US Biosimilars Market Analysis Report 2022 to 2030

US Biosimilars Market Analysis

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The US biosimilars market size was valued at $8.6 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 20.2% from 2022 to 2030 and will reach $35.1 Bn in 2030. The market is segmented by product type and indication type. The US biosimilars market will grow as chronic diseases including cancer and autoimmune conditions are more common and the demand for biosimilars is being fueled by the fact that they provide an affordable means of treating certain illnesses. The key market players are Pfizer (USA), Amgen (USA), Sandoz (CHE), Mylan (USA), and others.

ID: IN10USPH027 CATEGORY: Pharmaceuticals GEOGRAPHY: US AUTHOR: Chandani Patel

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US Biosimilars Market Executive Summary

The US biosimilars market size was valued at $8.6 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 20.2% from 2022 to 2030 and will reach $35.1 Bn in 2030. Biosimilars are biological products that are very similar to a reference product that has already received regulatory agency approval and differ from it in no clinically significant ways. Because they are made using a different manufacturing technique and may be sold at a lower price point than pricey biologic medications, biosimilars provide a more cost-effective substitute.

As more biosimilars are approved by the US Food and Drug Administration (FDA), the market for biosimilars in the US has been gradually expanding in recent years. The FDA has authorized 31 biosimilars for use in the US market as of April 2023, with indications ranging from autoimmune illnesses to cancer. The US biosimilar industry is still developing, with new approvals, legal issues, and policy modifications influencing the environment. It seems probable that biosimilars will keep playing a significant role in the US healthcare system as more of them are approved and made available to patients.

US biosimilars market analysis

Market Dynamics

Market Growth Drivers

Many biologic pharmaceuticals have reached or are about to reach the end of their patent protection, which gives biosimilar producers a chance to join the market with less expensive goods. Additionally, the high cost of biological medications has led to an increase in demand for affordable treatments. The fact that biosimilars are more reasonably priced than biologics is what is promoting their uptake.

Moreover, in the US, chronic diseases including cancer and autoimmune conditions are more common. The demand for biosimilars is being fueled by the fact that they provide an affordable means of treating certain illnesses.

Furthermore, a regulatory framework for the approval of biosimilars has been developed by the US FDA, which has made it easier for them to enter the market. Favorable governmental regulations have also been implemented. Additionally, the US has a regulatory framework in place for the approval and marketing of biosimilars according to the Biologics Price Competition and Innovation Act (BPCIA).

Market Restraints

The process of creating biosimilars is time-consuming and expensive. Because of the hefty development expenses, some firms can decide not to enter the market. Also, the complexity of biologic manufacturing processes: It is difficult to reproduce biologic medications since they are generated utilizing sophisticated manufacturing techniques. With biosimilars, this complexity can result in issues with quality and safety. Some manufacturers may find it difficult to enter the market due to the complicated and drawn-out regulatory approval procedure for biosimilars. Additionally, manufacturers may experience uncertainty due to the shifting regulatory framework for biosimilars.

Competitive Landscape

Key Players

Pfizer (USA)
Amgen (USA)
Sandoz (CHE)
Mylan (USA)
Teva (ISR)
Fresenius Kabi (DEU)
Coherus Biosciences (USA)
Momenta Pharmaceuticals (USA)
Pfenex (USA)
Biocon (IND)

Recent Developments

In November 2020, the FDA approved Pfizer's biosimilar, Ruxience (rituximab-pvvr), for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Expansion of Biosimilar Use: There has been a gradual increase in the use of biosimilars in the US market. According to a report by the Biosimilars Council, biosimilars saved the US healthcare system $2.2 Bn in 2020. This growth is expected to continue as more biosimilars are approved and as healthcare providers become more familiar with their use.

Healthcare Policies and Regulatory Landscape

The US Food and Drug Administration (FDA) oversees biosimilars in accordance with the Biologics Price Competition and Innovation Act (BPCIA). According to the BPCIA, biosimilars must show that they are extremely comparable to an authorized reference product in terms of safety, purity, and potency in order to receive regulatory clearance. To support the safety and effectiveness of the biosimilar, the FDA can potentially demand further information.

Reimbursement guidelines for biosimilars are still being developed in the US. Costs associated with healthcare can be decreased since biosimilars are frequently less expensive than their reference products. However, state and payer-specific reimbursement regulations for biosimilars may differ.

A payment strategy for biosimilars under the Medicare Part B program has been set by the Centres for Medicare and Medicaid Services (CMS). The average sales price (ASP) of the reference product + 6% of the ASP of the biosimilar is what is paid for biosimilars under this policy. By offering financial incentives to healthcare professionals, this program aims to encourage the adoption of biosimilars.

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

US Biosimilars Market Segmentation

By Product

The monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, enoxaparin sodium, glucagon, and calcitonin are among the product categories that make up the biosimilars market. Monoclonal antibodies held a sizable portion of the market in 2020. The market is being driven by elements including the widespread use of monoclonal antibodies in the treatment of autoimmune diseases, cancer, and osteoporosis, as well as the affordability of such treatments.

Monoclonal Antibodies
- Infliximab
- Trastuzumab
- Rituximab
- Adalimumab
- Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
Insulin
Granulocyte Colony-Stimulating Factor
Erythropoietin
Recombinant Human Growth Hormone
Etanercept
Follitropin
Teriparatide
Interferons
Enoxaparin Sodium
Glucagon
Calcitonin

By Indication

The biosimilars market is divided into oncology, autoimmune and inflammatory diseases, chronic illnesses, blood disorders, growth hormone insufficiency, infectious diseases, and other indications based on the indication (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). The market's largest sector in 2020 will be oncology. This market is expanding as a result of elements like the reduced cost of biosimilars compared to novel biologics and the increased incidence and prevalence of cancer.

Oncology
Inflammatory & Autoimmune Disorders
Chronic Diseases
Blood Disorders
Growth Hormone Deficiency
Infectious Diseases
Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

Methodology for Database Creation

Our database offers a comprehensive list of healthcare centers, meticulously curated to provide detailed information on a wide range of specialties and services. It includes top-tier hospitals, clinics, and diagnostic facilities across 30 countries and 24 specialties, ensuring users can find the healthcare services they need.

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How Do We Get It?

Our database is created and maintained through a combination of secondary and primary research methodologies.

1. Secondary Research

With many years of experience in the healthcare field, we have our own rich proprietary data from various past projects. This historical data serves as the foundation for our database. Our continuous process of gathering data involves:

Analyzing historical proprietary data collected from multiple projects.
Regularly updating our existing data sets with new findings and trends.
Ensuring data consistency and accuracy through rigorous validation processes.

With extensive experience in the field, we have developed a proprietary GenAI-based technology that is uniquely tailored to our organization. This advanced technology enables us to scan a wide array of relevant information sources across the internet. Our data-gathering process includes:

Searching through academic conferences, published research, citations, and social media platforms
Collecting and compiling diverse data to build a comprehensive and detailed database
Continuously updating our database with new information to ensure its relevance and accuracy

2. Primary Research

To complement and validate our secondary data, we engage in primary research through local tie-ups and partnerships. This process involves:

Collaborating with local healthcare providers, hospitals, and clinics to gather real-time data.
Conducting surveys, interviews, and field studies to collect fresh data directly from the source.
Continuously refreshing our database to ensure that the information remains current and reliable.
Validating secondary data through cross-referencing with primary data to ensure accuracy and relevance.

Combining Secondary and Primary Research

By integrating both secondary and primary research methodologies, we ensure that our database is comprehensive, accurate, and up-to-date. The combined process involves:

Merging historical data from secondary research with real-time data from primary research.
Conducting thorough data validation and cleansing to remove inconsistencies and errors.
Organizing data into a structured format that is easily accessible and usable for various applications.
Continuously monitoring and updating the database to reflect the latest developments and trends in the healthcare field.

Through this meticulous process, we create a final database tailored to each region and domain within the healthcare industry. This approach ensures that our clients receive reliable and relevant data, empowering them to make informed decisions and drive innovation in their respective fields.