BIOLOGICS MARKET ANALYSIS

Biologics Market Size and Trends

Global biologics market is estimated to be valued at USD 522.1 Mn in 2024 and is expected to reach USD 1,044.2 Mn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.4% from 2024 to 2031.

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This growth is primarily driven by the increasing demand for monoclonal antibodies and recombinant proteins, which are crucial in the treatment of chronic diseases such as cancer, diabetes, and cardiovascular diseases. As the prevalence of these diseases continues to rise globally, the need for advanced biologic therapies that offer more targeted and effective treatment options becomes even more critical. Additionally, significant investments by leading pharmaceutical and biotechnology companies in R&D, particularly in the development of biosimilars and personalized biologics, are driving the market expansion.

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Insights By Product - Rising prevalence of chronic diseases boosts demand for monoclonal antibodies

In terms of product, the monoclonal antibodies segment is estimated to contribute the highest market share of 32.1% in 2024, owing to the increasing prevalence of chronic diseases globally. Monoclonal antibodies have revolutionized the treatment of various conditions such as cancer, autoimmune disorders, infectious diseases, and others. Their high specificity allows them to precisely target molecular abnormalities, driving disease processes. The capability of monoclonal antibodies to modulate immune responses makes them very effective for conditions where traditional small molecule drugs have limitations.

Insights By Drug Classification - Branded drugs dominate due to intensive marketing and clinical research

In terms of drug classification, the branded drugs segment is estimated to contribute the highest market share of 52.1% in 2024, owing to strong marketing by pharmaceutical companies and extensive clinical evidence for branded products. Large pharmaceutical corporations invest heavily in promotional campaigns and branding activities to generate greater awareness about their products among physicians and patients. Clinicians tend to have more confidence in prescribing branded drugs due to availability of data from extensive clinical trials detailing their safety, efficacy and dosing.

Insights By Route of Administration - Oral route gains traction due to convenience and adherence benefits

In terms of route of administration, the oral segment is estimated to contribute the highest market share of 38.1% in 2024, owing to the major benefits it offers over parenteral drugs especially for chronic conditions. The oral route provides unmatched convenience as pills can be self-administered at home without any medical supervision or health staff involvement. This improves treatment accessibility. Oral drugs face less stigmatization compared to injections making them socially discreet. Their self-administrable nature increases adherence to medication schedules.

Regional Insights

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Dominating Region - North America

North America dominates the biologics industry with an estimated market share of 36.2% in 2024, due to strong presence of global pharmaceutical players like AbbVie Inc. and a well-established healthcare infrastructure. Major markets like the U.S. have fostered innovations in biologics through favourable research policies like the 21st Century Cures Act and financial support for R&D activities.

Fastest-Growing Region - Asia Pacific

Asia Pacific region exhibits the fastest growth due to rising healthcare expenditures, growing disease burden, and increasing focus on ensuring access to advanced treatment options. Counties like China and India are emerging as global biopharma hubs leveraging their large generics manufacturing base and a skilled workforce.

Biologics Market Outlook for Key Countries

U.S. FDA Approvals Boost Biologics Industry Growth

The U.S. dominates the biologics market due to increasing adoption of biologic drugs in oncology and immunology. The approval of breakthrough therapies such as gene therapies and monoclonal antibodies propels market growth. In July 2023, the U.S. FDA approved Eli Lilly and Company's antibody for Alzheimer's treatment, marking a major milestone in biologics.

Local Biosimilars Gain Traction in the Biologics Industry in China

The China biologics market is growing rapidly, driven by substantial investments in biopharmaceutical research and development, as well as production. A key trend is the rising shift toward domestic biologic manufacturing. In June 2023, the National Medical Products Administration (NMPA) approved several biosimilars developed locally, representing a major milestone in the country’s biologics industry.

Advanced Therapies Like CAR T-Cell Therapy Drive Demand in Japan

Japan is witnessing rapid growth in biologics, particularly in immune-oncology treatments. The Japanese government’s commitment to promoting advanced therapies, including CAR T-cell therapies, can drive the market growth. In March 2023, Japan’s Ministry of Health approved the first gene-editing biologic for cancer treatment.

Biotech Startups Thrive with Government Backing in India

India is rapidly emerging as a key player in biologics due to its growing biomanufacturing capabilities and cost-effective biosimilars. The Indian government’s support through its Biotechnology Industry Research Assistance Council (BIRAC) is accelerating market growth. In May 2023, India’s BIRAC announced funding for biotech startups focused on biologics.

Market Concentration and Competitive Landscape

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Dominating Region - North America

North America dominates the biologics industry with an estimated market share of 36.2% in 2024, due to strong presence of global pharmaceutical players like AbbVie Inc. and a well-established healthcare infrastructure. Major markets like the U.S. have fostered innovations in biologics through favourable research policies like the 21st Century Cures Act and financial support for R&D activities.

Fastest-Growing Region - Asia Pacific

Asia Pacific region exhibits the fastest growth due to rising healthcare expenditures, growing disease burden, and increasing focus on ensuring access to advanced treatment options. Counties like China and India are emerging as global biopharma hubs leveraging their large generics manufacturing base and a skilled workforce.

Biologics Market Outlook for Key Countries

U.S. FDA Approvals Boost Biologics Industry Growth

The U.S. dominates the biologics market due to increasing adoption of biologic drugs in oncology and immunology. The approval of breakthrough therapies such as gene therapies and monoclonal antibodies propels market growth. In July 2023, the U.S. FDA approved Eli Lilly and Company's antibody for Alzheimer's treatment, marking a major milestone in biologics.

Local Biosimilars Gain Traction in the Biologics Industry in China

The China biologics market is growing rapidly, driven by substantial investments in biopharmaceutical research and development, as well as production. A key trend is the rising shift toward domestic biologic manufacturing. In June 2023, the National Medical Products Administration (NMPA) approved several biosimilars developed locally, representing a major milestone in the country’s biologics industry.

Advanced Therapies Like CAR T-Cell Therapy Drive Demand in Japan

Japan is witnessing rapid growth in biologics, particularly in immune-oncology treatments. The Japanese government’s commitment to promoting advanced therapies, including CAR T-cell therapies, can drive the market growth. In March 2023, Japan’s Ministry of Health approved the first gene-editing biologic for cancer treatment.

Biotech Startups Thrive with Government Backing in India

India is rapidly emerging as a key player in biologics due to its growing biomanufacturing capabilities and cost-effective biosimilars. The Indian government’s support through its Biotechnology Industry Research Assistance Council (BIRAC) is accelerating market growth. In May 2023, India’s BIRAC announced funding for biotech startups focused on biologics.

Biologics Industry News

• On December 1, 2024, Biocon Biologics Ltd., a global biopharmaceutical company specializing in biosimilars, announced that the U.S. Food and Drug Administration (FDA) had approved YESINTEK (ustekinumab-kfce), a biosimilar to Janssen's Stelara (ustekinumab). YESINTEK is indicated for the treatment of several autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This approval marks a significant advancement in providing more accessible treatment options for patients with chronic autoimmune diseases.
• In July 2024, Lonza Group, a Swiss multinational chemicals and biotechnology company, reported a smaller-than-expected decline in first-half profits, attributed to strong performance in its Biologics unit, despite challenges in other segments
• In May 2024, Biogen Inc., a leading biotechnology company specializing in neurological treatments, announced the acquisition of Human Immunology Biosciences for US$ 1.15 billion upfront, with up to US$ 650 million in potential milestone payments. This move aims to strengthen Biogen's immunology portfolio.
• In May 2024, Genmab, a biotechnology company specializing in antibody therapeutics for cancer, acquired ProfoundBio, a U.S.-Chinese drugmaker, for US$ 1.8 billion. This acquisition aims to bolster Genmab's position in the biologics market.

Key Takeaways from Analyst

• Global biologics market growth is driven by rising prevalence of chronic diseases worldwide and growing demand for effective therapeutics. Biologics have proven to be a game changer in treatment of diseases like cancer, autoimmune disorders, and infectious diseases. Development of advanced biologic therapies with targeted action also aid the market expansion.
• North America currently dominates the biologics landscape and is expected to continue its leadership position. However, Asia Pacific is likely to emerge as the fastest growing region due to rising healthcare expenditure, increasing disposable incomes, and growing focus of global players on emerging countries in the region.
• High costs of developing and manufacturing biologics remains a major challenge for widespread adoption. Complexity of biological systems and products also adds to the financial risk. Manufacturers face substantial pressure to lower prices which may restrict future product development.
• Biosimilars are expected to open new avenues by providing near similar efficacy at lower costs. However, perceived risk of immunogenicity and substitutability by physicians and patients may dampen their acceptance initially. Strong pipeline and upcoming patent expiries of major biologics will offer lucrative opportunities for biosimilar makers.

Market Report Scope

Market Dynamics

Market Driver- Increasing prevalence of chronic diseases such as cancer and autoimmune disorders

Increasing prevalence of chronic diseases like cancer and autoimmune disorders has contributed to the global biologics market growth. Incidence and prevalence of cancers have been steadily rising worldwide. According to a WHO report, in September 2023, non-communicable diseases (NCDs) account for 74% of global deaths (41 million annually), with 17 million premature deaths occurring before age 70, predominantly in low- and middle-income countries (86%). Cardiovascular diseases (17.9 million), cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million) collectively cause over 80% of premature NCD deaths.

Market Challenge- High costs associated with biologics development and manufacturing

Key challenges faced by global biologics market includes high costs associated with biologics development and manufacturing. Developing a new biologic typically costs over US$ 2.6 billion and takes close to 10-12 years of extensive research and clinical testing. This is significantly more expensive than developing a traditional small molecule drug. Manufacturing of biologics is a complex process that requires sophisticated infrastructure and stringent regulatory standards. Biomanufacturing relies on living systems like cell culture which can be susceptible to contamination.

Market Opportunity - Expansion of biosimilars and their acceptance in various markets

Major opportunity for the global biologics market includes expansion of biosimilars and their acceptance in various markets. Biosimilars are biologic medical products that are similar to an already approved biological reference product. These offer cost savings of up to 30% compared to originator biologics which have lost patent exclusivity. Many developed regions like the European Union, the U.S., and Japan have established biosimilar pathways and regulations in last decade.

Key Stakeholders of Market

What does growth in the global biologics market mean for different stakeholders?

Global biologics market has multiple players with varied designations and offers multiple opportunities based on their scope of operations.

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Market Segmentation

• By Product Insights (Revenue, USD Mn, 2019 - 2031)
• • Monoclonal Antibodies
  • Vaccines
  • Recombinant Hormones/Proteins
  • Cellular-based Biologics
  • Gene-based Biologics
  • Others
• By Drug Classification Insights (Revenue, USD Mn, 2019 - 2031)
• • Branded Drugs
  • Generic Drugs
• By Route of Administration Insights (Revenue, USD Mn, 2019 - 2031)
• • Oral
  • Parenteral
  • Other Routes
• By Mode of Purchase Insights (Revenue, USD Mn, 2019 - 2031)
• • Prescription-Based Drugs
  • Over-The-Counter Drugs
• By Distribution Channel Insights (Revenue, USD Mn, 2019 - 2031)
• • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Regional Insights (Revenue, USD Mn, 2019 - 2031)
• • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
• • F. Hoffmann-La Roche Ltd.
  • AbbVie Inc.
  • Amgen Inc.
  • Johnson & Johnson Services, Inc.
  • Merck & Co., Inc.
  • Pfizer Inc.
  • Sanofi S.A.
  • Gilead Sciences, Inc.
  • Novartis AG
  • Bristol-Myers Squibb Company
  • Regeneron Pharmaceuticals, Inc.
  • Takeda Pharmaceutical Company Limited
  • Biogen Inc.
  • Eli Lilly and Company
  • Celltrion Healthcare Co., Ltd.