At 18.4% CAGR, North America Biologics Market is Projected to be Worth US$ 8,88,880.0 Million by 2031, says Business Market Insights

According to Business Market Insights' research, the North America biologics market was valued at US$ 2,30,256.1 million in 2023 and is expected to reach US$ 8,88,880.0 million by 2031, registering a CAGR of 18.4% from 2023 to 2031. Strategic initiatives by company and gene and cell therapy advancements in biologics are among the critical factors attributed to drive the North America biologics market growth.

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 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 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. This initial set included six products which are highly characterized and pure genomic DNA (gDNA) from cell lines that are used in bioproduction.
• 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 largest international private-sector investments in Slovenia.

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

• Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced that the company signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara, in the United States of America. (Source: Biocon, Press Release, 2023)
• Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd announced that the company completed the integration of the acquired biosimilars business from Viatris in North America (United States and Canada) effective September 1, 2023. (Source: Biocon, Press Release, 2023)
• Biodextris Inc., a subsidiary of Clean Biologics SAS, announced the development of a new industrial-scale vaccine and biologics development, manufacturing, and packaging plant (CDMO). The new facility would support companies in the development and characterization of next-generation biological products and help bridge the gap between research projects and large-scale commercial production. The project amounted to a US$ 25 million investment in indoor layout and state-of-the-art materials and equipment. (Clean Biologics, Press Release, 2023)

On the contrary, the high cost of biologics hampers the growth of North America biologics market.

Based on product, the North America biologics market is segmented into monoclonal antibodies, vaccine, recombinant hormones/proteins, cell and gene therapy, and others. The monoclonal antibodies segment held 36.5% market share in 2023, amassing US$ 84,152.14 million. It is projected to garner US$ 3,41,086.94 million by 2031 to register 19.1% CAGR during 2023-2031.

In terms of application, the North America biologics market is categorized into cancer, infectious diseases, autoimmune diseases, and others. The cancer segment held 42.8% share of North America biologics market in 2023, amassing US$ 98,487.24 million. It is anticipated to garner US$ 3,98,542.60 million by 2031 to expand at 19.0% CAGR during 2023-2031.

By source, the North America biologics market is bifurcated into mammalian and microbial. The mammalian segment held 62.5% share of North America biologics market in 2023, amassing US$ 1,43,892.18 million. It is projected to garner US$ 5,37,810.16 million by 2031 to expand at 17.8% CAGR from 2023 to 2031.

Based on manufacturing, the North America biologics market is bifurcated into outsourced and in-house. The outsourced segment held 76.1% share of North America biologics market in 2023, amassing US$ 1,75,222.79 million. It is predicted to garner US$ 6,89,904.18 million by 2031 to expand at 18.6% CAGR between 2023 and 2031.

Based on country, the North America biologics market is categorized into the US, Canada, and Mexico. Our regional analysis states that the US captured 77.4% share of North America biologics market in 2023. It was assessed at US$ 1,78,126.08 million in 2023 and is likely to hit US$ 7,01,148.53 million by 2031, registering a CAGR of 18.7% during 2023-2031.

Key players operating in the North America biologics market are AbbVie Inc, Pfizer Inc, Samsung Biologics Co Ltd, ADMA Biologics, Inc., Wuxi Biologics Inc, Catalent Inc, AGC Biologics AS, AstraZeneca Plc, Amgen Inc, Nitto Avecia, and Quality Assistance s.a., among others.

• In July 2023, India's Biocon Biologics launched a biosimilar version of AbbVie's, opens new tab blockbuster rheumatoid arthritis drug Humira in the United States. The launch of the copycat version, branded as Hulio, adds to a list of biosimilars introduced by drugmakers on Monday by Coherus Biosciences (CHRS.O), opens new tab and Germany's Fresenius, opens new tab.
• In April 2024, Pfizer Inc. received U.S. Food and Drug Administration (FDA) approval for BEQVEZ(fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test.
  
  

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