Etanercept Market Analysis, Biotechnology & CMO Role in Healthcare

This report provides a market assessment of Etanercept, a drug used to treat inflammatory conditions, and explores Amgen's market strategy, risks, profits, and commercialization challenges. It highlights the competitive landscape and potential adverse effects of Etanercept. The report also discusses the role of a Chief Medical Officer (CMO) in pharmaceutical organizations, emphasizing the importance of active listening and visionary leadership while cautioning against authoritarian approaches. The analysis considers market trends, target customers, and strategic opportunities for Etanercept in the context of emerging competitors and technological innovations within the biotechnology sector.

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Part A
Identified Therapeutic Area
The key therapeutic area (TA) which will be targeted for this brief market assessment is
‘inflammation’ with respect to the drug ‘Etanercept’, retailed by Amgen, under the drug name of
‘Enbrel’ (Enbrel, 2020).
Overall Concept and Strategy
Taking insights from the disease conditions and patients targeted by the drug Etanercept,
it can be observed that Amgen has adopted the market strategy resembling that of a ‘market pull’
within this TA. Etanercept achieved approval from the Food and Drug Administration (FDA)
long back since the early 1990s with respect to the use of recombinant DNA technology for the
treatment of severe forms of inflammatory conditions like rheumatoid arthritis in the year 1998
(Enbrel, 2020). Since then, Etanercept has continued to dominate this TA, generating gradual
profits annually and used popularly for the treatment of autoimmune disorders such as: psoriatic
arthritis, tumor necrosis factor and ankylosing spondylitis, since the early 1990s till the present
year. This demonstrates a market pull strategy where Amgen targets to maintain Etanercept’s
current position and profits in the market as against other emerging competitive pharmaceutical
products and organizations (Emery et al., 2017).
Risks
Amgen’s Etanercept currently demonstrates multiple FDA approval’s with respect to
psoriatic arthritis, plaque psoriasis and ankylosing spondylitis thus demonstrating adequate
operational flexibility for the purpose of functioning across multiple disease and healthcare
treatment markets (Emery et al., 2017). Its generation of rising profits over time demonstrates

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considerable revenue for Amgen with respect to this TA. However, Etanercept acquired a
warning from FDA with respect to adverse effects like sepsis, infections like hepatitis B and
tuberculosis. Such adversities demonstrate the prevalence of technological difficulties and the
need for further technological advancements by Amgen with respect to this TA (Reddy et al.,
2016).
Profits
Cost Development
The drug Etanercept at present, demonstrates a relatively high cost of $ 2225 in the
United States as compared to $1646 and $1017 across Canada and Switzerland. Such high prices
reflect the presumption of higher profits, increased revenue and lower organizational
expenditures concerning operations (van Vollenhoven et al., 2016).
Commercialization Challenges
At present, in addition to novel competitors, Amgen faces potential challenges in this TA
with respect to reports of adverse side effects of Etanercept like sepsis, infections like hepatitis B
and tuberculosis (Reddy et al., 2016).
After Market Safety, Market Size and Location
Amgen’s Etanercept continues to demonstrate considerable profits across markets in the
US, Switzerland and Canada with a reported rise in prices since 2008 till present cost of $ 2225,
thus demonstrating considerable market size of Amgen in this TA (van Vollenhoven et al.,
2016).

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Market Trend
At present, Etanercept in particular and Amgen’s position in this TA particularly are
likely to encounter challenges in the form of key competitors and technological innovations such
as: the manufacturing of a similar DNA recombinant patens by pharmaceutical strongholds like
Cipla, Biogen and Samsung (van Vollenhoven et al., 2016).
Target Customers and Strategic Opportunities
Amgen’s Etanercept was formulated initially for targeting patients with autoimmune
disorders like rheumatoid arthritis due to its mechanism as an inhibitor of TNF alpha. With time,
the market share of this drug and this TA has expanded to include diseases like psoriatic arthritis,
tumor necrosis factor and ankylosing spondylitis (Reddy et al., 2016).
Part B
The role of a Chief Medical Officer (CMO) is filled with a range of challenges and risks
due to his or her responsibility of not just ensuring the optimum functioning of pharmaceutical
organizations but also maintaining adequate health and safety across consumers. One of the most
important qualities of a CMO is active listening. In addition to placing his or her own opinions, a
CMO must also actively listen, empathize and address the views of stakeholders with equal
priority. This allows the incorporation of multiple ideas and opinions which in turn reduces the
risk of errors. An additional key quality of a CMO is to adopt a vision for the future (Perrault &
Inderstrodt-Stephens, 2017). This means that not only must a CMO analyze current benefits and
profits associated with a drug, but also envision long term outcomes and possibilities with
regards to the long term benefits and risks to health which can be associated with a new product
or medicinal drug. Alternatively, adoption of an authoritarian style of leadership is one of the
most disadvantageous and negative qualities which a CMO can possess. The pharmaceutical and

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healthcare industry is encountering new challenges and innivations every day. A CMO must be
open and inclusive to all suggestions and an authoritarian approach can halt progress and pave
the way for risks, profit loss and errors (Sheard and Donaldson 2018).
References
Emery, P., Vencovský, J., Sylwestrzak, A., Leszczyński, P., Porawska, W., Baranauskaite, A., ...
& Rodriguez, A. A. B. (2017). A phase III randomised, double-blind, parallel-group
study comparing SB4 with etanercept reference product in patients with active
rheumatoid arthritis despite methotrexate therapy. Annals of the rheumatic
diseases, 76(1), 51-57.
Enbrel. (2020). Enbrel® (etanercept). Retrieved 24 February 2020, from
https://www.enbrel.com/.
Perrault, E. K., & Inderstrodt-Stephens, J. (2017). US mothers' behaviors and preferences when
choosing physicians for their families: Assisting “Chief Medical Officers”. Health care
for women international, 38(11), 1234-1246.
Reddy, S. P., Shah, V. V., Lin, E. J., & Wu, J. J. (2016). Etanercept. In Therapy for Severe
Psoriasis (pp. 83-96). Elsevier.
Sheard, S. and Donaldson, L., 2018. The nation's doctor: the role of the Chief Medical Officer
1855-1998. CRC Press.
van Vollenhoven, R.F., Østergaard, M., Leirisalo-Repo, M., Uhlig, T., Jansson, M., Larsson, E.,
Brock, F. and Franck-Larsson, K., 2016. Full dose, reduced dose or discontinuation of
etanercept in rheumatoid arthritis. Annals of the rheumatic diseases, 75(1), pp.52-58.