1、ADVANCING BIOTECHNOLOGY&GENOMIC S IN SAUDI AR ABIABest practice strategies to develop the sector&maximize its impact2024CONTENTEXECUTIVE SUMMARY 31.THE GLOBAL GROWTH OF BIOTECHNOLOGY&GENOMICS 62.CURRENT STATUS OF BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIA 83.ACCELERATING PROGRESS WITHIN SAUDI ARABIA 124

2、.KEY SUCCESS FACTORS TO DEVELOP SECTOR IN SAUDI ARABIA 16CONCLUSION 20We would like to acknowledge all those who contributed in the review of this Report,especially:Dr.Ulrica Sehlstedt,Farhan Mirza,and Dr.Ali Ayach.VIKAS KHARBANDAPartner,Healthcare&Life Sciences Practice Lead for Middle East and Sou

3、th East Asia Riyadh/DubaiDR.PATRICK LINNENBANKPartner,Healthcare&Life Sciences Practice Riyadh/DubaiDR.ANKITA GULATIPrincipal,Healthcare&Life Sciences Practice Dubai HARSHA AGARWALConsultant New Delhi2HARNESSING THE BENEFITS OF BIOTECHNOLOGY IN SAUDI ARABIAFueled by advances in emerging technologies

4、 such as precision medicine,1 ultra-targeted therapies,“omics,”2 and many more,the global biotechnology and genomics sector is expected to expand at a double-digit growth rate going forward.Having understood the potential of the sector,governments across the world are making concerted efforts to har

5、ness and develop their own biotechnology industries.Recognizing the opportunity,The Kingdom of Saudi Arabia(KSA)has already launched multiple initiatives to encourage the sectors growth within the country.While KSAs biotechnology industry is still at a relatively nascent stage,it is already seeing a

6、ctivity from different players,along with collaboration on projects such as the Saudi Genome Program,which provide a promising foundation for the future.However,while these efforts are a step in the right direction,success requires a clear vision with specific priority areas outlined.This includes i

7、dentifying and targeting three key segments of the biotechnology value chain(sampling,analysis,and application)as high priorities based on the countrys current capabilities and requirements,as well as developing capacity across a minimum of four thematic areas to further foster growth:1 According to

8、 the European Federation of Pharmaceutical Industries and Associates(EFPIA),“Precision medicine is a healthcare approach that utilizes molecular information(genomic,transcriptomic,proteomic,metabolomic,etc.),phenotypic and health data from patients to generate care insights to prevent or treat human

9、 disease resulting in improved health outcomes”;see:“Precision Medicine.”European Federation of Pharmaceutical Industries and Associates(EFPIA),accessed March 2024.2 The term“omics”encompasses the scientific field of collecting,quantifying,and analyzing large pools of biologic molecules,from single

10、cells to whole organisms such as the human body,in both normal health and with disease(e.g.,cancer).Molecules can be DNA(genomics),all kinds of RNA(transcriptomics),proteins(proteomics),metabolites(metabolomics),lipids(lipidomics),and sugars(glycomics),as well as their interactions(interactomics).E

11、XECUTIVE SUMMARYARTHUR D.LITTLE3(1)genomic data repository set up,(2)widespread genomics adoption,(3)omics and precision medicine research and application,and(4)AI/machine learning(ML)utilization.Adopting best practices from other countries is an essential approach to catalyze the creation of an ind

12、igenous biotechnology and genomics innovation hub.Successful nations have already designed and implemented a range of programs and practices to solve potential challenges and ensure a seamless realization of their visions for biotechnology and genomics.These include:the creation of talent pools thro

13、ugh anchoring institutions and innovation hubs;enhanced,active collaboration between the public and private sector;delivering a supportive pro-business environment and regulations,including enhanced intellectual property(IP)protection;the creation of specific innovation-themed environments and ecosy

14、stems;setting a clear target picture of all research efforts;and providing start-ups with fast and easy access to public and private funds.As this Report explains,these best practices are all imperative to helping KSA achieve its objective of becoming a regional leader in the biotechnology and genom

15、ics space,delivering clear benefits in terms of public health,economic development,reputation,and overall competitiveness.4REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLE51.THE GLOBAL GROW TH OF BIOTECHNOLOGY&GENOMIC SThanks to ongoing advances,the fields of biotechnology and

16、genomics are set to play a major role in mankinds future wellness and healthcare journeys.Modern biotechnology provides breakthrough products and technologies to combat debilitating and rare diseases,delivering personalized and more effective treatments often based on genomic data.Globally,the marke

17、t is growing rapidly as nations and governments recognize its value for their citizens and tremendous transformative potential for their economies and healthcare systems.As of 2023,the worldwide biotechnology sector was estimated to be worth US$1.5 trillion,with an expectation that it will grow at a

18、 double digit CAGR to reach between$3.5-$4 trillion by 2030,according to Grand View Research.3This rapid growth will be driven by both demand-side factors(including rising demand for better and more efficient healthcare diagnostics and treatment services and an increasing focus on wellness and preve

19、ntion)and supply-side aspects,such as an increasing governmental focus on the sector,along with rising private sector investments and rapid technological advances.EMERGING TRENDS IN THE SECTORBoth the public and private sectors are exploring a range of biotechnology use cases along the wellness and

20、healthcare value chain.Demonstrating this,a study of funding patterns for AI/ML-powered digital health companies reflects multiple emerging trends.3“Biotechnology Market Size,Share&Trend Analysis by Technology(Nanobiotechnology,DNA Sequencing,Cell-Based Assays),by Application(Health,Bioinformatics),

21、by Region,and Segment Forecasts,20242030.”Grand View Research,accessed March 2024.4 Green,Eric D.,et al.“Strategic Vision for Improving Human Health at the Forefront of Genomics.”Nature,28 October 2020.These include a shift toward precision healthcare,including the rise of CAR-T cell therapy and com

22、panion diagnostics and the growth of ultra-targeted therapies,particularly in oncology,using genomic data,with a consequent focus on more precise patient population segments.The trends are driving new business models based on close collaboration among players across the entire healthcare ecosystem;t

23、hese models are critical for the successful development and implementation of novel approaches for preventive and curative care.At the same time,new treatment paradigms have emerged.Advanced therapeutics such as gene editing through CRISPR-Cas9 provide highly personalized and targeted therapies that

24、 are curing once-fatal diseases such as cancer and rare genetic disorders,while gene therapy,cell therapy,and immunotherapy are rapidly shifting the focus from mortality to morbidity.This brings implications for all players in the healthcare ecosystem,including developers,payors,providers,and patien

25、ts.Thanks to advances in next-generation sequencing(NGS)technologies,we are rapidly moving toward a future where generating and analyzing the whole human genome will be routine for any laboratory.4 Alongside this,gathering large-scale biological information and data from other pools of molecules(suc

26、h as proteomics,metabolomics,and transcriptomics)will help generate insights related to disease development and treatment effects.Genome data analysis using sophisticated technologies such as AI and ML is also a major emerging trend with several start-ups focusing on this segment.6REPORT:ADVANCING B

27、IOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLEGROWTH IN GENOMIC DATABASES TO SUPPORT RESEARCHGlobal priorities are shifting toward citizen-centered and patient-friendly genomic collaboration and research.This is leading to countries increasing their investments in biotechnology.In particular,t

28、hey are actively working to create diverse genome data sets,fostering equitable genomics and driving innovation to address health disparities:-The US National Institute of Health(NIH)All of Us Research Program now boasts a data set of nearly 100,000 genome sequences,supplemented by participants elec

29、tronic health records,Fitbit data,and survey responses,all accessible through a cloud-based platform.5-The EUs 1+Million Genomes Initiative,supported by over 25 signatory countries,is dedicated to establishing a European genomic data infrastructure and facilitating federated data access through comm

30、on national regulation.6-In the UK,the National Health Service(NHS)is taking steps to integrate genomics into its regular operations by offering whole genomics sequencing as standard to those with rare diseases or cancers.75“NIHs All of Us Research Program Releases First Genomic Dataset of Nearly 10

31、0,000 Whole Genome Sequences.”National Institutes of Health,17 March 2022.6“European 1+Million Genomes Initiative.”European Commission,accessed March 2024.7 Floden,Evan.“US Sets Bioeconomy Goals and Confronts Data Challenges.”Genetic Engineering&Biotechnology News,1 September 2023.8 Buntz,Brian.“The

32、 Global Biotech Funding Landscape in 2023:US Leads While Europe and China Make Strides.”Drug Discovery&Development,5 January 2024.9“The US Bioscience Industry:Fostering Innovation and Driving Americas Economy Forward.”TEConomy/BIO,2022.CRITICALITY OF SECTOR TO NATIONAL GROWTH AGENDAChanging global g

33、eopolitical dynamics and the rise of new diseases and pandemics mean that a strong biotechnology sector is increasingly vital to ensuring a countrys competitiveness,self-sufficiency,and health.Clearly,at a basic level,investing in the sector is essential to providing countries with rapid,immediate a

34、ccess to the latest innovative and cost-effective treatments.Globally,around$162 billion was invested in the biotech sector in 2023,with the US accounting for approximately 35%of total global funding.8A strong biotechnology industry also catalyzes growth in capability development across research and

35、 innovation,increasing jobs and investments and boosting the countrys GDP.Demonstrating this,the biosciences sector has outperformed the wider US economy post-COVID,contributing to around 10%of US GDP in 2021.Additionally,the industry generated 2.1 million direct jobs,with employees earning 85%more

36、than the average private sector salary.9 A strong biotech sector provides a reputational boost that enhances a countrys competitiveness in terms of acquiring talent,innovations,and investment.7While KSA accounts for 1.3%of global GDP,it only currently makes up 0.2%of the global genomics sector.10 Th

37、is demonstrates that the industry is still early in its development.Backing this up,the projected growth rate for the genomics sector across MENA(Middle East and North Africa)between 20222030 is around 9.5%CAGR,which is much lower than the overall global growth rate of approximately 16.5%.This highl

38、ights the opportunity and indicates the potential for the region to direct additional focus and resources toward the sector.CLEAR TARGETS GIVE IMPETUS&DIRECTIONGlobally,multiple countries economies have outlined specific goals and targets for their biotechnology and genomics sectors.For example,in t

39、he US,the White House Office of Science and Technology Policy report“Bold Goals for US Biotech and Biomanufacturing,”published in March 2023,highlights concrete objectives to strengthen the US bioeconomy,including collaboration with the private sector to advance innovation throughout the full health

40、care value chain.10“GDP Based on PPP,Share of World.”International Monetary Fund(IMF),accessed March 2024.11“Saudi Crown Prince to Prioritize Research,Development,and Innovation to Address Global Challenges.”The Embassy of The Kingdom of Saudi Arabia,1 July 2022.12 Riyadh Global Medical Technology S

41、ummit 2023 website,accessed March 2024.13 Objectives also include establishing KSA as a global hub for world-class collaborations on prevalent genetic diseases and ensuring genomics play a vital role in delivering high-quality healthcare to all Saudi citizens;see:“Saudi Genome Project.”Kingdom of Sa

42、udi Arabia Vision 2030,accessed March 2024.14“Saudi R&D Spending Tops$3.9bn.”Arabian Business,8 February 2023.15“Research and Development Expenditure(%of GDP).”The World Bank,27 November 2023.16“EU Investment in R&D Increased to 328 Billion in 2021.”Eurostat,29 November 2022.17“Saudi Arabias Leap in

43、 Research and Development Excellence.”Elsevier/Research,Development,and Innovation Authority(RDIA),2023.Along similar lines,Saudi Arabia has demonstrated a strong commitment toward developing its R&D agenda.Its“RDI(Research,Development and Innovation)National Aspirations and Priorities”for the next

44、two decades include“Health and Wellness”and“Economies of the Future.”11 Backing this up,multiple initiatives have been planned and announced in KSA,such as the creation of the National Biotechnology Strategy Committee and Riyadh Biotechnology City.12 The Saudi Genome Project 2.0 has also set ambitio

45、us objectives including enhancing the countrys position as the leader in genomics and genetics within the MENA region.13Objectives are being backed by investment in R&D to build a knowledge-based sustainable economy,as part of Saudi Arabias National Vision 2030 and National Transformation Program.KS

46、A has dedicated substantial funding for R&D,totaling$3.9 billion in 2021,14 equivalent to 0.46%of GDP15(see Figure 1).While this R&D intensity16 is currently much lower than the typical 1.5%-3.5%spent by regional and large global economies,this is set to change as Saudi Arabia aims to become a globa

47、l leader in research,development,and innovation through an annual investment equivalent to 2.5%of GDP by 2040.This is expected to not only add$16 billion to the economy,but also create high-value jobs in science and technology.172.CURRENT STATUS OF BIOTECHNOLOGY&GENOMIC S IN SAUDI AR ABIA8REPORT:ADV

48、ANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLESUPPORTIVE REGULATIONS ACCELERATE GROWTHIn the biotechnology sector,major economies have introduced regulations to encourage transparency and expedite clinical trial approvals.For instance,the UK is looking to introduce the Future Clinical

49、Trials Bill,18 while its Medicines and Healthcare products Regulatory Agency(MHRA)has introduced guidelines to expedite low-risk clinical trials.19Along similar lines,Saudi Arabia is developing and setting up a clear regulatory and governance mechanism for R&D.The Saudi Food and Drug Authority(SFDA)

50、has proposed new guidelines for clinical trials with the aim to regulate,support,and enhance collaboration between the different entities involved in them,20 while the Research,Development and Innovation Authority(RDIA)is aiming to act as an enabler,legislator,and regulator21 going forward.18 Eckfor

51、d,Catherine.“New Bill Could Enhance UK Clinical Trial Regulation.”European Pharmaceutical Review,27 October 2023.19 Medicines and Healthcare Products Regulatory Agency.“New Streamlined Notification Scheme for Lowest-Risk Clinical Trials Marks Start of MHRA Overhaul of Regulation.”Gov.UK,12 October 2

52、023.20“SFDAs New Contract Research Organization Draft Guideline.”Al Tamimi&Co.,24 March 2022.21“Saudi Crown Prince to Prioritize Research,Development,and Innovation to Address Global Challenges.”The Embassy of The Kingdom of Saudi Arabia,1 July 2022.22 Nature Research Custom Media.“KAIMRC Leads The

53、Kingdom into the First Phase I Clinical Trial.”Nature Portfolio,accessed March 2024.MULTIPLE LARGE-SCALE INITIATIVES ALREADY LAUNCHEDUnderstanding the opportunity,multiple entities within KSAs R&D ecosystem are working toward enhancing the biotechnology agenda,launching a range of initiatives.As par

54、t of this,there has been an increase in academic research and initiatives by Saudi institutions and a focus on developing the local talent pool in science and technology:-Research organizations-King Abdullah International Medical Research Centers(KAIMRC),launched in 2006,focuses on applied sciences

55、research and works with leading academic institutions around the world in areas such as vaccines,genetic research,therapeutics,and drug screening.For example,working with the University of Oxford,KAIMRC led The Kingdoms first phase I clinical trial of a vaccine into the MERS-CoV virus.22 The institu

56、tion is currently focused on multiple initiatives,including the Saudi Biobank,Cord Blood Bank,Research Trauma Project,and Saudi Stem Cell Donor Registry.Figure 1.R&D intensity vs.health&biotech innovation focus across countriesSource:Arthur D.Little,World Bank,World Intellectual Property Organizatio

57、n(WIPO),Capital IQ,Preqin,IBISWorld,European Medicines Agency(EMA),International Monetary Fund,and SCImago Journal Rank(SJR)Source:Arthur D.LittleFigure 1.R&D intensity vs.health&biotech innovation focus across countries2040608001001201401601802602803003200.00.51.01.52.02.53.03.54.04.55.05.5IsraelSa

58、udi ArabiaTurkeyUAEUSChinaIndiaCitations across health&biotech(19962021)per 1,000 capitaJapanGermanyUKSouth KoreaFranceCanadaSpainItalyR&D investment as%GDPThe NetherlandsSwitzerlandSwedenBelgiumSingaporeHong KongCyprusIranAustraliaOtherMiddle EastUSEuropeGDP(size)9MULTIPLE ENTITIES WITHIN KSAs R&D

59、ECOSYSTEM ARE WORKING TOWARD ENHANCING THE BIOTECHNOLOGY AGENDA-Academic institutions-The King Abdullah University of Science and Technology(KAUST)and King Abdulaziz City for Science and Technology(KACST)are fostering research in the fields of genomics and biosciences through memorandums of understa

60、nding(MoUs)and collaboration with industry bodies,with a deep focus on biotechnology.-The National Biotechnology Center,a joint effort between King Faisal Specialist Hospital and Research Centre(KFSH&RC)and KACST is focused on enhancing medical research and biotechnology.Over 110 projects have been

61、approved,and 67 are ongoing.23-Government initiatives-The Saudi National Institute of Health,launched by the Ministry of Health(MOH),is focused on supervision and backing of translational research and clinical trials in the health domain by providing funds and support to research personnel.24-Nonpro

62、fit organizations-The Hevolution Foundation,a non-profit organization,is focused on longevity medicine and receives up to$1 billion funding per year from the Saudi government.25-Pharmaceutical manufacturing companies-Lifera,a Public Investment Fund entity,is a pharmaceutical manufacturing company se

63、t up in June 2023 to focus on manufacturing life-saving and essential pharmaceutical products.To date,Lifera has established three platforms:Biologics&Innovation,Manufacturing,and Commercialization.23“National Biotechnology Center.”King Faisal Specialist Hospital&Research Centre,accessed March 2024.

64、24“Mechanisms and Incentives to Transform the Health Research into Discoveries and Knowledge with Health and Economic Benefits.”Saudi National Institute of Health(NIH),accessed March 2024.25 Hevolution website,accessed March 2024.26“Investment Ministry Signs 2 Deals to Enhance Biotechnology,Pharmace

65、utical Sector in Saudi Arabia.”Arab News,27 January 2023.27“Novartis Signs Deal to Help Saudi Arabia Expand Its Biopharma Capabilities.”Arab News,2 June 2022.Additionally,Saudi Arabia has built strong partnerships with many global pharmaceutical and biotech companies that are helping grow local capa

66、bilities:-Partnerships-KAUST signed two MoUs in 2023 with multinational firms(Boehringer Ingelheim and Novo Nordisk)focused on enhancing cooperation in the biotechnology and medicine sector.26-The Ministry of Investment(MISA)has partnered with Novartis to further strengthen Saudi Arabias biopharmace

67、utical capabilities.This partnership involves local investments in cell and gene therapy,technology transfer,and clinical research,aiming to alleviate healthcare budget pressures.Novartiss involvement is anticipated to contribute approximately$857 million to Saudi Arabias GDP by 2024.27-In 2023,Life

68、ra,Sanofi,and Arabio signed an MoU to manufacture and supply vaccines in Saudi Arabia,boosting local production with a new state-of-the-art manufacturing facility.However,while these agreements are a step in the right direction to bring big pharma and multinational biotech companies to Saudi Arabia,

69、there is a long way to go for developing local capabilities across the value chain.Recognizing this,academic and research institutes have put in place a range of accelerator and incubator programs to train and support entrepreneurs:-Research organizations-KAIMRCs Medical Biotechnology Park(MBP)provi

70、des a supportive environment to new and emerging medical and biomedical technology ventures and compatible businesses.This environment is designed to assist them during their start-up phase and enhance their prospects for local success.1 0REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR

71、 D.LITTLE-Academic institutions-KAUSTs accelerator programs include TAQADAM,one of the longest-running accelerator programs in Saudi Arabia.It provides six-month programs to innovators and entrepreneurs offering mentorship,funding,and targeted workshops.-KACST has an agreement with King Salman Youth

72、 Center to carry out a training project for entrepreneurs.This boosts KSAs ongoing efforts to fully realize the potential of Saudi youth by promoting their active participation in the development process.-In 2022,Dammam Valley,owned by Imam Abdulrahman bin Faisal University,established the Biotech S

73、tartups Program,a first-of-its-kind initiative designed to support and incentivize health and biotechnology entrepreneurs.Over 130 projects from various fields of genomics and therapeutics have participated since the programs inception.Entrepreneurship initiatives have so far primarily come from lea

74、ding institutions such as KAIMRC,KAUST,and KACST.However,as these institutes and their programs are independent of each other,this can limit collaboration and result in inefficient utilization of resources and facilities.28“Saudi Genome Project.”Kingdom of Saudi Arabia Vision 2030,accessed March 202

75、4.THE SAUDI GENOME PROGRAM:A BLUEPRINT FOR SUCCESSJoint efforts and strong collaboration between public and private entities will bolster the development of the Saudi Arabian biotechnology sector.The Saudi Genome Program represents a significant stride in this direction,specifically in the fight aga

76、inst genetic disorders.The program was developed through partnerships with international organizations to establish an extensive genetic repository.To date,63,000 genetic samples have been gathered,and 7,500 pathogen variants have been detected.This is a result of cross collaboration between institu

77、tes,including KACST,KAIMRC,KFSHD,and MOH.28 However,a stronger coordinated push is critical to ensure rapid innovation and commercialization in The Kingdom.1 1For development of KSAs biotechnology sector to gather pace,there needs to be a focus on three segments of the value chain(sampling,analysis,

78、and applications)and four thematic growth areas(creating a population-level genomic data repository,the widespread adoption of genomics as a screening/diagnostic tool,omics/precision medicine,and AI/ML-enhanced genomics).THE VALUE CHAIN:CONCENTRATE ON 3 SEGMENTS The genomics value chain comprises fi

79、ve steps,each of which requires different capabilities(see Figure 2).29 To enhance Saudi Arabias competitiveness in the biotechnology market,it is vital to identify which of these steps best align with the countrys core capabilities.As highlighted in the figure,KSA should increase its focus particul

80、arly across three segments in the value chain:sampling,analysis,and application due to the following reasons:29“Genomics Value Chain.”Thailand Center of Excellence for Life Sciences(TCELS),accessed March 2024.1.Sampling.Saudi Arabia can easily develop local capabilities in this area,given that there

81、 is a low dependence on highly trained clinicians or existing transportation infrastructure.While this component has a relatively low financial value compared to other steps,developing local capabilities will create a strong foundation for developing presence in more complex processes.2.Sequencing.L

82、arge,high-tech equipment is essential for sequencing work.Developed economies such as the US and UK have already built a strong presence in this area based on their high-tech manufacturing capability,tapping into the high potential for revenues.Establishing competitive equipment manufacturing facili

83、ties within KSA would be CAPEX-intensive and technically challenging given a lack of local knowledge and skilled labor.Consequently,Saudi Arabia should focus on importing sequencing machines at this stage.3.ACCELER ATING PROGRESS WITHIN SAUDI AR ABIAFigure 2.Genomic value chain:potential focus areas

84、 for KSASource:Arthur D.Little,Thailand Center of Excellence for Life Sciences(TCELS)Source:Arthur D.Little,Thailand Center of Excellence for Life Sciences(TCELS)Figure 2.Genomic value chain:potential focus areas for KSAKey players involved in value chainPotential focus area for KSAANALYSISSAMPLINGS

85、EQUENCINGINTERPRETATIONAPPLICATIONSample collectorsStorage&shipment/logistics management companiesDiagnostics labsSequencing equipment manufacturersDiagnostics/research labsData analytics&management firmsGovernment&research institutesDiagnostic labs CliniciansData analytics&management firmsPharma co

86、mpaniesResearch institutionsProviders Pharma&biotech companiesResearch institutions Collection&packaging of DNA samples,shipping&storageDetermining sequence of genome(e.g.,NGS);target sequencing,whole genome&whole exomeBioinformatics:processing&analyzing genomic data using software solutionsTranslat

87、ing(i.e.,clinical interpretation of observed variations into insights)Applying genomics data for diagnosis&treatment(companion diagnostics&drug discovery)-ExtractionConsumablesInstrumentsData cleansingVariant callingData serviceReportingLink with EHRsTailoring resultsDrug developmentClinical service

88、sDiagnosticsSub-components1 2REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLEIT IS VITAL TO IDENTIFY WHICH STEPS BEST ALIGN WITH THE COUNTRYS CORE CAPABILITIES3.Analysis.Bioinformatics plays a crucial role in processing and analyzing genomic data.Developing software capabilitie

89、s is a prerequisite for growth in this space;for example,comparison with various phenotypes can reveal meaningful data about diseases and biomarkers.In terms of financial value,this is a lucrative segment where important value can be derived by creating a population database.Marking this as an area

90、of focus,institutes such as KAUST and KACST are already creating academic and industry partnerships to develop AI and data analytics capabilities in KSA.4.Interpretation.Genetic data interpretation involves identifying clinically relevant genetic variations and their implications for an individuals

91、health.This segment is expected to significantly increase in size as human genome projects are completed,becoming a central area of research for many countries.However,to enter this area,KSA would need to develop processes and train skilled clinicians who can translate genomic data to predict and di

92、agnose genetic disorders.5.Applications.Genomic applications across diagnostics,drug development,and precision medicine are relevant for pharmaceutical companies,healthcare systems,and clinicians.This component of the value chain is at a relatively early stage and thus presents opportunities for KSA

93、.The Kingdom should continue to focus on developing the diagnostic services component(i.e.,genomics testing services)and maximize value generation from it.FOCUS ON 4 THEMATIC AREAS TO DRIVE GROWTHThe biotechnology sector has seen crucial advances that are shaping the genetic research and healthcare

94、landscape,including:-The increasing utilization of high-throughput sequencing technologies,which are enabling the rapid and cost-effective analysis of entire genomes.This has accelerated our understanding of genetic variation and its implications in health and disease.-The integration of genomics in

95、to precision medicine,with customized treatments and therapies being developed based on an individuals genetic profile.-The field of epigenomics has grown,shedding light on how environmental factors can influence gene expression and impact health.-The emergence of large-scale biobanks and collaborat

96、ive initiatives worldwide is facilitating the sharing of genetic data,promoting international collaboration,and enhancing our ability to tackle global health challenges.-Furthermore,AI/ML are also playing a pivotal role in genomics,aiding in data analysis and the identification of novel genetic asso

97、ciations.These trends present crucial opportunities that KSA can tap into to develop prevention,monitoring,and treatment technologies that reduce mortality and improve the entire populations quality of life.Foundations are being established through investment and regulatory framework setup,and now i

98、t is imperative to embark on specific actions aimed at fostering the next stage of growth.Globally,countries are selecting biotechnology and genomics sector priorities based on their populations healthcare burden and trends,existing capabilities,infrastructure,and the most promising emerging areas.K

99、SA must recognize the fast-evolving landscape and focus on four specific themes going forward to maximize value generation.These include:1 31.A population-level genomic data repository.Almost all major economies,including KSA,have been working toward creating a population-level genomic database.This

100、 is the first step toward developing precision medicine and is important for understanding how diseases develop so better ways of prevention and management can be devised.2.Widespread adoption of genomics as a regular tool for screening and diagnostics.It is important to develop a nation-wide underl

101、ying infrastructure and service network that facilitates adoption of genomics as a standard clinical diagnostic tool.Currently,due to sociocultural norms,the incidence of birth defects is relatively high.30 Consequently,genetic risk profiling,genetic screening,and newborn genetic testing could be in

102、corporated as a standard clinical guideline for certain cases.Over time,new clinical indications for genomic testing should be introduced in a phased manner based on the countrys requirements.313.Omics and precision medicine.Considering the keingdoms disease burden,it is imperative to focus on this

103、segment,and gather and analyze data to support with diagnosis and management of diseases.The burden of non-communicable diseases(NCDs)such as cardiovascular diseases and diabetes on KSAs economy is substantial.NCDs accounted for 73%of all deaths in KSA in 2018,higher than the global average of 71%.3

104、2 Approximately 10%of the population is at risk of developing cancer before the age of 75,a figure that is expected to rise going forward.33 By using biomarkers,omics could support individuals in preventing or effectively treating diseases,thus reducing costs to the healthcare system as well as incr

105、easing benefits to patients.In some countries,selected data from omics is being used in certain types of cancer treatments to screen for drug responsiveness and likelihood of adverse effects.30 Majeed-Saidan,Muhammad Ali.“Effect of Consanguinity on Birth Defects in Saudi Women:Results from a Nested

106、Case-Control Study.”Birth Defects Research Part A:Clinical and Molecular Teratology,Vol.103,No.2,February 2015.31“Accelerating Genomic Medicine in the NHS:A Strategy for Embedding Genomics in the NHS Over the Next 5 Years.”National Health Service(NHS)England,2022.32 Alqunaibet,Ada,et al.“Noncommunic

107、able Diseases in Saudi Arabia Toward Effective Interventions for Prevention.”International Bank for Reconstruction and Development/World Bank Group,2021.33“Global Cancer Observatory.”World Health Organization(WHO),accessed March 2024.34“Genomics and Biotechnology R&D in Singapore.”Government of the

108、Netherlands Ministry of Foreign Affairs,January 2022.CREATING A STRONG FOUNDATION FOR GENOMIC RESEARCH AND ANALYSIS IS A PREREQUISITE FOR SUCCESSFUL INNOVATION4.AI/ML in genomics.Advanced software and technologies are vital for rapidly and efficiently deriving insights from genetic material.Countrie

109、s across the globe are utilizing AI and ML for various use cases such as mapping rare mutations or drafting treatment regimes.34Overall,KSA will have to define and initiate focused efforts to develop technologies and platforms for a range of genomics applications.Creating a strong foundation for gen

110、omic research and analysis is a prerequisite for successful innovation in the sector.This can be achieved by the development of biobanks and genome databases for the Saudi population while encouraging the use of AI/ML to enable exhaustive research into genotypes and gene variations.It is also import

111、ant to increase research focus on precision medicine so that tailored solutions based on the countrys population characteristics and disease burden can be created and delivered.1 4REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLE15Saudi Arabia has embarked on multiple initiative

112、s aimed at fostering investment in R&D and introducing legislation to support innovation.Nonetheless,development of KSA biotechnology and genomics industry is currently at an early stage,requiring a focus on six key success factors to encourage progress.CREATE TALENT POOL The availability of a skill

113、ed and diverse talent pool to meet current and future needs across different research areas is arguably the most important success factor for innovation.This makes it imperative for Saudi Arabia to embrace a collaborative approach that bridges the gap between academia and industry to formulate progr

114、ams aimed at nurturing clinicians,engineers,scientists,and entrepreneurs.This can be accomplished through the development of internships,apprenticeships,and joint research projects.KSA should work toward building synergies between the talent pipelines of leading institutions such that it serves the

115、current and future needs of the country.The US,one of the worlds foremost leaders in biotech innovations,employs a multifaceted approach to address this challenge.In addition to establishing innovation hubs anchored around major academic institutes,cooperative agreements such as the one between NIH

116、and the Center for Disease Control and Prevention(CDC)to train public health workers in genetics and genomics to strengthen their Human Genome Program serve as exemplary strategies for building a robust talent pipeline.ENSURE COLLABORATION BETWEEN PUBLIC&PRIVATE SECTOR Saudi Arabia has directed subs

117、tantial investments toward the development of fundamental infrastructure,including laboratories and facilities,which serves as the cornerstone for scientific research.To ensure continued growth,it is imperative to allocate resources to cutting-edge research facilities that cultivate disruptive techn

118、ologies in intersecting and interdisciplinary fields like AI and data analytics,which play a pivotal role in genomics and bioinformatics.Identifying opportunities for public-private collaboration in these areas is essential to successful patient-centric innovation in KSA.Similarly,the establishment

119、of biotech parks and innovation campuses,designed to promote the collaborative use of workspaces and research facilities,is of paramount importance for fostering interdisciplinary innovation.A notable example of such a hub is the partnership between Karolinska Institutet and AstraZeneca(see“Case stu

120、dy:Sweden”).Other examples are Biohub and Stevenage Bioscience Catalyst in the UK and BioLabs,Johnson&Johnson Innovations JLABS,and the Mission Bay Innovation District in the US,all of which are home to renowned research institutions,biotech enterprises,and start-ups,thereby serving as hotbeds of bi

121、otech innovation.4.KE Y SUCCESS FAC TORS TO DE VELOP SEC TOR IN SAUDI AR ABIA1 6REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLEDELIVER SUPPORTIVE PRO-BUSINESS ENVIRONMENT®ULATIONS While the launch of the RDIA is a positive step toward creating legislation covering research,

122、development,and innovation,it is imperative to establish a regulatory framework that actively nurtures innovation.Critical components of this regulatory environment include safeguarding IP rights,facilitating market access through international trade agreements,and simplifying bureaucratic procedure

123、s to foster a culture of risk-taking.Singapores biotech research ecosystem is a good example of this(see“Case study:Singapore”).Led by the countrys Ministry of Health and a council for research,the state is known for its pro-business environment.Using regulation and supportive government infrastruct

124、ure,as well as centralized government coordination,has made Singapore a regional powerhouse in medical research.To compete,KSA must design and implement appropriate governance arrangements in addition to devising strong underpinning regulations and infrastructure to support and direct efforts toward

125、 the countrys chosen biotechnology priorities.CREATE INNOVATION ENVIRONMENTS&ECOSYSTEMSAs part of its Catapult Network initiative,the UK has set up specific cell and gene therapyfocused research centers,which bring together diverse public and private sector partners to create rapid solutions for key

126、 challenges(see“Case study:UK”).KSA can set up a similar network for hereditary disorders,where diverse companies,clinicians,and patients can come together to solve key challenges.Case study:SingaporeSingapore has worked for decades to establish its healthcare and medical research ecosystem.The rese

127、arch ecosystem is led by its Ministry of Health,which oversees delivery of services,and a separate council for research-driven innovation(National Medical Research Council).The countrys leading public sector R&D agency A*STAR(Agency for Science,Technology and Research)focuses on bridging the gap bet

128、ween academia and industry through collaboration and open innovation.The country set up its first R&D hub in biomedical sciences(Biopolis)in the early 2000s;as a result,many major pharmaceutical MNCs now have research or manufacturing centers in the country.Singapore offers a range of incentives,inc

129、luding tax benefits,grants,and simplified administrative processes to promote R&D and innovation.It has also established a strong IP protection framework,making it an attractive destination for tech start-ups.Case study:SwedenKarolinska Institutet/AstraZeneca Integrated Cardio Metabolic Centre(KI/AZ

130、 ICMC),a joint center for research on cardiovascular and metabolic diseases,was formed in 2013 by Karolinska Institutet and AstraZeneca,with the aim of identifying and validating novel targets within cardio-metabolic diseases.The centers focus is mainly on cardiac regeneration,islet health(diabetes)

131、,and diabetic nephropathy across modalities using small molecules and biologics.It is staffed with around 30 research scientists from both entities,led by a single director,and funded through a contribution from AstraZeneca of$100 million during the initial five-year contract period.This collaborati

132、on has founded capabilities around translational medicine that enables seamless transition of private sector developments into patient-centric care in a real-world environment.1 7FOCUS ON CLEAR TARGET PICTURE FOR ALL RESEARCHDelivering biotechnology success requires a clear target picture and the ri

133、ght operating model to centrally coordinate and promote the right research network with academia.This will streamline innovation from research to business.Technology-transfer offices play a pivotal role in the biotech industry by emphasizing the commercialization of research outcomes.They incentiviz

134、e research and maximize research impact by providing access to markets and industry and protecting the rights of innovators.35 Over 175 ATMP clinical trials were reported as ongoing in the UK in 2023;see:Cameron,Isabel.“UK Maintains Status as an Attractive Destination for Advanced Therapy Clinical T

135、rials.”BioPharmaReporter,18 January 2024.The UKs CGT Catapult(see“Case study:UK”)remains focused on commercialization by focusing both on supporting clinical trials35 and commercial manufacturing,by ensuring that the country has the necessary infrastructure,skills,and capacity.CGT Catapults manufact

136、uring facility aims to accelerate large-scale manufacturing of ATMPs.Emerging economies such as Lithuania are also investing in the health and biotech arena with a clear focus on driving commercialization.An early integration of commercial functions to prepare for launch can accelerate technology tr

137、ansfer,thereby reducing time to market.Case study:UKThe UK has set up the Catapult Network,a focused network of research centers.The Catapult Network is the evolution of the technology and innovation center initiative.A Catapult is a physical business center where businesses work alongside around 50

138、-300 Catapult-employed scientists,engineers,and commercialization support staff.Catapults aim to occupy a gap in translational research by providing the following:-Open access facilities state-of the-art kit and business accommodation-Technical experts skilled technical resource and domain experts-B

139、usiness know-how commercialization,routes to funding,networking,and IPKey features include:-Tailorization to address a particular market failure-Critical mass in one location potentially with satellites-Collaboration among organizations from different domainsCatapult example:The Cell and Gene Therap

140、y(CGT)Catapult focuses on supporting acceleration of cell and gene therapy to market throughout development,manufacturing,and clinical adoption by fostering collaborations between industry,government,research organizations,academia,and others.Nearly 170 companies have collaborated with CGT Catapult

141、on advanced therapy medicinal products(ATMP)innovation,contributing to the UK emerging as a global leader in the development of advanced therapies.CATAPULTS AIM TO OCCUPY A GAP IN TRANSLATIONAL RESEARCH1 8REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLEPROVIDE START-UPS ACCESS

142、TO PRIVATE&PUBLIC FUNDING Adequate sources of funding,including venture capital,angel investors,and public grants,are crucial for start-ups and innovative projects to thrive.Given the complex nature of the R&D and regulatory hurdles for commercialization of any biotechnology product,initial CAPEX an

143、d time requirements are significantly higher than other fields.This means that early-stage biotechnology companies almost always require large amounts of capital and resources to fund and fuel their R&D programs,which take years before they reach the market.INITIAL CAPEX AND TIME REQUIREMENTS ARE SI

144、GNIFICANTLY HIGHER THAN FOR OTHER FIELDSMost developed economies have public bodies such as the UKRI(UK Research&Innovation),Innovate UK,and the Biotechnology Innovation Organization(BIO).These catalyze and direct research and innovation funding to start-ups.Similar bodies should be created within K

145、SA.1 9MOVING FORWARD WITH BIOTECHNOLOGY IN KSAGiven the opportunities and potential benefits it provides,countries across the world are focusing on fostering innovation and setting national targets for the biotechnology and genomics sector.While the sector is at an early stage in KSA,the country und

146、erstands the large untapped potential that exists and is ramping up its efforts.While various entities such as KAIMRC,Hevolution Foundation,and Lifera are focusing extensively on the sector and forging partnerships to drive growth,a strong and coordinated push is necessary to achieve KSAs biotechnol

147、ogy potential.Learnings from proven and successful strategies across the globe must be rapidly adapted in KSA to achieve its objective of becoming a regional leader in the genomics and genetics space,benefiting its people,economy,and overall reputation.COUNTRIES ACROSS THE WORLD ARE FOCUSING ON FOST

148、ERING INNOVATION AND SETTING NATIONAL TARGETS FOR THE BIOTECHNOLOGY AND GENOMICS SECTOR CONCLUSION2 0REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIAARTHUR D.LITTLENOTES2 1REPORT:ADVANCING BIOTECHNOLOGY&GENOMICS IN SAUDI ARABIA2 2ARTHUR D.LITTLE2 3Arthur D.Little has been at the forefront of

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