The year 2011, is slated to be a year of consolidation and
collaboration for the biotech industry. Mergers and acquisitions,
strategic alliances and partnerships would be a continuing trend in
2011. Most of them will be inbound and like 2010, we will see
valuations of domestic companies reach sky rocketing heights. However,
we will witness more strategic alliances between MNCs and domestic
firms more on the lines of the Pfizer-Biocon deal ($350 million, with
$200 million upfront payment). Industry experts also predict that
domestic companies will now turn to investing in novel molecules rather
than plain low cost generics and follow on biologics.
Keeping their focus intact, Indian biotechs are foreseeing the
underlying opportunities and are optimistic about their growth in 2011.
Besides expanding their employee base, companies are looking forward to
significant investments in terms of R&D and on the commercial
front. Further, companies in the services sector look to strengthen
their existing capabilities and work on new business models that are
rapidly emerging in the contract research industry.
The dawn of the New Year is also expected to see the launch of newer
vaccines and biopharma products. Making vaccines affordable and within
the reach of poor and needy seems to be on the priority list of the
vaccine companies. While, Public Private partnerships are burgeoning in
the agri biotech sector, the companies in this space are betting big on
genetically-modified crops and improving hybrid varieties of different
crops. Although the moratorium on Bt brinjal continues, these companies
are hopeful that the government will review the situation in the New
Year. They are also optimistic that Bt brinjal will soon win the
confidence of farmers and consumers alike and will set the ball rolling
for other food crops, such as the Bt rice and Bt maize and Bt tomato.
In 2011, one can expect domestic companies to come up with indigenous
Bt genes. Bangalore-based Metahelix Life Sciences is one of the
forerunners, with its cry1c gene receiving approval from GEAC for its
use in two Bt cotton hybrids, MH5125 Bt and MH5174 Bt. India could also
see the launch of Bt rice in the coming year, with DuPont receiving
GEAC approval for field trials of its Bt rice. Tata Chemicals'
subsidiary, Rallis India acquiring majority stake of 53.5 percent in
Metahelix for over $20 million (
99.5 crore) is seen as another
important event in this sector.
There is no holding back for Bioindustrial companies too. While keeping
their focus on developing new products, these companies are also
majorly looking at exports. Diagnostic companies will look to leverage
the breadth of their portfolios to bring quality in vitro diagnostics
into the market. Industry associations like the CII, ABLE, FICCI and
ASSOCHAM are also looking forward to further catalyze the growth of
biotech industry by bringing together different stakeholders for
Even the Government of India is keen on supporting R&D activities
for developing novel molecules. In this regard it is planning to set up
a new venture fund to promote drug discovery in India, with a start up
capital of close to $45 million (
200 crore). This could bolster drug
discovery activities which till date, has been reeling under paucity of
funds and capital. Further, the Department of Biotechnology (DBT), has
been spending around $300 million-a-year (
1,300 crore) to support
research, development and innovation. India plans to spend over $150 mn
700 crore) in the next two years to boost
biopharmaceutical firms, even as the local industry gears up for a
global boom. The government will focus on developing infrastructure in
the sector that makes drugs using biotechnology on increased demand for
funding. DBT for the year 2010-11, had allocated an amount of about
$260 mn (
1,200 crore) as plan expenditure and $5
22 crore as
Experts across all segments unanimously agree that the regulatory
environment in India, come 2011, would become all the more stringent
and well-defined. This would be applicable in avenues like biosimilars,
stem cell therapies, clinical trials and pharmaceuticals. This will be
a big boost for India because in the past, global heads of many MNCs
were hesitant to invest in the country due to lack of a well defined
regulatory structure. Clearly, experts are optimistic that it will be
the pharma, biopharmaceutical and bioservices sectors, which will be
the primary driving forces for industry growth. Companies are fully
aware of the roadblocks that have been hindering the progress of the
sectors so far, and are confident about consolidating their positions.
Hence, 2011 will truly be a year of consolidation and collaboration!
In the ensuing pages, BioSpectrum
brings you some interesting
insights from the industry observers and leaders for the year 2011.Biosimilars to drive growth
More and more biosimilars would
be launched in India, thereby strengthening the country's position in
the global market. The regulatory environment in India would get
progressively stringent on quality of biosimilars.
Indian regulators can also be expected to subject imported biosimilars
to the same level of scrutiny and approval as with biosimilars
developed and manufactured in India.
2011 can witness more partnerships between Indian biotech and pharma
companies. There would be more stem cell therapies and tissue
engineered products in the Indian market. Regulations for stem cell
therapies would get better defined. India would begin to make a mark in
developing novel biotherapeutics as well.
Company Outlook: Reliance Life Sciences (RLS) would continue to
on developing and bringing in a range of biosimilars, including several
monoclonal antibodies, to the Indian market as well as take them to
other semi-regulated markets. RLS would be progressing its pipeline of
specialty pharma products in oncology, steroids, hormones and peptides
range. We are also looking to commercialize stem cell therapies
and tissue engineered products in India.
- Mr KV Subramaniam
Reliance Life Sciences
Understand the trend or 'perish'
India will gradually move
towards an integrated and robust healthcare financing system, ushering
in the dawn of a new paradigm, provided doctors should no longer remain
the sole decision-makers for the drugs they prescribe to the patients
and the way they treat the common diseases. Healthcare providers and
medical insurance companies will start playing a key role in these
areas by providing to the doctors well thought out treatment and
For a significant proportion of the products that the pharmaceutical
companies will sell, tough price negotiation is inevitable.
Health Technology Assessment (HTA) or 'outcome-based pricing' model
will play an important role in pricing healthcare products.
A shift from just 'brand marketing' to marketing of a bundle of
value-added comprehensive disease management processes along with the
brand, will gradually be the order of the day.
Over the counter medicines, especially originated from natural products
for common and less serious illness, will curve out a larger share as
appropriate regulations are put in place.Regulatory environment within
the pharmaceutical industry will be much more stringent.
Contrary to the expectations of many, valuation of the domestic
pharmaceutical companies will continue to remain high, which, however,
will not pose any serious impediment to the consolidation process in
With these emerging trends, required wherewithal in the ball game of
the Indian pharmaceutical industry will be quite different. In the
evolving scenario, it may not be easy for the domestic players to adapt
to all these changes fast and compete with the global players on equal
footing. Companies which are already global players in their own
rights, would be able to understand the nuances and implement them
better in the new paradigm. These players, I reckon, would offer a
tough competition to the global players, especially, in their own turf.
However, for the smaller local players, the new environment could prove
to be quite challenging, which in turn, could further accelerate the
consolidation process in the Indian pharmaceutical industry. Thus, the
'writing on the wall' appears to be - “understand the trend and start
preparing from now on or 'perish'.”
- Mr Tapan Ray,
Organisation of Pharmaceutical Producers of India (OPPI)
to take center stage
Biotech Industry will witness more strategic
alliances in terms of CMOs and CROs. Reverse innovation will be setting
in with more focus on vaccines, mAbs, and biopharmaceuticals. If
government takes initiatives with more incentives and tax holidays
backed by proper infrastructure, more overseas biotech companies will
set up their facilities for manufacturing in India.
Serum Institute of India will launch some new
affordable quality vaccines and biopharmaceuticals in line with the
philosophy of founder Chairman, Dr C S Poonawalla.
- Dr SD Ravetkar
Serum Institute of India
Biotech to boost agri production
Last year's moratorium on Bt Brinjal has
spurred the industry to play a more active role. People who value the
importance of growth in agriculture believe that biotechnology will
play a dominant role irrespective of temporary set back. Our
policymakers are well aware of the potential of biotechnology, both
genetic-enineering based or genome-based. I believe, they are going to
extend full support for the development and application of
biotechnology in agriculture. I believe, the increasing public-private
and private-private partnerships will help finding solution to issues
that are threatening the food and economic security of farmers. Many of
these have evaded solution through conventional breedings. Bt cotton
was success and North Zone was again flourishing with cotton trade.
India rose to the position of the second biggest producer and largest
exporter. If we do not harness biotechnology to find solution to this
problem in time, we will be back to square one. We see a continued
support to research, both to institutes and industry, so a synergy is
created to accelerate growth in agricultural sector. I am optimistic
that release of Bt Brinjal as first food crop is imminent and it will
win the confidence of farmers and consumers alike.
We are better determined to disseminate the
and hybrids that have been improved, using GMO and Non GMO approach.
Being a group committed to serve farmers and people, we are planning to
partner with public and private sector in application of biotechnology.
Our target is to invest more than three fold of what we have already
done for biotechnology segment
- Dr Govind Garg,
R&D, Krishidhan Seeds
CROs to see big boom
Over the last decade, rising pressure to reduce costs and
time-to-market has led to a rapid expansion of the global contract
research organization market. Pharma and biotech company spend on CRO
services has shown double digit growth in the past years highlighting
the importance of this fast growing market.
CROs today are critical contributors to the drug development programs
of pharma and biotech companies often resulting in substantial time and
cost saving. Many CROs and pharmaceutical companies are turning to
strategic partnerships to gain a competitive edge in the global
business environment. Various business models are being employed to
forge long-term relationships.
Consolidation of businesses has turned from a trend to reality today.
The CRO market, which is highly fragmented today, will see further
consolidation in 2011 where small as well as large CROs will continue
Company Outlook: While Dabur Research Foundation (DRF) already
required infrastructure and competence to take a new molecule from
early discovery to advanced preclinical stage of development, as a CRO
our focus in 2011 will be in the following critical areas –
(i) develop and offer in vitro alternatives to animal testing to drug
companies, especially those developing dermatological and skin care
(ii) offer state-of-art screening strategies in oncology to companies
developing drugs to treat cancer.
(iii) help reduce attrition rates in drug development and thereby
reduce costs by offering special drug screening modules that DRF has
developed over several years of painstaking research.
- Dr Manu Jaggi, CEO,
Dabur Research Foundation
M&A, sell-offs to linger till
In 2011, I expect mergers and acquisitions in the Indian clinical
research industry and consolidations between Indian CROs. There
are also possibilities of smaller Indian CROs selling-off their
business interests to larger CROs, as the spate of consolidation is
expected to continue till 2012.
Company Outlook: We are looking to build upon existing
India and the US, and expand our capabilities in the UK office to allow
sponsors the advantage of running studies through our UK office in both
Western and Eastern Europe.
- Mr SK Mukherjee, director,
India is in-sync with global trend
I expect global companies to acquire or partner with
Indian companies. There will be an increase in genomic spending by
academia. The industry is very much in tune with global trends. The
number of clinical trials in India will increase, and better
regulations for the industry are also expected.
Company Outlook: We will be moving into our new GLP campus to
services. Besides, we will further enhance and release the full blown
RaaS (research as a service) platform to open up for collaborations. In
the New Year, we will also invest in diagnostics and kits.
- Ms Anuradha Acharya,
chief executive officer and co-founder,
R&D to be the top priority
Indian pharmaceutical industry has shown
some very remarkable developments. Like Indian IT space, Indian pharma
companies are now considered key for entire global development. We have
lot to catch up in other biotechnology segments. But due to some
critical developments, India and Indian biotech companies are being
looked up now. Some very good work has also been done by several
biotech companies including Advanced Enzymes.
Research and development must be encouraged for next 10 years for
Indian companies to emerge as next destination for biotechnology. This
is indeed a “knowledge industry” and agriculture with industrial
biotechnology can help India proceed at a faster pace of growth. Our
agriculture is key for national growth with green technologies. Many
crop productivity is still quite low.
Company Outlook: Advanced Enzymes aims to become a global
manufacturing presence in all key economies. We plan to merge our
America operations and expect to grow our exports at rapid pace. We
foresee lot of opportunities there and we are optimistic about our
growth. In tune with that, we are setting up an 100 percent EOU in
Indore SEZ with massive capacity expansion plans - seven times bigger
than our present plant in two steps. Our first plant with double
capacity is expected to become operational by mid-2011. If every thing
goes well, we expect to cross our exports alone over $20 million
(1billion) in 2011-12.”
- Dr CL Rathi, managing director,
Non-urban demand for healthcare rises
Healthcare demand and availability in
non-urban areas will go up considerably. The increasing educated
patient population is posing huge demand for improved health services,
and a more focused approach to personalized healthcare.
Company Outlook: We will leverage the breadth of our portfolio
market leadership to bring quality in in-vitro diagnostics,
personalized healthcare. We are also looking at bringing new
technologies, such as, sequencing and microarray into diagnostic arena.
- Dr Bhuwnesh Agrawal, managing
It's the time to expand operations
Company Outlook: We are looking to expand
coverage of our foot & mouth disease program from 64
districts to 121 districts, a significant increase from $25 million
(110 crore) to $50 million (220 crore).
We are also doubling milk production by spending lot more on
nutraceuticals. Currently we have 15 percent share of the 2,000 crore
We are working on NDTB and have also partnered with Indian Vaccine
research Institute. We also expect 60-70 percent share in the cattle
and sheep vaccine industry.so looking at bringing new
technologies, such as, sequencing and microarray into diagnostic arena.
- Mr KV Balasubramaniam, managing
A mix of innovation and right
India is uniquely positioned to become a
leading global biotechnology centre. India’s success in biotechnology
will depend largely on how it implements policies for biopharmaceutical
products that balance innovation and competition, and make patient
safety and product quality paramount considerations.
Company Outlook: We are commited to improving the lives of
patients by transforming scientific discovery into health care guides.
In 2011, our focus would be to increase awareness about Multiple
Sclerosis (MS) in India, be an integral part of the health care system
in treatment of MS and enable neurologists to provide meaningful
solutions to their patients.
Our goal is to expand the Biogen Idec drug portfolio in India and
launch more products for Indian patients; we currently have AVONEX and
Tysabri for the treatment of MS.
We have made significant investments in India, both on the R&D as
well as on the commercial front. We have already integrated our India
operations into our global drug development strategy and investments
and plan to continue to enhance that in the coming months and years.
Our high caliber India team is well-poised to make significant
contributions in developing and growing this exciting field of
biotechnology in India.
— Dr Alpna Seth, chairman and managing
Innovation to play a major role
The growth of biotech industry is dependent
on extraordinarily high investments and long incubation times. For the
industry to sustain and become globally competitive in the future, the
focus will be on rapid innovation and effective R&D management,
collaboration and to explore opportunity for contract manufacturing.
Value creation through generation of strong pipelines leading to robust
intellectual property portfolios will be a big play in the future.
There will be increased spend on R&D and innovation, as more Indian
companies undertake new product development, increase in M&A
activity and more importantly product/franchise acquisitions by MNCs in
Company Outlook: Bharat Biotech’s focus is to consistently
innovate, bring out new molecules and vaccines to serve the 5.8 billion
emerging market. Our immediate goal is to bring out at least one ‘made
in India’ molecule. Bharat Biotech has delivered over one billion doses
of its vaccines. Our aim is to double the number in the next
five-to-six years. We are also investing substantially in R&D,
clinical trials and to add new facilities, including expansion of our
existing facility to meet the growing demand for our range of products.
In our new product pipeline, we have made significant advancements in
the development of vaccines for Malaria, Rotavirus, Japanese
encephalitis, Chikungunya, Typhoid-conjugate, and therapeutics for
myocardial infraction, wound healing, and Staph Aureus (MRSA). We are
also on target to file an IND with the USFDA for a novel biotech
— Dr Krishna Ella, chairman and
Investors increase biotech focus
As the world economy recovers from downturn, the investor
community will increase its focus on biotechnology. India is beoming a
big market for pharma/biotech products, Indian biotech firms are also
looking beyond borders to expand their market. This will lead to more
partnerships between Indian and international players, similar to the
one we saw between Biocon and Pfizer recently. Growth is predicted in
agri-biotech, biopharma, oncology products, vaccines and new therapies
such as regenerative medicine (stem cells). Systems and predictive
biology segment is poised to grow in India too.
Association Focus: The prime motivation of ABLE is to play a
catalytic role for the growth of the Indian biotechnology industry. We
will continue to be the platform for all the the stakeholders,
(industry, government, academia) of this sector to interact, connect,
deliberate and partner. One of our main focus will be to intensely
engage with the government to streamline regulation be in biopharma,
bioagri, diagnostics & devices, improve access to early stage
funding schemes and continue the dialogue on various issues that affect
— Dr Satya Dash, chief operating
Nayantara Som & Rahul Koul