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藥品市場概論及實務
Introduction to the pharmaceutical market and practice
2019/1/3
魏景成
新藥研發流程與原理
產業分析
INDUSTRY ANALYSIS
價值與價格
VALUE & PRICE
課
程
大
綱
AGENDA
01
03
05
競爭策略
COMPETITIVE STRATEGY
行銷策略
MARKETING STRATEGY
02
04...
魏景成
講師自介
製藥業職歷
 生達化學製藥 國際事業部課長
 國鼎生物科技 國際業務部副總經理
董事長特助
 展旺生命科技 事業發展專員
 語言:英文、日文、韓文
 藥事法規:RAC國際醫藥醫材法規人才認證(Regulatory
A...
產業分析
INDUSTRY ANALYSIS
產業分析
環境分析
競爭者分析
產品分析
市場分析
內部分析
4
Features of Pharmaceutical Market
医薬品マーケティング新戦略 高橋真人
5
Enormous
cost and
time are
required for
product
developmen
t.
Influ...
Environment
analysis
Macro-
environment
Demographic
Economy
Technical environment
Politics / regulation
Society / culture
...
PEST analysis for pharmaceutical products
Politics
1. Regulation relief
2. Healthcare system reform
3. Revision of Pharmac...
Healthcare environmental analysis
Epidemiology
1. Potential patients / diagnosed patients
2. Incidence
3. Average onset ag...
Geriatric Population B00ming
IMS Market Prognosis 2014-2018
9
Most countries will experience an increase in
pharmaceutical spending per capita by 2018
Pharmaceutical Spending
IMS Marke...
Spending growth in the total market
reaches $100 billion by 2018.
Pharmaceutical Spending
IMS Market Prognosis 2014-2018
1...
U.S. spending growth on medicines will peak
in 2014 and then moderates through 2018
Pharmaceutical Spending
IMS Market Pro...
Top 5 European markets spending growth will
be flat through 2018Pharmaceutical Spending
IMS Market Prognosis 2014-2018
13
Japan’s growth is expected to return to
historic patterns through 2018 after atypical
2014
Pharmaceutical Spending
IMS Mar...
Pharmerging growth steady with
greater access to medicines and
economic improvement increases
Pharmaceutical Spending
IMS ...
Pharmaceutical Spending Spending level increases are tied to recently
expanded access, with 95% of the population
now cove...
North America continues to contribute the
largest proportion to growth, but Asia is
gaining growth rapidly.
Pharmaceutical...
Generics continue to drive growth globally
IMS Market Prognosis 2014-2018
18
Pharmerging market growth is driven by
generics and non-branded products
Pharmaceutical Spending
IMS Market Prognosis 2014...
Specialty therapies continue to be more significant in developed markets than in pharmerging
IMS Market Prognosis 2014-201...
Therapeutic Area
Igea Hub Pharmaceutical Club
21
Top 10 therapy areas in 2024, market share & sales growth
World Preview 2018, Outlook to 2024, EvaluatePharma®
22
Ranking of top pharma
23
Ranking of best selling products
24
Ranking of most promising products
EP Vantage 2018 Preview
25
R&D investment
Igea Hub Pharmaceutical Club
26
R&D investment
IMS Market Prognosis 2014-2018
27
Consistent high numbers of innovative and
orphan medicines expected through 2018
NME launch
IMS Market Prognosis 2014-2018...
Biosimiliar in development by country
2018 Global life sciences outlook, Deloitte
29
競爭策略
COMPETITIVE STRATEGY
競爭策略
五力分析
3C分析
差異化策略
市場環境
策略聯盟
競爭戰略
30
Market environment and basic concept
Diverse needs
Narrow down
market
Segmented
market
Competition
intensification
Differe...
Mega player
(Almighty type)
• Covering primary area
and specialty area
• Marketing powerfully in
all directions
Multiplaye...
Leader
Feature
eager to M&A
domination by size and resources
brand
Product
blockbuster products
first-in-class
Competitive...
5 forces analysis for pharmaceutical products
New entrants
(from different
industries)
Competitive
relationship
within the...
3C analysis for pharmaceutical products
Customer Company Competitor
Where to compete? How to compete? What to compete?
Pat...
Decide priority of product
3 new products business strategies
Existing category
competition
New category entry
New busines...
8 Elements for product differentiation
Price
Dosage
Chemical
Formulation
Usage
ADME
Mechanism
Form
Core
function
Efficacy
...
Purpose of the Strategic Alliance
Cost reduction type
Time saving type
Risk avoidance type
Weakness complement type
Synerg...
Alliance & outsourcing viewed from value chain
Research
Development
Clinical Trial
Marketing Promotion
RD Alliance Co-prom...
價值與價格
VALUE & PRICE
價值與價格
併購
投資
授權
估值方法
40
武田460億收購Shire,躍進全球製藥Top10
41
目前武田在胃腸道疾病、神經系統及腫瘤具有
很強競爭力,收購shire能夠很大程度上豐富
武田的罕見病和血液病產品及研發管線,迅速
得到幾款處於臨床後期的產品,並給武田帶來
新的增長點。
42
價值計算:①市場基礎法
 亦稱市場比較法、相對評價法
 在於在市場內,具相當營業項目、成長率、財務特性與規模的公司,應有類似
的表現及價值。應用非常廣泛,許多股市的研究報告即用此類方法。
 因此某一公司的價值應可由其它類似公司的價值...
43
價值計算:②收益基礎法
 公司的價值主要來自於公司未來所能創造的現金流量的現值總和。
 企業經營之目的在追求股東價值最大化,此法同時考量公司所處的經濟產業環
境、歷史經營績效、未來成長率、市場風險、資金結構和賦稅等因素,因此最
能反應...
44
價值計算:③資產基礎法
 資產基礎法認為企業的價值,在於其擁有的資產價值,所以此方法的重點在於
如何評估企業所擁有的資產價值。
 採用資產基礎法評價時,所有資產負債科目需視為個別單一的評價標的,並視
各個評價標的特性,選擇適當的方法進...
Pharma & biotech M&A transactions announced each quarter
EP Vantage 2018 Preview
45
Licensing activity- total upfronts paid & deal volume
EP Vantage 2018 Preview
46
VC investment
EP Vantage 2018 Preview
47
行銷策略
MARKETING STRATEGY
行銷策略
擴散理論
研發與銷售
定價理論
銷售與行銷
行銷策略
推廣策略
48
Research
Div.
Development
Div.
Production
Div.
Distributio
n
Div.
Sales
Div.
Physician
Patient
Payer
Value chain in pharma...
Target Focus Time perspective
Sales Product Sales Short-term
Marketin
g
Market Profit Medium / Long-Term
Sales vs Marketin...
Technology changes
Existing product Improved product New product
Market
changes
Mature
market
Growing
market
New
market
Ma...
Innovator (dissemination) theory
医薬品マーケティング新戦略 高橋真人
52
Awareness Differentiation Loyalty Concentration
Attribute and behavior analysis
Attribute
analysis
Geographic
Demographics Age, Gender
Psychological Lifestyle, personalit...
Model in calculation drugs consumption
50
100
100% 70% 60% 50% 30% 20%
Potentialpatients
Consultationrate
Diagnosticrate
D...
Market composition of medical products and example of patient flow
Total p‘ts
Conscious
Consultation
Diagnosis
Prescriptio...
Examples of existing market and drug decision trees
Patient
Symptom(+)
Symptom(-)
Implemented
Not-implemented
Abnormalitie...
4 Ps marketing mix
Product Price Place Promotion
Generic name
Brand name
Effect, feature
Quality
Dosage form
Package desig...
Target Product Profile (TPP)
• Indication
• Efficacy
• Safety
• Dosage & Administration
• Sales Impact
• Superiority
• Tim...
TPP & strategy design in development stage
TPP design
Research design
STP design
4P design
PM assign
Market research
Compe...
Drug price
setter
Involvement of
the authority
Drug price of
new drug
Price reduction
after launch
Japan Government High L...
Relationship between drug price and prescription share and profit
100%
50%
50 100 150 200 250 300 350
Patient share
1 day ...
Marketing process & survey
Segmentatio
n & Targeting
Positioning
Branding
Promotion
Prescription share
Amount share
Fact
N...
Strengths Weaknesses
Sales force Effect is high
Provide highly complex info
Info exchange is possible
High cost (continuou...
Benefits
• Finely responding
• Provide advanced information
• Information exchange
• Prompt response and feedback
Human Pr...
Priority
Top
priority
Monitor Watching
Sensitivity analysis
Impact on sales
医薬品マーケティング新戦略 高橋真人
65
Mild Huge
High possibili...
Methods of Sales Forecasts
Sales forecast
New Products
Introduction/
growing
Short-term forecast
(within 1 year)
Medium- t...
產品生命週期
PRODUCT LIFE CYCLE
產品生命週期
研發到上市
獨占期
專利懸崖
新藥延遲
產品生命週期
學名藥
67
Development of new products and time
Marginratio
Time
Company
Existing Category
Priority Category
Existing category
Non-pr...
Stage Development Introduction Growth Mature Declining
Strategic
Issues
Product
design
Market
penetration
Increase
market ...
Lifecycle management up to drug launch
5~9y 3~9y 1~3y
Non-
clinical
Fundamen
tal
research
Phase I
Phase IIa
Phase IIb
Phas...
The availability of new medicines varies by country and disease
IMS Market Prognosis 2014-2018
71
Drug lag
US
JP
Preparation
period
Clinical trial
period
Review
Preparation
period
Clinical trial period Review
Drug lag
La...
Patent period, development and sales period in pharmaceuticals
Nonclinical
Fundamental
research
Clinical
trial
Dossier
sub...
Comparison of sales of originator and
generic sales between US & JP
US
JP
Originator
sales
Generic sales
医薬品マーケティング新戦略 高橋真...
Rank of lifecycle value-growth to mature
#2 Humira
Launched on 2002
115.9B USD
#9 Herceptin
Launched on 1998
79.2B USD
#12...
Rank of lifecycle value-mature to decline
#13 Abilify
Launched on 2005
63.5B USD
#19 Gleevec
Launched on 2001
56.2B USD
#2...
Goal of post market lifecycle management
Development Introduction Growth Mature Declining
Revenue
Launch
Years of post mar...
78
Case study: Quick death of Aliskiren
Small molecule patent expiries will moderate through 2018 after a peak in 2012
IMS Market Prognosis 2014-2018
79
• Launch next generation products
• New indication
• New dosage form
• Change Composition
• Maximize brand loyalty
• Strat...
81
Intelligence is everything
大陸某醫藥數據資料庫廣告
THANKS
FOR WATCHING
1637weiwenyi@gmail.com
82
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Presentation20190103 final

  1. 1. 藥品市場概論及實務 Introduction to the pharmaceutical market and practice 2019/1/3 魏景成 新藥研發流程與原理
  2. 2. 產業分析 INDUSTRY ANALYSIS 價值與價格 VALUE & PRICE 課 程 大 綱 AGENDA 01 03 05 競爭策略 COMPETITIVE STRATEGY 行銷策略 MARKETING STRATEGY 02 04 2 產品生命週期 PRODUCT LIFE CYCLE
  3. 3. 魏景成 講師自介 製藥業職歷  生達化學製藥 國際事業部課長  國鼎生物科技 國際業務部副總經理 董事長特助  展旺生命科技 事業發展專員  語言:英文、日文、韓文  藥事法規:RAC國際醫藥醫材法規人才認證(Regulatory Affair Certificate- General Scope)  專案管理:PMP國際專案管理師(Project Management Professional)  產品上市:NPDP國際新產品開發管理師 (New Product Development Professional)  企業鑑價:企業評價師證照(經濟部工業局培訓,中華無 形資產暨企業評價協會認證)  科技管理:MMOT跨領域科技管理與智財運用國際人才培 訓計畫先修班結訓  智財管理:智慧財產人員能力認證(TIPA):專利程式控管 類、專利檢索分析與加值運用類認證  日本醫藥:日本登錄販賣者試驗合格、日本藥學檢定一級  企業法務:日本企業法務(ビジネス法務)檢定二級  國際貿易:國貿大會考合格 3
  4. 4. 產業分析 INDUSTRY ANALYSIS 產業分析 環境分析 競爭者分析 產品分析 市場分析 內部分析 4
  5. 5. Features of Pharmaceutical Market 医薬品マーケティング新戦略 高橋真人 5 Enormous cost and time are required for product developmen t. Influenced by pharmaceuti cal regulation. Price of the drug is determined by the drug pricing system. Complicated and exact information Promotion and advertiseme nt is regulated
  6. 6. Environment analysis Macro- environment Demographic Economy Technical environment Politics / regulation Society / culture Micro- environment External factors Internal factors Management HR & Organization Financial ability R&D ability Formulation Tech Production capacity Market entry Marketing power Product lineup Sales force Client Market Competition Supplier Environment analysis of Pharmaceutical Market 医薬品マーケティング新戦略 高橋真人 6
  7. 7. PEST analysis for pharmaceutical products Politics 1. Regulation relief 2. Healthcare system reform 3. Revision of Pharmaceutical Affairs Law 4. Strategies against intractable diseases Economics 1. GDP/ appreciation/ depreciation 2. Increasing drug expenses 3. Promotion of generic products Society 1. Aging 2. Increase of lifestyle diseases 3. Stressful society Technology 1. Development of regenerative medicine 2. Genomic medicine 3. New treatment method 医薬品マーケティング新戦略 高橋真人 7
  8. 8. Healthcare environmental analysis Epidemiology 1. Potential patients / diagnosed patients 2. Incidence 3. Average onset age · mean disease duration 4. Gender/ age composition ratio 5. Survival rate / mortality Etiology 1. Condition (pathogenic mechanism) 2. Pathological findings 3. Classification on pathology, pathology 4. Presence of inheritance Diagnosis / examination 1. Criteria 2. Main symptoms 3. Inspection method (insurance reimbursement?...) 4. Monitoring method (blood concentration…) 5. Criteria for determining severity Treatment 1. Non medication therapy 2. Medication therapy 3. Guidelines 4. Market size (amount, number of patients) 5. Competition situation (number of products / share) 医薬品マーケティング新戦略 高橋真人 8
  9. 9. Geriatric Population B00ming IMS Market Prognosis 2014-2018 9
  10. 10. Most countries will experience an increase in pharmaceutical spending per capita by 2018 Pharmaceutical Spending IMS Market Prognosis 2014-2018 10
  11. 11. Spending growth in the total market reaches $100 billion by 2018. Pharmaceutical Spending IMS Market Prognosis 2014-2018 11 (Rest of world)
  12. 12. U.S. spending growth on medicines will peak in 2014 and then moderates through 2018 Pharmaceutical Spending IMS Market Prognosis 2014-2018 12
  13. 13. Top 5 European markets spending growth will be flat through 2018Pharmaceutical Spending IMS Market Prognosis 2014-2018 13
  14. 14. Japan’s growth is expected to return to historic patterns through 2018 after atypical 2014 Pharmaceutical Spending IMS Market Prognosis 2014-2018 14
  15. 15. Pharmerging growth steady with greater access to medicines and economic improvement increases Pharmaceutical Spending IMS Market Prognosis 2014-2018 15
  16. 16. Pharmaceutical Spending Spending level increases are tied to recently expanded access, with 95% of the population now covered by public health insurance plans. IMS Market Prognosis 2014-2018 16
  17. 17. North America continues to contribute the largest proportion to growth, but Asia is gaining growth rapidly. Pharmaceutical Spending IMS Market Prognosis 2014-2018 17
  18. 18. Generics continue to drive growth globally IMS Market Prognosis 2014-2018 18
  19. 19. Pharmerging market growth is driven by generics and non-branded products Pharmaceutical Spending IMS Market Prognosis 2014-2018 19
  20. 20. Specialty therapies continue to be more significant in developed markets than in pharmerging IMS Market Prognosis 2014-2018 20
  21. 21. Therapeutic Area Igea Hub Pharmaceutical Club 21
  22. 22. Top 10 therapy areas in 2024, market share & sales growth World Preview 2018, Outlook to 2024, EvaluatePharma® 22
  23. 23. Ranking of top pharma 23
  24. 24. Ranking of best selling products 24
  25. 25. Ranking of most promising products EP Vantage 2018 Preview 25
  26. 26. R&D investment Igea Hub Pharmaceutical Club 26
  27. 27. R&D investment IMS Market Prognosis 2014-2018 27
  28. 28. Consistent high numbers of innovative and orphan medicines expected through 2018 NME launch IMS Market Prognosis 2014-2018 28
  29. 29. Biosimiliar in development by country 2018 Global life sciences outlook, Deloitte 29
  30. 30. 競爭策略 COMPETITIVE STRATEGY 競爭策略 五力分析 3C分析 差異化策略 市場環境 策略聯盟 競爭戰略 30
  31. 31. Market environment and basic concept Diverse needs Narrow down market Segmented market Competition intensification Differentiated market Products differentiatio n Market change Product value change Product life cycle 医薬品マーケティング新戦略 高橋真人 31
  32. 32. Mega player (Almighty type) • Covering primary area and specialty area • Marketing powerfully in all directions Multiplayer (Diversified type) • Covering both original and generic drugs • Larger company size Niche player (Concentrated type) • Covering intensively the niche area • No.1 or first three in the target category Category players (Specialty type) • Covering mainly on specialty areas • No. 1 in target category Classifications of Originators 医薬品マーケティング新戦略 高橋真人 32 ① ② ③ ④
  33. 33. Leader Feature eager to M&A domination by size and resources brand Product blockbuster products first-in-class Competitive strategies in pharmaceutical industry Challenger Feature research intensive type differentiation alliance Product blockbuster products best-in-class Followers Feature conventional sales & marketing resist to merge Product medium market size product cloner & imitator Nicher Feature centralized type resist to merge high profit Product small to medium market size products less competition area医薬品マーケティング新戦略 高橋真人 33
  34. 34. 5 forces analysis for pharmaceutical products New entrants (from different industries) Competitive relationship within the industry (competitors) Replacement/ Substitution (new TX, generic product) Buyer (hospitals / patients/ payers) Seller (API manufacturers) 供應商的議 價力量 客戶的 議價力量 替代品/ 服務的威脅 新加入者的威脅 医薬品マーケティング新戦略 高橋真人 34
  35. 35. 3C analysis for pharmaceutical products Customer Company Competitor Where to compete? How to compete? What to compete? Patient trend patient pool size recognition rate acceptance rate Actual medical condition number of physicians diagnostic rate specialty Treatment status dosage rate, efficacy rate, satisfaction level guideline Organization sales system quantities of MRs marketing system Status of products characteristics of products market share Market entry product lineup relationship with customers Organization sales system quantities of MRs marketing system Status of products characteristics of products market share Market entry product lineup relationship with customers 医薬品マーケティング新戦略 高橋真人 35
  36. 36. Decide priority of product 3 new products business strategies Existing category competition New category entry New business development Market analysis Customer analysis Product analysis Competitive analysis Resource and inventory check Macro-environment analysis · Industry analysis Market analysis · customer analysis · competitive analysis Impact on market entry & investment outcome investigation 医薬品マーケティング新戦略 高橋真人 36
  37. 37. 8 Elements for product differentiation Price Dosage Chemical Formulation Usage ADME Mechanism Form Core function Efficacy Safety Indicatio n 医薬品マーケティング新戦略 高橋真人 37
  38. 38. Purpose of the Strategic Alliance Cost reduction type Time saving type Risk avoidance type Weakness complement type Synergy type 医薬品マーケティング新戦略 高橋真人 38
  39. 39. Alliance & outsourcing viewed from value chain Research Development Clinical Trial Marketing Promotion RD Alliance Co-promotion CSOCRO Vertical integration Horizontal integration 医薬品マーケティング新戦略 高橋真人 AllianceOutsourcingIntegration 39
  40. 40. 價值與價格 VALUE & PRICE 價值與價格 併購 投資 授權 估值方法 40
  41. 41. 武田460億收購Shire,躍進全球製藥Top10 41 目前武田在胃腸道疾病、神經系統及腫瘤具有 很強競爭力,收購shire能夠很大程度上豐富 武田的罕見病和血液病產品及研發管線,迅速 得到幾款處於臨床後期的產品,並給武田帶來 新的增長點。
  42. 42. 42 價值計算:①市場基礎法  亦稱市場比較法、相對評價法  在於在市場內,具相當營業項目、成長率、財務特性與規模的公司,應有類似 的表現及價值。應用非常廣泛,許多股市的研究報告即用此類方法。  因此某一公司的價值應可由其它類似公司的價值估算而得。  有兩個基本的構成要素,市場乘數(Market Multiple)及類似可做對照的公司。  常用的市場乘數:  本益比:每股價格/每股盈餘  股價淨值比:每股價格/每股帳面價值  本銷比:每股價格/每股營收  市價現金流量比:每股價格/每股現金流量
  43. 43. 43 價值計算:②收益基礎法  公司的價值主要來自於公司未來所能創造的現金流量的現值總和。  企業經營之目的在追求股東價值最大化,此法同時考量公司所處的經濟產業環 境、歷史經營績效、未來成長率、市場風險、資金結構和賦稅等因素,因此最 能反應企業實際面臨的情境,而其結果亦最能代表公司的實際價值。  缺點在於未來現金流量不易準確估計,且方法中使用大量變數需要估計,操作 較為複雜,過程中主觀判斷因素亦較多。  有股利折現法、盈餘折現法、經濟利潤折現法、 自由現金流量折現法等。
  44. 44. 44 價值計算:③資產基礎法  資產基礎法認為企業的價值,在於其擁有的資產價值,所以此方法的重點在於 如何評估企業所擁有的資產價值。  採用資產基礎法評價時,所有資產負債科目需視為個別單一的評價標的,並視 各個評價標的特性,選擇適當的方法進行評價,故其複雜繁瑣的程度並不下於 其他評價方法。  一般而言,資產基礎法應用時機多為企業進行清算時或企業併購進行購買價值 分攤(Purchase Price Allocation, PPA )。
  45. 45. Pharma & biotech M&A transactions announced each quarter EP Vantage 2018 Preview 45
  46. 46. Licensing activity- total upfronts paid & deal volume EP Vantage 2018 Preview 46
  47. 47. VC investment EP Vantage 2018 Preview 47
  48. 48. 行銷策略 MARKETING STRATEGY 行銷策略 擴散理論 研發與銷售 定價理論 銷售與行銷 行銷策略 推廣策略 48
  49. 49. Research Div. Development Div. Production Div. Distributio n Div. Sales Div. Physician Patient Payer Value chain in pharmaceutical companies Construction of value chain Unmet Medical Needs 医薬品マーケティング新戦略 高橋真人 49 Marketin g Div.
  50. 50. Target Focus Time perspective Sales Product Sales Short-term Marketin g Market Profit Medium / Long-Term Sales vs Marketing 医薬品マーケティング新戦略 高橋真人 50
  51. 51. Technology changes Existing product Improved product New product Market changes Mature market Growing market New market Marketing Marketing vs R&D: Who leads product development? 医薬品マーケティング新戦略 高橋真人 51 R&D
  52. 52. Innovator (dissemination) theory 医薬品マーケティング新戦略 高橋真人 52 Awareness Differentiation Loyalty Concentration
  53. 53. Attribute and behavior analysis Attribute analysis Geographic Demographics Age, Gender Psychological Lifestyle, personality, prescription rights Behavioral Frequency of use, Loyalty, Consultation Awareness of disease / treatment Awareness of disease, Adaption rate of treatment Specialty · clinical dept. GI · CV… Facility Attribute University Hospital · Clinic Behavior analysis Product selection Problem recognition, Problem solving, Product selection, Product purchasing, Product valuation 医薬品マーケティング新戦略 高橋真人 53
  54. 54. Model in calculation drugs consumption 50 100 100% 70% 60% 50% 30% 20% Potentialpatients Consultationrate Diagnosticrate Dosagerate Prescriptionrate Persistencerate LOSS 医薬品マーケティング新戦略 高橋真人 54
  55. 55. Market composition of medical products and example of patient flow Total p‘ts Conscious Consultation Diagnosis Prescription Our p’t share Average dose Persistency Daily avg. price Non-conscious Non-consultation Non-diagnosis Non prescription Competitor’s p’t share Average dose Persistency Daily avg. price Realize it is a disease? Been consulted at a hospital? Been diagnosed? Drugs are prescribed? What is the patient share? Average amount daily intake? How long will it be taken? Existing market Potential market 医薬品マーケティング新戦略 高橋真人 55
  56. 56. Examples of existing market and drug decision trees Patient Symptom(+) Symptom(-) Implemented Not-implemented Abnormalities Normality Exclusion Mild to Moderate Mild Moderate to Severe Mild Exclusion Exclusion 1. Effect A 2. Safety 1. Effect B 2. Safety 1. Effect A 2. Effect B 1. Effect B 2. Safety Drug A Drug C Drug B Drug C Drug A Drug B Drug B Drug C Consult Examination Diagnosi s Treatment goal Prescriptio n Implemented Not-implemented Abnormalities Normality 100 60 40 42 18 32 8 12 30 9 9 12 20 医薬品マーケティング新戦略 高橋真人 56
  57. 57. 4 Ps marketing mix Product Price Place Promotion Generic name Brand name Effect, feature Quality Dosage form Package design Product logo Warranty Drug price Transferred price Sales price Allowance Discount Credit conditions Channel Distribution coverage Product assortment Location Stock Transport Advertising Sales Force Sales Promotion Public Relations Internet 医薬品マーケティング新戦略 高橋真人 57
  58. 58. Target Product Profile (TPP) • Indication • Efficacy • Safety • Dosage & Administration • Sales Impact • Superiority • Time • Form Proof of Concept 医薬品マーケティング新戦略 高橋真人 58
  59. 59. TPP & strategy design in development stage TPP design Research design STP design 4P design PM assign Market research Competition survey PEST Analysis Needs Survey Fact Investigation SWOT Analysis 3C Analysis Segmentation Targeting Positioning Task extraction Promotion scenario Scenario investigation Branding Promotion strategy Price strategy Distribution strategy PMS design MR training MR promotion PMSNDAPhase IIIPhase IIbPhase IIaPhase I 医薬品マーケティング新戦略 高橋真人 Approval 59
  60. 60. Drug price setter Involvement of the authority Drug price of new drug Price reduction after launch Japan Government High Low High France Government Medium Medium Low England Free Medium Medium Low Germany Free Medium Medium Low US Free Low High NA Drug pricing system 医薬品マーケティング新戦略 高橋真人 60
  61. 61. Relationship between drug price and prescription share and profit 100% 50% 50 100 150 200 250 300 350 Patient share 1 day drug price Share Profit drug price*patient share* (1 - cost rate) Share at best price Best price 医薬品マーケティング新戦略 高橋真人 61 Profit/day
  62. 62. Marketing process & survey Segmentatio n & Targeting Positioning Branding Promotion Prescription share Amount share Fact Needs & insights Positioning & Message Branding Survey Scenario survey Mind share survey Dynamic survey Market share Treatment algorithm (decision tree) Patient flow Drug evaluation, treatment motivation Tx issues, dissatisfied or worried points, ideal status Major treatment goal, clinical benefit, product characteristics Visual, logo, tagline, signal Understanding and acceptance of promotional content Understanding, conviction, differentiation, prescription intention New patient share, Switching share, Additional share, Maintenance share, Total share IMS share 医薬品マーケティング新戦略 高橋真人 62
  63. 63. Strengths Weaknesses Sales force Effect is high Provide highly complex info Info exchange is possible High cost (continuous) Coverage is limited Latent effect Advertisement High coverage Messages can be transmitted quickly High impact High cost (depends on cost) Difficult to provide complex info Publicity Reliability is high Reasonable cost Difficult to control by company Negative information may be spread Promotion Fast Effect Synergy is expected (with sales force) Effect period is short High cost Word-of- mouth reviews Reliable and low cost Difficult to control by company Negative information may be spread Internet Internet can be seen anytime, anywhere No restriction in amount of info Comparation and exchange is possible Weak impact Strengths and weaknesses of promotion methods 医薬品マーケティング新戦略 高橋真人 63
  64. 64. Benefits • Finely responding • Provide advanced information • Information exchange • Prompt response and feedback Human Promotion Process Discover existing customers' needs Search for new customers Detail presentation Attention-drawing, Interest facilitation Occurrence of desire (counterargument, differentiation) Prescription occurrence Follow-up (confirmation of customer satisfaction) 医薬品マーケティング新戦略 高橋真人 64
  65. 65. Priority Top priority Monitor Watching Sensitivity analysis Impact on sales 医薬品マーケティング新戦略 高橋真人 65 Mild Huge High possibility/ frequency Low possibility/ frequency
  66. 66. Methods of Sales Forecasts Sales forecast New Products Introduction/ growing Short-term forecast (within 1 year) Medium- to long- term forecast (longer than 2 years) Existing Products maturity/ deline Short-term forecast (within 1 year) Medium- to long- term forecast (longer than 2 years) Market breakdown method Benchmark method Growth rate analysis method Survey analysis method · Product competitiveness Statistical prediction method Product life cycle analysis method subjective intensive method 医薬品マーケティング新戦略 高橋真人 66
  67. 67. 產品生命週期 PRODUCT LIFE CYCLE 產品生命週期 研發到上市 獨占期 專利懸崖 新藥延遲 產品生命週期 學名藥 67
  68. 68. Development of new products and time Marginratio Time Company Existing Category Priority Category Existing category Non-priority category New category 医薬品マーケティング新戦略 高橋真人 68
  69. 69. Stage Development Introduction Growth Mature Declining Strategic Issues Product design Market penetration Increase market share Maintaining revenue Maintaining profit Profit (revenue) minus + - increase max reduction Product lifecycle and profit Revenu e Cost Sales Profit Marketing cost Production cost Development cost ApprovalDiscovery Launch 医薬品マーケティング新戦略 高橋真人 69
  70. 70. Lifecycle management up to drug launch 5~9y 3~9y 1~3y Non- clinical Fundamen tal research Phase I Phase IIa Phase IIb Phase III Expert committee Pharmaceutical committee Pharmaceutical Affairs Post marketing surveyApplication for re- examination Clinical Trial Submission TPP Plan (indications, target countries) TPP Decision Sales scale, sales system, production system evalua Scale of trial, facilities, PI, etc. Response to deficits, launch plan and sales strategy Plan for post-marketing surveillance 医薬品マーケティング新戦略 高橋真人 70
  71. 71. The availability of new medicines varies by country and disease IMS Market Prognosis 2014-2018 71
  72. 72. Drug lag US JP Preparation period Clinical trial period Review Preparation period Clinical trial period Review Drug lag Launch Launch 医薬品マーケティング新戦略 高橋真人 72 Time
  73. 73. Patent period, development and sales period in pharmaceuticals Nonclinical Fundamental research Clinical trial Dossier submission 3~5y 2~3y 3~9y 1~3y R & D period Reexamination Revaluation period Patent application Originator sales period Generic sales period Patent period 医薬品マーケティング新戦略 高橋真人 73
  74. 74. Comparison of sales of originator and generic sales between US & JP US JP Originator sales Generic sales 医薬品マーケティング新戦略 高橋真人 74patent expiration time revenue in US
  75. 75. Rank of lifecycle value-growth to mature #2 Humira Launched on 2002 115.9B USD #9 Herceptin Launched on 1998 79.2B USD #12 Nexium Launched on 2001 65.3B USD #3 Remicade Launched on 1998 105.1B USD 史上最畅销的21个药,你认识几个? 药事纵横 75
  76. 76. Rank of lifecycle value-mature to decline #13 Abilify Launched on 2005 63.5B USD #19 Gleevec Launched on 2001 56.2B USD #20 Losec Launched on 1992 52.0B USD #1 Lipitor Launched on 1998 152.0B USD 史上最畅销的21个药,你认识几个? 药事纵横 76
  77. 77. Goal of post market lifecycle management Development Introduction Growth Mature Declining Revenue Launch Years of post marketing 医薬品マーケティング新戦略 高橋真人 77
  78. 78. 78 Case study: Quick death of Aliskiren
  79. 79. Small molecule patent expiries will moderate through 2018 after a peak in 2012 IMS Market Prognosis 2014-2018 79
  80. 80. • Launch next generation products • New indication • New dosage form • Change Composition • Maximize brand loyalty • Strategic pricing • Switch to OTC • Release of generics by our company • Liquidation/ license out the product Strategy against Patent Expiration Strategy against Patent Expiration 医薬品マーケティング新戦略 高橋真人 80
  81. 81. 81 Intelligence is everything 大陸某醫藥數據資料庫廣告
  82. 82. THANKS FOR WATCHING 1637weiwenyi@gmail.com 82

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