From Gila Monster to Global Phenomenon: The Peptide Revolution

At the turn of the century, the electric lightbulb was invented, alongside the foundational definitions of peptide bonds and synthesis. At about the time of the invention of television, insulin, a peptide therapeutic, was discovered and began revolutionizing diabetes treatment. Near the time of the ARPANET (Advanced Research Projects Agency Network), the internet’s precursor, the invention of solid phase peptide synthesis (SPSS) won the Nobel Prize in Chemistry. Twenty years later, the worldwide web (www) was a reality, and the Food and Drug Administration (FDA) approved Humalin, the first large-scale synthetic peptide therapeutic. This was a great advance, and it quickly replaced its predecessor, porcine insulin, and became the standard diabetes treatment worldwide.

Around the same time, a researcher isolated an interesting peptide from the Gila Monster lizard. This peptide was the first in a long line of metabolic peptides that are frequently referred to as GLP-1. Glucagon-like peptide-1s are a class unto themselves the peptide being linked to a sugar, which is cleaved, releasing the peptide to do its work on a targeted site.

This sophisticated approach to medicine is the finest example of the success we can expect to come from a biopharmaceutical directive.

What This Means for the Future
As with many meaningful things in life, we start with a single contributor making a small step and watch a community grow this into its most awesome potential. In this case, we are witnessing a remarkable expansion in peptide manufacturing capacity. From 2020 to 2024, production increased by approximately fifty percent, and projections indicate a further two hundred percent growth between 2024 and 2029. Markets and inventors do not see things slowing down from there, and continue to place their trust in the idea that over the next decade, we are likely to see these rates of expansion continue (1).

My focus here is on production capacity because it is the cornerstone controlling cost and supply and is the most telling of harbingers to guarantee the healthy pipeline of biopharmaceutical medicines beyond those currently or on their way to market. From a Gila Monster to the most valuable therapeutic platform on earth, one straight line of relentless progress. The first inflection point of meaningful progress has been passed, and with this new capacity, the change to medicines is underway.

Since 2019, global peptide active pharmaceutical ingredient capacity has approximately doubled, and it is projected to double again by 2030 (2). Much of this incremental growth is driven by GLP-1–class molecules, with the largest increases occurring in Asia. Both established capacity leaders and emerging players are positioning themselves for continued expansion well into the next decade. Peptide leaders in integrated pharma like Eli Lilly, Novo Nordisk, Roche, GlaxoSmithKline, Novartis, Pfizer, Amgen, Sanofi, Takeda, Viking, Teva, and many more are updating their peptide discovery, synthetic routes, and engineering their way through the current dialectic of downstream challenges. Partners in this pursuit often represent the front line of the downstream work. They are the contract organizations, such as:

•Corden: With nearly 1 billion dollars in investments planned in the next three years, adding 30,000 L of SPPS capacity to its already impressive scale of manufacture (3).• Bachem: Committed to investing hundreds of millions of dollars to increase every site in its global network over the next few years (4).
• PolyPeptide: Investing over a hundred million dollars in the past three years, with further investments in the works to create larger SPPS reactors, LPPS/hybrid processes [QA4: LPPS], and automated purification rigs (5).
• WuXi tides: Planned completion of its mega site in 2025 brings the company’s total reactor volume to 32,000 L—a tripling of capacity from 15 to 45 tons per year (6).
•Ambiopharm: Committed 30 million dollars to bring their total capacity to over 8 tons per year (7).
• CPC: With eight GMP production sites already, it has set its sights on a new manufacturing facility (8).

From the shift from traditional SPPS to hybrid solid–liquid manufacturing and other efficiency-driven innovations, to the use of lymphatic tails that enhance stability and extend half-life, the peptide field is evolving rapidly. Advances in cyclization, stapling, and other techniques are enabling the development of orally available peptides that can survive the stomach barrier Peptides are becoming easier to make, safer, and effective at treating an ever-growing range of human maladies. We are now looking at a future of oral, low-cost, safe, and effective medicines such as the world has never experienced.

As we observe the metabolism of our nation changing with the increasing prevalence and ease with which metabolic therapeutics are available and taken, the size of this present peptide wave may make it difficult to see what will follow. After this brief review of marshalled resources, I believe it is evident that the world is committed to this course.

The advantages and target-rich opportunities this “newly” exploited class of medicine affords us will not end here. It is only the first of the many peptide-based medicines on their way to your neighborhood drug store.

References

1. Market Growth Reports. Peptide API Market Size, Share, Growth, and Industry Analysis, By Type (Generic APIs, Innovative APIs), By Application (Cancer Treatment, Metabolic Disorders, Cardiovascular, Infectious Diseases), Regional Insights and Forecast to 2033 https://www.marketgrowthreports.com/market-reports/peptide-api-market-112901
2. Roots Analysis. Peptide Synthesis Market Growth https://www.rootsanalysis.com/press-releases/peptide-contract-manufacturing-market.html#:~:text=Growth%20Factors,growth%20in%20the%20foreseen%20future
3. Corden Pharma. CordenPharma Invests €900m in Transformational Peptide Platform Expansion in the USA & Europe https://cordenpharma.com/articles/press-release-cordenpharma-invests-900-million-euros-in-transformational-peptide-platform-expansion-in-usa-and-europe/

4. Bachem. SCALING UP FOR THE FUTURE: MAJOR INVESTMENTS IN PEPTIDE PRODUCTION https://www.bachem.com/articles/blog/scaling-up-for-the-future-major-investments-in-peptide-production/

5. PolyPeptide. Business review https://report.polypeptide.com/ar/24/business-review

6. Osta. WuXi AppTec Triples Peptide Manufacturing Capacity and Launches the New Taixing API Manufacturing Site https://sta.wuxiapptec.com/wuxi-apptec-triples-peptide-manufacturing-capacity-and-launches-the-new-taixing-api-manufacturing-site/

7. APi. AmbioPharm Breaks Ground on $28M Expansion of Pharmaceutical Manufacturing Site in Shanghai https://www.ambiopharm.com/news-press/ambiopharm-breaks-ground-on-28m-expansion-of-pharmaceutical-manufacturing-site-in-shanghai/

8. CPC. Understanding API Manufacturing in Peptide & Oligonucleotide Therapeutics https://cpcscientific.com/understanding-api-manufacturing-in-peptide-oligonucleotide-therapeutics/

Biography
Jonathan Edelman began his career as an analytical chemist in the pharmaceutical industry. Inspired by his long-standing love of science and natural ease with sales and marketing, he is currently working as the general manager of the Americas for Osaka Soda, as well as Fawn Hall Consulting. He volunteers his time to a wide variety of nonprofit organizations within the chromatography community. Edelman serves as the treasurer of the ACS SCSC, in addition to serving as coordinator for the International Symposium on the Separation of Proteins, Peptides, and Polynucleotides conference, executive committee person at the Chromatography Forum of Delaware Valley, president emeritus of the Washington Chromatography Forum, and founder and president of the Separation Community Mixer.