Biologics Market Size To Reach $1,009.37 Billion By 2030

Biologics Market Growth & Trends

The global biologics market size is expected to reach USD 1,009.37 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 10.3% from 2023 to 2030. Increasing burden of cancer, neurological diseases, genetic diseases and autoimmune diseases and approval of novel biologic drugs such as gene therapy, RNAi therapeutics, and antibody-drug conjugates are a few factors driving the biologics market.

As of 2022, there were already 27 cell and gene therapy drugs approved in the U.S., with five of them receiving approval that year. Sarepta’s gene therapy SRP-9001, which is currently in phase 3 trials for the treatment of duchenne muscular dystrophy has a PDUFA date set for May 29, 2023. Other potential gene therapy candidates in the pipeline include Krystal Biotech’s Beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa; UniQure’s AMT-130 for Huntington disease; Intellia’s NTLA-2001 and NTLA-2002 for transthyretin (ATTR) amyloidosis; Nanoscope’s MCO-010 and Pfizer’s Fidanacogene elaparvovec for hemophilia B. The approval and subsequent commercialization of these gene therapy candidates are expected to drive growth in the biologics market.

Monoclonal antibodies account for the largest number of biologics approved. While the approval of traditional monoclonal antibodies has slowed down, next-generation antibodies such a bispecific-monoclonal antibodies, antibody fragments, radio-immunotherapies, nanobodies, and antibody-drug conjugates is driving the growth of this segment. For instance, in September 2021, the U.S. FDA approved Seagen’s Tivdak a new antibody-drug conjugate for the treatment of cervical cancer.

The biologics market faces significant challenges, primarily related to the high costs associated with their development and production. Biologics are complicated compounds that necessitate specialized production procedures, and the development cost might be prohibitively expensive. Furthermore, increasing competition from biosimilars is also a key restraining factor for the market. In 2021, Europe approved seven new biosimilars, a slight decrease from the nine approved in 2020. It is anticipated that during the forecast years oncology, endocrine and blood related disorders are the key therapies areas in which biologic drugs will face patent expiry.

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Biologics Market Report Highlights

• Based on source, the mammalian expression systems segment is expected to grow at the fastest CAGR during the forecast period. The microbial expression system dominated the market in 2022

• Based on disease category, the oncology segment dominated the biologics market in 2022 with a share of 28.40%. Most of monoclonal antibodies and other biologic drugs have been approved for cancer indication

• The haemotological diseases segment is expected to expand at the fastest CAGR during the forecast period, owing to the approval of gene therapy candidates for hemophilia

• Based on product, the monoclonal antibodies segment dominated the market with a share of 66.42% in 2022

• North America was the largest revenue generating region in the biologics market in 2022. The availability of favorable reimbursement policies of high-cost biologics, presence of major players and high investment in R&D are some of the key factors for the regions dominance

Biologics Market Segmentation

Grand View Research has segmented the global biologics market on the basis of source, product, disease category, manufacturing, and region.

Biologics Source Outlook (Revenue, USD Billion, 2018 - 2030)

• Microbial

• Mammalian

• Others

Biologics Product Outlook (Revenue, USD Billion, 2018 - 2030)

• Monoclonal Antibodies 

  • MABs by Application

    • Diagnostic

      • Biochemical Analysis

      • Diagnostic Imaging

    • Therapeutic

      • Direct MAB Agents

      • Targeting MAB Agents

    • Protein Purification

    • Others

  • MABs by Type

    • Murine

    • Chimeric

    • Humanized

    • Human

    • Others

• Vaccines

• Recombinant Proteins

• Antisense & RNAi Therapeutics

• Others

Biologics Disease Category Outlook (Revenue, USD Billion, 2018 - 2030)

• Oncology

  • By Product

    • MABs

    • Vaccines

    • Recombinant Proteins

    • Antisense & RNAi Therapeutics

    • Others (Certain products under trials related to blood products etc)

• Infectious Diseases

• By Product

  • Vaccines

  • MABs

  • Antisense & RNAi Therapeutics

  • Recombinant Proteins

  • Others

• Immunological Disorders

• Cardiovascular Disorders

• Hematological Disorders

• Others

Biologics Manufacturing Outlook (Revenue, USD Billion, 2018 - 2030)

• Outsourced

• In-house

Biologics Regional Outlook (Revenue, USD Billion, 2018 - 2030)

• North America

  • U.S.

  • Canada

• Europe

  • Germany

  • U.K.

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East and Africa (MEA)

  • South Africa

  • Saudi Arabia

  • UAE

  • Kuwait

List of Key Players in the Biologics Market

• Samsung Biologics

• Amgen Inc.

• Novo Nordisk A/S

• AbbVie Inc.

• Sanofi

• Johnson & Johnson Services, Inc.

• Celltrion Healthcare Co.,Ltd.

• Bristol-Myers Squibb Company

• Eli Lilly and Company

• F. Hoffmann La-Roche Ltd.