Biosimilars & Follow-On Biologics Market – By Technology , By Route of Administration , By Application , By Distribution Channel , By Geography - Opportunity Analysis & Industry Forecast, 2025-2031

Report Code: HCR 80583 Report Format: PDF + Excel

Biosimilars & Follow-On Biologics Market Overview:

The Biosimilars & Follow-On Biologics Market size is estimated to reach $1050 billion by 2031, growing at a CAGR of 20.6% during the forecast period 2025-2031. The Biosimilars & Follow-On Biologics Market is witnessing robust growth due to the need for more affordable alternatives to expensive biologic treatments, especially in areas like cancer, immune system disorders and chronic conditions. The expiration of patents for popular biologic drugs and the rising healthcare needs in both developed and emerging countries are also contributing to the market's expansion.

Advancements in biomanufacturing technology is helping global healthcare systems integrate biosimilars into care models, reduce costs, and support treatment decision-making. In October 2024, Archon Biosciences, with $20 million in seed funding to advance its computationally designed Antibody Cages. Additionally, patient and physician awareness is a growing trend too. For example, in April 2024, the US FDA launched the Biosimilars Action Plan to encourage innovation and competition in the biologics market. The plan outlines the FDA's commitments and focuses on initiatives that support the development of biosimilars and interchangeable biosimilars, aiming to improve patient access to these therapies and increase awareness among healthcare providers.

Market Snapshot: 

Biosimilars & Follow-On Biologics Market

Biosimilars & Follow-On Biologics Market - Report Coverage:

The “Biosimilars & Follow-On Biologics Market Report - Forecast (2025-2031)” by IndustryARC, covers an in-depth analysis of the following segments in the Biosimilars & Follow-On Biologics Market.

Attribute Segment

By Technology

 
  • Mammalian Expression Systems
  • Microbial Expression Systems
  • Yeast Expression Systems
  • Plant-Based Expression Systems

By Product

 
  • Monoclonal Antibodies
  • Insulin
  • Granulocyte Colony-Stimulating Factor
  • Erythropoietin
  • Recombinant Human Growth Hormone
  • Etanercept
  • Follitropin
  • Teriparatide
  • Interferons
  • Anticoagulants
  • Others

By Route of Administration

 
  • Oral
  • Injectable
  • Topical

By Application
  • Blood Disorder
  • Cancer
  • Chronic and Autoimmune Disease
  • Hormone Disorders
  • Infectious Diseases
  • Others

By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Geography

  • North America (U.S., Canada and Mexico)
  • Europe (Germany, France, UK, Italy, Spain, Netherlands, Belgium and Rest of Europe),
  • Asia-Pacific (China, Japan, South Korea, India, Australia & New Zealand and Rest of Asia-Pacific),
  • South America (Brazil, Argentina, Chile, Colombia and Rest of South America)
  • Rest of the World (Middle East and Africa).

Key Takeaways:

  •  Europe Leads the Market

In 2024, Europe leads the global biosimilars and follow-on biologics market, particularly in the insulin segment, thanks to its robust regulatory framework, early adoption of biosimilar policies, and strong emphasis on cost-effective healthcare. According to IQVIA, biologics represent 40% of medicine spending in Europe at list prices in 2024, underscoring their significant role in the region's pharmaceutical landscape. Global spending on medicines using list prices grew by 35% over the past five years and is projected to increase by 38% through 2028, with Europe expected to contribute an additional $70 billion in spending during this period. This growth is driven by new brands but will be offset by the increasing use of generics and biosimilars, which help control costs. According to Medicines in Europe, in December 2024, Biosimilar medicines competition has already delivered €56 billion in cumulative biologic treatment cost reductions across Europe. 

  • Oncology is the largest

According to a February 2024 article by WHO, it is predicted that over 35 million new cancer cases will be diagnosed by 2050, marking a 77% increase from the 20 million cases estimated in 2022. Biologics, which harness the body's immune system to treat cancer, play a critical role in combating tumors, especially when other treatments are ineffective. As seen in a May 2024 strategic collaboration between Glenmark and BeiGene, Glenmark will oversee the development, registration, and distribution of BeiGene's innovative oncology medicines, Tislelizumab and Zanubrutinib, offering access to these life-saving treatments for cancer patients in India. This collaboration exemplifies the growing emphasis on biologics in the fight against cancer and highlights the increasing demand for biologic therapies in cancer care.

  • Monoclonal Antibodies are the largest segment

Monoclonal antibodies (mAbs) held the largest market share in 2024, due to their broad range of applications in both therapeutic and diagnostic settings. In June 2024, the U.S. Department of Defense (DoD) enlisted Just – Evotec Biologics, a subsidiary of Evotec, in a multi-year antibody manufacturing program, with a potential award of up to $39 million. The initiative focuses on accelerating monoclonal antibody development and manufacturing to enhance the U.S. government's rapid response capabilities for biologic medical countermeasures. Additionally, in November 2024, Precision Biologics, Inc. reported advancements in its monoclonal antibody PB-223, with research on its affinity maturation and characterization set to be presented at the Society for Immunotherapy of Cancer (SITC). 

  • Increasing acceptance of biosimilars due to their cost-effectiveness drives the Market

As biosimilars enhance competition in the biopharmaceutical market, they are expected to reduce the costs associated with expensive biological medicines. A Jan 2025 article by the National Institute of Health highlights the positive impact of biosimilars, reporting that in Denmark, a nationwide mandatory switch from the originator drug (Humira) to biosimilar adalimumab did not increase total healthcare costs over a nine-month period. In fact, hospital costs even decreased for those who switched to the biosimilar, reinforcing the potential for biosimilars to lower healthcare expenses while providing effective alternatives to costly originator biologics.

Biosimilars & Follow-On Biologics Market

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Key Market Players: 

Product/Service launches, approvals, patents and events, acquisitions, partnerships, and collaborations are key strategies adopted by players in the Biosimilars & Follow-On Biologics Market. The top 10 companies in this industry are listed below:

  1. Pfizer Inc.
  2. Eli Lilly and Company
  3. Novartis AG
  4. Amgen Inc.
  5. Celltrion Inc.
  6. Samsung Bioepis Co., Ltd.
  7. Novo Nordisk A/S
  8. Bristol Myers Squibb Co.
  9. Sanofi S.A
  10. Dr. Reddy's Laboratories

Scope of the Report: 

Report Metric Details

Base Year Considered

2024

Forecast Period

2025–2031

CAGR

20.6%

Market Size in 2031

$1050 Billion

Segments Covered

By Technology, By Product, By Route of Administration, By Application, By Distribution Channel and By Geography.

Geographies Covered

North America (U.S., Canada and Mexico), Europe (Germany, France, UK, Italy, Spain, Netherlands, Belgium and Rest of Europe), Asia-Pacific (China, Japan, South Korea, India, Australia & New Zealand and Rest of Asia-Pacific), South America (Brazil, Argentina, Chile, Colombia and Rest of South America), Rest of the World (Middle East and Africa).

Key Market Players
  1. Pfizer Inc.
  2. Eli Lilly and Company
  3. Novartis AG
  4. Amgen Inc.
  5. Celltrion Inc.
  6. Samsung Bioepis Co., Ltd.
  7. Novo Nordisk A/S
  8. Bristol Myers Squibb Co.
  9. Sanofi S.A
  10. Dr. Reddy's Laboratories

 

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  1.    Biosimilars & Follow-On Biologics Market - Overview
      1.1.    Definitions and Scope
  2.    Biosimilars & Follow-On Biologics Market - Executive Summary
      2.1.    Key trends by Voltage
      2.2.    Key trends by Insulation Type 
      2.3.    Key trends by Use Case
      2.4.    Key trends by Phase
      2.5.    Key trends by End Use Industry
      2.6.    Key trends by Geography
  3.    Biosimilars & Follow-On Biologics Market - Comparative Analysis
      3.1.    Company Benchmarking - Key Companies
      3.2.    Financial Analysis - Key Companies
      3.3.    Market Share Analysis - Key Companies
      3.4.    Patent Analysis
      3.5.    Pricing Analysis
  4.    Biosimilars & Follow-On Biologics Market - Start-up Companies Scenario
      4.1.    Key Start-up Company Analysis by
            4.1.1.    Investment & Revenue
            4.1.2.    Venture Capital and Funding Scenario
  5.    Biosimilars & Follow-On Biologics Market – Market Entry Scenario Premium
      5.1.    Regulatory Framework Overview
      5.2.    New Business and Ease of Doing Business Index
      5.3.    Case Studies of Successful Ventures
  6.    Biosimilars & Follow-On Biologics Market - Forces
      6.1.    Market Drivers
      6.2.    Market Constraints
      6.3.    Market Challenges
      6.4.    Porter's Five Force Model
            6.4.1.    Bargaining Power of Suppliers
            6.4.2.    Bargaining Powers of Customers
            6.4.3.    Threat of New Entrants
            6.4.4.    Rivalry Among Existing Players
            6.4.5.    Threat of Substitutes
  7.    Biosimilars & Follow-On Biologics Market – Strategic Analysis
      7.1.    Value Chain Analysis
      7.2.    Opportunities Analysis
      7.3.    Product Life Cycle/Market Life Cycle Analysis
      7.4.    Supplier/Distributor Analysis
  8.    Biosimilars & Follow-On Biologics Market - By Technology (Market Size -$Million / $Billion)
      8.1    Mammalian Expression Systems 
      8.2    Microbial Expression Systems
      8.3    Yeast Expression Systems
      8.4    Plant-Based Expression Systems    
  9.    Biosimilars & Follow-On Biologics Market - By Product (Market Size -$Million / $Billion)
      9.1     Monoclonal Antibodies
            9.1.1 Infliximab
            9.1.2 Trastuzumab
            9.1.3 Rituximab
            9.1.4 Adalimumab
            9.1.5 Others
      9.2    Insulin
      9.3    Granulocyte Colony-Stimulating Factor
      9.4    Erythropoietin
      9.5    Recombinant Human Growth Hormone
      9.6    Etanercept
      9.7    Follitropin
      9.8    Teriparatide
      9.9    Interferons
      9.10    Anticoagulants
      9.11    Others
  10.    Biosimilars & Follow-On Biologics - By Route of Administration (Market Size -$Million / $Billion)
      10.1    Oral
      10.2    Injectable
      10.3    Topical
  11.    Biosimilars & Follow-On Biologics - By Application (Market Size -$Million / $Billion)
      11.1    Blood Disorder
      11.2    Cancer
      11.3    Chronic And Autoimmune Disease
      11.4    Hormone Disorders
      11.5    Infectious Diseases
      11.6    Others
  12.    Biosimilars & Follow-On Biologics - By Distribution Channel (Market Size -$Million / $Billion)
      12.1    Hospital Pharmacies
      12.2    Retail Pharmacies
      12.3    Online Pharmacies
  13.    Biosimilars & Follow-On Biologics Market – by Geography (Market Size – $Million/$Billion) 
      13.1.    North America
            13.1.1.    U.S
            13.1.2.    Canada
            13.1.3.    Mexico
      13.2.    Europe
            13.2.1.    Germany
            13.2.2.    France
            13.2.3.    UK
            13.2.4.    Italy
            13.2.5.    Spain
            13.2.6.    Netherlands
            13.2.7.    Belgium
            13.2.8.    Rest of Europe
      13.3.    Asia-Pacific
            13.3.1.    China
            13.3.2.    Japan
            13.3.3.    South Korea
            13.3.4.    India
            13.3.5.    Australia & New Zealand
            13.3.6.    Rest of Asia-Pacific
      13.4.     South America
            13.4.1.    Brazil
            13.4.2.    Argentina
            13.4.3.    Chile
            13.4.4.    Colombia
            13.4.5.    Rest of South America
      13.5.    Rest of The World
            13.5.1.    Middle East
            13.5.2.    Africa
  14.    Biosimilars & Follow-On Biologics Market – Entropy
      14.1.    New product launches
      14.2.    M&A's, collaborations, JVs and partnerships
  15.    Biosimilars & Follow-On Biologics Market – Industry/Segment Competition Landscape 
      15.1.    Market Share Analysis
            15.1.1.    Market Share by Global 
            15.1.2.    Market Share by Region
            15.1.3.    Market Share by Country
  16.    Biosimilars & Follow-On Biologics Market – Key Company List by Country Premium 
  17.    Biosimilars & Follow-On Biologics Market – Company Analysis
      15.1    Pfizer Inc.
      15.2    Eli Lilly and Company
      15.3    Novartis AG
      15.4    Amgen Inc.
      15.5    Celltrion Inc.
      15.6    Samsung Bioepis Co., Ltd.
      15.7    Novo Nordisk A/S
      15.8    Bristol Myers Squibb Co.
      15.9    Sanofi S.A
      15.10    Dr. Reddy's Laboratories
  "Financials to the Private Companies would be provided on a best-effort basis."
   

LIST OF TABLES

1.Global India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 ($M)
1.1 Erythropoetin Market 2023-2030 ($M) - Global Industry Research
1.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 ($M) - Global Industry Research
1.3 Growth Hormone Market 2023-2030 ($M) - Global Industry Research
1.4 Alfa Interferon Market 2023-2030 ($M) - Global Industry Research
1.5 Beta Interferon Market 2023-2030 ($M) - Global Industry Research
1.6 Monoclonal Antibody Market 2023-2030 ($M) - Global Industry Research
1.7 Follitropin Market 2023-2030 ($M) - Global Industry Research
2.Global India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 ($M)
2.1 In-House Manufacturing Market 2023-2030 ($M) - Global Industry Research
2.2 Contract Manufacturing Organization Market 2023-2030 ($M) - Global Industry Research
3.Global India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 (Volume/Units)
3.1 Erythropoetin Market 2023-2030 (Volume/Units) - Global Industry Research
3.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 (Volume/Units) - Global Industry Research
3.3 Growth Hormone Market 2023-2030 (Volume/Units) - Global Industry Research
3.4 Alfa Interferon Market 2023-2030 (Volume/Units) - Global Industry Research
3.5 Beta Interferon Market 2023-2030 (Volume/Units) - Global Industry Research
3.6 Monoclonal Antibody Market 2023-2030 (Volume/Units) - Global Industry Research
3.7 Follitropin Market 2023-2030 (Volume/Units) - Global Industry Research
4.Global India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 (Volume/Units)
4.1 In-House Manufacturing Market 2023-2030 (Volume/Units) - Global Industry Research
4.2 Contract Manufacturing Organization Market 2023-2030 (Volume/Units) - Global Industry Research
5.North America India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 ($M)
5.1 Erythropoetin Market 2023-2030 ($M) - Regional Industry Research
5.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 ($M) - Regional Industry Research
5.3 Growth Hormone Market 2023-2030 ($M) - Regional Industry Research
5.4 Alfa Interferon Market 2023-2030 ($M) - Regional Industry Research
5.5 Beta Interferon Market 2023-2030 ($M) - Regional Industry Research
5.6 Monoclonal Antibody Market 2023-2030 ($M) - Regional Industry Research
5.7 Follitropin Market 2023-2030 ($M) - Regional Industry Research
6.North America India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 ($M)
6.1 In-House Manufacturing Market 2023-2030 ($M) - Regional Industry Research
6.2 Contract Manufacturing Organization Market 2023-2030 ($M) - Regional Industry Research
7.South America India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 ($M)
7.1 Erythropoetin Market 2023-2030 ($M) - Regional Industry Research
7.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 ($M) - Regional Industry Research
7.3 Growth Hormone Market 2023-2030 ($M) - Regional Industry Research
7.4 Alfa Interferon Market 2023-2030 ($M) - Regional Industry Research
7.5 Beta Interferon Market 2023-2030 ($M) - Regional Industry Research
7.6 Monoclonal Antibody Market 2023-2030 ($M) - Regional Industry Research
7.7 Follitropin Market 2023-2030 ($M) - Regional Industry Research
8.South America India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 ($M)
8.1 In-House Manufacturing Market 2023-2030 ($M) - Regional Industry Research
8.2 Contract Manufacturing Organization Market 2023-2030 ($M) - Regional Industry Research
9.Europe India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 ($M)
9.1 Erythropoetin Market 2023-2030 ($M) - Regional Industry Research
9.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 ($M) - Regional Industry Research
9.3 Growth Hormone Market 2023-2030 ($M) - Regional Industry Research
9.4 Alfa Interferon Market 2023-2030 ($M) - Regional Industry Research
9.5 Beta Interferon Market 2023-2030 ($M) - Regional Industry Research
9.6 Monoclonal Antibody Market 2023-2030 ($M) - Regional Industry Research
9.7 Follitropin Market 2023-2030 ($M) - Regional Industry Research
10.Europe India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 ($M)
10.1 In-House Manufacturing Market 2023-2030 ($M) - Regional Industry Research
10.2 Contract Manufacturing Organization Market 2023-2030 ($M) - Regional Industry Research
11.APAC India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 ($M)
11.1 Erythropoetin Market 2023-2030 ($M) - Regional Industry Research
11.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 ($M) - Regional Industry Research
11.3 Growth Hormone Market 2023-2030 ($M) - Regional Industry Research
11.4 Alfa Interferon Market 2023-2030 ($M) - Regional Industry Research
11.5 Beta Interferon Market 2023-2030 ($M) - Regional Industry Research
11.6 Monoclonal Antibody Market 2023-2030 ($M) - Regional Industry Research
11.7 Follitropin Market 2023-2030 ($M) - Regional Industry Research
12.APAC India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 ($M)
12.1 In-House Manufacturing Market 2023-2030 ($M) - Regional Industry Research
12.2 Contract Manufacturing Organization Market 2023-2030 ($M) - Regional Industry Research
13.MENA India Biosimilars Follow-On Biologics Market, By Product Market 2023-2030 ($M)
13.1 Erythropoetin Market 2023-2030 ($M) - Regional Industry Research
13.2 Granulocyte-Colony Stimulating Factor Market 2023-2030 ($M) - Regional Industry Research
13.3 Growth Hormone Market 2023-2030 ($M) - Regional Industry Research
13.4 Alfa Interferon Market 2023-2030 ($M) - Regional Industry Research
13.5 Beta Interferon Market 2023-2030 ($M) - Regional Industry Research
13.6 Monoclonal Antibody Market 2023-2030 ($M) - Regional Industry Research
13.7 Follitropin Market 2023-2030 ($M) - Regional Industry Research
14.MENA India Biosimilars Follow-On Biologics Market, By Type Of Manufacturing Market 2023-2030 ($M)
14.1 In-House Manufacturing Market 2023-2030 ($M) - Regional Industry Research
14.2 Contract Manufacturing Organization Market 2023-2030 ($M) - Regional Industry Research

LIST OF FIGURES

1.US India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
2.Canada India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
3.Mexico India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
4.Brazil India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
5.Argentina India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
6.Peru India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
7.Colombia India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
8.Chile India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
9.Rest of South America India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
10.UK India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
11.Germany India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
12.France India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
13.Italy India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
14.Spain India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
15.Rest of Europe India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
16.China India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
17.India India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
18.Japan India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
19.South Korea India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
20.South Africa India Biosimilars And Follow-On Biologics Market Revenue, 2023-2030 ($M)
21.North America India Biosimilars And Follow-On Biologics By Application
22.South America India Biosimilars And Follow-On Biologics By Application
23.Europe India Biosimilars And Follow-On Biologics By Application
24.APAC India Biosimilars And Follow-On Biologics By Application
25.MENA India Biosimilars And Follow-On Biologics By Application
26.Cadila Pharmaceutical, Sales /Revenue, 2015-2018 ($Mn/$Bn)
27.Lupin Limited, Sales /Revenue, 2015-2018 ($Mn/$Bn)
28.Torrent Pharmaceutical Ltd, Sales /Revenue, 2015-2018 ($Mn/$Bn)
29.F. Hoffmann-La Roche Ag, Sales /Revenue, 2015-2018 ($Mn/$Bn)
30.Sanofi S A, Sales /Revenue, 2015-2018 ($Mn/$Bn)
31.Wockhardt Limited, Sales /Revenue, 2015-2018 ($Mn/$Bn)
32.Reliance Life Science Private Limited, Sales /Revenue, 2015-2018 ($Mn/$Bn)
33.Intas Pharmaceutical Limited, Sales /Revenue, 2015-2018 ($Mn/$Bn)
34.Dr. Reddys Laboratory Limited, Sales /Revenue, 2015-2018 ($Mn/$Bn)
35.Biocon Limited, Sales /Revenue, 2015-2018 ($Mn/$Bn)

The Biosimilars & Follow-On Biologics Market is projected to grow at 20.6% CAGR during the forecast period 2025-2031.

The Biosimilars & Follow-On Biologics Market size is estimated to be $286 billion in 2024 and is projected to reach $1050 billion by 2031.

The leading players in the Biosimilars & Follow-On Biologics Market are Pfizer Inc., Eli Lilly and Company, Novartis AG, Amgen Inc., Celltrion Inc., and Others.

Advancements in biomanufacturing technology, patient and physician awareness are some of the major Biosimilars & Follow-On Biologics Market trends in the industry which will create growth opportunities for the market during the forecast period.

Rising demand for cost-effective treatment options, the increasing prevalence of chronic diseases and expanding regulatory support. are the driving factors of the market.