Intensifying Competition and Uncertainty in the Pharmaceutical Industry Development Environment
First written in FY2016. 14 of 20 entries say "Restated". Latest entry: 2026-08-14.
Linical moved to the "Worse" side of this theme in 2024, 5 years after the typical company in this theme (2019).
The whole theme swung hardest in 2022: 5 of 10 companies on the "Worse" side.
3 other companies' latest entry also says "Worsened".
- 2026-08-14WorsenedEarnings
「また日本でもドラッグ・ロス等により厳しい市場環境が続いており減収となりました。」
日本の医薬品市場について、ドラッグ・ロス等による厳しい環境が継続していると記載された。 - FY2026-H1WorsenedAnnual report
「Drug loss has become a serious social issue in Japan, and challenging market conditions continue. However, the company is securing orders by continuing sales activities in Japan and overseas in cooperation with its operations in Europe, the United States and Asia.」
The filing states that drug loss has become a serious social issue in Japan and that challenging market conditions continue in the Japanese pharmaceutical market. - FY2025-H1WorsenedAnnual report
「Structural reforms, including a succession of early-retirement programs at pharmaceutical companies in Japan, are under way, and challenging market conditions continue.」
The filing describes structural reforms involving a succession of early-retirement programs at Japanese pharmaceutical companies and challenging market conditions, illustrating the difficult business environment for domestic customers in addition to conventional drug pricing reforms and related factors. - FY2021-Q2WorsenedAnnual report
「The CRO (Contract Research Organization) industry to which the Group belongs is also affected by revisions to pharmaceutical companies' research and development plans, resulting in a severe competitive environment in which multiple companies compete for a limited number of development projects.」
The filing states that revisions to pharmaceutical companies' research and development plans have created a severe competitive environment in which multiple companies compete for a limited number of development projects. - FY2021-Q1RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Companies are being pressed to review the pipeline products they have on hand, and improvements in the productivity and efficiency of new drug development are required. At the same time, substantial unmet needs remain for diseases with low treatment satisfaction and for orphan drugs, while highly innovative medicines are eagerly awaited. In Japan, the Orphan Drug Designation System, the SAKIGAKE designation system and the conditional early approval system are now in operation, while regulatory authorities in the United States and Europe have also introduced similar preferential policies. In this environment, pharmaceutical companies are expected to accelerate shifts in their business models and research and development activities toward creating innovative new medicines, including in response to the expiration of patents on major products.」
While reiterating the pressure on the development environment from drug pricing reform, healthcare cost containment and efforts to promote generic drug use, the filing also describes demand for orphan drugs and innovative new medicines, as well as preferential policies in various countries. - FY2020RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Companies are being pressed to review the pipeline products they have on hand, and improvements in the productivity and efficiency of new drug development are required. At the same time, substantial unmet needs remain for diseases with low treatment satisfaction and for orphan drugs, while highly innovative medicines are eagerly awaited.」
While reiterating the pressure on the development environment from drug pricing reform and other factors, the filing also describes demand for orphan drugs and innovative new medicines. - FY2020-Q3RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Companies are being pressed to review the pipeline products they have on hand, and improvements in the productivity and efficiency of new drug development are required. At the same time, substantial unmet needs remain for diseases with low treatment satisfaction and for orphan drugs, while highly innovative medicines are eagerly awaited.」
While reiterating the pressure on the development environment from drug pricing reform and the promotion of generic drug use, the filing also describes demand for orphan drugs and other products, as well as expectations for innovative new medicines. - FY2020-Q1RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Companies are being pressed to review the pipeline products they have on hand, and improvements in the productivity and efficiency of new drug development are required.」
The filing continues to describe healthcare cost containment, efforts to promote generic drug use, drug pricing reform, pipeline reviews and pressure to improve the productivity and efficiency of new drug development. - FY2019-Q3RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Companies are being pressed to review the pipeline products they have on hand, and improvements in the productivity and efficiency of new drug development are required.」
The filing continues to describe drug pricing reform, efforts to promote generic drug use, pipeline reviews and pressure to improve the productivity and efficiency of new drug development. - FY2019-Q2RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system being implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Reports that companies are being pressed to review the pipeline products they have on hand indicate that improvements in the productivity and efficiency of new drug development are required.」
The filing continues to describe drug pricing reform, efforts to promote generic drug use, pipeline reviews and pressure to improve the productivity and efficiency of new drug development. - FY2019-Q1RestatedAnnual report
「In the pharmaceutical industry, containing rising healthcare costs has become a common challenge for countries worldwide, and developments such as the growing influence of insurers and efforts to promote the use of generic drugs are accelerating. In Japan, the sweeping reform of the drug pricing system being implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Reports that companies are being pressed to review the pipeline products they have on hand indicate that improvements in the productivity and efficiency of new drug development are required.」
The filing continues to describe drug pricing reform, efforts to promote generic drug use, pipeline reviews and pressure to improve the productivity and efficiency of new drug development. - FY2018WorsenedAnnual report
「In Japan, the sweeping reform of the drug pricing system being implemented from fiscal 2018, including a fundamental review of the premium system for promoting new drug creation and the elimination of off-label drugs, as well as revisions to the prices of long-listed products, is having a major management impact on pharmaceutical companies seeking to develop new drugs. Reports that companies are being pressed to review the pipeline products they have on hand indicate that improvements in the productivity and efficiency of new drug development are required.」
In addition to conventional issues involving drug prices, patents and approval reviews, the filing specifically describes the impact of drug pricing reform on pharmaceutical companies and pressure to improve development productivity and efficiency. - FY2018-Q3RestatedAnnual report
「Amid these economic conditions, competition in drug development in the pharmaceutical industry is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to describe intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews. - FY2018-Q2RestatedAnnual report
「Amid these economic conditions, competition in drug development in the pharmaceutical industry is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to describe intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews. - FY2018-Q1RestatedAnnual report
「Amid these economic conditions, competition in drug development in the pharmaceutical industry is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to describe intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews. - FY2017RestatedAnnual report
「In the pharmaceutical industry, competition in drug development is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to identify intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews as an external factor. - FY2017-Q3RestatedAnnual report
「In the pharmaceutical industry, competition in drug development is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to describe intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews. - FY2017-Q2RestatedAnnual report
「In the pharmaceutical industry, competition in drug development is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to describe intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews. - FY2017-Q1RestatedAnnual report
「In the pharmaceutical industry, competition in drug development is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing continues to describe intensifying competition in drug development due to cost-containment measures, patent expiries and stricter approval reviews. - FY2016First statedAnnual report
「In the pharmaceutical industry, competition in drug development is becoming increasingly intense due to stronger measures to contain pharmaceutical spending, including reductions in official drug prices and efforts to promote the use of generic drugs, as well as the expiration of patents on major products and increasingly stringent global reviews for new drug approvals.」
The filing identifies official drug prices, patent expiries and stricter approval reviews as external factors intensifying competition in pharmaceutical companies' development activities.