BLEOMYCIN SULFATE - Generic Drug Details

What are the generic sources for bleomycin sulfate and what is the scope of freedom to operate?

Bleomycin sulfate is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Cipla, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Pharmachemie Bv, Teva Parenteral, and Teva Pharms Usa, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for bleomycin sulfate. Six suppliers are listed for this compound.

Summary for BLEOMYCIN SULFATE

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	79
Patent Applications:	7,511
Drug Prices:	Drug price trends for BLEOMYCIN SULFATE
What excipients (inactive ingredients) are in BLEOMYCIN SULFATE?	BLEOMYCIN SULFATE excipients list
DailyMed Link:	BLEOMYCIN SULFATE at DailyMed

See drug prices for BLEOMYCIN SULFATE

Recent Clinical Trials for BLEOMYCIN SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jinnah Postgraduate Medical Centre	Phase 2
University of Arkansas	Phase 1
AIDS Malignancy Consortium	Phase 1

See all BLEOMYCIN SULFATE clinical trials

Pharmacology for BLEOMYCIN SULFATE

Drug Class

Cytoprotective Agent

Medical Subject Heading (MeSH) Categories for BLEOMYCIN SULFATE

Antibiotics, Antineoplastic

Anatomical Therapeutic Chemical (ATC) Classes for BLEOMYCIN SULFATE

L01DC	Other cytotoxic antibiotics
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BLEOMYCIN SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065033-001	Jun 27, 2000		DISCN	No	No
Teva Parenteral	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	064084-002	Jun 1, 1996		DISCN	No	No
Fresenius Kabi Usa	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065185-001	Jan 28, 2008	AP	RX	No	Yes
Teva Parenteral	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	064084-001	Jun 1, 1996		DISCN	No	No

BLEOMYCIN SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bleomycin Sulfate

Introduction to Bleomycin Sulfate

Bleomycin sulfate is an antineoplastic antibiotic isolated from Streptomyces verticillus, primarily used in the treatment of various types of cancer, including Hodgkin's lymphoma, squamous cell carcinoma, and testicular cancer. It works by binding to DNA, inhibiting DNA synthesis, and causing single-strand scission of DNA[5].

Market Size and Growth Projections

The global market for bleomycin sulfate has been experiencing significant growth. As of 2023, the market was estimated to be worth approximately $285 million. Projections indicate that this market will expand to a readjusted size of $436.7 million by 2030, with a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period of 2024-2030[4].

Market Segmentation

The bleomycin sulfate market is segmented based on several key factors:

By Type

• The primary form of bleomycin sulfate in the market is injectable bleomycin. This form is widely used due to its efficacy and ease of administration[1].

By Application

• The market is driven by its applications in treating various cancers, including:
  • Hodgkin's Lymphoma: A type of lymphoma that affects the immune system.
  • Squamous Cell Carcinoma: A common type of skin cancer.
  • Testicular Cancer: Cancer that affects the testicles[1].

By Geography

• The market is geographically segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics influenced by local healthcare infrastructure, regulatory environments, and patient demographics[1].

Key Drivers of the Market

Several factors are driving the growth of the bleomycin sulfate market:

Increasing Incidence of Cancer

• The rising incidence of cancer globally is a significant driver. As the population ages and lifestyle factors contribute to higher cancer rates, the demand for effective cancer treatments like bleomycin sulfate increases[4].

Advancements in Treatment Modalities

• Research into new delivery methods, such as nanoaerosols, is enhancing the efficacy and safety of bleomycin sulfate. For instance, studies on bleomycin nanoaerosol have shown promising results in treating multiple lung metastases[3].

Regulatory Support

• Favorable regulatory environments in various countries are facilitating the approval and distribution of bleomycin sulfate. This support helps in expanding the market reach and accessibility of the drug.

Market Restraints and Challenges

Despite the growth potential, the market faces several challenges:

Side Effects and Toxicity

• Bleomycin sulfate can cause significant side effects, including pulmonary toxicity, which can limit its use in some patients. Managing these side effects is a critical challenge for healthcare providers[5].

Competition from Alternative Treatments

• The emergence of new cancer therapies and treatments can pose a competitive threat to bleomycin sulfate. Patients and healthcare providers may opt for newer treatments with potentially better efficacy and safety profiles.

Storage and Handling Requirements

• Bleomycin sulfate has specific storage and handling requirements, such as refrigeration at 2°C to 8°C, which can be a logistical challenge, especially in regions with limited healthcare infrastructure[2].

Key Players in the Market

The bleomycin sulfate market is dominated by several major pharmaceutical companies:

Pfizer Inc.

• Known for its extensive portfolio of oncology drugs, Pfizer is a significant player in the bleomycin sulfate market.

Bristol-Myers Squibb Company

• This company has a strong presence in the oncology segment and contributes substantially to the bleomycin sulfate market.

Teva Pharmaceutical Industries Ltd.

• Teva is another major player, offering a range of generic and branded oncology products, including bleomycin sulfate.

Fresenius Kabi AG

• Fresenius Kabi is a global healthcare company that provides a variety of oncology treatments, including bleomycin sulfate[1].

Financial Performance and Projections

The financial trajectory of the bleomycin sulfate market is promising, with significant growth expected over the next few years.

Revenue Forecast

• The market is projected to grow from $285 million in 2023 to $436.7 million by 2030, indicating a robust financial performance driven by increasing demand and expanding applications[4].

Market Share

• Key players are expected to maintain their market share through strategic investments in research and development, marketing, and distribution. New entrants may also emerge, contributing to market competition and innovation.

Regional Market Analysis

The growth of the bleomycin sulfate market varies by region:

North America and Europe

• These regions are expected to continue as major markets due to their well-developed healthcare systems and high incidence of cancer.

Asia-Pacific

• This region is anticipated to show significant growth due to increasing healthcare spending, a growing population, and rising cancer incidence rates.

South America and Middle East & Africa

• These regions are also expected to grow, albeit at a slower pace, due to improving healthcare infrastructure and increasing awareness about cancer treatments[1].

Conclusion

The bleomycin sulfate market is poised for significant growth driven by increasing cancer incidence, advancements in treatment modalities, and favorable regulatory environments. Despite challenges such as side effects and competition from alternative treatments, the market is expected to expand substantially over the next few years.

Key Takeaways

• The global bleomycin sulfate market is projected to grow from $285 million in 2023 to $436.7 million by 2030.
• The market is driven by its applications in treating Hodgkin's lymphoma, squamous cell carcinoma, and testicular cancer.
• Key players include Pfizer, Bristol-Myers Squibb, Teva Pharmaceutical Industries, and Fresenius Kabi.
• The market faces challenges such as side effects, competition from new treatments, and specific storage and handling requirements.
• Regional growth varies, with North America and Europe leading and Asia-Pacific showing significant potential.

FAQs

Q: What is the primary use of bleomycin sulfate?

A: Bleomycin sulfate is primarily used in the treatment of various types of cancer, including Hodgkin's lymphoma, squamous cell carcinoma, and testicular cancer.

Q: What is the projected market size of bleomycin sulfate by 2030?

A: The market is forecast to reach $436.7 million by 2030, growing at a CAGR of 6.4% from 2024 to 2030[4].

Q: Which companies are the major players in the bleomycin sulfate market?

A: Major players include Pfizer Inc., Bristol-Myers Squibb Company, Teva Pharmaceutical Industries Ltd., and Fresenius Kabi AG[1].

Q: What are the specific storage and handling requirements for bleomycin sulfate?

A: Bleomycin sulfate must be stored under refrigeration at 2°C to 8°C and should not be reconstituted or diluted with dextrose-containing diluents[2].

Q: How does bleomycin sulfate work?

A: Bleomycin sulfate binds to DNA, inhibits DNA synthesis, and causes single-strand scission of DNA, leading to the inhibition of tumor growth and induction of apoptosis[5].

Sources

1. Market Research Intellect: "Bleomycin Sulfate Sales Market Size, Scope And Forecast Report"
2. Pfizer Medical Information: "Bleomycin for Injection, USP How Supplied/Storage and Handling"
3. MDPI: "Antitumor Effect of Bleomycin Nanoaerosol in Murine Carcinoma"
4. Valuates Reports: "Bleomycin Sulfate - Market, Report Size, Worth, Revenue, Growth"
5. Sigma-Aldrich: "Bleomycin sulfate (B5507) - Product Information Sheet"