Somatropin - Biologic Drug Details

Summary for somatropin

Tradenames:	11
High Confidence Patents:	17
Applicants:	9
BLAs:	10
Suppliers: see list	7
Recent Clinical Trials:	See clinical trials for somatropin
Drug Prices:	Drug price information for somatropin

Recent Clinical Trials for somatropin

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Dr. David Wasserstein	PHASE1
Sunnybrook Research Institute	PHASE1
Northwell Health	Phase 3

See all somatropin clinical trials

Pharmacology for somatropin

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. DrugPatentWatch analysis and 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 somatropin Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for somatropin Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	5,334,162	2013-03-15	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	5,383,865	2013-03-15	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	5,454,786	2014-03-28	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	5,618,697	2015-01-13	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	5,626,566	2014-03-24	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	5,691,169	2015-03-10	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	5,849,700	2015-06-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for somatropin 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
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,016,338	2036-12-20	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,045,943	2036-04-08	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,154,856	2034-02-06	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,335,463	2037-11-28	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,364,451	2036-12-21	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,479,868	2035-09-04	Patent claims search
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	10,493,113	2038-11-14	Patent claims search

International Patents for somatropin

Country	Patent Number	Estimated Expiration
Czech Republic	20001034
Denmark	0741556
China	1313168
Taiwan	202140531
Montenegro	00380
Japan	2018000205
World Intellectual Property Organization (WIPO)	9312812

Supplementary Protection Certificates for somatropin

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC008/2003	Ireland		SPC008/2003: 20030508, EXPIRES: 20121217
CA 2022 00020	Denmark		PRODUCT NAME: LONAPEGSOMATROPIN; REG. NO/DATE: EU/1/21/1607 20220117
PA2022506	Lithuania		PRODUCT NAME: LONAPEGSOMATROPINAS; REGISTRATION NO/DATE: EU/1/21/1607 20220117
2022014	Norway		PRODUCT NAME: LONAPEGSOMATROPIN; REG. NO/DATE: EU/1/21/1607 20220121
25/2022	Austria		PRODUCT NAME: LONAPEGSOMATROPIN; REGISTRATION NO/DATE: EU/1/21/1607 (MITTEILUNG) 20220117
SPC/GB22/023	United Kingdom		PRODUCT NAME: LONAPEGSOMATROPIN; REGISTERED: UK EU/1/21/1607(FOR NI) 20220117; UK FURTHER MAS ON IPSUM 20220117
301172	Netherlands		PRODUCT NAME: LONAPEGSOMATROPINE; REGISTRATION NO/DATE: EU/1/21/1607 20220117

Market Dynamics and Financial Trajectory for the Biologic Drug: Somatropin

Last updated: July 27, 2025

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Introduction

Somatropin, a recombinant form of human growth hormone (HGH), is a biologic drug primarily used for treating growth hormone deficiencies and other related conditions. Since its initial approval by the FDA in the 1980s, somatropin has carved a significant niche within endocrinology, driven by advances in biotechnology, expanding indications, and evolving healthcare landscapes. This report investigates the current market dynamics, key drivers, challenges, and the projected financial trajectory of somatropin in the global bioscience industry.

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Market Overview and Size

The global growth hormone market, which includes somatropin, was valued at approximately $4.2 billion in 2022 and is projected to reach $6.4 billion by 2030, exhibiting a compound annual growth rate (CAGR) of around 5.4% (2023–2030) [1]. The expansion reflects both the increased adoption of biologics and the broadening of therapeutic indications, such as growth failure, Turner syndrome, Prader-Willi syndrome, and adult growth hormone deficiency.

Key players include multinational pharmaceutical giants such as Pfizer, Novo Nordisk, Genentech (a Roche subsidiary), and Sandoz. These companies possess a robust pipeline of biosimilars and innovative formulations, heightening competition and influencing market dynamics.

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Market Drivers

1. Expanding Therapeutic Indications

While somatropin's primary use remains in pediatric growth deficiencies, approval of new indications such as cachexia associated with HIV/AIDS, short bowel syndrome, and adult growth hormone deficiency fuel demand. Regulatory agencies, including the FDA and EMA, are increasingly approving expanded uses, broadening patient eligibility.

2. Rising Prevalence of Growth Disorders

The increased diagnosis rate of growth hormone deficiencies, osteoporosis, and other endocrine disorders, coupled with heightened awareness, directly increases demand. Global pediatric growth deficiencies are estimated at 1 per 4,000–10,000 children, with adult deficiencies often underdiagnosed but on the rise [2].

3. Advances in Biotechnology and Manufacturing

Recombinant DNA technology has improved the safety, efficacy, and production efficiency of somatropin. Enhanced formulations, including long-acting variants, are reducing dosing frequency, thereby improving patient compliance and treatment outcomes.

4. Patent Expirations and Biosimilar Market Entry

Patent expirations of original biologics such as Genentech's Nutropin have led to biosimilar entrants, intensifying price competition. Biosimilars are projected to capture approximately 30% of the growth hormone market by 2030, substantially impacting pricing and revenue streams [3].

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Market Challenges

1. High Cost and Reimbursement Hurdles

Biologics like somatropin entail significant manufacturing costs, reflected in high retail prices. Reimbursement policies vary globally, with some insurers limiting coverage, impacting patient access and market growth.

2. Biosimilar Competition and Price Erosion

The entry of biosimilars, particularly in mature markets like Europe and North America, is exerting downward pressure on prices. This trend challenges profit margins for originator brands, compelling companies to innovate further.

3. Regulatory and Manufacturing Complexities

Biologics manufacturing requires sophisticated, high-cost facilities, with stringent quality controls. Regulatory pathways for biosimilars are complex, and any deviations can delay approvals, impacting revenue timelines.

4. Ethical and Safety Concerns

Concerns related to the long-term safety of growth hormone therapy, particularly in off-label uses, influence prescribing practices and regulatory scrutiny.

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Technological Innovations and Pipeline Developments

Emerging innovations include long-acting somatropin formulations, self-administration devices, and personalized dosing algorithms. Key candidates in clinical development aim to reduce dosing frequency from daily injections to weekly or monthly, thus increasing patient adherence. Companies like Ascendis Pharma (TransCon hGH), Pfizer, and Novo Nordisk are investing heavily in such modalities [4].

Furthermore, continuous manufacturing enhancements and biosimilar development are extending market reach and affordability, positioning somatropin amidst a rapidly evolving therapeutic landscape.

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Financial Trajectory and Market Share Projections

Revenue Growth Outlook:
The global somatropin market is projected to grow at a CAGR of 5.4% from 2023 to 2030, reaching approximately $6.4 billion as demand from pediatric and adult indications increases.

Impact of Biosimilars:
Biosimilar products are anticipated to account for nearly 30% of global sales by 2030, with price reductions of up to 25–30% compared to brand-name counterparts. This dynamic will pressure existing players to innovate on formulation and delivery methods to maintain market share.

Competitive Landscape:
Large biotech firms are investing in long-acting products, with several candidates in late-stage trials. The accelerated pipeline diversification is expected to stimulate market growth through offering patients more convenient and economically accessible options.

Regional Dynamics:
North America will remain the largest market, driven by advanced healthcare infrastructure, high healthcare spending, and favorable reimbursement policies. Europe will follow, albeit with more stringent price controls. Growth in emerging markets (Asia-Pacific, Latin America) hinges on expanding healthcare access and regulatory approvals, with the Asia-Pacific CAGR projected at approximately 6.2%.

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Regulatory and Economic Influences

Government policies on biologic approvals, pricing, and reimbursement significantly influence market sizes. The ongoing expansion of biosimilar regulations, exemplified by the European Medicines Agency’s (EMA) biosimilar pathways, creates opportunities for increased competition and affordability.

Healthcare economic pressures globally are prompting payers to negotiate better prices and demand value-based reimbursement models, which could impact the revenue potential for originator somatropin products.

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Key Opportunities and Risks

Opportunities:

• Development of long-acting, less-invasive formulations.
• Expansion into novel indications, such as anti-aging or metabolic diseases.
• Entering emerging markets where growth hormone therapy remains underpenetrated.

Risks:

• Delayed regulatory approvals for biosimilars.
• Market saturation and price erosion.
• Safety concerns or adverse effects leading to reduced prescribing.

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Conclusion

The somatropin market exhibits resilient growth aligned with technological advances and expanding indications. While patent expiry and biosimilar emergence temper price trajectories, ongoing pipeline innovations—particularly long-acting formulations—are poised to sustain revenue growth. Strategic positioning within emerging markets, coupled with innovation to improve patient adherence, will be central to capturing future market share.

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Key Takeaways

• The global somatropin market is set to grow at a CAGR of approximately 5.4% through 2030, driven by broader indications and technological innovation.
• Biosimilar entry will intensify price competition, prompting originators to innovate in formulations and delivery.
• Long-acting somatropin formulations represent a significant growth potential, addressing adherence issues and expanding therapeutic applications.
• Regulatory landscapes vary globally, influencing market access and reimbursement policies.
• Emerging markets present untapped opportunities, although infrastructure and regulatory frameworks require development.

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FAQs

1. What are the main therapeutic indications for somatropin?
Somatropin treats growth hormone deficiencies in children and adults, Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, and cachexia associated with chronic illnesses like HIV/AIDS.

2. How do biosimilars affect the somatropin market?
Biosimilars introduce cost competition, typically reducing prices by 25–30%, which can increase accessibility but challenge established manufacturers’ profit margins.

3. What innovations are emerging in somatropin formulations?
Long-acting formulations reducing injection frequency from daily to weekly or monthly, along with novel delivery devices, are advancing the paradigm of GH therapy.

4. What regional factors influence somatropin market growth?
North America and Europe dominate due to advanced healthcare systems, but emerging markets are experiencing growth driven by increased diagnosis rates and expanding healthcare access.

5. What are the major risks facing the somatropin market?
Regulatory delays, biosimilar price erosion, safety concerns, and reimbursement restrictions pose persistent risks to market stability and growth.

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References

[1] MarketsandMarkets. (2023). Growth Hormone Market Forecast & Analysis.
[2] CDC. (2021). Growth Hormone Deficiency Prevalence Data.
[3] IQVIA. (2022). Biosimilar Market Reports.
[4] BioPharm Insight. (2022). Pipeline Review: Long-Acting Growth Hormone Products.