Adalimumab-fkjp - Biologic Drug Details

Summary for adalimumab-fkjp

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	3

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 adalimumab-fkjp Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for adalimumab-fkjp Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for adalimumab-fkjp Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Adalimumab (HUMIRA)

Market Overview

Adalimumab, marketed under the brand name HUMIRA, is a biologic drug used to treat various autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ulcerative colitis, ankylosing spondylitis, and Crohn's disease. The market for adalimumab is experiencing significant growth driven by several key factors.

Drivers of Market Growth

Rise in Autoimmune Diseases

The increasing incidence of autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease is a major driver of the adalimumab market. As the prevalence of these chronic conditions rises, so does the demand for effective treatments like adalimumab[1][3].

Increasing Healthcare Expenditure

Growing healthcare expenditure is another significant factor. Investments in healthcare infrastructure and the expansion of healthcare services are enhancing the accessibility and affordability of biologic drugs like adalimumab[1].

Rising Geriatric Population

The surging number of geriatric individuals, who are more prone to chronic ailments, is also propelling the market's growth. By 2050, the global population of people aged 65 and above is expected to increase to 1.5 billion, further boosting the demand for adalimumab[1].

Market Size and Forecast

The global adalimumab market was valued at USD 20,912.1 million in 2021 and is projected to reach USD 31,610.01 million by 2029, growing at a CAGR of 5.30% during the forecast period of 2022 to 2029[1].

Regional Market Dynamics

North America

North America dominates the adalimumab market, driven by excellent healthcare infrastructure, effective government policies, and high public awareness about diagnosis and medical assistance. The region's large base of multinational corporations and significant spending on healthcare also contribute to its leading position[3].

Europe

Europe is another significant market for adalimumab, with key players and increasing investment in research and development activities. The presence of advanced healthcare infrastructure and high prevalence of autoimmune diseases in Europe support the market's growth[3].

Asia Pacific

The Asia Pacific region is expected to grow at the highest CAGR during the forecast period, driven by increasing awareness about autoimmune diseases and rising healthcare expenditure. This region offers substantial growth opportunities due to its large population and improving healthcare infrastructure[3].

Impact of Biosimilars

Market Share and Adoption

Adalimumab biosimilars have seen a significant increase in market share, rising from 2% in early 2024 to 22% by September 2024. This growth is driven by payers and pharmacy benefit managers prioritizing biosimilars over the reference product, HUMIRA, due to their cost-effectiveness[4].

Financial Implications

The introduction of biosimilars is expected to bring sizable savings. For instance, the average sales prices (ASPs) of all biosimilars have decreased by 53% over the first five years post-launch. However, manufacturers must balance the ASPs of biosimilars to ensure reasonable reimbursement while offering competitive pricing[4][5].

Key Players and Competitive Landscape

The global adalimumab market is dominated by several key players, including AbbVie Inc., Amgen Inc., Fresenius Kabi AG, Celltrion Healthcare Co Ltd, Alvotech Ehf., Bio-Thera Solutions Ltd., and Biocon Biologics Limited. These companies are investing heavily in research and development and expanding their market shares through strategic collaborations and product launches[2][3].

Financial Performance of Key Players

Biocon Biologics

Biocon Biologics, a subsidiary of Biocon Limited, reported a strong performance in Q1FY25, with a 30% year-on-year growth in consolidated revenue to Rs 4,567 crore. The biosimilars business delivered an 11% like-for-like growth, driven by market share gains, tender wins, and new product launches. This growth was underpinned by significant investments in research and development and strategic collaborations[2].

Challenges and Opportunities

High R&D Costs

One of the major challenges in the adalimumab market is the high cost of clinical trials and research and development. Despite heavy R&D spending, manufacturers must keep their product prices competitive, which can limit growth opportunities[3].

Increasing Awareness and Government Initiatives

Rising initiatives by public and private organizations to spread awareness about autoimmune diseases and the growing adoption of biologic drugs present significant opportunities for market growth. Government initiatives and optimal costs of biosimilar drugs are also driving the market forward[1][3].

COVID-19 Impact

The COVID-19 pandemic caused disruptions in the supply chain and manufacturing activities of adalimumab, but the market is expected to recover in the post-pandemic period. The increasing demand for effective treatments for autoimmune diseases is driving the market's recovery[3].

Key Takeaways

• The global adalimumab market is expected to reach USD 31,610.01 million by 2029, growing at a CAGR of 5.30%.
• The rise in autoimmune diseases and increasing healthcare expenditure are key drivers of market growth.
• North America dominates the market, followed by Europe and the Asia Pacific region.
• Biosimilars are significantly impacting the market, with a notable increase in market share and cost savings.
• Key players are investing heavily in R&D and strategic collaborations to expand their market shares.

FAQs

What is the current market size of the global adalimumab market?

The global adalimumab market was valued at USD 20,912.1 million in 2021[1].

What is the projected CAGR for the adalimumab market from 2022 to 2029?

The adalimumab market is expected to grow at a CAGR of 5.30% from 2022 to 2029[1].

Which region dominates the adalimumab market?

North America dominates the adalimumab market, followed by Europe and the Asia Pacific region[3].

How have biosimilars impacted the adalimumab market?

Biosimilars have increased their market share from 2% to 22% by September 2024, driven by their cost-effectiveness and prioritization by payers and pharmacy benefit managers[4].

What are the major challenges in the adalimumab market?

High R&D costs and the need to balance ASPs of biosimilars to ensure competitive pricing are major challenges in the market[3][5].

Sources:

1. Data Bridge Market Research - Global Adalimumab Market – Industry Trends and Forecast to 2029
2. Biocon - Biocon Q1FY25 Revenue up 30% at Rs 4567 Cr EBITDA up 117%
3. Expert Market Research - HUMIRA (Adalimumab) drug Market Research, Size, Share, 2032
4. Center for Biosimilars - Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
5. Pharmacy Times - Biosimilar Market Outlook Looks Strong