Lectenz® Bio is targeting several overlapping biotechnology market segments including proteomics, glycomics, diagnostics, and biotherapeutics, with both research and clinical uses. The global market for proteomics is expected to reach $21 billion by 2021 (Markets and Markets, 2017), driven by increasing adoption in life sciences research in both developed and emerging markets. 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 finding is in agreement with a relatively recent estimate that more than two thirds (69%) of therapeutic biologics are glycosylated (Dove, 2001; Li, 2009). This would result in a global glycoprotein and carbohydrate-based drug market of approximately $120 billion.
There has been a significant rising trend in biosimilar development and subsequent approvals. In general, many biotechnology companies venture into the biosimilar space to produce less-expensive copies of existing biologics. The FDA approved the first biosimilar in 2015 and since then there has been a flood of biosimilar development globally (Kelly Scientific Report, 2015). Moreover, it is estimated that 50% of the biologics market will go off-patent by 2019, setting the stage for a high market potential for biosimilars. Trends such as clearer regulatory pathways in developed markets and higher efficacy and safety in emerging markets will back the market growth during the forecast period. In fact, the valuation of the biosimilar market is forecast to be approximately $35 billion by 2020 (Allied Market Research Report, 2014). In 2015 the global biosimilars market was valued at $2.29 billion (Kelly Scientific Report, 2015).
US MARKET OPPORTUNITY
LECTENZ® BIO MARKET OPPORTUNITY
FDA DRUG APPROVALS – PERCENT THERAPEUTICS BIOLOGICS ANNUALLY
Approximately 50% 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. Therefore, our estimate for the global glycoprotein and carbohydrate-based biosimilar market is greater than $1 billion and this market size is evidently increasing. 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). 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).
- More than 25% of currently approved FDA-approved drugs are therapeutic biologics.
- Of the 123 approved biologics in the US, 73% 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.
This 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|