product launch failure & success study

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Success Factors and Failure Points in Biopharmaceutical Product Launches: An

Updated Road Map for Strong Market Entry

Strategic Benchmarking Research, Analysis & Recommendations

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Table of ContentsTable of ContentsBackground

Summary of Business Issue, Key Insights, Findings and Lessons Learned p.4-18

Universe of Learning: Research Participants, Launch Experience, Cardiology, Metabolics & Other Therapeutic Area Demographics p.19-25

Main Deck

Winning on Differentiated Product Positioning p.26-33 Winning a Physician’s Initial Trial of a New Product p.34-35 Articulating Benefits that Shape Positive Market Perception p.36-38 New Product Pricing Strategy p.39-49 Thought Leader Engagement p. 50-55 Early Physician Education p.56-64 Payer Education p. 65-67 Patient Advocacy and Education p.68-70 Preparing Market Constituents p.71-75 Access Insights & Success Factors p.76-83 Winning Hospital Formulary Access p.84-85 Resource Allocation for Key Stakeholders in the Current & Future Marketplaces p. 86-8

8 Investment Requirements, Resource Allocation & Timing p.89-99

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Table of ContentsTable of Contents

Internal Launch Readiness p.100-111

New Technologies for Informing Patients & Physicians p.112-115

Pitfalls & Stumbling Blocks p.116-130

Demonstrating Efficacy p.131-137

Rating Different Safety Dimensions p.138-144

Lessons Learned, Best Practices & Future Changes p.145-147

About Best Practices, LLC p.148

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Framework for Presenting Insights, Practices & Pitfalls

The performance benchmark and field research have harvested scores of insights and observations. They have been organized into the following summary framework for discussion and planning purposes.

Insights, Best Practices,

Pitfalls

Insights, Best Practices,

Pitfalls 3. Invest in Launch & Support

3. Invest in Launch & Support

4. Engage Thought Leaders

4. Engage Thought Leaders

5. Educate Key Stakeholders: (Physicians,

Patients, & Payers)

5. Educate Key Stakeholders: (Physicians,

Patients, & Payers)

6. Demonstrate Value Across

Multiple Fronts

6. Demonstrate Value Across

Multiple Fronts

2. Clearly Define Target Patient Population

2. Clearly Define Target Patient Population

7. Utilize New Technologies To Inform

7. Utilize New Technologies To Inform

1. Differentiate Your Product1. Differentiate Your Product8. Avoid Pitfalls & Stumbling Blocks

8. Avoid Pitfalls & Stumbling Blocks

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Differentiating Your Product - Secondary Benefits Can Be Win Themes: Differentiated positioning begins on factors established in clinical trials – such as efficacy, unmet needs, safety and target patient population. Secondary positioning factors have less overall impact – but can be useful in a crowded market – and are often more directly influenced through Marketing. Using secondary benefits can be an effective strategy for positioning a product in a highly competitive market.

As one executive observed during interviews: “You like to go to market with an efficacy message, that’s what you want.. If you can’t do efficacy, fall back to safety. If you can’t do safety, you fall back to convenience. If you can’t do convenience, you fall back to pricing.” Secondary or even tertiary positioning factors have been win themes. Quality of life, ease of use, cost effectiveness, patient compliance, or even a celebrity spokesperson are examples. Use of secondary factors varies considerably across TAs.

Differentiating Your Product - Secondary Benefits Can Be Win Themes: Differentiated positioning begins on factors established in clinical trials – such as efficacy, unmet needs, safety and target patient population. Secondary positioning factors have less overall impact – but can be useful in a crowded market – and are often more directly influenced through Marketing. Using secondary benefits can be an effective strategy for positioning a product in a highly competitive market.

As one executive observed during interviews: “You like to go to market with an efficacy message, that’s what you want.. If you can’t do efficacy, fall back to safety. If you can’t do safety, you fall back to convenience. If you can’t do convenience, you fall back to pricing.” Secondary or even tertiary positioning factors have been win themes. Quality of life, ease of use, cost effectiveness, patient compliance, or even a celebrity spokesperson are examples. Use of secondary factors varies considerably across TAs.

1. Differentiate Your Product In A Crowded MarketDifferentiation is a key factor in a new product’s launch success. While efficacy and safety are considered the best ways to differentiate a new product, new therapies also can use secondary benefits to gain traction at launch.

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Universe of Learning: 38 Companies Engaged

Participating Companies

Research participants included 44 executives and managers from 38 leading

pharmaceutical, biotech and medical device companies.

Laboratorios Dermatologicos Darier

TGC MedTech

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Executive Interviews and Field Insights

Executive Interviews

Laboratorios Dermatologicos Darier

More than six hours of executive interviews, in addition to field commentaries and insights from 17 executives, shed light on the market entry success and failure factors. Perspectives range from frontline prescriber to veteran pharma executive with decades of successful launch experiences.

Executive Field Insights

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Sample Participant Titles

Vice President/Director Largest Respondent Group

Nearly 40 leaders in biotechnology and pharmaceutical product launches participated in this research project. A majority of respondents were either at the vice president or director levels.

Other:• Founder and President• Principal• Partner• Coordinator, Marketing• Product Physician• Senior Consultant

Assistant/ Associate

Director, 5%

Other, 15%

Manager, 26%

Senior Manager, 8%

Director, 26%

Senior Vice President, 8%

Senior/ Executive

Director, 8%

Vice President, 5%

(n=39)

• Senior Vice President, Commercial Strategy

• Senior Vice President, Marketing & Sales

• Vice President, Marketing

• Director, Health Outcomes

• Director, Marketing

• Director, Medical

• Director, Strategic Planning

• Associate Director, Managed Care Marketing

• Senior Manager, Global Marketing

• Manager, Business Intelligence

• Manager, Business Unit

• Manager, Category Marketing

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• Metabolics

• Cardiology

• Central Nervous System

• Oncology

• Neurology

• Pulmonary

• Immunology

• Gastro-enterology

• Musculoskeletal

• Hormonal Systems

• HIV Infections

• Medical Nutrition

• Urology

Participants Reflected on Wide Range of TherapiesResearch participants reflected on almost 30 products, ranging from blockbusters like Januvia and Rituxan to new products like Onglyza and Victoza. The broad spectrum of products launch experiences informed the benchmark class’ understanding of critical success factors, stumbling blocks and failure points.

(n=33)

Belatacept

Cladribine (Movectro)

Clivarine

Enteral feeding products

Levothyroxine

MAb for Asthma/COPDNaproxcinod

New CTC Advance catheter

Taspoglutide

Therapeutic Areas Products Represented by Participants

Endothelin Receptor Antagonist

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Efficacy, Unmet Need Offer Best Positioning Tools

Q5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical to market entry success. Rate the effectiveness of different positioning strategies and tactics for

winning in the marketplace.

n = Total Benchmark Class Not Used

Highly Ineffective

Somewhat Ineffective

Somewhat Effective

Highly Effective

Total Effective

43 Efficacy Profile 2% 0% 2% 35% 60% 95%

44 Unmet medical need 2% 2% 2% 14% 80% 93%

43 Clearly Defined Patient Population / Sub-population

5% 2% 5% 51% 37% 88%

44 Differences from current therapies 2% 5% 7% 32% 55% 86%

44 Safety Profile 5% 0% 14% 52% 30% 82%

44 Health Outcomes 7% 2% 16% 48% 27% 75%

44 Tolerability 2% 2% 23% 45% 27% 73%

44 Ease-of -use/ patient compliance 11% 9% 9% 48% 23% 70%

44 Dosing 11% 7% 14% 43% 25% 68%

44 Cost Effectiveness 14% 2% 18% 36% 30% 66%

For respondents as a whole, efficacy and unmet need remain the most attractive positioning tools for differentiating. But participants indicated that an effective use of a tight target patient population/sub-population presents an opportunity where efficacy and unmet need may not be differentiating options for a new product’s launch.

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The fact that the BMS/AZ Diabetes product Onglyza had a safety and efficacy profile very similar to market leader Januvia created problems across a number of critical fronts: Payers, KOLs, Prescribers and Patients. The result - a disappointing launch.

Lack of Differentiation Creates Domino Effect

“I think they didn’t have a great differentiation strategy. Their efficacy was undifferentiated. If you’re the same efficacy-wise, you have to have some other good compelling reason, or interesting reason or a promotional reason to consider it. I never got the sense of what that really was.”

– Januvia Marketing Leader

“There isn’t anything good to say because there’s no mention of why is this better or why this is different.” – Januvia Marketing Leader

Pitfalls Created by Onglyza’s Lack of Differentiation

Insurers reluctant to add to formulary at same tier as like-priced Januvia.

No good reason for prescribers to shift from tried-and-true Januvia.

KOLs unlikely to advocate change in prescribing habits.

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Ease-of-Use Seen as Secondary Benefits Differentiator

Q7. Articulating Benefits That Shape Positive Market Perception: Once you've established your efficacy and safety profile, rate the effectiveness of various product benefits that can differentiate

one's market entry positioning to enable rapid launch uptake.


Highly Ineffective


Somewhat Effective

Highly Effective

Total Effective

41 Ease-of-use 5% 2% 7% 44% 41% 85%

42 Unmet Medical Need 7% 2% 7% 12% 71% 83%

43 Reduced side effects 9% 2% 7% 60% 21% 81%

42 Health Outcomes 12% 0% 10% 48% 31% 79%

44 Health benefit (eg. Prevents stroke or seizures)

20% 0% 2% 30% 48% 77%

43 Cost Effectiveness 14% 2% 12% 42% 30% 72%

43 Superior speed of action 21% 2% 7% 42% 28% 70%

Following efficacy and safety, launch leaders see ease-of-use and unmet need as the product benefits that should be used to differentiate a new product at market entry. Note that unmet medical need won the largest “Highly Effective” rating.

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New Product Needs 11-30% Higher Efficacy for Charge More

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Q10. Efficacy & Pricing: Estimate what's the minimum level of superior efficacy required to charge more than a branded competitor product in a crowded marketplace.

Total Benchmark Class

(n=41)

Two thirds of the overall Benchmark Class indicated a new product requires at least 11% to 30% superior efficacy in order to win a higher price in a competitive market.

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Ad Boards & Trial Involvement Effective TL Strategies

Q22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagement strategies for creating an informed and receptive marketplace at launch for your new product.


Highly Ineffective


Somewhat Effective

Highly Effective

Total Effective

34 Advisory boards: Using TLs from therapeutic areas to understand what aspects of the drug to focus on for interactions with the physician community

0% 0% 0% 24% 76% 100%

34 Clinical trial involvement: Working with thought leaders to gain their involvement in investigators in clinical trials.

0% 0% 0% 44% 56% 100%

34 Protocol Design: Engage key thought leaders to help design Phase III and Phase IV clinical trial protocols

0% 0% 3% 35% 62% 97%

34 Scientific Publications: Engage in writing scientific publications

0% 0% 3% 44% 53% 97%

33 Medical Science Liaisons: Using MSLs to educate thought leaders about benefits of new drug compared with competitors.

3% 0% 6% 39% 52% 91%

To engage thought leaders, overall participants rate advisory boards and clinical trial involvement as effective strategies for creating an informed, receptive marketplace at launch. Asking key thought leaders to help design Phase III and IV clinical trial protocols and to contribute to scientific publications are also effective engagement strategies.

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KOLs Should Span Across Various Levels of Influence

“Well, I’d say you have to have enough on sort

of every different level. You’ve got maybe the

top 50 or 100 national thought leaders and

those are obviously the same within a

therapeutic category. The second level is one

that is probably where there is a significant

amount of real influence like regional academic

medical centers. It’s in the regional KOLs

within certain hospital or academic systems

that may not have the publication power, but

get them involved and in on publications and

second author - stuff like that.”

– Marketing Manager, Top 10 Pharma

The size of the KOL group needed to create market acceptance should be spread across different levels of the KOL landscape – national, regional, academic and local. Look for the influencers in your particular therapeutic area who may fall under the industry’s radar or who may be shadow thought leaders in a related therapeutic area.

Source: http://pharmexec.findpharma.com/pharmexec/article/articleDetail.jsp?id=197784

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Price, Reimbursement Discussions Effective for Payers

Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities that prove most critical to market entry and success.


Highly Ineffective


Somewhat Effective

Highly Effective

Total Effective

30 Price Parameters: Get guidance on acceptable parameters for label

7% 0% 7% 37% 50% 87%

30 Unmet Needs: Understand Managed Markets' view of unmet medical needs

10% 0% 3% 50% 37% 87%

30 Reimbursement Prospects: Gain insight on reimbursement prospects in context of competitive landscape

17% 0% 0% 23% 60% 83%

30 Health Outcomes: Get reaction to health outcomes/ economics data

17% 0% 3% 37% 43% 80%

29 Advisory Boards: Payer advisory boards to hear payer perspectives

17% 0% 3% 17% 62% 79%

30 Improving Position: Understand how to Improve formulary positioning

17% 0% 7% 43% 33% 77%

30 Efficacy & Safety: Learn minimum requirements to enter market

13% 0% 13% 27% 47% 73%

Discussions around pricing, comparative effectiveness and reimbursement are effective early payer education tactics, participants said. In interviews, executives said these discussions need to be approached in a collaborative manner so that payers are learning about your perspective while you are learning about their wants and needs as well.

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Win Share: Focus Shifts to Specialists

n = TBC No Low High

35 Specialists 0% 20% 80%

33 KOLs 0% 24% 76%

31 Payers 10% 35% 55%

33 Primary Care Physicians

15% 36% 48%

32 Patients / Patient Advocacy Groups

13% 50% 38%

32 Policymakers / Government

13% 53% 34%

Q19. Preparing Market Constituents: Rate the importance of educating and winning support from each market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market.

Win Share

For winning share in the marketplace, 80% of participants place high importance on educating and winning support from specialists. Also note at this stage education increases for primary care physicians (from 6% at Enter Market to 48% at Win Share stage).

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DTC Campaigns Used to Push Patients to Doctors

A majority of participants see the value in DTC campaigns as a way to educate on the disease and spur patients to engage with physicians about their ailments and speak to their doctors about the new therapy they saw on TV. Will it work for them?

Q29. DTC Value Drivers: Note all factors that informed your rationale for employing DTC campaigns after launch.

35%

45%

50%

60%

30%

30%Not applicable/ None

Communicate product benefits

Educate on symptomidentification

Provide disease stateinformation

Reach large patientpopulations

Encourage patients to speak todoctors


(n=20)

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Q44. Launch Risk & Market Change: Please estimate the risk level of each physician pitfall that can derail a new product coming into a crowded market. First assess each pitfall in terms of its current

importance / risk level observed during the past two years. Then estimate the risk-level / priority change you anticipate for the next two to three years for this risk or failure point.


(n=24)

Out of Step With Thought Leader

Perspectives: New product's clinical trials

lag thought leader views or evolving

guidelines; product claims are misaligned

with thought leader perspectives.

Missed Critical Specialists: New

product fails to win critical

specialists or Key Opinion Leaders - who oppose new product because of unaddressed

concerns.

Failed Physician Segmentation: New

product fails to segment market in a way that allows it to

address specific physician segment

needs; market execution fails to reach

critical segments.

New Science Education Missteps: New method-of-action

products change treatment paradigms

but fail to inform physicians on

biology /new science to support paradigm

shift.

Access Barriers: New products stumble or fail

because of limited access to health care providers,

managed care and institutions.

Past 24 Months To Present

Red Alert- High Risk 71% 70% 52% 39% 58%

Yellow Alert- Medium Risk 25% 30% 39% 52% 33%

Green Alert- Low Risk 4% 0% 9% 9% 8%

Next 24-36 Months- Anticipated Changes

Decreasing Risk or Priority 10% 14% 5% 0% 14%

No Risk Change 90% 86% 95% 100% 86%

Increasing Risk or Priority 0% 0% 0% 0% 0%

Physician Pitfalls At Launch Across The Benchmark Class

Thought leaders and specialists are the highest risk physician stumbling blocks that can trip up a new product upon market entry. Poor physician segmentation and weak access also emerge as critical physician pitfalls. During the next 36 months, most of these risk factors are expected to stay the same in terms of risk and priority at launch.

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