Biosimilars Market Outlook, 2030

BiosimilarsThe biosimilars industry has emerged as a transformative force in the global healthcare landscape, representing a vital frontier in biopharmaceutical innovation and affordability. Biosimilars are biologic medical products that are highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, and potency. Unlike generic drugs for small molecules, which are chemically synthesized and relatively straightforward to replicate, biosimilars are derived from living organisms through complex manufacturing processes, making their development, approval, and commercialization uniquely challenging.

However, as patents on several blockbuster biologics expire, the biosimilars market has gained momentum, offering a promising avenue to reduce healthcare costs, enhance patient access, and foster competition in the biologics space. One of the most compelling drivers of growth in the biosimilars industry is the escalating global demand for cost-effective biologic therapies. Biologics have revolutionized the treatment of chronic and life-threatening diseases such as cancer, autoimmune disorders, and diabetes, but they come with prohibitively high price tags. In many countries, these high costs limit patient access and strain national healthcare budgets.

Biosimilars present a strategic solution, offering comparable therapeutic efficacy at a lower cost, which can lead to significant savings for both patients and healthcare systems. According to industry estimates, biosimilars can be priced 15-30% lower than their reference biologics, and their widespread adoption could lead to billions in savings over the next decade, particularly in markets such as the United States and the European Union. The biosimilars industry is poised for robust expansion, driven by patent expirations, rising healthcare expenditure, and increasing awareness of biosimilar benefits.

Markets in North America and Europe currently dominate the sector, but Asia-Pacific, Latin America, and the Middle East are expected to witness accelerated growth due to supportive regulatory reforms, expanding healthcare infrastructure, and local production capabilities. Oncology, immunology, and endocrinology remain the top therapeutic areas for biosimilars, with monoclonal antibodies (mAbs) representing the most lucrative segment. Moreover, the evolution of interchangeable biosimilars in the U.S. - those that can be substituted for the reference product without physician intervention - is likely to further fuel market penetration and transform pharmacy practices.

According to the research report “Global Biosimilars Market Outlook, 2030” the global Biosimilars market is projected to reach market size of USD 83.40 Billion by 2030 increasing from USD 30.84 Billion in 2024, growing with 18.42% CAGR by 2025-30. The regulatory environment has played a pivotal role in shaping the trajectory of the biosimilars industry. Regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) have developed stringent yet supportive frameworks to ensure the safety and efficacy of biosimilar products.

These frameworks emphasize a stepwise approach to demonstrate biosimilarity, including analytical, preclinical, and clinical comparisons with the reference biologic. The FDA’s Biologics Price Competition and Innovation Act (BPCIA) and the EMA’s early adoption of biosimilar guidelines have set global benchmarks for biosimilar approval, encouraging pharmaceutical companies to invest in the development of biosimilar pipelines. Additionally, regulatory initiatives in emerging markets, such as India, South Korea, and Brazil, are bolstering the global presence of biosimilars, with local manufacturers increasingly entering international markets.

Market competition is intensifying as major pharmaceutical companies, biosimilar-focused firms, and contract development and manufacturing organizations (CDMOs) expand their presence in the sector. Leading companies such as Amgen, Sandoz (a Novartis division), Biocon, Samsung Bioepis, and Celltrion are at the forefront of biosimilar development, often engaging in strategic partnerships to share risks, access novel technologies, and accelerate commercialization. These collaborations also help companies navigate diverse regulatory environments and scale up manufacturing efficiently.

The competitive landscape is also witnessing the entry of Big Pharma players that previously focused solely on innovator drugs, signaling a broader industry shift toward diversified biologics portfolios. Furthermore, the digitalization of manufacturing, integration of artificial intelligence in process control, and the development of biosimilars with improved delivery mechanisms are setting the stage for the next phase of growth and innovation in the industry.

Market Drivers

• Patent Expiry of Blockbuster Biologics: A significant wave of patent expirations for high-revenue biologics such as Humira (adalimumab), Herceptin (trastuzumab), and Remicade (infliximab) is opening up massive opportunities for biosimilar manufacturers. These expirations remove legal and market exclusivity barriers, allowing biosimilar versions to enter the market and offer more affordable alternatives to patients.
• Rising Healthcare Cost Pressures Worldwide: Governments and private payers are under increasing pressure to control skyrocketing healthcare costs. Biosimilars offer a cost-effective solution to reduce expenditure on biologic therapies, especially for chronic diseases like cancer, rheumatoid arthritis, and diabetes. This economic incentive is pushing healthcare systems to adopt biosimilars more aggressively.

Market Challenges

• Physician and Patient Perception and Reluctance: A significant barrier remains the skepticism among physicians and patients about the safety, efficacy, and interchangeability of biosimilars compared to original biologics. Misinformation, lack of education, and limited real-world experience often delay acceptance and prescribing behavior, particularly in conservative or specialist medical communities.
• Manufacturing Complexity and High Development Costs: Unlike chemical generics, biosimilars require sophisticated biologic manufacturing infrastructure, cell line development, and rigorous testing to prove similarity. The cost of developing a biosimilar can range between $100 million and $300 million, much higher than generics. Any variability in the manufacturing process can lead to batch inconsistencies, making production scale-up and quality control major hurdles.

Market Trends

• Shift Toward Interchangeable Biosimilars in the U.S. : The U.S. FDA has begun approving biosimilars with the interchangeable designation (e.g., insulin glargine, adalimumab biosimilars), allowing pharmacists to substitute them without prescriber approval. This shift is expected to greatly boost biosimilar uptake, change pharmacy-level dynamics, and reshape market competition.
• Increased Strategic Collaborations and Outsourcing: To offset the high costs and complexities of biosimilar development, companies are increasingly engaging in joint ventures, licensing agreements, and partnerships with CDMOs (Contract Development and Manufacturing Organizations). These alliances are enabling faster time-to-market, access to regulatory expertise, and global market expansion, especially in emerging economies.

Monoclonal antibodies (mAbs) dominate the biosimilars market because they target high-prevalence, high-cost chronic diseases, making them the most economically attractive and clinically impactful category for biosimilar development.

Monoclonal antibodies have emerged as the leading class in the biosimilars market primarily due to their extensive use in treating complex, chronic, and life-threatening conditions such as cancer, autoimmune diseases (like rheumatoid arthritis and psoriasis), and inflammatory bowel disease. These conditions affect millions globally and often require long-term or lifelong biologic treatment, making the original reference mAb products some of the most expensive drugs on the market - with annual costs per patient often exceeding tens of thousands of dollars.

As many of these blockbuster biologics have lost or are nearing the end of patent protection (e.g., Herceptin, Avastin, and Humira), they present a high-value target for biosimilar developers seeking to introduce lower-cost alternatives. The massive global demand, coupled with the potential to significantly reduce healthcare expenditure, has driven intense R&D and investment in biosimilar versions of mAbs. Furthermore, regulatory agencies have now established well-defined pathways for the approval of mAb biosimilars, encouraging more entrants and accelerating product availability.

Clinically, mAbs also offer measurable and standardized outcomes, which facilitates the demonstration of biosimilarity through rigorous comparative trials. All these factors - medical necessity, economic viability, and regulatory clarity - converge to make monoclonal antibodies the most dominant and strategically prioritized category in the biosimilars landscape.

Oncology leads the biosimilars market because cancer biologics are among the most expensive and widely used treatments, creating a strong demand for cost-effective biosimilar alternatives that can improve patient access and reduce healthcare spending.

The oncology segment has taken the lead in the biosimilars market due to the high clinical and economic burden associated with cancer care. Biologic therapies, especially monoclonal antibodies such as trastuzumab (Herceptin), bevacizumab (Avastin), and rituximab (Rituxan), are cornerstones of modern oncology treatment, used across multiple tumor types and often in combination regimens. These drugs have significantly improved survival outcomes, but their high cost poses a major challenge for patients, healthcare systems, and insurers worldwide. As a result, the expiration of patents for key oncology biologics has created an urgent and lucrative opportunity for biosimilar developers.

The introduction of oncology biosimilars has the potential to generate massive cost savings while expanding access to life-saving therapies, particularly in lower- and middle-income countries where affordability is a critical barrier. Moreover, oncology treatments often involve large patient populations and chronic dosing schedules, enhancing the commercial viability of biosimilars in this space. Regulatory bodies have prioritized the review of oncology biosimilars due to their potential public health impact, and oncologists are increasingly familiar with biosimilar science, contributing to growing physician confidence and clinical adoption.

In-house manufacturing leads the biosimilars market because it allows companies to maintain full control over quality, cost, and regulatory compliance, which are critical for the complex and sensitive production of biologic medicines.

The dominance of in-house manufacturing in the biosimilars market is largely driven by the need for stringent control over the entire production process of these complex biologic drugs. Unlike small-molecule generics, biosimilars are developed using living cells and require highly sophisticated processes that are sensitive to even minor variations, which can affect the product’s safety, efficacy, and immunogenicity. By keeping manufacturing in-house, companies can ensure consistent product quality, better protect proprietary cell lines and production methods, and swiftly implement process improvements or respond to regulatory feedback.

This level of oversight is crucial for gaining and maintaining approvals from stringent regulatory bodies such as the FDA and EMA. In-house capabilities also help reduce reliance on third-party contract manufacturers, which can introduce variability, limit flexibility, and lead to supply chain vulnerabilities. Moreover, controlling production internally allows companies to better manage costs and streamline operations, especially as biosimilars move into large-scale commercialization. This strategic integration is particularly beneficial in a competitive market where speed to market, cost-efficiency, and quality assurance determine long-term success.

North America leads the biosimilars market due to its large biologics-consuming population, high healthcare spending, and the recent regulatory and policy shifts that have accelerated biosimilar approvals and adoption.

North America, particularly the United States, has rapidly become a dominant force in the biosimilars market, largely because it represents the largest and most lucrative biologics market globally. The U.S. has a high prevalence of chronic and life-threatening conditions such as cancer, autoimmune diseases, and diabetes - many of which are treated with costly biologic drugs. For years, biosimilar adoption in the U.S. lagged behind Europe due to a more cautious regulatory environment, patent litigation hurdles, and limited interchangeability policies. However, recent developments have significantly changed the landscape. The U.S.

Food and Drug Administration (FDA) has streamlined its biosimilar approval pathways and begun approving interchangeable biosimilars, allowing pharmacy-level substitution. Additionally, government initiatives, including Medicare reforms and pricing transparency laws, are encouraging wider acceptance and use of biosimilars to curb escalating healthcare costs.

Payers, pharmacy benefit managers (PBMs), and health systems are increasingly promoting biosimilar uptake to improve affordability and expand access to biologic therapies. With major pharmaceutical companies and biosimilar developers investing heavily in the U.S. market, and a growing number of biosimilars gaining both regulatory and commercial traction, North America has quickly emerged as a global leader in the biosimilars space, driving significant growth and innovation.

• In March 2025, The FDA approved Celltrion USA's Omlyclo (omalizumab-igec) as the first biosimilar to reference Xolair (omalizumab). The biosimilar, granted interchangeability status, is the first respiratory biosimilar in the US. Omlyclo is approved for managing moderate to severe asthma in adults and children aged 6 and older with allergies unresponsive to inhaled steroids. It is also approved for adults with chronic sinus inflammation and nasal polyps unresponsive to nasal corticosteroids.
• In October 2023, Pfizer’s Abrilada (adalimumab-afzb) received approval from the U.S. FDA as the second interchangeable Humira biosimilar. An interchangeable designation is granted by the FDA to only those biosimilars that meet additional data requirements. This data demonstrates that patients who alternate between the reference product and the biosimilar exhibit the same clinical result as patients who are being treated with the reference product alone.
• In May 2022, Amneal Pharmaceuticals, Inc. received United States Food and Drug Administration ("FDA") approval for a Biologics License Application ("BLA") for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.

Considered in this report

• Historic Year: 2019
• Base year: 2024
• Estimated year: 2025
• Forecast year: 2030

Aspects covered in this report

• Biosimilars Market with its value and forecast along with its segments
• Various drivers and challenges
• On-going trends and developments
• Top profiled companies
• Strategic recommendation

By Product

• Monoclonal Antibodies
• Insulin
• Erythropoietin
• Others (Includes recombinant glycosylated and non-glycosylated proteins)

By Application

• Oncology
• Chronic & Autoimmune Disorders
• Blood Disorders
• Growth Hormonal Deficiency
• Infectious Disease
• Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept)

By Manufacturer

• In-house
• Contract Research and Manufacturing Services

The approach of the report:

This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases.

After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources.

Intended audience

This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.