Biologics Market to Register an Impressive CAGR of 10.5% During 2019 – 2023 (ABBVIE, AMGEN, F. HOFFMANN-LA ROCHE LTD, PFIZER INC., GLAXOSMITHKLINE PLC, MERCK & CO, ELI LILLY AND COMPANY, NOVO NORDISK)

The global biologics market is expected to register a CAGR of about 10.5% during 2018-2023 (the forecast period). Due to the growing demand for biologics treatment for chronic diseases, North America is dominating the market.

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Key Developments in the Market
December 2017: The US Food and Drug Administration (US FDA) approved GlaxoSmithKline’s biologic Nucala for the treatment of a rare disease called eosinophilic granulomatosis, with polyangiitis (EPGA).
October 2017: The US Food and Drug Administration (US FDA) accepted F. Hoffmann-La Roche Ltd’s supplemental Biologics License Application for Avastin as a front-line treatment for women, with advanced ovarian cancer.

Major Players: ABBVIE INC., AMGEN, F. HOFFMANN-LA ROCHE LTD, PFIZER INC., GLAXOSMITHKLINE PLC,, MERCK & CO, ELI LILLY AND COMPANY, NOVO NORDISK, SANOFI, AND JOHNSON & JOHNSON, amongst others.

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Increasing Capital Investment by the Key Market Players
In 2016, biologics accounted for six of the top-eight drugs, in terms of revenue. AbbVie’s Humira (adalimumab) for rheumatoid arthritis, psoriasis, Crohn’s, and other autoimmune diseases led the way, with a total of USD 18.4 billion sales. The growing success rate of biologics drugs and their demand have led to huge capital investment for the expansion of commercial biologics manufacturing capacities, among CMO and big pharmaceutical companies. For instance, Novartis AG invested around USD 700 million in its biologics facility in Singapore, and Bristol-Myers Squibb invested nearly USD 900 million in an Irish large-scale biologics facility that is anticipated to be completed by 2019. In addition, the rise in the prevalence of chronic diseases, loss of patent exclusivity of the leading biologics drugs, and growing demand and higher acceptability for innovative therapies are the factors driving the global biologics market growth.

Stringent Regulatory Process and High Capital Investment
Biologics drugs are highly complex and require controlled conditions and maintenance, throughout the development and production process. Such regulated environment and quality-control procedures involve huge capital in the initial phase of process. Further, biologics are extremely susceptible to light, heat conditions, and need extremely favorable environment that is not available uniformly across the globe. In most emerging markets, biologics currently have little-to-no presence. Stringent regulatory policies and high-capital investment, coupled with limited patient access to affordable biologics, especially in the developing countries, owing to the rising control and cost for accessing biologics, are likely to impede the growth of the global biologics market.

North America to Dominate the Market
The biologics market has been segmented on the basis of product type, application, and geography. By geography, the market has been categorized into North America, Europe, Asia-Pacific, the Middle East & Africa, and South America.
Owing to the presence of well-established pharmaceuticals companies and increase in the number of biotech companies, being funded by venture capital, North America is dominating the biologics market. Asia-Pacific is also expected to grow at a great pace during forecast period, owing to factors, such as rise in the outsourcing of biologics contract manufacturing in emerging countries of the region, less stringent regulatory environment for clinical trials of drugs, and the growing awareness regarding the success of biologics for the treatment of chronic diseases.

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