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Global Biological Drugs Market to Reach US$634.4 Billion by 2030

The global market for Biological Drugs estimated at US$376.3 Billion in the year 2024, is expected to reach US$634.4 Billion by 2030, growing at a CAGR of 9.1% over the analysis period 2024-2030. Therapeutic Protein, one of the segments analyzed in the report, is expected to record a 10.3% CAGR and reach US$289.1 Billion by the end of the analysis period. Growth in the Monoclonal Antibody segment is estimated at 8.3% CAGR over the analysis period.

The U.S. Market is Estimated at US$106.1 Billion While China is Forecast to Grow at 8.4% CAGR

The Biological Drugs market in the U.S. is estimated at US$106.1 Billion in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$96.2 Billion by the year 2030 trailing a CAGR of 8.4% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 8.4% and 7.2% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 7.3% CAGR.

Global Biological Drugs Market - Key Trends & Drivers Summarized

What Sets Biological Drugs Apart from Traditional Pharmaceuticals?

Biological drugs, or biologics, represent a distinct class of therapies derived from living organisms, including cells, tissues, or recombinant DNA technology. Unlike conventional pharmaceuticals, which are chemically synthesized, biologics are large, complex molecules that target specific disease mechanisms at a cellular or molecular level. These drugs have transformed the treatment of chronic conditions such as cancer, autoimmune diseases, and diabetes by offering highly targeted, effective therapies. Biologics are also at the forefront of precision medicine, enabling treatments to be tailored to an individual’s genetic makeup, which enhances therapeutic outcomes and reduces side effects.

How Is the R&D Pipeline Shaping the Future of Biological Drugs?

The biological drugs market is witnessing significant innovation, particularly in monoclonal antibodies, gene therapies, and therapeutic proteins. New biologics are being developed to address unmet medical needs, especially in areas like oncology, neurology, and rare genetic disorders. Advances in biotechnology, including CRISPR and CAR-T therapies, are allowing for the development of personalized biologics that can modify disease pathways or even repair defective genes. The growing number of biologics in the development pipeline, coupled with advances in manufacturing techniques like continuous bioprocessing, is making it easier to produce biologics at scale, which will be key to meeting global healthcare needs in the future.

How Is the Adoption of Biological Drugs Impacting Healthcare Systems?

As biologics become more prevalent in treating chronic and life-threatening diseases, they are reshaping healthcare delivery systems. However, their high cost has led to challenges in terms of affordability and accessibility, particularly in developing markets. To address this, biosimilars—essentially, cheaper, highly similar versions of biologic drugs—are gaining traction. The introduction of biosimilars is expected to reduce the overall healthcare burden and make these life-saving treatments more accessible to a broader population. Regulatory frameworks are evolving to facilitate the approval and market entry of biosimilars, which could significantly influence pricing dynamics and competition in the biological drugs market.

What Role Does Regulatory Approval Play in the Expansion of Biological Drugs?

The regulatory landscape for biological drugs is a critical factor in market growth. Stringent approval processes ensure that biologics meet the highest safety and efficacy standards, which can be a lengthy and expensive endeavor for drug manufacturers. However, as regulatory bodies such as the U.S. FDA and European Medicines Agency (EMA) streamline pathways for both biologics and biosimilars, the pace of approvals has increased, particularly for drugs targeting rare diseases and unmet medical needs. Favorable regulations and accelerated approval processes for orphan drugs and breakthrough therapies are helping to bring innovative biologics to market more quickly, contributing to the overall expansion of this sector.

The growth in the biological drugs market is driven by several factors, including the increasing prevalence of chronic diseases, the rise of precision medicine, and advancements in biotechnological research. The growing demand for personalized therapies that offer more effective treatment with fewer side effects is a major driver. Additionally, the approval of novel biologics for rare and complex conditions, along with favorable government policies supporting biologics R&D, is boosting market expansion. The rise of biosimilars is also playing a critical role, as they are poised to increase market accessibility and reduce treatment costs, thereby further driving growth in the biologics segment.

SCOPE OF STUDY:

The report analyzes the Biological Drugs market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:

Product Type (Therapeutic Protein, Monoclonal Antibody, Vaccine)

Geographic Regions/Countries:

World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 46 Featured) -

• Abbott Laboratories
• Amgen, Inc.
• Baxter International, Inc.
• Biogen, Inc.
• Bristol-Myers Squibb Company
• Eli Lilly and Company
• GlaxoSmithKline PLC
• Merck & Co., Inc.
• Novartis AG
• Pfizer, Inc.

TABLE OF CONTENTS

I. METHODOLOGY

II. EXECUTIVE SUMMARY

• 1. MARKET OVERVIEW
  • Influencer Market Insights
  • World Market Trajectories
  • Impact of Covid-19 and a Looming Global Recession
  • Biological Drugs - Global Key Competitors Percentage Market Share in 2025 (E)
  • Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)
• 2. FOCUS ON SELECT PLAYERS
• 3. MARKET TRENDS & DRIVERS
  • Rising Prevalence of Chronic Diseases Driving Demand for Biological Drugs
  • Advancements in Biotechnological Research and Drug Development
  • Growing Adoption of Biologics in Oncology and Autoimmune Disease Treatments
  • Increased Focus on Personalized Medicine and Targeted Therapies
  • Regulatory Support for Biosimilars Expanding Access to Biological Drugs
  • Technological Innovations in Bioprocessing Improving Drug Production
  • Rising Investments in R&D by Biopharma Companies
  • Impact of Expiring Patents on Biologics and Growth of Biosimilars
  • Global Expansion of Healthcare Infrastructure Supporting Market Growth
• 4. GLOBAL MARKET PERSPECTIVE
  • TABLE 1: World Biological Drugs Market Analysis of Annual Sales in US$ Million for Years 2015 through 2030
  • TABLE 2: World Recent Past, Current & Future Analysis for Biological Drugs by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 3: World Historic Review for Biological Drugs by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 4: World 15-Year Perspective for Biological Drugs by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets for Years 2015, 2025 & 2030
  • TABLE 5: World Recent Past, Current & Future Analysis for Therapeutic Protein by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 6: World Historic Review for Therapeutic Protein by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 7: World 15-Year Perspective for Therapeutic Protein by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2015, 2025 & 2030
  • TABLE 8: World Recent Past, Current & Future Analysis for Monoclonal Antibody by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 9: World Historic Review for Monoclonal Antibody by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 10: World 15-Year Perspective for Monoclonal Antibody by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2015, 2025 & 2030
  • TABLE 11: World Recent Past, Current & Future Analysis for Vaccine by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 12: World Historic Review for Vaccine by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 13: World 15-Year Perspective for Vaccine by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific and Rest of World for Years 2015, 2025 & 2030

III. MARKET ANALYSIS

• UNITED STATES
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United States for 2025 (E)
  • TABLE 14: USA Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 15: USA Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 16: USA 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• CANADA
  • TABLE 17: Canada Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 18: Canada Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 19: Canada 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• JAPAN
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Japan for 2025 (E)
  • TABLE 20: Japan Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 21: Japan Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 22: Japan 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• CHINA
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in China for 2025 (E)
  • TABLE 23: China Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 24: China Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 25: China 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• EUROPE
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Europe for 2025 (E)
  • TABLE 26: Europe Recent Past, Current & Future Analysis for Biological Drugs by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Million for Years 2024 through 2030 and % CAGR
  • TABLE 27: Europe Historic Review for Biological Drugs by Geographic Region - France, Germany, Italy, UK and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 28: Europe 15-Year Perspective for Biological Drugs by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK and Rest of Europe Markets for Years 2015, 2025 & 2030
  • TABLE 29: Europe Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 30: Europe Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 31: Europe 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• FRANCE
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in France for 2025 (E)
  • TABLE 32: France Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 33: France Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 34: France 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• GERMANY
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Germany for 2025 (E)
  • TABLE 35: Germany Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 36: Germany Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 37: Germany 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• ITALY
  • TABLE 38: Italy Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 39: Italy Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 40: Italy 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• UNITED KINGDOM
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in the United Kingdom for 2025 (E)
  • TABLE 41: UK Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 42: UK Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 43: UK 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• REST OF EUROPE
  • TABLE 44: Rest of Europe Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 45: Rest of Europe Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 46: Rest of Europe 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• ASIA-PACIFIC
  • Biological Drugs Market Presence - Strong/Active/Niche/Trivial - Key Competitors in Asia-Pacific for 2025 (E)
  • TABLE 47: Asia-Pacific Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 48: Asia-Pacific Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 49: Asia-Pacific 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030
• REST OF WORLD
  • TABLE 50: Rest of World Recent Past, Current & Future Analysis for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine - Independent Analysis of Annual Sales in US$ Million for the Years 2024 through 2030 and % CAGR
  • TABLE 51: Rest of World Historic Review for Biological Drugs by Product Type - Therapeutic Protein, Monoclonal Antibody and Vaccine Markets - Independent Analysis of Annual Sales in US$ Million for Years 2015 through 2023 and % CAGR
  • TABLE 52: Rest of World 15-Year Perspective for Biological Drugs by Product Type - Percentage Breakdown of Value Sales for Therapeutic Protein, Monoclonal Antibody and Vaccine for the Years 2015, 2025 & 2030

IV. COMPETITION