ORENCIA Drug Profile

Summary for Tradename: ORENCIA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ORENCIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ORENCIA

Recent Clinical Trials for ORENCIA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1
Idelberto Badell	Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1

See all ORENCIA clinical trials

Recent Litigation for ORENCIA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
AMGEN INC. v. APOTEX INC.	2022-06-14
Pharmacyclics LLC v. Alvogen Pine Brook, LLC	2020-03-20

See all ORENCIA litigation

PTAB Litigation

Petitioner	Date
Crescendo Bioscience, Inc et al.	2017-04-12

See all ORENCIA litigation

Pharmacology for ORENCIA

Physiological Effect	Decreased Cytokine Activity
Established Pharmacologic Class	Selective T Cell Costimulation Modulator
Chemical Structure	Recombinant Fusion Proteins

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 ORENCIA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for ORENCIA 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
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2033-03-11	Patent claims search
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2029-01-22	Patent claims search
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2030-10-19	Patent claims search
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2034-01-13	Patent claims search
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2032-02-15	Patent claims search
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2035-03-20	Patent claims search
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118		2039-04-18	Patent claims search

ORENCIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ORENCIA

Introduction

ORENCIA (abatacept) is a biologic drug developed by Bristol-Myers Squibb, primarily used to treat autoimmune diseases such as rheumatoid arthritis (RA) and psoriatic arthritis. Understanding the market dynamics and financial trajectory of ORENCIA is crucial for stakeholders, including investors, healthcare providers, and patients.

Market Size and Forecast

The global market for ORENCIA (abatacept) was valued at approximately USD 2.154 billion in 2023 and is projected to reach USD 2.2268 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 2.2% during the forecast period of 2024-2030[1][4].

Applications and Types

ORENCIA is categorized based on its applications and product types. The primary applications include:

• Rheumatoid Arthritis: This is the most significant application, given the drug's efficacy in moderating to severe early RA.
• Psoriatic Arthritis: Another key application, where ORENCIA helps in managing symptoms.
• Other: This includes other autoimmune conditions where the drug may be prescribed off-label or in clinical trials[1][4].

The product types are:

• Prefilled Syringe
• Vial[1][4].

Geographical Segmentation

The market is segmented geographically into:

• North America: Including the U.S., Canada, and Mexico.
• Europe: Including Germany, the UK, France, and the rest of Europe.
• Asia-Pacific: Including China, Japan, India, and the rest of Asia-Pacific.
• South America
• Middle East and Africa[4].

Competitive Landscape

Bristol-Myers Squibb is the primary player in the ORENCIA market. The competitive environment is analyzed using Porter's Five Forces, which includes buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition. The report also provides insights into the financial statements, product benchmarking, and SWOT analysis of key companies[4].

Financial Performance of Bristol-Myers Squibb

Bristol-Myers Squibb's financial performance is a key indicator of the market's health. In 2022, the company reported total revenues of $46.385 billion, with a 3% increase from the previous year. The revenue from newer products, including those in the immunology segment like ORENCIA, contributed significantly to this growth[5].

Revenue Highlights

• Total Revenues: $46.385 billion in 2022.
• U.S. Revenues: $4.8 billion, up 15% from the previous year.
• Earnings Per Share: $1.07 GAAP and $1.84 non-GAAP for 2022[5].

Research and Development

Research and Development (R&D) expenses are crucial for the continued efficacy and market position of ORENCIA. Bristol-Myers Squibb has consistently invested in R&D, with expenses increasing by 17.7% in FY2023 compared to the previous year. This investment is expected to continue, with a slight decrease to ¥112.0 billion forecasted for FY2024[2].

Clinical Efficacy and Mechanistic Studies

Studies have shown that ORENCIA interferes with disease progression in moderate to severe early rheumatoid arthritis patients. A mechanistic study explored the relationship between a key genetic marker and the clinical efficacy of ORENCIA and another treatment, adalimumab, highlighting the drug's effectiveness in managing RA[3].

Market Drivers and Constraints

Drivers

• Increasing Prevalence of Autoimmune Diseases: The rising incidence of rheumatoid arthritis and psoriatic arthritis drives the demand for effective treatments like ORENCIA.
• Advancements in Biotechnology: Continuous advancements in biologic therapies enhance the efficacy and safety profile of drugs like ORENCIA.
• Government Support and Reimbursement Policies: Favorable reimbursement policies and government support for biologic treatments contribute to market growth[4].

Constraints

• High Cost of Biologic Drugs: The high cost of ORENCIA can be a barrier to access for many patients.
• Competition from Biosimilars: The potential entry of biosimilars could reduce the market share of ORENCIA.
• Regulatory Challenges: Stringent regulatory requirements and the need for continuous clinical trials can pose challenges to the market growth[4].

Regional Market Dynamics

North America

North America, particularly the U.S., is a significant market for ORENCIA due to high healthcare spending and a large patient population. The region is expected to continue driving the market growth[4].

Europe

Europe is another major market, with countries like Germany, the UK, and France contributing substantially. The region's strong healthcare system and favorable reimbursement policies support the market[4].

Asia-Pacific

The Asia-Pacific region, especially countries like China, Japan, and India, is growing rapidly due to increasing healthcare expenditure and a large patient base. This region is expected to play a crucial role in the future growth of the ORENCIA market[4].

Future Outlook

The future outlook for ORENCIA is positive, driven by increasing demand for biologic treatments and ongoing R&D investments. However, the market must navigate challenges such as competition from biosimilars and regulatory hurdles.

Statistics and Projections

• Market Size in 2030: Expected to reach USD 2.2268 billion[1].
• CAGR: 2.2% from 2024 to 2030[1][4].
• Revenue Growth: Driven by increasing prevalence of autoimmune diseases and advancements in biotechnology[4].

Key Takeaways

• The global ORENCIA market is projected to grow at a CAGR of 2.2% from 2024 to 2030.
• The primary applications of ORENCIA are rheumatoid arthritis and psoriatic arthritis.
• Bristol-Myers Squibb is the main player in the market.
• The market is driven by increasing prevalence of autoimmune diseases and advancements in biotechnology.
• High costs and competition from biosimilars are significant constraints.

FAQs

What is the forecasted market size of ORENCIA by 2030?

The forecasted market size of ORENCIA by 2030 is expected to be USD 2.2268 billion[1][4].

Who is the primary manufacturer of ORENCIA?

Bristol-Myers Squibb is the primary manufacturer of ORENCIA[1][4].

What are the main applications of ORENCIA?

The main applications of ORENCIA are rheumatoid arthritis and psoriatic arthritis[1][4].

What are the key drivers of the ORENCIA market?

The key drivers include the increasing prevalence of autoimmune diseases, advancements in biotechnology, and favorable government support and reimbursement policies[4].

What are the significant constraints to the ORENCIA market?

Significant constraints include the high cost of biologic drugs, competition from biosimilars, and regulatory challenges[4].

Sources

1. Valuates Reports: Orencia (Abatacept) Drug - Market Size.
2. Ono Pharma: FY2023 Financial Results Meeting.
3. Bristol Myers Squibb: New Mechanistic Study Explores the Relationship Between a Key Genetic Marker and Clinical Efficacy of ORENCIA.
4. Market Research Intellect: Global Orencia Abatacept Drug Market Size, Trends and Projections.
5. Bristol Myers Squibb: Fourth Quarter and Full-Year Financial Results for 2022.