Biosimilars Market Snapshot
“The Biosimilars Market is estimated to increase at a CAGR 16.67% from $ 23.43 Billion in 2023 to $ 88.43 Billion by 2030.”
A biosimilar is a biological product that closely resembles and has no clinically significant differences from an FDA-approved biological product, also known as the reference product.
Biosimilars are medications created by drug companies after a biological medicine's patent expires, which are nearly identical replicas of the original. These new medications undergo testing and obtain a license for use, similar to other new medications.
Biosimilars differ from generics due to their molecular size, structure, complexity, and development costs, as well as higher R&D expenditures, hazards, and manufacturing difficulties compared to small-molecule generics.
Biosimilars are safe, effective treatments for various disorders like chronic skin and bowel diseases, arthritis, kidney disease, and cancer, improving access to life-saving drugs and potentially lowering costs.
Biosimilar medications, being closely resembling reference biologics, require less research and development for the same efficacy and safety, making them cheaper to produce and potentially reinvested.
Filgrastim-sndz, the first biosimilar medication approved by the FDA in the US, has been found to be equally effective and safe as the reference drug, filgrastim, in preventing neutropenia in cancer patients.
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Key Benefits
- In 2022, the Asia Pacific biosimilars market generated a revenue share of approximately 27.34%.
- In 2022, the monoclonal antibodies segment accounted for 39.89% of the total revenue generated by the product.
- By application, oncology segment has held revenue share of around 23.56% in 2022.
- In 2022, the in-house segment of 3B manufacturers accounted for 84.23% of the total revenue share.
Growth Drivers
The FDA approves biosimilar products, providing scientific and regulatory guidance for safe and effective use. Approval of biosimilar drugs can enhance patient care by expanding treatment options at potentially lower costs.
Several major market companies are prioritizing biosimilar development, with the FDA having approved 40 biosimilars as of December 2022. Despite a slowdown during the COVID-19 pandemic, approvals returned in 2022 with seven additional biosimilars.
All seven referenced previously approved biosimilars, and no new reference items were approved. Four new products were introduced, including the first two Lucentis (ranibizumab) biosimilars.
Restraints
Pharmaceutical industry expansion is hindered by the high cost of biologics, with biosimilars requiring significant investments and a 7-8 year manufacturing process. The complexity of monoclonal antibody creation also contributes to higher production costs, further limiting industry development. The manufacturing process costs $100-250 million.
- The availability of alternative medications is a significant concern.
- The statement is ambiguous and lacks a clear statement.
- The development process can be costly and time-consuming.
- The manufacturing process is complex and multifaceted.
Biosimilars Market Segment Analysis
The oncology category is expected to dominate the biosimilars market due to the increasing global cancer incidence, with the International Agency for Research on Cancer (IARC) predicting 27.5 million new cases and 16.3 million deaths by 2040. This growth is expected to boost demand for improved cancer medications for efficient patient treatment.
The market expansion is expected to be fueled by expanding oncology-focused research and development activities, as well as increasing regulatory approvals.
The oncology segment dominated the global biosimilars business in 2022, expected to continue so due to the availability of lower-cost biosimilars for cancer therapy and the rising global cancer prevalence.
The growth hormonal deficit category is expected to be the fastest-growing segment due to the increasing prevalence of children experiencing uncommon growth hormone insufficiency during pregnancy, with a 50% chance of a child developing this condition, according to the National Organisation for Rare Disorders.
Competitive Landscape of the Biosimilars Market Analysis
New Developments in Biosimilars Market
Jul 20, 2023- Sandoz announces plans to build a Biosimilar Technical Development Center in Slovenia to support future growth of biosimilar pipeline
Sandoz, a global leader in generic and biosimilar medicines, today announced an investment of approximately USD 90 million at its site in Ljubljana, Slovenia to establish a dedicated Sandoz Biopharma Development Center by 2026.
Jun 15, 2023- Sandoz introduces Act4Biosimilars Action Plan to accelerate patient access to biosimilar medicines
Sandoz, a global leader in generic and biosimilar medicines, today announced the launch of a global roadmap to increase patient access to biologic medicines. The Act4Biosimilars Action Plan is part of the Act4Biosimilars initiative, founded by Sandoz and launched in 2022, and aims to increase global biosimilar adoption by at least 30 percentage points in 30+ countries by 2030.
JULY 24, 2023- Teva Pharmaceuticals and Alvotech Provide Update on Strategic Biosimilars Partnership
Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., a global leader in generic and innovative medicines and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announcedthat they have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech.
May 09, 2023- Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just - Evotec Biologics, the Seattle-based subsidiary of Evotec SE. The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion and is the most recent step towards strengthening the Sandoz foundation as a stand-alone off-patent medicines company.
Regional Analysis of Global Biosimilars Industry
The biosimilars market in North America is expected to grow rapidly due to the high prevalence of chronic illnesses like cancer and increased research and development expenditure by leading players.
In 2022, the US had 2,281,658 new cancer cases and 612,390 deaths, with breast cancer having the highest incidence. Lung, prostate, and colon cancers also had the highest incidences.
Asia Pacific is predicted to grow at a CAGR of 17.2% over the forecast period, with leading companies like Dr. Reddy's Laboratories, Biocon, Pfizer Inc., and Celltrion developing and commercializing biosimilars. The growth of biosimilars in this region is driven by market developments and growing health expenditure, as China's health expenditure increased from 4.34% in 2015 to 5.34% in 2020, according to World Bank data.
Segments Covered in the Biosimilars Market Report
by Product
- Adverse Event Reporting Software
- Drug Safety Audits Software
- Issue Tracking Software
- and Fully Integrated Software
By Mode of Delivery
- On-premise Delivery
- On-demand/Cloud-based (SaaS) Delivery
By End User
- Pharmaceutical and Biotechnology Companies
- Contract Research Organizations
- Business Process Outsourcing Firms
- and Other Pharmacovigilance Service Providers
Market by Region
- North America
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Australia
- Rest of Asia-Pacific
- Rest of the World
- Middle East
- Africa
- Latin America
Frequently Asked Questions
What are some applications of Biosimilars?
Biosimilars is FDA approved for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis (PsO), inflammatory bowel disease (IBD): adult Crohn disease (CD), ulcerative colitis (UC).
What is the expected growth rate of the Biosimilars market over the next 7 years?
The Biosimilars Market is estimated to increase at a CAGR 16.67% from $ 23.43 Billion in 2023 to $ 88.43 Billion by 2030.
Who are the major players in the Biosimilars market and what is their market share?
Novartis, Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono, Biogen idec, Inc., Genentech, are prominent players operating and dominating in the market.
Who are the top 3 Biosimilars Market Key Vendors?
Novartis, Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd, are key players in the Biosimilars market.
Which geographical areas dominate the worldwide market for Biosimilars?
North America region are emerging as the top regional markets for Biosimilars solutions.
1.SUMMARY
1.1. Biosimilars Market Overview
1.2. Key Insights
1.3. Report Scope
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
- DECISION-MAKING SUMMARY
- INTRODUCTION
3.1. Overview of Biosimilars
3.2. Key Historical Events
3.3. Structure
3.4. Biochemical Interaction
3.5. Target Indications
3.6. Advantages of Biosimilars
3.7 Challenges associated with Biosimilars
3.8. Future Perspectives.
- MARKET LANDSCAPE
4.1. Methodology
4.2 Biosimilars: Developer Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters (Region-wise)
4.2.4. Analysis by Location of Headquarters (Country-wise)
4.2.5. Analysis by Year of Establishment, Company Size and Location of Headquarters (Region-wise)
4.2.6. Most Active Players
- COMPANY
5.1. Company Overview
5.1.2 Management Team
5.1.3. Product Portfolio
5.1.4. Recent Developments and Future Outlook
- PARTNERSHIPS AND COLLABORATIONS
6.1. Partnership Models
6.2. Biosimilars: Partnerships and Collaborations
6.2.1. Analysis by Year of Partnership
6.2.2. Analysis by Type of Partnership
6.2.3. Analysis by Year and Type of Partnership
6.2.4. Analysis by Type of Partner
6.2.5. Analysis by Year of Partnership and Type of Partner
6.2.6. Analysis by Type of Partnership and Type of Partner
6.2.7. Analysis by Type of Partner and Parent Company Size
- ACADEMIC GRANTS ANALYSIS
7.1. Methodology and Key Parameters
7.2. Biosimilars: Academic Grants Analysis
7.2.1. Analysis by Year of Grant Award
7.2.2. Analysis by Amount Awarded
7.2.3. Analysis by Funding Institute Center
7.2.4. Analysis by Support Period
7.2.5. Analysis by Funding Institute Center and Support Period
7.2.6. Analysis by Type of Grant Application
7.2.7. Analysis by Purpose of Grant
- PUBLICATION ANALYSIS
8.1. Analysis Methodology and Key Parameters
8.2. Biosimilars: Publication Analysis
8.2.1. Analysis by Year of Publication
8.2.2. Analysis by Type of Publication
8.2.3. Analysis by Type of Conjugate
8.2.4. Analysis by Target Indication
8.2.5. Analysis by Copyright Holder
8.2.6. Word Cloud: Emerging Focus Area
8.2.7. Most Active Publishers: Analysis by Number of Publications
- SUCCESS PROTOCOL ANALYSIS
9.1. Methodology and Key Parameters
9.2. Key Assumptions and Scoring Criteria
9.3. Success Protocol Analysis
9.4. Assessment of Approved Biosimilars
- Appendix 1: Tabulated Data
- Appendix 2: List of Companies
- Novartis
- Synthon Pharmaceuticals, Inc.
- Teva Pharmaceutical Industries Ltd.
- LG Life Sciences
- Celltrion
- Biocon
- Hospira
- Merck Serono
- Biogen idec, Inc.
- Genentech
