1、For updated information,please visit www.ibef.orgNovember 2024BIOTECHNOLOGY2Executive Summary3Advantage India 5Market Overview 7Recent Trends and Strategies11Growth Drivers18Opportunities 22Key Industry Contacts28Appendix31Table of Contents3Executive summary4.LEADING DESTINATION FOR CLINICAL TRIALST

2、he New Drugs and Clinical Trials Rules,2019 were developed to create a streamlined legal framework for the biopharmaceutical market to reduce costs,approval timelines and cut bureaucratic red tape.In October 2021,drug firm AstraZeneca launched a clinical data and insights division in Bengaluru,India

3、,for data-related management of its clinical trials.In November 2021,US-based Akston Biosciences announced that it will start clinical trials of its second-generation Covid-19 vaccine AKS-452 in India soon.1.GLOBAL POSITIONIndia is among the top 12 biotechnology destinations in the world and the thi

4、rd-largest in the Asia-Pacific region.The country holds 3-5%of the global biotechnology industry pie.The country is also the worlds third-largest producer of recombinant Hepatitis B vaccine and second-largest producer of BT cotton.The country is one of the worlds leading suppliers of DPT,BCG&measles

5、 vaccines,contributing 70%to WHOs vaccines.India was one of the first countries to establish a Biotechnology Department.Indias bio-economy industry has grown from US$8 billion in 2014 to US$100 billion in the last 8 years in 2022 and reach US$130 billion in 2024 and US$300 billion by 2030.3.STRONG G

6、ROWTH IN BIOPHARMACEUTICALSIn the Indian bio-economy market,bio-pharmaceuticals and medical devices industry are the two largest segments,accounting for for nearly 79%of the total contribution.The Indian biotechnology industry growth is driven by vaccines and recombinant therapeutics.By 2025,the vac

7、cination market in India is projected to be worth Rs.252 billion(US$3.04 billion).In January 2022,BIRAC made a major contribution to developing the worlds first Intranasal vaccine for Covid through Bharat Biotech International Limited(BBIL).In December 2022,the worlds first COVID-19 intranasal vacci

8、ne,iNCOVACC was launched which has been developed by Bharat Biotech.2.STRONG START-UP ECOSYSTEMIndia has a strong start-up ecosystem,originating from gradual improvements in the ease of doing business,proof-of-concept funds for start-ups,and favourable government policies.The biotechnology industry

9、in India comprises US$130 billion in 2024 and 75 bio-incubators across 21 states/UTs supporting 1800+incubates,6,500 plus biotech start-ups,which are estimated to reach 10,000 by 2025.02031234Notes:BT Cotton:Genetically modified pest resistant plant cotton,DPT:diphtheria,pertussis,tetanus,BCG:Bacill

10、e Calmette-GuerinSource:Global Bio-India 2019,Biotechnology Industry Research Assistance Council,FDI India4Key Statistics:Department of BiotechnologySource:Department of BiotechnologyProjects Sanctioned as of October 20241,916International Collaborative Projects as of October 20243Research Personnel

11、 as of October 202448,502Ongoing Projectsas of October 20241,547PatentsFiled as of July 20241,171Scientists Supported as of July 202422,128Publications as of July 202422,708Technology Generated as of October 20241,0425Advantage India6Advantage IndiaADVANTAGE INDIA1432 With a total population of 1.4

12、billion,47%being under the age of 25,India has a large pool of young and skilled workforce.India has a large reservoir of scientific human resources including scientists and engineers.Biotechnology has emerged as a trending career option among the youth.According to a survey of Class 12th students i

13、n Delhi,Biotechnology was ranked as the preferred stream at No.4/5.1.Skilled human capital Patient pool expected to increase over 20%in the next 10 years,mainly due to rise in population.New diseases&lifestyle changes to boost demand for drugs and devices.4.Epidemiological factors 9 DBT-supported bi

14、otech parks and 60 BIRAC-supported bio-incubators.Dr.Jitendra Singh inaugurates the Northeasts first International Biotech Conclave.In February 2023,Serum Institute of India announces centre of excellence in Hyderabad to tackle future pandemics.In July 2023,15 companies sign MoUs worth Rs.2,000 cror

15、e(US$239.99 million),in a day,for investments in biotech sector.2.Infrastructure facilitiesSource:Department of Biotechnology,FDI India National Biopharma Mission is supporting 101 projects including more than 150 organizations and 30 MSMEs.It has increased employment opportunities and engaged 1,065

16、 manpower including 304 scientists/researchers.While 74%is permitted under automatic route for brownfield projects,100%under government route is permitted for brownfield investments.DPIITs launched ttup SEED fund scheme is inspired by BIRACs BIG scheme and guided by BIRACs MII cell interface.The Cab

17、inet has endorsed the consolidation of two Department of Biotechnology schemes into Biotechnology Research Innovation and Entrepreneurship Development(Bio-RIDE)with a new Biomanufacturing and Biofoundry component.The allocated budget for Bio-RIDE is Rs.9,197 crore(US$1.1 billion)for 2021-22 to 2025-

18、26 under the 15th finance commission.3.Policy support7Market Overview8Biotechnology marketUnion Minister Dr.Jitendra Singh stated that the next Industrial revolution would be driven by the Bioeconomy during the Curtain Raiser ceremony of the 4th edition of Global Bio India 2024.The biotechnology sec

19、tor in India is witnessing a strong growth trajectory and has proved to be highly inventive.The biotechnology sector,mainly due to its multidisciplinary approach,holds the potential to provide an array of solutions for challenges in various sectors such as health,agriculture,environment,energy,and i

20、ndustrial processes.India is among the top 12 biotechnology destinations in the world and the third-largest in the Asia-Pacific region.The Indian biotech industry holds about 3%of the global market share.The growth of the Indian biotechnology sector is driven by increasing demand both domestically a

21、nd internationally.Initiatives like Aatmanirbhar Bharat and Make In India are key factors contributing to the rise in domestic demand.India exports vaccines to more than 150 countries and is a prime destination for contract manufacturing and clinical trials.Indias bio-economy industry has grown from

22、 US$10 billion in 2015 to US$130 billion in 2024.The Indian biotechnology industry is likely to reach US$150 billion by 2025 and has the potential to reach US$270-300 billion by the year 2030.By 2025,the contribution of the Indian biotechnology industry in the global biotechnology market is expected

23、 to increase to 19%.India has 665 FDA-approved plants outside of the US,which is the highest in the world.India also has a 44%share of the global abbreviated new drug applications(ANDA)and 1400 manufacturing plants which comply with WHO requirements.Notes:FDA:Food and Drug AdministrationSource:DPT-B

24、IRAC,Association of Biotechnology Led Enterprises(ABLE)445163130300050100150200250300350FY17FY18FY19FY24FY30EIndian biotechnology industry valuation(US$billion)CAGR 15.8%Indian bioeconomy at a glance(2023)US$12 billionIndias BiotechIndustry Revenue1 millionIndias BiotechWorkforce6,000+Biotech Compan

25、iesin India15,500+Biotech GraduatesEvery Year9Indian biotechnology sector is divided into five segmentsBiopharmaBiosimilarsVaccinesInsulinRegenerative medicinesMedical devicesBio-ServicesContract manufacturingClinical researchBio-AgriHybrid seedsBio-fertilisersBio-pesticidesBioindustrialBiofuelsIndu

26、strial enzymesBio-polymersBio-ITBio-infomaticsBig dataPrecision medicineSource:Association of Biotechnology Led Enterprises(ABLE)Biotechnology10BioconIndian pharmaceutical company based in Bangalore that manufactures generic active pharmaceutical ingredients.Serum Institute of IndiaManufacturer of i

27、mmuno-biologicals,which include Diphtheria,Tetanus,Pertussis,Hib,BCG,r-Hepatitis B,Measles,Mumps and Rubella vaccines.Panacea Biotec LimitedInnovation-driven biotechnology company,undertaking research and development,manufacturing,sales,distribution and marketing of pharmaceuticals,vaccines and bios

28、imilars.Dr Reddys Laboratory LimitedIntegrated pharmaceutical company,providing affordable and innovative medicines.WockhardtGlobal pharmaceutical and biotechnology organisation,manufacturing pharmaceuticals,biopharmaceutical formulations and active pharmaceutical ingredients.Jubilant Life Sciences

29、CoIntegrated global pharmaceutical and life sciences company,engaged in pharmaceuticals,life science ingredients,drug discovery solutions and India-branded pharmaceuticals.AstraZeneca Pharma India Ltd.Indian biopharmaceutical company based in Bengaluru that manufactures cardiovascular,renal and meta

30、bolic diseases,oncology,and respiratory medicines.Bharat Serums and Vaccines LtdIndian pharmaceutical company based in Mumbai that manufactures plasma derivatives,monoclonals,fertility hormones,antitoxins,antifungals,anaesthetics,cardiovascular drugs and diagnostic products.Indian Immunologicals Ltd

31、Indian biopharmaceutical company based in Hyderabad that manufactures animal and human vaccine including rabies,Hepatitis B,Diptheria and Influenza vaccines.Bharat BiotechIndian biotechnology company based in Hyderabad that engages in drug discovery,drug development as well as manufactures vaccines,

32、bio-therapeutics,pharmaceuticals and health care products.Note:News ArticlesKey players11Recent Trends and Strategies12National and international partnershipsNotes:BIRAC:Biotechnology Industry Research Assistance CouncilSource:Company Website,News ArticlesIn June 2022,Serum Institute of India partne

33、red with US company Novavax to manufacture their Covid vaccine(NVX-CoV2373)for the US market.Serum Institute of India to manufacture Novavaxs Covid vaccine for the US market One Health ConsortiumIn October 2021,the Department of Biotechnology launched a One Health consortium that will survey importa

34、nt bacterial,viral and parasitic infections of zoonotic as well as transboundary pathogens in the country.The consortium consists of 27 organisations,and is led by the DBT-National Institute of Animal Biotechnology,Hyderabad.Partnership between Mylab Solutions&Shilpa BiologicalsIn February 2022,Pune

35、-based Mylab Discovery Solutions entered into a strategic partnership with Shilpa Biologicals,a subsidiary of Shilpa Medicare,to manufacture vaccines and therapeutics,starting with the Covid-19 vaccine.In February 2022,DBT inked a five-year MoU with the Indian Council of Medical Research(ICMR)and IA

36、VI.INOVIOs INNOVATE Phase 3 Trial for Covid-19 DNA Vaccine in IndiaIn November 2021,INOVIO announced that it has received authorisation from Indias Central Drugs Standard Control Organizations(CDSCO)Drug Controller General of India(DCGI)to proceed with the Phase 3 segment of INNOVATE(INOVIO INO-4800

37、 Vaccine Trial for Efficacy)in India.INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co.,Ltd.(Advaccine)to conduct the trials.WHO issued EUL for COVAXINIn November 2021,the World Health Organization(WHO)issued an emergency use listing(EUL)for Bharat Biotechs Covid-19 vaccine COVAXIN.It

38、 was found to have 78%efficacy against Covid-19 virus of any severity.Two PSUs ink pact with Covaxin maker Bharat Biotech to manufacture COVID vaccinesIn May 2021,Indian Immunologicals Limited(IIL)and Bharat Immunologicals and Biologicals Corporation(BIBCOL)signed technology transfer pacts with Bhar

39、at Biotech to develop the vaccine locally to boost Indias vaccination drive.IIL started supplying the vaccines to Bharat Biotech in August 2021,while BIBCOL plans to finish production of the trial batch of Covaxin in February 2022.13Recent DevelopmentsSource:News Articles,ABLE IndiaIndia allows 100%

40、FDI under the automatic route(a non-resident or Indian company will not require any approval from the government)for greenfield pharmaceuticals and manufacturing medical devices.2023-24Note:CSIR-CMERI-Council of Scientific&Industrial Research-Central Mechanical Engineering Research InstituteIn the F

41、Y24,Indias pharmaceutical exports increased by 9.67%to reach US$27.9 billion.The United States continues to be the largest market,accounting for more than 31%of the exports,with the UK and the Netherlands following.In March 2024,Union Minister of Science&Technology,Dr.Jitendra Singh,inaugurated the

42、pioneering National Speed Breeding Crop Facility at the National Agri-Food Biotechnology Institute(NABI)in Mohali.In January 2024,Union Minister of State(Independent Charge)Science&Technology,Dr Jitendra Singh inauguration of Biotech Startups Expo on“Emerging Startup Trends in North India at Biotech

43、 Park,Kathua.In December 2023,the Gujarat Chief Minister also inaugurated the Start-Up Product Launch which included innovative products developed by startups such as Bioscan,SynerSense,Iota,and STRUmed Solutions during the 10th Vibrant Gujarat Global Summit.The Pre-Summit also witnessed the signing

44、 of a Memorandum of Understanding(MoU)between Indus Setu Global Foundation and Gujarat State Biotechnology Mission.In November 2023,Bharat Biotech signs MoU with University of Sydney Infectious Diseases Institute(Sydney ID)to collaborate on vaccine research initiatives and strengthen academic-indust

45、ry partnerships.In October 2023,the Uttarakhand government signed several MoUs worth Rs.5,450 crore(US$653.97 million)with industrial bodies in Dubai.In August 2023,CSIR-National Institute of Science Communication and Policy Research(NIScPR)published a special issue of the Indian Journal of Biochemi

46、stry and Biophysics(IJBB)on Biological Electron Microscopy and Nanobiotechnology.In August 2023,the Department of Biotechnology(DBT)and the United States-National Science Foundation(US-NSF)announced to build bilateral collaborations between India and the USA through this Implementation Arrangement.I

47、n August 2023,the Technology Development Board(TDB)and the Department of Science&Technology(DST)partnered with Chemlife Innovations for the Innovative Bio-Trace Minerals Project to enhance livestock productivity,optimize feed and fodder resources and infuse technology into livestock management.In Ju

48、ly 2023,National Biopharma Mission is supporting 101 projects including more than 150 organizations and 30 MSMEs.It has increased employment opportunities and engaged 1,065 manpower including 304 scientists/researchers.In July 2023,Aurigene Pharmaceutical Services to set up US$40 million facility in

49、 Hyderabad.In April 2023,under the Biotech-KISAN scheme,160,000 farmers received benefits during the last one-year(January-December 2022).14Recent Developments2022-23Note:CSIR-CMERI-Council of Scientific&Industrial Research-Central Mechanical Engineering Research InstituteIn December 2022,Union Heal

50、th Minister Dr.Mansukh Mandaviya and the Minister of State,Ministry of Science and Technology,Earth Science,Personnel,Public Grievances,Pensions,Space and Atomic Energy Minister,Dr.Jitendra Singh launched the worlds first COVID-19 intranasal vaccine,iNCOVACC,which has been developed by Bharat Biotec

51、h.In December 2022,Bengaluru-headquartered Centre for Cellular and Molecular Platforms(C-CAMP),an initiative supported by the Department of Biotechnology,announced a next-generation Indo-Dutch bilateral collaboration to address challenges posed by Antimicrobial Resistance(AMR).In December 2022,the D

52、epartment of Biotechnology has financed 51 Biotech-Kisan centres,of which 44 are operational.These centres are spread across 15 agro-climatic regions of the nation and operate in 169 districts.In November 2022,Yara India,which is part of the Oslo-based,Norwegian multinational Yara International,has

53、tied up with a Bengaluru-based start-up and ABLE Member Sea6 Energy,to market and distribute its bio-stimulant AG Boost in India.On November 14th,2022,India and Finland agreed to advance bilateral collaboration and expand cooperation in sectors like digital education,future mobile technologies,biote

54、chnology,and the digital partnership in ICT.In FY22,Indias pharmaceutical exports touched Rs.1.8 trillion(US$23.04 billion).Formulations and biologicals account for 73.31%of the countrys total exports,followed by bulk drugs and drug intermediates.In February 2022,Genova Biopharmaceuticals,who were c

55、onducting phase 2 and 3 trials of Indias first indigenous mRNA vaccine on humans,finished those trials.The data is currently being reviewed by the Drug Controller General of India(DCGI).In February 2022,American biotech company Vaxart announced plans to start phase II clinical trials of its oral tab

56、let-based Covid-19 vaccine in India soon.In February 2022,India administered the worlds first DNA vaccine ZYCOV-D in Patna,which was developed by Ahmedabad-based vaccine manufacturer Zydus Cadila.In February 2022,the Malaysian Drug Control Authority(DCA)approved Bharat Biotechs Covaxin to be used in

57、 Malaysia.In February 2022,DCGA of India granted restricted emergency use authorisation to Biological Es Covid-19 vaccine Corbevax for kids in the 12-18 years age bracket.In February 2022,Union Minister Dr.Jitendra Singh inaugurates the Northeasts first International Biotech Conclave.In February 202

58、2,the Indian government has accepted to announce a new initiative to encourage pharmaceutical research and development(R&D)in the Union Budget for 2023-24.Source:News Articles,ABLE India15National Biopharma MissionNotes:GCLP:Good clinical laboratory practice,GLP:Good laboratory practice,EMI:Electrom

59、agnetic interference,EMC:electromagnetic compatibility,PDL:preferred drug list,GMP:Good manufacturing practicesSource:Department of BiotechnologyFacilitiesMedical devicesVaccinesBiosimilarsDeveloping Specific ProductsStrengthening EcosystemTraditional research consortiaTechnology platformsEnhancing

60、clinical trial capacityThe mission engaged Biotech Consortium India Limited(BCIL)to organise a series of lecture-based workshops to facilitate skill development to build next-generation interdisciplinary skills for product innovations across the countrySkill developmentEstablished Technology Transfe

61、r Offices to support technology transfer and entrepreneurshipTechnology transfer officesGCLP lab for clinical immunogenicity,cell line repository,PDL+GMPGLP lab for biologics,cell line repository,PDL+GMPEMI/EMC testing facility,large animal testing facility,prototyping facilitiesViral repositoriesHi

62、gh throughput assays Animal modelsRaw materialsNovel biologicsAnimal modelsNovel assaysNovel cell lines developmentIndigenous manufacturing techniquesCore technology developmentField site capacities for clinical trialsHospital based clinical trial networksHospital based clinical trial networksAfford

63、able Products16Atal Jai Anusandhan Biotech Mission Atal Jai Anusandhan Biotech Mission is implemented by Department of Biotechnology(DBT),Ministry of Science and Technology.The purpose of this mission is to address the challenges of maternal and child health,antimicrobial resistance,vaccines for inf

64、ectious disease,food and nutrition,and clean technologies.Ind-CEPI vaccinies for endemic preparedessUNATI Mission Clean Technologies for Swachh BharatGARBH-Ini for mental and child healtBifortified and protein rich wheat for Poshan AbhiyanGlobal Antimicrobial Resistance Research and Development Hub

65、for affordable healthSource:Department of BiotechnologyAtal Jai Anusandhan Biotech Mission 17State-specific policiesSource:State Government WebsiteSouthAndhra PradeshBiotechnology Policy 2015-2020Enhance Andhra Pradeshs competitiveness as a top biotech investment destination,creating 5,000 skilled j

66、obs by 2020 and 10,000 by 2025.KarnatakaBiotechnology Policy 2023-2028Building on a strong foundation,this policy aims to transform Karnataka biotech sector through impactful implementation,synergizing with existing state policies for exponential growth.TelanganaLife Sciences Policy 2015-2020Develop

67、ment of suitable infrastructure to attract life science companies and become a leading investment destination in the sector.NorthUttarakhandBiotechnology Policy 2018-2023Aims to attract new investments worth US$709 million in the sector;generate employment opportunities for 5000 people by 2023.Himac

68、hal PradeshBiotechnology Policy 2014Aims to make Himachal a globally competitive destination for development of biotechnology products,processes and services.WestRajasthanBiotechnology Policy 2015Aims to establish world-class research institutes and biomanufacturing infrastructure.GujaratBiotechnolo

69、gy Policy 2022-27To make Gujarat a preferred and globally competitive destination for development of biotechnology products and services.EastAssamBiotechnology Policy 2018-2022Development of the biotechnology industry in Assam,following the growth of bio-agri segment in the state.OdishaBiotechnology

70、 Policy 2024To transform Odisha into a globally recognized biotechnology hub and progressive bio-economy by leveraging its natural bioresources,human resources,and knowledge capital.CentralMadhya PradeshBiotechnology Policy 2003Conservation and sustainable utilisation of bio-resources to promote soc

71、ioeconomic growth in the state.18Growth Drivers19Strong demand and policy support driving investmentsInvitingResulting inGrowing demandPolicy supportIncreasing investmentRising demand for agriculture-based productsGrowing incidence of chronic ailmentsDemand for personalised medicines and biosimilars

72、100%FDI under automatic route for greenfield projects 100%FDI under government route for brownfield investments74%FDI under automatic route for brownfield investmentsExpandingproduction and distribution facilities in IndiaIncreasing R&D activitiesProviding support toglobal projectsEstablishing LSSSD

73、C under NSDC to promote skill development in thelife sciences sectorNotes:LSSSDC:Life Sciences Sector Skill Development Council,NSDC:National Skill Development Corporation,R&D-Research and DevelopmentSource:Department of Biotechnology,Association of Biotechnology Led Enterprises(ABLE)20Visakhapatnam

74、 port traffic(million tonnes)Ecosystem for start-upsThe start-up ecosystem in India is strongly supported on the back of gradual improvements in the ease of doing business,proof-of-concept funds for start-ups and favorable government policies.The biotechnology sector has witnessed a significant rise

75、 in new startup registrations across the nation in 2021,with approximately 1,128 fresh startups entering the market.This surge has contributed to the overall count of biotechnology startups reaching around 6,000 by the year 2023.BIRAC,a public sector undertaking of DBT,partnered with innovative foun

76、dations and universities to focus on Make in India and Start-up India programmes.BIRAC established several industry-focussed schemes such as SBIRI,BIPP Biotechnology Ignition Grant,BioNEST,SITARE,PACE,SIIP,SEED,LEAP and Fund of Funds-AcE.BIRAC has supported 60 bio-incubators for potential entreprene

77、urs.In July 2023,India and Argentina agreed to a bilateral exchange of young researchers and Startups,particularly in the field of Biotechnology and Agriculture.In May 2023,India and Israel will strengthen their connection in areas such as innovation and start-ups,ushering in a new period of deeper

78、bilateral cooperation.The Department of Biotechnology(DBT)of the Ministry of Science and Technology in India,and UNESCO-TWAS established a fellowship programme for foreign scholars from developing countries who wish to pursue research towards a PhD/post-doctoral research in biotechnology.Source:BIRA

79、C,DBTBIRAC(Bio-Incubator)(As of October,2024)Incubators supported74Startups follow on funding raisedUS$480.6 millionIncubation area supported713,132 sq.ft.Incubatees supported3,500Total products/technologies supported600+Total employment generated32,474Academic Institutes Supported344Total IPs gener

80、ated1,250+Total trainings/workshops conducted1,000Vertical-wise distribution of start-ups,FY21(%)29%24%23%12%12%Herbal TissueCulture/MicropropagationFood Nutrition/Bio FertilisersDiagnostic/BiomedicalDeviceFermentationMolecular Biology21Biotech parksBiotechnology parks and incubators are established

81、 across the country by the Department of Biotechnology(DBT),under the Ministry of Science and Technology,to translate research into products and services by providing necessary infrastructure support.The Department of Biotechnology(DBT)has supported 11 Biotechnology Parks in various States.These bio

82、technology parks offer facilities to scientists,and small and medium sized enterprises(SMEs)for technology incubation,technology demonstration and pilot plant studies to accelerate commercial development of biotechnology.The government,at present,supports nine biotechnology parks in various states,w

83、ith the bulk being in the southern region.In October 2023,the Uttar Pradesh government is planning to establish a Biotech Park in Pilibhit.Source:Association of Biotechnology Led Enterprises(ABLE),News Articles“These parks are successfully accelerating the commercialisation of new technologies,nurtu

84、ring and maintaining emerging ventures and assisting new enterprises to forge appropriate linkages with other stakeholders of biotechnology sector including academia and the government.”-Secretary,DBTTamil NaduTelanganaKeralaKarnatakaAssamUttar PradeshJammu&KashmirChhattisgarhGolden Jubilee Biotech

85、Park for WomenLocation:Tharamani,ChennaiTidco Centre for Life Sciences(TICEL)Biotech ParkLocation:Navalur,south suburban,ChennaiBiotechnology Incubation CentreLocation:Habsiguda,HyderabadBiotechnology Incubation CentreLocation:Kalamassery,KochiBiotechnology ParkLocation:Chandapura,BengaluruBiotech P

86、ark Technology Incubation CentreLocation:GuwahatiBiotech ParkLocation:Jankipuram,LucknowIndustrial Biotechnology ParksLocation:Kathua districtChhattisgarh Biotech ParkLocation:Indira Gandhi Agricultural UniversitySouth IndiaNorth India22OpportunitiesOPPORTUNITIES23Opportunities in various segmentsSo

87、urce:Association of Biotechnology Led Enterprises(ABLE),Institute for CompetitivenessBio-ServicesBioindustrialsBiopharmaBio-AgriBio-ITIndia has potential for clinical trials due to a large and low-cost market.Clinical trials in India are regulated by the Central Drug Standard Control Organisation,wh

88、ich has reduced approval time to about 30-60 days,giving opportunity for market growth.The country also has the advantage of English-speaking researchers and required medical infrastructure to conduct medical research.Biofuels and bioenergy are considered alternative resources and are gaining popula

89、rity in India.Rise in energy demand is leading to an increase in dependence on fossil fuel imports.As a result,companies can develop a strategy to reduce import dependence through biofuels and bioenergy.The Indian biologics market is expected to register a CAGR of 22%from 2019 to 2025,to reach US$12

90、 billion by 2025.Growth of biologics provides opportunity for biosimilars in the market.Indias Union budget 2021-22 stated the governments plan to enhance farm productivity and focus on food security.This increased the importance of bio-agriculture,which will enhance efficient food production.Biotec

91、hnology has immense growth potential in the Bio-IT segment,given the rising need for technology to transform data generated by R&D institutes,clinics,hospitals,etc.,into a defined format.Indias IT industry is witnessing substantial growth and has the requisite IT infrastructure to cater to the needs

92、 of the global Bio-IT industry.In the Union Budget 2024-25,the Department of Biotechnology(DBT)was allotted Rs.2,275.7 crore(US$273.5 million).24172024293542500102030405060702019202020212022202320242025ESource:News ArticlesKey investment opportunities1.92.12.22.42.72.93.2012345FY19FY20FY21FY22FY23FY

93、24FY25EClinical trials market in India(US$billion)CAGR 8.8%Medical devices market in India(US$billion)CAGR 17.0%India is among the preferred destinations for clinical trials owing to a large patient pool,transformation of the healthcare market,well-educated physicians and cost competitiveness.The Un

94、ion Ministry for Health and Family Welfare had introduced new Drugs and Clinical Trials Rules in 2019,which changed the regulatory landscape for approval of new drugs and conducting clinical trials in the country.The Indian medical devices industry is expected to reach US$50 billion by 2025 from Rs.

95、75,611 crore(US$10.36 billion)in 2020.In December 2023,IPL Biologicals signed a MoU with the Gujarat government to establish a Rs.400 crore(US$48.1 million)bio-fertilizer and bio-pesticide facility in the state.In August 2023,the Department of Biotechnology(DBT)and the United States-National Science

96、 Foundation(US-NSF)announced to build bilateral collaborations between India and the USA through this Implementation Arrangement.In August 2023,Technology Development Board(TDB)and the Department of Science&Technology(DST)partnered with Chemlife Innovations for the Innovative Bio-Trace Minerals Proj

97、ect to enhance livestock productivity,optimize feed and fodder resources and infuse technology into livestock management.In July 2023,Aurigene Pharmaceutical Services to set up US$40 million facility in Hyderabad.In July 2023,India and Argentina agreed to a bilateral exchange of young researchers an

98、d Startups,particularly in the field of Biotechnology and Agriculture.In February 2023,Bristol-Myers Squibb intends to invest Rs.800 crore(US$96.69 million)in establishing a cutting-edge centre in Telegana to boost its global medical development and IT capabilities.Note:US FDA-United States Food and

99、 Drug Administration,EMA-European Medicines Agency,UK MHRA United Kingdom Medicines and Healthcare products Regulatory Agency,PMDA-Pharmaceuticals and Medical Devices Agency,Japan,News Articles25Source:News ArticlesUpcoming Biotechnology ProjectsState PresenceCost of the Project(US$million)The Genom

100、e India ProjectBangalore2.15Mangalapuram Bio 360 Life Sciences Park Project-Phase IIKerala56.56Kupwara Biotechnology Jammu&Kashmir4.5Upcoming biotechnology projects in India26Visakhapatnam port traffic(million tonnes)India:Emerging hub for biologics and biosimilarsIndias first biosimilar was approve

101、d in 2000 for hepatitis B.In 2021,there were approximately 127 approved biosimilars.In July 2023,Biocon Biologics launched a biosimilar version of AbbVies top-selling biologic Humira(generically called adalimumab)in the US market under the brand name HULIO.With the help of recombinant and biosimilar

102、 products,the therapeutics sector is predicted to generate US$15 billion in bioeconomic activity by 2025.Significant contributions to the BioEconomy and the global acceptance of biosimilar products are driving an expected growth to nearly US$63 billion by 2025,indicating a promising trajectory.Biolo

103、gics economy in India is forecasted to reach US$12 billion by 2025,growing at a CAGR of 22%.In India,the biologics segment is led by Biocon Ltd.,who has commercialised the biosimilars Trastuzumab and Pegfilgrastim,among others,in partnership with Mylan.Source:Biologics Division,CDSCO,Association of

104、Biotechnology Led Enterprises(ABLE)The global life sciences industry is shifting from chemical-based drug to biologics and biosimilars;India approved its first biosimilar as early as 2000.2328241742112158518301020304050FY14FY15FY16FY17FY18FY19BiologicsBiosimilarsNumber of biologics and biosimilars a

105、pproved in IndiaDrug nameOriginator companyActive companiesFirst launchedNuPTHCadila PharmaceuticalsCadila Pharmaceuticals02-Oct-20bevacizumabDr Reddys Laboratories Ltd.Dr Reddys Laboratories Ltd19-Aug-19trastuzumabDr Reddys Laboratories LtdDr Reddys Laboratories Ltd26-Jul-18pegfilgrastimLupin LtdLu

106、pin Ltd25-Jul-18pegfilgrastimBiocon LtdBiocon Ltd;Mylan NV30-Jun-18adalimumabHetero GroupHetero Group03-Jan-18bevacizumabBiocon LtdBiocon Ltd;Mylan NV23-Nov-1727Opportunity in Biopharma4.INSULINIndia is likely to witness 100 million diabetics by 2030.With the rising number of patients,50%are undiagn

107、osed,providing domestic market opportunity to the country.Indian players are also creating opportunities in the international market.For example,Biologics and its partner Mylan N.V.launched their insulin glargine injection under the brand name Semglee in the US.1.BIOSIMILARSIndia has 125 approved bi

108、osimilar products and the market is expected to reach US$2.2 billion by 2025.Expiry of US$70 billion biologics drugs patent in 2020 provided export opportunities.Global companies are leveraging generics to contain healthcare costs and Indian companies such as Biocon are positioning themselves to del

109、iver affordable access to innovative and inclusive healthcare solutions.In July 2023,Biocon Biologics launched a biosimilar version of AbbVies top-selling biologic Humira(generically called adalimumab)in the US market under the brand name HULIO.3.REGENERATIVE MEDICINESeveral research institutes in I

110、ndia are investigating the use of stem cells to regenerate nerve,heart and adult muscle cells,and repair damaged bone tissues.Rise in chronic disease incidents is driving the demand for regenerative medicine.The Indian Council of Medical Research has issued the National Guideline for Stem Cell Resea

111、rch to promote clinical applications of stem cell research in ophthalmology,cardiology and spinal cord repair.The first phase I clinical trial on gene therapy for haemophilia,enhancing the quality and shelf life of stored blood,potential therapy for psoriasis,testing over 3 lakh samples for COVID-19

112、,novel nanobody inhibiting SARS-COV2 entry,germicidal masks and many more.2.VACCINESIndia exports vaccines to about 150 countries.The country covers 40-70%of the World Health Organisations(WHO)demand for DPT(diphtheria,pertussis or whooping cough,and tetanus)and BCG(Bacille Calmette-gurin)vaccines a

113、gainst tuberculosis,followed by 90%of its demand for the measles vaccine.By 2025,the vaccination market in India is projected to be worth Rs.252 billion(US$3.04 billion).In July 2022,Indias 1st indigenously developed quadrivalent Human Papilloma Virus(qHPV)vaccine against cervical cancer supported b

114、y DBT and BIRAC received market authorization from DCGI1234Source:BIRAC,CII28Key Industry Contacts29Key industry organisationsAgencyContact InformationDepartment of Biotechnology,Ministry of Science&Technology6th-8th Floor,Block 2 CGO Complex,Lodhi Road New Delhi 110 003.IndiaPhone:91-11-2436 2950We

115、bsite:www.dbtindia.gov.inDepartment of Science and Technology,Ministry of Science and TechnologyDepartment of Science&Technology,Technology Bhavan,New Mehrauli Road,New Delhi-110 016Phone:+91-11-26562122/25/33/44,26567373,26962819Fax+91-11-26863847,26515637Website:www.dst.gov.inBiotechnology Industr

116、y ResearchAssistance Council(BIRAC)1st Floor,MTNL Building,9,CGO Complex,Lodhi Road,New Delhi-110003Website:www.birac.nic.in,E-mail address:birac.dbtnic.in Phone:+91-11-24389600Fax:+91-11-24389611Council of Scientific and IndustrialResearch(CSIR)Council of Scientific and Industrial Research,Anusandh

117、an Bhawan,2 Rafi Ahmed Kidwai Marg,New Delhi-110001Phone:+91-11-23737889Website:www.csir.res.inAssociation of Biotechnology Led Enterprises#123/C,16th Main Road,5th Cross,4th Block,Near Sony World showroom/Headstart school,Koramangala,Bangalore-560034,IndiaPhone:+91-80-41636853Fax:+91-80-25633853Web

118、site:www.ableindia.in,E-mail address:infoableindia.org.inThe Biotech Research Society,IndiaBiotechnology Division,NIIST,Industrial Estate P.O.,Trivandrum 695019Phone:+91-471-251 5279 Website:https:/www.brsi.in/30Departments concerning biotech approvalsDepartment of BiotechnologyDepartment of Environ

119、ment,Forests&WildlifeDepartment of PharmaceuticalsCentral Drug Standards Control Review Committee on Genetic ManipulationRecombination DNA Advisory CommitteeInstitutional Biosafety CommitteeGenetic Engineering Approval CommitteeClinical TrialsMinistry of Science&TechnologyMinistry of Environment&For

120、estsMinistry of Chemicals&FertilisersMinistry of Health&Family WelfareGovernment of India31Appendix32GlossaryCAGR:Compound Annual Growth RateCapex:Capital ExpenditureCENVAT:Central Value-added TaxEHTP:Electronic Hardware Technology ParkEPCG:Export Promotion Capital Goods SchemeFDI:Foreign Direct Inv

121、estmentFY:Indian Financial Year(April to March);So,FY10 implies April 2009-March 2010LCD:Liquid Crystal DisplayR&D:Research and DevelopmentUS$:US DollarWherever applicable,numbers have been rounded off to the nearest whole number33Exchange ratesExchange Rates(Fiscal Year)Exchange Rates(Calendar Year

122、)YearRs.Equivalent of one US$2004-0544.952005-0644.282006-0745.292007-0840.242008-0945.912009-1047.422010-1145.582011-1247.952012-1354.452013-1460.502014-1561.152015-1665.462016-1767.092017-1864.452018-1969.892019-2070.492020-2173.202021-2274.422022-2378.602023-2482.802024-25*83.89YearRs.Equivalent

123、of one US$200544.11200645.33200741.29200843.42200948.35201045.74201146.67201253.49201358.63201461.03201564.15201667.21201765.12201868.36201969.89202074.18202173.93202279.82202382.612024*83.70Source:Foreign Exchange Dealers Association of IndiaNote:*-Until October 2024,*-April-October 202434Disclaime

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