Biologic market
Biosimilars have grown rapidly from 1% to 2.5% of all drugs in the last 5 years. Biological drugs are very expensive but offer innovative treatments to serious illnesses. Biosimilars are designed as cheap copies for the mass market. They are nonetheless complex molecules, requiring huge resources, time, scientific know-how and technology (see link 1), eg. deeper biological expertise for designs; high-quality control & high tech for manufacture; and a lengthy development cycle.
God-sent opportunity
IMS study: massive savings ($110b up to 2020) possible in health budgets of US & Europe. Even the US has reduced exclusivity period for early biosimilars induction. Lucrative possibilities open up for chronic illnesses like diabetes, arthritis, multiple sclerosis, cancer, skin ailments. For competent Indian firms, this is a god-sent opportunity (see link 2). After US and Europe opened up in 2015, firms active in biotechnology arena could exploit two vast biologic markets (see link 2). Many Indian firms (eg Biocon, Dr Reddy’s, Zydus Cadila, Wockhardt, Intas, etc) are active and growing.
Why the rush?
Key to successful exploitation is making drugs affordable and garner the huge unmet markets, eg. scaling up manufacture; rapid simultaneous inductions in many markets; overseas production for greater market acceptance (quality) and global reach (access). Larger markets mean cheaper prices, so a rapid roll-out will garner mass markets and substantial profits.
Hurdles
1. India doesn't have an abundance of biological expertise.
2. Small firms don't have all-around strength.
3. Highest quality manufacture is not India's forte.
4. Current regulations may not be in sync.
Established players are likely to lead the development curve, though specialist or smaller firms (incl startups) have a vital niche role, esp in new methodologies, techniques, innovative design solutions. Indian firms are going overseas and not waiting to sort out issues of regulations and manufacture. GOI has been pushing for wholesale changes to drive down costs and make India a "global hub".
Indian firms on a high
Dr Reddy: "We can reduce costs dramatically and target vast unmet needs"; "We will gain rapid acceptance from the medical community due to our competencies"; "We are taking our drugs to India, SE Asia, Russia, CIS, Latin America, North Africa, etc as well as the US"; "We have increased access by 7-10 times - our revenues are growing at 30%"; "We have 4 out, 2 to be launched, many undergoing toxicology trials, will have 15 products by FY20!!".
Biocon: "Diabetes medicine has cracked Japan and 60 emerging markets"; "Our 4 drugs will be early birds- when approved in US/ Europe- in a $30b market".
Cipla: "Our strength is manufacturing - so for global reach, we are opening new facilities in SAf". "Our portfolio of products come out from 2018".
Zydus Cadila has arthritis biosimilar and 8 others. Intas has launched drug for eye degenerative disease.
Biosimilars have grown rapidly from 1% to 2.5% of all drugs in the last 5 years. Biological drugs are very expensive but offer innovative treatments to serious illnesses. Biosimilars are designed as cheap copies for the mass market. They are nonetheless complex molecules, requiring huge resources, time, scientific know-how and technology (see link 1), eg. deeper biological expertise for designs; high-quality control & high tech for manufacture; and a lengthy development cycle.
God-sent opportunity
IMS study: massive savings ($110b up to 2020) possible in health budgets of US & Europe. Even the US has reduced exclusivity period for early biosimilars induction. Lucrative possibilities open up for chronic illnesses like diabetes, arthritis, multiple sclerosis, cancer, skin ailments. For competent Indian firms, this is a god-sent opportunity (see link 2). After US and Europe opened up in 2015, firms active in biotechnology arena could exploit two vast biologic markets (see link 2). Many Indian firms (eg Biocon, Dr Reddy’s, Zydus Cadila, Wockhardt, Intas, etc) are active and growing.
Why the rush?
Key to successful exploitation is making drugs affordable and garner the huge unmet markets, eg. scaling up manufacture; rapid simultaneous inductions in many markets; overseas production for greater market acceptance (quality) and global reach (access). Larger markets mean cheaper prices, so a rapid roll-out will garner mass markets and substantial profits.
Hurdles
1. India doesn't have an abundance of biological expertise.
2. Small firms don't have all-around strength.
3. Highest quality manufacture is not India's forte.
4. Current regulations may not be in sync.
Established players are likely to lead the development curve, though specialist or smaller firms (incl startups) have a vital niche role, esp in new methodologies, techniques, innovative design solutions. Indian firms are going overseas and not waiting to sort out issues of regulations and manufacture. GOI has been pushing for wholesale changes to drive down costs and make India a "global hub".
Indian firms on a high
Dr Reddy: "We can reduce costs dramatically and target vast unmet needs"; "We will gain rapid acceptance from the medical community due to our competencies"; "We are taking our drugs to India, SE Asia, Russia, CIS, Latin America, North Africa, etc as well as the US"; "We have increased access by 7-10 times - our revenues are growing at 30%"; "We have 4 out, 2 to be launched, many undergoing toxicology trials, will have 15 products by FY20!!".
Biocon: "Diabetes medicine has cracked Japan and 60 emerging markets"; "Our 4 drugs will be early birds- when approved in US/ Europe- in a $30b market".
Cipla: "Our strength is manufacturing - so for global reach, we are opening new facilities in SAf". "Our portfolio of products come out from 2018".
Zydus Cadila has arthritis biosimilar and 8 others. Intas has launched drug for eye degenerative disease.
No comments:
Post a Comment