Parathyroid hormone - Biologic Drug Details

Summary for parathyroid hormone

Tradenames:	1
High Confidence Patents:	1
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for parathyroid hormone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for parathyroid hormone

Recent Clinical Trials for parathyroid hormone

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Thammasat University Hospital	Phase 1/Phase 2
Odense University Hospital, Department of Nephrology	Phase 4
Aarhus University Hospital, Department of Nephrology	Phase 4

See all parathyroid hormone clinical trials

Recent Litigation for parathyroid hormone

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Pandora Marketing LLC	2024-01-31
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.	2023-11-17
Genentech, Inc. v. Biogen MA Inc.	2023-07-13

See all parathyroid hormone litigation

PTAB Litigation

Petitioner	Date
	2018-07-13
	2017-07-28
Pfizer, Inc.	2017-05-19

See all parathyroid hormone litigation

Pharmacology for parathyroid hormone

Established Pharmacologic Class	Parathyroid Hormone
Chemical Structure	Parathyroid 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 parathyroid hormone Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2039-03-29	Company disclosures

3) Low Certainty: US Patents for parathyroid hormone 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
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2031-06-07	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2033-03-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2032-03-30	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2024-07-05	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511		2033-02-15	Patent claims search

International Patents for parathyroid hormone

Country	Patent Number	Estimated Expiration
China	1116897
European Patent Office	1880732
Finland	962593
Hong Kong	1010336
Portugal	735896

Market Dynamics and Financial Trajectory for Parathyroid Hormone

Introduction to Parathyroid Hormone

Parathyroid hormone (PTH) is a crucial regulator of calcium levels in the body, produced by the parathyroid glands. It plays a pivotal role in maintaining bone health and calcium homeostasis. The market for PTH, particularly in its biologic form, is experiencing significant growth driven by various factors.

Market Size and Growth

The global parathyroid hormone market is projected to grow substantially over the next few years. By 2028, the market size is expected to reach $3.5 billion, growing at a compound annual growth rate (CAGR) of 9.6% from 2023 to 2028[1].

Segmentation

The market is segmented by disease type, product type, and end-user.

• By Disease Type: The market is primarily segmented into hypocalcemia and hypoparathyroidism. Hypocalcemia, characterized by low calcium levels in the blood, and hypoparathyroidism, marked by insufficient PTH production, are key drivers of this market[1].
• By Product Type: Recombinant parathyroid hormone and parathyroid hormone analogues are the main product types. Recombinant PTH, such as NATPARA, is gaining traction due to its efficacy in treating hypoparathyroidism[1][4].
• By End-User: Hospitals, clinics, and other end-users are the primary consumers of PTH products. The expansion of private healthcare sectors and increasing healthcare access are boosting demand in these segments[1].

Key Drivers of Market Growth

Several factors are driving the growth of the parathyroid hormone market:

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic kidney disease (CKD) and osteoporosis is a significant driver. CKD often leads to secondary hyperparathyroidism, while osteoporosis benefits from PTH therapy to reduce fracture risk[1][2].

Growing Geriatric Population

The expanding geriatric population is more susceptible to bone health issues, such as osteoporosis and hypoparathyroidism, thereby increasing the demand for PTH treatments[1].

Advances in Drug Delivery and Technology

Advances in drug delivery systems, combination therapies, and digital health integration are enhancing the efficacy and accessibility of PTH treatments. These innovations are expected to continue driving market growth[1].

Government Funding and Initiatives

Increased government funding for research and the designation of PTH-related drugs as orphan products by regulatory bodies like the FDA and European Commission are providing significant incentives for market growth. These initiatives include tax incentives for clinical trials and market exclusivity upon regulatory approval[4].

Increasing Awareness and Healthcare Access

Growing awareness of bone health and expanding healthcare access, particularly in emerging markets, are contributing to the increased adoption of PTH treatments. India, for example, is seeing a rise in demand due to its large patient pool and increasing adoption of advanced treatments[1][4].

Financial Trajectory

Current Market Size

As of 2023, the parathyroid hormone market was valued at approximately $2.35 billion. It is expected to grow to $2.43 billion in 2024, reflecting a CAGR of 3.5% in the historic period[1].

Forecasted Growth

By 2028, the market is projected to reach $3.5 billion, with a CAGR of 9.6% during the forecast period. This growth is driven by the factors mentioned above, including the rising geriatric population, expansion of private healthcare sectors, and emerging indications for PTH treatments[1].

Regional Performance

North America was the largest region in the parathyroid hormone market in 2023. However, the Middle East is expected to be the fastest-growing region during the forecast period. Other significant regions include Asia-Pacific, Western Europe, and South America[1].

Competitive Landscape

The market is characterized by a few key players, including Takeda Pharmaceutical Company Limited, which acquired Shire Plc to enhance its portfolio in rare disease treatments, including PTH products like NATPARA. Other companies like Ascendis Pharma A/S, EnteraBio Ltd, ProLynx, Inc., and Extend Biosciences, Inc. are also developing hormonal therapies with promising patient outcomes[1][4].

Treatment Market Dynamics for Hypoparathyroidism

The hypoparathyroidism treatment market, which heavily relies on PTH, is also growing rapidly. This market was valued at $777.4 million in 2022 and is expected to reach $1,767.4 million by 2033, growing at a CAGR of 7.7% during the forecast period[4].

Dominance of Calcium Supplements

Historically, calcium supplements have dominated the treatment market due to their cost-effectiveness and efficacy. However, the shift towards biologics, such as recombinant PTH, is gaining momentum due to their superior efficacy in mimicking natural body hormones[4].

Emerging Trends

The emergence of personalized medicines, the rapid rise in demand for biologics, and consolidation activities by market players are expected to create significant opportunities for the expansion of the hypoparathyroidism treatment market. Government initiatives, such as orphan drug designations, are further propelling this growth[4].

Key Takeaways

• The parathyroid hormone market is expected to grow significantly, driven by increasing prevalence of chronic diseases, a growing geriatric population, and advances in drug delivery.
• The market is segmented by disease type, product type, and end-user, with recombinant PTH and parathyroid hormone analogues being key product types.
• Government funding and initiatives, such as orphan drug designations, are crucial for market growth.
• The hypoparathyroidism treatment market is shifting towards biologics due to their superior efficacy.
• Regional growth is varied, with North America being the largest market and the Middle East expected to be the fastest-growing region.

FAQs

Q: What is the primary role of parathyroid hormone in the body?

A: Parathyroid hormone (PTH) regulates calcium levels in the body by stimulating bone resorption, reducing renal calcium clearance, and enhancing intestinal calcium absorption through the synthesis of 1,25-dihydroxyvitamin D[2].

Q: Which regions are expected to drive the growth of the parathyroid hormone market?

A: North America is currently the largest region, but the Middle East is expected to be the fastest-growing region during the forecast period[1].

Q: What are the key drivers of the parathyroid hormone market growth?

A: Key drivers include the rising prevalence of chronic diseases like CKD and osteoporosis, a growing geriatric population, advances in drug delivery, and government funding and initiatives[1].

Q: How is the hypoparathyroidism treatment market evolving?

A: The market is shifting towards biologics, such as recombinant PTH, due to their superior efficacy over conventional calcium and vitamin D supplements[4].

Q: What government initiatives are supporting the growth of the parathyroid hormone market?

A: Government initiatives include orphan drug designations, tax incentives for clinical trials, and market exclusivity upon regulatory approval, which are providing significant incentives for market growth[4].

Sources

1. The Business Research Company: Parathyroid Hormone Market Share, Analysis and Growth.
2. American Academy of Family Physicians: Parathyroid Disorders.
3. Maximize Market Research: Hypoparathyroidism Treatment Market - Global Industry Analysis 2029.
4. Future Market Insights: Hypoparathyroidism Treatment Market Analysis & Trends.
5. American Academy of Family Physicians: Parathyroid Disorders (2013).