on the rise
Despite slowdown, the
biologics manufacturing business in India is growing
There were only a handful of companies manufacturing biologicals in
India sometime back. But now there are over a dozen Indian
biopharmaceutical and pharmaceutical companies that are producing
biologics. These include APIs and intermediates and vaccines. Indian
companies are strengthening their bases and capabilities.
Shantha Biotechnics Ltd, the first Indian company to develop,
manufacture and market recombinant human healthcare products in India,
laid foundation for a new state-of-the-art vaccine
manufacturing complex at Muppi Reddy Pally village in Medak district in
Andhra Pradesh. Shantha will manufacture its next generation vaccines
in this complex. The first vaccines to be manufactured in the premises
will be from the entric vaccine portfolio like cholera and rotavirus
vaccines. Dr J Geetha Reddy, minister for major industries, sugar,
commerce and export promotion, Andhra Pradesh initiated the ground
breaking ceremony of Shantha's new facilities in Muppireddy
Pally village in February.
This facility will have the capacity to manufacture more than 100
million doses of vaccines per year. The company has plans to initially
invest Rs 50 crore with future investments going up to Rs 100 crore.
The new facility is part of Shantha Biotechnics strategic expansion
plans focused on servicing existing and growing market demands for its
range of vaccines.
Dr Varaprasad Reddy, managing director, Shantha Biotechnics, said,
“The new vaccine complex will address the capacity
constraints of our existing facilities to manufacture range of entric
vaccines and the new generation pneumococal vaccine which are under
development. Shantha obtained WHO-Geneva Pre-qualification for its
pentavalent vaccine in 2009 and has started supplying the vaccine to
UNICEF. Shantha has the distinction of receiving the EMEA certification
for one of its products in the current year”.
Shantha is also focusing its R&D efforts in the development of
novel vaccines like HPV and novel therapeutic antibodies. Shantha
Biotech is part of the global healthcare giant Merieux Alliance.
Biocon, India's largest integrated biopharmaceutical entity,
produces a humanized anti-EGFR monoclonal antibody for the treatment of
head and neck cancer and insulin products. Its full set of
manufacturing capabilities, include mammalian cell culture
fermentation, microbial cell culture fermentation, synthetic chemistry,
formulation development for solid dosage (tablets and capsules) for
immediate and modified release, injectables (vials, cartridges,
lyophilized and pre filled syringes) and a fill finish facility.
Pune-based Serum Institute of India is one of the world leaders in
vaccine production. Its product line includes MMR, a quadrivalent
vaccine for diptheria, tetanus, pertussis, and hepatitis B, rabies
vaccine, and a recombinant hepatitis B vaccine. Vaccine major Panacea
Biotec manufactures liquid pentavalent vaccine introduced in India,
which immunizes children against five dreadful diseases (DTwP+ Hep B+
Hib) of early childhood, besides other vaccines like EasyFour (DTP +
Hib) and Ecovac (DTP + Hep B) and is also a pre-qualified supplier of
Intas Biopharmaceuticals Ltd (IBPL) is a fully integrated EU GMP
certified biopharmaceuticals company with the capability to provide a
range of development and manufacturing services. The company expanded
its Contract Research and Manufacturing Services (CRAMS) business with
the acquisition of US-based biotechnology company Biologics Process
Development. Bharat Biotech manufactures a haemophilus influenza B
conjugate vaccine for Wyeth Lederle, and a human lactoferrin product
for Agenix, Inc.
Some major Indian pharmaceutical companies like Dr Reddy's,
Lupin and Wockhardt are also involved in biologics. Dr
Reddy's markets two generic biologics that are versions of
Roche's Rituxan and Amgen's Neupogen.
According to Frost & Sullivan, in 2006, the contract
manufacturing accounted for over 71 percent of the revenues of the
CRAMS market. In 2007, the Indian contract manufacturing market was
valued at $869 million, and consisted mainly of companies manufacturing
older, generic molecules, some specialized generics and custom
synthesis and scale-up of in-patent drugs. The Boston Consulting Group
estimated that the contract manufacturing market for global companies
in India would touch $900 million by 2010.
Currently, 80 percent of the pharmaceutical contract work undertaken by
Indian firms consists of the manufacturing of active pharmaceutical
ingredients (APIs) and intermediates, compared to 60 percent globally.
Outsourcing API manufacturing of patented products has gradually
increased with companies signing API contract manufacturing agreements
with Indian CMOs. According to PwC, the pharma CMO market as a whole in
India in 2010 is expected to reach $916 million from $492 million in
Hareesh C P, head, Business Development (CRAMS Biz), Intas
Biopharmaceuticals, India said, “Contract manufacturing is a
market-driven industry and CMOs must be competitive with not only each
other, but with the option to build manufacturing capacity. The fact
that the contract manufacturing industry is projected to continue
growing suggests that it is delivering value to its customers. Contract
manufacturing market is expected to touch $2.46 billion by 2010 with a
CAGR of 41.7 percent from $869 million in 2007, according to KPMG
report published in September 2008. Indian companies, through their
high quality-low cost production models, have bagged some impressive
deals in the contract manufacturing space. These deals validate
India's potential to achieve a larger share of the global
manufacturing outsourcing market. Currently, India is among the top
five countries in the Asia-Pacific region in terms of
However, Hareesh added, “These are challenging times where
the global financial crisis has affected many biotech start up which
were working on Novel Biologics. Many others that are mid-way into
development may be forced to license out earlier than they had
originally planned to. The large pharma is on an acquisition spree of
biotechs to boost up the number of biologics in the pipeline. Under
such a complex situation, it is difficult for the small or large
pharma/biotechs to make decisions on outsourcing. However, it is
important for the industry to stay visible and be on the radar of these
Biopharmaceutical contract manufacturing has tougher requirements for
technology, human capital, and regulatory aptitude. In recent years,
there have also been signs of adequate capacity, and new businesses
have faced stiff competition. The market for biosimilars is yet to take
off because the US and Europe have been slow in issuing guidelines in
Despite all this, growth of biopharmaceutical contract manufacturing
has been fairly robust at about 25 percent annually and there is going
to be the need for outsourcing capacity at CMOs. Some of that may
directed towards India.
Biologics manufacturing on the rise
biologics market is estimated to be $ 53 billion (excluding vaccines)
constituting 9 percent of global pharmaceutical market.
Nearly 125 biologics currently marketed.
research and development costs associated with biologics are high
because biologics are structurally complex and difficult to
Genentech, estimated that it has invested $6.4 billion in research over
the last 28 years.
Biologic treatments range anywhere from $10,000 to $25,000 a year. In
some rare cases, costs can exceed $170,000 per year.
Erythropoietin is the leading class of biologic constituting
nearly 22 percent of biologic market (excluding vaccines)
in Indian generics universe have gross margins closer to 50 percent.
This means that an Indian generics company could enter the market,
manufacture the same product, and be content to sell it at
$4,000-5,000, a 50–60 percent discount.
Dr. Reddy's launched a
Biogeneric version of Roche's Rituxan/Mabthera in the Indian
Rs 20,000 per vial, or approximately $505, a 50 percent discount to
Roche's price in India.
With additional entrants and lower-cost
manufacturing, prices could be driven down further. For example,
Wockhardt recently invested $38 million to build a facility capable of
manufacturing 15 percent of the worldwide supply of biologics.
brands of Erythropoietin products have become key targets for
biogenerics, after accounting for 18.7 percent ($12bn) of global
pharmaceutical sales in 2006. Amgen's Aransep held 55 percent
EPO market in 2006, typifying the rapid growth of long-acting products.
Compiled by Dr
Gita Sharma, Head, Biotech, Claris Biosciences
scheduled for launch in Eastern Europe
||G-CSF (Filgastrim), Insulin, and
(Insulin in India and China),
Erypro (EPO) G-CSF,
Nimotruzmab, BIOMAb EGFR
glargine and HGH
||Alpheon (INF-α) and EPO
||Autoimmune, cancer and
||GBR 500 (mAb for MS), GBR600
(antithrombotic) and mAbs for adhesion molecular inhibitors
||Neukine (G-CSF), Erykine (EPO),
and Intalfa (INF-alpha2b)
||Six (6) development
and other PEGylated proteins
|Selected biologics with
colony stimulating factor (G-CSF)
(mAb), anti-EGFR (mAb)