製藥業和其他消費性用品產業有許多不同，像是需要大量地投資於新產品研發與創新。許多藥品和其他消費品相比，有較長的產品生命週期，而且藥品購買者通常並非是藥品使用者。儘管藥品有較長的生命週期，最終仍會面對專利到期的一天。對於製藥業而言，近年來的市場准入(market access)變得更具挑戰性，臨床試驗的障礙、法規核可，和健保給付核可價格也變得比以前困難。藥品需要較長時間以準備進入市場，因此在專利到期前的市場銷售期也縮短許多。如何在有限的市場銷售期極大化銷售業績和利潤對於藥品行銷者而言，也日益重要。即使是在專利過期後，如何管理以及延展藥品生命週期對於製藥業也是一門學問。
為了縮短藥品上市前的準備期，製藥公司需要了解管制法規的申請策略，和選擇最適宜者。下一步是思考健保價格策略。了解中央健康保險局的機制，可以有效減少反覆送件的過程。
度過藥品上市前的準備期後，下一個任務是如何延展產品生命週期。常見策略有1)增加原藥品的新適應症；2)推出機轉類似，但稍微改良過的新產品，以替換即將專利保護過期的藥品；3)將即將專利保護過期的舊產品在劑型上導入新科技，而此新劑型具有專利保護;4)導入固定劑量複方藥品;5)投資學名藥。
產品生命週期的管理對於製藥業非常重要，公司應該強化縮短產品上市前準備期間的能力，在市場銷售期極大化銷售業績與利潤，並在專利到期後延展產品生命週期。
對健康保險環境的研究，以及醫生行為受保險體制的改變，與長時間對人們健康的影響仍待未來進行進一步地探討。 / Pharmaceutical industry is quite different from other consumer products industry. It needs heavy investment on product development and innovation. Most of drugs have longer lifecycle than consumer products, and usually the drug buyer is not drug user. Though drug has long lifecycle, eventually it will face patent-off. Recently market access becomes more and more challenging for pharmaceutical industry. The barriers of clinical trials, regulatory approval, and reimbursement price approval are more difficult than before. Drugs need longer time to go-to-market, and the period of commercialization before patent-off is shorter. How to maximize sales and profits within limited commercialization time becomes more critical for marketers. And how to well manage drug lifecycle and extend lifecycle even after patent-off are the other crucial lessons for industry.
In order to shorten “go-to-market” period, drug company needs to understand the regulatory submission strategies, and choose the most appropriate one for submission. Next step is considering reimbursement price strategies. Understanding Bureau of National Health Insurance’s (BNHI) mechanism can minimize back-and-forth process.
After “go-to-market”, the next task is how to extend product lifecycle. The most common methods are 1) launch new indication, 2) launch new/ improved generation to replace old drug, 3) launch new dosage/ presentation form, which have patent to extend compound patent, 4) introduce fix-dosed combination, 5) invest in generics.
Lifecycle management is critical for pharmaceutical industry. Company should strengthen the competencies to shorten product “go-to-market” period, maximize the sales and profits during commercialization, and extend lifecycle after patent-off.
The research of health insurance environment, the changes of physicians’ behaviors and impacts on people health need further studies.
| Identifer | oai:union.ndltd.org:CHENGCHI/G0099932127 |
| Creators | 李宜真 |
| Publisher | 國立政治大學 |
| Source Sets | National Chengchi University Libraries |
| Language | 中文 |
| Detected Language | English |
| Type | text |
| Rights | Copyright © nccu library on behalf of the copyright holders |
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