Potential "Pipeline Disruptors" - New Products That Will Drive The Future Pharmaceutical Market

May 15, 2017
120 Pages - Pub ID: KLI15346128
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New Pharmaceuticals Could Take Over Leadership in Key Chronic Disease Areas

The pharmaceutical market is fluid and at times can defy predictions of observers of today's pipelines. In recent years, several 'disruptors' have hit the market and pushed aside the current standard treatment protocols.

Consider these two cases:
  • Gilead Sciences has turned the Hepatitis C (HCV) treatment market upside down, for its competitors at least. In 2013, Gilead began to rollout its new therapies for HCV, of which the company claimed were superior products to the established market. A bold claim considering it was going up against some of the biggest names in biopharmaceutical participation - mainly Merck and Roche. The market showed favor for Gilead's products, which began to erode sales for Merck and Roche's HCV products. By 2015, Gilead had a solid hold on the market with about 80% market share. 
  • In December 2014, Bristol-Myers Squibb was granted approval for its PD-1 monoclonal antibody Opdivo (nivolumab). Opdivo was originally granted approval for advanced melanoma; by the end of 2016, lung cancer, renal cell carcinoma, lymphoma, and head & neck cancer were also approved. Approvals continue to be pursued and granted for 2017. 
In this report, Kalorama looks for the next "Pipeline Disruptors" - the innovative therapies that impact current therapies with significant competition and alter the course of treatment. For the purpose of this study, it may affect current therapies that were also considered disruptor innovations at one time or involves a new innovation that is expected to displace other treatments.

What will be the next source of disruption in the market? This report covers market opportunities based on pipeline developments for six key therapeutic specialties:
  • Alzheimer's Disease
  • Asthma
  • Breast Cancer
  • Leukemia
  • Lung Cancer
  • Lymphoma
These six areas are expected to show the strongest pipeline impact and candidates are likely to replace current therapies. The market is evaluated for 2015 and 2016 with forecast data provided through 2022. Forecast data were derived from a combination of pipeline analyses, current product treatment guidelines, potential candidate clinical trial results and other factors that may affect the performance of either current or future sales of a particular therapy. Although a thorough analysis and best effort has been made to provide a reliable market forecast, changes can occur which would affect company sales forecasts, market positions/shares, and overall market values. These may include a high-profile merger, a promising late development project deemed not approvable, an unforeseen patent extension of a high-sale therapy, a major production or manufacturing setback, or any other similarly unpredictable event.

Developing new therapies comes with an assortment of challenges from premarketing development and approval to post-marketing surveillance and product lifecycle extension. New technologies, new therapeutic approaches and new information about drug development, in general, are still hindered by the challenges of the market dynamics and understanding how drug therapies work and how they may fail. The process of identifying targets for successful development continues to be a major innovation challenge.

The biotech industry is generally thought of as the leading source for innovative drug products. New biologic drug approvals have been climbing for the past 10 years and have been making up a larger portion of all drugs approved. Some of the major mergers and acquisitions in the last year have been from transitioning pharmaceutical companies that want to take advantage of leading biopharma businesses.

Where They Stand and What They Plan To Do: Analysis of Top Company Strategies and Market Position

As part of this report analyst Melissa Elder takes a look at the strategies of the top companies including: 

•AbbVie: Immunology Made a Priority

Allergan'sGrowth Through Strategic Acquisitions Strategy

•Astellas: A Focus on the Developing World

•AstraZeneca Bets on Oncology  

•Bayer's Broad Life-Science Play

•Boehringer Ingelheim'sBiotechnology and Biosimilar Push

•Bristol-Myers Squibb Goes Specialty Biopharmaceutical 

•Celgene Aims For Oncology Leadership

•Eli Lilly: Product Development a Key

•Gilead: Hepatitis C and Beyond   

•GlaxoSmithKline's Focus on Vaccines

•Johnson & Johnson Benefits from Scale

•Novartis' New Cancer Portfolio

•Pfizer: More Biopharma

•Roche's 900M Manufacturing Investment Pays Off

•Teva Remains Generic First-Mover 



Trends To Watch in a Changing Pharmaceutical Market

The report looks at changes in the market, including:

Age-Driven Growth - Feeling the True Impact

For years, we have been aware of the impact the growing population and, to a more extreme extent, the aging population will have on chronic diseases. Despite the ongoing awareness, companies must keep pace with the shift in demographics and how it continues to impact certain markets. From 2010 to 2050, global population growth is forecast to be 0.8% annually on average, growing from 6.9 billion in 2010 to 9.4 billion in 2050. In comparison, aging populations for the same period will increase by 2.7% annually, reaching 1.6 billion people in 2050 compared to 533 million in 2010. The aging population will account for 16.7% of the global population by 2050, as compared to 7.8% in 2010.

Key Chronic Diseases Driving Markets

Chronic disease is the leading cause of death worldwide, representing approximately 60% of all deaths. In 2015, 56.4 million deaths were recorded worldwide - equal to 7.79 deaths/1,000 population; 108 deaths per minute or 1.8 deaths every second. The six markets discussed in this report will experience moderate impact due to population growth and aging demographics, driving disease prevalence.

Demand for Alzheimer's Products Surges With New Cases

Alzheimer's disease will increase by 5,000 new cases annually worldwide. This moves the number affected from about 44 million to more than 80 million over the next decade, taking into account new cases and mortality rates. As the population ages the number affected by Alzheimer's will climb. About 11% of people over the age of 65 have Alzheimer's disease; in the over 85 age group, 32% of people have Alzheimer's.

Asthma currently affects about 300 million people worldwide. Several factors are contributing to the expected increase to about 400 million by 2025, these include environmental factors, an increase in respiratory infections and conditions, occupational irritants and, even though tobacco consumption is lower than a decade ago, it is still a concern as a contributor to asthma.

Disease-Modifying Therapies for Alzheimer's DiseaseThe highly-anticipated development of an effective Alzheimer's disease treatment that focuses on modifying the progression of disease is coming closer to fruition. There are six therapies in advance stages that have been reviewed by Kalorama Information and are expected to move to market. These therapies will add up to $6.5 billion in sales by 2022.

Cancer Treatments

Cancer as a whole will impact future markets with increasing incidence and a growing demand for effective therapies. Lung cancer, in particular, is expected to see an increase in incidence by 2.8% annually. Considering the poor prognosis associated with the disease, effective treatments fulfil an unmet need. Increases in breast cancer incidence will be slower, yet significant. There will likely be an increase in breast cancer incidence equal to about 1.8-1.9% annually. Lymphoma and leukemia will also increase at about a rate of 2.5% annually. New methods of detection at an earlier stage, changes in guidelines for prevention and an aging population are all contributors to the growing incidences.

Watch Combination TherapiesThe asthma treatment market, currently valued at $16.6 billion, is expected to climb to nearly $20 billion by 2022. Combination treatments, consisting of Beta2-agonists, corticosteroids and muscarinic antagonists, will account for about 42% of the market in 2022, as compared 33% in 2016.

Outcomes-Based Reimbursement Changes Game

The changing landscape for reimbursement of medical therapies is forcing developers to show benefits of new therapies. As the market shifts to an outcomes-based reimbursement system, developers will have to stay ahead of the changing landscape and focus on data in clinical results that show significant benefits over current therapies, particularly if a higher price is to be pursued. As a whole, the medical industry is moving toward a system of documented outcomes and proven benefits of treatments. This is the major driver for new patient monitoring technologies, electronic medical records systems, and similar technologies. Although the approach is a bit different with therapies, the basis of the topic is the same. Without solid documentation and 'proof' of benefits and outcomes, reimbursement is at risk.

The Cost of Developing New Targets 

This is Increasing and the Risk of Failed Development is a Real Threat to New InnovationCompanies are finding more disease targets using advanced research techniques, but if the therapies fail in late-stage trials, it is usually very expensive. Selecting the right disease target from the start, may lead to the development of more effective therapies and waste less in lost R&D investment. In 2014, the Tufts Center for the Study of Drug Development put the average cost of developing a drug at $2.6 billion ($1.4 billion in out-of-pocket costs, $1.2 billion in time costs). This is up from about $800 million reported in 2001 by the Tufts Center.

Big Biosimilars Are Coming: Is the Industry Ready? 

 Development activities of biosimilar therapies targeting Avastin, Herceptin, and Rituxan are currently at full speed. Development efforts are on pace to reach market penetration by 2018 and are expected to be strong performers, upsetting original therapy performance. The changing legislative environment and new healthcare reform should be carefully observed to adapt strategies and adjust development plans. In the area of biosimilars, the changes will likely continue to support additional activity in development and adoption as the industry as a whole looks to cost-saving strategies while continuing to provide access to vital therapies.

This report covers these trends and what the top companies are doing to match them.  This report is an essential resource for benchmarking pharmaceutical activities and making long-term assessments of the market.  
CHAPTER 1: EXECUTIVE SUMMARY
INTRODUCTION
WHAT ARE PIPELINE DISRUPTORS?
Gilead Sciences Disrupts HCV Market
Figure 1-1: Gilead Sciences Dominates HCV Market, Displaces Current Therapies ($ millions)
Bristol-Myers Squibb - Opdivo Disrupts Monoclonal Antibody Performance in Cancer
Figure 1-2: Monoclonal Antibodies in Cancer Treatment, Opdivo Performance vs. Industry, 2010-2022
SCOPE AND METHODOLOGY
MARKET OUTLOOK
Figure 1-3: Projected Opportunities in Six Major Biopharmaceutical Specialties, 2010-2022
CHAPTER 2: THE STATUS OF THE GLOBAL BIOPHARMACEUTICAL MARKET
TARGET SELECTION PROCESS INCREASES IN IMPORTANCE
TOP R&D SPENDERS
Table 2-1: Top R&D Spenders in the Pharmaceutical Industry - 2014-2016, (millions of $)
Figure 2-1: Top R&D Spenders in the Pharmaceutical Industry, 2016 ($ millions)
MAJOR SEGMENT BREAKTHROUGHS
Monoclonal Antibodies (mAbs)
Figure 2-2: Monoclonal Antibody Market Penetration, All Indications (percent of total biopharmaceutical market)
Kinase Inhibitors
Figure 2-3: Tyrosine Kinase Inhibitor Market Penetration, All Indications (percent of total biopharmaceutical market)
INDUSTRY TRENDS
Healthcare Spending
Table 2-2: Total Healthcare Expenditures as a Percent of GDP by Country 2010 and 2015
GLOBAL DEMOGRAPHICS AND THE NEED FOR EFFECTIVE THERAPIES
Table 2-3: Global Population will Increase to Nearly 9.4 billion by 2050 (population in millions) 1980-2050
Figure 2-4: The Global Population, 1980-2050 (in millions)
Aging Population
Figure 2-5: Global Population Trend, Age 65+ (thousands)
CHAPTER 3: COMPANY INNOVATION STRATEGIES
STRATEGIES: THE PATH TO PIPELINE DISRUPTOR INNOVATION
AbbVie's Growth Strategy
Allergan's Growth Strategy
Astellas' Growth Strategy
AstraZeneca's Growth Strategy
Bayer's Growth Strategy
Boehringer Ingelheim's Growth Strategy
Bristol-Myers Squibb's Growth Strategy
Celgene's Growth Strategy
Eli Lilly & Company's Growth Strategy
Gilead Sciences' Growth Strategy
GlaxoSmithKline's Growth Strategy
Johnson & Johnson's Growth Strategy
Novartis' Growth Strategy
Pfizer's Growth Strategy
Roche's Growth Strategy
Teva Pharmaceuticals' Growth Strategy
CHAPTER 4: PIPELINE DISRUPTORS: ALZHEIMER'S DISEASE
MARKET OPPORTUNITY
Figure 4-1: Global Incidence and Prevalence of Alzheimer's Disease by Country, 2016 estimates
TREATMENT OPTIONS IN ALZHEIMER'S DISEASE: CURRENT MARKET LANDSCAPE
Aricept (donepezil)
Exelon (rivastigmine)
Namenda/Namzaric (memantine)
Razadyne (galantamine)
Figure 4-2: Alzheimer's Disease Market by Drug Type ($ millions)
INNOVATION PIPELINE
Table 4-1: AstraZeneca/Eli Lilly - Lanabecestat (AZD3293/LY3314814)
Table 4-2: Biogen/Neurimmune - Aducanumab
Table 4-3: Biogen/Eisai - E2609
Table 4-4: Roche - RG1450 (gantenerumab)
Table 4-5: Roche - RG7412 (crenezumab)
Table 4-6: Takeda - AD-4833/TOMM40
MARKET IMPACT FORECAST
Figure 4-3: Monoclonal Antibodies and BACE Inhibitors will Drive Alzheimer's Disease Treatment Growth, 2016-2022 ($ millions)
Figure 4-4: Roche and Biogen Expected to Dominate Alzheimer's Treatment Market in 2022 (% market share)
CHAPTER 5: PIPELINE DISRUPTORS: ASTHMA
MARKET OPPORTUNITY
Figure 5-1: China and U.S. at Top of List for Asthma Prevalence, 2016 estimates
THE HEAVY HITTERS IN ASTHMA TREATMENT: CURRENT MARKET LANDSCAPE
Pulmicort (budesonide)
Seretide/Advair (fluticasone/salmeterol)
Spiriva (tiotropium bromide)
Symbicort (budesonide/formoterol)
Ventolin (albuterol)
Xolair (omalizumab)
Table 5-1: Leading Asthma Product Sales (Global), 2016 ($ in millions)
Figure 5-2: Asthma Market Shows Corticosteroids Treatment of Choice, Sales by Drug Type 2010-2016 ($ millions)
INNOVATION PIPELINE
Table 5-2: AstraZeneca - Tralokinumab
Table 5-3: AstraZeneca - Benralizumab
Table 5-4: Novartis - QVM149
Table 5-5: Novartis - Fevipiprant
Table 5-6: Novartis - QMF149
MARKET IMPACT FORECAST
Figure 5-3: Combination Treatments Expected to Revive Asthma Treatment Market, Product Growth by Segment 2016-2022 ($ millions)
Figure 5-4: Novartis will Surge Ahead in Asthma Treatment Market by 2022 (% market share)
CHAPTER 6: PIPELINE DISRUPTORS: BREAST CANCER
MARKET OPPORTUNITY
Table 6-1: Most Common Cancer by Incidence, by Region and Gender
Figure 6-1-: Global Incidence and Mortality of Breast Cancer by Country, 2012*
THE HEAVY HITTERS IN BREAST CANCER TREATMENT: CURRENT MARKET LANDSCAPE
Abraxane (paclitaxel)
Afinitor (everolimus)
Avastin (bevacizumab)
Herceptin (trastuzumab)
Ibrance (palbociclib)
Perjeta (pertuzumab)
Table 6-2: Leading Breast Cancer Product Sales (Global), 2016 ($ in millions)
Figure 6-2: Breast Cancer Market Driven by Monoclonal Antibodies, Market by Drug Type 2010-2016 ($ millions)
INNOVATION PIPELINE
Table 6-3: Novartis - Alpelisib
Table 6-4: Novartis - Kisqali (ribociclib)
Table 6-5: Pfizer - Trastuzumab
Table 6-6: Roche - Taselisib
MARKET IMPACT FORECAST
Figure 6-3: 2 Leading Product Segments in Breast Cancer Treatment, 2016-2022 ($ millions)
Figure 6-4: A New Market Leader Will Emerge in 2022 (% market share)
CHAPTER 7: PIPELINE DISRUPTORS: LEUKEMIA
MARKET OPPORTUNITY
Table 7-1: Leukemia Overview by Type
Figure 7-1: Distribution of Leukemia Cases by Type
Figure 7-2: Global Incidence and Mortality of Leukemia by Country, 2012*
THE HEAVY HITTERS IN LEUKEMIA TREATMENT: CURRENT MARKET LANDSCAPE
Gleevec/Glivec (imatinib)
Imbruvica (ibrutinib)
Rituxan/MabThera (rituximab)
Sprycel (dasatinib)
Tasigna (nilotinib)
Table 7-2: Leading Leukemia Product Sales (Global), 2016 ($ in millions)
Figure 7-3: Leukemia Market Driven by Tyrosine Kinase Inhibitors, Market for Leukemia Treatment by Drug Type, 2010-2016 ($ millions)
INNOVATION PIPELINE
Table 7-3: AstraZeneca - Acalabrutinib
Table 7-4: Celgene - Enasidenib
Table 7-5:
Daiichi Sankyo - Quizartinib
Table 7-6: Novartis - CTL019
Table 7-7: Novartis - GP2013 (rituximab)
Table 7-8: Novartis - Midostaurin
Table 7-9:
Pfizer - Besponsa (inotuzumab ozogamicin)
Table 7-10:
Roche - RG7388 (idasanutlin)
MARKET IMPACT FORECAST
Figure 7-4: Leukemia Treatment Product Growth ($ millions)
Figure 7-5: Novartis will Maintain Leading Position in Leukemia Treatment Market Through 2022 (% market share)
CHAPTER 8: PIPELINE DISRUPTORS: LUNG CANCER
MARKET OPPORTUNITY
Table 8-1: Types of Primary Lung Cancer
Table 8-2: Most Common Cancer by Incidence, by Region and Gender
Figure 8-1: Global Incidence and Mortality of Lung Cancer by Country, 2012*
THE HEAVY HITTERS IN LUNG CANCER TREATMENT: CURRENT MARKET LANDSCAPE
Abraxane (paclitaxel)
Alimta (pemetrexed)
Avastin (bevacizumab)
Opdivo (nivolumab)
Tarceva (erlotinib)
Table 8-3:
Leading Lung Cancer Product Sales (Global), 2016 ($ in millions)
Figure 8-2: Lung Cancer Market by Drug Type ($ millions)
INNOVATION PIPELINE
Table 8-4:
Boehringer Ingelheim - BI 695502
Table 8-5:
Novartis - INC280
Table 8-6:
Pfizer - PF-06439535
Table 8-7:
Roche - Alecansa
MARKET IMPACT FORECAST
Figure 8-3: Lung Cancer Treatment Product Growth, 2016-2022 ($ millions)
Figure 8-4: Eli Lilly Slips, Who Gains in 2022? (% market share)
CHAPTER 9: PIPELINE DISRUPTORS: LYMPHOMA
MARKET OPPORTUNITY
Non-Hodgkin's Lymphoma
Table 9-1:
Classification of Non-Hodgkin's Lymphomas
Hodgkin's Lymphoma
Figure 9-1: Global Incidence and Mortality of Lymphoma by Country, 2012*
THE HEAVY HITTERS IN LYMPHOMA TREATMENT: CURRENT MARKET LANDSCAPE
Alimta (pemetrexed)
Imbruvica (ibrutinib)
Opdivo (nivolumab)
Revlimid (lenalidomide)
Rituxan/MabThera (rituximab)
Velcade (bortezomib)
Table 9-2:
Leading Lymphoma Product Sales (Global), 2016 ($ in millions)
Figure 9-2: Lymphoma Market by Drug Type ($ millions)
INNOVATION PIPELINE
Table 9-3:
Bayer - Copanlisib
Table 9-4:
Novartis - CP2013 (rituximab)
Table 9-5:
Pfizer - PF-05280586
MARKET IMPACT FORECAST
Figure 9-3: Lymphoma Treatment Product Growth, 2016-2022 ($ millions)
Figure 9-4: Bayer's Lymphoma Candidate and Potential in the Market (% market share)
CHAPTER 10: MARKET CONCLUSIONS
AGE-DRIVEN GROWTH - FEELING THE TRUE IMPACT
KEY CHRONIC DISEASES THAT WILL AFFECT MARKETS
WATCH COMBINATION THERAPIES
OUTCOMES-BASED REIMBURSEMENT CHANGES GAME
DISEASE-MODIFYING THERAPIES FOR ALZHEIMER'S DISEASE
THE COST OF DEVELOPING NEW TARGETS IS INCREASING AND THE RISK OF FAILED DEVELOPMENT IS A REAL THREAT TO NEW INNOVATION
BIOSIMILAR DEVELOPMENT WILL CUT INTO SALES FOR ORIGINAL THERAPIES

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