Chairman & MD, Concord Biotech
The author has around 35 years of experience in the development of
biopharmaceutical products, production management, marketing, US FDA
approvals and strategic planning. His last job assignment was as
director-fermentation with Ranbaxy Laboratories, where he initiated and
successfully completed biotechnology green field projects.
The biotechnology industry is one of the fastest growing sectors with
total global sales for the pharmaceutical and biotech sector at around
$400 billion. Therefore, this market represents a significant target
for the generic companies. Due to the patent expiry of several biotech
products, a great opportunity is emerging for the pharmaceutical
companies in India. However, these opportunities are also associated
with a lot of marketing challenges. If these challenges are understood
well by the companies in India, they can definitely have an edge over
the Chinese companies. The major formulation companies in India
understand these challenges very well as far as the marketing of the
finished products is concerned, but it is not well taken by the bulk
biopharmaceuticals companies in India who are getting very tough
competition from the Chinese companies.
marketing challenge for the biotech industry is to understand
intellectual property (IP) relating to its drug candidates on a variety
of levels during the early stages. How strong is patent protection?
Will the company have freedom to operate in the regulated or the
semi-regulated markets? How will a buyer or partner view the IP rights?
How well will the patents hold up against the challenges from generic
companies? What plans are in place to develop and commercialize drugs
in the US, Europe, Asia and the emerging markets?
It is very important to understand the IP-related issues and spend
wisely and analyze the global patents to avoid an IP nightmare. Concord
Biotech has understood this issue and works to develop its own
non-infringing processes to enter the major markets on the day-one
launch with its abbreviated new drug application partners to get the
maximum advantage of the generic market.
Life-cycle of drugs:
In a world
where new products are constantly entering the market, making other
products obsolete, one of the marketing challenges faced by the biotech
industry is the selection of the products, understanding its lifecycle
and proactively working on adding new molecules to its portfolio in
order to reduce any financial risk to the organization.
One of the main reasons for the success of Concord is faster
identification and commercialization of the product, to get the benefit
of the market as an early entrant. This way, Concord enters the market
when the product is in its early lifecycle phase.
It is very well-known fact that the market for all matured antibiotics
or secondary metabolites made through the fermentation route are now
controlled by China and they have become a big challenge for the
companies in India. For such products, Concord’s team first evaluates
their commercial viability and then utilizes its R&D team’s
expertise and knowledge base to deliver high quality products at
major hurdles are the different regulatory approvals that delay the
entry of a product in the markets. The approvals from the different
regulatory authorities come within 24-to-36 months, which makes it very
difficult for the companies to enter markets, such as the US, Europe,
Japan and Mexico.
It requires proper planning to enter these markets and to get the
advantage from them. Concord has already got all the approvals from
different regulatory authorities, such as the US FDA, EUGMP, the
regulatory authority of Japan and among others, and has dedicated
facilities for all its products, which makes it different from other
companies in the same segment.
One of the
other challenges faced by the biotech industry in India is that due to
the global economic uncertainty, companies have become slightly more
risk averse in selecting new products for their portfolio. This has led
to delay in decision on selection of products for their portfolio.
Long gestation period: On certain occasions, the therapeutic segment,
to which the company is catering to, can also become a challenge in the
short term and critical to the growth of the organization. Usually, for
products that fall under the life saving drugs’ category, the generic
penetration is much slower as patients don’t like to change the brand
and requires convincing the doctors and their patients.
Considering the fact that the biotechnology segment is highly
capital-intensive, such a prolonged gestation period can affect
profitability of the company in the short term. In the long run, this
creates a barrier in entry. Companies need to build such a portfolio in
which risk from one therapeutic class or product can be mitigated by
another, hence not affecting the short-term business profitability.
biopharmaceutical industry, particularly in the generics sector, the
new trend is towards having novel business models, such as hybrid
models, between generic and innovator companies, and between generic
companies partnering and third-party sales teams, to increase
growth. The benefits from these partnerships are wide-ranging for the
generics companies, from better access to R&D capabilities to
innovator drugs access and wider penetration in new markets. The
challenge is to collaborate with the right kind of partner and Concord
is constantly working on identifying such partners and working with
them to enter different markets for its existing and new products.
of the challenges faced by the innovator companies is the pricing
pressure on drugs from a larger number of generic players. This erodes
profitability and the challenge is to retain market share once the
product patent is over. One of the ways to overcome this challenge is
the strategy of authorized generics, which are copycat versions of a
company’s branded drugs, sold through licensing agreements between the
innovator company and generic drug manufacturers. Concord with its
expertise in biopharmaceuticals is looking at such opportunities.
These are some of the challenges faced by the generic biopharmaceutical
companies, and Concord Biotech is proactively working to overcome these
challenges in order to create a solid base for the company and to make
its business sustainable.