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Meaning of Biotechnology
Biotechnology means any technological application that uses biological systems, living
organisms, or derivatives thereof, to make or modify products or processes for specific
use.
In its purest form, the term "biotechnology" refers to the use of living organisms
or their products to modify human health and the human environment. Prehistoric
biotechnologists did this as they used yeast cells to raise bread dough and to ferment
alcoholic beverages, and bacterial cells to make cheeses and yogurts and as they bred
their strong, productive animals to make even stronger and more productive offspring.
Scope of Biotechnology
Biotechnology is that branch of science with amalgamates biology and technology in
order to derive productive results from biological organisms through technological
applications. Although modern technology is relatively a newer field of study, the
element of biotechnology has been profound in many forms of traditional practices by
man. This includes production of vinegar, alcoholic beverages, yogurt, cheese and many
more. The understanding and application of biotechnology adds great value to various
aspects of life. Biotechnology can be used as an effective tool for food production, food
storing, environmental conservation and preservation, development of important life
saving drugs and vaccines etc and many more. It involves production of newer and viable
products or developing older products into cheaper and more effecting forms. With the
value addition of biotechnology, today it engulfs many disciplines of science and
technology. They include:
• Stem cell techniques
• Gene Therapy
• Immuno-technologies
• Genetic engineering
• Tissue culture
• Enzyme engineering
• Biosensor
• Bioremediation
• Photosynthetic efficiency
Today the essence of biotechnology is most prominent in the field of genetic researches
and drug designing. However, it is being effectively being used for conservation of
natural resources and developing newer sources of alternative energy as well.
Indian sub-continent is known to house one of the world’s largest bio. The Scope of
Biotechnology in India is thus very wide. Diverse marine systems, topography,
abundance of sunshine, cost effective infrastructure and skilled manpower, altogether
form a suitable laboratory and experimenters for research and development of
Biotechnology in India. As Biotechnology is a newer field of study, there are several
problems in this area. But, the future of Biotechnology in India is very bright.
History of Biotechnology
Biotechnology is not limited to medical/health applications (unlike Biomedical
Engineering, which includes much biotechnology). Although not normally thought of as
biotechnology, agriculture clearly fits the broad definition of "using a biotechnological
system to make products" such that the cultivation of plants may be viewed as the earliest
biotechnological enterprise. Agriculture has been theorized to have become the dominant
way of producing food since the Neolithic Revolution. The processes and methods of
agriculture have been refined by other mechanical and biological sciences since its
inception. Through early biotechnology, farmers were able to select the best suited and
crops having the highest yield to produce enough food to support a growing population.
Other uses of biotechnology were required as crops and fields became increasingly large
and difficult to maintain. Specific organisms and organism by-products were used to
fertilize, restore nitrogen, and control pests. Throughout the use of agriculture, farmers
have inadvertently altered the genetics of their crops through introducing them to new
environments and breeding them with other plants—one of the first forms of
biotechnology. Cultures such as those in Mesopotamia, Egypt, and India developed the
process of brewing beer. It is still done by the same basic method of using malted grains
(containing enzymes) to convert starch from grains into sugar and then adding specific
yeasts to produce beer. In this process the carbohydrates in the grains were broken down
into alcohols such as ethanol. Ancient Indians also used the juices of the plant Ephedra
vulgaris and used to call it Soma.[citation needed] Later other cultures produced the process of
Lactic acid fermentation which allowed the fermentation and preservation of other forms
of food. Fermentation was also used in this time period to produce leavened bread.
Although the process of fermentation was not fully understood until Pasteur’s work in
1857, it is still the first use of biotechnology to convert a food source into another form.
For thousands of years, humans have used selective breeding to improve production of
crops and livestock to use them for food. In selective breeding, organisms with desirable
characteristics are mated to produce offsprings with the same characteristics. For
example, this technique was used with plants to produce largest and sweetest corn in
order to produce the most desirable crops.
The field of modern biotechnology is thought to have largely begun on June 16, 1980,
when the United States Supreme Court ruled that a genetically modified microorganism
could be patented in the case of Diamond v. Chakrabarty.[4] Indian-born Ananda
Chakrabarty, working for General Electric, had developed a bacterium (derived from the
Pseudomonas genus) capable of breaking down crude oil, which he proposed to use in
treating oil spills.
Rising demand for biofuels is expected to be good news for the biotechnology sector,
with the Department of Energy estimating ethanol usage could reduce U.S. petroleum-
derived fuel consumption by up to 30% by 2030. The biotechnology sector has allowed
the U.S. farming industry to rapidly increase its supply of corn and soybeans—the main
inputs into biofuels—by developing genetically modified seeds which are resistant to
pests and drought. By boosting farm productivity, biotechnology plays a crucial role in
ensuring that biofuel production targets are met.
Biotechnology in India
The Department of Biotechnology (DBT) was set up under the Ministry of Science and
Technology in 1986. This gave a new boost to the development of biotechnology in
India. The DBT has set up many Centres of Excellence in the country. These centers are
responsible for generating skilled manpower, developing research initiatives and
opportunities as well as supporting R&D efforts of private industries and providing
platform to them to out source their research activities to these centres. This has
promoted interactions between the academics and the industry which has resulted in
several industry houses and entrepreneur initiatives to take root and grow biotechnology
in India.
The Indian Government has evolved biosafety guidelines and has helped to lay down
patent rules. It has also participated in technology transfers and international
collaborations. The center is also planning to introduce additional venture capital funds in
line with its Technology Development Fund (TDF) to promote small and medium biotech
enterprises.
The Indian government has laid down a decent regulatory framework to approve GM
crops and r-DNA products for human health. A proactive government policy allows stem
cell research in the country while having in place sound ethical guidelines. The product
patent regime which has come into force since the year 2005 and resulted in giving a
message to the world as well as Indian Industry that India supports world regulatory
framework and rewards new research and initiatives. The second amendment of the
Indian Patents Bill include a 20-year patent term, emergency provisions and
commencement of R&D immediately after the filing of patents. The bill is compatible
with the provisions of WTO and TRIPS and make Indian laws compatible with what has
been agreed within the framework of these multi lateral negotiations.
Several states have taken their own initiatives in terms of defining their own biotech
policies to give an impetus to the industry in this sector and to biotechnology in India as a
whole. States like Andhra Pradesh, Karnataka, Gujrat, Maharashtra, Kerala, Tamil Nadu
and Himachal Pradesh are developing biotech parks. They are encouraging research
activities, establishing links between their research institutions and industry. Several
concessions are being offered to the industry in terms of single window clearance, speedy
customs clearance, exemption from tax, creation of funds to be used for the incubation of
new project.
Due to the concerted efforts of the Ministry for Science and Technology, a number of
centers of excellence in the field have been established. These places have world-class
infrastructure and fully developed research centres. These centers are open for
collaboration. Some of these are: Plant Genomics Center, New Delhi, Center for Human
Genetics, Bangalore, National Institute of Biologicals, New Delhi, Center for Cellular
and Molecular Biology (CCMB), Hyderabad, National Facility for Macromolecular
Crystallography, BARC, Mumbai, National Facility for High Field NMR, Tata institute
of Fundamental research (TIFR), Mumbai, Central Drug Research Institute, Lucknow,
National Brain Research Center, New Delhi, CIMAP.
• Bio pharma deals with the production of vaccines, therapeutics and diagnostics,
while the end products of the biotech industry find two different kinds of buyers,
the first type include private hospitals, governments; patients and the second type
include industries like pharmaceutical.
• Agri-biotech deals with hybrid seeds and transgenic crops, biopesticides and
biofertilizers.
• Bio informatics deals with creation and maintenance of extensive electronic
databases on various biological systems.
• Bioservices market deals with clinical trial, contract research and manufacturing
activities.
• Bio Industrial industry deals with enzyme manufacturing and marketing
companies and these enzymes are used in detergent, textile, food, leather, paper
and pharmaceutical industry.
At present there are more than 350 biotech companies in India providing employment for
over 20,000 scientists. Most of the companies are located in the six major cities of Delhi,
Mumbai, Pune, Chennai, Bangalore, Hyderabad and Ahmadabad. The leading companies
in India are Biocon, Serum Institute of India(in the biopharma space),MahycoMonsanto,
Rasi seeds(in the agri-bio tech field),Strand Genomics, GVK Biosciences (in the
bioinformatics arena),Syngene and Quintiles in the (in bio services).
Importance of Biotechnology:
• According to reports bio technology industry in India has become the fourth
largest adopter of biotech crop in the world, replacing Canada. The Indian
biotechnology industry is slated to become a US$ 5 billion industry by 2010.
• India is gaining recognition in the field of clinical trial. A large number of
companies are providing research and development expertise to global
pharmaceutical companies.
• The availability of a vast pool of English speaking science graduates, good
regulatory processes and the cost advantage have positioned India as a favorable
investment destination by the way of globalization, mergers and acquisition and
alliances.
• Indian companies are also expanding overseas. The acquisition of 70 per cent
stake of the German pharma company AxiCorp by Biocon is a case in testimony.
• In terms of technology, the nanotechnology is the next big opportunities.
• Stem Cell Therapy research also has huge potential.
Biotech companies mainly work in the fields of medicine, agriculture, crop production,
non-food use of crops and heavy industry. The mining industry, for example, uses
naturally present bacteria in bioleaching.
Biotechnology fields are divided into four groups, named by color. Companies working
with red biotechnology apply it to medical processes, such as the production of
antibiotics and genetic cures. White biotechnology is used in industrial processes, while
green biotechnology is applied to agricultural processes. Blue biotechnology is issued in
marine applications.
Achaogen:
The company is currently pursuing strategies to prevent drug resistance. Located on the
shores of San Francisco Bay, USA, it contains extensive research facilities.
Acumen Pharmaceuticals:
Acumen is doing groundbreaking diagnostics and developing medicines for Alzheimer's
disease and memory loss. The company is based in Manchester, UK.
Aerie Pharmaceuticals:
Aerie focuses on development of medical innovations in opthalmology. The company is
located in Research Triangle Park, North Carolina.
Amaxa GMBH:
Amaxa markets, develops and produces innovative transfection technologies. This
company is located in Nattermannallee, Germany.
Genzyme:
Genzyme's products are for treatment of inherited disorders, kidney diseases, cancer, etc.
The company is located in Cambridge, UK.
Evolution of Biotechnology
Biotechnology is a very broad term which is applicable to old and new, sophisticated and
simple, familiar and strange applications of living organisms- anything from simple
fermentation to sophisticated gene therapy. The evolution of the biotechnology sector is as
follows:
20th Century: In early 20th century modern biotechnology movement started, particularly in
immunology and genetics. Penicillin, computers, discovery of DNA as the genetic basis, use
of bacteria to treat raw sewage (bioremediation project) are significant developments in this
direction. Revolution in forensics and biomedical science took place with the new lab
methods, such as DNA Sequencing, protein analysis, Polymerase Chain Reaction (PCR). The
millennium ended with the introduction of first cloned sheep Dolly, debate over the ethical
issues relating to biotechnology, stem cell research, genetic testing and genetically modified
organisms.
Located in Bangalore, India, Biocon has two subsidiaries, Syngene, a custom research
organization, and Clinigene, a clinical research organization. Biocon’s presence straddles
four main therapeutic areas – Diabetology, Cardiology, Nephrology and Oncology – even
as it plans to introduce two new divisions, Comprehensive Care, and Immunotherapy,
this year.
Between 2005 and 2010, Biocon entered into more than 2,200 high-value R&D licensing
and other deals within the pharmaceuticals and bio-pharmaceutical space. It has also
expanded its global footprint to emerging and developed markets through acquisitions,
partnerships and in-licensing. Biocon’s Corporate Social Responsibility wing, the Biocon
Foundation, is involved in numerous health and education outreach programs targeting
the underprivileged sections of India.
In 2009-10, Biocon’s net income increased 44% to Rs. 24,048 million, crossing the half-
billion-dollar mark and profits grew 215% to Rs. 2,933 million. The pharmaceutical
business exceeded Rs. 200,871 million in revenue and the net R&D expenditure
increased to Rs. 917 million, growing 42% over 2008 and up 282% over 2005, while its
research services business crossed Rs. 2,807 million.
Biocon’s portfolio consists of 36 key brands across the four therapeutic divisions of
Diabetology, Nephrology, Oncology and Cardiology.
Diabetology
This is the oldest of Biocon’s four divisions and has acquired 10% of the market share in
the Indian insulin segment through its flagship product INSUGEN® which has since been
introduced into several overseas markets. In 2009, the division launched its first insulin
analog, BASALOGTM, in the Indian market. It can be used just once a day and is
effective for 24 hours. Both INSUGEN® and BASALOGTM are being developed for
registration in Europe and USA between 2012 and 2016. BLISTO-MFTM and
METADOZE-IPR® are Biocon’s oral anti-diabetic formulations while OLISATTM is an
oral anti-obesity formulation.
Nephrology
ERYPRO safeTM (erythropoietin) is among the top 5 brands in the 30-brand EPO market.
RENODAPT®, Biocon’s premium immunosuppressant, mycophenolatemofetil ranks 4th
among 25 brands, while the newly introduced immunosuppressant, tacrolimus branded
TACROGRAFTM is 3rd among 20 brands. Biocon has newly launched dosage forms like
TACROGRAFTM 3 mg, RENODAPT® 750 mg, RENODAPT®-S 540 mg and
RAPACANTM 2 mg to suit Indian patient needs through ideal dosage, enhanced
compliance and reduced pill burden. In 2009, Biocon launched a specially formulated
protein supplement, NARITA+TM in the renal nutrition segment, for dialysis patients
suffering from malnutrition.
Oncology
This division’s BIOMAb EGFR®, approved in 22 countries, is a successful formulation
for indications like head-and-neck cancers, both adult and paediatric glioma, and
nasopharyngeal carcinoma. Abraxane®, launched in July 2008, is being used to treat
metastatic breast cancer and also other tumors such as pancreatic cancer, non-small cell
lung cancer and ovarian cancer. It is a first-in-class, innovative treatment regimen
designed to address unmet needs associated with solvent-based paclitaxel such as
hypersensitivity reactions, increased myelosuppression and axonal degeneration. NUFIL
safeTM for the treatment of chemotherapy-induced neutropenia is among the top 10
brands in the filgrastim segment.
Cardiology
Apart from these oral insulin, anti-CD6, targeted immune-conjugates, anti-CD20, peptide
hybrid, biosimilarMAbs and insulin analogs are under various stages of development.
Customers of BIOCON
BIOCON is a leading distributor in the global life science, research and pharma industry
with offices in Singapore, Malaysia, Thailand and India. BIOCON's business is highly
diversified across products and services, geographic regions and customer segments. The
company offers products from a wide range of manufacturers, to a large number of
customers primarily in Asia Pacific locations.
Many of the challenges in producing new medical devices and medical implants center
around materials. There's no shortage of innovative ideas, but they can't become reality
without biocompatible, functional materials. If you want to be at the foundation of
bioengineering and biomedical engineering, materials science is a great place to be!
Biocon Ltd
BSE: 532523 | NSE: BIOCON | ISIN: INE376G01013
Market Cap: [Rs.Cr.] 8,892 | Face Value: [Rs.] 5
Industry: Pharmaceuticals - Indian - Bulk Drugs & Formln
Raw Materials
% Inst. Sales
% of Sales
Product Name Unit Cap. Prod. Prodn Sales Qty (Rs.) /
Stock (Cr.)
Util. Cap Unit
Pharmaceutical 100. 11,779,97 1,051.4 929.2
Kg 88.1 0 11,314,663
Preparations 0 3 2 5
Pharmaceutical 102,307,81
No 8.9 0.0 0 0 106.68 10.43
Products-Traded 3
Contract Research Fees NA 2.9 0.0 0 0 0 35.01 -
Others NA 0.0 0.0 0 0 0 0.00 -
Excise Duty NA 0.0 0.0 0 0 0 0.00 -
Enzymes Kg 0.0 0.0 0 0 0 0.00 -
Enzymes - Traded Kg 0.0 0.0 0 0 0 0.00 -
Bangalore: There is now no dispute as to which is the biotechnology capital of India. The
Association of Biotech-Led Enterprises (ABLE) survey has found Bangalore to be the
most powerful biotech city in the country with 28 companies rooted here, generating
revenues worth Rs 500 crore in 2002-03. Bangalore is followed by the Mumbai/ Pune
belt with 32 companies accounting for revenues of Rs 480 crore. The 32 companies are
largely made up of equipment suppliers to agri-bio and biopharma companies. Delhi
comes third with revenues of Rs 370 crore, hosting 23 companies. Bangalore's
information technology rival Hyderabad is in the fourth place with biotech revenues' of
Rs 200 crore from 21 companies. The Ahmedabadi/ Vadodara/ lndore belt is No.' 5 with
revenues of Rs 80 crore from 7 companies and Chennai took the sixth place with 11
companies together earning over Rs 60 crore. South-based companies account for nearly
39 per cent of the business done. The reason for the South's dominance is partly on
account of Biocon, 'which is 1.5 times larger than the next competitor.
Global Markets Direct’s ""Biocon Limited - Financial Analysis Review” is an in-depth business and
financial analysis of Biocon Limited. The report provides a comprehensive insight into the
company, including business structure and operations, executive biographies and key
competitors. The hallmark of the report is the financial analysis of the company. This highlights
the company’s ratio analysis for the past five years.
Recent Developments
Dec 10, 2009: Biocon, HCG Group of Hospitals Collaborate To Fight Cervical Cancer
Oct 26, 2009: Biocon Reports Profits Of INR74 crore
Sep 11, 2009: Biocon Seals Development, Commercialisation Agreement With Amylin
Scope
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1. Pfizer linked up with India’s Biocon in a deal that will see Biocon take the lead in
development of four biosimilar insulin products that gives Biocon $200 million
up front. Coverage of the deal in the Business Standard highlights the country’s
overall strength in biosimilars, which fall midway between new molecule
development and small molecule generics in terms of the R&D and
manufacturing sophistication required. Biocon cites the deal as proof that India
can move up the value chain, doing for biosimilars what it did for generics. This
is especially true if they continue to attract backing and partnerships from the
Pfizers of the world.
2. Novartis’ generics unit, Sandoz, reported Q3 revenues of $292 million from a
single biosimilar product — enoxaparin, a copy of Sanofi-Aventis’ anticoagulant
Lovenox — which is not expected to hit blockbuster status in its own right. As we
have noted before, the high level of expertise required to make biosimilars creates
a high barrier to entry and contributes to the field’s attractiveness to traditional
pharmas (e.g., Pfizer, above) as well as to the major generics players.
FierceBiotech notes further growth is expected as the first biosimilar antibodies
hit the market in 2014-2015.
The Economist picked up the relevant trends in an article today entitled “Attack of the
Biosimilars“:
1) “Innovator” pharmas are moving into the biosimilars business, reversing their recent
role as the predominant plaintiffs in IP litigation:
“…it is ironic that the next great opportunity for traditional drugs firms is to do to the
biotechnology interlopers exactly what the generics firms have done to them: shred their
profit margins with cheaper copies…”
2) India in moving up the innovation value chain, increasing that country’s incentive to
protect IP more forcefully:
“And as if to remind the world that new ideas don’t all come from America, it is the
Indian firm that will design and manufacture the original drugs; Pfizer will only market
them.”
Bottom line: biosimilars are at least as big a business as predicted. This success is
another challenge to the concept that pharma’s patent cliff challenge will be met by more
in-licensing from small biotechs or by increased R&D spending. Revenue is revenue, and
biosimilars are poised to generate lots more of it.