Biologics Global Market Report 2021: COVID-19 Impact and Recovery to 2030

Major companies in the biologics market include Johnson & Johnson; F. Hoffmann-La Roche Ltd.; Bristol-Myers Squibb; GlaxoSmithKline Plc. and AbbVie.

The global biologics market is expected to grow from $253.41 billion in 2020 to $268.51 billion in 2021 at a compound annual growth rate (CAGR) of 6%. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $420.55 billion in 2025 at a CAGR of 12%.

The biologics market consists of sales of biologics and related services by entities (organizations, sole traders and partnerships) that produce biologics to treat and prevent various microbial diseases and cancers. Biological products include a wide range of products such as vaccines, allergenics, somatic cells, tissues, and recombinant therapeutic proteins. This industry includes establishments that produce products that are composed of sugars, proteins, nucleic acids, and combination of all these substances isolated from humans, animal and microorganisms or produced from biotechnology methods. Specifically, most biologic medicines are developed using recombinant DNA (rDNA) technology. The biologics market is segmented into monoclonal antibodies (mabs); therapeutic proteins; and vaccines.

North America was the largest region in the global biologics market, accounting for 53% of the market in 2020. Asia Pacific was the second largest region accounting for 21% of the global biologics market. Africa was the smallest region in the global biologics market.

The US Food and Drug Administration (FDA) has revised its regulations to eliminate outdated biologics requirements, thus allowing drug manufacturers to employ new manufacturing technologies and testing capabilities. Standard preparations (standard solutions containing a precisely known concentration of an element), which help to ensure safety, purity and potency of biologics can now be obtained from sources other than FDA’s Center for Biologics Evaluation and Research (CBER), or can be developed internally by the biologics license applicant. The FDA has also removed a rule (Section 610.21 of FDA code) which specifies minimal potency limits to be met for certain antibodies and antigens. In addition, FDA is also updating regulations (Section 610.53 of FDA code) regarding storage periods and storage conditions for biologics. These amendments in regulations are expected to increase regulatory flexibility by allowing the pharmaceutical industry and the FDA to incorporate current scientific technologies in the manufacture of licensed biological products.

The early generation of biologics is losing its patent protection and are expected to face greater competition going forward from the entry of biosimilars into the market. Biosimilars are the pharmaceuticals that are developed to have similar properties to a biologic drug that has already been approved. Demand for biosimilars is being fueled by governments around the world trying to reduce healthcare costs. In India, a new biosimilar policy called the ‘Guidelines on Similar Biologics’ prepared by the Central Drugs Standard Control Organization (CSDCO) is expected to give a major boost to the Indian biosimilars industry. In the EU, a pathway for approving biosimilar medicines has existed since 2003. These less expensive alternatives increase competitiveness for the biologics market putting downward pressure on pricing and market value growth.

Technology is expected to be a continued driver of market growth during this period. An area of particular development is likely to be physiology simulation modeling. Markets such as this one will benefit from the greater efficiencies offered by developments in this area. For example, Eli Lilly and Pfizer have adopted Amazon’s Elastic Compute Cloud (EC2) platform to conduct simulation models in early drug discovery that have been operational within hours, whereas traditional models would have taken weeks to conduct simulations. The Open Innovation Drug Discovery program is another initiative by Lilly to enhance the research and development of biologics. Such technological advances are likely to reduce costs and expedite the development phase of biologics, allowing companies to launch their products early.