Alemtuzumab - Biologic Drug Details

Summary for alemtuzumab

Tradenames:	2
High Confidence Patents:	7
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for alemtuzumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alemtuzumab

Recent Clinical Trials for alemtuzumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1
Assistance Publique - Hôpitaux de Paris	Phase 2
City of Hope Medical Center	Phase 1

See all alemtuzumab clinical trials

Recent Litigation for alemtuzumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all alemtuzumab litigation

PTAB Litigation

Petitioner	Date
Miltenyi Biomedicine GmbH et al.	2022-04-12
GEMoaB Monoclonals GmbH et al.	2019-12-20
Forty Seven, Inc.	2018-01-08

See all alemtuzumab litigation

Pharmacology for alemtuzumab

Mechanism of Action	CD52-directed Antibody Interactions
Established Pharmacologic Class	CD52-directed Cytolytic Antibody

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 alemtuzumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	5,545,403	2013-08-13	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	5,545,405	2013-08-13	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	5,654,403	2014-08-05	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	5,846,534	2015-12-08	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	6,290,961	2013-12-28	Company disclosures
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	6,569,430	2020-05-27	Company disclosures

3) Low Certainty: US Patents for alemtuzumab 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
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10,016,338	2033-03-11	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10,022,427	2028-04-10	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10,022,451	2039-02-26	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10,047,163	2033-02-08	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10,053,498	2034-11-21	Patent claims search
Genzyme Corporation	CAMPATH	alemtuzumab	Injection	103948	10,059,765	2023-07-24	Patent claims search

International Patents for alemtuzumab

Country	Patent Number	Estimated Expiration
Austria	E95068
European Patent Office	1477183
European Patent Office	0770395
European Patent Office	1502600
Germany	10199051
Japan	2002068989

Supplementary Protection Certificates for alemtuzumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
25/2016	Austria		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 (MITTEILUNG) 20130916
CA 2016 00026	Denmark		PRODUCT NAME: ALEMTUZUMAB; REG. NO/DATE: EU/1/13/869 20130916
16C0023	France		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 20130916
122008000043	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
122008000042	Germany		PRODUCT NAME: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYP A (150KD), FREI VON KOMPLEXPROTEINEN; REGISTRATION NO/DATE: 57093.00.00 20050531
PA2016019,C2066352	Lithuania		PRODUCT NAME: ALEMTUZUMABAS; REGISTRATION NO/DATE: EU/1/13/869 20130912

Market Dynamics and Financial Trajectory of Alemtuzumab

Introduction to Alemtuzumab

Alemtuzumab is a monoclonal antibody that targets the CD52 protein on immune cells, making it a crucial treatment for relapsing-remitting multiple sclerosis (RRMS), certain non-Hodgkin lymphomas, and chronic lymphocytic leukemia. By depleting these immune cells, alemtuzumab reduces the inflammatory reactions that target nerve structures, although this can also lead to side effects such as thyroid problems and increased infection risk[1].

Market Overview

The alemtuzumab market is anticipated to grow at a robust compound annual growth rate (CAGR) over the next decade. This growth is driven by several key factors, including increasing disease prevalence, innovations in therapy, and rising healthcare investments[4].

Global Market Size and Forecast

The alemtuzumab market is projected to reach a significant value by 2034, with North America currently dominating the market, holding more than 47% of the revenue share. This dominance is attributed to strong research institutions, advanced healthcare facilities, a thriving pharmaceutical sector, and supportive legislative frameworks[1].

Regional Market Dynamics

• North America: This region leads the market due to its well-developed healthcare infrastructure, strong research institutions, and favorable regulatory environment[1].
• Europe: Europe is the second-largest region, driven by comprehensive healthcare legislation, efficient reimbursement programs, and a strong emphasis on cutting-edge medicines[1].
• Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period, driven by rising healthcare spending, improved access to advanced medicines, and an increasing prevalence of autoimmune disorders and leukemia[1].

Key Drivers of Market Growth

Increasing Disease Prevalence

The rising prevalence of autoimmune diseases and cancers is a significant driver of the alemtuzumab market. As more patients are diagnosed with conditions such as RRMS and chronic lymphocytic leukemia, the demand for effective treatments like alemtuzumab increases[4].

Advancements in Immunotherapy

Ongoing research and innovations in immunotherapy are expanding the therapeutic applications of alemtuzumab. This includes exploring its use in treating other autoimmune disorders and cancers, which is expected to further boost market growth[4].

Rising Healthcare Investments

Increasing global healthcare investments are another critical factor. Emerging economies in Asia-Pacific, Latin America, and Africa are investing heavily in healthcare, which is improving access to advanced therapies like alemtuzumab[4].

Financial Trajectory

Budgetary Impact

The inclusion of alemtuzumab in treatment protocols can have a positive budgetary impact. For instance, a study in Quito showed that using alemtuzumab as escalation therapy for RRMS patients resulted in a 5.73% reduction in the total 5-year budget, representing an average saving of $7,146 per patient over five years[2].

Cost Breakdown

The total costs associated with alemtuzumab treatment include drug costs, administration costs, monitoring costs, and costs related to adverse events and relapses. While the initial drug costs may be higher, the overall cost savings come from reduced administration, monitoring, and relapse costs over time[2].

Revenue Estimates and Forecasts

The alemtuzumab market is estimated to grow significantly, with revenue projections indicating a substantial increase by 2034. The market size in 2024 is valued at USD XX Million and is expected to grow at an approximate CAGR of XX% during the forecast period[1].

Distribution Channels

The distribution of alemtuzumab occurs through various channels, including hospitals, specialty clinics, retail pharmacies, and online pharmacies. Each channel plays a crucial role in ensuring the drug reaches patients efficiently[1].

Key Market Players

The alemtuzumab market is dominated by several major companies, including Sanofi, TargetMol Chemicals, DC Chemicals, Hefei Hirisun Pharmatech, and others. These companies are driving innovation and market expansion through strategic partnerships and continuous research[1].

Challenges and Opportunities

Regulatory Hurdles

Despite its growth potential, the alemtuzumab market faces challenges such as stringent regulatory approvals, which can delay the launch of new formulations and expanded indications. However, consistent clinical success is expected to overcome these challenges[4].

Competition from Alternative Therapies

Alemtuzumab faces competition from other therapies, but its unique mechanism of action and proven results ensure its continued relevance in the pharmaceutical industry. Innovations in drug delivery and expanding therapeutic indications are key strategies to maintain market leadership[4].

Emerging Markets

Emerging economies present significant opportunities for the alemtuzumab market. Improved healthcare access and rising awareness about autoimmune and cancer therapies in regions like Asia-Pacific, Latin America, and Africa are boosting demand for this drug[4].

Recent Trends and Innovations

Expanding Therapeutic Indications

Ongoing research is exploring the use of alemtuzumab in broader therapeutic areas, including other autoimmune disorders and cancers. This expansion is expected to further drive market growth[4].

Innovations in Drug Delivery

Innovations in drug delivery systems are enhancing the efficacy and convenience of alemtuzumab treatment. These advancements are crucial for maintaining the drug's market position[4].

Strategic Partnerships

Companies are engaging in strategic partnerships to enhance market reach and product efficacy. These partnerships are vital for driving growth and overcoming market challenges[4].

Conclusion

The alemtuzumab market is poised for significant growth driven by increasing disease prevalence, advancements in immunotherapy, and rising healthcare investments. Despite facing regulatory hurdles and competition, the unique mechanism of action and proven results of alemtuzumab ensure its continued relevance and growth potential.

Key Takeaways

• The alemtuzumab market is expected to grow at a robust CAGR over the next decade.
• North America dominates the market, followed by Europe and the Asia Pacific.
• Increasing disease prevalence and advancements in immunotherapy are key drivers.
• The drug offers budgetary savings through reduced long-term costs.
• Regulatory hurdles and competition are challenges, but innovation and strategic partnerships mitigate these issues.
• Emerging markets present significant growth opportunities.

Frequently Asked Questions (FAQs)

What is Alemtuzumab used for?

Alemtuzumab is used to treat relapsing-remitting multiple sclerosis (RRMS), certain non-Hodgkin lymphomas, and chronic lymphocytic leukemia by targeting the CD52 protein on immune cells[1].

Which region dominates the Alemtuzumab market?

North America currently dominates the alemtuzumab market, holding more than 47% of the revenue share[1].

What are the key drivers of the Alemtuzumab market growth?

The key drivers include increasing disease prevalence, advancements in immunotherapy, and rising global healthcare investments[4].

How does Alemtuzumab impact the budget in healthcare settings?

The inclusion of alemtuzumab can result in budgetary savings over the long term, with an average saving of $7,146 per patient over five years in some scenarios[2].

What challenges does the Alemtuzumab market face?

The market faces challenges such as stringent regulatory approvals and competition from alternative therapies, but consistent clinical success and innovation help mitigate these issues[4].

Cited Sources:

1. We Market Research: Alemtuzumab Market 2024-2034 | Segmented by Type, Application...
2. PMC: The budgetary impact of alemtuzumab in multiple sclerosis in Quito...
3. IQVIA: Realizing Biosimilar Potential in the Middle East & Africa
4. Market Research Intellect: Alemtuzumab Market Size And Projection[4]