Biologics Market is expected to reach US$ 1,793.9 Billion by 2031

Outsourced Manufacturing Segment to Lead Biologics Market During 2023–2031

According to our new research study on “Biologics Market Forecast to 2031 – COVID-19 Impact and Global Analysis – by Product, Application, Source, Manufacturing, and Geography,” the market size is expected to grow from US$ 469.2 billion in 2023 to US$ 1,793.9 billion by 2031; it is projected to register a CAGR of 18.2% during 2023–2031. The biologics market growth is attributed to the increasing prevalence of chronic diseases and the preference for outsourcing manufacturing operations. The evolution of the biotechnology industry in developing regions is likely to offer opportunities for market growth. However, the high cost of biologics hinders the market growth.

Biologics are medicinal compounds derived from biological sources, including human blood and plasma; they may include carbohydrates, proteins, nucleic acids, and complicated mixtures of these elements. The biologics sector is driven by ongoing research activities for developing disease-modifying treatments with the use of monoclonal antibodies. Novel products that include RNAi treatments, gene therapy, and mRNA-based vaccinations have been successfully marketed in recent years. Furthermore, rising demand and acceptance of innovative therapies, and the increasing number of clinical trials are expected to benefit the biologics market. However, stringent approval guidelines for biosimilars are among the main challenges limiting the biologics market growth. The biologics market report emphasizes key factors impacting the market and showcases the developments of prominent players.

Biologics Market, by Region, 2023 (%)

Source: The Insight Partners Analysis

Based on product, the biologics market is segmented into monoclonal antibodies, vaccines, recombinant hormones/proteins, cell and gene therapies, and others. The monoclonal antibodies segment held the largest biologics market share in 2023; it is estimated to register the highest CAGR during 2023–2031. Monoclonal antibody biologics have reformed the field of therapeutics and enhanced the quality of life of patients suffering from inflammatory diseases, autoimmune conditions, and other diseases. Monoclonal antibodies are significantly larger than other protein biologics, including insulin and growth factors, and their manufacturing process is also complicated. A pair of Fab (i.e., fragment antigen binding) arms and Fc (i.e., fragment crystallization) domain are the functional domains of a monoclonal antibody. Fab arms facilitate the binding of antibodies with antigens, and the Fc domain is responsible for interactions with the immune system. Monoclonal antibodies are biologics designed to copy the natural antibodies produced by the body, and their potency depends on the strength of their binding, composition of epitopes where antibodies bind, and activity of the Fc domain. Monoclonal antibody biologics are more successful at treating certain types of cancer, along with other specific diseases. They facilitate a more precise treatment than the conventional approaches.

Based on manufacturing, the market is bifurcated into outsourced and in-house. The outsourced segment held a larger biologics market share in 2023 and is estimated to register a higher CAGR during 2023–2031. Biologics outsourcing businesses are growing continuously owing to the rising demand for biologics. According to an article published in Pharma’s Almanac 2024, there are many other factors responsible for the growth of outsourcing, in addition to the growing demand for biologics. For instance, it takes 5–10 years on average to build a new biopharmaceutical manufacturing facility before it is put into operation, and the overall project may cost up to US$ 2 billion, which can be burdensome for small-to-mid-sized organizations. Companies having their own manufacturing capabilities tend to adopt the outsourcing approach for biologics production to benefit from the knowledge and experience of contract manufacturing and development organizations (CDMOs).

Strategic Initiatives by Companies to Bring New Trends in Market in Coming Years

Companies operating in the biologics market focus on strategic developments such as expansions, partnerships, agreements, collaborations, and new product launches, which help them improve their sales, expand their geographic reach, and enhance their capacities to cater to a larger than existing customer base. A few of the noteworthy developments in the biologics market are mentioned below.

• In March 2024, Selvita SA expanded its services portfolio with the addition of comprehensive therapeutic antibody discovery and development capabilities to enter into the field of biologics discovery and development.
• In March 2024, Bristol Myers Squibb received approval from the US FDA for Breyanzi, the first and only CAR-T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• In February 2024, Takeda and Biological E. Limited (BE) entered into a strategic partnership to enhance access to QDENGA multidose vials (MDVs).
• In December 2023, Merck received approval from the US FDA for a new Biologics License Application (BLA) for V116, its 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal diseases in adults.
• In October 2023, American Type Culture Collection (ATCC) and US Pharmacopeia launched their first joint products to improve quality control and decrease risk associated with the manufacturing of vaccines and biological therapies.
• In March 2023, Sandoz signed a memorandum of understanding (MoU) to build a new biologics production plant in Lendava, Slovenia. The company had plans to invest at least US$ 400 million in this project, which is one of the most significant international private-sector investments in Slovenia.

Thus, product approvals, product launches, and expansion strategies are likely to bring new biologics market trends in the coming years.

Key players identified and evaluated while performing biologics market analysis are AbbVie Inc.; Pfizer Inc.; Samsung Biologics; ADMA Biologics, Inc.; WuXi Biologics; Catalent, Inc; AGC Biologics; AstraZeneca; Amgen Inc.; Avecia Biologics; and Quality Assistance s.a.

The biologics market, by product, is segmented into monoclonal antibodies, vaccines, recombinant hormones/proteins, cell and gene therapy, and others. Based on application, the market is categorized into cancer, infectious diseases, autoimmune diseases, and others. In terms of source, the market is bifurcated into mammalian and microbial. By manufacturing, the market is divided into outsourced and in-house.

The geographic scope of the biologics market report encompasses North America (US, Canada, and Mexico), Europe (France, Germany, UK, Spain, Italy, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (Saudi Arabia, UAE, South Africa, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America). North America held the largest share of the market in 2023. The biologics market size in North America is expected to register a CAGR of 18.4% during 2023–2031. The market in Asia Pacific is expected to record the highest CAGR during the forecast period. The rapid market growth in this region is ascribed to population aging, particularly in countries such as Japan and China, leading to an upsurge in the prevalence of chronic diseases. The biopharmaceutical industry in China is undergoing a tremendous shift, evolving from a generics-focused landscape to a thriving innovation hub. Further, the growing number of market players focusing on countries in Asia Pacific for their geographic expansion and other growth strategies, the rising count of research centers, and a notable increase in government funding fuel the biologics market in Asia Pacific.

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