................................................................................... 7
4.1 Market Overview .................................................................................................................... 7
4.2 Indian Players in Biosimilars Industry ................................................................................ 8
4.3 Current and Future Products of Indian Players................................................................. 10
5. INDUSTRY CHALLENGES AND POSSIBLE SOLUTIONS .................................................... 11
5.1 Regulated Markets ............................................................................................................... 11
5.2 Unregulated/Semi-Regulated Markets .............................................................................. 12
6. NEW TRENDS, PRACTICES AND THEMES .......................................................................... 12
7. CONCLUSION AND PATH FORWARD ................................................................................... 13
3. ........................................................................................................................
1. GLOBAL BIOSIMILARS INDUSTRY
1
1.1 Market Overview
Biosimilars products/ 'follow-on' biologics are medicines similar to already
patented/registered biotech products, but are manufactured by new
companies after the patent expiry of the originator product. The global
Biosimilars market is expected to grow to US$ 10 billion by 2015, with growth
largely driven by US$79 billion worth of biologics going off-patent by 2015 and
more broadly, growing demand for biologic medicines as opposed to
conventional pharmaceuticals. The number of companies producing
Biosimilars is likely to remain limited, because unlike the small molecule
generic industry which is highly fragmented, the Biosimilars industry is defined
by long product development lead-times (8-10 years) and high fixed costs.
Conventional vs. Biotech Global Patent Expiry
Source: Credit Suisse Report on Biosimilars
The global Biosimilars
market is expected to
grow to US$ 10 billion by
2015, with growth largely
driven by US$ 79 billion
worth of biologics going
off-patent by 2015
Formula of Success
Emerging trends in Biosimilars in India
4. ........................................................................................................................
Despite costly development and manufacturing, Biosimilars are typically
marketed at prices 25 to 40 percent below original branded products, which is
their primary appeal to customers. From a product perspective, sales remain
highly concentrated, with the top 25 Biosimilars products currently driving 83
percent of global Biosimilars sales. Geographically, sales of biotech products
are concentrated in the United States (US) and Europe, which not only provide
the greatest market opportunities, but also the highest regulatory hurdles for
Biosimilars.
Biotech Patent Expiries in US and Europe
Source: Credit Suisse Report on Biosimilars
2. GLOBAL BIOSIMILARS INDUSTRY: COMPETITIVE ANALYSIS
AND SOLUTIONS
2.1 SWOT Analysis
The Biosimilars industry is fast-growing and has a strong economic value
proposition. However, there are a number of competitive threats that make a
well-developed strategy critical to any country wishing to develop this sector.
2 Formula of Success
Emerging trends in Biosimilars in India
5. ........................................................................................................................
Strengths
Lower price point and similar effectiveness to originator products ·
· Shorter time to market than originator products
· Higher probability of Return on Investment (ROI) than with new product
R&D
· Due to rapidly increasing healthcare costs, there is high consumer
demand for discounted high quality treatments
Weaknesses
· Cost of Biosimilars products to consumers in emerging markets is still
relatively high unlike small molecule generics that are at heavy discounts
to originators
· Extensive funding is required due to emerging rigorous regulatory
requirements
· Lack of widespread awareness and credibility of industry
Opportunities
· Large and growing market for biopharmaceutical products
· Emerging regulatory frameworks provide structured approval guidelines
· High-revenue bio-pharmaceutical projects that have less equivalent
Biosimilars approved / available in their portfolio
Threats
· Future regulations for Biosimilars is still being defined
· Particularly in the US, few Biosimilars have been formally approved,
resulting in little precedence for future rulings
· The industry will require greater focus on new investments for future
growth
3 Formula of Success
Emerging trends in Biosimilars in India
7. ........................................................................................................................
2.3 A Complex Global Industry
Market and competitive pressures for Biosimilars vary from country to country,
but may be broadly segmented according to countries that are:
· Regulated markets
· Semi-regulated markets
United States
0 Approved
Products
Under New
Framework
European
Union
~ 14 Approved
Products
India
~ 50 Approved
Products
Along with being a potential niche low-cost power in unregulated and semi-regulated
markets, Indian players are gearing to adopt guidelines more in line
with the US or European Union (EU).As more and more Indian companies pass
the rigid approval processes including extensive clinical trials, India will soon
emerge in a strong position as a relatively low cost supplier of Biosimilars
products.
China
~ 2000 Marketed
Products
Regulated Markets Semi-Regulated Markets
5 Formula of Success
Emerging trends in Biosimilars in India
8. ........................................................................................................................
3. GOVERNMENT REGULATION AND POLICIES
The dynamic and complex nature of the global Biosimilars industry has made
it difficult for regulatory organizations to formulate and implement a uniform
set of standards for approval of new products.
Divergent Interests
Producers of originator drugs
have a lot to lose from the
widespread adoption of
Biosimilars and have
questioned the safety of
Biosimilars products.
Uncertain Long-Term Impact
Even in countries with
regulatory bodies that have
approved Biosimilars, the
credibility of such products
within the medical community
as equivalent long-term
substitutes for originator
products is often debated.
Complex Molecules
The molecular complexity of
biotechnology products has
traditionally driven regulators
to treat Biosimilars cautiously,
often requiring expensive
clinical trials and preventing
smaller players from entering
the space.
An Evolving Global Regulatory Environment
While the European Medicines Agency (EMA) has been a global leader in providing a formal
path for approval of Biosimilars products, adoption of Biosimilars products varies on a country
to country basis within the EU's member nations. Regulation drafted by developed countries
outside US are often based on EMA approval standards.
European Union
United States
The Food and Drug Administration (FDA) has lagged the EU in providing a clear path for
Biosimilars approval in the United States. However, the Biologics Price Competition and
Innovation Act (BPCIA) of 2009 provides a framework for Biosimilars approval and the FDA is
preparing to provide further guidance to companies seeking approval for Biosimilars products.
World Health
Organization
In 2009, The World Health Organization (WHO) published Guidelines for Evaluation of Similar
Bio- therapeutic Products, outlining high-level guidance for national regulatory agencies to
determine similarity and comparability of Biosimilars with originator products. While the WHO
guidelines provide a framework for regulatory agencies in developing markets, regulators'
ability to evaluate and formally approve products often remains minimal.
India
A National Biotechnology Regulatory Authority (NBRA) Bill is soon expected to be passed,
which is likely to significantly streamline the approval process. Currently, companies
seeking to market Biosimilars in India must receive approval from multiple government
agencies, significantly increasing the time it takes to bring products to market. A clearer
pathway will reduce complexity and cost currently associated with the approval process.
China
Despite a long history of domestically produced and consumed Biosimilars products, there
remains no specific process for approval of Biosimilars products, separate from the process
for simple molecule products. Generally, the bar for product approval set by the Chinese State
Food and Drug Administration remains lower than in Europe or the United States.
6 Formula of Success
Emerging trends in Biosimilars in India
9. ........................................................................................................................
4. BIOSIMILARS INDUSTRY IN INDIA
4.1 Market Overview
Source: Frost and Sullivan Biosimilars Report and Deloitte Analysis
The Indian Biosimilars industry is estimated to be a US$ 338 million industry
that has been growing at a Compounded Annual Growth Rate (CAGR) of 30 per
cent since 2008. This growth rate is expected to continue till 2012. There are
around 25 Indian companies operating in the Biosimilars space, marketing
close to 50 products in the Indian market and few of these products in some of
the unregulated markets.
Industry Growth Drivers
US$ 79 billion worth of biologics is expected to go off-patent globally by 2015,
providing a lucrative global opportunity for Biosimilars companies. At the
same time, rising cost of treatment with original branded products is resulting
in Biosimilars being used globally as substitutes since they are 25 to 40
percent less expensive as compared to branded originators.
Currently, there is a market shift towards diseases such as cardiac, diabetes
and cancer which have treatment options with complex biotech drugs. A rise in
the number and quality of tertiary care centers is resulting in greater usage of
biotech products. Following figure shows the key industry growth drivers for
Biosimilars in India.
US$ 79 billion worth of
biologics is expected to
go off-patent globally by
2015, providing a
lucrative global
opportunity for
Biosimilars companies.
7 Formula of Success
Emerging trends in Biosimilars in India
10. ........................................................................................................................
· Patented drugs going off patent
· Shift in disease patterns and product demand
· Better tertiary care products
· Rising healthcare costs
Shift in
disease
patterns and
product
demand
Industry Growth
Drivers
Patented
drugs going off
patent
Better tertiary
care centers
Rising
healthcare
costs
4.2 Indian Players in Biosimilars Industry
Indian companies enjoy lower facility and development costs than peers in
developed countries and seem poised to repeat successes achieved in small
molecule generics by partnering with larger multinational corporations
(MNCs) for clinical trials, regulatory approval process in the EU / US and
marketing to physicians / consumers.
Following table provides an analysis of the capabilities of Indian players and
their partnerships with foreign companies. Many Indian players have
developed and matured their product development and manufacturing
capabilities and are progressing towards achieving better clinical trial
capabilities.
8 Formula of Success
Emerging trends in Biosimilars in India
12. ........................................................................................................................
4.3 Current and Future Products of Indian Players
Indian companies have launched Biosimilars across product areas, but certain
product types remain more attractive entry opportunities. A number of
companies are focusing on monoclonal antibodies (MAB) for their role in cancer
therapy. A large share of the market is expected from MABs in the future
Biosimilars marketplace. Likewise, Enbrel (for treating inflammatory disease)
and Insulin (diabetes) may be favourable product areas to enter due to the high
anticipated market potential and relatively low market penetration by Indian
suppliers.
1 Erythropoietin 2 Human Growth Hormone 3
Granulocyte Colony-Stimulating Factor
Source: Credit Suisse Report on Biosimilars; company web sites; BioPharm International
10 Formula of Success
Emerging trends in Biosimilars in India
13. ........................................................................................................................
5. INDUSTRY CHALLENGES AND POSSIBLE SOLUTIONS
5.1 Regulated Markets
Due to the inherently complex nature of Biosimilars, companies face several
challenges for regulatory approval and market place acceptance in regulated
markets.
Regulatory and Legislative Considerations
Unlike traditional pharmaceuticals that may be replicated to exact chemical
specifications in a laboratory, Biosimilars are complex structures of molecules,
making it more difficult to prove equivalence to branded predecessors. Strict
regulations and expensive clinical trials, as well as relatively new approval
processes in some countries (e.g. US) make regulatory approval difficult.
Quality and Safety Considerations
Due to the complex nature of biopharmaceutical products and differences in
the source living cells used by producers, it is difficult to exactly replicate an
originator's product, raising questions about quality and efficacy of Biosimilars
products. Many physicians are opting to wait before they recommend
Biosimilars products to patients, encouraged by campaigns from originator
companies.
Cost Considerations
Barriers to entry into the Biosimilars market are high, without guaranteed
return on investment. Developing a Biosimilars product is still a relatively
expensive and time consuming process (it can take 8-10 years to introduce a
Biosimilars drug in the market). The expensive research and development
lifecycle more closely resembles next-generation drugs rather than
inexpensive generics.
Often compared to the
market for generic drugs
in which India has
experienced success as a
manufacturer and
exporter, the evolving
Biosimilars industry has
unique economics and
challenges.
11 Formula of Success
Emerging trends in Biosimilars in India
14. ........................................................................................................................
5.2 Unregulated/Semi-Regulated Markets
The focus of Indian companies thus far has been primarily on semi-regulated
and unregulated markets, which present a unique set of accompanying
challenges.
Regulatory and Legislative Considerations
Without formal regulatory framework for Biosimilars in India (and other
emerging markets such as Brazil and China), the path to approval is
unpredictable, sometimes increasing costs and process complexities. Recent
indications are that India will move to a more structured approval process,
which is good news for Indian companies and consumers, assuming that the
final process is not as costly as in regulated countries.
Quality and Safety Considerations
While the less burdensome clinical trial and approval process reduces the cost
associated with delivering products to consumers, Indian produced Biosimilars
do not have the same credibility as international competitors. A formal and
replicable approval path would increase transparency and help Indian
companies gain credibility in international circles.
Cost Considerations
Indian patients and those in similar emerging markets are price sensitive, with
products that are 25-40 per cent lower prices compared to originator products
not being affordable to majority of the population. The new middle class in India
and other developing markets present an attractive emerging demographic
sector to which Indian Biosimilars companies may market cost effective
products.
6. NEW TRENDS, PRACTICES AND THEMES
Partnerships will continue to transform the Biosimilars Industry. With limited
growth potential in generic drugs, global pharmaceutical companies are
increasing their focus on Biosimilars drugs. In order to gain access to
developed markets in the long-term, Indian companies are increasingly
partnering with international pharmaceutical giants to develop and market
Biosimilars products. Indian companies gain marketing capabilities,
technological know-how, and regulatory process expertise from MNCs, while
international companies seek to build their product pipelines and low cost
manufacturing capabilities.
The new middle class in
India and other
developing markets
present an attractive
emerging demographic
sector for Biosimilars
Industry
12 Formula of Success
Emerging trends in Biosimilars in India
15. ........................................................................................................................
Cipla pays US$ 65 million for stake in two Asian
Bio-techs
Pfizer invests US$ 200 million in Biocon
Cipla purchased a 25 percent share in Shanghai
based Bio Mabs and a 40 percent stake in Goa
based Mab Farm in 2010.
· The acquisition will provide Cipla with the
right to market Biosimilars drugs of the two
companies in India and abroad.
· The main goal of these investments was to
create Biosimilars of current expensive
biologics such as Avastin, Herceptin and
Enbrel for sale in India.
Pfizer's 2010 investment gives it the right to
market Biosimilars insulin drugs across major
global markets
Aside from the initial investment, Biocon is
eligible to receive developmental and
regulatory payments of US$150 million
·
· The deal gives Pfizer access to the lucrative
US$ 14 billion insulin market
Mylan partners with Biocon to enter the
Biosimilars space
Ranbaxy enters into a strategic alliance with
Pfenex
American pharmaceutical company, Mylan,
entered into an agreement with Biocon in 2009 to
collaborate in the development, manufacture,
supply and commercialization of multiple
Biosimilars drugs in the global marketplace.
In March 2010, Ranbaxy announced its decision to
enter into an alliance with American
Pharmaceutical company - Pfenex, for the
development of an undisclosed therapeutic
Biosimilars protein.
· As part of the agreement both companies
will share development, capital and other
costs to take the products to market
· Under this agreement, Pfenex would receive
royalty payments and maintenance fees on
product sales
· Mylan granted exclusive rights for
commercialization in US, Europe and
Japan, while rights will be shared in other
markets
· Scientists from both companies would
collaborate in developing the strains and the
process for development and commercial
production of the Biosimilars product
7. CONCLUSION AND PATH FORWARD
Biosimilars in India has already attracted large investments in areas of
research, clinical trials and manufacturing. In future, Indian market will also
see lot of strategic partnerships emerging between global and Indian
companies to leverage each other's potential. The Indian Biosimilars market
provides numerous growth and investment opportunities for Indian and Foreign
players.
13 Formula of Success
Emerging trends in Biosimilars in India
16. ........................................................................................................................
Establish Clear
Pathway for
Regulatory Approval
1
of Products
2
Path Forward
for Indian
Biosimilars
3
Market to
Physicians Serving
the Emerging
Middle Class
4
5
Huge
Opportunity for
Investment in
Indian market
Establish
Partnerships with
International Industry
Leaders
Export to
Unregulated
and Semi-
Regulated
Countries
Market to Physicians Serving the Emerging Middle Class
As new middle class continues to emerge in India and other developing
economies, demand for high quality, reasonably priced Biosimilars products is
likely to increase.
Huge Opportunity for Investment in Indian Market
The requirement of intensive research and clinical trial demands large scale
investment for Biosimilars Industry. Increased funding will allow Indian
companies to build robust product pipelines and increase the number of
products that come to market.
Establish Partnerships with International Industry Leaders
Access to state of the art labs, experience with rigorous clinical trials, and
funding to support these activities mean that international pharmaceutical
giants have much to offer India based market entrants. A lower R&D and
manufacturing cost structure and a highly skilled workforce, make India an
ideal location for international companies looking to reduce costs and increase
margins.
14 Formula of Success
Emerging trends in Biosimilars in India
17. ........................................................................................................................
Export to Unregulated and Semi-Regulated Countries
Due to fewer regulatory hurdles, developing countries are the most attractive
export opportunities in the short-term. In the long-term, developed countries
are the most significant opportunities for revenue generation and ROI due to a
high demand for advanced treatments.
Establish Clear Pathway for Regulatory Approval of Products
A transparent approval process will increase product quality and decrease the
time-to-market for affordable and potentially life-saving Biosimilars products.
Reforming the regulatory environment will increase Indian Biosimilars
companies' credibility and provide a platform to enter other regulated global
markets in the future.
15 Formula of Success
Emerging trends in Biosimilars in India
19. ........................................................................................................................
DISCLAIMER
India Brand Equity Foundation (IBEF) engaged Deloitte Touche Tohmatsu India
Private Limited (DTTIPL) to prepare this report and the same has been prepared
by DTTIPL in consultation with IBEF. All rights reserved. All copyright in this
report and related works is solely and exclusively owned by IBEF. The same may
not be reproduced, wholly or in part in any material form (including photocopying
or storing it in any medium by electronic means and whether or not transiently
or incidentally to some other use of this presentation), modified or in any manner
communicated to any third party except with the written approval of IBEF.
This report is for information purposes only. While due care has been taken
during the compilation of this report to ensure that the information is accurate
to the best of and IBEF's knowledge and belief, the content is not to be
construed in any manner whatsoever as a substitute for professional advice and
IBEF neither recommends nor endorses any specific products or services that
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liability or responsibility for the outcome of decisions taken as a result of any
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Neither DTTIPL nor IBEF shall be liable for any direct or indirect damages that
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17 Formula of Success
Emerging trends in Biosimilars in India