Policy Research Institute News

This is a bulletin summarizing the activities and topics of the institute at the time.
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Latest Issue No.76 November 2025

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No.75 July 2025

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No.74 March 2025

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No.73 November 2024

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No.72 Issued Jul. 2024

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No.71 Issued Mar. 2024

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No.70 Issued in Nov. 2023

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No.69 Published in Jul. 2023

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No.68 Published in Mar. 2023

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Topics
Points of View
The Pharmaceutical Industry at a Glance

No.67 Published in November 2022

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No.66 Published in Jul. 2022

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No.65 Issued Mar. 2022

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No.64 Published in Nov. 2021

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No.63 Jul. 2021

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No.62 Issued Mar. 2021

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No.61 Issued in Nov. 2020

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No.60 Issued Jul. 2020

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No.59 Issued Mar. 2020

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No.58 November 2019 Issue

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No.57 Issued Jul. 2019

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Opinion
  • Preparation of the Pharmaceutical Industry for Future Healthcare - Based on the Interim Report of the Future Innovation WG
The Pharmaceutical Industry at a Glance
  • Comparison of Financial Indicators among R&D-Oriented Manufacturing Industries - Based on the Business Characteristics of the Pharmaceutical Industry
  • R&D Status of New Modalities in Japan - Based on a Questionnaire Survey by the Pharmaceutical Manufacturers Association of Japan
  • A Comparison of the Launch Status of the World's Top 300 Products in terms of Sales in Japan, the U.S. and Europe: Is the Drug Lag Being Resolved?
  • Countries where drugs approved under special regulatory measures in Japan, the U.S., and Europe are created
  • Status of spin-out companies from major global pharmaceutical companies
Topics
  • Trends in Clinical Trials for Designated Intractable Diseases - Focusing on Drug Combination Therapy
  • Differences in Priority of Needs for Therapeutic Drugs between the General Public and Physicians (Preliminary Survey)
Points of View
  • Health in your pocket - Status of Digital Therapeutics clinical trials using video games and mobile apps
  • Considering the "Quality" of Lifecourse Health Data - Perspectives on the realization of data-driven healthcare
  • Recent Trends in Patient Reported Outcome (PRO) - Survey and Analysis Using Clinical Trial Registry Databases
  • Regulatory Reform in the Health Care Sector - A Turning Point in One Street

No.56 March 2019 Issue 20th anniversary issue

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On the Occasion of the 20th Anniversary
Director, Pharmaceutical and Industrial Policy Research Institute
Sadao Nagaoka
Chairman, Japan Pharmaceutical Manufacturers Association
Joji Nakayama
Chairman, Japan Pharmaceutical Manufacturers Association
Tadaharu Goto
Chairman, Chugai Pharmaceutical Co.
Osamu Nagayama
Second Director, Pharmaceuticals and Industrial Policy Research Institute
Yoshihito Takahashi
Third Director, Pharmaceuticals and Industrial Policy Research Institute
Hitoshi Okuda
Topics
  • Evaluation of Innovativeness by Comparison of Similar Drugs: Analysis Using Matched Data with Comparison Drugs
  • Data Integration and Distribution Platform Based on Individuals (2) - Distributed Data Distribution by PLR (Personal Life Repository)
Points of View
  • Level and Direction of Drug Discovery Innovation: Importance of Demand and Incentives
  • Toward Early Development of AI Human Resources in the Pharmaceutical Industry
  • Exploring the trend of practical application of CAR-T cell therapy based on related literature and citation count information
  • New Payment Methods for High Cost Drugs -Trends in Western Countries
  • Usage of Anti-Tumor Drugs under the DPC System (DPC/PDPS)
Opinion
  • Proposal of a Consortium Concept for the Dissemination of Solutions Leading to Early Diagnosis and Continuation of Treatment
  • A Study on the Regulation of Pharmaceutical Advertisements (Part 2) - Toward the Realization of Patient Centricity
The Pharmaceutical Industry at a Glance
  • Current Status of Digitalization Promotion in Pharmaceutical Companies -CDO/CIO and Establishment of Digitalization Promotion Department
  • New drugs approved in Japan in 2018 and their review periods
  • Comparison of Patent Term and Reexamination Term for Drugs Containing New Active Ingredients-2
  • Status of Licensing-in in the Pharmaceutical Industry - Comparison of Japanese and Global Companies

No.55 Issued Nov. 2018

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Topics
  • The Value of Drugs: A Study by the "Study Group on the Value of Drugs" of the Policy Research Institute (PRIRI)
  • Data Integration and Distribution Platform Based on Individuals - Toward the Era of Individuals Managing Data
Points of View
  • Establishment of Reference Values for Cost-Effectiveness Evaluation - Verification of the Variability of the Amount of Willingness to Pay under Different Conditions
  • Economic value of the curative effect of innovative drugs - Contribution of drugs and surgery to inpatient outcomes
  • Toward the Widespread Use of "Virtual" Clinical Trials -Web-based and Site-less Clinical Trials
  • Access to the Next Generation of Preventive Medicine
The Pharmaceutical Industry at a Glance
  • Comparison of New Drug Review Periods in Japan, the U.S., and Europe - Focusing on 2017 Approval Results
  • Trends of Research Alliances in Pharmaceutical Companies -From Press Releases of Each Company
  • Survey of Development Trends of New Modalities - Focusing on Nucleic Acid Drugs, Gene Therapy and Cell Therapy
  • Trends of AI startups in pharmaceutical R&D
  • Patent Productivity in the Pharmaceutical Manufacturing Industry
  • Nationality of the Top Global Sales Drug Creators - 2017 Trends
  • Survey on the Leaders in the Creation of Innovative Medicines -From the Origin Analysis of the Top Global Sales of Medicines

No.54 July 2018 Issue

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Points of View
  • Trends in Payment Systems for Outcome-Based Drugs -Shift from "Quantity" to "Quality" in Healthcare
  • Trends in AI utilization mainly by member companies of the Pharmaceutical Manufacturers Association of Japan -From a survey of media information
  • Stage of consideration of social security system reform -Central conference body for revision of medical fees
  • A Study on the Regulation of Pharmaceutical Advertisements - From the Perspective of Risk Communication between Patients and Pharmaceutical Companies
The Pharmaceutical Industry at a Glance
  • A Glimpse into the Self-Medication Situation in Japan from the Data - Perspectives on the Trend of Switch OTC Drugs
  • Transition of the world's top pharmaceutical companies in terms of sales and their dependence on top-selling products - Positioning of Japanese companies in the world
  • Countries Generating Orphan Drugs Approved in Japan -Fiscal Years 2008 to 2017
  • Women in the Pharmaceutical Industry and Corporate Performance - Based on the Database of Companies Promoting Women's Activities, Ministry of Health, Labour and Welfare, etc.
Topics
  • Construction of a Medical Health Big Data Platform through PPPs (Public Private Partnerships) - Significance of Industry-Academia-Government Collaboration for the Development of Disease Cures
  • Introduction of "DDrare," a database of designated intractable diseases

No.53 March 2018 Issue

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Points of View
  • Initial Prices and Price Dynamics of New Drugs: Initial Findings from U.S.-Japan Panel Data
  • Introduction and Challenges of Cost-Effectiveness Assessment in Japan - Implications from Overseas Case Studies
  • Drug Innovation and Price Dynamics - The Case of Hepatitis C
  • Analysis of NDB Open Data and Issues -About Drug Data
  • Number of Published Substance Patents for Small Molecular Drugs - Survey Based on Applicant Classification and Target Molecule Classification
Topics
  • Consideration of drug benefits - from the viewpoint of benefit and burden
  • Issues and Measures for Secondary Use of Medical Data -Focusing on the Use of Electronic Medical Record Templates
  • Trends and Possibilities of Digital Therapeutics - "Therapeutic Apps" with Evidence of Therapeutic Effects
  • Analysis of Patent Term Extension for Biopharmaceuticals - Focusing on Antibody Drugs
  • Trends in Clinical Trials for Designated Intractable Diseases Based on Drug Modalities
  • Approval Status and Review Period of New Drugs in Japan - Survey of New Drugs Approved in 2017

No.52 November 2017 Issue

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Opinion
  • Expectations for the "Guidelines for the Promotion of Optimal Use
Points of View
  • Business Models of R&D-Oriented Domestic Pharmaceutical Companies - Sustained Fulfillment of Social Mission
Topics
  • Pharmaceutical Industry Vision in the Public and Private Sectors -Warming up and Renewal
  • How to Handle Productivity Losses in Health Economic Evaluation
  • Comparison of New Drug Review Periods in Japan, the U.S., and Europe -Analysis Based on 2016 Approval Results
  • Utilization of Real World Data with a Focus on Patient Registries - From Clinical Trial Streamlining to Beyond
  • Modality Analysis of Drugs Used in Clinical Trials for Designated Intractable Diseases
  • Addressing Unmet Medical Needs with Biopharmaceuticals
The Pharmaceutical Industry at a Glance
  • Nationality of the Top Global Sales Generators of Pharmaceuticals - 2016 Trends
  • Development and approval status of drugs for unmet medical needs -Trends in 2017
  • Trends in the number of new drug target molecules

No.51 July 2017 Issue

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Points of View
  • Target molecules and molecular weights of small molecule drugs -Survey from products launched in the past 47 years
  • Production Trends of Biopharmaceuticals (Antibody Drugs) -Analysis from Sales Weight
  • Comparison of Patent Term and Reexamination Term for Drugs Containing New Active Ingredients
Topics
  • Clinical Research Utilizing IoT - Benefits and Future Challenges - Report of "Big Data Utilization and Study Group on Medical and Health Fields
  • Efforts to Improve Treatment Continuation Rates Using ICT
The Pharmaceutical Industry at a Glance
  • Success or Failure of Clinical Development from the Perspective of Company and Product Characteristics

No.50 March 2017 Issue

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Points of View
  • Trend Analysis of Target Molecules of Small Molecular Drugs - Survey of Products Launched in the Past 47 Years
  • Examination of formulation and dosage form of biopharmaceuticals (antibody drugs) -Improvement of convenience and future development
  • Approval status and review period of new drugs in recent years - based on the approved products in 2016
  • Nationalities of the top-selling global drug generators and key distributors -Trends in 2015
Topics
  • Impact of the New U.S. Administration on the Japanese Pharmaceutical Industry - Obamacare and the NHI Price Review
  • Utilization of Personal Health Record "Utilization of Big Data in Medical and Health Fields" Report
  • IoT-based Medication Management - Toward Improving Medication Adherence Rates
  • Marketed drugs used in clinical trials for designated intractable diseases
The Pharmaceutical Industry at a Glance
  • Success rate of clinical development

No.49 November 2016 Issue

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Topics
  • Number and Molecular Weight of Low Molecular Weight Drugs Launched -A Survey from Products Launched in the Past 45 Years
  • Comparison of the global and Japanese biopharmaceutical markets
  • Current Status and Future Development of Subsequent Biologics
  • Electronic Health Record - Toward Diversified Use of Medical Big Data - "Utilization of Big Data in Medical and Health Care Fields, Study Group" Report
  • Internet of Things (IoT) in medicine and healthcare
  • Conductors of clinical trials for designated intractable diseases
  • Linkage with databases of information on designated intractable diseases

No.48 Published Jul. 2016

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Points of View
  • Performance and challenges of R&D-oriented pharmaceutical companies
  • Productivity and efficiency of R&D
Topics
  • Pathophysiological elucidation and new drug discovery centered on genome analysis in the era of big data - Expectations for genetic statistics - "Utilization of Big Data in Medical and Health Fields, Study Group" Report
  • Status of Implementation of Clinical Trials for Designated Intractable Diseases
  • Clinical Development of New Drugs and Review Periods -2015 Results
  • Status of International Clinical Trials for New Drugs and Number of Cases -From the Survey on Clinical Development and Duration of Approval Review for New Drugs
  • Factors Related to Development Time of New Drugs -Analysis of Approved Drugs from 2005 to 2015
  • Number of Small Molecular Drugs Created and Companies Originating Them -In light of Venture Activities
  • Life Cycle Management of Biopharmaceuticals - Perspectives on Expansion of Indications
  • The status of personnel exchange between academia and industry - with reference to the number of researchers who moved in and out of other organizations

No.47 March 2016 Issue

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Points of View
  • Number of countries in which patents have been filed for the world's top-selling drugs
  • Survey of R&D Trends in Biopharmaceuticals (Antibody Drugs) - Molecular Structural Changes toward Next-generation Antibodies
  • Trends in the Number of Published Patents for Small Molecular Compounds by Japanese Pharmaceutical Companies
Topics
  • Movement toward AI (Artificial Intelligence) Drug Discovery - What is Deep Learning? ~ Report on "Big Data Utilization and Study Group on Health and Medical Fields
  • Big Data for Better Outcomes in Europe
  • Trends in the Government's Promotion of R&D in the Medical Field - with Reference to the Budget and Progress of the Cooperative Projects of Each Ministry
  • Vaccines for Prevention of Infectious Diseases in Japan
The Pharmaceutical Industry at a Glance
  • Nationalities of the top-selling pharmaceutical generators and key distributors in the world - trends in 2014
  • Current Status of Orphan Drugs in Japan, the U.S. and Europe -2010-2015

No.46 Published in Nov. 2015

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Points of View
  • Changes in the Business Environment Surrounding Pharmaceutical Companies and Mid-term Business Plan
  • Survey on R&D Trends of Biopharmaceuticals (Antibody Drugs) -Expansion of Indications and Target Molecules-.
  • Research Activities of Drug Discovery Chemists in Companies
Topics
  • Learning Healthcare System -Verification and Improvement of Medical Care with Real Clinical Data- Report of "Big Data Utilization and Study Group in the Health and Medical Field
  • Medical Information Databases in the U.S.
  • Accelerating Medicines Partnership in the U.S.
  • Cooperation with External Organizations of Domestic Pharmaceutical Companies -A Study Focusing on Annual Securities Reports- (Japanese only)
  • Priority Review and Characteristics of New Drugs in the Approval Process
The Pharmaceutical Industry at a Glance
  • Sales Share of Domestic Pharmaceutical Companies in the Global Market
  • First-in-Class in the U.S.
  • Research Trends in the Developmental Origins of Health and Disease (DOHaD) Hypothesis

No.45 Published Jul. 2015

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Points of View
  • Contribution of Science -Analysis from Drugs, Life Span and Length of Hospital Stay
  • Precision Medicine Initiative in the U.S.
  • Clinical development and review period for new drugs -2014 results
  • Unapproved and Ineligible Drugs Requested by Pharmaceutical Companies for Development -Activity of Measures to Promote Practical Application as Seen in Regulatory Approval
  • The Japanese Pharmaceutical Industry from the Perspective of Sales Revenue Trends
Topics
  • Development Status of Drugs for Unmet Medical Needs -Trends in 2015
  • Anti-Doping Initiatives

No.44 March 2015

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Opinion
  • Light and Shadow of Open Innovation
Points of View
  • Infrastructure Development Desired for Big Data Utilization -Current Status and Challenges in the Medical Field
  • Creation of Pharmaceuticals from Academia - Based on the case study of obtaining regulatory approval through the use of investigator-initiated clinical trials
  • Analysis of Requests for Improvement in the Approval Review Process - Based on the Survey on Clinical Development and Review Periods of New Drugs (2013 Results)
Topics
  • Status of Research and Development of Small Molecular Drugs and Biopharmaceuticals
  • Development Trends of Drugs for Intractable Neurological Diseases with High Unmet Medical Needs
The Pharmaceutical Industry at a Glance
  • Status of removal of conditions for investigation of all cases during the reexamination period for new drugs
  • International comparison of the number of major basic and clinical medical papers published
  • Status of Utilization of Female Researchers in the Pharmaceutical Industry -Activities of Female Doctoral Talent

No.43 Published in November 2014

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Opinion
  • Expectations for the Japan Agency for Medical Research and Development (AMED)
Points of View
  • Registration Status of Japanese, Korean, and Chinese Versions of the PRO Evaluation Tool
  • -Examination by the Global Database PROQOLID
  • Survey of Business Models of Japanese Pharmaceutical Companies as Seen in Press Releases
Topics
  • Voluntary Application of IFRS (International Financial Reporting Standards) by Pharmaceutical Companies
The Pharmaceutical Industry at a Glance
  • First-in-Human Trial Countries in Clinical Trial Registries
  • Research Status of Domestic Pharmaceutical Companies from the Viewpoint of Patents
  • Number of Health Economics Research Papers in Recent Years

No.42 Published Jul. 2014

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Opinion
  • An Attractive Place for Drug Discovery Open to the World
Points of View
  • Clinical Development of New Drugs and Review Periods -2013 Results
  • Special Regulatory Measures for New Drug Approval
  • Keyword
    〈explanation〉Special Measures on Pharmaceutical Affairs in the U.S., Europe and Japan
Topics
  • The European Medicines Agency's Initiatives for Early Patient Access to New Medicines
  • -Adaptive Licensing" - a topic of ongoing debate
The Pharmaceutical Industry at a Glance
  • Drug Discovery and Rights Attribution from the Perspective of Nationality
  • Origins of the Development Pipeline of Japanese Pharmaceutical Companies

No.41 March 2014

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Points of View
  • Use of Health-Related Quality of Life (QOL) Information in the Appendix - Status of Use in Japan, the U.S., and Europe, and Noteworthy Case Studies
  • Status of International Clinical Trials -Analysis by Number of Trials Conducted
The Pharmaceutical Industry at a Glance
  • Development Status of Drugs for Unmet Medical Needs -Trends in 2013
  • Research Trends of Early Diagnostic Biomarkers

No.40 November 2013

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Opinion
  • Exporting Pharmaceuticals to the World
Points of View
  • Patient-Focused Drug Development - Utilizing Patients' Voices in New Drug Development
  • Training for Physicians on Clinical Trials and Clinical Research
  • Preventive Medicine by Comprehensive Genome Analysis
  • Efforts in Packaging and Formulation to Prevent Mishandling and Improve Adherence
Topics
  • Is ¥2.4 trillion in funds being diverted overseas due to over-importation of pharmaceuticals?
The Pharmaceutical Industry at a Glance
  • Efforts in drug development - with a focus on new drug approvals in the last 5 years
  • Is ¥2.4 trillion in funds being diverted overseas due to over-importation of pharmaceuticals?

No.39 July 2013

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Points of View
  • Market structure of ethical drugs and performance of pharmaceutical companies
  • New Drug Development Trends for Neglected Diseases" with High Drug Discovery Needs
  • Current Status and Future Issues Concerning Prevention of Similar Names for Drugs
  • Clinical Development of New Drugs and Review Periods - 2012 Results
  • Effects of Policies to Promote the Use of Generic Drugs -Impact of Alternative Preparations by Launch Date and Drug Class

No.38 March 2013

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Points of View
  • Neglected Disease Drug Discovery Partnerships - Evolving Forms of Partnerships
  • Clinical application of Patient Reported Outcome (PRO) and challenges
  • Drug costs and pharmaceutical company performance
  • Survey of Physicians' Current Clinical Trial Initiatives - Results of a Questionnaire Survey of Clinical Investigators in Japan, Korea, and the U.S.
  • Current Status and Challenges of Pharmacogenomics Initiatives in Clinical Trials by Pharmaceutical Companies
  • Drug Approval and Development Status for Unmet Medical Needs -Trends in 2011 and 2012
  • Effects of Policies to Promote the Use of Generic Drugs - Impact of Additional Generic Drug Dispensing System in 2010

No.37 November 2012

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Points of View
  • Patient Reported Outcome and New Drug Development - Clinical Evaluation of New Drugs Focusing on Direct Evaluation by Patients
  • Current Status and Challenges of R&D Funding for Neglected Diseases
  • International Projects as a Foundation for Personalized Medicine
  • RNAi Drug Development Initiatives
  • Drugs and Life Span -Analysis by Year of Market Launch and Disease Area
  • Effects of Policies to Promote the Use of Generic Drugs -Impact of Alternative Dispensing Methods due to Changes in Prescription Forms
  • Corporate Tax Policy and Corporate Behavior in the Profit and Loss Structure of Pharmaceutical Firms
Topics
  • Nationality of the company creating the new drug in Japan and the country where the clinical trial is conducted
  • Presence of Japanese Pharmaceutical Companies in the Pharmaceutical Market

No.36 Jul. 2012

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Points of View
  • Contribution of New Drugs - Life Span, Medical Expenditure and Economic Value Perspective
  • International Comparison of Guidelines and Reimbursement for Companion Diagnostics
  • Current Status and Prospects of Biobanks
  • Development Assistance Contribution Funds in the Fight against Infectious Diseases in Developing Countries
  • Clinical Development of New Drugs and Review Periods - 2011 Results
  • Number of cases per site in clinical trials for new drugs approved in Japan
  • Effects of Policies to Promote the Use of Generic Drugs - Impact of DPC Policies
Topics
  • Estimation of Pharmaceutical Expenditure as a Percentage of National Healthcare Expenditure -FY2001-FY2009
  • Excess Drug Imports and the Domestic Pharmaceutical Industry

No.35 March 2012

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Points of View
  • Drug repositioning and rare disease innovation
  • Neglected Tropical Diseases" and Pharmaceutical Industry Initiatives - Consideration of Drug Needs in Emerging Countries
  • Trends and Challenges in the Use of Pharmacogenomics
  • Impact of Biomarkers on Productivity of Drug Development
  • Industry-academia-government consortium support and incentives for companies to invest in R&D
  • Expansion of "pre-competitive collaboration
  • Effects of Policies to Promote the Use of Generic Drugs
Topics
  • International comparison of the number of major basic and clinical medical papers published
The Pharmaceutical Industry at a Glance
  • Use of Foreign Clinical Trial Data for New Drugs Approved in Japan
  • Launch period for the world's top 100 selling products

No.34 November 2011

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Points of View
  • Approaches to Rare and Intractable Diseases Using iPS Cells
  • R&D Trends in Tuberculosis and Malaria Vaccines: Exploring the Background of Progress
  • Development and Approval Status of Drugs for Unmet Medical Needs
  • Current Status and Challenges of Companion Diagnostics
  • Three Approaches to Realization of Personalized Medicine
  • Current Clinical Trial Performance of Medical Institutions and Clinical Development Monitors - Comparison with Major Asian Regions
  • Impact on Corporate Tax Burden of Light Taxation Country Operations: Estimation Using a Business Model

No.33 July 2011

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Points of View
  • Current Status and Trends of Cancer Therapy Vaccine R&D in Japan: The Dynamism of University-Launched Bio-Business Ventures
  • R&D Strategies for Tuberculosis and Malaria Drugs: Who Will Lead the Development of Drugs for Developing Countries?
  • Clinical Development of New Drugs and Review Periods - 2010 Results
  • Trends in the Use of PGx Information in Drug Labeling
  • Governance of Cluster Policies: The Cases of Japanese, German, and French Bio-Clusters
  • Technology Trade and the Pharmaceutical Industry in Japan's Manufacturing Sector
  • Key Risks for Pharmaceutical Companies and Business Risk Management
The Pharmaceutical Industry at a Glance
  • Market Impact of New Drug Creation Additions: Data from the Pharmaceutical Market in FY2009-2010
  • Current Status of Pharmaceutical Patent Applications from China

No.32 February 2011

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Points of View
  • Domestic Pharmaceutical Industry Contributing to the Growth of the Japanese Economy
  • Rare Disease Drug Development Trends in Japan, the U.S. and Europe and Challenges for Rare Disease Innovation in Japan
  • Trends in Pharmaceutical Companies Toward the Realization of Personalized Medicine
  • Characteristics of Biomarker Use in Clinical Trials
  • Current Status of Clinical Trial Costs for Medical Institutions - Comparison with Major Asian Regions
  • New Drug Creation Additions and Consumer Surplus: A Hypothetical Case Analysis of the Ulcer Drug Market
  • Market Impact of Increasing Penetration of Generic Drugs: Perspectives on Market Growth Rate and Improved Innovation

No.31 October 2010

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Points of View
  • Development and Approval Status of Drugs for Unmet Medical Needs
  • Current Status of Orphan Drugs in Japan, the U.S. and Europe
  • Trends in Clinical Trials Using Biomarkers
  • Efforts toward Realization of Personalized Medicine -Current Status and Challenges
  • Penetration of Generic Drugs in the Domestic Pharmaceutical Market: A Comparative Analysis by Therapeutic Area
  • Effective Tax Rates and Overseas Expansion of Japanese Pharmaceutical Companies
  • Patient Attitudes and Image of Pharmaceutical Companies in Large Chinese Cities
  • Principal-agency issues between patients and physicians

No.30 April 2010

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Points of View
  • The Japanese Drug Discovery System from the Perspective of Epigenetics Research
  • Additional Allowance for New Drug Discovery and Innovation
  • Clinical Development of New Drugs and Review Period - 2009 Results
  • Reasons for Discontinuation of Drug Development: A Questionnaire Survey
  • International Comparison of Effective Tax Rates of Major Pharmaceutical Companies
  • Characteristics of Business Risks of Pharmaceutical Companies -Analysis Based on Publicly Available Information
  • Current Status of Utilization of Pharmacoepidemiological Research for Appropriate Use of Drugs
The Pharmaceutical Industry at a Glance
  • Research Trends of Small Molecular Drugs in the Patent Applications of Major U.S. Biopharmaceutical Companies
  • Bio-Industry Innovation Policy in Singapore

No.29 January 2010

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Points of View
  • Duration and Cost of Drug Development: A Questionnaire Survey
  • Proposal for Standardization of Examination Timelines
    -A Comparison of 2005-2008 Approved Products with the EU
  • Nationalities of countries and companies creating innovative drugs
    -Analysis from the perspective of New Class and Best in Class drugs
  • Challenges for the Japanese Pharmaceutical Industry in the First Half of the Fiscal Year Ending March 31, 2010
  • Increasing Alliances with Foreign Ventures
  • Industrial Cluster Policies and Firm Performance
    -Effects of R&D Support and Networking Support
  • Team Medicine and Provision of Drug Information
The Pharmaceutical Industry at a Glance
  • China's Pharmaceutical Market by Therapeutic Category

No.28 August 2009

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Points of View
  • Research Environment for Biomarkers in the Drug Discovery Process
    -Issues in Japan as Seen in Questionnaire Survey and Analysis of Patent Applications
  • Trends in Clinical Development of New Drugs in Japan
  • Improved Innovation and Value-Added Pharmaceutical Products
  • Structural Changes in the Global Pharmaceutical Market and the Profit Base of the Pharmaceutical Industry
The Pharmaceutical Industry at a Glance
  • Drug Patent Term in Japan and the U.S.
  • Number of Health Economics Research Papers by Nationality

No.27 March 2009

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Points of View
  • Global Competitiveness and Growth Models of Major Japanese, U.S., and European Pharmaceutical Companies: Comparison of Sales Composition by Product, Therapeutic Area, and Region
  • Research-based Pharmaceutical Companies and Biosimilars
  • Alliances between Pharmaceutical Companies and Drug Discovery Ventures: Characteristics of Alliances in an International Comparison
  • Drug Licensing and Development Success Factors
  • The Role of Biomarkers in the Drug Discovery Process and Patent Application Trends in Japan
  • Review Period for New Drugs in Japan - Drugs Approved in 2008
  • Timing of Additions to Indications for Drugs - Recent Approval and Unchanged Applications for Top-Selling Drugs - Pediatric Indications
The Pharmaceutical Industry at a Glance
  • Profile of All Patient Surveillance Products

No.26 December 2008

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Points of View
  • Increasing Number of Global Clinical Trials and Positioning of Emerging Countries-Analysis of Countries and Companies Conducting Clinical Trials
  • Current Status and Challenges of International Clinical Trials Including Japan
  • R&D Assets and Value Added in the Pharmaceutical Industry - Inter-industry Comparison Based on Consolidated Financial Data
  • Trends and Prospects in the Use of Pharmacoeconomic Valuation
  • Patent Application Trends of Pharmaceutical-Related Biomarkers: Challenges for Japan
  • The Role of Biotech Ventures in the Drug Discovery Process in the U.S.
Angle
  • Cost Structure and Scale: A Comparison of Japanese, U.S., and European Pharmaceutical Companies

No.25 July 2008

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Points of View
  • Future Forecast of the Japanese Pharmaceutical Market and Its Impact on New Drug Creation: Market Characteristics as a Factor for Access to New Drugs
  • Intra-cluster Regional Collaboration and Innovation: Networking and R&D Productivity in Drug Discovery Biotech Ventures
  • Licensing Trends in Japanese Pharmaceutical Companies
  • Current Status of Clinical Medical Research in Japan and International Comparison
  • Development Period of New Drugs in Japan: Approval Review Period and Clinical Development Period
  • Access to Medicines based on Top Global Sales in 2007: Analysis of Unlaunched Products and Launch Lag
The Pharmaceutical Industry at a Glance
  • Characteristics of Biomarker-related Patent Applications by Pharmaceutical Companies
  • Trends of Japanese Biotech Ventures in terms of Products under Development

No.24 February 2008

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Points of View
  • Internationalization of R&D Activities
  • Comparison of Patent Applications of Major Japanese, U.S. and European Pharmaceutical Companies
  • Number of Clinical Trials and Cases of New Drugs in Japan
  • Globalization of Japanese Companies in Drug Development
  • Challenges to Be Addressed to Shorten the Drug Lag -Analysis Based on a Questionnaire Survey of Pharmaceutical Companies
  • Patent Applications in Key Translational Research Technology Areas
The Pharmaceutical Industry at a Glance
  • Access to Biopharmaceuticals and Companies Creating and Developing Biopharmaceuticals
  • Increasingly Active International Licensing Activities of Pharmaceutical Companies

No.23 August 2007

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Points of View
  • Improvement of Review Performance and Target Management
  • Public Funding for Drug Discovery Biotech Ventures
  • International Comparison of Biopharmaceutical Development
  • European Pharmaceutical Industry in Comparison with the Japanese Pharmaceutical Industry
  • Dynamism of the Pharmaceutical Market
  • Institutional Framework for Expediting Development and Approval of New Drugs
The Pharmaceutical Industry at a Glance
  • Disease Areas of Development Products in Japan, the U.S. and Europe
  • Trends in Combination Drug Development
Angle
  • Drug Lag from the Perspective of Start of Clinical Trials in Japan
  • U.S. FDA Research Scheme for Commercialization of New Biomarkers

No.22 March 2007

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Points of View
  • Comparison of satisfaction with medical care and drugs between general medical consumers and disease-specific patient groups patients
  • Current Status of New Drug Launches in Japan from the Perspective of Filing and Approval Timing in the U.S. and Japan
The Pharmaceutical Industry at a Glance
  • Asia as a New Drug Development Hub
  • Overseas Shift of New Drug Development by Japanese Companies
  • Time from Start of Clinical Trials to Approval of New Drugs
Topics
  • IT Initiatives in Healthcare

No.21 October 2006

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Points of View
  • Development and Launch of New Drugs and Changes in Treatment Satisfaction
  • The Japanese Pharmaceutical Market in terms of Changes in the Composition by Therapeutic Category
  • Comparison of New Drugs in Clinical Development by Originator's Nationality and Size
  • The Current State of Clinical Medical Research in Japan as Seen in Published Papers
  • Status of International Clinical Trials Including Japan
The Pharmaceutical Industry at a Glance
  • Trends in R&D Expenditures and Number of Employees in Clinical Development
  • Development Status in Six Countries (Japan, U.S. and Europe) (2006)
  • Priority Areas of Government R&D Investment in the Life Science Sector
Research
  • International Comparison of Image of the Pharmaceutical Industry

No.20 June 2006

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Points of View
  • Current Status of Post-Marketing Clinical Research as a Condition for Approval
  • Current Status of New Drug Development in Japan in terms of Number of Patients in Clinical Trials
  • New Drug Approval Status in Japan
  • Trends in Vaccine Development
Topics
  • Features of Financial Results for the Fiscal Year Ended March 31, 2006 (Consolidated)

No.19 February 2006

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Points of View
  • Characteristics of Clinical Data Packages as Seen in Documents Filed for Approval in Japan
  • Current Status of New Drug Development in Japan in terms of Number of Drugs Developed
  • Status of New Drug Applications in Japan
  • Japan's Challenges in Access to New Drugs
  • NHI Reform Requires Discussion from a Long-Term, Broader Perspective
Research
  • Drug Therapy for Persistently Infected Patients with Hepatitis C Virus
The Pharmaceutical Industry at a Glance
  • Trends in Biopharmaceutical Development

No.18 October 2005

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Points of View

~Creating a conducive environment for new drug discovery

  • Japan's Challenges in Access to New Drugs
  • Factors Contributing to the Decline in Competitiveness of the German R&D-Based Pharmaceutical Industry
  • NHI (National Health Insurance) Drug Pricing System Reflecting the Value of New Drugs
  • Conditions for Effective Industry-Academia-Government Collaboration
  • Time Required for New Drugs to Obtain Approval from the Late Stage of Exploratory Research in Japan

~Communication between Medical Consumers and Physicians

  • Are Patients Making Appropriate Choices in Medical Institutions?
  • Comparison of Satisfaction and Dissatisfaction with Medical Examinations
The Pharmaceutical Industry at a Glance
  • Positioning of the Pharmaceutical Industry in Major Countries

No.17 June 2005

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Points of View
  • Opportunities for Government-Industry Dialogue
  • Characteristics of Life Science Patents in Japan
  • Efforts of Pharmaceutical Companies to Promote Patient Empowerment
  • Information Disclosure Required of Review Authorities
  • Factors for Patient-Centered Medicine
Topics
  • Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2005
  • Review Times for New Drugs Approved in 2004
The Pharmaceutical Industry at a Glance
  • Ranking of Drugs Launched in Japan

No.16 February 2005

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Points of View
  • Factors Influencing the Creation of New Drugs
  • Clinical Trial Consultation and Development Time
  • Product age in the Japanese and U.S. pharmaceutical markets
  • Regulations, Policies and the Pharmaceutical Industry in Europe
  • Differences in Attitudes of Medical Consumers and Physicians in Decision-Making for Treatment and Drug Selection

No.15 October 2004

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Points of View
  • Value of Pharmaceutical Products
  • Review Period for New Drugs Approved in 2003
  • Characteristics of the Pharmaceutical Market by Country
  • Innovation at the required development stage
  • Provision of information from pharmaceutical companies to medical consumers
  • Economic and Medical Benefits of New Drugs
Research
  • Japanese Pharmaceutical Companies from the Perspective of Financial Data

No.14 July 2004

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Points of View
  • Differences in Patient Behavior by Disease as Seen in an Attitude Survey
  • Attitude Survey of Patients Participating in Clinical Trials
Topics
  • Future Forecast of the Ethical Drug Market
  • Biotechnology Promotion Policy in the U.K.
  • Three features in the 2003 financial results
Research
  • Impact of the public health insurance system on "equity in access to health care

No.13 March 2004

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Points of View
  • Survey of healthcare consumers' involvement in and knowledge of diseases and medicines
  • R&D Investments and Outcomes in Major Japanese Pharmaceutical Companies
  • The Role of Biotech Ventures in the U.S. Biotechnology Industry
  • Future New Drugs in Japan in terms of Application Status and R&D Areas
  • Approval Review Period for Drugs Containing New Active Ingredients
Topics
  • Establishment of a Drug Prescribing Database and Empirical Studies in Japan
Research
  • Government Funded Projects and Joint R&D

No.12 November 2003

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Points of View
  • Approval Review Periods for New Drugs in Japan
  • Japanese Pharmaceutical Companies in terms of the number of new drug ingredients approved
  • Pharmaceuticals Agency Funded Projects and Joint Research and Development
  • Aging of the Population and Changes in Medical Treatment Rates
Topics
  • Comprehensive Evaluation System and the Positioning of Pharmaceuticals
The Pharmaceutical Industry at a Glance
  • The Pharmaceutical Industry in the Japanese Economy

No.11 Jul. 2003

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Points of View
  • Drug Price Calculation and Pharmacoeconomics
  • Changes in Cost Structure of Pharmaceutical Companies due to Business Restructuring
  • Comprehensive Evaluation System and Innovative Drugs
Research
  • Self-Supporting Principle of Japanese Pharmaceutical Companies in Drug Development
The Pharmaceutical Industry at a Glance
  • Overseas Markets and Internationally Expanded Products Supporting the Growth of Pharmaceutical Companies

No.10 March 2003

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Points of View
  • Considering R&D Promotion Policies for Biotech Ventures
  • Development Period of Biopharmaceuticals
  • Role of Government in Promoting Clinical Trials
  • Crisis Management and the Role of Regulatory Science
  • Economic Profit Margin as a Management Indicator
The Pharmaceutical Industry at a Glance
  • Trends in R&D Expenditures in the Life Sciences in the U.S.

No.9 December 2002

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Points of View
  • Biopharmaceutical Development and the Role of Venture Companies
  • Prospects and Challenges of Antibody Drugs
  • R&D Promotion System of the Ministry of Health, Labour and Welfare
  • Comparison of Economic Profit Ratios between Japan and the U.S.
Topics
  • Promotion of Self-Medication and the Role of the Pharmaceutical Industry
The Pharmaceutical Industry at a Glance
  • Drug Usage Based on the Social Medical Practice Survey

No.8 October 2002

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Points of View
  • Attractiveness of the U.S. Market as Seen in the Launch of New Active Ingredients
  • Industry-Academia Collaboration and Drug Development
  • Highly Advanced Medical Care and Special Zones
  • The Pharmaceutical Industry in Economic Profitability
Research
  • Current Status and Issues of R&D Management in Pharmaceutical Companies
The Pharmaceutical Industry at a Glance
  • National Medical Expenditure and Drug Expenditure in FY2000

No.7 July 2002

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Points of View
  • Forecast of the Number of Biopharmaceuticals Launched
  • Changes in Disease Structure and Drug Development Pipeline
Research
  • Characteristics of Japanese Biotech Ventures in terms of Patent Application Trends
  • Alliances among Japanese, U.S. and European Pharmaceutical Companies
Topics
  • Recent Developments in Japan's Intellectual Property Policy
The Pharmaceutical Industry at a Glance
  • Biopharmaceutical Development and Venture Companies

No.6 May 2002

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Points of View
  • Current Status and Trends of Biopharmaceutical Development
  • Increasing Dependence of Pharmaceutical Companies on Foreign Countries
  • Accelerating Review of Production Systems
OPIR Research
  • Toward Revitalization of Clinical Trials in Japan
Topics
  • Clinical Research at University Hospitals

No.5 March 2002

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Points of View
  • Science and Technology Policy and Industry-Academia-Government Collaboration in the U.S.
  • University Ventures and TLOs in the U.K.
  • Increasing Industry-University Joint Research
Topics
  • Recent Trends in the Commercialization of New Medical Technologies
The Pharmaceutical Industry at a Glance
  • R&D Capability from the Perspective of Technology Trade Value
OPIR Views and Actions
  • Clinical Trials and Pharmacology: Participation in the Pharmacological Society of Japan Symposium

No.4 Jan. 2002

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Points of View
  • Desired shift to innovation-promoting regulations
  • Toward Strengthening Industry-Academia-Government Collaboration
  • Current Status of TLOs and Characteristics of Technology Transfer in the Pharmaceutical and Biotech Fields
  • R&D Investment and International Strategy
  • MRs and IT Strategies of Pharmaceutical Companies
Topics
  • Administrative Movements Related to Health Care System Reform (Latter Half of 2001)
The Pharmaceutical Industry at a Glance
  • R&D System of Pharmaceutical Companies

No.3 November 2001

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Points of View
  • Leadership for Reform
  • Alliance Strategies of Pharmaceutical Companies
  • Importance of CRC in Clinical Trials
OPIR Research
  • R&D Productivity in the Japanese Pharmaceutical Industry
Topics
  • Once Again, "Patenting Lives
The Pharmaceutical Industry at a Glance
  • Market Growth Potential as Seen in New Active Ingredients under Development

No.2 September 2001

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Points of View
  • Toward Promotion of Clinical Trials in Japan
  • Drug Evaluation Using Pharmacoeconomics
  • The Increasing Role of MRs
OPIR Research
  • Advances in Information and Communication Technology and MR Activities
  • Survey of New Drug Development
Topics
  • Administrative Movements Related to Health Care System Reform
The Pharmaceutical Industry at a Glance
  • Comparison of Profitability of Japanese and U.S. Pharmaceutical Companies

No.1 July 2001

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Points of View
  • Pharmaceutical Industry and Innovation
  • Government Support for R&D in the U.S.
  • Not "Life or Patents" but "Patents for Life
  • The Pharmaceutical Industry in FY2000 Financial Results
OPIR Research
  • Is the Cost Accounting Method Appropriate as a Method of Calculating Drug Prices for Innovative Drugs?
Topics
  • Government and Pharmaceutical Industry Developments in Biotechnology
The Pharmaceutical Industry at a Glance
  • Large-Scale Drugs in the World by Therapeutic Category

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