Biosimilar and Biologics Market

Biosimilar and Biologics Market Outlook from 2024 to 2034

The global biosimilar & biologics market size is expected to expand from USD 520.9 billion in 2024 to a staggering USD 1,060.7 billion by 2034. It will likely exhibit robust growth, with overall sales of biosimilars & biologics rising at 7.6% CAGR.

Global Biosimilar and Biologics Market Insights

Attributes	Key Insights
Base Market Value (2023)	USD 480.1 billion
Estimated Biosimilar and Biologics Market Value (2024)	USD 520.9 billion
Estimated Biosimilar & Biologics Market Revenue (2034)	USD 1,060.7 billion
Value CAGR (2024 to 2034)	7.6%

Biosimilar and Biologics Market Overview

• Biosimilars and biologics are revolutionizing the healthcare landscape by offering innovative treatments, enhancing patient outcomes, and increasing accessibility. As a result, their demand is growing significantly across the world.
• Growing popularity of biosimilar biologics or biosimilar biologic drugs due to their higher effectiveness and affordability is expected to foster market growth.
• Biologics have revolutionized the treatment of various diseases by offering targeted therapies that specifically address disease mechanisms. Unlike traditional small molecule drugs, which often have off-target effects, biologics and biosimilars are designed to precisely target pathways, minimizing adverse reactions.
• Advances in biotechnology and manufacturing technologies have enabled more efficient and cost-effective production of biologics and biosimilars. They are changing the biologics manufacturing dynamics. Novel expression systems, cell culture techniques, and purification methods have improved yield, purity, and consistency of biological products, reducing production costs and increasing scalability. This is expected to foster growth of the biologics & biosimilar market.
• Pharma manufacturers specializing in biosimilar and biologic production employ strategies to stay ahead of the competition. These include research and development activities, introduction of artificial intelligence for innovative therapies, strategic collaborations for novel drug development, and geographic expansion to tap into diverse markets.
• Emphasis on regulatory approvals and cost-effectiveness contributes to product adoption and enhances market growth.

Key Factors Propelling Biosimilar and Biologics Market Growth Include

• Rising prevalence of chronic diseases like cancer and diabetes
• Growing need for effective and affordable treatments
• Surging popularity of biologics like insulin, vaccines, and gene therapy
• Increasing prices of drugs, along with rising healthcare costs

Opportunities in the Biosimilar and Biologics Industry

• Increasing acceptance of biosimilars due to their cost-effectiveness
• Expiration of patents on biologics
• Supportive regulatory environment
• Introduction of favorable reimbursement policies in developing and developed nations

Latest Trends in the Biosimilar and Biologics Market

• Advancements in biomanufacturing technology
• Shifting preference toward value-based care
• Growing demand for personalized and targeted therapies

Historical Performance Vs. Future Biosimilar and Biologic Sales Outlook

Global biosimilar and biologic sales grew at a CAGR of 5.8% from 2019 to 2023. Total market valuation at the end of 2023 reached around USD 480.1 billion at the end of 2023. Over the forecast period, the global market for biosimilars and biologics is set to expand at 7.6% CAGR.

• The emergence of orphan drugs as the new standard of care in rare diseases marks a significant advancement in biosimilars and biologics. Orphan drugs target rare diseases, which often lack effective treatment options due to their low prevalence and complexity. By providing innovative therapies for conditions with limited or no existing treatments, orphan drugs fill critical gaps in patient care and improve outcomes for individuals affected by these diseases.
• Many orphan drugs represent first-in-class therapies, introducing novel mechanisms of action. Despite targeting niche patient populations, orphan drugs have demonstrated remarkable commercial success. Sales exceeding USD 1 billion within a few years of market entry highlight the significant demand for these therapies and the willingness of healthcare systems to invest in treatments for rare diseases.
• Examples such as Hemlibra (emicizumab) for hemophilia A with factor VIII inhibitors, lanadelumab for hereditary angioedema, and patisiran for hereditary transthyretin amyloidosis illustrate the transformative impact of orphan drugs. These therapies have shown promising results in clinical trials and are expected to become the new standard of care for their respective indications. Hence, the rise of orphan drugs as the new standard of care represents a paradigm shift in healthcare, offering hope and improved outcomes for individuals living with rare diseases.

Insights into Factors Propelling Biosimilars and Biologics Market Growth

• Advancements in Biosimilar and Biologic Production

The pharmaceutical industry has seen significant advancements in developing and manufacturing biosimilars and biologics, presenting numerous opportunities for innovation, growth, and improved patient access to essential therapies. Advances in biotechnology and manufacturing technologies have enabled more efficient and cost-effective production of biologics and biosimilars.

Manufacturers of the original biologics can leverage bio-better development strategies to reinforce their market position and defend against competition, including biosimilars, by offering upgraded versions of their products with enhanced sensitivity. Novel expression systems, cell culture techniques, and purification methods have improved biological products' yield, purity, and consistency, driving down production costs and increasing scalability.

Sophisticated analytical techniques, manufacturing processes, and the introduction of artificial intelligence have facilitated in-depth characterization and comparability assessment of biosimilars with their reference products. These analytical advancements ensure biosimilars' quality, safety, and efficacy, supporting regulatory approval and market acceptance.

Regulatory agencies globally have established clear pathways and guidelines for developing and approving biosimilars. These established pathways reduce barriers to entry for biosimilar developers, encouraging competition and market growth.

The biosimilar market is increasingly globalizing, with manufacturers from both developed and emerging countries participating in biosimilar and biologic development and commercialization. Nations like India, China, and South Korea are emerging as key players in the biosimilar & biologic landscape, offering cost-competitive manufacturing capabilities.

Overview of Factors Limiting Growth of the Biosimilar and Biologics Market

Multiple factors limit the expansion of the global biosimilar and biologics market globally. These include regulatory complexities, high development costs, and supply chain issues.

Biosimilars require extensive clinical trials and data to demonstrate their safety and similarity to original biologics. This leads to lengthy and expensive development processes, thereby limiting market expansion to some extent.

Biosimilars and biologics necessitate specific handling protocols, including refrigeration and stringent processing, to prevent contamination by microorganisms and other impurities. Given that these products are typically administered via injection or intravenous infusion, maintaining sterility is very important to avoid a lethal impact on the patient’s life.

Due to their distinctive characteristics and the complexities involved in their production and distribution, biologics are often categorized as specialty drugs. Adherence to stringent good manufacturing practices (GMP), guidelines, and regulations is essential to ensure that manufacturing facilities are designed, operated, and maintained to minimize contamination risks and uphold aseptic conditions.

Another factor that may affect the uptake of biosimilars is that a biosimilar generally cannot be automatically substituted for the reference product (i.e., brand-name biologic) at the pharmacy level unless it is determined to be interchangeable with the reference product. An interchangeable product should have the same effect as the original product for each patient.

Unlike generic drugs, where substitution at the pharmacy level is typically automatic, biosimilars cannot be automatically substituted for the reference product unless they have been determined to be interchangeable by regulatory authorities. This is negatively impacting market growth.

An interchangeable biosimilar should meet specific criteria set by regulatory agencies, such as the CDSCO in India and the FDA in the United States. These criteria typically include demonstrating that the biosimilar produces the same clinical result as the reference product in any given patient and that switching between the biosimilar and the reference product does not pose greater risk than using the reference product alone.

Country-wise Insights

The table below shows the estimated growth rates of the top five countries. The United States, China, and Spain are set to record high CAGRs of 5.9%, 8.8%, and 7.4%, respectively, through 2034.

Market Growth Outlook by Key Countries

Countries	Value CAGR
United States	5.9%
China	8.8%
Japan	4.0%
Germany	4.6%
Spain	7.4%

United States to Retain its Monopoly in the Biosimilar and Biologics Industry

The United States is expected to dominate the global biosimilar & biologics market during the forecast period. It will likely register steady growth, with overall demand for biosimilars and biologics rising at a CAGR of 5.9% through 2034.

• Rising incidence of chronic illnesses like cancer, autoimmune disorders, and diabetes is a key factor propelling demand for biosimilars & biologics in the nations. This is because these diseases often require treatment with biologics.
• High adoption of biosimilars in the United States will likely boost the market during the assessment period.
• The competitive landscape in the United States healthcare sector fosters innovation and high standards of care. The nation is home to several leading medical research institutions, technology companies, and healthcare providers. The collaborative environment and access to cutting-edge research can foster innovation in pharmaceutical market, including biosimilars and biologics.
• A well-established regulatory framework for pharmaceuticals overseen by the Food and Drug Administration (FDA) is expected to benefit the market. Companies that successfully navigate and comply with these regulations may gain a competitive edge, as FDA approval is often seen as a benchmark for quality and safety.
• Introduction of government health initiatives and programs, such as the Affordable Care Act, will continue to encourage adoption of biosimilars and biologics, thereby boosting sales growth.
• Top biosimilar & biologic manufacturers in the United States are constantly investing in research to develop novel treatment solutions. This will likely enhance the United States’ biosimilar and biologics market share through 2034.

Growing Popularity of Biosimilars Boosting Sales Growth in China

China is emerging as a highly lucrative market for biosimilars & biologics, and the trend will likely persist during the forecast period. As per the latest analysis, sales of biosimilars and biologics in China are anticipated to grow at 8.8% CAGR through 2034.

• High disease burden and growing popularity of affordable medications like biosimilars are key factors driving sales growth in China.
• Growing demand for precision medicine approaches, including personalized biologic therapies tailored to individual patients' genetic makeup and disease characteristics, will likely facilitate market expansion in the country.
• Advancements in genomics, biomarker identification, targeted therapy development, and investment in the biopharmaceutical sector are other factors influencing the China market.

Category-wise Insights

The table section offers deeper insights into leading segments in the global industry. The information will likely help companies maximize profits and stay ahead of the curve.

• Based on drug class, the monoclonal antibody is expected to dominate the market, holding a value share of 31.0% in 2024.
• By source, the bacterial cells segment is set to progress at 6.7% CAGR, holding a prominent market share of 44.0% in 2024.
• In terms of application, the oncology segment will likely expand at 6.2% CAGR, accounting for a revenue share of 25.9% in 2024.
• By distribution channel, pharmacies segment is estimated to hold a market share of 37.5% in 2024.
• Based on manufacturing type, contract manufacturing segment is anticipated to have a value share of 56.7% in 2024.

Rising Adoption of Monoclonal Antibodies in Targeted Therapy Driving Demand

Market Growth Outlook by Drug Class

Drug	Value CAGR
Monoclonal Antibody	5.7%
Vaccines	9.4%
Recombinant Insulin	7.8%
Growth factors	6.7%
Immune Modulators	8.5%
Fusion Protein	6.9%
Erythoprotein	11.1%
Therapeutic Enzymes	10.1%
Interferons	12.9%
Colony Stimulation Factors	11.9%
Oligonucleotides	13.9%
Others Drug	5.8%

As per the latest analysis, the monoclonal antibody segment is expected to dominate the global biosimilar & biologic industry during the forecast period. It will likely rise at a CAGR of 5.7%, generating revenue worth USD 161.1 billion in 2024.

• Growing usage of monoclonal antibodies in targeted therapies is a key factor driving the target segment forward.
• Monoclonal antibodies are designed to target specific molecules, such as proteins and cells, with high precision. This specificity reduces the possibility of off-target effects, making them suitable for treating a wide range of diseases.
• Monoclonal antibodies can be engineered to target various diseases, including cancer cells, autoimmune disorders, and infectious agents. This versatility allows for the development and manufacturing of biotherapeutics for diverse medical conditions.
• Rising prevalence of chronic diseases like cancer and diabetes is expected to drive demand for effective treatments, including monoclonal antibodies.
• Specific advantages of monoclonal antibodies, including their minimal side effects, makes them attractive to both patients and healthcare professionals.
• Development of high-quality and cost-effective biosimilars for mAbs due to advancements in biosimilar technology will further boost the target segment.

Bacterial Cells to be the Top Sources for Biosimilar and Biologic Production

Market Growth Outlook by Source

Source	Value CAGR
Bacterial Cells	6.7%
Yeast Cells	8.2%
Plant Cells	9.9%
Animal Cells	7.4%
Other Sources	8.8%

Bacterial cells are widely used for producing biosimilars and biologics. This is due to their multiple advantages, including faster and cheaper production, scalability, and lower immunogenicity.

The bacterial cells segment is estimated to account for a dominant market share of 44.0% in 2024. Further, it will likely witness a CAGR of 6.7% during the forecast period, totaling a valuation of USD 229.2 billion in 2024.

• Bacterial cells, such as Escherichia coli (E. coli) and Bacillus subtilis, are relatively easy and inexpensive to culture and manipulate in laboratories, making them cost-effective sources for large-scale biologics production.
• Bacterial cells with short doubling times are allowing for rapid growth and high yields of recombinant proteins within a relatively short period. This is advantageous for meeting the high demand for biosimilars and biologics in the pharmaceutical market.
• Due to the versatility of bacterial cells, they can be engineered to express a wide range of proteins, including enzymes, antibodies, and hormones. This makes them ideal for producing a large variety of biologics and biosimilars.

Oncology to be a Highly Remunerative Application for Biosimilars and Biologics

Market Growth Outlook by Application

Application	Value CAGR
Oncology	6.2%
Autoimmune Disease	6.9%
Infectious Diseases	8.9%
Rare Disease	9.7%
Cardiovascular Disorders	10.6%
Hematological Disorders	7.8%
Others Application	8.3%

Based on application, the oncology segment is anticipated to generate significant revenue for the biosimilar & biologics market. It will likely grow at a CAGR of 6.2% during the assessment period, totaling USD 134.8 billion in 2024. This can be attributed to factors like:

• Rising cancer cases globally
• Increasing demand for effective and affordable treatments
• Growing awareness and acceptance of biosimilars in cancer treatments

Increased life expectancy and improved diagnostics lead to more cancer diagnoses, driving the need for effective treatments. Advancements in personalized medicine require diverse treatment options customized to individual patients' mutations and tumor profiles. Biologics and biosimilars offer this diversity.

The prevalence of cancer is increasing globally due to factors such as aging population, lifestyle changes, and environmental factors. As cancer rates rise, there is a greater need for effective treatments, including biologics.

Biologics, including monoclonal antibodies and targeted therapies, have become standard treatments for lung cancer. These pharmaceuticals possess improved efficacy and reduced toxicity compared to traditional chemotherapy.

Contract Manufacturing Segment Leading the Global Industry

Market Growth Outlook by Manufacturing Type

Manufacturing Type	Value CAGR
Contract Manufacturing	7.4%
In-house Manufacturing	7.9%

The contract manufacturing industry is expected to lead the biosimilar and biologic industry during the assessment period, holding a share of 56.7% in 2024. Over the forecast period, the target segment will likely exhibit a CAGR of 7.4%.

• Contract manufacturing organizations (CMOs) have specialized expertise and state-of-the-art facilities dedicated to specific manufacturing processes for biologics production. As a result, pharmaceutical giants often opt for contract manufacturing.
• CMOs offer economies of scale, flexible capacity, and optimized production processes, resulting in lower manufacturing costs for pharmaceutical companies.
• Contract manufacturing allows pharmaceutical companies to quickly produce biosimilar and biologics without investing in their own manufacturing capabilities.
• Contract manufacturing can be more cost-effective than building and maintaining in-house manufacturing facilities. As a result, this segment is dominating the target industry.
• Rising trend of pharmaceutical outsourcing is expected to further boost the contract manufacturing segment through 2034.

Hospital Pharmacies Witnessing High Sales of Biosimilars and Biologics

Market Growth Outlook by Distribution Channel

Distribution Channel	Value CAGR
Hospital Pharmacies	6.8%
Retail Pharmacies	7.7%
Specialty Pharmacies	8.2%
Mail Order Pharmacies	8.8%

In terms of distribution channel, the hospital pharmacies segment is poised to exhibit a CAGR of 6.8% during the forecast period. It will likely account for a revenue share of 37.5% in 2024.

• Hospital pharmacies serve as a centralized distribution channel for medication procurement, storage, dispensing, and management within healthcare institutions.
• Pharmaceutical companies manufacturing biosimilars and biologics can streamline their distribution processes by supplying medications directly to hospital pharmacies, reducing logistical complexities and ensuring efficient inventory management.

Competitive Landscape

Key manufacturers of biosimilars and biologics are rigorously investing in research and development to develop novel solutions for different applications, including cancer treatments.

They are employing strategies like collaborations, mergers, acquisitions, partnerships, facility expansions, and distribution agreements to expand their footprint and stay ahead of the competition.

Recent Developments in the Biosimilar and Biologics Market

• In January 2024, Gilead Sciences and Arcus Biosciences announced an amended collaboration agreement along with a separate equity investment. Gilead invested USD 320 billion in Arcus common stock at USD 21 per share. This strategic move aims to accelerate the growth of both companies through enhanced collaboration and increased financial support.
• In October 2021, Boehringer Ingelheim inaugurated a biopharmaceutical production facility in Vienna, Austria. With this addition, the company strengthened its position in the European region.

Key Players in the Biosimilar and Biologics Market

• Pfizer Inc.
• Hoffmann-La Roche AG
• AbbVie Inc.
• Novartis AG
• Merck & Co., Inc.
• Bristol Myers Squibb Co.
• GSK plc
• AstraZeneca
• Eli Lilly & Co.
• Bayer AG.
• Gilead Sciences
• Amgen Inc.
• Boehringer Ingelheim International GmbH
• Novo Nordisk A/S
• Viatris Inc.
• Johnson & Johnson (Janssen Pharmaceuticals, Inc.)
• Sanofi Winthrop Industries S.A
• Serum Institute of India
• Biocon Limited
• Intas Pharmaceuticals Limited

Key Coverage in the Global Biosimilar and Biologics Market Research Report

• Adjacent Study on Global Complex Biologics Market, Biosimilar Antibodies Market, Generic Biologics Market, and Biosimilar Products Market
• Detailed Analysis of Global Biologics Manufacturing Market
• A Separate Chapter Dedicated to Biosimilar Drugs Market Vs Biologic Drugs Market Analysis
• Factors Propelling the Global Biosimilars Market
• Growth Prospects for the Biosimilars & Biologics Market in India
• Recent Advances in the Biopharmaceuticals Market
• Demand Outlook for Biosimilars in India and other Developing Nations
• The Potential and Challenges of Bringing Biosimilars to Market
• Promising Opportunities of Biosimilar in the Middle East and Africa Market
• Anticipated Impact of Biosimilars on Pharmaceutical Companies

Biosimilar and Biologics Market Segmentation

By Drug Class:

• Monoclonal Antibody
• Vaccines
• Recombinant Insulin
• Growth Factors
• Immune Modulators
• Fusion Protein
• Erythoprotein
• Therapeutic Enzymes
• Interferons
• Colony Stimulation Factors
• Oligonucleotides
• Others Drug

By Source:

• Bacterial Cells
• Yeast Cells
• Plant Cells
• Animal Cells
• Other Sources

By Application:

• Oncology
• Autoimmune Disease
• Infectious Diseases
• Rare Disease
• Cardiovascular Disorders
• Hematological Disorders
• Other Application

By Manufacturing Type:

• Contract Manufacturing
• In-house Manufacturing

By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Specialty Pharmacies
• Mail Order Pharmacies

By Region:

• North America
• Latin America
• East Asia
• South Asia & Pacific
• Western Europe
• Eastern Europe
• Middle East & Africa

Frequently Asked Questions

How big is the biosimilar & biologics market?

The global biosimilar & biologics market value is set to reach USD 520.9 billion in 2024.

What is the future of biosimilars and biologics?

By 2034, the biologics and biosimilar market size is expected to reach USD 1,060.7 billion.

What was the historical CAGR for the global market?

The global market for biosimilars & biologics increased at 5.8% CAGR from 2019 to 2023.

What is the demand outlook for biosimilars and biologics?

Demand for biosimilar & biologics is projected to grow at 7.6% CAGR.

Which drug class segment dominates the market?

With 31.0% share in 2023, the monoclonal antibody segment dominated the global market.

What is the United States market outlook?

The United States biosimilar & biologics market is estimated to grow at 5.9% CAGR.

What is the sales forecast for China market?

Biosimilar & biologic sales in China are estimated to surge at 8.8% CAGR through 2034.

What are biologics and biosimilars?

Biologics are medications derived from living organisms, while biosimilars are medications similar to existing biologics.

How big is the biologics market?

The biologics market was valued at around USD 335.4 billion in 2021.