Key findings
- More than 80 peptide drugs have reached the market worldwide since insulin was introduced, according to a 2021 Nature Reviews Drug Discovery review.
- Eli Lilly reported 2025 revenue of $22,965 million for Mounjaro and $13,542 million for Zepbound, both tirzepatide peptide drugs.
- 12% of US adults said they were currently taking a GLP-1 drug in KFF's October to November 2025 poll, and 18% had ever taken one.
- FDA had received 990 adverse event reports linked to compounded semaglutide and more than 730 linked to compounded tirzepatide as of May 31, 2026.
- An FDA advisory committee voted 8-6 in July 2026 to recommend BPC-157, KPV and TB-500 for the 503A compounding list, against the advice of FDA staff.
How big is the peptide drug market?
peptide drugs have reached the market since the introduction of insulin almost a century ago1
Uses include diabetes, cancer, osteoporosis, multiple sclerosis, HIV infection and chronic pain.
non-insulin peptide drugs had been approved worldwide since 2000, as of a 2022 review2
peptides were in active clinical development, with many more in preclinical studies2
As of the 2022 review.
in worldwide peptide drug sales in 20192
The review describes this as more than a two-fold increase compared with 2013.
in 2025 worldwide revenue for Mounjaro (tirzepatide), up 99% from $11,540 million in 20243
in 2025 revenue for Zepbound (tirzepatide for obesity), up 175% from $4,926 million in 20243
in 2025 sales of Ozempic (semaglutide), up 6% in Danish kroner and 10% at constant exchange rates4
in 2025 sales of Wegovy (semaglutide for obesity), up 36% in Danish kroner and 41% at constant exchange rates4
in Novo Nordisk obesity care sales in 2025, up from DKK 6 billion in 20194
How many peptide drugs does the FDA approve?
TIDES (peptide and oligonucleotide drugs) were approved by the FDA in 20235
Including the first core-symptom treatment for Rett syndrome, which is peptide-based.
novel drugs were approved by the FDA in 2024, including four TIDES (two peptides and two oligonucleotides)6
novel drugs were approved by the FDA in 2025, including elamipretide, the first disease-specific treatment for Barth syndrome7
FDA approved the first oral GLP-1 for obesity, once-daily oral semaglutide 25 mg (Wegovy pill)4
total weekly prescriptions for the Wegovy pill as of January 23, 2026, after its January 5, 2026 launch4
Novo Nordisk says uptake was mainly driven by the 1.5 mg starter dose in the self-pay channel.
How many Americans take GLP-1 peptide drugs?
of US adults said they were currently using a GLP-1 drug8
KFF Health Tracking Poll fielded October 27 to November 2, 2025.
of US adults said they had ever used a GLP-1 drug8
of adults aged 50 to 64 said they were currently using a GLP-1 drug, the highest of any age group8
Versus 11% of those 30 to 49, 9% of those 65 and older and 4% of those 18 to 29.
of adults who had ever used a GLP-1 drug got it from an online provider or website8
76% got it from a primary care doctor or specialist and 9% from a medical spa or aesthetic medical center.
of GLP-1 users said the drugs were difficult to afford8
14% of past users said they stopped because of cost.
What has the FDA done about compounded GLP-1 peptides?
FDA determined the semaglutide shortage was resolved9
Enforcement discretion for 503B outsourcing facilities ran until May 22, 2025; the 503A period has also ended.
FDA reaffirmed that the tirzepatide shortage, first declared resolved on October 2, 2024, was over9
Enforcement discretion for 503B outsourcing facilities ran until March 19, 2025.
adverse event reports associated with compounded semaglutide had been received by FDA as of May 31, 202610
FDA notes some dosing-error events required hospitalization.
adverse event reports associated with compounded tirzepatide had been received by FDA as of May 31, 202610
Are research peptides like BPC-157 legal to compound?
FDA added several peptides, including GHRP-2, GHRP-6, ipamorelin and kisspeptin-10, to category 2 (substances that may present significant safety risks)11
Category 2 is part of FDA's interim policy for bulk substances nominated for compounding.
bulk drug substances remain in FDA's category 2 list of substances that may present significant safety risks11
Count of entries listed on the page, content current as of April 22, 2026.
substances, including BPC-157, TB-500, CJC-1295, Melanotan II and MOTs-C, are listed by FDA as previously in category 2 but withdrawn by their nominators11
FDA still lists its safety concerns, such as immunogenicity risk, for each. Leaving category 2 does not add a substance to the 503A bulks list, which requires rulemaking.
peptides (BPC-157, KPV, TB-500, MOTs-C, emideltide, Semax and epitalon) were scheduled for FDA Pharmacy Compounding Advisory Committee review on July 23 and 24, 202612
FDA evaluated BPC-157 for ulcerative colitis, TB-500 for wound healing and MOTs-C for obesity and osteoporosis.
advisory committee vote, with 1 abstention, to recommend BPC-157, KPV and TB-500 for the 503A bulks list13
News report. MOTs-C passed 7-5 with 2 abstentions, emideltide was voted down and FDA staff had recommended against all seven. The votes are nonbinding and rulemaking would be required.
clinical study was found among 36 studies of BPC-157 included in a 2025 systematic review; the other 35 were preclinical14
The review found no clinical safety data. In the one clinical study, 7 of 12 patients reported knee pain relief for more than 6 months.
Peptide statistics: FAQ
How many FDA-approved peptide drugs are there?
More than 80 peptide drugs have reached the market worldwide since insulin, and 33 non-insulin peptide drugs were approved worldwide from 2000 to the time of a 2022 review. FDA approvals continue each year; in 2024 the FDA approved 50 novel drugs, including two peptides.
How big is the peptide drug market?
Worldwide peptide drug sales exceeded $70 billion in 2019. GLP-1 peptides now lead the category: Lilly's Mounjaro and Zepbound generated $22,965 million and $13,542 million in 2025, and Novo Nordisk's Ozempic and Wegovy sold DKK 127,089 million and DKK 79,106 million.
How many Americans use GLP-1 drugs?
In KFF's poll fielded October 27 to November 2, 2025, 12% of US adults said they were currently using a GLP-1 drug and 18% had ever used one. Use was highest among adults 50 to 64, at 22%.
Is compounded semaglutide or tirzepatide still allowed?
FDA declared the tirzepatide shortage resolved (reaffirmed December 19, 2024) and the semaglutide shortage resolved on February 21, 2025, and its enforcement discretion periods for compounders have ended. FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide as of May 31, 2026.
Is BPC-157 FDA approved?
No. BPC-157 is not an FDA-approved drug. It was previously in FDA's category 2 of risky compounding substances and is now listed as withdrawn by its nominator. In July 2026 an FDA advisory committee voted 8-6 to recommend it for the 503A bulks list, but the vote is nonbinding and FDA staff had recommended against it. A 2025 systematic review found only 1 clinical study among 36 and no clinical safety data.
Sources
- Trends in peptide drug discovery (Muttenthaler et al.). Nature Reviews Drug Discovery, 2021. peer-reviewed
- Therapeutic peptides: current applications and future directions (Wang et al.). Signal Transduction and Targeted Therapy, 2022. peer-reviewed
- Lilly reports fourth-quarter 2025 financial results and provides 2026 guidance. Eli Lilly and Company (SEC Form 8-K, Exhibit 99.1), 2026. company-filing
- Financial report for the period 1 January 2025 to 31 December 2025. Novo Nordisk A/S (SEC Form 6-K), 2026. company-filing
- 2023 FDA TIDES (Peptides and Oligonucleotides) Harvest (Al Shaer et al.). Pharmaceuticals (Basel), 2024. peer-reviewed
- 2024 FDA TIDES (Peptides and Oligonucleotides) Harvest (Al Musaimi et al.). Pharmaceuticals (Basel), 2025. peer-reviewed
- 2025 FDA TIDES (Peptides and Oligonucleotides) Harvest (AlShaer et al.). Pharmaceuticals (Basel), 2026. peer-reviewed
- KFF Health Tracking Poll: Prescription Drug Costs, Views on Trump Administration Actions, and GLP-1 Use. KFF, 2025. survey
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize. U.S. Food and Drug Administration, 2025. government
- FDA's concerns with unapproved GLP-1 drugs used for weight loss. U.S. Food and Drug Administration, 2026. government
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. Food and Drug Administration, 2026. government
- Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments. Federal Register (FDA notice, Docket No. FDA-2025-N-6895), 2026. government
- FDA panel backs 6 peptides for compounding. AJMC (American Journal of Managed Care), 2026. news
- Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review (Vasireddi et al.). HSS Journal, 2025. peer-reviewed
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Lindy Health. “Peptide statistics 2026: the peptide drug market, FDA approvals and compounded peptide use.” Updated October 18, 2026. https://lindyhealth.com/statistics/peptide-statistics/