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US Breast
Cancer Market
Breast Cancer Therapeutics Market Size, And Share, By Therapy
(Targeted Therapy, Hormonal Therapy, Chemotherapy,
Immunotherapy), By Cancer Type (Hormone Receptor, HER2+), By
Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online
Pharmacies), and Forecast, 2019-2028
2
2 Confidential
Table of Content
1. US Breast Cancer Market Overview……………………………………..……………………………………………………………………………………………….05
a. Market size and forecast
2. Market Growth Drivers………………………………………………………………………………………………………...............................................................07
a. Increase in diagnosis and treatment
b. Increase in prevalence of Breast Cancer
c. Technologically advanced therapeutics
3. Major Indication Contributing US Breast Cancer Market ……………………………………………………………………………………………….................12
a. Prevalence of different cancer type
i. Hormone receptor
ii. HER2+
b. Unmet needs
4. Breast Cancer Market Segmentation………………………………………………………………………………………………………………………………………16
a. Drugs By Therapy class
i. Chemotherapy
ii. Targeted therapy
iii. Immunotherapy
iv. Hormonal therapy
3
3 Confidential
Table of Content
b. By Drug Type
i. HER2 Inhibitors
ii. Mitotic Inhibitors
iii. Aromatase Inhibitors
iv. CDK 4/6 Inhibitors
v. Hormonal Receptors
c. By Distribution Channel
i. Hospital Pharmacies
ii. Retail Pharmacies
iii. Online Pharmacies
5. Breast Cancer Epidemiology..………………………………………………………………………………………………………………………………….……….20
a. By Type of cancer
b. By Incidence cases and mortality
6. Competitive Landscape ..………………………………………………………………………………………………………………………………….…………...23
a. Top companies in R&D Pipeline
b. Key advancements in breast cancer market of US
c. Key Industry Start-ups for Breast Cancer in US
7. Key Company Profiles………………………………………………………………………….………………………………………………………………………..28
a. Agilent Technologies overview, Product & Services, Strategies & Financials
4
4 Confidential
Table of Content
b. AstraZeneca overview, Product & Services, Strategies & Financials
c. Bristol Myers Squibb overview, Product & Services, Strategies & Financials
d. Eli Lilly overview, Product & Services, Strategies & Financials
e. Novartis overview, Product & Services, Strategies & Financials
f. Onyx Pharmaceuticals overview, Product & Services, Strategies & Financials
g. Orion overview, Product & Services, Strategies & Financials
h. Pfizer overview, Product & Services, Strategies & Financials
i. Philips Healthcare
j. Siemen Healthineers
8. Access and Reimbursement Scenario…………………………………………………….………………………………………………………………………….49
a. Key market access considerations
b. General reimbursement environment
9. Factors Driving Future Growth…………………………………………………………………………………………………………………………………...……51
a. Key Industry Developments of Breast Cancer market
b. Ongoing clinical trials for breast cancer patients in US
10. Conclusion…………………………………………………………………………………………………………………………………………………………………54
5
US Breast Cancer Market Overview
6
6 Confidential
US Breast Cancer Market- Market Size & Forecast Overview
The overall Breast Cancer market in US will experience sizable growth over the forecast period, increasing from $xx billion in 2019 to
over xx billion in 2028 with a CAGR of 9.1%
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
US Breast Cancer Market Size ($Bn) (2019-2028)
 U.S. market accounted for the highest regional share in
2018 and was valued around USD 6,698.3 million. The
growth is attributed to growing prevalence of breast
cancer and increasing R&D funding through public and
private sectors
 In 2021, an estimated 281,550 new cases of invasive
breast cancer are expected to be diagnosed in women
in the US., along with 49,290 new cases of non-invasive
(in situ) breast cancer
 We expect the market to continue to grow at a rate of
over xx% annually, driven primarily by the release of key
treatment guidance, new drug launches in the US and
increasing drug availability in other regions, and
increasing physician education
Key Findings
7
US Breast Cancer Market Growth Drivers
8
8 Confidential
Market Growth Drivers
Technologically advanced
Therapeutics
Increase in prevalence of Breast
Cancer
Increase in diagnosis and
treatment
Market Growth Drivers of US
Breast Cancer Market
9
9 Confidential
Market Growth Drivers
Increase in diagnosis and treatment
New Jersey’s healthcare institutions are developing targeted, individualized treatments to improve breast cancer
outcomes and provide patients with a better quality of life
Content
Content
Content
10
10 Confidential
Market Growth Drivers
Increase in prevalence of breast cancer
Increased prevalence is one of the foremost US growth driver of breast cancer and is expected to result in large
patient population demanding accurate and efficient treatment options
The increase in demand of preventive care and early treatment has led many individuals to undergo cancer
screening tests driving number of patients to demand treatment in the forecast period
Content
Content
11
11 Confidential
Market Growth Drivers
Technologically advanced therapeutics
Some of the new product launches in US are specifically aimed at the treatment of breast cancer that was previously
untreatable, or the earlier treatments were not successful in terms of improved outcomes for patients, for example,
Trodelvy
The US FDA granted accelerated approval to Trodelvy (Sacituzumab govitecan-hziy) for the treatment of adult
patients with triple negative breast cancer that has spread to the other parts of the body
Content
Content
12
Major Indications Contributing US Breast Cancer
Market
13
13 Confidential
Major Indications- Prevalence Of Cancer Type
Hormone
Receptor
 Hormone receptor segment is likely to dominate the market during the forecast period
because of rising volume of breast cancer patients belonging to this type of cancer and is
expected to maintain dominance during the forecast period
 Content
14
14 Confidential
Major Indications- Prevalence Of Cancer Type
HER2+
 The HER2+ segment accounted for a lower share of the global market but is expected to
register a comparatively higher CAGR in US due to the recent launches of therapeutics for
the treatment of breast cancer
 Several HER2-targeted therapies are approved for the treatment of HER2-overexpressing
breast cancer
 The approval of trastuzumab deruxtecan underscores that this specifically engineered HER2-
directed antibody-drug conjugate is delivering on its intent to establish an important new
treatment for patients with HER2-positive metastatic breast cancer
 Content
15
15 Confidential
Major Indications- Unmet Needs
 Despite the number of therapy options available,
advanced or metastatic HR-positive / HER2-negative
breast cancer remains incurable and a major cause of
mortality and morbidity in women
 There is a greater need for treatment regimens that are
less burdensome for patients and their caregivers, as
well as reducing health care costs associated with the IV
administration of anticancer regimens
 Content
 Despite the number of treatment options for patients with
mBC, unmet needs remain pertaining to disease control,
prolonging the interval to intensive cytotoxic therapy, and
treatment-related complications
 Content
 Content
16
US Breast Cancer Market Segmentation
17
17 Confidential
Market Segmentation- By Therapy Class
Market Share, By Therapy Class, 2019
 The targeted therapy segment held a dominant share of
the market in 2019 owning to the greater adoption in US
 The hormonal therapy segment is anticipated to register a
lower market share in the forecast period. This is primarily
attributed to the increasing availability of generic
equivalents of hormonal therapy drugs
 Chemotherapy is anticipated to register a lower growth rate
and share due to the increasing influx of generic
equivalents
 The Immunotherapy is set to register a higher growth rate
due to their recent regulatory approvals by the US FDA
 Content
Key Highlights
18
18 Confidential
Market Segmentation- By Drug type
Market Share, By Drug Type (%), 2019
 The targeted CDK 4/6 segment held a dominant share of
the market in 2019 owning to the greater adoption in US
 The HER2 Inhibitors segment is anticipated to register a
lower market share in the forecast period. This is primarily
attributed to the increasing availability of generic
equivalents of hormonal therapy drugs
 Content
Key Highlights
19
19 Confidential
Market Segmentation- By Distribution Channel
 The hospital pharmacies segment is projected to account
for a higher share of the US market because of the
dependency of patients on these pharmacies for the
administration of therapies, such as chemotherapy
 Retail pharmacies segment account for the second largest
share in the forecast period since a large number of
patients depend on them for the filling up of oral
prescription drugs
 Online pharmacies segment is expected to showcase the
highest CAGR as the increasing number of patients have
shifted to these pharmacies as a means of acquiring
therapeutics due to their greater ease in terms of usage
 Content
Key Highlights
Market Share, By Distribution Channel, 2019
20
Breast Cancer Epidemiology
21
21 Confidential
Epidemiology Population - By Type
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
HR-/HER2+ 4 xx xx xx xx xx xx xx xx xx
HR-/HER2- 12 xx xx xx xx xx xx xx xx xx
HR+/HER2+ 11 xx xx xx xx xx xx xx xx xx
HR+/HER2- 73 xx xx xx xx xx xx xx xx xx
 HR+/HER2- type of breast cancer in US is most prevalent compared to others in 2019
 Content
Key Highlights
Epidemiology Population - By Type of Breast Cancer (2019-2028), by %
22
22 Confidential
Epidemiology Population - By Incidence cases and mortality
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028
Invasive Breast Cancer xx 276,480 281,550 xx xx xx xx xx xx xx
Ductal Carcinoma xx xx 49290 xx xx xx xx xx xx xx
Mortality xx 42,170 43600 xx xx xx xx xx xx xx
 The American Cancer Society's estimates for breast cancer in the United States for 2021 is that, about 281,550 new cases of
invasive breast cancer will be diagnosed in women, about 49,290 new cases of ductal carcinoma will be diagnosed and, about
43,600 women will die from breast cancer
 Content
Key Highlights
Epidemiology Population - By Prevalence and mortality of Breast Cancer (2019-2028), by number
23
Competitive Landscape
24
24 Confidential
Competitive Landscape- R & D
 The ongoing R&D initiatives for the development and the marketing of efficient drugs for the breast cancer treatment for the
development of advanced therapeutics for better outcomes
 The trends is expected to significantly boost the global breast cancer therapeutics market growth with the launch of new
product, increasing sales of breast cancer drugs and the inclusion of new patients in the treatment process as more types of
breast cancer are anticipated to be treated through these new drugs
 Content
Sanofi, one of the key players in the breast cancer therapeutics industry has been conducting R&D initiatives for the
development of novel oral treatments for metastatic breast cancer
AstraZeneca has been conducting R&D activities for the development of therapeutics to treat estrogen receptor-positive
breast cancer
Content
R&D Initiatives
25
25 Confidential
Key advancement in breast cancer market of US
Novartis breast cancer drug - Piqray have improved patient outcomes, several treatment gaps
remain
Radius Health’s Elacestrant, an oral Selective Estrogen Receptor Degrader (SERD) that is being
studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast
cancer and has been anticipated that this analysis will take place in the second half of 2021
Gilead Sciences’ acquisition of Immunomedics, the manufacturer of sacituzumab govitecan-hziy, is
expected to advance the development of the antibody-drug conjugate not only across additional
types of breast cancer beyond triple-negative disease, but also in other solid tumors
Content
Content
26
26 Confidential
Key Industry Start-ups For Breast Cancer in US
1.4
5.9
24.7
100.5
868.6
Ithema
TeVideo Biodevices
iSono
Cyrcadia Health
Anixa Biosciences
Actuate Therapeutics
Osiris Therapeutics
Epic Sciences
Paige
23andMe
 23andMe start-up holds the highest finding
for breast cancer treatment followed by Paige
in US
 Content
Top Startups In US By Funding, ($Mn) Key Highlights
27
27 Confidential
Key Industry Start-ups For Breast Cancer
 23andMe is the first and only genetic service available directly that includes reports that meet FDA standards
 Paige.AI, stands for Pathology AI Guidance Engine, a new start-up that uses artificial intelligence to fight cancer. The
company focus on breast, prostrate and other major cancers, and expects to partner with other medical centers beyond
MSK, as well as commercial labs and pharmaceutical companies as it grows and develops its applications
 Epic Sciences, a diagnostics company improving cancer management by providing real-time biopsy material to guide
personalized medicine
 Actuate Therapeutics, a biopharmaceutical company focused on the development of compounds for use in the
treatment of cancer, and inflammatory diseases leading to fibrosis and neurodegeneration
 Content
Startups Overview
28
Key Company Profiles
29
29 Confidential
Agilent Technologies
Company Name
Agilent Technologies
Year of establishment
1999
Headquarter
Santa Clara, California, US
Revenue
$1.05 Bn per yr.
Website
www.agilent.com
Company Overview
 Agendia is a privately held, leading molecular diagnostics
company that develops and markets genomic diagnostic
products, which help support physicians with their complex
treatment decisions
 gendia's breast cancer tests were developed using an unbiased
gene selection by analyzing the complete human genome and
the offerings include MammaPrint®, a 70-Gene Breast Cancer
Risk-of-Recurrence test, and BluePrint
 Agilent Technologies Inc. and Agendia, Inc. announced an
agreement to expand their relationship to include the
development of an RNA-Seq kit version of Agendia's currently
marketed MammaPrint and BluePrint tests
 Content
30
30 Confidential
Agilent Technologies
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
31
31 Confidential
AstraZeneca
Company Name
AstraZeneca
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
32
32 Confidential
AstraZeneca
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
33
33 Confidential
Bristol-Myers Squibb
Company Name
Bristol-Myers Squibb
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
34
34 Confidential
Bristol-Myers Squibb
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
35
35 Confidential
Eli Lilly Co
Company Name
Eli Lilly Co
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
36
36 Confidential
Eli Lilly Co
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
37
37 Confidential
Novartis
Company Name
Novartis
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
38
38 Confidential
Novartis
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
39
39 Confidential
Onyx Pharmaceuticals
Company Name
Onyx Pharmaceuticals
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
40
40 Confidential
Onyx Pharmaceuticals
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
41
41 Confidential
Orion
Company Name
Orion
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
42
42 Confidential
Orion
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
43
43 Confidential
Pfizer
Company Name
Pfizer
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
44
44 Confidential
Pfizer
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
45
45 Confidential
Siemen Healthineers
Company Name
Simen Healthineers
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
46
46 Confidential
Siemen Healthineers
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
47
47 Confidential
Philips Healthcare
Company Name
Philips Healthcare
Year of establishment
Headquarter
Revenue
Website
Company Overview
Content
48
48 Confidential
Philips Healthcare
Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019
Analysis
 The company is profiled for the financial year ended, 2028
 Content
Sample
49
Access And Reimbursement Scenario
50
50 Confidential
Access and reimbursement scenario
 Commercial insurance remains the largest and most lucrative system, providing healthcare coverage to more than 170 million
people
 Drug manufacturers often engage in complex pricing and formulary negotiations with numerous health plans offered by
manufacturers
 Public scrutiny on the high cost of branded medications in the US has grown, prompting some manufacturers to launch drugs at
below market prices
 Content
General Reimbursement Environment
Key Market Access Considerations
1
The physicians’ ability to prescribe brands is more
controlled, because of variety of generic versions
available in the US
Despite the variety of generics available,
physicians encounter difficulties with
reimbursement as a downstream consequence of
individual variability in response to drugs
2
51
Future Development Growth
52
52 Confidential
Key Industry Developments – New offerings and drug approvals
On Sept 2020, Natco Pharma announced that its marketing partner, Lupin, Launched Lapatinib Tablets in US after receiving
the final approval for its Abbreviated New Drug Application (ANDA) from US Federal Drug Administration (USFDA). NACTO
was the first ANDA applicant for Lapatinib Tablets
On June 2020, US FDA announced approval of Phesgo for injection under skin to treat adult patients with HER-positive breast
cancer that has spread to other parts of the body and for treatment of adult patients with early HER2-positive breast cancer.
The patient undergoing this therapy are selected based on FDA approved companion diagnostic test
Hologic Inc announced new product offerings representing Hologic's next generation of molecular diagnostics innovation
allowing laboratories to scale their instrumentation to meet testing demands in both their current workflow and their future
growth plans in US and EU
Content
53
53 Confidential
Ongoing clinical trials for breast cancer patients in US
The randomized, open-label, BRACELET-1 study is designed to support the results of a prior successful phase II trial (IND-
213) that showed a near doubling of overall survival (OS) with pelareorep treatment
Clinical trial, the randomized, open-label, phase III monarchE study, is designed to investigate abemaciclib (Verzenio®; Eli Lilly
and Company) in combination with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in
patients with high-risk, node-positive, early-stage, hormone-receptor-positive, human epidermal receptor 2 negative, breast
cancer
Content
Content
54
Conclusion
55
55 Confidential
US breast cancer market is showing large opportunities owing to
approvals of novel drugs and therapies in the market
 In US, breast cancer therapeutics market is considered to be one of the highly advanced therapy markets carrying innovative and
imperative medicines. To an extreme level, the respective cancer market is also considered to be one of the prominent reasons
for high-end market size gathered by the US pharmaceutical market in short period of time
 Presence of several parameters in the country such as increasing cases of breast cancer and many more are analysed to be
boosting the total clinical research parameter for breast cancer market
 The overall association of the market with several progressive trends, high-rate involvement of major key players, elite
educational research centres and opportunities are believed to incline the market to deliver impressive healthcare outcomes
 Over the past few years, there has been a sudden increase in the rate of research and development activities for breast cancer
market in the US. This has eventually led to the arrival of hundreds of efficient therapies for breast cancer patients as well as
increased rate of export of the drugs to other developing market who are still undergoing clinical development in order to become
an independent market
 Total increase in the growing interest of the world-class researchers towards expanding the market therapies has also bend the
market towards contributing the highest shares to the global breast cancer therapeutics market
 Regardless of growing breast cancer cases in the country, the US market has been successful in delivering multi-prolonged
approaches to the patients who are in utmost need. At present time, among all the markets that have entered the race of breast
cancer market, the US is receiving high level appreciation and complex clinical landscape, that is however inclining the entire
market towards experiencing high compound growth rate

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  • 1. 1 US Breast Cancer Market Breast Cancer Therapeutics Market Size, And Share, By Therapy (Targeted Therapy, Hormonal Therapy, Chemotherapy, Immunotherapy), By Cancer Type (Hormone Receptor, HER2+), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and Forecast, 2019-2028
  • 2. 2 2 Confidential Table of Content 1. US Breast Cancer Market Overview……………………………………..……………………………………………………………………………………………….05 a. Market size and forecast 2. Market Growth Drivers………………………………………………………………………………………………………...............................................................07 a. Increase in diagnosis and treatment b. Increase in prevalence of Breast Cancer c. Technologically advanced therapeutics 3. Major Indication Contributing US Breast Cancer Market ……………………………………………………………………………………………….................12 a. Prevalence of different cancer type i. Hormone receptor ii. HER2+ b. Unmet needs 4. Breast Cancer Market Segmentation………………………………………………………………………………………………………………………………………16 a. Drugs By Therapy class i. Chemotherapy ii. Targeted therapy iii. Immunotherapy iv. Hormonal therapy
  • 3. 3 3 Confidential Table of Content b. By Drug Type i. HER2 Inhibitors ii. Mitotic Inhibitors iii. Aromatase Inhibitors iv. CDK 4/6 Inhibitors v. Hormonal Receptors c. By Distribution Channel i. Hospital Pharmacies ii. Retail Pharmacies iii. Online Pharmacies 5. Breast Cancer Epidemiology..………………………………………………………………………………………………………………………………….……….20 a. By Type of cancer b. By Incidence cases and mortality 6. Competitive Landscape ..………………………………………………………………………………………………………………………………….…………...23 a. Top companies in R&D Pipeline b. Key advancements in breast cancer market of US c. Key Industry Start-ups for Breast Cancer in US 7. Key Company Profiles………………………………………………………………………….………………………………………………………………………..28 a. Agilent Technologies overview, Product & Services, Strategies & Financials
  • 4. 4 4 Confidential Table of Content b. AstraZeneca overview, Product & Services, Strategies & Financials c. Bristol Myers Squibb overview, Product & Services, Strategies & Financials d. Eli Lilly overview, Product & Services, Strategies & Financials e. Novartis overview, Product & Services, Strategies & Financials f. Onyx Pharmaceuticals overview, Product & Services, Strategies & Financials g. Orion overview, Product & Services, Strategies & Financials h. Pfizer overview, Product & Services, Strategies & Financials i. Philips Healthcare j. Siemen Healthineers 8. Access and Reimbursement Scenario…………………………………………………….………………………………………………………………………….49 a. Key market access considerations b. General reimbursement environment 9. Factors Driving Future Growth…………………………………………………………………………………………………………………………………...……51 a. Key Industry Developments of Breast Cancer market b. Ongoing clinical trials for breast cancer patients in US 10. Conclusion…………………………………………………………………………………………………………………………………………………………………54
  • 5. 5 US Breast Cancer Market Overview
  • 6. 6 6 Confidential US Breast Cancer Market- Market Size & Forecast Overview The overall Breast Cancer market in US will experience sizable growth over the forecast period, increasing from $xx billion in 2019 to over xx billion in 2028 with a CAGR of 9.1% 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 US Breast Cancer Market Size ($Bn) (2019-2028)  U.S. market accounted for the highest regional share in 2018 and was valued around USD 6,698.3 million. The growth is attributed to growing prevalence of breast cancer and increasing R&D funding through public and private sectors  In 2021, an estimated 281,550 new cases of invasive breast cancer are expected to be diagnosed in women in the US., along with 49,290 new cases of non-invasive (in situ) breast cancer  We expect the market to continue to grow at a rate of over xx% annually, driven primarily by the release of key treatment guidance, new drug launches in the US and increasing drug availability in other regions, and increasing physician education Key Findings
  • 7. 7 US Breast Cancer Market Growth Drivers
  • 8. 8 8 Confidential Market Growth Drivers Technologically advanced Therapeutics Increase in prevalence of Breast Cancer Increase in diagnosis and treatment Market Growth Drivers of US Breast Cancer Market
  • 9. 9 9 Confidential Market Growth Drivers Increase in diagnosis and treatment New Jersey’s healthcare institutions are developing targeted, individualized treatments to improve breast cancer outcomes and provide patients with a better quality of life Content Content Content
  • 10. 10 10 Confidential Market Growth Drivers Increase in prevalence of breast cancer Increased prevalence is one of the foremost US growth driver of breast cancer and is expected to result in large patient population demanding accurate and efficient treatment options The increase in demand of preventive care and early treatment has led many individuals to undergo cancer screening tests driving number of patients to demand treatment in the forecast period Content Content
  • 11. 11 11 Confidential Market Growth Drivers Technologically advanced therapeutics Some of the new product launches in US are specifically aimed at the treatment of breast cancer that was previously untreatable, or the earlier treatments were not successful in terms of improved outcomes for patients, for example, Trodelvy The US FDA granted accelerated approval to Trodelvy (Sacituzumab govitecan-hziy) for the treatment of adult patients with triple negative breast cancer that has spread to the other parts of the body Content Content
  • 12. 12 Major Indications Contributing US Breast Cancer Market
  • 13. 13 13 Confidential Major Indications- Prevalence Of Cancer Type Hormone Receptor  Hormone receptor segment is likely to dominate the market during the forecast period because of rising volume of breast cancer patients belonging to this type of cancer and is expected to maintain dominance during the forecast period  Content
  • 14. 14 14 Confidential Major Indications- Prevalence Of Cancer Type HER2+  The HER2+ segment accounted for a lower share of the global market but is expected to register a comparatively higher CAGR in US due to the recent launches of therapeutics for the treatment of breast cancer  Several HER2-targeted therapies are approved for the treatment of HER2-overexpressing breast cancer  The approval of trastuzumab deruxtecan underscores that this specifically engineered HER2- directed antibody-drug conjugate is delivering on its intent to establish an important new treatment for patients with HER2-positive metastatic breast cancer  Content
  • 15. 15 15 Confidential Major Indications- Unmet Needs  Despite the number of therapy options available, advanced or metastatic HR-positive / HER2-negative breast cancer remains incurable and a major cause of mortality and morbidity in women  There is a greater need for treatment regimens that are less burdensome for patients and their caregivers, as well as reducing health care costs associated with the IV administration of anticancer regimens  Content  Despite the number of treatment options for patients with mBC, unmet needs remain pertaining to disease control, prolonging the interval to intensive cytotoxic therapy, and treatment-related complications  Content  Content
  • 16. 16 US Breast Cancer Market Segmentation
  • 17. 17 17 Confidential Market Segmentation- By Therapy Class Market Share, By Therapy Class, 2019  The targeted therapy segment held a dominant share of the market in 2019 owning to the greater adoption in US  The hormonal therapy segment is anticipated to register a lower market share in the forecast period. This is primarily attributed to the increasing availability of generic equivalents of hormonal therapy drugs  Chemotherapy is anticipated to register a lower growth rate and share due to the increasing influx of generic equivalents  The Immunotherapy is set to register a higher growth rate due to their recent regulatory approvals by the US FDA  Content Key Highlights
  • 18. 18 18 Confidential Market Segmentation- By Drug type Market Share, By Drug Type (%), 2019  The targeted CDK 4/6 segment held a dominant share of the market in 2019 owning to the greater adoption in US  The HER2 Inhibitors segment is anticipated to register a lower market share in the forecast period. This is primarily attributed to the increasing availability of generic equivalents of hormonal therapy drugs  Content Key Highlights
  • 19. 19 19 Confidential Market Segmentation- By Distribution Channel  The hospital pharmacies segment is projected to account for a higher share of the US market because of the dependency of patients on these pharmacies for the administration of therapies, such as chemotherapy  Retail pharmacies segment account for the second largest share in the forecast period since a large number of patients depend on them for the filling up of oral prescription drugs  Online pharmacies segment is expected to showcase the highest CAGR as the increasing number of patients have shifted to these pharmacies as a means of acquiring therapeutics due to their greater ease in terms of usage  Content Key Highlights Market Share, By Distribution Channel, 2019
  • 21. 21 21 Confidential Epidemiology Population - By Type 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 HR-/HER2+ 4 xx xx xx xx xx xx xx xx xx HR-/HER2- 12 xx xx xx xx xx xx xx xx xx HR+/HER2+ 11 xx xx xx xx xx xx xx xx xx HR+/HER2- 73 xx xx xx xx xx xx xx xx xx  HR+/HER2- type of breast cancer in US is most prevalent compared to others in 2019  Content Key Highlights Epidemiology Population - By Type of Breast Cancer (2019-2028), by %
  • 22. 22 22 Confidential Epidemiology Population - By Incidence cases and mortality 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 Invasive Breast Cancer xx 276,480 281,550 xx xx xx xx xx xx xx Ductal Carcinoma xx xx 49290 xx xx xx xx xx xx xx Mortality xx 42,170 43600 xx xx xx xx xx xx xx  The American Cancer Society's estimates for breast cancer in the United States for 2021 is that, about 281,550 new cases of invasive breast cancer will be diagnosed in women, about 49,290 new cases of ductal carcinoma will be diagnosed and, about 43,600 women will die from breast cancer  Content Key Highlights Epidemiology Population - By Prevalence and mortality of Breast Cancer (2019-2028), by number
  • 24. 24 24 Confidential Competitive Landscape- R & D  The ongoing R&D initiatives for the development and the marketing of efficient drugs for the breast cancer treatment for the development of advanced therapeutics for better outcomes  The trends is expected to significantly boost the global breast cancer therapeutics market growth with the launch of new product, increasing sales of breast cancer drugs and the inclusion of new patients in the treatment process as more types of breast cancer are anticipated to be treated through these new drugs  Content Sanofi, one of the key players in the breast cancer therapeutics industry has been conducting R&D initiatives for the development of novel oral treatments for metastatic breast cancer AstraZeneca has been conducting R&D activities for the development of therapeutics to treat estrogen receptor-positive breast cancer Content R&D Initiatives
  • 25. 25 25 Confidential Key advancement in breast cancer market of US Novartis breast cancer drug - Piqray have improved patient outcomes, several treatment gaps remain Radius Health’s Elacestrant, an oral Selective Estrogen Receptor Degrader (SERD) that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer and has been anticipated that this analysis will take place in the second half of 2021 Gilead Sciences’ acquisition of Immunomedics, the manufacturer of sacituzumab govitecan-hziy, is expected to advance the development of the antibody-drug conjugate not only across additional types of breast cancer beyond triple-negative disease, but also in other solid tumors Content Content
  • 26. 26 26 Confidential Key Industry Start-ups For Breast Cancer in US 1.4 5.9 24.7 100.5 868.6 Ithema TeVideo Biodevices iSono Cyrcadia Health Anixa Biosciences Actuate Therapeutics Osiris Therapeutics Epic Sciences Paige 23andMe  23andMe start-up holds the highest finding for breast cancer treatment followed by Paige in US  Content Top Startups In US By Funding, ($Mn) Key Highlights
  • 27. 27 27 Confidential Key Industry Start-ups For Breast Cancer  23andMe is the first and only genetic service available directly that includes reports that meet FDA standards  Paige.AI, stands for Pathology AI Guidance Engine, a new start-up that uses artificial intelligence to fight cancer. The company focus on breast, prostrate and other major cancers, and expects to partner with other medical centers beyond MSK, as well as commercial labs and pharmaceutical companies as it grows and develops its applications  Epic Sciences, a diagnostics company improving cancer management by providing real-time biopsy material to guide personalized medicine  Actuate Therapeutics, a biopharmaceutical company focused on the development of compounds for use in the treatment of cancer, and inflammatory diseases leading to fibrosis and neurodegeneration  Content Startups Overview
  • 29. 29 29 Confidential Agilent Technologies Company Name Agilent Technologies Year of establishment 1999 Headquarter Santa Clara, California, US Revenue $1.05 Bn per yr. Website www.agilent.com Company Overview  Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions  gendia's breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome and the offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint  Agilent Technologies Inc. and Agendia, Inc. announced an agreement to expand their relationship to include the development of an RNA-Seq kit version of Agendia's currently marketed MammaPrint and BluePrint tests  Content
  • 30. 30 30 Confidential Agilent Technologies Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 31. 31 31 Confidential AstraZeneca Company Name AstraZeneca Year of establishment Headquarter Revenue Website Company Overview Content
  • 32. 32 32 Confidential AstraZeneca Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 33. 33 33 Confidential Bristol-Myers Squibb Company Name Bristol-Myers Squibb Year of establishment Headquarter Revenue Website Company Overview Content
  • 34. 34 34 Confidential Bristol-Myers Squibb Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 35. 35 35 Confidential Eli Lilly Co Company Name Eli Lilly Co Year of establishment Headquarter Revenue Website Company Overview Content
  • 36. 36 36 Confidential Eli Lilly Co Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 37. 37 37 Confidential Novartis Company Name Novartis Year of establishment Headquarter Revenue Website Company Overview Content
  • 38. 38 38 Confidential Novartis Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 39. 39 39 Confidential Onyx Pharmaceuticals Company Name Onyx Pharmaceuticals Year of establishment Headquarter Revenue Website Company Overview Content
  • 40. 40 40 Confidential Onyx Pharmaceuticals Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 41. 41 41 Confidential Orion Company Name Orion Year of establishment Headquarter Revenue Website Company Overview Content
  • 42. 42 42 Confidential Orion Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 43. 43 43 Confidential Pfizer Company Name Pfizer Year of establishment Headquarter Revenue Website Company Overview Content
  • 44. 44 44 Confidential Pfizer Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 45. 45 45 Confidential Siemen Healthineers Company Name Simen Healthineers Year of establishment Headquarter Revenue Website Company Overview Content
  • 46. 46 46 Confidential Siemen Healthineers Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 47. 47 47 Confidential Philips Healthcare Company Name Philips Healthcare Year of establishment Headquarter Revenue Website Company Overview Content
  • 48. 48 48 Confidential Philips Healthcare Revenues ($ Mn), 2019-2028 Breakdown of net sales (%) by segment, 2019 Analysis  The company is profiled for the financial year ended, 2028  Content Sample
  • 50. 50 50 Confidential Access and reimbursement scenario  Commercial insurance remains the largest and most lucrative system, providing healthcare coverage to more than 170 million people  Drug manufacturers often engage in complex pricing and formulary negotiations with numerous health plans offered by manufacturers  Public scrutiny on the high cost of branded medications in the US has grown, prompting some manufacturers to launch drugs at below market prices  Content General Reimbursement Environment Key Market Access Considerations 1 The physicians’ ability to prescribe brands is more controlled, because of variety of generic versions available in the US Despite the variety of generics available, physicians encounter difficulties with reimbursement as a downstream consequence of individual variability in response to drugs 2
  • 52. 52 52 Confidential Key Industry Developments – New offerings and drug approvals On Sept 2020, Natco Pharma announced that its marketing partner, Lupin, Launched Lapatinib Tablets in US after receiving the final approval for its Abbreviated New Drug Application (ANDA) from US Federal Drug Administration (USFDA). NACTO was the first ANDA applicant for Lapatinib Tablets On June 2020, US FDA announced approval of Phesgo for injection under skin to treat adult patients with HER-positive breast cancer that has spread to other parts of the body and for treatment of adult patients with early HER2-positive breast cancer. The patient undergoing this therapy are selected based on FDA approved companion diagnostic test Hologic Inc announced new product offerings representing Hologic's next generation of molecular diagnostics innovation allowing laboratories to scale their instrumentation to meet testing demands in both their current workflow and their future growth plans in US and EU Content
  • 53. 53 53 Confidential Ongoing clinical trials for breast cancer patients in US The randomized, open-label, BRACELET-1 study is designed to support the results of a prior successful phase II trial (IND- 213) that showed a near doubling of overall survival (OS) with pelareorep treatment Clinical trial, the randomized, open-label, phase III monarchE study, is designed to investigate abemaciclib (Verzenio®; Eli Lilly and Company) in combination with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in patients with high-risk, node-positive, early-stage, hormone-receptor-positive, human epidermal receptor 2 negative, breast cancer Content Content
  • 55. 55 55 Confidential US breast cancer market is showing large opportunities owing to approvals of novel drugs and therapies in the market  In US, breast cancer therapeutics market is considered to be one of the highly advanced therapy markets carrying innovative and imperative medicines. To an extreme level, the respective cancer market is also considered to be one of the prominent reasons for high-end market size gathered by the US pharmaceutical market in short period of time  Presence of several parameters in the country such as increasing cases of breast cancer and many more are analysed to be boosting the total clinical research parameter for breast cancer market  The overall association of the market with several progressive trends, high-rate involvement of major key players, elite educational research centres and opportunities are believed to incline the market to deliver impressive healthcare outcomes  Over the past few years, there has been a sudden increase in the rate of research and development activities for breast cancer market in the US. This has eventually led to the arrival of hundreds of efficient therapies for breast cancer patients as well as increased rate of export of the drugs to other developing market who are still undergoing clinical development in order to become an independent market  Total increase in the growing interest of the world-class researchers towards expanding the market therapies has also bend the market towards contributing the highest shares to the global breast cancer therapeutics market  Regardless of growing breast cancer cases in the country, the US market has been successful in delivering multi-prolonged approaches to the patients who are in utmost need. At present time, among all the markets that have entered the race of breast cancer market, the US is receiving high level appreciation and complex clinical landscape, that is however inclining the entire market towards experiencing high compound growth rate