Published Date: August, 2017
The market size of global biosimilar market was valued over USD 2.5 billion during 2014 and it surpassed USD 3.30 billion during 2016. The global biosimilar market is projected to surpass USD 10.50 billion by 2023, growing with a CAGR between 25.0% and 26.0% from 2017 to 2023.
A product is termed as biosimilar product, if it is a biological product with similar characteristics as that of a reference biological product, which possesses approval from agencies such as FDA. There would not be any major clinical difference in effectiveness and safety as that of reference product. Biosimilar products are made of complex molecules with high molecular weight produced through genetic engineering in living cells. Biologics drugs are costlier than respective chemical drugs. Biosimilar drugs can save around 30 to 40 % in terms of price relative to the respective biologics drugs. Biosimilars are useful for the treatment of illnesses such as anemia, autoimmune diseases, cancer, diabetes, growth hormone deficiencies, hematological diseases, kidney failure, rheumatoid arthritis and others. For the manufacturing of biosimilars, manufacturers have to develop environments that are ideal for the living cells, which remain sensitive to environmental conditions. Moreover, they need to develop distinctive process to entice the living cells for producing similar outcome to a prevalent biological treatment. The substitution of biological drugs with biosimilar drugs can save lot of money for public health care sector and patients. The regulatory authorities in developed nations are promoting biosimilar products.
awareness about biosimilars among the patients and doctors is a major factor
for the growth of the global biosimilar market. Presence of large number of
geriatric population is expected to aid the growth of the global biosimilar
market during the forecast period, as they need treatment for various chronical
illnesses. Increasing number of patients with chronic illnesses such as
diabetes and cancer drive the demand for effective patented biologics
medicines. Due to the lower cost, biosimilar medicines are expected attain more
demand and drive the growth of the global biosimilar market during the forecast
period. Segments related to diabetes medicine and oncology are expected to
attain faster growth during the forecast period.
Expiry of patents of various blockbuster drugs is a major factor for the growth of the global biosimilar market, as it is expected to provide the opportunities for the smaller pharmaceutical manufacturer to produce biosimilars in those segments. The reimbursement policies of various governments and the increasing interests from the insurance companies are expected to make biosimilars affordable to more people and drive the growth of the global biosimilar market. Non-original biologics and bio betters provide major challenge to the biosimilar market. Non-original biologics are duplicate products of reference biologics found in markets with lesser regulations or relaxed intellectual property protection. Though bio betters are regulated, as stepwise upgrade of innovator molecules, they are finding space in the drugs market. The lack of clear guidelines for the interchangeability or substitution of drugs with bio-similar is a restraint for the growth of the biosimilar market. The high manufacturing cost and complexity of production, along with the unclear regulatory policies in many countries are expected to be the major restraints for the global biosimilar market during the forecast period. However, due to the lower prices of biosimilars, the treatment for many diseases such as diabetes , rheumatoid arthritis and types of cancers, are anticipated to become affordable in developing countries and it provide opportunities for major players in the global biosimilar market to expand during the forecast period. Moreover, strategic partnerships between biosimilar manufacturers, manufacturing of multiple biosimilar products in same production facility and outsourcing of manufacturing to third parties are expected to help the major players to expand faster during the forecast period.
The report segments the global biosimilar market by product, application and region. On the basis of product, the market is segmented as human growth hormones, monoclonal antibodies, insulin, peptides, erythropoietin and others. Based on application, the market is segmented as oncology, chronic and autoimmune diseases, growth hormone deficiency, infectious diseases and others.
Geographic Coverage and Analysis:
The report provides regional analysis covering geographies such as North America, Europe, Asia-Pacific, and Rest of the World. With the maximum number of approved biosimilars, European market is the major biosimilar market in the world. Countries such as France, Germany, Italy and United Kingdom drive the growth of the European biosimilar market with high demand for low cost alternatives for biologics medicines. Expiry of patents for certain biologics medicines and presence of good regulatory frameworks set up by European Medical Association are expected to aid the growth of the European biosimilar market, during the forecast period. Asia-Pacific region has significant biosimilars in use due to the relaxed regulations in various countries. Due to the presence of large population and need for low cost alternative medicines for various diseases in countries such as China, India, South Korea and others drive the growth of biosimilar market in Asia-Pacific. As the rate of approvals for biosimilars are increasing at a faster pace in the U.S., the North-American region is expected to become the fastest growing biosimilar market during the forecast period. The pharmaceutical companies in the North American region are expected to make use of the research and development initiatives related to biosimilars and expiring biologics patents for increasing the production of biosimilar medicine to meet the requirements of the geriatric population and the patients with chronic illnesses depending upon the reimbursement and insurance policies.
Figure: Global Biosimilar Market by Region
The report provides deep insights on demand forecasts, market trends and micro and macro indicators. In addition, this report provides insights on the factors that are driving and restraining the demand of biosimilar globally as well as regionally. Moreover, IGR-Growth Matrix analysis given in the report brings an insight on the investment areas that existing or new market players can consider. The report provides insights into the market using analytical tools such as Porter’s five forces analysis and DRO analysis of biosimilar market. Moreover, the study highlights current market trends and provides forecast from 2017 to 2023. We also have highlighted future trends in the biosimilar market that will impact the demand during the forecast period. Moreover, the competitive analysis given in each regional market brings an insight on the market share of the leading players. Additionally, the analysis highlights rise and fall in the market shares of the key players in the market.
1.1 Report Description
1.2 Research Methods
1.3 Research Approaches
2. Executive Summary
3. Global Biosimilar Market Overview
3.2 Market Dynamics
3.3 Porter’s Five Forces
3.4 IGR – Growth Matrix Analysis
3.5 Competitive Landscape in the Biosimilar Market
4. Global Biosimilar Market Analysis, by Product 2017 – 2023
4.1 Human Growth Hormones
4.2 Monoclonal Antibodies
5. Global Biosimilar Market Analysis, by Application 2017 – 2023
5.2 Chronic and Autoimmune Diseases
5.3 Growth Hormone Deficiency
5.4 Infectious Diseases
6. Global Biosimilar Market Analysis, by Region 2017 – 2023
6.1 North America
6.1.1 North America Biosimilar Market by Product
6.1.2 North America Biosimilar Market by Application
6.1.3 North America Biosimilar Market by Country
6.2.1 Europe Biosimilar Market by Product
6.2.2 Europe Biosimilar Market by Application
6.2.3 Europe Biosimilar Market by Country
6.3.1 Asia-Pacific Biosimilar Market by Product
6.3.2 Asia-Pacific Biosimilar Market by Application
6.3.3 Asia-Pacific Biosimilar Market by Country
6.4 Rest of the World (RoW)
6.4.1 RoW Biosimilar Market by Product
6.4.2 RoW Biosimilar Market by Application
6.4.3 RoW Biosimilar Market by Sub-region
7. Company Profiles
7.1 Allergan plc
7.4 BioXpress Therapeutics SA
7.5 Boehringer Ingelheim GmbH
7.6 Celltrion Inc.
7.7 Coherus BioSciences, Inc
7.8 Dr. Reddy’s Laboratories Ltd.
7.9 Genor BioPharma Co. Ltd
7.10 Intas Pharmaceuticals Limited
7.11 Novartis AG
7.12 Pfizer, Inc.
7.13 Reliance Life Sciences