Biologics are medicines created from living cells, as opposed to small molecules, which are either produced synthetically or purified from plants. Although small molecules comprise >90% of drugs on the market, pharma and biotech companies are progressively shifting their focus to manufacturing and developing highly profitable biologics drugs.
The global biologics consulting services market is anticipated to witness a CAGR of >15%, driven by the rising biopharmaceutical market, increasing R&D in advanced therapies like cell & gene, growing biologics regulatory approvals, and significant VC funding for biologics.
The Complex Nature of Biologics & its Increasing Importance Drives the Demand for Consulting Services
Compared to small molecules, biologics are large, highly complex, heterogeneous molecules, more expensive, sensitive to external conditions, need to go through challenging manufacturing processes and have stringent regulatory requirements, thus requiring a greater level of expertise.
With the increasingly complex and quickly evolving biopharma industry, companies are searching for consultancies that can offer significant regulatory leadership, product development consulting, and knowledge in all stages from early-stage discovery to commercialization. In addition, new biologics drugs have become more significant over the past several years, with biologics contributing to 25% of new molecule approvals in the US in 2020. This further boosts the demand for biologics consulting.
“Continued development of blockbuster biologics (antibody, immunosuppressants, anticancer, atopic dermatitis, etc.), an increase in the number of biosimilars being approved as patents continue to expire, the entry of small, virtual pharma startups in the market with no manufacturing capacity and/or limited development expertise, and rising prevalence of chronic infectious diseases & cancer are some of the key factors that are likely to drive the global biologics consulting market.” – Head of Process Development, Leading Biologics Consulting Company, US
Increasing Influx of Small Biotech Lacking Manufacturing/Development Expertise
There is a growing influx of tiny biotech companies, which typically lack internal resources and knowledge, as a result of the increased demand for novel therapies. These firms are largely reliant on biologics consulting companies for end-to-end services from the exploratory phase to commercial manufacturing. However, big biopharma companies need to work in a complex and dynamic environment that requires strict attention to meeting new regulatory standards. They also approach consulting firms to help them to keep a strong track record of quality, compliance, and regulatory expertise.
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Rising Demand for Advanced Technologies Consulting
Advanced therapies, such as cell and gene therapies and personalized vaccines require specialized expertise throughout the development, manufacturing, and regulatory process. Newer vaccine technologies like viral vector and mRNA where demand exceeds supply and capabilities/technical expertise may not exist even in large biopharma.
Additionally, the quickly growing regulatory landscape makes it crucial to have up-to-date knowledge and expertise to successfully develop a product and gain a centralized market authorization (MA) in Europe and/or a Biologic License Authorization (BLA) in the US. Biologics consulting services are in high demand as a result of the rapidly expanding market for advanced biologic therapies.
North America Leads the Adoption of Biologics Consulting Services Market
Geographically speaking, North America has a major market share of the global biologics consulting services market. This is mostly attributed to the expanding biopharmaceutical industry, favorable government policies, supporting biologics invention, the existence of biologics consulting firms, significant R&D spending in the US, strict FDA regulations, and a greater focus on advanced therapies.
Competitive Landscape Analysis of Biologics Consulting Services Market
The global biologics consulting services market is highly competitive and fragmented. Some of the key/promising players in this market include IQVIA, NNE, ProductLife Group, Clarkston Consulting, Fingerpaint, Azenta Life Sciences, Biologics Consulting Group, UDG Healthcare, ProPharma Group, APCER Life Sciences, Freyr Solutions, ADVANCED CELL & GENE THERAPY, LLC, Dark Horse Consulting, and eXmoor pharma concepts limited.
Companies in the biologics consulting services market are concentrating on expanding their portfolio with high-growth advanced therapy consulting services as a major growth strategy.
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