Lectenz Bio is targeting several overlapping biotechnology and biopharma market segments including proteomics, glycomics, diagnostics, and biotherapeutics, for both research and clinical applications.
Therapeutic Biologics: The biopharma industry is rapidly investing in developing therapeutic biologics, which is an estimated $190B global market (Kelly Scientific Report, 2015). The serviceable addressable market includes biologics that are glycosylated recombinant proteins and approximately two-thirds of currently marketed biologics in the US (73%) and EU (65%) are glycosylated. This analysis is consistent with an independent estimate reporting that more than two thirds (67%) of therapeutic biologics are glycosylated (Dove, 2001; Li, 2009), resulting in a global glycoprotein and carbohydrate-based drug market of approximately $120 billion.
The Rise of Biosimilars: In 2015 the global biosimilars market was valued at $2.29 billion (Kelly Scientific Report, 2015). By 2024, the biosimilar market is forecasted to be approximately $41 billion (Grandview Research Report, 2016), driven by biologics patent expirations. Approximately 50% of the biologics market went off-patent in 2019, setting the stage for a high market potential for biosimilars. Additionally, 35 of the 40 best-selling biologics with recent or upcoming patent expirations are glycosylated, and therefore slated to face competition from biosimilars (GABI Report, 2015). Thus, biopharma companies are increasingly venturing into the biosimilar space to produce less-expensive versions of off-patent reference biologics.
The FDA approved the first biosimilar in 2015 and there continues to be a flood of biosimilar development in the US and globally (Kelly Scientific Report, 2015). Approximately 81% of currently approved biosimilars in the US and approximately 55% of currently approved biosimilars in the EU are glycosylated. In addition, ~90% of biosimilars currently under development in the US are glycosylated. Trends such as clearer regulatory pathways in developed markets and improving safety, efficacy, and reliability in emerging markets support continued market growth. This growing trend towards biosimilar development provides a unique opportunity for Lectenz® Bio products since variations in glycosylation can be used to distinguish between biosimilars (Taylor, 2008).
US MARKET OPPORTUNITY
FDA DRUG APPROVALS – PERCENT THERAPEUTICS BIOLOGICS ANNUALLY
- More than 25% of currently approved FDA-approved drugs are therapeutic biologics.
- Of the 268 approved biologics in the US, 67% are glycosylated.
- Approximately 90% of biosimilars currently under development in the US are glycosylated.
- Due to the expiration of several biologics patents, the biosimilars market is expanding significantly. Globally there are over 1400 biosimilars currently under development that would benefit Lectenz Bio’s products and services.
Lectenz Bio Market Opportunity: The steady growth of therapeutic biologics and biosimilars creates a rapidly growing market need for glycan detection technologies and products that provide Quality Assurance via batch monitoring during biomanufacturing and also permit batch recovery. However the current glycan detection process is a costly and labor intensive, as variation within batches is not detected until after the biomonitoring process is complete. Glycan heterogeneity can negatively impact batch-to-batch consistency, immunogenicity, pharmacokinetics, activity, and clearance.
Read more about glycosylation and quality control in Genetic Engineering & Biotechnology News’ recent report titled “Glycosylation: Windows into Quality.”
With the growth of the biologics and biosimilars market, the company’s products and services are being positioned for significant customer acquisition in the glycoscience research and biomanufacturing market segments by offering enhanced methods for glycan detection and analysis including applications for monitoring batch consistency and assessing protein glycosylation during biologic development and biomanufacturing.
APPLICATIONS FOR LECTENZ® AND GLYCOSENSETM PRODUCTS
|Infection & Inflamation|
|Congenital Disorders of Glycosylation|
|Glycoprofiling of therapeutic biopharmaceuticals|
|Process Analytical Technology|
|Potential diagnostics for altered glycosylation in disease states|