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Biosimilar Market: Description
Biosimilar is also known as follow-on Biologics, which refers to a Bio-Therapeutic product that is highly similar to a reference Biologic Drug. It is usually manufactured by a different company than the one which manufactures the original product. It is produced with the help of living organisms or cells. They have a very complex molecular structure. When the permit of a biologic drug expires, manufacturers retreat to the approval from the regulatory authorities so as to start the production of Bio-Similar. They have been labelled as Biosimilar, a biological drug should also be proven alike in terms of quality, efficacy and safety. In accordance with the generic drugs, Bio-Similar is expensive because its production process is more complicated and requires higher investment in development and research.
Source: WMR
Biosimilar Market: Overview
The Global Biosimilar Market is expected to be valued at USD 159,020 million by 2033 from USD 15,600 million in 2023, at a CAGR of 23.5% during the forecast period. Market growth is majorly pushed by the rising incidence of chronic diseases and increasing demand of Bio-Similar for their cost-effectiveness. Official approvals and other regulations that favour the Bio-Similar adoption in different countries is also a major factor contributing in the growth of the Biosimilar Market. Somehow, the complications in the development and manufacturing of Bio-Similar and resistance from reference biologic manufacturers is expected to restrain the growth of this market during the forecast period.
Source: WMR
Biosimilar Market: Key Trends
Adoption of Recombinant Non-Glycosylated Proteins
Recombinant Non-Glycosylated Proteins gathered a notable revenue share for the Biosimilar Market. Recombinant Non-Glycosylated Proteins are Biosimilar Products that include human growth hormones, insulin, interferons and Granulocyte Colony-stimulating factor (Filgrastim). The advancement of technological innovations in the analytical systems has led to the efficient production and sales of these products. The heavy demand for Filgrastim and the penetration of insulin glargine across some of the prominent countries will boost the prospects for biosimilar companies.
Potential in the treatment of Anaemia
Biosimilar drugs have seen a high adoption in Hematology and this application classification contributed to more than USD 4,552.1 Million in Global Remuneration in the overall market. The American Society of Hematology reported that over 3 Million people who are residents of U.S have been diagnosed with Anaemia. Generality of conditions like Anaemia and Neutropenia will encourage the consumption of Biosimilar to treat these blood disorders. Establishment of Recombinant DNA (rDNA) Technology in the manufacturing of Biosimilar products like human growth hormones, erythropoietin and insulin has registered 80% of the total Biosimilar Market share.
Coronavirus is an acute respiratory disease caused by severe Acute Respiratory Syndrome Coronavirus 2 (SARS?CoV?2). Hardly known before the outbreak began in Wuhan (China) in December 2019. COVID-19 has moved from a regional crisis to a global pandemic in a blink of an eye. The World Health Organization (WHO) announced COVID-19 a pandemic on 11th March, 2020. There has been a tremendous amount of effort put into discovering new treatments and vaccines to cure the infection. Soon after the pandemic, companies started coming up with drugs and treatments to treat the infection.
Global Biosimilar Market: Segment Analysis
Biosimilar Market segment based on Molecule
Filgrastim
Rituximab
Filgrastim injection is for the treatment of Neutropenia, that is low white blood cells in the body, which is caused by cancer medicines. It is a synthetic form of substance that is produced naturally in your body known as colony stimulating factor. Filgrastim helps the bone marrow in the body to make new white blood cells itself. Rituximab is used to treat certain types of Cancer such as Non-Hodgkins Lymphoma and Chronic Lymphocytic Lukemia. It slows or stops the growth of cancer cells. Some products of Rituximab are also used to treat the pain of Rheumatoid Arthritis and can also decrease swelling and pain of the joints.
Segmentation based on Indication Insights
Oncology
Female Infertility
Oncology is the largest segment in this market due to the availability of Biosimilar at a lower price than Innovation Biologics and a large number of cancer patients. The availability of Biosimilar in Oncology has reduced the prices and made cancer treatment more accessible and affordable. Due to the high prevalence of cancer, healthcare systems across the globe are more concentrated on reducing the burden of cancer by adopting cost effective treatment options. Biologics are too expensive and cannot be afforded by everyone. Therefore, cost-effective and new Biosimilars are being manufactured in the market.
Segmentation based on Manufacturing
Contract Manufacturing
In- house Manufacturing
Based on the manufacturing, the market is classified into in-house manufacturing and contract manufacturing. Amongst these, in-house manufacturing holds the majority of the market share.
Segmentation based on Region
Region-wise, the market has been segmented into the United States, Germany, United Kingdom, France, Spain, Italy, India, Japan, South Korea and Others.
North America: The United States and Canada are the major markets for biosimilars in North America. The market is driven by the high incidence of chronic diseases such as cancer and diabetes, and the growing demand for cost-effective treatments. The regulatory environment in North America is favorable for biosimilars, with the FDA and Health Canada issuing guidelines and regulations to support their development and approval.
Europe: Europe is the largest biosimilar market, with countries such as Germany, France, and the United Kingdom leading the way. The market is driven by a high demand for biologics, the expiration of patents for many biologics, and the need for cost-effective alternatives. The regulatory environment in Europe is also favorable for biosimilars, with the European Medicines Agency (EMA) issuing guidelines and regulations to support their development and approval.
Asia-Pacific: The Asia-Pacific region is a rapidly growing biosimilar market, with countries such as India, China, and South Korea leading the way. The market is driven by the high prevalence of chronic diseases, a growing demand for affordable treatments, and a supportive regulatory environment. The regulatory environment in Asia-Pacific is evolving, with regulatory agencies such as the Indian FDA and China FDA issuing guidelines and regulations to support the development and approval of biosimilars.
Biosimilar Market: Competitive Landscape
The competitive landscape of the Global Biosimilar Market is as following; Novartis, Pfizer, Celltrion, Teva, Merck & Co, Biocon, Amgen and Eli Lilly are some the major market players in the Biosimilar market. This ranges from macro overview of the market to micro details of the industry performance, key market drivers, recent trends and challenges, SWOT analysis, value chain analysis, Porters five forces analysis, etc.
Report Scope:
Historical Years: 2020-2021
Forecast Years: 2023-2033
Countries Covered: UK, Japan, Germany, Italy, Spain, US. France, India, China, South Korea and others.
Segment Coverage: Molecule, Indication, Manufacturing and Country
1. Global Biosimilars Market Introduction and Market Overview
1.1. Objective of the Market Research Study
1.2. Biosimilars Market Definition & Description
1.3. Research Data Parameters & Reporting Timelines
1.3.1. Historical Data Reporting Years 2020 to 2021
1.3.2. Projected Data Reporting Years 2023 to 2033
1.3.3. Reporting Data Parameters Value (US$ Million)
1.4. Global Biosimilars Market Scope and Market Estimation
1.4.1. Global Biosimilars Overall Market Size (US$ Million), Market CAGR (%), Market Estimates & Forecast (2020 to 2033)
1.4.2. Global Biosimilars Market Revenue Share (%) and Growth Rate (Y-o-Y) from 2020 to 2033
1.5. Biosimilars Market Segmentation
1.5.1. Product Type of Global Biosimilars Market
1.5.2. Indication of Global Biosimilars Market
1.5.3. Technology of Global Biosimilars Market
1.5.4. Application of Global Biosimilars Market
1.5.5. Service of Global Biosimilars Market
1.5.6. Key Regions of Global Biosimilars Market
2. Global Biosimilars Market - Executive Summary
2.1. Global Biosimilars Market Summary & Snapshot
2.2. Global Biosimilars Market, By Product Type (US$ Million)
2.3. Global Biosimilars Market, By Indication (US$ Million)
2.4. Global Biosimilars Market, By Technology (US$ Million)
2.5. Global Biosimilars Market, By Application (US$ Million)
2.6. Global Biosimilars Market, By Service (US$ Million)
2.7. Global Biosimilars Market, By Geography (US$ Million)
2.8. Global Biosimilars Market Outlook & Future Opportunities
3. Biosimilars Market Trends, Outlook, and Factors Analysis
3.1. Global Biosimilars Market Industry Development Trends under COVID-19 Outbreak
3.1.1. Global COVID-19 Status Overview
3.1.2. Influence of COVID-19 Outbreak on Global Biosimilars Market Industry Development
3.1.3. Pre & Post COVID-19 Trends and Scenarios
3.2. Biosimilars Market Dynamics (Growth Impacting Factors & Rationales)
3.2.1. Drivers
3.2.1.1. Biosimilar medications are becoming more popular as a result of their cost-effectiveness.
3.2.1.2. Increasing chronic diseases such as cancer and diabetes are becoming more common.
3.2.1.3. Increasing pharmaceutical drug demand, particularly for high-priced patented pharmaceuticals
3.2.2. Restraints
3.2.2.1. The financial strain is exacerbated by the high cost of reference products.
3.2.2.2. Numerous population allergic from some compounds of biosimilar
3.2.3. Opportunities
3.2.3.1. Blockbuster biologics' patents are about to expire, and researchers are looking towards new indications.
3.2.3.2. Increasing research and development activities by key players
3.2.3.3. Biosimilar can help in Post-COVID-19 Health Care
3.2.4. Impact Analysis of Drivers and Restraints
3.3. Ecosystem/ Value Chain Analysis
3.4. Porters Five Forces Analysis
3.5. SWOT Analysis
3.6. PEST Analysis
3.7. Average Selling Prices and Pricing Trends Analysis of Biosimilars Market
3.8. Technological Roadmap
3.9. Key Investment Pockets of Biosimilars Market
3.9.1. By Product Type
3.9.2. By Indication
3.9.3. By Technology
3.9.4. By Application
3.9.5. By Service
3.9.6. By Regions
4. Global Biosimilars Market: Estimates & Historic Trend Analysis (2020 to 2021)
4.1. Global Biosimilars Market, 2020 2021 (US$ Million)
4.2. Global Biosimilars Market, By Product Type, 2020 to 2021 (US$ Million)
4.3. Global Biosimilars Market, By Indication, 2020 to 2021 (US$ Million)
4.4. Global Biosimilars Market, By Technology, 2020 to 2021 (US$ Million)
4.5. Global Biosimilars Market, By Application, 2020 to 2021 (US$ Million)
4.6. Global Biosimilars Market, By Service, 2020 to 2021 (US$ Million)
4.7. Global Biosimilars Market, By Region, 2020 to 2021 (US$ Million)
5. Global Biosimilars Market Estimates & Forecast Trend Analysis, by Product Type
5.1. Global Biosimilars Market Share (%) Estimates and Forecasts, by Product Type, 2023 & 2033
5.2. Global Biosimilars Market Revenue (US$ Million) Estimates and Forecasts, by Product Type, 2023 to 2033
5.2.1. Human growth hormone
5.2.2. Erythropoietin
5.2.3. Interferon
5.2.4. Granulocyte-Colony Stimulating Factor
5.2.5. Monoclonal antibodies
5.2.5.1. Infliximab
5.2.5.2. Rituximab
5.2.5.3. Trastuzumab
5.2.6. Etanrcept
5.2.7. Glucagon
5.2.8. Calcitonin
5.2.9. Insulin
5.2.10. Others
6. Global Biosimilars Market Estimates & Forecast Trend Analysis, by Indication
6.1. Global Biosimilars Market Share (%) Estimates and Forecasts, by Indication, 2023 & 2033
6.2. Global Biosimilars Market Revenue (US$ Million) Estimates and Forecasts, by Indication, 2023 to 2033
6.2.1. Oncology
6.2.2. Chronic Disease
6.2.3. Blood Disorder
6.2.4. Autoimmune Disease
7. Global Biosimilars Market Estimates & Forecast Trend Analysis, by Technology
7.1. Global Biosimilars Market Share (%) Estimates and Forecasts, by Technology, 2023 & 2033
7.2. Global Biosimilars Market Revenue (US$ Million) Estimates and Forecasts, by Technology, 2023 to 2033
7.2.1. Monoclonal Antibodies (MAb) Technology
7.2.2. Recombinant DNA Technology (rDNA Technology)
7.2.3. Nuclear Magnetic Resonance (NMR)
7.2.4. Electrophorsis
7.2.5. Mass Spectrometry
7.2.6. Bioassay
8. Global Biosimilars Market Estimates & Forecast Trend Analysis, by Application
8.1. Global Biosimilars Market Share (%) Estimates and Forecasts, by Application, 2023 & 2033
8.2. Global Biosimilars Market Revenue (US$ Million) Estimates and Forecasts, by Application, 2023 to 2033
8.2.1. Blood disorders
8.2.2. Growth hormone deficiencies
8.2.3. Oncology diseases
8.2.3.1. Lungs Cancer
8.2.3.2. Breast Cancer
8.2.3.3. Cervical Cancer
8.2.3.4. Colorectal Cancer
8.2.3.5. Prostate Cancer
8.2.3.6. Leukaemia
8.2.4. Chronic and autoimmune diseases
8.2.4.1. Diabetes
8.2.4.2. Neutropenia
8.2.4.3. Multiple Sclerosis
8.2.4.4. Cystic Fibrosis
8.2.4.5. Acromegaly
8.2.4.6. Leprosy
8.2.4.7. Growth Hormone Deficiency
8.2.4.8. Others
9. Global Biosimilars Market Estimates & Forecast Trend Analysis, by Service
9.1. Global Biosimilars Market Share (%) Estimates and Forecasts, by Service, 2023 & 2033
9.2. Global Biosimilars Market Revenue (US$ Million) Estimates and Forecasts, by Service, 2023 to 2033
9.2.1. Contact Research and Manufacturing
9.2.2. Clinical Trials
10. Global Biosimilars Market Analysis and Forecast, by Region
10.1. Global Biosimilars Market Share (%) Estimates and Forecasts, by Region, 2023 & 2033
10.2. Global Biosimilars Market Revenue (US$ Million) Estimates and Forecasts, by Region, 2023 to 2033
10.2.1. North America
10.2.2. Europe
10.2.3. Asia Pacific
10.2.4. Middle East and Africa
10.2.5. Latin America
11. North America Biosimilars Market: Estimates & Forecast Trend Analysis
11.1. North America Biosimilars Market Assessments & Key Findings
11.2. North America Biosimilars Market Share (%) Estimates and Forecasts, 2023 & 2033
11.3. North America Biosimilars Market Size Estimates and Forecast (US$ Million) (2023 to 2033)
11.3.1. By Product Type
11.3.2. By Indication
11.3.3. By Technology
11.3.4. By Application
11.3.5. By Service
11.3.6. By Major Country
11.3.6.1. The U.S.
11.3.6.2. Canada
12. Europe Biosimilars Market: Estimates & Forecast Trend Analysis
12.1. Europe Biosimilars Market Assessments & Key Findings
12.2. Europe Biosimilars Market Share (%) Estimates and Forecasts, 2023 & 2033
12.3. Europe Biosimilars Market Size Estimates and Forecast (US$ Million) (2023 to 2033)
12.3.1. By Product Type
12.3.2. By Indication
12.3.3. By Technology
12.3.4. By Application
12.3.5. By Service
12.3.6. By Major Country
12.3.6.1. Germany
12.3.6.2. The U.K.
12.3.6.3. France
12.3.6.4. Italy
12.3.6.5. Spain
12.3.6.6. Rest of Europe (includes all other European countries)
13. Asia Pacific Biosimilars Market: Estimates & Forecast Trend Analysis
13.1. Asia Pacific Biosimilars Market Assessments & Key Findings
13.2. Asia Pacific Biosimilars Market Share (%) Estimates and Forecasts, 2023 & 2033
13.3. Asia Pacific Biosimilars Market Size Estimates and Forecast (US$ Million) (2023 to 2033)
13.3.1. By Product Type
13.3.2. By Indication
13.3.3. By Technology
13.3.4. By Application
13.3.5. By Service
13.3.6. By Major Country
13.3.6.1. China
13.3.6.2. Japan
13.3.6.3. India
13.3.6.4. ASEAN
13.3.6.5. South Korea
13.3.6.6. Rest of Asia Pacific (includes all other Asia Pacific countries)
14. Middle East & Africa Biosimilars Market: Estimates & Forecast Trend Analysis
14.1. Middle East & Africa Biosimilars Market Assessments & Key Findings
14.2. Middle East & Africa Biosimilars Market Share (%) Estimates and Forecasts, 2023 & 2033
14.3. Middle East & Africa Biosimilars Market Size Estimates and Forecast (US$ Million) (2023 to 2033)
14.3.1. By Product Type
14.3.2. By Indication
14.3.3. By Technology
14.3.4. By Application
14.3.5. By Service
14.3.6. By Major Country
14.3.6.1. GCC
14.3.6.2. South Africa
14.3.6.3. Egypt
14.3.6.4. Rest of Middle East & Africa (includes all other Middle East & Africa countries)
15. Latin America Biosimilars Market: Estimates & Forecast Trend Analysis
15.1. Latin America Market Assessments & Key Findings
15.2. Latin America Biosimilars Market Share (%) Estimates and Forecasts, 2023 & 2033
15.3. Latin America Biosimilars Market Size Estimates and Forecast (US$ Million) (2023 to 2033)
15.3.1. By Product Type
15.3.2. By Indication
15.3.3. By Technology
15.3.4. By Application
15.3.5. By Service
15.3.6. By Major Country
15.3.6.1. Brazil
15.3.6.2. Mexico
15.3.6.3. Rest of Latin America (includes all other Latin America countries)
16. Competitive Landscape
16.1. Biosimilars Market Revenue Share Analysis (%), by Major Players (2021)
16.2. Biosimilars Market Competition Matrix, by Leading Players
16.3. Biosimilars List of Emerging, Prominent and Leading Players
16.4. Major Mergers & Acquisitions, Partnership, Joint Venture, Expansions, Deals, Recent Developments, etc.
17. Company Profiles
17.1. Novartis (Sandoz)
17.1.1. Company Overview & Insights
17.1.2. Financial Performance
17.1.3. Product / Service Portfolio
17.1.4. Geographical Footprint & Share
17.1.5. Strategic Initiatives & Key Developments
*Similar details would be provided for all the players mentioned below
17.2. LG Life Sciences
17.3. Fresenius SE & Co. KGaA
17.4. Pfizer, Inc.
17.5. Hospira
17.6. STADA Arzneimittel AG
17.7. Dr. Reddys Laboratories Ltd.
17.8. Eli Lilly and Company
17.9. Genentech (Roche Group).
17.10. Synthon Pharmaceuticals, Inc.
17.11. Celltrion
17.12. Boehringer Ingelheim
17.13. Amgen, Inc.
17.14. Gedeon Richter PLC
17.15. Merck Serono (Merck Group)
17.16. Teva Pharmaceutical Industries Ltd.
17.17. Biocon Limited
17.18. Samsung Biologics
17.19. Biogen idec, Inc.
17.20. Coherus BioSciences
17.21. Viatris, Inc
17.22. Fujifilm Kyowa Kirin Biologics Co., Ltd.
17.23. Others
18. Assumptions and Research Methodology
18.1. Data Mining
18.2. Secondary Research
18.3. Primary Research
18.4. Subject Matter Expert Advice
18.5. Quality Check
18.6. Final Review
18.7. Data Triangulation
18.8. Bottom-Up Approach
18.9. Top Down Approach
18.10. Research Flow
18.11. Key Insights from Industry Experts
18.12. Data Sources
18.13. Assumptions
18.14. Limitations
19. Conclusions and Recommendations
19.1. Key Research Findings and Conclusion
19.2. Key Insights & Recommendations from Analyst