Non-Oncology Biologics and Biosimilars Market Size, Share & Trends Analysis Report By Drug Category (Monoclonal Antibody, Toxins, Fusion Proteins, Insulin, Hormones, Gene Therapy, and Others), By Application Type, By Product Type, By Region, And By Segment Forecasts, 2025-2034

Global Non-Oncology Biologics and Biosimilars Market Size is predicted to witness a 22.0% CAGR during the forecast period for 2025-2034.

Key Industry Insights & Findings from the Report:

• Advances in biotechnology enable the development of new biological drugs with improved efficacy, safety, and patient outcomes.
• Increasing incidences of autoimmune diseases like rheumatoid arthritis, psoriasis, and multiple sclerosis drive the demand for biologics and biosimilars that offer effective treatment options.
• North America dominated the market and accounted for a global revenue share in 2024.
• The production process for biologics is complex and costly, requiring sophisticated technology, stringent quality control, and specialized facilities.

Biologics used to treat illnesses other than cancer are known as non-oncology biologics. These medicines are either directly or indirectly derived from living organisms. For inflammatory, infectious, and autoimmune diseases, various biological products are available, such as vaccinations and therapeutic proteins. The term "biosimilar" refers to a class of biologic treatments extremely similar to an already-approved biological product. Their goal is to lower healthcare costs and increase accessibility for patients. Biologics and biosimilars outside of cancer majorly influence contemporary healthcare because they treat a wide range of illnesses and ailments effectively. In contrast, biosimilars provide more affordable alternatives to essential medications, which helps to expand access to these treatments. Furthermore, the increasing number of research and development initiatives aimed at new indications and the upcoming biologic patent expiration. The pout of various formulas and ultimate revenue is funding these research endeavours.

However, the market growth is hampered by the strict regulatory and lack of awareness criteria for the safety and health of non-oncology biologics and biosimilars market and the product's inability to prevent fog in environments with dramatic temperature fluctuations or high humidity non-oncology biologics and biosimilars, Biosimilars and non-oncology biologics have a lengthy and complicated regulatory approval process due to the large amounts of clinical data needed to prove their efficacy and similarity.

Complex manufacturing procedures produce biologics and biosimilars not used in oncology. These processes are only sometimes easy to replicate exactly, which can cause variances in product consistency and quality. One challenge for manufacturers in this sector is maintaining consistent quality. Businesses across all industries felt the effects of the global COVID-19 pandemic and consequent lockdown on their bottom lines. The private healthcare sector was one area where the pandemic made a big splash. The coronavirus pandemic profoundly affected global healthcare corporations' operations, including research and development, manufacturing, and delivery of medicines. Industrial enterprises, except those that produce essential goods, have been shuttered due to the outbreak. Additionally, product supply lines have been disrupted.

Competitive Landscape

Some Major Key Players In The Non-Oncology Biologics and Biosimilars Market:

• Accord Healthcare S.L.U.
• Alvotech
• Amgen
• AYUMI Pharmaceutica
• Biocon
• Biogen
• Biosimilar Collaborations Ireland Limited
• Boeheringer Ingelheim
• Celltrion
• Cipla
• Coherus Biosciences
• Cordavis Ltd.
• Epirus Biopharmaceuticals
• Formycon AG
• Fresenius Kabi
• Glenmark Pharmaceuticals
• Hanwha Chemical
• Hetero
• Innovent Biologics
• Kyowa Hakko Kirin (Fujifilm Kyowa Kirin Biologics)
• LG Chem
• Lupin
• Mabpharm
• Merck
• Midas Pharma GmbH
• Mylan
• Nichi-Iko Pharmaceutical
• Organon & Co.
• Pfizer
• Qilu Pharma Spain S.L.
• Ranbaxy Laboratories (now Sun Pharma)
• Samsung Bioepis
• Sandoz
• Shanghai CP Guojian Pharmaceutical
• Sorrento Therapeutics (partner)
• STADA Arzneimittel AG
• Sunshine Guojian Pharmaceutical
• Synermore
• Teva
• Torrent Pharmaceuticals
• YL Biologics
• Zydus Cadila
• Other prominent players

Market Segmentation:

The global Non-Ooncology Biologics and Biosimilars Market is segmented based on drug category, application type, and product type. Based on the drug category, the market is segmented into monoclonal antibody, toxins, fusion proteins, insulin, hormones, gene therapy, and cell therapy. By application type, the market is segmented into dermatology, endocrinology, neurology, immunology, respiratory, rheumatology, ophthalmology, and others. By product type, the market is segmented into biologics and biosimilars.

Based On The Product Type, The Biologics Segment Is Accounted As A Major Contributor To The Global Non-Oncology Biologics And Biosimilars Market.

The biologics non-oncology biologics and biosimilars market is expected to lead with a major market share in 2022. Biologics can target specific disease pathways and provide tailored therapy procedures, allowing them to provide potent and specialized therapies for various ailments. The segment's commercial dominance can be attributed to its broad acceptability.

In The Region, The North American Global Non-Oncology Biologics And Biosimilars Market Holds A Significant Revenue Share.

The North American global non-oncology biologics and biosimilars market is expected to record the maximum market share in revenue in the near future. It can be attributed to the high incidence of chronic diseases, and the regulatory framework favours biosimilar approval. Biosimilars and non-oncology biologics are in high demand due to many factors, including a large ageing population and supportive reimbursement policies. In addition, Asia Pacific is estimated to grow rapidly in the global non-oncology biologics and biosimilars market because there are a lot of generic manufacturers in this area. The region's healthcare infrastructure development and increasing elderly population are two additional factors that will drive the market's growth rate.

Recent Developments:

• In March 2023, Sandoz, a division of Novartis, has entered into a Memorandum of Understanding to build a new facility in Slovenia for the production of biologics. This action was intended to address the increasing worldwide need for biosimilar medications. The Sandoz investment was anticipated to be a minimum of USD 400 million, bolstering the company's aspiration to propel the future expansion of its worldwide biosimilars portfolio. This investment in Slovenia is one of the greatest ever made by the worldwide private sector.  

Non-Oncology Biologics and Biosimilars Market Report Scope

Segmentation Of Global Non-Oncology Biologics And Biosimilars Market-

Non-Oncology Biologics And Biosimilars Market By Drug Category-

• Monoclonal Antibody
• Toxins
• Fusion Proteins
• Insulin
• Hormones
• Gene Therapy
• Others

Non-Oncology Biologics And Biosimilars Market By Application Type-

• Dermatology
• Endocrinology
• Neurology
• Immunology
• Respiratory
• Rheumatology
• Ophthalmology
• Others

Non-Oncology Biologics And Biosimilars Market By Product Type-

• Biologics
• Biosimilars

Non-Oncology Biologics And Biosimilars Market By Region-

North America-

• The US
• Canada

Europe-

• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific-

• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific

Latin America-

• Brazil
• Argentina
• Mexico
• Rest of Latin America

 Middle East & Africa-

• GCC Countries
• South Africa
• Rest of the Middle East and Africa