US Biosimilar Contract Manufacturing Market Research Report: By Product (Recombinant Non-glycosylated Proteins, Recombinant Glycosylated Proteins), By Production Technology (Mammalian, Non-Mammalian) and By Application (Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic & Autoimmune Disorders, Rheumatoid Arthritis, Others) - Forecast to 2035

US Biosimilar Contract Manufacturing Market Overview:

As per MRFR analysis, the US Biosimilar Contract Manufacturing Market Size was estimated at 1.82 (USD Billion) in 2023. The US Biosimilar Contract Manufacturing Market Industry is expected to grow from 2.2(USD Billion) in 2024 to 14.5 (USD Billion) by 2035. The US Biosimilar Contract Manufacturing Market CAGR (growth rate) is expected to be around 18.7% during the forecast period (2025 - 2035).

Key US Biosimilar Contract Manufacturing Market Trends Highlighted

The US Biosimilar Contract Manufacturing Market is witnessing several significant trends driven by the increasing acceptance of biosimilars among healthcare providers and patients. This acceptance is largely fueled by the need for cost-effective alternatives to expensive biologics, which has led to growth in the number of biosimilars receiving regulatory approval from the FDA. Additionally, various initiatives by the US government focused on promoting competition in the pharmaceutical sector are encouraging greater investment in biosimilar manufacturing capabilities. This is creating opportunities for contract manufacturers to expand their services and enhance production capacity to meet rising demand.Furthermore, there is an emerging trend of collaboration between biosimilar developers and CMOs (Contract Manufacturing Organizations), aimed at bolstering the supply chain and ensuring high-quality production. As the regulatory landscape evolves, companies are increasingly seeking partnerships that can offer expertise in navigating complex approval processes, allowing for more efficient time-to-market for biosimilars. In recent times, with the growing focus on personalized medicine, manufacturers are also exploring opportunities in the development of tailor-made biosimilar solutions, appealing to niche markets within the broader healthcare landscape.The shift towards sustainability in manufacturing processes is also becoming prominent, as stakeholders are more focused on environmentally friendly production methods. With these trends, the US Biosimilar Contract Manufacturing Market is positioned for dynamic growth, driven by innovation, strategic partnerships, and an overall commitment to enhancing patient access to affordable medication alternatives.

Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

US Biosimilar Contract Manufacturing Market Drivers

Growing Demand for Cost-Effective Biologics

The rising demand for cost-effective biologics in the US is a significant driver for the US Biosimilar Contract Manufacturing Market Industry. With the increasing burden of healthcare costs, especially for chronic diseases, patients and healthcare providers are actively seeking alternatives that can reduce expenses. According to the Centers for Medicare & Medicaid Services, United States healthcare spending is projected to reach approximately USD 6.2 trillion by 2028, indicating a dire need for cost-effective solutions.Furthermore, the introduction of biosimilars can reduce drug expenditures by approximately 30% to 50%, as noted in various studies. Major pharmaceutical companies, such as Amgen and Pfizer, are investing heavily in the production of biosimilars, which is expected to further accelerate market growth. By leveraging these opportunities, the US Biosimilar Contract Manufacturing Market industry is likely to witness substantial growth in the coming years.

Regulatory Support for Biosimilars

Regulatory bodies in the US, such as the Food and Drug Administration, are increasingly providing support for the development and approval of biosimilars. This favorable regulatory environment is a prominent driver of growth within the US Biosimilar Contract Manufacturing Market Industry. The FDA has implemented streamlined pathways for biosimilar approvals, as well as clear guidelines for demonstrating biosimilarity. As of now, around 30 biosimilars have received approval since the introduction of the Biologics Price Competition and Innovation Act in 2010, indicating the responsiveness of the regulatory framework.This regulatory support has encouraged many companies to invest in biosimilar development, thereby catalyzing the growth of the contract manufacturing landscape in the US.

Increase in Chronic Diseases and Aging Population

The rising incidence of chronic diseases and an aging population in the US serve as vital drivers for the US Biosimilar Contract Manufacturing Market Industry. According to the National Council on Aging, approximately 80% of older adults in the US have at least one chronic disease, contributing to an overall shift towards biologic therapies. As the aging populace demands more biologics for treating age-related conditions such as diabetes and cancer, the need for biosimilar options to meet this demand becomes critical.The American Cancer Society has also highlighted that cancer is expected to affect approximately 1 in 3 individuals in their lifetime, further emphasizing the need for affordable treatment options. The increase in chronic disease prevalence and the aging demographic are pivotal factors propelling the adoption of biosimilars and fostering growth in contract manufacturing within the US.

US Biosimilar Contract Manufacturing Market Segment Insights:

Biosimilar Contract Manufacturing Market Product Insights

The US Biosimilar Contract Manufacturing Market, a crucial domain within the pharmaceutical industry, is experiencing exponential growth driven by the increasing demand for cost-effective biologics. This market is characterized by its focus on various products, particularly Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins. Recombinant Non-glycosylated Proteins play a vital role in therapeutic applications, often utilized in treatments for conditions such as cancer and autoimmune diseases. These proteins, typically produced using prokaryotic systems, have gained recognition for their consistency and ease of manufacturing, making them significant contributors to the market. Meanwhile, Recombinant Glycosylated Proteins, which are essential for proper biological functions and interactions, are produced using eukaryotic systems that enable more complex structures and post-translational modifications. This segment addresses the growing needs for innovative therapeutic solutions, particularly in the realms of biopharmaceuticals and personalized medicine. Both product categories are influenced by key market trends such as the shift towards biosimilars due to their potential for cost savings compared to original biologics. The increasing incidence of chronic diseases in the US further fuels the demand for these products, presenting vast opportunities for growth and development in contract manufacturing capabilities. The regulatory landscape also plays a pivotal role, as the US Food and Drug Administration has established pathways for the approval of biosimilars, thereby encouraging competition and novel approaches within the market. However, challenges like ensuring quality and compliance standards in production processes remain critical, driving manufacturers to invest in advanced technologies and stringent quality control measures. Overall, the focus on Recombinant Non-glycosylated Proteins and Recombinant Glycosylated Proteins highlights the importance of enhancing manufacturing efficiencies and leveraging scientific advancements to meet the evolving demands of healthcare markets across the United States. This sector is poised for significant transformations, supported by a robust framework encouraging the development of biosimilars that can address the complexities of patient care and treatment accessibility.

Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

Biosimilar Contract Manufacturing Market Production Technology Insights

The Production Technology segment within the US Biosimilar Contract Manufacturing Market is crucial for the growth of this industry as it significantly impacts the overall supply chain efficiency and product quality. This segment encompasses various methodologies, including both Mammalian and Non-Mammalian approaches, which cater to diverse biopharmaceutical needs. The Mammalian processes are known for their complex post-translational modifications, which are essential for the functionality of therapeutic proteins, making them vital for the development of highly effective biosimilars.In contrast, Non-Mammalian systems, often utilizing microbial systems like yeast and bacteria, provide faster production times and lower costs, making them appealing for high-volume manufacturing. This diversification in production technology is particularly beneficial in the US, where regulatory frameworks encourage innovation while ensuring rigorous quality standards. The rising demand for affordable biologics and government initiatives supporting biosimilar development further enhance the significance of innovative production technologies in this market.In summary, the integration of both Mammalian and Non-Mammalian technologies facilitates adaptability and responsiveness to market needs, thus driving the overall progress of the US Biosimilar Contract Manufacturing Market.

Biosimilar Contract Manufacturing Market Application Insights

The Application segment of the US Biosimilar Contract Manufacturing Market plays a vital role in providing cost-effective and efficient biopharmaceutical solutions. This segment addresses various therapeutic areas including Oncology, Blood Disorders, Growth Hormonal Deficiency, Chronic and Autoimmune Disorders, and Rheumatoid Arthritis, among others. Oncology remains a critical focus area due to the rising incidence of cancer, necessitating innovative treatment options. Blood Disorders, which include conditions like hemophilia, are also significant as they require continuous and effective management.Moreover, Growth Hormonal Deficiency and Chronic and Autoimmune Disorders present opportunities, given the increasing prevalence of these conditions in the aging population of the US. Rheumatoid Arthritis, as a widespread autoimmune condition, underscores the demand for biosimilars that can offer similar efficacy at a reduced cost. The segment's diversification into these areas highlights its importance in addressing unmet medical needs and improving patient access to essential medications. As the market evolves, advancements in technology and increased regulatory support at the federal level further bolster growth in this vital sector.Together, these factors create a dynamic landscape for the US Biosimilar Contract Manufacturing Market, enhancing overall market data and statistics, while promoting sustainable market growth.

US Biosimilar Contract Manufacturing Market Key Players and Competitive Insights:

The US Biosimilar Contract Manufacturing Market is characterized by a complex and evolving landscape, with increasing focus on the development and production of biosimilar products aimed at improving patient access to essential medicines while reducing overall healthcare costs. This market has attracted considerable attention due to the growing acceptance of biosimilars among healthcare professionals and regulatory agencies, leading to a surge in demand for contract manufacturing services that cater to this specific segment. Competition within the market is fueled by the entry of numerous players, each vying for partnerships with established pharmaceutical companies. The dynamics of this market are influenced by factors such as technological advancements, regulatory challenges, and the need for robust quality assurance processes, all of which determine the operational capability and market reach of contract manufacturers.Teva Pharmaceutical Industries, a prominent player in the US Biosimilar Contract Manufacturing Market, has established a strong foothold through its extensive portfolio of biosimilar products. The company benefits from a well-developed infrastructure that supports large-scale manufacturing processes tailored for biosimilars, allowing Teva to deliver high-quality and competitively priced products to the market. Teva’s commitment to innovation is evident in its efforts to enhance manufacturing technologies and processes, which also accounts for its agility in responding to market demands. Additionally, the company's established relationships with healthcare providers and payers bolster its competitive position, ensuring greater market access and a strong reputation for reliability in biosimilar manufacturing.Samsung Biologics is another key player in the US Biosimilar Contract Manufacturing Market, renowned for its state-of-the-art biomanufacturing facilities and comprehensive service offerings. The company provides a wide range of services including cell line development, process development, and comprehensive manufacturing solutions that ensure timely delivery of high-quality biosimilars. Samsung Biologics has made significant investments in expanding its operational capacity, ensuring it remains flexible and responsive to the unique demands of the biosimilar space. Additionally, strategic collaborations and partnerships with various pharmaceutical companies have enhanced its market presence and operational capabilities in the US. Through its commitment to innovation and quality, Samsung Biologics aims to be a leader in the biopharmaceutical contract manufacturing space, further solidifying its position by leveraging advanced technologies and maintaining a strong focus on regulatory compliance and customer satisfaction.

Key Companies in the US Biosimilar Contract Manufacturing Market Include:

Teva Pharmaceutical Industries

Samsung Biologics

Lonza

Sandoz

BristolMyers Squibb

Eli Lilly and Company

Boehringer Ingelheim

Fujifilm Diosynth Biotechnologies

Catalent

Pfizer

Generium

Amgen

AbbVie

Roche

Mylan

US Biosimilar Contract Manufacturing Market Industry Developments

Recent developments in the US Biosimilar Contract Manufacturing Market indicate significant activity among key players. Companies like Teva Pharmaceutical Industries, Samsung Biologics, and Lonza continue to expand their manufacturing capabilities to meet rising industry demand. Bristol-Myers Squibb and Eli Lilly and Company have actively engaged in partnerships aimed at enhancing their biosimilar pipelines, which were highlighted in the market earlier this year. Notably, in September 2023, Catalent announced a major strategic collaboration with Amgen to bolster its biosimilar production capabilities, demonstrating a commitment to addressing the growing need for affordable biologic medicines. Similarly, Pfizer and Boehringer Ingelheim each reported advancements in their respective manufacturing processes, with a focus on increasing efficiency and compliance with regulatory standards. Additionally, the US government's initiatives to support the biosimilars market have catalyzed a competitive landscape, affecting valuations and investment strategies for companies like Roche and Mylan. Over the past two to three years, the market has witnessed an upward trend, with numerous investments aimed at strengthening production and reducing costs for biosimilar medications, aligning with ongoing healthcare reforms that emphasize affordability and access.

US Biosimilar Contract Manufacturing Market Segmentation Insights

Biosimilar Contract Manufacturing Market Product Outlook

Recombinant Non-glycosylated Proteins

Recombinant Glycosylated Proteins

Biosimilar Contract Manufacturing Market Production Technology Outlook

Mammalian

Non-Mammalian

Biosimilar Contract Manufacturing Market Application Outlook

Oncology

Blood Disorders

Growth Hormonal Deficiency

Chronic & Autoimmune Disorders

Rheumatoid Arthritis

Others

Report Scope:

Report Attribute/Metric Source:	Details
MARKET SIZE 2018	1.82(USD Billion)
MARKET SIZE 2024	2.2(USD Billion)
MARKET SIZE 2035	14.5(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)	18.7% (2025 - 2035)
REPORT COVERAGE	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR	2024
MARKET FORECAST PERIOD	2025 - 2035
HISTORICAL DATA	2019 - 2024
MARKET FORECAST UNITS	USD Billion
KEY COMPANIES PROFILED	Teva Pharmaceutical Industries, Samsung Biologics, Lonza, Sandoz, BristolMyers Squibb, Eli Lilly and Company, Boehringer Ingelheim, Fujifilm Diosynth Biotechnologies, Catalent, Pfizer, Generium, Amgen, AbbVie, Roche, Mylan
SEGMENTS COVERED	Product, Production Technology, Application
KEY MARKET OPPORTUNITIES	Increasing demand for cost-effective therapies, Expanding regulatory support for biosimilars, Enhanced focus on oncology biosimilars, Rising prevalence of chronic diseases, Growing partnerships with biotech firms
KEY MARKET DYNAMICS	growing demand for cost-effective alternatives, increasing regulatory approvals, advancements in biomanufacturing technologies, rising healthcare expenditure, strategic partnerships and collaborations
COUNTRIES COVERED	US