As per our recently published analysis report, the global biosimilars market size was worth USD 4.49 billion in 2020. This figure is forecasted to grow at a remarkable CAGR of 39.39% and will reach USD 23.63 Billion by 2025.
History of Biosimilars
Biosimilars were introduced to the world in the early 1990s and are not like generic drugs. Around 59 in the United Kingdom and 19 biosimilar products in the United States have received approval from the FDA by April 2019. Currently, over 1040 biosimilars are operating in the biopharma R&D pipeline. Various drug-related authorities such as European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada are monitoring the quality and safety of biosimilar products. They have their guidance of requirements for demonstration.
According to the Biologics Price Competition and Innovation (BPCI) Act - FDA 351(k) is the pathway for approval of biosimilars. But the first approval happened in the year 2015 for Sandoz Zarxio in the United States. On Jan 2018, the Food and Drug Administration in the United States had introduced a plan named Biosimilar Action Plan (BAP) which promotes and protects public health services.
Adalimumab was the first biosimilar product in the world. Zydus, one of the known and critical company in the biosimilars market, manufactured it. It has a vast number of monoclonal antibodies under the development and is the highest-selling biosimilar in history and also was the alpha monoclonal antibody which was first approved in 2002 and is the most favoured treatment for the patients with autoimmune diseases.
MARKET DRIVERS
The cost-effective nature of biosimilars majorly drives global market growth.
The low cost of the biosimilars, when compared to biologics and various government cost-saving initiatives, is one of significant factor accelerating the market. Several factors, such as patent expire of biological drugs, and low prices cost-saving initiatives by the governments are also fuelling the growth of the market. Furthermore, the rise in the scale of pharmaceutical companies and also growing prevalence to improve the quality of the drugs are expanding the market. Increasing focus on introducing medications with the latest technology and the growing number of new-entry level of biosimilars manufacturers are also accelerating.
Additionally, Patents of several drugs have expired, and a large number of drugs expect to lose patent protection in the upcoming years are the crucial factors driving the market. The increase in the acceptance and adoption by various stakeholders with the need for diversity in technology and business models and growing commonness of chronic diseases are propelling the market growth.
The emergence of advanced technologies and the launch of innovative techniques in manufacturing the drugs and increasing demand for proper diabetic health management treatment are few of the other significant areas offering scope to the biosimilars market to excel further. The rise in the awareness over the availability of various products and increasing initiatives by the government through campaigns in undeveloped countries is significantly helping the market to achieve new heights in the market growth.
MAJOR CHALLENGES
Lack of skilled persons in producing the desired products similar to the approved products and the difficulty in getting approval from higher authorities are significant factors hampering the biosimilars market. The high cost required for installation and maintenance of the devices has remained a challenging factor for the market. Furthermore, the factors such as lack of serving guidelines and the unwillingness of physicians to prescribe biosimilar drugs are limiting the market growth to a significant extent.
REPORT COVERAGE
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REPORT METRIC |
DETAILS |
|
Market Size Available |
2019 to 2025 |
|
Base Year |
2019 |
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Forecast Period |
2020 to 2025 |
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Segments Covered |
By Product Type, Technology, Disease & Region |
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Various Analyses Covered |
Global, Regional & Country Level Analysis, Segment-Level Analysis, Drivers, Restraints, Opportunities, Challenges, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities |
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Regions Covered |
North America, Europe, Asia Pacific, Latin America, Middle East & Africa |
The global biosimilar market is segmented and sub-segmented into the product type, technology, disease and end-user.
By Product Type
Based on the product type, the Recombinant non-glycosylated protein product type is holding the highest shares of the global biosimilar market. A rise in the production rate of insulin and growth hormone drugs globally is leveraging the growth rate of the market. Growing incidences of cancer are also to boost up the demand of the Bio-similar Market.
Recombinant Glycosylated Proteins segment is likely to witness with a high CAGR value during the period. The patent expiration of biological drugs like erythropoietin and monoclonal antibodies in expected for the growth of this segment during the period.
By Technology
Based on Technology, Recombinant DNA Technology holds a significant share and has a share value of USD 8,123.6 million. The bio-similar products like human growth hormones, insulin and erythropoietin are manufactured using this segment. The advance technologies help to intensify the ability of the bio-similar to treat the diseases instantly and efficiently.
The monoclonal antibody technology expects to grow at a CAGR of 30.0% during the period. It is due to the number of monoclonal antibody applications that are for the treatment of cancer and autoimmune diseases that has resulted in the growth of monoclonal antibody technology which is accelerating the market.
By Disease
Based on disease, the Oncology sector is leading with the most significant shares of the global biosimilar market due to the increase in obtaining less cost bio-similar drugs for the treatment of cancer. This segment is leading due to the factors like the approval for different types of drugs and the massive number of oncology products in the stream of cancer treatment is one of the significant factors that make this oncology disease segment proliferate.
Blood disorders segment is likely to increase with producing profits during the period. Common diseases like anaemia, haemophilia and positive results of the continuous clinical trials are some of the factors that boost up the market growth.
By Region
In 2019, North America held the largest share in the global biosimilars market. It is due to the acceptance of the advance technologies that are coming into the market in this region. The introduction of various drugs and products that receive approval from the FDA is expanding the market growth in this region.
The Asia-Pacific market has the quickest region during recent years and also in the upcoming years. The area is to hit the industry with a CAGR value during the period. The growing annual income of a person per annum, in developing countries, is accelerating the growth of the biosimilar market.
The Middle East & Africa has to continue their growth rate during the forecast period.
Europe region is followed by North America that is influencing the market growth during the period due to the increase in constructional activities on healthcare centres for providing proper care for the patient.
TOP COMPANIES IN THE MARKET
Key market participants dominating the global biosimilars market profiled in the report are Sandoz International GmbH, Wockhardt Ltd, Hospira, Inc., Teva Pharmaceutical Industries Ltd., Dr Reddy’s Laboratories, Biocon Limited, Mylan, Inc., Zydus Cadila, Celltrion Inc., Roche Diagnostics and Cipla Ltd.
MAJOR DEVELOPMENTS IN THE BIOSIMILAR MARKET BY LEADING COMPANIES:
Product Approvals
On November 05, 2019, Sandoz received an FDA approval for its new drug-related to its oncology care biosimilar Ziextenzo TM. This drug is to reduce the occurrence of febrile neutropenia which is the most significant adverse effects of chemotherapy which is one of the treatments for cancer.
On May 15, 2018, Pfizer received approval acceptance by FDA for RETACRIT which is a biosimilar for Epogen and Procrit. It is the first biosimilar that has approved in the U.S. This Retacrit is used for patients with anaemia and also decrease the red blood cells transfusion with growing access to low-cost alternative treatment.
On May 06, 2020, Dr Reddy Laboratories received approval for ELYXYB by FDA, which is for the patients with migraine in adults with or without aura and is the most successful migraine treatments.
On June 13, 2019, the FDA approved the Amgen’s Knajinti, which is the 5th bio-similar to be approved for Roche’s Herceptin (traztuzumab) and the 20th bio-similar.
On December 02, 2019, Mylan and Biocon companies have introduced a new drug together called Ovigri, which is a biosimilar for Herceptin. It was approved by the FDA for the patients to provide dosage and flexible treatment for those with breast cancer and stomach cancer like gastric or gastroesophageal. It is available in two types of dosages like 420mg multi-dose and 150mg single-use.
Partnerships
On November 07, 2019, Teva pharmaceuticals and Celltrion, both the companies united and announced the TRUXIMA injection, which is for the patients with non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukaemia (CLL) in adults.
On March 16, 2020, Teva pharmaceuticals and Celltrion joined and launched the fourth biosimilar traztuzumab of Herzuma. This bio-similar is available in the form of an injection that is commonly used by patients who have breast cancer.
On July 29, 2019, Cipla and Alvotech has made a partnership has introduced a new AVTO2 which is a bio-similar for HUMIRA. This drug is to treat autoimmune diseases like Psoriasis, Rheumatoid Arthritis, and Ankylosing Spondylitis and so on.
Mergers and Acquisitions
On January 08, 2016, Mylan made a public statement that it is going to integrate with Momenta for the development of six bio-similar products. This integration is to develop bio-similar products and release them into the market.
On January 18, 2018, Biocon joined with Swiss pharma Sandoz to develop and manufacture multiple bio-similar patients with immunology and oncology. The objective of this partnership is to boost the ability to end bio-similar and share up the cost and profit.
On January 20, 2018, Dr Reddy’s laboratories made a partnership with Turkish firm for the development and commercialization of three bio-similar products which are based on the drug substance and product.
On February 05, 2015, Pfizer stated that it is going to obtain Hospira for $17billion to increase and confirm the drug business to develop sterile injectable within the Pfizer’s pharma industry.
On February 17, 2020, Dr.Reddy’s laboratories have acquired Wockhardt assets. Dr Reddy’s stated that the deal would include treatments like respiratory, neurology, pain and vaccines. This acquisition will help the company to increase its business across domestic countries.
On July 18, 2019, Celltrion and Nan Fung group together integrate to confirm Vcell Healthcare Limited to develop and market bio-similar in China. This bio-similar had the approval from the US FDA and EMA where these products were Celltrion CT-P13 and CT-P10.
On February 12, 2016, Sandoz obtained Pfizer’s bio-similar Infliximab to widen its portfolio of bio-similar. Infliximab is a tumour necrosis factor-alpha that is to treat autoimmune diseases which include psoriasis and arthritis.
1.Introduction
1.1 Market Definition
1.2 Study Deliverables
1.3 Base Currency, Base Year and Forecast Periods
1.4 General Study Assumptions
2. Research Methodology
2.1 Introduction
2.2 Research Phases
2.2.1 Secondary Research
2.2.2 Primary Research
2.2.3 Econometric Modelling
2.2.4 Expert Validation
2.3 Analysis Design
2.4 Study Timeline
3. Overview
3.1 Executive Summary
3.2 Key Inferences
4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
4.1 Market Drivers
4.2 Market Restraints
4.3 Key Challenges
4.4 Current Opportunities in the Market
5. Market Segmentation
5.1 By Type
5.1.1 Protein
5.1.2 Insulin
5.1.3 Human Growth Hormones
5.1.4 Granulocyte Colony-stimulating Factor (G-CSF)
5.1.5 Interferons
5.1.6 Recombinant Glycosylated Proteins
5.1.7 Erythropoietin
5.1.8 Monoclonal Antibodies
5.1.9 Follitropin
5.1.10 Recombinant Peptides
5.1.11 Glucagon
5.1.12 Calcitonin
5.2 By Technology
5.2.1 Mass Spectroscopy
5.2.2 Chromatography
5.2.3 Monoclonal Antibody Technology
5.2.4 Recombinant DNA Technology
5.2.5 Nuclear magnetic resonance (NMR) technology
5.2.6 Electrophoresis
5.2.7 Bioassay
5.3 By Application
5.3.1 Oncology diseases
5.3.2 Blood disorders
5.3.3 Growth hormone deficiencies
5.3.4 Chronic and autoimmune diseases
5.3.5 Others
6. Geographical Analysis
6.1 North America
6.1.1 Introduction
6.1.2 United States
6.1.3 Canada
6.2 Europe
6.2.1 Introduction
6.2.2 U.K
6.2.3 Spain
6.2.4 Germany
6.2.5 Italy
6.2.6 France
6.3 Asia-Pacific
6.3.1 Introduction
6.3.2 China
6.3.3 India
6.3.4 Japan
6.3.5 South Korea
6.3.6 Australia
6.4 Latin America
6.4.1 Introduction
6.4.2 Brazil
6.4.3 Argentina
6.4.4 Mexico
6.5 Middle East & Africa
6.5.1 Introduction
6.5.2 Middle-East
6.5.3 Africa
7.Strategic Analysis
7.1 PESTLE analysis
7.1.1 Political
7.1.2 Economic
7.1.3 Social
7.1.4 Technological
7.1.5 Legal
7.1.6 Environmental
7.2 Porter’s Five analysis
7.2.1 Bargaining Power of Suppliers
7.2.2 Bargaining Power of Consumers
7.2.3 Threat of New Entrants
7.2.4 Threat of Substitute Products and Services
7.2.5 Competitive Rivalry within the Industry
8.Market Leaders' Analysis
8.1 Sandoz International GmbH
8.1.1 Overview
8.1.2 Product Analysis
8.1.3 Financial analysis
8.1.4 Recent Developments
8.1.5 SWOT analysis
8.1.6 Analyst View
8.2 Wockhardt
8.3 Hospira
8.4 Teva Pharmaceutical Industries
8.5 Dr. Reddy’s Laboratories
8.6 Biocon
8.7 Mylan
8.8 Zydus Cadila
8.9 Celltrion
8.10 Roche Diagnostics
8.11 Cipla
9.Competitive Landscape
9.1 Market share analysis
9.2 Merger and Acquisition Analysis
9.3 Agreements, collaborations and Joint Ventures
9.4 New Product Launches
10.Market Outlook and Investment Opportunities
Appendix
a) List of Tables
b) List of Figures
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