OMNITROPE Drug Profile

Summary for Tradename: OMNITROPE

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for OMNITROPE
Recent Clinical Trials:	See clinical trials for OMNITROPE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMNITROPE

See drug prices for OMNITROPE

Recent Clinical Trials for OMNITROPE

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
Albert Einstein College of Medicine	Phase 1
Columbia University	Phase 1

See all OMNITROPE clinical trials

Recent Litigation for OMNITROPE

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all OMNITROPE litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

See all OMNITROPE litigation

Pharmacology for OMNITROPE

Established Pharmacologic Class	Recombinant Human Growth Hormone
Chemical Structure	Human Growth Hormone

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for OMNITROPE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for OMNITROPE Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for OMNITROPE Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,016,338	2033-03-11	Patent claims search
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,045,943	2034-11-02	Patent claims search
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,154,856	2033-02-06	Patent claims search
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,335,463	2030-12-23	Patent claims search
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,364,451	2033-05-30	Patent claims search
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,479,868	2034-09-04	Patent claims search
Sandoz Inc.	OMNITROPE	somatropin	For Injection	021426	10,493,113	2037-11-14	Patent claims search

The Omnitrope Market: Understanding Market Dynamics and Financial Trajectory

Introduction

Omnitrope, a biosimilar somatropin and a recombinant form of human growth hormone (rhGH), has been a significant player in the biologic drug market, particularly in the treatment of growth hormone deficiency (GHD) and other growth abnormalities. Here, we delve into the market dynamics and financial trajectory of Omnitrope, highlighting key drivers, regional performance, and future projections.

Market Size and Growth Projections

The global Omnitrope market was valued at USD 1,256.1 million in 2023 and is anticipated to reach USD 2,308.2 million by 2032, reflecting a projected Compound Annual Growth Rate (CAGR) of 7.1% from 2024 to 2032[1].

Key Drivers of Market Growth

Increasing Incidence of Growth Disorders

The rising prevalence of growth hormone deficiencies, particularly among children, is a major driver of the Omnitrope market. Growth hormone deficiency can result from genetic disorders, brain injuries, or idiopathic reasons, necessitating therapeutic intervention to regulate growth patterns and improve quality of life. According to global healthcare data, growth hormone deficiency affects approximately one in every 4,000 to 10,000 infants each year[1].

Advancements in Biopharmaceutical Technology

Technological advancements in biopharmaceutical formulations and delivery systems have significantly enhanced the treatment efficiency of Omnitrope. Companies are focusing on improving product formulations to increase shelf life and stability, even under varying storage conditions. Additionally, innovations in injection devices such as pre-filled syringes and pen devices have streamlined the administration process, making it more convenient and precise, especially for pediatric and geriatric patients[1].

Government Support and Public Health Campaigns

Governments in emerging economies are promoting the adoption of biosimilars through subsidies and public health campaigns. These initiatives aim to reduce the economic burden of treating chronic and lifelong conditions like growth hormone deficiencies, thereby increasing the market penetration of Omnitrope[1].

Regional Market Performance

North America

North America dominates the Omnitrope market, accounting for 35% of the global share. This dominance is attributed to widespread awareness of growth hormone therapy, advanced healthcare infrastructure, and robust reimbursement systems. The United States is a key player in this region due to the presence of major market participants, well-established diagnostic systems, and a large patient base[1].

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth in the Omnitrope market, driven by increasing healthcare spending, greater awareness of growth abnormalities, and improved access to sophisticated medicines. Countries like China, India, and Japan are emerging as significant markets due to their large populations and rising prevalence of pediatric GHD patients. Investments in healthcare infrastructure and biosimilar manufacturing capabilities are driving market expansion in this region[1].

Europe

Europe also holds a significant share in the Omnitrope market, with a strong focus on biosimilar adoption. The region's market is supported by a well-developed healthcare system and favorable regulatory environments that encourage the use of biosimilars[4].

Financial Trajectory

Revenue Growth

The Omnitrope market has seen significant revenue growth, particularly from hospital end-users. The increasing adoption of home injection systems for patient convenience is also a notable trend. The injection type segment has the largest earnings within the Omnitrope market, indicating a preference for this mode of administration[1].

Cost Savings and Economic Impact

The introduction of biosimilars like Omnitrope has led to substantial cost savings. According to economic analyses, the entry of follow-on protein products (FoPPs) can result in significant cost reductions. For instance, FoPPs can offer price discounts of up to 20%, leading to increased demand and overall cost savings estimated to be in billions of dollars over several years[3].

Market Players and Competitive Landscape

Novartis

Novartis, the manufacturer of Omnitrope, has a strong presence in the global biologic drug market. The company's financial performance is bolstered by its portfolio of innovative drugs, including Omnitrope. Novartis's strategic focus on cost efficiency and operational excellence has contributed to its financial success, as evident from its annual reports[2].

Future Projections and Trends

Biosimilars Market Growth

The global biosimilars market, which includes Omnitrope, is poised for significant growth. The market size is expected to reach around USD 150.26 billion by 2033, growing at a CAGR of 17.7% from 2024 to 2033. The growth hormonal deficiency segment is anticipated to be one of the fastest-growing segments within the biosimilars market during this period[4].

Technological Innovations

Future growth in the Omnitrope market will be driven by continued technological innovations in drug delivery systems and diagnostic methods. Smart delivery devices and better diagnostic tools will enhance patient compliance and treatment outcomes, further expanding the market[1].

Key Takeaways

• The Omnitrope market is projected to reach USD 2,308.2 million by 2032, with a CAGR of 7.1% from 2024 to 2032.
• The increasing incidence of growth disorders and advancements in biopharmaceutical technology are key drivers of market growth.
• North America and Asia-Pacific are significant regions, with North America dominating the market and Asia-Pacific experiencing rapid growth.
• Government support and public health campaigns are crucial in promoting biosimilar adoption.
• The biosimilars market, including Omnitrope, is expected to grow substantially, reaching USD 150.26 billion by 2033.

FAQs

What is Omnitrope used for?

Omnitrope is used to treat growth abnormalities in children and adults, including conditions such as Turner syndrome, idiopathic short stature, and adult-onset growth hormone deficiencies.

What are the key drivers of the Omnitrope market?

The key drivers include the increasing incidence of growth disorders, advancements in biopharmaceutical technology, and government support for biosimilar adoption.

Which regions are significant in the Omnitrope market?

North America and Asia-Pacific are the most significant regions, with North America currently dominating the market and Asia-Pacific experiencing rapid growth.

How does Omnitrope impact the healthcare economy?

Omnitrope and other biosimilars can lead to significant cost savings by offering lower prices compared to originator biologics, thereby reducing the economic burden of treating chronic conditions.

What are the future projections for the Omnitrope market?

The Omnitrope market is expected to grow at a CAGR of 7.1% from 2024 to 2032, driven by technological innovations and increasing demand for biosimilars.

Sources

1. Acumen Research and Consulting, "Omnitrope Market Size to Reach USD 2,308.2 Million by 2032," December 4, 2024.
2. Novartis, "Novartis Annual Report 2019," January 28, 2020.
3. ASPE, "Economic Analysis of Availability of Follow-on Protein Products," July 23, 2009.
4. BioSpace, "Biosimilars Market Size Poised to Hit USD 150.26 Billion by 2033," June 17, 2024.