Global Biosimilars Market - 2022-2029

Global Biosimilars Market - 2022-2029

Market Overview

The Biosimilars Market size was valued at USD 12,915.10 million in 2021 and is estimated to reach at a compound annual growth rate CAGR of 12.4% over the forecast period 2022 to 2029.

A biosimilar or biosimilar drug is very adjacent in structure and functions to that of biologic medicine. These biosimilars are used to treat immune disease, cancer and other diseases. They are FDA-approved, tested, safe and efficacious drugs and has similar dose, used for the same condition to treat a specific disease or disorder.

Market Dynamics

The biosimilars market growth is driven by the rise in prevalence of different diseases such as cancer and immune disease, rising adoption of biosimilars to treat diseases, increase in the geriatric population, and rising FDA approval of biosimilars drugs.

The rising number of biosimilar drug approvals by the FDA is expected to drive the market growth

Growth in the biosimilars market is anticipated to be fueled by a rise in the number of authorized biosimilars due to improved FDA (U.S. Food and Drug Administration) review procedures, aside from the manufacturing and development procedures. For instance, Amneal Pharmaceuticals, Inc. announced in March 2022 that the U.S. Food and Drug Administration had approved the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar known as Neupogen (FDA). The item will be offered for sale under the RELEUKO brand name. Furthermore, as manufacturers have grown more accustomed to the intricate regulatory and legal frameworks connected with submitting a biosimilar application, the quantity of biosimilar submissions has increased. For instance, in July 2021, Biocon Ltd. (Biocon Biologics) received FDA approval for the first interchangeable biosimilars SEMGLEE (insulin glargine-yfgn injection) for the treatment of diabetes in collaboration with Viatris, Inc.

In addition, the market players are collaborating to expand the biosimilar product portfolio. For instance, in December 2021, Gedeon Richter, Hungary's largest drug maker, partnered with Hikma Pharmaceuticals, a London-listed drug maker, to out-license biosimilars denosumab for commercialization in the United States region.

The more time and cost for biosimilars drug development will hamper the growth of the market

However, one of the main factors slowing acceptance rates in developing and impoverished nations is the high research costs of biosimilar medication. According to recent studies, developing a biosimilar takes about 7 to 8 years and costs between $100 million and $250 million. High development costs for biosimilar drugs will continue to restrain market expansion throughout the projection period. Additionally, several manufacturing difficulties for biosimilars are anticipated to restrain market expansion since biologics are structurally more complex than most small-molecule pharmaceuticals and are more challenging to describe, create, and replicate. The safety and effectiveness of the medication may be affected by a minor change in the manufacturing process.

COVID-19 Impact Analysis

The spread of COVID-19 worldwide has positively impacted the biosimilars market as many clinical trials were conducted. For instance, in April 2020, Lilly collaborated with the National Institutes of Allergy and Infectious Diseases (NIAID) to study baricitinib as part of NIAID’s Adaptive COVID-19 treatment clinical trial. NIAID, part of the National Institutes of Health (NIH), and Lilly progressed LY3127804, an investigational selective monoclonal antibody against Angiopoietin 2 (Ang2), to Phase 2 testing in pneumonia patients hospitalized with COVID-19. The Pfizer initiative, the COVID-19 Therapeutics Accelerator, will assess, identify, and scale-up treatments to make products available and affordable for vulnerable communities. It will screen thousands of safety-related compounds and consider new investigational compounds and monoclonal antibodies.

On the other hand, many clinical trials are postponed due to managing protocols, decreasing acute care needs, and patients’ inability due to transportation restrictions. Also, the present limited infrastructure, burdened healthcare system, and social distancing guidelines created a very difficult environment for biologics and biosimilar industries during the pandemic in the short and medium term.

Segment Analysis

The oncology segment is expected to grow at the fastest CAGR during the forecast period (2022-2029)

The oncology segment is expected to boost the market throughout the forecast. Every biosimilar drug is very similar to its FDA-approved reference biologic in terms of safety, efficacy, and quality without being identical to it and has less cost than its reference drugs, making them more accessible in the market. These biosimilars are used to treat various cancers such as breast cancer, colorectal cancer, stomach cancer and other types of cancers. The biosimilar is approved in developed countries such as Europe and United States due to many oncology biologics patents being expired. As far as May 2021, 39 biosimilars of bevacizumab, filgrastim, pegfilgrastim, trastuzumab, and rituximab have been approved in Europe, and 14 oncology biosimilars were approved by the FDA for use in the United States region.

Moreover, in the article published in Future Oncology, in June 2020, as per the WHO, worldwide cancer cases are predicted to increase by around 60%, from 18.1 million in 2018 to 29.4 million by 2040. Along with that treatment cost of cancer patients reached approximately $150 million in 2018 to $240 million by 2023, rising 9-12% per year. Cost and accessibility are the main barriers to imbalace in cancer treatments and patient clinical outcomes. Many drugs, such as biosimilars, have oncology space, and they are cost-effective, which turn the patients access to efficacious therapies, which drives the oncology biosimilars market worldwide.

Geographical Analysis

North America region holds the largest market share of the global biosimilars market

North America dominates the market for biosimilars and is expected to show a similar trend over the forecast period. It is anticipated to hold a significant market size over the forecast period (2022-2029) due to advanced healthcare infrastructure, FDA approval for biosimilar drugs, and increasing diseases such as cancer. The government initiatives to support the healthcare system drive the market in the North American region. For instance, In 2020, the FDA Commissioner introduced a new partnership between the FDA and the US Federal Trade Commission to assist biosimilar competition and affordability, discourage anticompetitive behavior, and enhance efforts to simplify the competition within the biologics marketplace by reducing health care costs of oncology biologics.

In addition, as per the article published in JCO Oncology Practice, in May 2021, To date, the FDA has approved 29 biosimilar drugs for use in the United States, including 17 products for the treatment of cancer (biosimilars for trastuzumab, bevacizumab, and rituximab) or as a supportive care agent used in the cancer patients (biosimilars for peg-filgrastim, filgrastim, and epoetin alpha). For the pending expiration of several additional biologic patents, additional biosimilar approvals are predicted in the United States, and cancer treatments are likely to continue to be a significant proportion of these approved biosimilars.

Competitive Landscape

The biosimilars market is a moderately competitive presence of local and global companies. Some of the key players contributing to the market's growth are Amgen Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., Biocon, Samsung Bioepis, Mylan NV, Celltrion, Biogen, and Intas Pharmaceutical Ltd., among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, contributing to the biosimilar market growth globally.

For instance,

• In May 2022, Biocon Biologics, and Viatris Inc., introduced Abevmy, a bevacizumab drug in Canada. The Abevmy is a biosimilar to Avastin, developed by Roche and was approved by Health Canada for four oncology indications.

• In September 2021, Sandoz, a Novartis division, announced the commercialization agreement with Bio-Thera Solutions for the biosimilar BAT1706, bevacizumab. This agreement helps to Sandoz’s leading off-patent portfolio for oncology & helped in market expansion.

Novartis AG

Overview:

Sandoz, a Novartis division, produces and distributes generic pharmaceuticals and biosimilars. They offer new, cost-effective treatment to meet the requirements of the patients. The company has an oncology portfolio and over 50 generic medicines worldwide.

Treatment type Portfolio:

Bevacizumab: It is a recombinant humanized monoclonal IgG1 antibody that works with other therapies to target vascular endothelial growth factor (VEGF), a crucial modulator of angiogenesis in cancer.

The global biosimilars market report would provide access to approximately 65+ market data tables, 65+ figures, and in the range of 200+ (approximate) pages.


1. Market Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Market Definition and Overview
3. Executive Summary
3.1. Market Snippet By Product
3.2. Market Snippet By Technology
3.3. Market Snippet By Application
3.4. Market snippet By Distribution Channel
3.5. Market Snippet by Region
4. Market Dynamics
4.1. Market Impacting Factors
4.1.1. Drivers
4.1.2. An increasing number of biosimilar drug approvals by the FDA
4.1.3. Increasing demand for biosimilar drugs due to their cost effectiveness
4.1.4. Restraints:
4.1.5. High development cost of the biosimilar drug
4.1.6. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Forces Analysis
5.2. Supply Chain Analysis
5.3. Regulatory Analysis
5.4. Pricing Analysis
5.5. Unmet Needs
6. COVID-19 Analysis
6.1. Analysis of Covid-19 on the Market
6.1.1. Before COVID-19 Market Scenario
6.1.2. Present COVID-19 Market Scenario
6.1.3. After COVID-19 or Future Scenario
6.2. Pricing Dynamics Amid Covid-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturer’s Strategic Initiatives
6.6. Conclusion
7. By Product
7.1. Introduction
7.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Segment
7.1.2. Market Attractiveness Index, By Product Segment
7.2. Monoclonal Antibodies*
7.2.1. Introduction
7.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
7.3. Recombinant Human Growth Hormone (rhGH)
7.4. Insulin
7.5. Anti-coagulants
7.6. Erythropoietin
7.7. Fusion Proteins
7.8. Granulocyte Colony Stimulating Factor
7.9. Follitropin
7.10. Others
8. By Technology
8.1. Introduction
8.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology Segment
8.1.2. Market Attractiveness Index, By Technology Segment
8.2. Recombinant DNA Technology (rDNA technology)*
8.2.1. Introduction
8.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
8.3. Monoclonal Antibodies (MAb) Technology
9. By Application
9.1. Introduction
9.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
9.1.2. Market Attractiveness Index, By Application
9.2. Oncology*
9.2.1. Introduction
9.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
9.3. Chronic and Immune Diseases
9.4. Infectious Diseases
9.5. Growth Hormone Deficiency
9.6. Blood Disorders
9.7. Others
10. By Distribution Channel
10.1. Introduction
10.1.1. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
10.1.2. Market Attractiveness Index, By Distribution Channel
10.2. Hospital Pharmacies*
10.2.1. Introduction
10.2.2. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029
10.3. Retail Pharmacies
10.4. Online Pharmacies
11. By Region
11.1. Introduction
11.1.1. Market Size Analysis, US$ Million, 2020-2029 and Y-o-Y Growth Analysis (%), 2021-2029, By Region
11.1.2. Market Attractiveness Index, By Region
11.2. North America
11.2.1. Introduction
11.2.2. Key Region-Specific Dynamics
11.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
11.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
11.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
11.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
11.2.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
11.2.7.1. The U.S.
11.2.7.2. Canada
11.2.7.3. Mexico
11.3. Europe
11.3.1. Introduction
11.3.2. Key Region-Specific Dynamics
11.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
11.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
11.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
11.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
11.3.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
11.3.7.1. Germany
11.3.7.2. U.K.
11.3.7.3. France
11.3.7.4. Italy
11.3.7.5. Spain
11.3.7.6. Rest of Europe
11.4. South America
11.4.1. Introduction
11.4.2. Key Region-Specific Dynamics
11.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
11.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
11.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
11.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
11.4.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
11.4.7.1. Brazil
11.4.7.2. Argentina
11.4.7.3. Rest of South America
11.5. Asia Pacific
11.5.1. Introduction
11.5.2. Key Region-Specific Dynamics
11.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
11.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
11.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
11.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
11.5.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
11.5.7.1. China
11.5.7.2. India
11.5.7.3. Japan
11.5.7.4. Australia
11.5.7.5. Rest of Asia Pacific
11.6. Middle East and Africa
11.6.1. Introduction
11.6.2. Key Region-Specific Dynamics
11.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product
11.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Technology
11.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
11.6.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channel
12. Competitive Landscape
12.1. Key Developments and Strategies
12.2. Company Share Analysis
12.3. Treatment type Benchmarking
13. Company Profiles
13.1. Amgen Inc.*
13.1.1. Company Overview
13.1.2. Treatment type Portfolio and Description
13.1.3. Key Highlights
13.1.4. Financial Overview
13.2. Teva Pharmaceutical Industries Ltd.
13.3. Novartis AG
13.4. Pfizer Inc.
13.5. Biocon
13.6. Samsung Bioepis
13.7. Mylan NV
13.8. Celltrion
13.9. Biogen
13.10. Intas Pharmaceutical Ltd.
LIST NOT EXHAUSTIVE
14. Global Biosimilars market– DataM
14.1. Appendix
14.2. About Us and Services
14.3. Contact Us

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