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Diabetes Market Grows Ever More Crowded

Kunj Gohil PharmD, RPh
Devin Enhoffer PharmD, RPh

Type-2 diabetes mellitus (T2DM) is a chronic disease that affects the body’s ability to regulate sugar levels in the blood. Elevated blood sugar (hyperglycemia) can have long-term detrimental effects on the heart, blood vessels, eyes, kidneys, and nerves.1 Approximately 189 million cases of T2DM were recorded globally in 2012, with only 120 million of those cases actively receiving treatment; prevalence is expected to grow to 330 million cases globally by 2022.2

The global T2DM market has become increasingly crowded with the emergence of generic medications. In 2012, the global diabetes market yielded $28.1 billion in sales, with $16.4 billion in the U.S. With the predicted increase in disease prevalence, global sales are expected to grow to $67.7 billion in 2022, with $38.8 billion in the U.S.2

Pharmaceutical manufacturers are developing diabetes medications to address unmet needs. Although various medications are in phase 3 investigation, most of the pipeline consists of “me-too” drugs.3 Among the newest medications to reach the market, Jardiance, a sodium-glucose cotransporter 2 inhibitor, and Tanzeum and Trulicity, two glucagon-like peptide-1 receptor agonists, aim to increase patient adherence through easier administration and strong efficacy/safety profiles.47

Future Therapies
Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricinga
LY2605541 (insulin peglispro)
Eli Lilly and Co.
Phase 3 5–10 units via SC injection QD IMAGINE program 2015 Priced at a 20% discount to Tresiba
Lyxumia (lixisenatide)
Sanofi Aventis US
Phase 3 Starting dose: 10 mcg QD for 14 days; maintenance dose: 20 mcg QD starting on day 15 NCT02200991
NCT02049034
NCT02276196
2015 Priced at $3,189
Semaglutide
Novo Nordisk
Phase 3 0.8–1.6 mg SC injection once weekly SUSTAIN program 2016 Priced at a 10% discount to Trulicity (which now costs about $6,348 a year)
Omarigliptin (MK-3102)
Merck Sharp & Dohme
Phase 3 10–25 mg once weekly, orally NCT01717313
NCT01704261
NCT01682759
NCT01697592
NCT01703221
Total of 10 key studies
2016 Priced at a 10% premium to Januvia (which now costs about $1,099 a year)
Tofogliflozin8
Chugai Pharmaceutical Co.
Phase 3 10–40 mg QD, orally JapicCTI-10351
JapicCTI-10352
2016 Priced at a 5% discount to Jardiance (which now costs about $3,660 a year)
Tresiba (insulin degludec— ultra-LA)
Novo Nordisk
Phase 3 10 units via SC injection, daily BEGIN study
BEGIN Once Long
2016 Priced at $394 in United Kingdom
LY2409021
Eli Lilly and Co.
Phase 2 5–200 mg QD, orally NCT00871572
NCT01241448
NCT02111096
2017 Priced similarly to Januvia (which now costs about $1,099 a year)

LA = long-acting; QD = once daily; SC = subcutaneous

aPrices of existing drugs, if given, were calculated using wholesale acquisition costs and regimens provided in the following tables and rounded to the nearest dollar.

Sources: FDA; GlobalData; company websites; Clinicaltrials.gov

Selected Current Non-Insulin Therapiesa
Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy Per Yeard
Biguanides
Glucophage XR (metformin ER)
Bristol-Myers Squibb
October 13, 2000 T2DM (ages ≥ 17) 500–2,000 mg
QD, orally
$369–$1,475 (generic, $47–$190)
Glucophage (metformin)
Bristol-Myers Squibb
March 3, 1995 T2DM (ages ≥ 10) 500 mg BID–850 mg
TID, orally
$723–$1,807 (generic, $58– $146)
Sulfonylureas and other insulin secretagogues
Amaryl (glimepiride)
Sanofi Aventis US
November 30, 1995 T2DM (ages ≥ 18) 1–8 mg QD, orally $365–$2,920 (generic, $15–$117)
Glucotrol XL (glipizide ER)
Pfizer
April 24, 1994 T2DM (ages ≥ 18) 5–20 mg QD, orally $329–$1,314 (generic, $106–$423)
Glucotrol (glipizide) Pfizer May 8, 1984 T2DM (ages ≥ 18) 5 mg QD–20 mg
BID, orally
$329–$2,628 (generic, $15–$117)
Diabeta (glyburide)
Sanofi Aventis US
May 1, 1984 T2DM (ages ≥ 18) 1.25–20 mg daily in single or divided doses, orally $164–$2,628 (generic, $24–$248)
Alpha-glucosidase inhibitors
Glyset (miglitol)
Pharmacia and Upjohn
December 18, 1996 T2DM (ages ≥ 18) 100 mg TID, orally $2,130
Precose (acarbose) Bayer Healthcare September 6, 1995 T2DM (ages ≥ 18) 50–100 mg TID, orally $1,103–$2,207 (generic, $482–$964)
Thiazolidinediones
Actos (pioglitazone)
Takeda
July 15, 1999 T2DM (ages ≥ 18) 15–45 mg QD, orally $3,458–$10,370 (generic, $91–$274)
Avandia (rosiglitazone)
SB Pharmco
May 25, 1999 T2DM (ages ≥ 18) 4 mg daily, orally $1,424
Glucagon-like peptide-1 receptor agonists
Trulicity (dulaglutide)
Eli Lilly and Co.
September 18, 2014 T2DM (ages ≥ 18) 0.75 mg once weekly, SC injection $6,348
Tanzeum (albiglutide)
GlaxoSmithKline
April 15, 2014 T2DM (ages ≥ 18) 30 mg once weekly, SC injection $4,237
Bydureon (exenatide)
AstraZeneca
January 27, 2012 T2DM (ages ≥ 18) 2 mg once weekly, SC injection $5,281
Victoza (liraglutide)
Novo Nordisk
January 25, 2010 T2DM (ages ≥ 18) 0.6–1.8 mg QD, SC injection $2,386– $7,161
Byetta (exenatide)
AstraZeneca
April 28, 2005 T2DM (ages ≥ 18) 5–10 mcg BID, SC injection $2,597–$5,198
Dipeptidyl peptidase 4 inhibitors
Nesina (alogliptin)
Takeda
January 25, 2013 T2DM (ages ≥ 18) 6.25–25 mg QD, orally $3,453–$13,812
Tradjenta (linagliptin)
Boehringer Ingelheim
May 2, 2011 T2DM (ages ≥ 18) 5 mg QD, orally $3,661
Onglyza (saxagliptin)
AstraZeneca
July 31, 2009 T2DM (ages ≥ 18) 2.5–5 mg QD, orally $3,595
Januvia (sitagliptin)
Merck Sharp & Dohme
October 16, 2006 T2DM (ages ≥ 18) 25–100 mg QD, orally $1,099
Sodium-glucose cotransporter 2 inhibitors
Jardiance (empagliflozin)
Boehringer Ingelheim
August 1, 2014 T2DM (ages ≥ 18) 10–25 mg QD, orally $3,660
Farxiga (dapagliflozin)
AstraZeneca
January 8, 2014 T2DM (ages ≥ 18) 5–10 mg QD, orally $3,796
Invokana (canagliflozin)
Janssen
March 29, 2013 T2DM (ages ≥ 18) 100–300 mg QD, orally $3,796

BID = twice daily; ER = extended release; QD = once daily; SC = subcutaneous, TID = three times daily; T2DM = type-2 diabetes mellitus; XR = extended release

aThis list is not all-inclusive; additional therapies may be available for this disease state.

bAbbreviated indication provided as all non-insulin medications are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-2 diabetes; for full indication, please refer to prescribing information.

cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.

dCosts calculated using wholesale acquisition cost and regimen provided and rounded to the nearest dollar.

Sources: Red Book; Drugs@FDA; and prescribing information for all medications

Selected Current Insulin Therapiesa,b
Drug
Manufacturer
Approval Date Indicationc Approximate Cost of Course of Therapy Per Yeard
Levemir (insulin detemir–LA)
Novo Nordisk
October 19, 2005 T2DM (ages ≥ 18); T1DM (ages ≥ 2) $2,876 (vial)
Levemir FlexTouch (insulin detemir–LA)
Novo Nordisk
June 16, 2005 T2DM (ages ≥ 18); T1DM (ages ≥ 2) $866 (pen)
Apidra, Apidra Solostar (insulin glulisine–RA)
Sanofi Aventis US
April 16, 2004 T2DM and T1DM in adults and children $2,403 (vial)
$928 (pen)
Novolog, Novolog FlexTouch (insulin aspart–RA)
Novo Nordisk
June 7, 2000 T2DM (ages ≥ 18); T1DM (ages ≥ 2) $2,403 (vial)
$893 (pen)
Lantus, Lantus Solostar (insulin glargine–LA)
Sanofi Aventis US
April 20, 2000 T2DM (ages ≥ 18); T1DM (ages ≥ 6) $2,887 (vial)
$866 (pen)
Humalog, Humalog KwikPen (insulin lispro–RA)
Eli Lilly and Co.
June 14, 1996 T2DM (ages ≥ 18); T1DM (ages ≥ 3) $2,396 (vial)
$926 (pen)
Novolin N (insulin NPH human–IA)
Novo Nordisk
July 1, 1991 T2DM and T1DM in adults and children $1,296 (vial)
Novolin R (insulin regular–SA) Novo Nordisk June 25, 1991 T2DM (ages ≥ 18); T1DM (ages ≥ 2) $1,296 (vial)
Humulin R (insulin regular–SA)
Eli Lilly and Co.
October 28, 1982 T2DM and T1DM in adults and children $1,298 (vial)
Humulin N, Humulin N Kwikpen (insulin NPH human–IA)
Eli Lilly and Co.
October 28, 1982 T2DM and T1DM in adults and children $1,298 (vial)
$823 (pen)

IA = intermediate-acting; LA = long-acting; NPH = neutral protamine Hagedorn; RA = rapid-acting; SA = short-acting; T2DM = type-2 diabetes mellitus, T1DM = type-1 diabetes mellitus

aThis list is not all-inclusive; additional therapies may be available for this disease state.

bPatients will be titrated individually to achieve appropriate glycemic control via injection; doses and schedules will vary based on patient-specific requirements.

cAbbreviated indication provided; for full indication, please refer to prescribing information.

dWholesale acquisition cost, rounded to the nearest dollar. Costs represent the price of 13 pens or vials per year, as each pen or vial is typically viable for 28 days once opened. Actual regimens and costs will vary depending on patient-specific insulin requirements and usage.

Sources: Red Book; Drugs@FDA; and prescribing information for all medications

References

  1. American Diabetes Association. Facts about type 2 August 2013;Available at: http://www.diabetes.org/diabetes-basics/type-2/facts-about-type-2.html?loc=db-slabnav. Accessed November 3, 2014
  2. Global Data. Type 2 Diabetes—Global Drug Forecast and Market Analysis to 2022—Event-Driven Update January 2014;
  3. Eli Lilly and Boehringer Ingelheim closing in on diabetes market lead with Jardiance approval, says GlobalData analyst. Fierce PharmMarketing August 2014;Available at: http://www.fiercepharma-marketing.com/press-releases/eli-lilly-and-boehringer-ingelheim-closing-diabetes-market-lead-jardiance-a. Accessed November 3, 2014
  4. Drugs@FDA FDA approved drug products Silver Spring, Maryland: Food and Drug Administration. 2014;Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed November 3, 2014
  5. Jardiance (empagliflozin) prescribing information Ridgefield, Connecticut: Boehringer Ingelheim Pharmaceuticals, Inc.. August 2014;
  6. Tanzeum (albiglutide) prescribing information Wilmington, Delaware: Glaxo-SmithKline LLC. June 2014;
  7. Trulicity (dulaglutide) prescribing information Indianapolis, Indiana: Eli Lilly and Company. September 2014;
  8. Poole RM, Prossler JE. Tofogliflozin: first global approval. Drugs 2014;74;(8):939–944.