A fact is that FDA drug approvals are declining. The approval rate is reduced by 13% in 2007. With lowered expectations about FDA approved drugs, there were only 19 in 2007 and 25 in 2009. The reality with a need from stronger finance to support a product is demanded; it ends up with hundreds of millions to billions spent from basic research, clinical trials, regulatory and manufacturing, to marketing a product.
Life science industry has some unique characteristics different from other industries, for example, a longer development time. For instance, the development time for drugs is 10-15 years to market and the development time for medical devices is 5-8 years to market. The extensive regulatory constraints are required for all biotech product companies. The development of life science products and technology is a high risk business and may cost up to $800 million; the product launch may cost $500 million for blockbuster drugs. In addition, there are more ethical and political issues threaten this industry’s growth.
Therefore, the challenges, lead to new industry drivers, are to improve the safety for all bioscience products, to cut costs and speed up R&D, to meet new market needs with affordable solutions for customers, and to personalize Rx while maintaining profitability.
Six Pillars of Success for Life Science Products and Technology are given here:
Simple screening tool for potential product and technology
Product profile meets critical market need
Product has profitable revenue stream
Company has ownership of IP
Price is affordable and/or reimbursable
Experienced management team and staff
Together, the six pillars form the “value proposition” or basis for “unique story” will be beneficial for your company/technology/product. In summary, life science industry is being pushed to achieve new products with improved efficacy, safety, efficiency, productivity at lower costs while making a satisfactory return on investment for their investors.
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