The Rise of Monoclonal Antibodies in Biopharmaceuticals - Amity Institute Of Training & Development

Table of Contents

Introduction

Since the approval of muromonab-CD3 (trade name Orthoclone OKT3, marketed by Janssen-Cilag) for the prevention of kidney-transplant rejection in 1986, therapeutic MAbs have grown to become the dominant product class within the biopharmaceutical market.

The rate of approvals and marketing has grown exponentially, and in 2019, global sales revenue for all mAb drugs was nearly US$163 billion (70% of all biopharmaceutical products—about $230 billion), and by this time a total of 139 mAb products were approved in Europe and/or the USA, of which 119 were produced by mammalian cells, with most being full-length naked mAbs (60%), followed by biosimilar full-length naked mAbs (19%), with 36 of these achieving annual sales of over $1 billion, with five products reaching sales of >$7 billion (AbbVie Humira sales of about $19 billion in 2 years).

It is anticipated that 180 or more mAb drugs will be in the global market in 2025. The sale of mAbs grew by 93% in a 5-year time period between 2014 and 2019 ($84 to $163 billion).

Varied applications

Their use varies, from those for orphan indications, hemophagocytic lymphohistiocytosis, some cancers, and multiple sclerosis, or for conditions involving huge pools of patients; asthma and rheumatoid arthritis, and some recent approvals for infectious diseases including Clostridium difficile, anthrax, and human immunodeficiency virus (HIV) infections.

The different types of mAb products also include antibody-related products such as Fc-fusion proteins, antibody fragments, and antibody-drug conjugates. Some typical examples are Merck’s Keytruda (pembrolizumab), Regeneron’s Eylea (aflibercept), Bristol-Myers Squibb’s Opdivo (nivolumab), and Genentech/Roche’s Avastin (bevacizumab).

Global sales of MAb products

MAbs have grown very fast. Corresponding to the increasing sales of mAb products, by 2019, nearly 25 metric tonnes of mAb products were produced globally—as against 11 metric tonnes of all other biologicals. This has resulted in a significant increase in global manufacturing capacity and significantly improved methods and approaches to mAb manufacturing process design and optimisation.

The five-year compound annual growth rate (CAGR) of 14.1% for the MAb product market and a CAGR of 10% or more is projected over the next several years. So sales of currently approved mAb products combined with those of new products approved in the coming years could be $315 billion by 2025.

Factors for very fast growth

With mAb drug approvals rising over time along with the demand for and revenue generated by such products, interest in developing them remains strong. Significant funding availability, ongoing advancements in mAb technologies, expansion of mAb products into new markets, and the emergence of biosimilars all have contributed to nearly all pipeline mAb products, thus driving regulatory approvals and widening the market.

Market leaders in mAbs

GlaxoSmithKline PLC, Novartis AG, Pfizer Inc., Thermo Fisher Scientific Inc., Eli Lilly, Shanghai Junshi Bioscience Co., Ltd., Seattle Genetics, Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd., and Teva Pharmaceutical Industries Ltd. are the current leaders.

Some typical approved and marketed mAbs

S.No	MAb	Indication	Approvals
1	Muromonab	Transplant rejection	FDA/EMEA/PMDA
2	Nebacumab	Sepsis	FDA/EMEA/PMDA
3	Abciximab	Unstable angina	FDA/EMEA/PMDA
4	Edrecolomab	Colorectal cancer	FDA/EMEA/PMDA
5	Daclizumab	Organ transplant	FDA/EMEA/PMDA
6	Rituximab	RA, FL	FDA/EMEA/PMDA
7	Infliximab	Ankylosing Spondylitis	FDA/EMEA/PMDA
8	Trastuzumab	Breast Cancer	FDA/EMEA/PMDA
9	Palivizumab		FDA/EMEA/PMDA
10	Basiliximab	Organ transplant	FDA/EMEA/PMDA
11	Etanercept	Ankylosing spondylitis	FDA/EMEA/PMDA
12	Gemtuzumab	Acute leukemia	FDA/EMEA/PMDA
13	Alemtuzumab	Chronic lymphocytic leukemia	FDA/EMEA/PMDA
14	Adalimumab	Ankylosing spondylitis, RA, PA, Uicerative colitis, Crohn’s disease	FDA/EMEA/PMDA
15	Ibritumomab	Non Hodgkins Lymphoma	FDA/EMEA/PMDA
16	Cetuximab	Colorectal cancer	FDA/EMEA/PMDA
17	Bevacizumab	Breast, cervical, colorectal cancer	FDA/EMEA/PMDA
18	Natalizumab	Crohn’s disease	FDA/EMEA/PMDA
19	Tocilizumab	RA	FDA/EMEA/PMDA
20	Abatacept	PA, RA	FDA/EMEA/PMDA
21	Panitumumab	Colorectal cancer	FDA/EMEA/PMDA
22	derlotuximab	Lung cancer	FDA/EMEA/PMDA
23	Metuximab	Liver cancer	FDA/EMEA/PMDA
24	Nimotuzumab	Brain cancer	FDA/EMEA/PMDA
25	Ranibizumab	Choroidal cancer	FDA/EMEA/PMDA
26	Racotumomab	NSCLC	FDA/EMEA/PMDA
27	Rilonacept	Pericarditis	FDA/EMEA/PMDA
28	Certolizumab	AS	FDA/EMEA/PMDA
29	Romiplostim	Aplastic anemia	FDA/EMEA/PMDA
30	Catumaxomab	Gastric cancer	FDA/EMEA/PMDA
31	Ofatumumab	Multiple schlerosis	FDA/EMEA/PMDA
32	Golimumab	RA, PA, AS	FDA/EMEA/PMDA
33	Denosumab	RA, Bone cancer, Osteoporesis	FDA/EMEA/PMDA
34	Belatacept	Renal Transplant rejection	FDA/EMEA/PMDA
35	Aflibercept	Colorectal cancer	FDA/EMEA/PMDA
36	Ipilimumab	Liver cancer	FDA/EMEA/PMDA
37	Pertuzumab	Breast cancer	FDA/EMEA/PMDA
38	Raxibacumab Serplulimab	Anthrax infection	FDA/EMEA/PMDA
39	Nemolizumab	Atopic dermatitis	FDA/EMEA/PMDA
40	Cadonilimab	Cervical cancer	FDA/EMEA/PMDA
41	Sutimlimab	Autoimmune hemolytic anemia	FDA/EMEA/PMDA
42	Anifrolumab	SLE	FDA/EMEA/PMDA
43	Sotrovimab	SARS	FDA/EMEA/PMDA
44	Aducanumab	AD	FDA/EMEA/PMDA
45	Amivantamab	NSCLC	FDA/EMEA/PMDA

Final Thoughts: The Unstoppable Rise of mAbs in Biopharma

Monoclonal antibodies (MAbs) have undeniably revolutionised modern medicine since their debut in 1986. From preventing organ rejection to treating cancers, autoimmune disorders, and even infectious diseases, mAbs have become the cornerstone of biological therapies. Their journey from a niche innovation to a $163 billion global market powerhouse—capturing 70% of biopharmaceutical sales in 2019—is a testament to their transformative impact on healthcare.

Behind this success lies a dynamic ecosystem. Industry giants like Roche, AbbVie, and Bristol-Myers Squibb, alongside emerging players like Shanghai Junshi Bioscience, have propelled mAbs to blockbuster status. Drugs like Humira ($19 billion in two years) and Avastin underscore their commercial dominance, while advancements in mammalian cell culture and manufacturing optimisation ensure scalable, high-quality production. Looking ahead, the mAb market shows no signs of slowing. With a 14.1% CAGR and expanding applications in oncology, neurology (e.g., Aducanumab for Alzheimer’s), and infectious diseases (e.g., Sotrovimab for COVID-19), mAbs are poised to redefine treatment paradigms. As biosimilars gain traction and technologies like AI-driven drug design accelerate development, these therapies will continue to bridge innovation with accessibility. In essence, mAbs are not just leading biological therapies—they are the vanguard of a healthcare revolution. Their scientific ingenuity, commercial resilience, and life-saving potential ensure they will remain at the forefront of medicine, empowering patients and reshaping global health for decades to come.

mAbs Are Reshaping Biopharma—Stay Ahead of the Curve!

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