Biologics Market Outlook to Exceed USD 855.8 Billion by 2031 at 6.9% CAGR | Analysis by TMR

The global biologics market is set for sustained growth as breakthrough advancements in biotechnology, rising demand for personalized therapies, and the proliferation of biosimilars transform treatment paradigms across oncology, autoimmune disorders, and beyond.
The global biologics market was valued at US$ 515.6 billion in 2022 and is projected to grow at a CAGR of 6.9% from 2023 to 2031, surpassing US$ 855.8 billion by the end of the forecast period.

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Analysts' Viewpoint: Innovations and Biosimilars Propel the Biologics Market
The biologics market is poised for continued momentum as personalized medicine drives the development of targeted therapies tailored to individual patient profiles. Advancements in gene editing and synthetic biology are unlocking new therapeutic opportunities, while the rise of biosimilars offers more affordable treatment options that foster healthy competition. Additionally, the expansion of biologics into emerging areas such as gene therapy and regenerative medicine is expected to further fuel market growth.

Market Introduction: Revolutionizing Therapeutic Approaches
Biologics are complex medicinal products derived from living organisms or their components. Unlike conventional chemical drugs, biologics encompass large molecules such as proteins, nucleic acids, and antibodies produced via biotechnological processes. These therapies have revolutionized the treatment landscape for conditions including cancer, autoimmune disorders, infectious diseases, and genetic abnormalities, and continue to expand into new therapeutic areas.

Key Market Drivers

Strong Pipeline with Accelerated Approval:

A robust pipeline of novel biologic therapies, coupled with expedited regulatory pathways, is significantly reducing development timelines. Major pharmaceutical players, such as Pfizer and others, are advancing an array of biologics across various therapeutic areas. Accelerated approval processes-exemplified by emergency use listings during the COVID-19 pandemic-enable swift market entry for innovative treatments, bolstering market growth.

Extensive Use of Monoclonal Antibodies:

Monoclonal antibodies (mAbs) have emerged as the predominant class within biologics, owing to their high specificity and lower adverse effect profiles. With blockbuster drugs like Keytruda (pembrolizumab) and Humira (adalimumab) leading the market, mAbs continue to address significant unmet needs in oncology and autoimmune disorders. Concurrently, recombinant proteins are gaining traction due to their rapid development timelines and enhanced safety profiles.

In-House Manufacturing and Outsourcing Trends:

Large biopharma companies typically favor in-house manufacturing to maintain control over quality and confidentiality. However, smaller biotech firms are increasingly relying on Contract Development and Manufacturing Organizations (CDMOs) to scale production economically-particularly for innovative therapies such as CAR-T and gene therapies.

Oncology: A Key Therapeutic Frontier

The oncology segment is anticipated to dominate applications during the forecast period. Biologic drugs-ranging from therapeutic vaccines and checkpoint inhibitors to advanced mAbs-are transforming cancer treatment. Top-selling oncology biologics such as Avastin, Rituxan, Herceptin, Opdivo, and Keytruda have not only generated significant revenues but have also markedly improved patient survival rates compared to traditional chemotherapy.

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Regional Outlook: North America Leads, with Promising Growth in Asia Pacific
Leading Region: North America
North America remains at the forefront of biologics innovation, supported by robust R&D infrastructure, significant investments in cutting-edge therapies (e.g., checkpoint inhibitors and CAR-T-cell therapies), and a favorable regulatory landscape.

Asia Pacific and Europe:
Asia Pacific is emerging as a high-growth region, driven by increasing healthcare expenditures, a vast patient pool, and rapid advancements in biotechnology in countries like China, India, and South Korea. Europe, with strong government backing and a mature pharmaceutical market, continues to hold a substantial market share.

Analysis of Key Players
Key industry players are intensifying their focus on research, product innovation, and strategic collaborations. Prominent companies include:

AbbVie

Amgen

AstraZeneca

Bristol-Myers Squibb Company

Eli Lilly

Gilead Sciences, Inc.

GlaxoSmithKline

Johnson & Johnson Services Inc.

Merck & Co., Inc.

Novartis AG

Pfizer Inc.

F. Hoffmann-La Roche AG

These market leaders are profiled based on company overviews, product portfolios, strategic initiatives, and recent developments, underscoring their commitment to expanding biologics pipelines and manufacturing capabilities.

Key Developments

February 2024: AbbVie Inc. entered a multiyear partnership with Tentarix Biotherapeutics to advance conditionally-active, multi-specific biologic candidates in immunology and oncology.

September 2023: Novartis announced a US$ 300 million investment to establish a dedicated scientific environment across facilities in Switzerland, Slovenia, and Austria, aimed at bolstering early-stage biologics development.

August 2021: Amgen signed an acquisition agreement with Teneobio to discover and develop new biologics across multiple therapeutic areas.

Market Segmentation

By Product:

Monoclonal Antibodies, Recombinant Proteins, Vaccines, Cell & Gene Therapy, Others

By Application:

Oncology, Autoimmune & Immunological Disorders, Hematological Disorders, Infectious Diseases, Others (e.g., Cardiovascular Disorders)

By Manufacturing:

Outsourced, In-House

By Regions Covered:

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Countries Covered:

U.S., Canada, Germany, U.K., France, Italy, Spain, China, Japan, India, Australia & New Zealand, Brazil, Mexico, GCC Countries, South Africa

Companies Profiled:

AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly, Gilead Sciences, Inc., GlaxoSmithKline, Johnson & Johnson Services Inc., Merck & Co., Inc., Novartis AG, Pfizer Inc., F. Hoffmann-La Roche AG, and others.

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Frequently Asked Questions

What was the global biologics market value in 2022?
The market was valued at US$ 515.6 billion in 2022.

What is the projected market value by 2031?
The market is expected to exceed US$ 855.8 billion by 2031.

What is the forecast CAGR for the biologics market during the period 2023-2031?
The market is projected to grow at a CAGR of 6.9%.

Which product segment is expected to dominate the biologics market?
Monoclonal antibodies are projected to lead the market, driven by their extensive use in oncology and autoimmune disorders.

Which region is currently the market leader?
North America is the leading region, owing to its advanced healthcare infrastructure and robust R&D investments.

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