The biosimilars market is expected to reach $6.

22 Billion by 2020
from $2.29 Billion in 2015, growing at a CAGR of 22.1% from 2015
to 2020. Key factors such as
- growing pressure to curtail healthcare expenditure,
-growing demand for biosimilar drugs due to their cost-effectiveness,
rising incidences of various diseases,
- increasing number of off-patented drugs,
-positive outcomes in the ongoing clinical trials, and
rising demand for biosimilars in different therapeutic applications
such as rheumatoid arthritis and blood disorders are propelling the
growth of the global market.
However, factors such as high manufacturing complexities and
costs, stringent regulatory requirements in countries, and
innovative strategies by biologic drug manufacturers to restrict
the entry of new players are restraining the growth of this
market.
The global biosimilars market is segmented on the basis of products
and applications.
On the basis of products, the market is segmented into recombinant
nonglycosylated proteins, recombinant glycosylated proteins, and
recombinant peptides. The recombinant nonglycosylated proteins
market is further segmented into insulin, granulocyte colonystimulating factor (G-CSF), interferons, and human growth hormone;
whereas, the recombinant glycosylated proteins market is further
segmented into erythropoietin, monoclonal antibodies, and follitropin.
The recombinant peptides market is segmented into calcitonin and
glucagon. The recombinant glycosylated proteins segment is expected
to witness the highest growth rate owing to the increased demand for

monoclonal antibodies in the treatment of cancer (oncology),

autoimmune disorders, blood disorders, and infectious diseases.
On the basis of applications, the biosimilars market is segmented
into oncology, blood disorders, growth hormonal deficiency, chronic
and autoimmune disorders, and other applications (female infertility,
hypoglycemia, myocardial infarction, postmenopausal osteoporosis,
and chronic kidney failure). Oncology accounts for the largest share
of the global market, owing to the launch of new biosimilars,
namely, Remsima (monoclonal antibody) in Europe, and Neutroval
and tbo-filgrastim in the U.S. On the other hand, the chronic and
autoimmune disorders segment is expected to grow at the highest
CAGR of 25.7% from 2015 to 2020. The high growth in this segment
can be attributed to the rising incidences of autoimmune disorders
such as rheumatoid arthritis, Crohn's disease, ulcerative colitis,
psoriatic arthritis, Type 1 diabetes, and psoriasis.
Geography, the biosimilars market is segmented into North America,
Europe, Asia-Pacific, and the RoW (Latin America, Middle East,
and Africa). In 2015, Europe is expected to dominate the global
market; growth in this market can be attributed to the growing
pressure to curtail healthcare costs, patent expiry of biologic products,
launch of new biosimilar products, rising incidences of chronic
disorders (such as cancer, diabetes, and rheumatoid arthritis), and
emergence of new market participants in this region. However, the
Asia-Pacific market is expected to grow at the highest CAGR from
2015 to 2020, owing to the developing healthcare infrastructure,
presence of a large patient population, increasing funding/investment
towards the development of biosimilars, and growing focus of both
international and domestic players on Asia-Pacific countries.
New product launches and expansions are the key strategies adopted
by major players to strengthen their positions in the global biosimilars
market. Moreover, strategies such as partnerships, agreements,
collaborations, joint ventures, and acquisitions were also adopted by a

significant number of market players to strengthen their product

portfolios and expand their geographic presence.
The key players in the global biosimilars market include
Sandoz International GmbH (Germany),
Hospira, Inc. (U.S.),
Teva Pharmaceutical Industries Ltd. (Israel),
Dr. Reddys Laboratories (India),
Biocon Limited (India),
Mylan, Inc. (U.S.),
Amgen (U.S.),
Celltrion Inc. (South Korea),
Roche Diagnostics (Switzerland),
and Merck KGaA (Germany).
The biosimilars market was estimated at USD 3.1 billion in 2015.
Since the guidelines on the similar biological medicinal products
came into effect in Europe, in 2005, there has been a significant
development in the field of biosimilars. These drugs are highly similar
copies of a previously approved biologic (reference product) and may
differ from the reference drug in terms of clinically inactive
components without consequential clinical implications.
These drugs possess similar clinical properties in terms of safety,
potency, and purity as compared to the original biologic drug. The
global biosimilars market is expected to grow at a rapid pace as
blockbuster biologics are approaching patent expiration; and thus,
creating a huge potential for the similar biological medicinal products.
The U.S. and APAC markets present profitable growth opportunities

for the similar biological medicinal products industry, which is

expected to grow at a significant rate in the coming years.
The key factors responsible for the growth of the industry are the
cost-effectiveness of the dissimilar drugs and the increasing
encumbrance to cut down expenditures across the healthcare systems
in the world. Additionally, positive clinical evidential data obtained
for the similar biological medicinal drugs have slowly led to the
increased acceptance levels of these drugs by the regulatory bodies;
and hence, the subsequent, higher approval rates of the biosimilars.
However, high complexities and costs involved in the manufacturing
of similar biological medicinal products, the presence of a rigorous
regulatory framework governing their approval in countries around
the world, and the presence of substitutes, such as non-original
biologics and bio-betters are likely to hinder the growth of this
sector.
Product Insights
The biosimilars market by product is divided into recombinant nonglycosylated proteins and recombinant glycosylated proteins. The
recombinant non-glycosylated proteins segment is categorized into
insulin, human growth hormones, granulocyte colony-stimulating
factor (G-CSF), and interferons; this segment captured the largest
industry share in 2015 and is anticipated to grow at a healthy CAGR
from 2016 to 2024.
On the other hand, recombinant glycosylated proteins segment is
categorized into erythropoietin, monoclonal antibodies, and
follitropin. As a result of the wide applicability of the products in
oncology, blood, and other chronic disorders, this segment is expected
to grow at a rapid pace.
Application Insights
The similar biological medicinal products market by application is
segmented into oncology, blood disorders, growth hormone
deficiency, chronic and autoimmune disorders, and others. The
similar biological medicinal products find its application in the large
range of blood disorders and the different oncology areas; these
application segments are estimated to grow at a profitable rate due to

the surging global cancer epidemic and the high incidence rates of
blood disorders.
Cancer cases in the world were estimated to be approximately around
14.1 million in 2012. This estimate directly reflects the resultant
increase in demand for these drugs for its application in oncology in
the coming future.
Regional Insights
The key regions taken into consideration in the biosimilars report are
North America, Europe, Asia Pacific, and rest of the world. The
European biosimilars sector is estimated to be the largest at a global
level. In 2015, the German similar biological medicinal products
market accounted for the maximum share in Europe. With respect to
the growth rate, the industry in North America is anticipated to grow
at the highest CAGR during the study period.
In the Asia Pacific region, India and China are expected to exhibit the
highest growth and emerge as the leading players in the market. Asiabased biotech companies including Celltrion Healthcare Co., Ltd.,
Biocon Ltd., and Dr. Reddys Laboratories, Inc. are actively involved
in building a stronghold in the industry, which is going to be a
significant contributing factor in pushing forward the industry growth.
Competitive Market Share Insights
Some established players in this biosimilars market are Roche
Diagnostics, Amgen, Inc., Biocon Ltd., Teva Pharmaceutical
Industries Ltd., Merck & Co., Mylan, Inc., Dr. Reddys Laboratories,
Inc., Sandoz, Inc., Celltrion Healthcare Co., Ltd., Abbvie, Inc., and
Hospira, Inc.