Biosimilars Market Synopsis

Global Biosimilars Market Size Was Valued at USD 34.01 Billion in 2023 and is Projected to Reach USD 143.97 Billion by 2032, Growing at a CAGR of 17.39% From 2024-2032.

The biosimilars market has experienced significant growth and evolution in recent years. Biosimilars are highly similar versions of approved biologic products, offering comparable efficacy and safety profiles. This market expansion is fueled by factors such as patent expirations of major biologics, cost-saving initiatives by healthcare systems, and favorable regulatory pathways for biosimilar approval in many regions. Therefore, pharmaceutical companies are investing heavily in biosimilar development, fostering competition and expanding patient access to critical treatments across various therapeutic areas such as oncology, autoimmune diseases, and diabetes.

The biosimilars market continues to gain traction globally, driven by the increasing pressure to contain healthcare costs while ensuring access to innovative therapies. With the expiry of patents for several blockbuster biologic drugs, biosimilars represent a significant opportunity for cost savings, potentially offering reductions in healthcare expenditure by providing more affordable treatment options.

• Biosimilars present a range of benefits within the pharmaceutical sphere, fueling their growing demand and widespread applications across various medical fields. These advantages derive from their likeness to original biologics, alongside their potential for cost reduction and expanded patient accessibility. Biosimilars offer a more economical option compared to pricier biologic therapies, aiding in the containment of healthcare expenditures globally. This heightened affordability facilitates broader patient access to critical treatments, particularly in regions grappling with limited healthcare resources.
• The call for biosimilars continues to escalate across diverse medical domains, encompassing oncology, autoimmune disorders, hematological conditions, and infectious ailments. Biosimilars are progressively integrated into treatment regimens, boasting efficacy and safety profiles akin to their originator counterparts. Furthermore, with the expiration of patents for biologic drugs opening avenues for biosimilar development, the biosimilar market is poised for further expansion.
• Prominent trends in this market include the rise of strategic alliances and collaborations among pharmaceutical entities, advancements in biosimilar manufacturing technologies, and evolving regulatory frameworks designed to streamline biosimilar approvals. Additionally, the growing acceptance of biosimilars among healthcare professionals and patients, coupled with heightened awareness of their advantages, fosters market growth and adoption. Overall, biosimilars represent a promising avenue for enhancing healthcare affordability, elevating patient outcomes, and propelling innovation within the pharmaceutical sector.

Biosimilars Market Trend Analysis

Increased Prevalence of Chronic Diseases

• The escalating occurrence of chronic ailments stands out as a significant driver in propelling the biosimilars market forward. Chronic diseases, encompassing conditions like cancer, autoimmune disorders, diabetes, and inflammatory ailments, are becoming more widespread globally due to factors such as aging populations, sedentary lifestyles, and evolving dietary patterns. These conditions often necessitate long-term treatment with biological therapies, placing substantial strains on healthcare systems and patients alike.
• Biosimilars offer a financially viable substitute to original biologics for managing chronic diseases, providing comparable effectiveness and safety profiles at reduced costs. This enhanced affordability widens patient access to vital treatments, particularly in regions grappling with limited healthcare resources or prohibitively high medical expenses.
• The expiration of patents for biologic medications used in chronic disease management opens doors for biosimilar manufacturers to enter the market and offer more economical alternatives. By introducing biosimilars, healthcare systems can achieve cost efficiencies and allocate resources more effectively to meet the escalating demand for chronic disease care.

Improved Patient Targeting and Adherence

• Enhanced patient targeting and adherence emerge as pivotal opportunities within the biosimilars market, fostering better treatment outcomes and healthcare efficacy. The introduction of biosimilars widens the array of available treatment options for healthcare providers, enabling them to tailor therapeutic strategies to individual patient requirements and preferences. Biosimilars, with their demonstrated similarity in effectiveness and safety to originator biologics, instill confidence in healthcare professionals when prescribing these treatments to suitable patient cohorts.
• The accessibility of biosimilars at potentially reduced costs can facilitate greater patient access to biologic therapies, particularly in regions facing healthcare resource limitations or reimbursement challenges. This heightened accessibility is conducive to higher treatment adherence rates, as patients are more inclined to adhere to treatments that are both financially viable and readily accessible.
• Biosimilars may offer added benefits such as improved dosing convenience or alternative administration routes, thereby further bolstering patient adherence. By surmounting obstacles to treatment adherence and offering more precise therapeutic choices, biosimilars have the potential to optimize patient outcomes, alleviate disease burden, and enhance overall healthcare efficiency. Consequently, enhanced patient targeting and adherence stand as critical opportunities for biosimilar manufacturers to drive market expansion and distinction within the ever-evolving healthcare landscape.

Biosimilars Market Segment Analysis:

Biosimilars Market Segmented on the basis of Product Class, Application, and Distribution Channel.

By Product Class, Monoclonal Antibodies (mAbs) segment is expected to dominate the market during the forecast period

• The Monoclonal Antibodies (mAbs) segment is anticipated to emerge as the dominant force in the biosimilars market due to several key factors. To begin with, monoclonal antibodies encompass a broad spectrum of biological drugs utilized in treating a multitude of ailments, ranging from cancer to autoimmune disorders and inflammatory conditions. This extensive therapeutic scope translates into a substantial market opportunity for biosimilar manufacturers focusing on mAbs.
• Numerous blockbuster biologics belong to the monoclonal antibodies category, with many of these original products either having already lost patent protection or nearing patent expiration. This presents a significant opening for biosimilar developers to introduce lower-cost alternatives, thus spurring adoption and market expansion.
• Regulatory bodies like the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established clear pathways for approving biosimilar monoclonal antibodies. This regulatory transparency streamlines the development, evaluation, and commercialization processes, encouraging investment and innovation within the mAbs segment. Increasing acceptance of biosimilar monoclonal antibodies among healthcare providers and patients, owing to their proven efficacy, safety, and potential cost savings, further solidifies the segment's dominance in the biosimilar market.

By Application, Oncology segment is expected to dominate the market during the forecast period

• The oncology segment is anticipated to lead the biosimilar market due to several factors that underscore its prominence in driving market expansion. the widespread occurrence of cancer globally necessitates a continuous demand for effective and economical treatments, making oncology a focal point for biosimilar development. With biological therapies being pivotal in cancer care, the availability of biosimilars presents a promising avenue for broadening treatment options while alleviating the financial strain associated with cancer treatment.
• The expiration of patents for several blockbuster biologics used in oncology, coupled with the escalating costs of cancer therapies, creates a favorable climate for biosimilar adoption. Biosimilars offer comparable efficacy and safety profiles to originator biologics at potentially reduced costs, rendering them an appealing alternative for healthcare providers, payers, and patients alike.
• Regulatory authorities have streamlined pathways for biosimilar approval in oncology, facilitating their market entry and acceptance. This regulatory endorsement, combined with growing recognition among healthcare practitioners and patients, further solidifies the oncology segment's position as a key driver of biosimilar market dominance.

Biosimilars Market Regional Insights:

Asia Pacific is Expected to Dominate the Market Over the Forecast period

• The Asia-Pacific region is anticipated to take the lead in the biosimilar market due to several factors propelling its growth and prominence in the sector. Primarily, the escalating prevalence of chronic ailments, alongside the surge in healthcare spending, is driving the demand for economical treatment alternatives, notably biosimilars. With a substantial and expanding population, particularly evident in nations like India and China, the Asia-Pacific area presents a vast market potential for biosimilar manufacturers.
• Conducive regulatory frameworks and supportive governmental measures are expediting the development and approval processes for biosimilars across many Asia-Pacific nations. Governments are implementing policies to encourage biosimilar utilization, including stimulating local production, streamlining regulatory procedures, and establishing reimbursement schemes. These initiatives enhance market accessibility and affordability, consequently propelling adoption rates.
• The presence of well-established pharmaceutical industries and growing expertise in biotechnology and manufacturing practices contribute to the region's leadership in biosimilar production. Companies based in countries such as South Korea and India have showcased their capabilities in biosimilar development and manufacturing, positioning themselves as key contenders in the global arena.
• Strategic collaborations and partnerships between domestic and international pharmaceutical firms facilitate knowledge exchange and technology transfer, fostering innovation and market expansion. Collectively, these elements position the Asia-Pacific region as a dominant force in the biosimilar market, offering significant prospects for further growth and market dominance in the foreseeable future.

Biosimilars Market Top Key Players:

• Coherus Biosciences (US)
• Viatris (US)
• Biogen Inc. (US)
• Merck & Co., Inc. (US)
• Pfizer Inc. (US)
• Amgen Inc. (US)
• Apobiologix (Canada)
• Biocad (Russia)
• Fresenius Kabi (Germany)
• Samsung Bioepis (South Korea)
• Celltrion Inc. (South Korea)
• Samsung Bioepis Co., Ltd. (South Korea)
• Novartis International AG (Switzerland)
• Sandoz (Switzerland)
• Bio-Thera Solutions (China)
• Dr. Reddy's Laboratories Ltd. (India)
• Biocon Ltd (India)
• Reliance Life Sciences (India)
• Intas Pharma (India)
• Zydus Cadila (India)
• Lupin Pharma (India)
• Teva Pharmaceutical Industries Ltd. (Israel), and Other Major Players.

Key Industry Developments in the Biosimilars Market:

• In May 2023, Boehringer Ingelheim obtained clearance from the U.S. Food and Drug Administration (FDA) for Cyltezo Pen, a newly introduced autoinjector option for Cyltezo (adalimumab-adbm). Cyltezo is an FDA-approved interchangeable biosimilar to Humira.
• In May 2022, Amneal Pharmaceuticals, Inc. secured approval from the United States Food and Drug Administration (FDA) for a Biologics License Application (BLA) related to pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The approved product will be marketed under the brand name FYLNETRA.

1. INTRODUCTION
   1. RESEARCH OBJECTIVES
   2. RESEARCH METHODOLOGY
   3. RESEARCH PROCESS
   4. SCOPE AND COVERAGE
      1. Market Definition
      2. Key Questions Answered
   5. MARKET SEGMENTATION
2. EXECUTIVE SUMMARY
3. MARKET OVERVIEW
4. GROWTH OPPORTUNITIES BY SEGMENT
5. MARKET LANDSCAPE
   1. PORTER’S FIVE FORCES ANALYSIS
      1. Bargaining Power Of Supplier
      2. Threat Of New Entrants
      3. Threat Of Substitutes
      4. Competitive Rivalry
      5. Bargaining Power Among Buyers
   2. INDUSTRY VALUE CHAIN ANALYSIS
   3. MARKET DYNAMICS
      1. Drivers
      2. Restraints
      3. Opportunities
      4. Challenges
   4. MARKET TREND ANALYSIS
   5. REGULATORY LANDSCAPE
   6. PESTLE ANALYSIS
   7. PRICE TREND ANALYSIS
   8. PATENT ANALYSIS
   9. TECHNOLOGY EVALUATION
   10. MARKET IMPACT OF THE RUSSIA-UKRAINE WAR
       1. Geopolitical Market Disruptions
       2. Supply Chain Disruptions
       3. Instability in Emerging Markets
   11. ECOSYSTEM
6. BIOSIMILARS MARKET BY PRODUCT CLASS (2017-2032)
   1. BIOSIMILARS MARKET SNAPSHOT AND GROWTH ENGINE
   2. MARKET OVERVIEW
   3. MONOCLONAL ANTIBODIES
      1. Introduction And Market Overview
      2. Historic And Forecasted Market Size in Value (2017 – 2032F)
      3. Historic And Forecasted Market Size in Volume (2017 – 2032F)
      4. Key Market Trends, Growth Factors And Opportunities
      5. Geographic Segmentation Analysis
   4. RECOMBINANT HORMONES
   5. IMMUNOMODULATORS
   6. ANTI-INFLAMMATORY AGENTS
7. BIOSIMILARS MARKET BY APPLICATION (2017-2032)
   1. BIOSIMILARS MARKET SNAPSHOT AND GROWTH ENGINE
   2. MARKET OVERVIEW
   3. BLOOD DISORDERS
      1. Introduction And Market Overview
      2. Historic And Forecasted Market Size in Value (2017 – 2032F)
      3. Historic And Forecasted Market Size in Volume (2017 – 2032F)
      4. Key Market Trends, Growth Factors And Opportunities
      5. Geographic Segmentation Analysis
   4. GROWTH HORMONAL DEFICIENCY
   5. CHRONIC AND AUTOIMMUNE DISORDERS
   6. ONCOLOGY
8. COMPANY PROFILES AND COMPETITIVE ANALYSIS
   1. COMPETITIVE LANDSCAPE
      1. Competitive Positioning
      2. BIOSIMILARS Market Share By Manufacturer (2023)
      3. Industry BCG Matrix
      4. Heat Map Analysis
      5. Mergers & Acquisitions
   2. PFIZER, INC
      1. Company Overview
      2. Key Executives
      3. Company Snapshot
      4. Role of the Company in the Market
      5. Sustainability and Social Responsibility
      6. Operating Business Segments
      7. Product Portfolio
      8. Business Performance (Production Volume, Sales Volume, Sales Margin, Production Capacity, Capacity Utilization Rate)
      9. Key Strategic Moves And Recent Developments
      10. SWOT Analysis
   3. Amgen, Inc.
   4. Eli Lilly and Company
   5. Coherus Biosciences, Inc.
   6. Merck & Co., Inc.
   7. AbbVie Inc.
   8. Biogen Inc.
   9. Epirus Biopharmaceuticals
   10. Apotex Inc.
   11. Mylan N.V.
   12. Alvotech
   13. Boehringer Ingelheim International GmbH
   14. Fresenius Kabi AG
   15. Formycon AG
   16. STADA Arzneimittel AG
   17. Novartis AG
   18. Samsung Bioepis Co., Ltd
   19. Celltrion Inc.
   20. Fujifilm Kyowa Kirin Biologics Co., Ltd.
9. GLOBAL BIOSIMILARS MARKET BY REGION
   1. OVERVIEW
   2. NORTH AMERICA
      1. Key Market Trends, Growth Factors And Opportunities
      2. Key Manufacturers
      3. Historic And Forecasted Market Size By Product Class
      4. Historic And Forecasted Market Size By Application
      5. Historic And Forecasted Market Size By Country
         1. USA
         2. Canada
         3. Mexico
   3. EASTERN EUROPE
      1. Key Market Trends, Growth Factors And Opportunities
      2. Key Manufacturers
      3. Historic And Forecasted Market Size By Segments
      4. Historic And Forecasted Market Size By Country
         1. Russia
         2. Bulgaria
         3. The Czech Republic
         4. Hungary
         5. Poland
         6. Romania
         7. Rest Of Eastern Europe
   4. WESTERN EUROPE
      1. Key Market Trends, Growth Factors And Opportunities
      2. Key Manufacturers
      3. Historic And Forecasted Market Size By Segments
      4. Historic And Forecasted Market Size By Country
         1. Germany
         2. United Kingdom
         3. France
         4. The Netherlands
         5. Italy
         6. Spain
         7. Rest Of Western Europe
   5. ASIA PACIFIC
      1. Key Market Trends, Growth Factors And Opportunities
      2. Key Manufacturers
      3. Historic And Forecasted Market Size By Segments
      4. Historic And Forecasted Market Size By Country
         1. China
         2. India
         3. Japan
         4. South Korea
         5. Malaysia
         6. Thailand
         7. Vietnam
         8. The Philippines
         9. Australia
         10. New-Zealand
         11. Rest Of APAC
   6. MIDDLE EAST & AFRICA
      1. Key Market Trends, Growth Factors And Opportunities
      2. Key Manufacturers
      3. Historic And Forecasted Market Size By Segments
      4. Historic And Forecasted Market Size By Country
         1. Turkey
         2. Bahrain
         3. Kuwait
         4. Saudi Arabia
         5. Qatar
         6. UAE
         7. Israel
         8. South Africa
   7. SOUTH AMERICA
      1. Key Market Trends, Growth Factors And Opportunities
      2. Key Manufacturers
      3. Historic And Forecasted Market Size By Segments
      4. Historic And Forecasted Market Size By Country
         1. Brazil
         2. Argentina
         3. Rest of South America
10. INVESTMENT ANALYSIS
11. ANALYST VIEWPOINT AND CONCLUSION
    1. Recommendations and Concluding Analysis
    2. Potential Market Strategies