You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

KADCYLA Drug Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Tradename: KADCYLA
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for KADCYLA
Recent Clinical Trials for KADCYLA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Seagen Inc.Phase 2
M.D. Anderson Cancer CenterPhase 2
HighField Biopharmaceuticals CorporationPhase 1

See all KADCYLA clinical trials

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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 KADCYLA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

3) Low Certainty: US Patents for KADCYLA Derived from Patent Text Search

These patents were obtained by searching patent claims

KADCYLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KADCYLA

Introduction to KADCYLA

KADCYLA, developed by Roche, is an antibody-drug conjugate (ADC) that has been a cornerstone in the treatment of HER2-positive breast cancer. Here, we delve into the market dynamics and financial trajectory of KADCYLA, highlighting its performance, challenges, and future outlook.

Market Dominance of KADCYLA

Global ADC Market Leadership

KADCYLA has consistently held a dominant share in the global antibody-drug conjugates market. In 2022, it accounted for the largest share of the ADC market, driven primarily by its extensive use in breast cancer treatment[3][5].

Revenue Performance

KADCYLA generated significant revenues over the years, with sales of approximately USD 1.8 billion, 2 billion, and 2 billion in 2020, 2021, and 2022, respectively. Despite a 3% decline in sales in the US in 2022 due to competition, KADCYLA saw a strong uptake in the EU, Japan, and other international markets, particularly in the adjuvant early breast cancer setting[1].

Market Drivers

Rising Prevalence of Cancer

The increasing incidence of breast cancer is a key driver for the growth of KADCYLA. The rising demand for effective treatments, coupled with the drug's approval for various indications, has propelled its market performance[3][5].

Clinical Expansions and Approvals

KADCYLA's label expansion to include patients with early breast cancer has been a significant factor in its market success. The drug received FDA approval in 2013 for HER2-positive metastatic breast cancer treatment and has since seen approvals in other settings, further boosting its market share[1].

Industrial Collaborations and Research

The ADC market, including KADCYLA, benefits from robust research and development activities and industrial collaborations. For instance, collaborations between major pharmaceutical companies to develop and commercialize new ADCs are driving market growth[5].

Market Restraints

Competition from Other ADCs

The emergence of other ADCs, such as ENHERTU, poses a significant challenge to KADCYLA's market dominance. ENHERTU, approved for the second-line setting, has been included in the ASCO treatment guidelines and has seen its annual sales surge, potentially threatening KADCYLA's market share[1].

Biosimilar Impact

The launch of biosimilars for HERCEPTIN, another Roche product, could impact KADCYLA's sales as patients with residual disease may switch to these more affordable alternatives. This was evident in the decline of PERJETA sales in certain regions due to the launch of PHESGO[1].

Regional Variations

KADCYLA's performance varies by region. While it has seen growth in the EU, Japan, and internationally, it faced declines in the US and EU due to different market dynamics and competition[1].

Financial Performance

Sales and Revenue

KADCYLA's sales have been substantial, contributing significantly to Roche's pharmaceutical division. The drug's sales growth has been steady, although it faced a slight decline in 2022 in certain regions[1].

Royalty Revenues

ImmunoGen, the company that developed the technology used in KADCYLA, receives royalty revenues from Roche's sales of the drug. In 2015, ImmunoGen reported $13.9 million in cash royalty revenues and $5.5 million in non-cash royalty revenues from KADCYLA sales[4].

Strategic Moves and Market Adaptation

Price Adjustments

Roche made a strategic move by reducing the price of KADCYLA by over 50% in China, aiming to capture a larger market share through competitive pricing. This move has been pivotal in China, which has become one of Roche's largest markets[5].

Market Expansion

KADCYLA's approval in China in January 2022 marked a significant expansion of its market reach. This approval, along with other regional approvals, has helped in maintaining its market dominance[5].

Future Outlook

Market Growth Projections

The global ADC market, including KADCYLA, is projected to grow significantly. The market is expected to reach USD 19.8 billion by 2028 from USD 9.7 billion in 2023, at a CAGR of 15.2% during the forecast period[3].

Competitive Landscape

Despite the emergence of competitors like ENHERTU, KADCYLA is expected to remain a major player in the ADC market. However, it will need to navigate the competitive landscape and adapt to changing market dynamics to maintain its position[1][3].

Regional Growth

Asia-Pacific Region

The Asia-Pacific region is anticipated to grow at a significant CAGR during the forecast period, driven by rising approvals for ADCs in China and Japan. This region is expected to be a key growth driver for KADCYLA and the broader ADC market[3][5].

Key Takeaways

  • Market Leadership: KADCYLA has consistently dominated the global ADC market, particularly in breast cancer treatment.
  • Revenue Performance: Despite regional variations, KADCYLA has generated substantial revenues, with a slight decline in some regions due to competition.
  • Market Drivers: Rising cancer prevalence, clinical expansions, and industrial collaborations drive KADCYLA's market success.
  • Market Restraints: Competition from other ADCs and the impact of biosimilars are significant challenges.
  • Future Outlook: The ADC market is projected to grow significantly, with KADCYLA expected to remain a major player despite competitive pressures.

FAQs

What is KADCYLA used for?

KADCYLA is an antibody-drug conjugate used primarily for the treatment of HER2-positive breast cancer, including metastatic and early breast cancer settings.

How has KADCYLA performed in terms of sales?

KADCYLA generated sales of approximately USD 1.8 billion, 2 billion, and 2 billion in 2020, 2021, and 2022, respectively, with a slight decline in the US in 2022 due to competition.

What are the main drivers of KADCYLA's market growth?

The main drivers include the rising prevalence of breast cancer, clinical expansions and approvals, and robust industrial collaborations and research activities.

What are the key challenges facing KADCYLA in the market?

Key challenges include competition from other ADCs like ENHERTU, the impact of biosimilars, and regional market variations.

What is the projected growth of the ADC market, including KADCYLA?

The global ADC market is projected to reach USD 19.8 billion by 2028 from USD 9.7 billion in 2023, at a CAGR of 15.2% during the forecast period.

How has Roche adapted its strategy for KADCYLA in different markets?

Roche has made strategic price adjustments, such as a 50% price reduction in China, to capture a larger market share and has expanded its market reach through approvals in new regions.

Sources

  1. Roche's HER2-Positive Breast Cancer Treatment Franchise - DelveInsight
  2. Finance Report 2022 - Roche - Roche
  3. Kadcyla Leads the Global Antibody Drug Conjugates Market with Extensive Use in Breast Cancer Treatment - PR Newswire
  4. ImmunoGen, Inc. Reports Fourth Quarter and Fiscal Year 2015 - ImmunoGen
  5. Antibody Drug Conjugates Market Size to Reach USD 28.61 Bn by 2033 - BioSpace

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.